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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - vs. Placebo; BRIEF: A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase. ; DRUG USED: MN-166; DRUG CLASS: New Molecular Entity (NME); INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Macrophage Migration Inhibitory Factor (MIF), Phosphodiesterase 10 (PDE10) , Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: MediciNova; CRITERIA: Major Inclusion Criteria: - Male or female subjects age 18 - 80 years, inclusive; - Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [clinically definite, clinically probable, probable-laboratory-supported]; - ALS onset of ≤18 months from first clinical signs of weakness prior to screening; - If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiation of study drug; - If currently using edaravone, subject should have completed at least 14 days of their initial treatment cycle prior to initiation of study drug; - Last documented pulmonary function test result (i.e., slow vital capacity or forced vital capacity) must be greater than or equal to 70% predicted; - Able to swallow study medication capsules; - No known allergies to the study drug or its excipients; - Received pneumococcal vaccine within 6 years prior to starting clinical trial. Major Exclusion Criteria: - Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT >3 times upper limit of normal); - Currently diagnosed with a clinically significant psychiatric disorder or dementia that would preclude evaluation of symptoms; - Currently use or treated with parenteral (intramuscular or intravenous) high dose (>25 mg/week) Vitamin B12 within 30 days prior to study drug administration; - Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator; - Currently participating, or has participated in a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent; - Use of tracheostomy or >22/24-hour ventilatory support. ; PRIMARY OUTCOME: Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time.; SECONDARY OUTCOME 1: Mean change from baseline of muscle strength measured by hand-held dynamometry[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ASPIRE - 009; BRIEF: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting. ; DRUG USED: Kyprolis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: 1. Symptomatic multiple myeloma 2. Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization): - Serum M-protein ≥ 0.5 g/dL - Urine Bence-Jones protein ≥ 200 mg/24 hours - For immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL) 3. Prior treatment with at least one, but no more than three, regimens for multiple myeloma 4. Documented relapse or progressive disease on or after any regimen 5. Achieved a response to at least one prior regimen 6. Age ≥ 18 years 7. Life expectancy ≥ 3 months 8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 9. Adequate hepatic function, with serum alanine aminotransferase (ALT) ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 21 days prior to randomization 10. Absolute neutrophil count ≥ 1.0 × 10^9/L within 21 days prior to randomization 11. Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization 12. Platelet count ≥ 50 × 10^9/L (≥ 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization 13. Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization 14. Written informed consent in accordance with federal, local, and institutional guidelines 15. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception 16. Male subjects must agree to practice contraception Exclusion Criteria: 1. If previously treated with bortezomib (alone or in combination), progression during treatment 2. If previously treated with a lenalidomide and dexamethasone (len/dex) combination: - Progression during the first 3 months of initiating treatment - Any progression during treatment if the len/dex combination was the subjects most recent line of therapy 3. Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded 4. Prior carfilzomib treatment 5. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 6. Waldenströms macroglobulinemia or IgM myeloma 7. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential) 8. Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization 9. Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization 10. Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization 11. Pregnant or lactating females 12. Major surgery within 21 days prior to randomization 13. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization 14. Known human immunodeficiency virus infection 15. Active hepatitis B or C infection 16. Myocardial infarction within 4 months prior to randomization, New York Hear Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker 17. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization 18. Other malignancy, including myelodysplastic syndromes (MDS), within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas 19. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization 20. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib) 21. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment 22. Ongoing graft-vs-host disease 23. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization 24. Any other clinically significant medical disease or condition that, in the Investigators opinion, may interfere with protocol adherence or a subjects ability to give informed consent ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RAP-MD-01 (Adjunctive); BRIEF: This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT. ; DRUG USED: Rapastinel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Receptor - Glycine Site; THERAPY: Monotherapy; LEAD SPONSOR: Naurex, Inc, an affiliate of Allergan plc; CRITERIA: Inclusion Criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD - Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1 - Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant - If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test. Exclusion Criteria: - DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1 - Lifetime history of meeting DSM-5 criteria for: 1. Schizophrenia spectrum or other psychotic disorder 2. Bipolar or related disorder 3. Major neurocognitive disorder 4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participants ability to consent, follow study directions, or otherwise safely participate in the study 5. Dissociative disorder 6. Posttraumatic stess disorder 7. MDD with psychotic features - Significant suicide risk, as judged by the Investigator. ; PRIMARY OUTCOME: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial; SECONDARY OUTCOME 1: Change From Baseline in MADRS Total Score[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Lu AA21004_310; BRIEF: The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Generalized Anxiety Disorder (GAD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Has a primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria. - Has a Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline. - Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline. - Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline. Exclusion Criteria: - Has 1 or more of the following: - Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]). - Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. - Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR® and subject must have a negative urine drug screen prior to Baseline. - Presence or history of a clinically significant neurological disorder (including epilepsy). - Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc.). - Any Axis II disorder that might compromise the study. - Is taking excluded medications. - Has a significant risk of suicide according to the investigators opinion or has a score greater than or equal to 5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months. - Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors. - Has received electroconvulsive therapy within 6 months prior to Screening. - Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study. - Has a clinically significant unstable illness. - Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level greater than 1.5 times the upper limit of normal. - Has a serum creatinine of greater than 1.5 times the upper limit of normal. - Has a previous history of cancer that had been in remission for less than 5 years. - Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator. - Has an abnormal electrocardiogram. ; PRIMARY OUTCOME: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8; SECONDARY OUTCOME 1: Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - E1609 (Adjuvant); BRIEF: This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma. ; DRUG USED: Yervoy; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization; imaging studies must include a total body positron emission tomography (PET)-computed tomography (CT) scan (with or without brain) and brain magnetic resonance imaging (MRI) or CT (if MRI is contraindicated); if PET-CT cannot be done, CT of neck, chest, abdomen, and pelvis should be done - If for some reason a CT cannot be done, an MRI may be done instead; any other imaging studies if performed (eg, bone scan) must show no evidence of disease - Patients must have primary cutaneous melanoma that belong to one of the following American Joint Commission on Cancer (AJCC) stages (2009 AJCC Melanoma Staging System): - Stage IIIB - T1-4b N1a M0 - T1-4b N2a M0 - T1-4b N1b M0 - T1-4b N2b M0 - T1-4b N2c M0 - Stage IIIC - T1-4b N1b M0 - T1-4b N2b M0 - T1-4b N2c M0 - Any T N3 M0 - Stage IV - M1a - M1b - NOTE: patients with stage IV melanoma must have normal lactate dehydrogenase (LDH) and either distant skin, subcutaneous, lymph node, or lung metastases, but no other visceral metastases in order to be eligible; for patients with resected stage IV melanoma, LDH within the institutional upper limit of normal (ULN) must be documented within 4 weeks prior to randomization - Patients with disease recurrence after adequate surgical excision of the original primary cutaneous/unknown primary melanoma are allowed even if they dont fit the strict staging criteria, but only as follows: - Recurrence in a regional lymph node basin after a prior complete lymph node dissection; relapsed disease must be completely surgically resected with free margins - Recurrence in the form of in-transit or satellite metastases or distant skin/subcutaneous, nodal, or lung metastases that are completely surgically resected with free margins - Recurrence in a regional lymph node basin; relapsed disease must be completely surgically resected with free margins - Patients with unknown primary melanoma (Tx) who present with cutaneous, subcutaneous, nodal and/or lung metastases that are completely surgically resected with free margins are allowed; these patients are allowed even if they dont fit the strict staging criteria; for stage IV patients LDH within the institutional ULN must be documented within 4 weeks prior to randomization (M1c is not eligible) - NOTE: all subjects should be classified as IIIB, IIIC, M1a or M1b including subjects with disease recurrence after adequate surgical excision of the original primary melanoma; that is the treating team/physician investigator should review an overall TNM status (that includes primary tumor presentation and disease recurrence status) and provide a designation of IIIB, IIIC, M1a or M1b - Patients must be randomized within 84 days (12 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, the patient must be randomized within 12 weeks of the last surgery - NOTE: patients with clinically positive lymph nodes for melanoma involvement or those with positive lymph nodes identified through lymphoscintigraphic and/or dye lymphographic techniques in the groin, axilla, or neck should have additional lymphadenectomy in those sites; the complete lymph node dissection procedure would be considered as the last surgery in counting the 84 days unless a subsequent surgical procedure(s) was clinically required to ensure the disease free status - Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Given that serious adverse events may occur with ipilimumab and IFN-alpha and that these may impact a patients wellbeing, it is possible that the occurrence of other serious adverse events (SAEs) may seriously impact an underlying state of mental depression and lead to suicidal ideation; therefore, patients should be carefully screened for depression at baseline and if there are indications or a history of depression it is strongly recommended that these patients be closely followed together with behavioral health or psychiatric medical support; patients with an established diagnosis of depression that, in the assessment of the investigator may make the administration of IFN-alpha or ipilimumab hazardous, should not be enrolled on this protocol; the risks and benefits of being treated with standard adjuvant IFN-alpha should be weighed very carefully in consultation with behavioral health or psychiatry - Due to the possible effect of treatment with ipilimumab on the immunologic response to infectious disease vaccines, patients must not have had any infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, tetanus toxoid) within 4 weeks prior to randomization - WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI, in such a manner that the risk of pregnancy is minimized; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential - Men of fathering potential and WOCBP must be using an adequate method of contraception to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible - WOCBP are not eligible if they satisfy any of the following: - A positive pregnancy test at baseline - Pregnant or breastfeeding - White blood cell (WBC) >= 3,000/uL (obtained within 4 weeks prior to randomization) - Absolute neutrophil count (ANC) >= 1,500/uL (obtained within 4 weeks prior to randomization) - Platelets >= 100 x 10^3/uL (obtained within 4 weeks prior to randomization) - Hemoglobin >= 10 g/dL (obtained within 4 weeks prior to randomization) - Serum creatinine =< 1.5 mg/dL (obtained within 4 weeks prior to randomization) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (obtained within 4 weeks prior to randomization) - Serum bilirubin =< 1.5 x ULN, (except patients with Gilberts syndrome, who must have a total bilirubin less than 3.0 mg/dL) (obtained within 4 weeks prior to randomization) - No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C due to the unknown effects of ipilimumab; patients must have negative testing for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) within 4 weeks prior to randomization Exclusion Criteria: - Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial - NOTE: previous radiation therapy, including after the surgical resection, is allowed as long as 21 days have elapsed between the radiation and initiation of this adjuvant systemic therapy - Prior treatment with anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) monoclonal antibodies or prior CTLA-4 inhibitor or agonist or prior clusters of differentiation (CD)137 agonist or prior interferon-alfa is not allowed; other forms of prior treatment for melanoma (e.g., aldesleukin [IL-2], anti-tumor vaccine, chemotherapy) are allowed if given before the resection(s) that make(s) the patient eligible for this trial, but these must have been completed at least 4 weeks prior to randomization - Patients must not have an active infection requiring current treatment with parenteral antibiotics - Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients with a baseline of frequent diarrhea (e.g. irritable bowel syndrome) are not eligible because of the difficulty in interpreting later expected GI toxicities that may lead to suboptimal management and complications - Patients must not have a documented history of inflammatory bowel disease (including ulcerative colitis and Crohns disease) or diverticulitis (history of diverticulosis is allowed) - Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study - Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogrens syndrome, autoimmune vasculitis [e.g., Wegeners granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis) - Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible - Patients must not be prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness; this is due to concerns about subject safety and compliance with study procedures - Patients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization; patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ are eligible; patients with prior history of basal or squamous skin cancer are eligible; patients who have had multiple primary melanomas are eligible - Women must not be pregnant or breast-feeding due to the unknown effects of ipilimumab and HDI on conception and the fetus; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy - NOTE: a woman of childbearing potential (WOCBP) is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); post-menopause is defined as: - Amenorrhea >= 12 consecutive months without another cause, or - For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL ; PRIMARY OUTCOME: Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP]); SECONDARY OUTCOME 1: Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ALLELE (EBV-PTLD after SOT); BRIEF: The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab. ; DRUG USED: Tabelecleucel; DRUG CLASS: Biologic; INDICATION: Hematologic Cancer; TARGET: Epstein Barr Virus (EBV), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Atara Biotherapeutics; CRITERIA: Inclusion Criteria: 1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (SOT cohort); or prior allogeneic HCT (HCT cohort) 2. A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD 3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor 4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used.For subjects with treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria. 5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (SOT subgroup A or HCT cohort) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (SOT subgroup B) for treatment of PTLD. 6. Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged ≥ 16 years; Lansky score ≥ 20 for subjects < 16 years 7. For HCT cohort only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the subject underwent transplant must be in morphologic remission 8. Adequate organ function 1. Absolute neutrophil count ≥ 1000/μL, (SOT cohort) or ≥ 500/μL (HCT cohort), with or without cytokine support 2. Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For HCT cohort, platelet count < 50,000/μL but ≥ 20,000/μL, with or without transfusion support, is permissible if the subject has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institutes Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) 3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each < 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and/or PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction 9. Subject or subjects representative is willing and able to provide written informed consent Exclusion Criteria: 1. Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma 2. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis 3. Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE:Subjects with previously treated CNS PTLD may enroll if CNS-directed therapy is complete. 4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment 5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment 6. For HCT cohort: active adenovirus viremia 7. Need for vasopressor or ventilatory support 8. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment 9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts), or unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only) 10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception 11. Inability to comply with study-related procedures ; PRIMARY OUTCOME: Objective response rate (ORR) in the SOT or HCT cohort; SECONDARY OUTCOME 1: Duration of response (DOR) in SOT and HCT cohorts separately[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VIOLET (CL-012); BRIEF: Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral antifungal medicines. This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patients current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period. In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161). This study is identical to VMT-VT-1161-CL-011. ; DRUG USED: Oteseconazole; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fungal Infections - Non-Systemic; TARGET: Cytochrome p450; THERAPY: Monotherapy; LEAD SPONSOR: Mycovia Pharmaceuticals Inc.; CRITERIA: Key Inclusion Criteria: - 3 or more episodes of acute VVC in the past 12 months - Positive KOH or Gram stain test - Total vulvovaginal signs and symptoms score of ≥3 at screening visit - Total vulvovaginal signs and symptoms score of <3 at baseline visit - Must be able to swallow pills Key Exclusion Criteria: - Presence or a history of another vaginal or vulvar condition(s) - Evidence of major organ system disease - History of cervical cancer - Poorly controlled diabetes mellitus - Pregnant - Recent use of topical or systemic antifungal or antibacterial drugs - Recent use of immunosuppressive or systemic corticosteroid therapies ; PRIMARY OUTCOME: Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population.; SECONDARY OUTCOME 1: [/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 1033 (Confirmatory); BRIEF: The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction. ; DRUG USED: Amitiza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Opioid Induced Constipation (OIC); TARGET: Chloride Channel 2 (CIC-2/CLCN-2); THERAPY: Monotherapy; LEAD SPONSOR: Sucampo Pharma Americas, LLC; CRITERIA: Inclusion Criteria: A patient can be considered for eligibility to participate if he/she: - Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening - Is diagnosed with OBD - Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs) - Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study Exclusion Criteria: A patient cannot be considered for eligibility to participate if he/she: - Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction ; PRIMARY OUTCOME: Number of Participants Classified as Treatment Responders Within 12 Weeks; SECONDARY OUTCOME 1: Number of SBMs Per Week at Week 8[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HALO-301; BRIEF: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). ; DRUG USED: PEGPH20; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Hyaluronic acid; THERAPY: Combination; LEAD SPONSOR: Halozyme Therapeutics; CRITERIA: Inclusion criteria: Participants must satisfy all the following inclusion criteria to be enrolled in the study: 1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF). 2. Stage IV PDA with histological or cytological confirmation of PDA. 3. Participants must be determined to be HA-high based on archived or fresh tumor core biopsy or sample obtained after the participant has documented metastatic disease. Biopsies/samples must meet the following requirements: 1. Pancreas tumor biopsies/samples obtained on or after the date that metastatic disease is documented or tumor biopsies/samples from a metastatic lesion are acceptable. 2. Tumor biopsies or samples must meet the requirements provided in the Study Laboratory Manual with regard to tumor tissue architecture. Note: cytology samples from fine needle aspirates without maintained tissue architecture or brushing biopsies are not acceptable. 3. Tumor tissue (formalin-fixed paraffin-embedded [FFPE] block preferred) must include enough tumor to make a minimum of 5-10 unstained, consecutive FFPE slides (10 slides are preferred) of 1 archival block that meet specific tissue sample requirements. 4. Radiographic confirmation of Stage IV PDA with at least 1 tumor metastasis measurable on computed tomography (CT) scan or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion. 5. If a participant has had adjuvant/neoadjuvant therapy and/or therapy for locally advanced disease (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of the aforementioned therapies, provided all toxicities have returned to baseline or less than or equal to (≤) Grade 1. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7. Life expectancy greater than or equal to (≥) 3 months. 8. Age ≥18 years. 9. A negative urine or serum pregnancy test within 7 days before Cycle 1, Day 1 (C1D1; first dose of study medication) if female participant is of childbearing potential. 10. Screening clinical laboratory values as follows: 1. Total bilirubin ≤1.5 times upper limit of normal (ULN) (participants with Gilbert syndrome are eligible independent of bilirubin levels). 2. Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase) ≤2.5 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed). 3. Serum creatinine ≤2.0 milligrams/deciliter (mg/dL) or calculated creatinine clearance ≥40 milliliters/minute (mL/min). 4. Serum albumin ≥2.5 grams/deciliter (g/dL). 5. Prothrombin time or international normalized ratio (INR) within normal limits (±15%), unless participant takes warfarin, in which case prothrombin time or INR result must be within therapeutic range. 6. Partial thromboplastin time (PTT) within normal limits (±15%). 7. Hemoglobin ≥9 g/dL (transfusion and erythropoietic agents allowed). 8. Absolute neutrophil count ≥1,500 cells/cubic millimeter (cells/mm^3). 9. Platelet count ≥100,000/mm^3. 11. For women of childbearing potential (WOCBP) and for men, agreement to use a highly effective contraceptive method from the time of screening throughout the study until 1 month (WOCBP) or 6 months (men) after administration of the last dose of any study medication. Highly effective contraceptive methods consist of prior sterilization, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), oral or injectable contraceptives, barrier methods, and/or true sexual abstinence. Exclusion criteria: Participants are ineligible for enrollment if they meet any of the following exclusion criteria: 1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period. 1. Participants with superficial vein thrombosis are eligible. 2. Participants with visceral/splanchnic vein thrombosis are still eligible if, in the opinion of the Investigator, the visceral/splanchnic vein thrombosis is primarily associated with the anatomic location of the underlying disease of metastatic pancreatic cancer (there must be primary or metastatic disease in reasonable proximity to the thrombosis, and the Investigator determines that the thrombosis is due to a local tumor event and not a coagulation issue). 2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed. 3. Known central nervous system involvement or brain metastases. 4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months. 5. History of cerebrovascular accident or transient ischemic attack. 6. Clinically significant pre-existing carotid artery disease. 7. Known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C within the past 12 months. 8. Known allergy to hyaluronidase. 9. Current use of megestrol acetate or megestrol acetate-containing drugs (use within 10 days of Day 1). 10. Contraindication to heparin as per institutional guidelines. 11. Women currently pregnant or breastfeeding. 12. Intolerance to dexamethasone. 13. History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ. 14. Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect the interpretation of the results, or that may render the participant at high risk for treatment complications. 15. Immunization with a live vaccine up to 2 weeks prior to Day 1. 16. Hypersensitivity to the active substance or ingredients of PEGPH20, gemcitabine, and nab-paclitaxel. 17. Inability to comply with study and follow-up procedures as judged by the Investigator. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Progression-Free Survival (PFS)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LemKids; BRIEF: Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT. Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL). ; DRUG USED: Lemtrada; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 52 (CD52); THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion criteria : - Participants with RRMS aged from 10 years to <18 years at study entry are eligible. Participants must meet the criteria of diagnosis of MS as defined by the International Pediatric MS Study Group (IPMSSG) criteria for pediatric MS and the criteria of MS based on 2010 McDonald criteria. - Signed written informed consent/assent obtained from participant and participants legal representative (parent or guardian) according to local regulations. - Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening. - At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last year during treatment with a beta interferon therapy (IFNB) or glatiramer acetate (GA) after being on that therapy for at least 6 months, and was currently still taking the same therapy. - At least 1 of the following: - >=1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion while on that same prior therapy (IFNB or GA), or - Two or more relapses in the prior year, or - Tried at least 2 MS DMTs. Exclusion criteria: - Any progressive or non-relapsing forms of MS. - Conditions/situations such as: - Impossibility to meet specific protocol requirements. - Current participation in another interventional clinical study. Participants who are treated with a comparator agent approved for screening inclusion (INF or GA) may be considered for this trial. - Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. - Uncooperative participant or any condition that could make the participant potentially non-compliant to the study procedures in the opinion of the Investigator. - Mental condition rendering the participant or parent/guardian unable to understand the nature, scope, and possible consequences of the study. - Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator. - History of drug or alcohol abuse. - History of known human immunodeficiency virus (HIV) positivity. - Pregnant or breast-feeding female participants or those who had planned to become pregnant during the study. - Unwilling to agree to use a highly effective contraceptive method when receiving a course of alemtuzumab treatment and for 4 months following that course of treatment (fertile participants only). - Female participants who have commenced menstruating (i.e., are of childbearing potential) and are unwilling or unable to be tested for pregnancy. - Previous treatment with alemtuzumab. - Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months prior to screening, or determined by the treating physician to had residual immune suppression from these or other MS treatments. - Treatment with teriflunomide in the last 12 months except if the participant underwent the recommended elimination procedure as per Summary of Product Characteristics (SmPC). - Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, ocrelizumab, leflunomide, or any cytotoxic therapy. - Previous treatment with any investigational medication (drug that had not been approved at any dose or for any indication). Use of an investigational medication that is subsequently licensed and nonstandard use of a licensed medication (e.g., using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) was not exclusionary. Prior treatment with herbal medications or nutritional supplements was also permitted. - Intolerance of pulsed corticosteroids, especially a history of steroid psychosis. - History of malignancy. - Prior documented history of thrombocytopenia, or platelet count at screening < lower limits of normal (LLN). - Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS. - Participants with known Type 1 hypersensitivity or anaphylactic reactions to the active substances or any of the excipients, or intolerance of acyclovir or its therapeutic equivalent. - Major systemic disease or other illness that would, in the opinion of the Investigator, compromise participant safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease, or other conditions that might predispose to hemorrhage, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis. - Medical, psychiatric, cognitive, or other conditions that, in the Investigators opinion, compromise the participants ability to understand the participant information, to give informed consent, to comply with the trial protocol, or to complete the study. - Major psychiatric disorder that is not adequately controlled by treatment in the opinion of the Investigator. - Epileptic seizures that are not adequately controlled by treatment. - Magnetic resonance imaging (MRI)-related conditions: conditions that could interfere with MRI acquisition and/or interpretation of MRI results (eg, claustrophobia, orthopedic implants/treatments, orthodontic treatments etc). - Known bleeding disorder (e.g., dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrands disease, disseminated intravascular coagulation, fibrinogen deficiency, clotting factor deficiency). - Prior history of invasive fungal infections. - Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation. - In the Investigators opinion, participant is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection). The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan; SECONDARY OUTCOME 1: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - PROTECT-VIII; BRIEF: Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability. The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day. In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A. 120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary. Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study. ; DRUG USED: Jivi; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male; 12-65 years of age - Subjects with severe hemophilia A - Previously treated with factor VIII for a minimum of 150 exposure days Exclusion Criteria: - Inhibitors to FVIII (current evidence or history) - Any other inherited or acquired bleeding disorder in addition to Hemophilia A - Platelet count < 100,000/mm3 - Creatinine > 2x upper limit of normal or AST/ALT (aspartate aminotransferase/alanine aminotransferase) > 5x upper limit of normal ; PRIMARY OUTCOME: Annualized Number of Total Bleeds in On-demand Treatment Arm (Weeks 0 -36) and in Each Prophylaxis Arm (Weeks 10 - 36, Excluding Rescue Bleeds) - Part A, Main Trial; SECONDARY OUTCOME 1: Annualized Number of Joint Bleeds, Trauma, Spontaneous Bleeds in On-demand Treatment Arm (Weeks 0 -36) and in Each Prophylaxis Arm (Weeks 10 - 36, Excluding Rescue Bleeds) - Part A[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - STRATUS; BRIEF: The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers. ; DRUG USED: Pomalyst; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent. - Patients must have documented diagnosis of Multiple Myeloma and have measurable disease. - Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy. - Patients must have either refractory or relapsed and refractory disease. - Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens. - Patients must have received adequate alkylator therapy Exclusion Criteria: - Prior history of malignancies, other than Multiple Myeloma. - Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone. - Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant. - Patients who are planning for or who are eligible for stem cell transplant. - Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment. - Patients with a current disease that can interfere with protocol procedures or study treatment. - Patients unable or unwilling to undergo antithrombotic prophylactic treatment. - Pregnant or breastfeeding females. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: Overall Response[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Tenofovir Disoproxil Fumarate (Antigen-Positive); BRIEF: The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection. ; DRUG USED: Vemlidy; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: DNA polymerase, Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. - Adult males and non-pregnant, non-lactating females. - Documented evidence of chronic HBV infection. - HBeAg-positive, chronic hepatitis B with all of the following: - HBeAg-positive at screening. - Screening HBV DNA ≥ 2 x 10^4 IU/mL - Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN). - Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue) OR treatment-experienced participants (defined as participants meeting all entry criteria [including HBV DNA and serum ALT criteria] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue). - Previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit. - Adequate renal function. - Normal electrocardiogram (ECG). Key Exclusion Criteria: - Females who are breastfeeding. - Males and females of reproductive potential who are unwilling to use an effective, protocol specified method(s) of contraception during the study. - Co-infection with hepatitis C virus, human immunodeficiency virus (HIV), or hepatitis D virus. - Evidence of hepatocellular carcinoma . - Any history of, or current evidence of, clinical hepatic decompensation. - Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN. - Received solid organ or bone marrow transplant. - History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible. - Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion. - Individuals receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients. - Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance. - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements. Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48; SECONDARY OUTCOME 1: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CONTINUATION-PV; BRIEF: Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic increase of red blood cells and frequently also of white blood cells. The thickening of the blood in relation with a modified function of the cells has several consequences like increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the brain as well as fingers and toes and an increased risk of arterial and venous thrombosis (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction, deep vein thrombosis in the legs. In case of a strong increase of platelets there is an additional risk of bleedings. As the disease progresses the size of spleen and liver increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a progression at a later time point to a leukemia (increased formation of white blood cells) can occur. The aim of this study is to show that the study drug AOP2014 (pegylated proline interferon alpha-2b) has the long term efficacy and safety in controlling the disease. A comparison arm is receiving best available therapy as selected by the investigator. Response to the treatment is measured by several blood parameters as well as size of the spleen. Interferon-alpha has been shown to be effective in controlling the blood parameters by immunologically influencing the blood building cells. This can lead to a suppression of the disease-causing stem cells and help healthy stem cells to proliferate. Through this mechanism it is possible that Interferon-alpha can avoid long-term damaging effects of the disease. ; DRUG USED: Ropeginterferon alfa-2b; DRUG CLASS: Biologic; INDICATION: Polycythemia Vera (PV); TARGET: Interferon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AOP Orphan Pharmaceuticals AG; CRITERIA: Inclusion Criteria: 1. Patients who completed the 12 months AOP2014 treatment arm of the PROUD-PV study and at the end-of-treatment visit (EoT) of the PROUD-PV study who fulfill at least one of the following criteria: - normalization of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were moderately increased (Hct<50%, WBC<20 x 109/L, PLTs<600 x 109/L) at baseline of the PROUD-PV study, OR - >35% decrease of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were massively increased (Hct>50%, WBCs>20 x 109/L, PLTs>600 x 109/L), at baseline of the PROUD-PV study, OR - normalization of spleen size, if spleen was enlarged at baseline of the PROUD-PV study, OR - otherwise a clear, medically verified benefit from treatment with AOP2014 (e.g. normalization of disease-related micro-vasculatory symptoms, substantial decrease of JAK2 allelic burden). 2. Signed written ICF. Exclusion criteria: Withdrawal criteria, as specified in the PROUD-PV study, which mandate treatment discontinuation: 1. Non-recovery from the AOP2014 related toxicities to the grade (usually, Grade I) which allows continuation of the treatment. 2. HADS score of 11 or higher on either or both of the subscales, and /or development or worsening of the clinically significant depression or suicidal thoughts. 3. Progressive and clinically significant increase of liver enzyme levels despite dose reduction, or if such increase is accompanied by increased bilirubin level, any signs or symptoms of a clinically significant autoimmune disease. 4. Clinically significant development of a new ophthalmologic disorder, or worsening of a pre-existing one, during the study. 5. Loss of efficacy of AOP2014 or any comparable situation where no further benefits of treatment continuation are expected by the investigator. The main efficacy evaluation criterion will be disease response defined as Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L, and normal spleen size. The main efficacy endpoint will be the maintenance rate of disease response at assessment visits (every three months). ; PRIMARY OUTCOME: Disease response at quarterly assessment visits; SECONDARY OUTCOME 1: [/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Extension; BRIEF: The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group. ; DRUG USED: Menveo; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: Subjects enrolled in V59P13: - healthy subjects who have completed the V59P13 study. Naïve subjects: - healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old). Exclusion Criteria: Subjects who had completed the V59P13 study: - who received any meningococcal vaccine after the V59P13 trial; - who have had previous confirmed or suspected disease caused by N. meningitidis; - who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y); - subjects with any serious, acute or chronic progressive disease. Naïve subjects: - who previously received any meningococcal vaccine; - who have had previous confirmed or suspected disease caused by N. meningitidis; - who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y); - subjects with any serious, acute or chronic progressive disease. ; PRIMARY OUTCOME: Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine; SECONDARY OUTCOME 1: Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Treatment Naive Mono; BRIEF: The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise ; DRUG USED: Onglyza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Type 2 diabetes mellitus - Drug naive - Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm) - Fasting C-peptide >= 1 ng/mL - Body mass index <= 40 kg/m2 Exclusion Criteria: - Symptomatic poorly controlled diabetes - Recent cardiac or cerebrovascular event - Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing Potential ; PRIMARY OUTCOME: Hemoglobin A1c (A1C) Changes From Baseline at Week 24; SECONDARY OUTCOME 1: Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ILLUMINATE-B; BRIEF: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1). ; DRUG USED: Oxlumo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperoxaluria; TARGET: Glycolate Oxidase (GO); THERAPY: Monotherapy; LEAD SPONSOR: Alnylam Pharmaceuticals; CRITERIA: Inclusion Criteria: - Has genetic confirmation of primary hyperoxaluria type 1 (PH1) - Meets urinary oxalate excretion requirements - If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days Exclusion Criteria: - If <12 months old at screening, has an abnormally high serum creatinine - If ≥12 months old at screening, has an estimated glomerular filtration rate (GFR) of ≤45 mL/min/1.73m^2 - Clinical evidence of systemic oxalosis - History of kidney or liver transplant ; PRIMARY OUTCOME: Percentage Change in Spot Urinary Oxalate:Creatinine Ratio From Baseline to Month 6; SECONDARY OUTCOME 1: Percentage Change in Urinary Oxalate Excretion From Baseline to End of Study (Month 60)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GAMMA; BRIEF: AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine. ; DRUG USED: Ganitumab; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Combination; LEAD SPONSOR: NantCell, Inc.; CRITERIA: Inclusion Criteria: - Untreated metastatic adenocarcinoma of the pancreas - Adequate hematologic, renal and liver function - Eastern Cooperative Oncology Group (ECOG) 0 or 1 Exclusion Criteria: - Prior chemotherapy or radiotherapy for pancreatic cancer - Central nervous system metastases - External biliary drain ; PRIMARY OUTCOME: To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas; SECONDARY OUTCOME 1: Progression free survival[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Failed Docetaxel-Based Chemotherapy; BRIEF: The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when co-administered with prednisone in Asian patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy. ; DRUG USED: Zytiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Cytochrome P450c17; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate except neuroendocrine carcinoma including small cell carcinoma - Disease progressed on or after prior docetaxel-containing chemotherapy - Prior 1 or 2 cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer, at least 1 of which contains docetaxel - Documented prostate cancer progression as documented by prostate specific antigen progression according to Prostate Specific Antigen Working Group criteria or radiographic progression in soft tissue or bone - Surgically or medically castrated, with serum testosterone level <50 ng/dL (1.7 nmol/L) - Eastern Cooperative Oncology Group performance status score of <=2 - Protocol-defined laboratory values - Agrees to protocol-defined use of effective contraception Exclusion Criteria: - Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated - Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily - Pathological finding consistent with neuroendocrine carcinoma of prostate including small cell carcinoma - Uncontrolled hypertension (systolic BP >=160 mmHg or diastolic BP >=95 mmHg; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy) - Active or symptomatic viral hepatitis or chronic liver disease, have a known infection with human immunodeficiency virus and/or hepatitis B virus or hepatitis C virus - History of pituitary or adrenal dysfunction. - Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of <50% at baseline - Atrial fibrillation, or other cardiac arrhythmia requiring therapy - Other malignancy within past 3 years (except basal or nonmetastatic squamous cell carcinoma of the skin) - Known brain metastasis - Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer - Prior therapy with ketoconazole for prostate cancer - Surgery or local prostatic intervention within 30 days of the first dose - Radiotherapy, chemotherapy, or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1 - Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute-Common Terminology Criteria for Adverse Events grade of <=1 (chemotherapy induced alopecia and grade 2 peripheral neuropathy is allowed) - Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1 - Anti-androgen treatment must not be given within 4 weeks (flutamide) or 6 weeks (bicalutamide or nilutamide) prior to Cycle 1 Day 1 - Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4 weeks prior to Cycle 1 Day 1 - Has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients - Has contraindications to the use of prednisone per local prescribing information - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: DB Phase: Time to Prostate-Specific Antigen Progression (PSA); SECONDARY OUTCOME 1: DB Phase: Overall Survival[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric Glaucoma (vs. Timolol); BRIEF: The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients. ; DRUG USED: Izba; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin F receptor (FP)/PGF2 alpha receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - Diagnosis of pediatric glaucoma or ocular hypertension. - Qualifying mean IOP at the Eligibility Visit in at least one eye. - Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures. - History of chronic, recurrent or severe inflammatory eye disease. - Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit. - Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit. - Clinically significant or progressive retinal disease. - Severe ocular pathology (including severe dry eye) that, in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker. - Intraocular surgery in the study eye within 30 days prior to the Screening Visit. - Any abnormality preventing reliable applanation tonometry. - Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Mean Change From Baseline in IOP at Month 3; SECONDARY OUTCOME 1: [/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - P05692 - 26wk Extension; BRIEF: Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion criteria: - Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment - Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691 Exclusion criteria: - A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subjects continuation into this long-term extension trial - A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691 - A participant must not be at imminent risk of self-harm or harm to others ; PRIMARY OUTCOME: Number of participants experiencing clinical and laboratory adverse events (AEs); SECONDARY OUTCOME 1: [/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Kinect 3; BRIEF: The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms. ; DRUG USED: Ingrezza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tardive Dyskinesia; TARGET: Vesicular monamine transporters (VMATs); THERAPY: Monotherapy; LEAD SPONSOR: Neurocrine Biosciences; CRITERIA: Inclusion Criteria: 1. Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study. 2. Female subjects must not be pregnant. 3. Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder. 4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening. 5. Have moderate or severe TD. 6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses. 7. Be in good general health. 8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol. 9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, phencyclidine, cocaine, opiates, or cannabinoids Exclusion Criteria: 1. Have an active, clinically significant unstable medical condition within 1 month prior to screening. 2. Have a known history of substance dependence, or substance (drug) or alcohol abuse 3. Have a significant risk of suicidal or violent behavior. 4. Have a known history of neuroleptic malignant syndrome. 5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia. 6. Have a cancer diagnosis within 3 years of screening (some exceptions allowed) 7. Have received an investigational drug within 30 days prior to screening or plan to use an investigational drug (other than NBI-98854) during the study. 8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline. 9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine. 10. Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study. 11. Are currently pregnant or breastfeeding. ; PRIMARY OUTCOME: Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6; SECONDARY OUTCOME 1: Clinical Global Impression of Change - TD (CGI-TD) at Week 6[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KEYNOTE-587 (Long-term, Ext.); BRIEF: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready. - Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase. Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587: - Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase. - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Demonstrates adequate organ function. - Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention. - A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity. Additional eligibility criteria for participants who enter dosing with Lenvatinib: - Adequately controlled blood pressure (BP) to <150/90 mmHg, with or without antihypertensive medications. - For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib. - Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse. Exclusion Criteria: -There are no exclusion criteria to participate in MK-3475-587. Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies: - Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients. - Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase. - Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy. - Has known active central nervous system metastases and/or carcinomatous meningitis. - Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible. - Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease. - Has an active infection requiring systemic therapy. - Has a known history of human immunodeficiency virus (HIV) infection. - Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis. - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment. - Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease. - Has hepatic decompensation (Child-Pugh score >6 [class B and C]). - Has uncontrolled thyroid dysfunction. - Has uncontrolled diabetes mellitus. - Has had an allogeneic tissue/solid organ transplant. - Has a known history of active tuberculosis (TB; Bacillus tuberculosis). Additional exclusion criteria for participants who enter dosing with Lenvatinib: - Has had major surgery within 3 weeks prior to first dose of study intervention(s). - Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula. - Has urine protein ≥1 g/24 hours. - Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO). - Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. - Prolongation of QT intervals corrected for heart rate using Fridericias (cube root) correction (QTcF) interval to >480 ms. - Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. - Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib. - Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug. - Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Duration of Response (DOR) Per Evaluation Criteria Used in the Parent Study[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ADVANCE (PSOR-022); BRIEF: This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks. ; DRUG USED: Otezla; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF). 2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF. 3. Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline. 4. Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline. 5. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. 6. Subject must meet laboratory criteria. 7. Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. 2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB. 4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease). 5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening. 6. Subject has prior history of suicide attempt at any time in the subjects life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial. 8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). 9. Subject had prior treatment with apremilast. ; PRIMARY OUTCOME: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase; SECONDARY OUTCOME 1: Percentage of Participants With a ≥ 75 Percent (%) Improvement From Baseline in Affected Body Surface Area (BSA) at Week 16[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ASPECT-NP (vs. Meropenem, VABP); BRIEF: This is a phase 3, multicenter, prospective, randomized study of intravenous (IV) ceftolozane/tazobactam versus IV meropenem in the treatment of adult participants with either ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial pneumonia (HABP). The primary objective is to demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) based on the difference in Day 28 all-cause mortality rates in the Intent-to-treat (ITT) population using a non-inferiority margin of 10%. ; DRUG USED: Zerbaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Key Inclusion Criteria: - Adult participants diagnosed with either VABP or ventilated HABP requiring IV antibiotic therapy; - Intubated and on mechanical ventilation at the time of randomization; - New or progressive infiltrate on chest radiography consistent with pneumonia; - Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial pneumonia. Key Exclusion Criteria: - History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics; - Prior non-study antibiotics for > 24 hours; - Gram stain of lower respiratory tract specimen showing only gram positive bacteria; - Active immunosuppression; - End-stage renal disease or requirement for dialysis; - Expected survival < 72 hours; - Severe confounding respiratory condition (i.e., chest trauma with paradoxical respiration); - Known or suspected community-acquired bacterial pneumonia. - Anticipated concomitant use of any of the following medications during the course of study therapy: valproic acid or divalproex sodium. Anticipated concomitant use of serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin 5-HT1 receptor agonists (triptans), meperidine, or buspirone during the course of linezolid treatment. - Receipt of a monoamine oxidase inhibitor within 14 days prior to the first dose of study drug or anticipated concomitant use during the course of linezolid therapy. ; PRIMARY OUTCOME: Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28; SECONDARY OUTCOME 1: Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GETGOAL DUO-2 (vs. Apidra); BRIEF: Primary Objective: - To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: - To compare the treatments/regimens on: - The percentage of participants reaching the target of HbA1c <7% or ≤6.5%, - Body weight, - Self-Monitored Glucose profiles, - Fasting Plasma Glucose (FPG), - Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants), - Daily doses of insulins, - Safety and tolerability. ; DRUG USED: Adlyxin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1). - Participants treated with basal insulin for at least 6 months. - Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1. - Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1. Exclusion criteria: - At screening: age < legal age of majority. - At screening, HbA1c: <7.5% and >10.0% for participants treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide. - Women of childbearing potential with no effective contraceptive method, pregnancy or lactation. - Type 1 diabetes mellitus. - Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening. - Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness. - Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy. - At screening, Body Mass Index (BMI) ≤20 or >40 kg/m^2. - Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening. - Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures. - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. - At screening resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg. - Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposed to MTC (e.g. multiple endocrine neoplasia syndromes). - Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide. - Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. - At screening, amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN). - At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN. - At screening calcitonin ≥20 pg/ml (5.9 pmol/L). Exclusion Criteria for randomization at the end of the screening period before randomization: - HbA1c <7.0% or >9.0%. - 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L). - Amylase and/or lipase >3 times ULN. The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Change in HbA1c From Baseline to Week 26; SECONDARY OUTCOME 1: Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III/IV - STRIIVING; BRIEF: This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled, multicenter, parallel group, non-inferiority study. This study is designed to demonstrate the non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams (mg)/Dolutegravir(DTG) 50 mg/Lamivudine (3TC) 300 mg fixed-dose combination (FDC) compared with continuing the subjects current suppressive regimen through 24 weeks. The study will be conducted in approximately 538 Human Immunodeficiency Virus -1 (HIV-1) infected individuals who are on stable suppressive combination antiretroviral therapy (cART) with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) plus either a protease inhibitor (PI), an non-nucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor (INI). Eligible subjects will be randomly assigned 1:1 to continue their current regimen (approximately 269 subjects) or be switched to ABC/DTG/3TC FDC (approximately 269 subjects) once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue their current regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24 weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and tipranavir (TPV) in a subgroup of subjects who switch from EFV, NVP, fosamprenavir/ritonavir (FPV/r) or tipranavir/ritonavir (TPV/r). ; DRUG USED: Triumeq; DRUG CLASS: Non-NME; INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Monotherapy; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Be able to understand and comply with protocol requirements, instructions, and restrictions; - Be likely to complete the study as planned; - Be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country, etc.). - Signed and dated written informed consent is obtained from the subject or the subjects legal representative prior to screening - HIV-1 infected men or women >=18 years of age; - A female may be eligible to enter and participate in the study if she: a. Is of non-childbearing potential either defined as post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, - A female may be eligible to enter and participate in the study if she: b. Is of childbearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: Complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 2 weeks after discontinuation of all study drugs; Double barrier method (e.g., male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year ; Male partner sterilization prior to the female subjects entry into the study and this male is the sole partner for that subject; Approved hormonal contraception for subjects randomly assigned to the ABC/DTG/3TC arm or approved hormonal contraception plus a barrier method for subjects assigned to continued antiretroviral therapy arm; Any other method with published data showing that the expected failure rate is <1% per year. - Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of study drug. A childbearing potential female subject who starts the study using complete abstinence as her contraceptive method and decides to become sexually active must use the double barrier method either as a bridge to an approved hormonal contraception (if possible) or as a method of choice to be maintained from that moment onwards. - All subjects participating in the study should be counselled on safer sexual practices including the use of effective barrier methods (e.g., male condom/spermicide). - Within the last year, 2 consecutive plasma HIV-1 Ribonucleic acid (RNA) measurements <50 copies/millilitres (c/mL) and plasma HIV-1 RNA<50 c/mL at Screening (<75 b Deoxyribonucleic acid [bDNA] is considered equal to <50 c/mL); Subjects who present at initial screening with a viral load between 50 to 200 c/mL can be retested once within the screening period. - Must be on current regimen (whether first or second line Combination antiretroviral therapy [cART]) for at least 6 months prior to Screening; - Acceptable stable cART regimens prior to Screening include: • Boosted PI (or Atazanavir [ATV]) unboosted) + 2 NRTIs, NNRTI + 2 NRTIs, • INI + 2 NRTIs. For subjects on an INI, their INI at Screening must be RAL or Elvitegravir (EVG) - Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns. - Subject must have achieved plasma HIV-1 RNA level <50 c/mL within 6 months of start of initial cART regimen with no plasma HIV-1 RNA level >200 c/mL following initial suppression; - Documentation that the subject is negative for the human leukocyte antigen (HLA) B*5701 allele; Exclusion Criteria: Exclusionary Medical Conditions - Women who are breastfeeding; - Any evidence of an active (Centers for Disease Control and Prevention [CDC] Category C) disease. Exceptions include cutaneous Kaposis sarcoma not requiring systemic therapy and historic CD4+ cell counts of <200 cells/cubic millimeter (mm). - Subjects with any degree of hepatic impairment; - Subjects positive for hepatitis B virus surface antigen (+HBsAg) at Screening or with an anticipated need for hepatitis C virus (HCV) therapy during the study; - History or presence of allergy to the study drugs or their components or drugs of their class; - Ongoing malignancy other than cutaneous Kaposis sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study medical monitor for inclusion of the subject; - Subjects who, in the investigators judgment, pose a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk; Exclusionary Treatments Prior to Screening or Day 1 - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening; - Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulators that alter immune responses; - Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study drug; - A history of use of only mono or dual NRTI therapy prior to starting cART; - Use of etravirine at time of switch; - Use of DTG at time of switch; - Subjects receiving any prohibited medication listed in the protocol and who are unwilling or unable to switch to an alternate medication Exclusionary Laboratory Values or Clinical Assessments at Screening - Evidence of primary viral resistance based on the presence of any resistance-associated major PI or any NRTI, NNRTI, or INI mutation in any prior resistance genotype assay result; - Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 triglyceride abnormalities. A single repeat test is allowed during the screening period to verify a result; - Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the subjects participation in the study of an investigational compound; - Alanine aminotransferase (ALT) >=5 times the upper limit of normal (ULN), or ALT >=3 × ULN and bilirubin >=1.5 × ULN (with >35% direct bilirubin); - Subject has CrCl of <50 mL/min using Modification of Diet in Renal Disease (MDRD); - QTc (Bazett) >=450 msec or QTc (Bazett) >=480 msec for subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to Bazetts formula (QTcB). The QTc should be based on a single QTc value electrocardiogram (ECG) obtained. - Eligibility of subjects for study participation will be decided by the investigators after taking into consideration various country specific guidelines, and notwithstanding the above mentioned minimum inclusion and exclusion criteria. ; PRIMARY OUTCOME: Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 24 Using the Snapshot Algorithm; SECONDARY OUTCOME 1: Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Linezolid; BRIEF: This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia. ; DRUG USED: Dalvance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Cell wall synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Durata Therapeutics Inc., an affiliate of Allergan plc; CRITERIA: Inclusion Criteria: 1. Adults aged 18 to 85, inclusive 2. Has given written, informed consent 3. Has acute illness with onset within previous 7 days 4. Has at least 2 of the following symptoms: - Difficulty breathing or shortness of breath - Cough - Production of purulent sputum - Pleuritic chest pain 5. Has at least 2 vital sign abnormalities: - Fever (> 38°C or < 35°C) - Hypotension (systolic BP < 90 mm Hg) - Tachycardia (> 100 beats /min) - Tachypnea (> 24 breaths /min) 6. Has at least one other clinical or laboratory abnormalities: - Hypoxemia (room air SaO2 < 90% ) - Clinical evidence of pulmonary consolidation - Elevated WBC count or neutropenia (> 12,000/mm3 or < 4,000/mm3) 7. Has new lobar or multi-lobar infiltrates on chest radiograph 8. Has CURB-65 risk category 1 to 4. Patients with CURB-65 risk category 1 will be limited to 20% of the total patient population Exclusion Criteria: 1. Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1) 2. Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life < 8 hours) antibiotic 3. Has aspiration pneumonia 4. Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days 5. Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis 6. Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant 7. Has primary or metastatic lung cancer 8. Has known bronchial obstruction or a history of post-obstructive pneumonia 9. Requires admission to ICU at baseline 10. Has empyema requiring drainage 11. Infection due to an organism known prior to study entry to be resistant to either treatment regimen 12. Has known or suspected infection due solely to an atypical pathogen such as Mycoplasma sp., Chlamydia sp. or Legionella sp. or positive Legionella urinary antigen at baseline 13. Absolute neutrophil count < 500 cells/mm3 14. Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count 15. Patients with a recent bone marrow transplant (in post-transplant hospital stay) 16. Patients receiving oral steroids > 40 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation 17. Patients with a rapidly fatal illness, who are not expected to survive for 3 months 18. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study 19. Has participated in another trial of an investigational pharmaceutical product in the 30 days prior to enrollment 20. Prior participation in this trial. ; PRIMARY OUTCOME: Treatment Response of CABP Symptoms; SECONDARY OUTCOME 1: Efficacy of dalbavancin to the comparator regimen[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Treatment IND; BRIEF: Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S. ; DRUG USED: Defitelio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sinusoidal Obstruction Syndrome (Veno-Occlusive Disease / VOD); TARGET: Eicosanoids; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: Entry criteria include the following: 1. Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or biopsy proven: 1.1 Baltimore Criteria- Bilirubin ≥2 mg/dL and at least 2 of the following clinical findings: - Ascites (radiographic or physical exam) - Weight gain of ≥5% compared to the day of conditioning-- if this value is not available, the weight on the date of admission to the SCT unit may be used) - Hepatomegaly; increased over baseline. 1.2 Modified Seattle Criteria: At least two of the following - Bilirubin ≥2 mg/dL - Ascites (radiographic or physical exam) and/or weight gain ≥5% above baseline weight (defined as weight on the first day of conditioning- if this value is not available, the weight on the date of admission to the SCT unit may be used) - hepatomegaly increased over baseline 1.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and have biopsy proven VOD are eligible. 2. Patient must also provide written informed consent. Exclusion Criteria: - Use of any medication which increases the risk of hemorrhage is disallowed. Use of heparin or other anticoagulants is disallowed within 12 hours unless being used for routine central venous line management, fibrinolytic instillation for central venous line occlusion, intermittent dialysis or ultrafiltration of CVVH. - Clinically significant uncontrolled acute bleeding, defined as hemorrhage requiring > 15 cc/kg of packed red blood cells (e.g., a pediatric patient weighing 20 kg and requiring > 300cc of packed red blood cells/24 hours, or an adult patient weighing 70 kg and requiring >3 units of packed red blood cells/24 hours) to replace blood loss, OR bleeding from a site which in the Investigators opinion constitutes a potential life-threatening source (e.g. pulmonary hemorrhage or CNS bleeding), irrespective of amount of blood loss, at any point from the date of SCT through the date of severe VOD diagnosis. - Hemodynamic instability as defined by a requirement for multiple pressors, or inability to maintain mean arterial pressure (for children: to maintain mean arterial pressure within 1 standard deviation of age-adjusted levels) with single pressor support. - Woman who are pregnant. ; PRIMARY OUTCOME: Survival by Day+100 Post Stem Cell Transplant or Chemotherapy; SECONDARY OUTCOME 1: [/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Efficacy; BRIEF: Study CV-0003 will be the second clinical trial administering CV-MG01 in humans. This will be a phase 2/3 proof-of-efficacy therapeutic confirmatory study following the proof-of-concept exploratory phase 1 study (CV-0002). ; DRUG USED: CV-MG01; DRUG CLASS: Vaccine; INDICATION: Myasthenia Gravis (MG); TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: CuraVac; CRITERIA: Inclusion Criteria: - Male or female Patient, with generalised myasthenia gravis (Grades 2, 3 and 4a) as per myasthenia gravis foundation of America (MGFA) classification system. - Quantitative Myasthenia Gravis (QMG) score of 10 or greater at screening and baseline. - Age of minimum 18, at the time of the consent form signature. - Patient with documented positive antibodies to AChR in one of the available validated laboratory test. - Patient may use corticosteroid treatment initiated for at least 3 months before screening, equivalent to a daily dose of 30mg prednisone as maximum, and stable (+/- 5mg change) at least 1 month before the screening and up to the first injection. - Patient may use one or two immunosuppressive drugs (initiated for a least 6 months) with or without concomitant use of corticosteroid, providing that the dosage has been stable/unchanged for 3 months before the screening and up to the first injection. - Venous access sufficient to allow blood sampling as per the protocol. - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. - Have given written informed consent approved by the relevant Ethics Committee (EC) governing the site. Exclusion Criteria: - MG patients of Grade 5 based on myasthenia gravis foundation of America (MGFA) classification. - Patients with history or presence of a primary or recurrent malignant disease including the presence or history of a thymoma. - Thymectomy planned during Part A of the study period or performed within 1 year prior to the first dose of study. - Any confirmed or suspected immunosuppressive or immunodeficient condition not related to the treatment of MG, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency. - History or evidence of administration of immunoglobulins and/or any blood products within 3 months prior to the first dose of study drug, or a planned administration of immunoglobulins during the first 3 months of the study. - History or evidence of rituximab treatment within 6 months prior to first dose of study. - History or evidence of plasmapheresis within 3 months prior to the first dose of study, or a planned plasmapheresis during the first 3 months of the study. - At high risk for aspiration. - Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity. - History of severe allergic disease or reactions likely to be exacerbated by any component of the vaccine. - History or evidence of Lambert-Eaton myasthenic syndrome, drug-induced myasthenia gravis, hereditary forms of myasthenic syndrome. - History of relevant chronic degenerative, psychiatric, or neurological disorder other than MG. - Severe hepatic, renal or cardiac insufficiency or uncontrolled hypertension - Major congenital defects or serious chronic illness other than MG. - Positive pregnancy test or desire to become pregnant during the study. - Female patients of child-bearing potential that do not use a reliable and highly effective method of contraception (see Section 7.2 Contraception) at least one month before first injection, during the study and until the end of Part A. - Any significant out-of-range Clinical Laboratory results considered as clinically significant and that prevent Subjects participation into the study according to Investigators judgment. - Previous completion or withdrawal from this study or study CV-0002. - Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted. - Any medical condition or concomitant medication that, in the opinion of the Investigator, might interfere with the subjects participation in the study, poses any added risk for the subject, or confounds the assessment of the subjects. ; PRIMARY OUTCOME: Clinical efficacy; SECONDARY OUTCOME 1: Safety (ohysical examens and laboratory tests) and local tolerance (FDA grading scale)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pulmonary Function (115805); BRIEF: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Signed and dated written informed consent - Male or females ≥ 40 years of age - Females must be post-menopausal or using a highly effective method for avoidance of pregnancy - Established clinical history of COPD by ATS/ERS definition - Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III) - Former or current smoker ≥10 pack years - A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following: - Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD) - Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD) - Previous stroke - Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional) - Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary) OR - Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker): - Current diagnosis of hypertension - Current diagnosis of hypercholesterolemia - Diabetes mellitus treated with pharmacotherapy Exclusion Criteria: - Current diagnosis of asthma - Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases - Lung volume reduction surgery within previous 12 months - Clinically significant abnormalities not due to COPD by chest X-ray or CT scan - Hospitalized for poorly controlled COPD within 12 weeks of Screening - Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician - Lower respiratory infection requiring antibiotics 6 weeks prior to Screening - A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period - An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization - An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization - An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects) - Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at >60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction <30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities - Carcinoma not in complete remission for at least 5 years - History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subjects participation will also be excluded - Known/suspected history of alcohol or drug abuse in the last 2 years - Women who are pregnant or lactating or plan to become pregnant - Subjects medically unable to withhold albuterol /salbutamol for 4 hours prior to spirometry testing at each study visit - Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications) - Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day - Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study - Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments - Non-compliance or inability to comply with study procedures or scheduled visits - History of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study - Affiliation with investigator site - Women who are pregnant or lactating or are planning on becoming pregnant during the study ; PRIMARY OUTCOME: Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84; SECONDARY OUTCOME 1: Time to Onset on Treatment Day 1[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ARTEMIS1 OL Safety Ext Study; BRIEF: The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters. ; DRUG USED: Nayzilam; DRUG CLASS: Non-NME; INDICATION: Seizure Disorders (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma S.P.R.L.; CRITERIA: Inclusion Criteria: - Has a competent, adult caregiver who can recognize and observe the subjects seizure cluster episodes - Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator Exclusion Criteria: - Has experienced status epilepticus during or since the P261-401 study - In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study - Has a neurological disorder that is likely to progress in the next year - Has a history of acute narrow-angle glaucoma - Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy - Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen - Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study - Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history - Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401 ; PRIMARY OUTCOME: Duration of Safety Observation; SECONDARY OUTCOME 1: Number of Treated Seizure Clusters Meeting Criteria for Treatment Success[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PRIME; BRIEF: The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer ; DRUG USED: Vectibix; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Man or woman at least 18 years old - Diagnosis of metastatic colorectal cancer - At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse Exclusion Criteria: - History or known presence of central nervous system (CNS) metastases - History of another primary cancer, except: Curatively treated in situ cervical cancer, or Curatively resected non-melanoma skin cancer, or Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization - Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization - Prior oxaliplatin therapy - Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib) - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan - Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > Common terminology criteria (CTC) grade 2 [CTCAE version 3.0]) - Peripheral sensory neuropathy with functional impairment ; PRIMARY OUTCOME: Progression-free Survival; SECONDARY OUTCOME 1: Overall Survival[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AURELIA (Platinum Resistant); BRIEF: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - female patients, >/=18 years of age - epithelial ovarian, fallopian tube or primary peritoneal cancer - platinum-resistant disease (disease progression within <6 months of platinum therapy) - EOCG performance status of 0-2 Exclusion Criteria: - non-epithelial tumours - ovarian tumours with low malignant potential - previous treatment with >2 chemotherapy regimens - prior radiotherapy to the pelvis or abdomen ; PRIMARY OUTCOME: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011); SECONDARY OUTCOME 1: Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - NEO-EXT (Long-Term Ext.); BRIEF: Primary Objective: Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa Secondary Objective: Long-term effect of avalglucosidase alfa on pharmacodynamic and exploratory efficacy variables ; DRUG USED: Nexviazyme; DRUG CLASS: Biologic; INDICATION: Pompe Disease; TARGET: Glycogen; THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion criteria: Patients with Pompe disease who previously completed a an avalglucosidase study. The patient and/or their parent/legal guardian is willing and able to provide signed informed consent, and the patient, if <18 years of age, is willing to provide assent if deemed able to do so. The patient (and patients legal guardian if patient is <18 years of age) must have the ability to comply with the clinical protocol. The patient, if female and of childbearing potential, must have a negative pregnancy test [urine beta-human chorionic gonadotropin] at baseline. Exclusion criteria: The patient is concurrently participating in another clinical study using investigational treatment. The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study. The patient has clinically significant organic disease (with the exception of symptoms relating to Pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the study or potentially decreases survival. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Assessment of adverse events (AEs) and treatment-emergent adverse events (TEAEs), including infusion-associated reactions (IARs) and deaths; SECONDARY OUTCOME 1: Electrocardiogram[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SELECT; BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period). ; DRUG USED: Lenvima; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thyroid Cancer; TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) or follicular thyroid cancer (FTC). 2. Measurable disease according to (RECIST 1.1) and confirmed by central radiographic review. 3. 131 I-refractory/resistant disease. 4. Evidence of disease progression within 12 months prior to signing informed consent (+1 month screening window). 5. Prior treatment with 0 or 1 vascular endothelial growth-factor (VEGF) or vascular endothelial growth-factor receptors (VEGFR) targeted therapy. 6. Adequate renal, liver, bone marrow, and blood coagulation function, as defined in the protocol. Exclusion criteria: 1. Anaplastic or medullary carcinoma of the thyroid 2. 2 or more prior VEGF/ VEGFR-targeted therapies 3. Received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug. Inclusion criteria for OOL Lenvatinib Treatment Period : Participants were eligible for lenvatinib treatment in the OOL Lenvatinib Treatment Period if the met the following criteria: 1. Placebo-treated participants in the Randomization Phase who had progressive disease (PD) confirmed by IIR, and who requested treatment with lenvatinib. 2. Participants who continued to satisfy specified inclusion and exclusion criteria as presented in the study protocol. 3. Participants with maximum interval between the day of confirmation of PD by IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period of less than or equal to 3 months. 4. No systemic anticancer treatment during the interval between the day of confirmation of PD by the IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period. ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Overall Response Rate (ORR)[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CARE (vs. Colistin); BRIEF: This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in the treatment of patients with bloodstream infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP) due to CRE. An additional cohort of patients with BSI, HABP, VABP, complicated urinary tract infection (cUTI), or acute pyelonephritis (AP) due to CRE, not eligible for inclusion in the other cohort, were enrolled into a single arm (Cohort 2) and treated with plazomicin-based therapy. Therapeutic drug management (TDM) was used to help ensure that plazomicin exposures lie within an acceptable range of the target mean steady-state area under the curve (AUC). ; DRUG USED: Zemdri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial); TARGET: Cell Membrane, Gram-Negative Bacteria, Protein synthesis; THERAPY: Combination; LEAD SPONSOR: Achaogen, Inc.; CRITERIA: Key Inclusion Criteria: - Cohort 1: APACHE II score between 15 and 30, inclusive; Cohort 2: BSI, HABP, VABP patients with an APACHE II score ≤30 (cUTI and AP patients do not need to have their APACHE II score calculated) - Positive culture that was collected ≤96 hours prior to randomization indicating a CRE infection, or a high likelihood of a CRE infection - Diagnosis of BSI as defined by at least one of the following: fever, hypothermia, new onset arterial hypotension, elevated total peripheral white blood cell (WBC) count, increased immature neutrophils (band forms), or leukopenia - Or, diagnosis of HABP defined as clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic-care facility, or acquired within 7 days after being discharged from a hospitalization of ≥3 days duration - Or, diagnosis of VABP defined by clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous mechanical ventilation - Or, diagnosis of cUTI or AP defined by clinical signs and symptoms consistent with cUTI or AP assessed within 24 hours prior to enrollment Key Exclusion Criteria: - Cohorts 1 and 2 BSI, HABP, and VABP patients: receipt of more than 72 hours of potentially effective antibacterial therapy; Cohort 2: cUTI and AP patients: receipt of any potentially effective antibacterial therapy in the 48 hours prior to enrollment - Cohort 1 only: knowledge that index CRE infection is resistant to colistin prior to randomization - Objective clinical evidence for any of the following clinical syndromes that necessitates study therapy for greater than 14 days: endovascular infection including endocarditis, osteomyelitis, prosthetic joint infection, meningitis and/or other central nervous system infections - Objective clinical evidence of infectious involvement of intravascular material potentially due to the study qualifying pathogen and not intended to be removed within 4 calendar days of the initial positive culture - HABP or VABP patients only: pulmonary disease that precludes evaluation of therapeutic response including known bronchial obstruction or a history of post-obstructive pneumonia, tracheobronchitis, primary lung cancer or malignancies metastatic to the lung, bronchiectasis, known or suspected active tuberculosis - cUTI or AP patients only: renal abscess, chronic bacterial prostatitis, orchitis or epididymitis, polycystic kidney disease, one functional kidney, vesicoureteral reflux, renal transplant, cystectomy or ileal loop surgery, fungal UTI or complete, permanent obstruction of the urinary tract - Patients in acute renal failure at the time of randomization - Patients receiving intermittent hemodialysis (IHD) at the time of screening - Pregnant or breastfeeding female patient ; PRIMARY OUTCOME: Percentage of Patients With All Cause Mortality (ACM) at Day 28 or Significant Disease-Related Complication (SDRC) in the Microbiological Modified Intent to Treat (mMITT) Population in Cohort 1; SECONDARY OUTCOME 1: Percentage of Patients With ACM at Day 28 in the mMITT Population in Cohort 1[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BURAN; BRIEF: The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy. ; DRUG USED: Buparlisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Adlai Nortye Biopharma Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Aged ≥18 years old. 2. Able to provide informed consent obtained before any trial related activities and according to local guidelines. 3. Patient has histologically and/or cytologically-confirmed HNSCC. 4. Patient has archival or new tumor tissue for the analysis of biomarkers and confirmation of HPV status (if unknown). One tumor block (preferred) or a recommended minimum of 5 unstained slides for patients with known HPV status (for tumor DNA characterization) or a recommended minimum of 10 slides for patients whose HPV status is unknown (5 slides for HPV testing plus 5 slides needed for biomarker testing). Enrollment in the study is contingent on confirmation of the availability of an adequate amount of tumor tissue, except in rare special circumstances, which must be reviewed and approved by the sponsor. 5. Patient has either progressive or recurrent disease after treatment with PDL1/PD1 based therapy for recurrent or metastatic disease: 1. PDLl/PD1 therapy alone for metastatic (monotherapy) disease 2. PDL1/PD1 in combination with chemotherapy for metastatic and recurrent disease 3. PDL1/PD1 used for metastatic disease, after or prior to receiving a platinum agent for locally advanced or metastatic disease. 6. 6. Patient has received no more than two prior lines of systemic treatment for HNSCC (single agent chemotherapy used as a radiosensitizer is not counted as a prior line of therapy). 7. Patient has measurable disease as determined per RECIST version 1.1. If the only site of measurable disease is a previously irradiated lesion, documented progression of disease and a four-week period since radiotherapy completion is required. 8. Patient has adequate bone marrow function and organ function as shown by the following: 1. Absolute neutrophil count (ANC) ≥1.5 x 109/L. 2. Hemoglobin ≥9 g/dL (which may be reached by transfusion). 3. Platelets ≥100 x 109/L (which may be reached by transfusion). 4. International normalized ratio (INR) ≤1.5. 5. Calcium (corrected for serum albumin) within normal limits (WNL) or ≤ grade 1 severity according to NCI-CTCAE version 5.0 if judged clinically not significant by the Investigator. Patients concomitantly taking bisphosphonates or denosumab for calcium correction are eligible. 6. Normal potassium and magnesium levels. 7. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN) or < 3.0 x ULN if liver metastases are present. 8. Total serum bilirubin ≤ ULN or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin below or within normal range in patients with well documented Gilberts Syndrome. Gilberts syndrome is defined as presence of episodes of unconjugated hyperbilirubinemia with normal results from cells blood count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis. 9. Serum creatinine ≤ 1.5 x ULN or calculated and directly measured creatinine clearance (CrCL) > 30 mL/min. 10. Haemoglobin A1c (glycosylated hemoglobin; HbA1c) ≤8%. 9. Patient has Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 10. Patient is able to swallow and retain oral medication. Patients able to swallow oral medication but mostly self-nourished through gastric or jejunal feeding tube are eligible. 11. Patients must apply highly effective contraception during and throughout the study, as well after the final dose of study treatment Exclusion Criteria: Patients meeting any of the following criteria will not be eligible for participation in the study: 1. Patient has received previous treatment with any protein kinase B (PKB/AKT), mammalian target of rapamycin (mTOR) inhibitors, or phosphatidylinositol 3 kinase (PI3K) pathway inhibitors. 2. Patient received treatment with a taxane as part of prior treatment for metastatic disease. 3. Patient has symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases may participate in this study. Patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy) and must be on a stable low dose of corticosteroid therapy. Radiosurgery must have been completed at least 14 days prior to start of study treatment. 4. Patient has received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment or who have adverse events which have not recovered to grade 1 or better from previous chemotherapy treatment (except alopecia, autoimmune endocrine events must be stable and controlled). 5. Patient has grade ≥ 2 neuropathy, colitis, pneumonitis, , and uncontrolled endocrinopathies (e.g., hypothyroidism, diabetes with hemoglobin A1c > 8%) from previous treatment 6. Patient has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects. 7. Patient is currently receiving increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent. The following uses of corticosteroids are permitted: single doses; standard premedication for paclitaxel, topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops, or local injections (e.g., intra-articular), or < 10 mg prednisolone or equivalent. 8. Patient is being treated at start of study treatment with any of the following drugs: 1. Drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4) including herbal medications (see Table 16). 2. Drugs with a known risk of inducing Torsades de Pointes. Note: The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to starting study treatment is allowed. 9. Patient is currently receiving warfarin or other coumarin-derived anti-coagulant, for treatment, prophylaxis, or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), fondaparinux or new oral anticoagulants (NOACs) is allowed. 10. Patient has a known hypersensitivity and/or contraindication to paclitaxel, standard premedication for paclitaxel, or other products containing Cremophor®. 11. Patient has other concurrent severe and/or uncontrolled medical conditions that would, in the Investigators judgment, contraindicate patient participation in the clinical study (e.g., active or uncontrolled severe infection, chronic active hepatitis, immunocompromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc). 12. Patient has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory). 13. Patient has any of the following cardiac abnormalities: 1. Symptomatic congestive heart failure within 12 months of the screening period. 2. History of documented congestive heart failure (New York Heart Association functional classification III-IV) or documented cardiomyopathy and left ventricular ejection fraction (LVEF) <50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO). 3. Myocardial infarction ≤six months prior to enrollment. 4. Unstable angina pectoris. 5. Serious uncontrolled cardiac arrhythmia. 6. Symptomatic pericarditis. 7. QT interval corrected according to the formula of Fridericia (QTcF) > 450 msec for males and > 470 msec for females, on the screening electrocardiogram (ECG). 8. Currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment. 14. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 15. Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g., risk of doing harm to self or others), or active severe personality disorders (defined according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition [DSM-V]) are not eligible. Note: For patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous six weeks prior to start of study treatment. 16. Patient has other prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, early gastric or GI cancer resected completely by endoscopy procedures or any other cancer from which the patient has been disease free for ≥ 3years. 17. Patient has a history of non-compliance to any medical regimen or inability to grant consent. 18. Patient is concurrently using or has used another approved or investigational cancer agent within 4 weeks of randomization. 19. Patient is pregnant or nursing (lactating). Patients with elevated human chorionic gonadotrophin (hCG) at baseline that is judged to be related to the tumor are eligible if hCG levels do not show the expected doubling when repeated five to seven days later, or pregnancy has been ruled out by vaginal ultrasound. 20. Patient has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed. Non-live COVID vaccinations or boosters should not occur within 30 days of study start. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression free survival[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - EUCLID; BRIEF: The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease. ; DRUG USED: Brilinta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral Arterial Disease (PAD); TARGET: Adenosine Diphosphate P2Y12 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Male and Female patients 50 years old or older Symptomatic peripheral artery disease Exclusion Criteria: - Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation - Patients with known bleeding disorders - Patients with a history of intracranial bleed - Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker ; PRIMARY OUTCOME: Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke; SECONDARY OUTCOME 1: Composite of CV Death, MI, Ischemic Stroke, and ALI[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric; BRIEF: The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age. ; DRUG USED: Durezol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - 0 to 3 years of age. - Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens. - Informed consent signed by a parent or legal guardian. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Presence of any active or suspected viral, bacterial, or fungal disease in the study eye. - Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery. - Patients with posttraumatic cataract. - Active uveitis in the study eye. - Ocular neoplasm in the study eye. - Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS). - Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patients only good eye. - Patients on systemic steroids or nonsteroidal anti-inflammatory drugs. - History of steroid-induced intraocular pressure (IOP) rise. - Currently on medication for ocular hypertension or glaucoma in the study eye. - Diabetes. - Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days; SECONDARY OUTCOME 1: Global Assessment Score of Postoperative Inflammation by Visit[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FINCH 4 (Ext.); BRIEF: The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA). ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Key Inclusion Criteria: - Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below: - Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug - OR - Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status - Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE) - Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception Key Exclusion Criteria: - Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator - Known hypersensitivity to the study drug or its excipients - Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply. ; PRIMARY OUTCOME: Proportion of Participants Experiencing Adverse Events (AEs); SECONDARY OUTCOME 1: Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - inTandem2 (Europe); BRIEF: This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy. ; DRUG USED: Zynquista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participant who gave written informed consent to participate in the study in accordance with local regulations. - Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent. - Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). - Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol. - At the Screening Visit, A1C was between 7.0% to 11.0%. - Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test. Exclusion Criteria: - Use of antidiabetic agent other than insulin or insulin analog at the time of screening. - Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening. - Chronic systemic corticosteroid use. - Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator. ; PRIMARY OUTCOME: Change From Baseline in A1C at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Long-Term Safety (EU/Asia/AUS/CA); BRIEF: The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A Exclusion Criteria: - Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR) - Female patients of childbearing potential who are not using effective contraception - Use of any psychoactive medication Other protocol-defined inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Number of Patients With Adverse Events (AEs); SECONDARY OUTCOME 1: Change From Baseline in MADRS Total Score After 52 Weeks of Treatment[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - V72_28E1; BRIEF: The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72_28 study. ; DRUG USED: Bexsero; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: For naïve subjects newly enrolled: 1. Healthy infants and children according to the following age groups: 1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age), 2. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age). 3. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age). 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator. For Subjects who participated in the V72_28 study (Follow-on Subjects): 1. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 2. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 3. in good health as determined by medical history, physical examination, clinical judgment of the investigator 4. who have completed the vaccination course in the V72_28 study and have received their last vaccination 24 to 36 months before enrollment in V72_28E1 Exclusion Criteria: For naïve subjects newly enrolled: 1. History of any serogroup B meningococcal vaccine administration; 2. Previous known or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization; 4. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine; 5. Pregnancy or nursing (breastfeeding) mothers; 6. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry; 7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example): - Receipt of any chronic immunosuppressive therapy - Receipt of any chronic immunostimulants - Immune deficiency disorder, or known HIV infection 8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable). 9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 10. Subjects parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 11. Intent to participate in another clinical study during this study. 12. Family members and household members of study staff; 13. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study. 14. Any significant chronic infection. 15. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). For Subjects who participated in the V72_28 study (Follow-on Subjects): Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1. ; PRIMARY OUTCOME: Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains; SECONDARY OUTCOME 1: Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Energy; BRIEF: The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA). ; DRUG USED: Nipocalimab; DRUG CLASS: Biologic; INDICATION: Autoimmune Hemolytic Anemia (AIHA); TARGET: Neonatal Fc Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion criteria: - Participants greater than or equal to (>=)18 years of age - Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive participants are not eligible) - Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures Exclusion criteria: - Participants must not be pregnant or breastfeeding - Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate - Have been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria ; PRIMARY OUTCOME: Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb); SECONDARY OUTCOME 1: Change From Baseline in the Total Score From the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale at the Time of Durable Response[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SERENA-4; BRIEF: The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein. ; DRUG USED: AZD9833; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Selective Estrogen Receptor Degrader (SERD); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: INCLUSION CRITERIA Full list of inclusion criteria - Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment. - De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patients last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation. - Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results. - Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease. - Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI. - Eastern Cooperative Oncology Group performance status of 0 or 1. - Adequate organ and marrow function. - Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. INFORMATION FOR TRIAL PARTICIPANTS Participants can join the trial if they: - Have breast cancer that cannot be treated with surgery or radiation - Have breast cancer that has already spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of a standard endocrine treatment - Have ER proteins but not overexpression of HER2 protein in their tumors - Have never received any type of cancer therapy that affects the whole body for advanced breast cancer - Are able to do their daily activities EXCLUSION CRITERIA Full list of exclusion criteria - Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment. - Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant. - Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. - Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term and/or impending visceral crisis - Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. - Any clinically important and symptomatic heart disease . - Currently pregnant (confirmed with positive pregnancy test) or breast-feeding. - As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigators opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. - Any concurrent anti-cancer treatment. - Active infection including tuberculosis, HBV and HCV. INFORMATION FOR TRIAL PARTICIPANTS Participants cannot join the trial if they: - Have uncontrolled cancer that has spread to the brain or the spinal cord - Have received certain treatments for cancer in the past but the cancer came back within 1 year - Had certain types of tumors in the past, which the study doctors think could come back - Are currently taking any treatment for cancer or are taking medications or supplements that affect certain proteins in the body - Have any major health problem, infection, or surgery that could make it difficult or dangerous to participate in this trial, such as tuberculosis, HIV, heart problems, or a kidney transplant The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1; SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SPIRIT 2; BRIEF: The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain. ; DRUG USED: Orgovyx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Endometriosis; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Combination; LEAD SPONSOR: Myovant Sciences GmbH; CRITERIA: Key Inclusion Criteria: 1. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form. 2. Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these. 3. Has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy. 4. During the Run-In Period (35 to 70 days prior to treatment period) has a dysmenorrhea NRS score ≥ 4.0 on at least 2 days and 1. Mean NMPP NRS score ≥ 2.5, or 2. Mean NMPP NRS score ≥ 1.25 and NMPP NRS score ≥ 5.0 on ≥ 4 days. Key Exclusion Criteria: 1. Has a history of chronic pelvic pain that is not caused by endometriosis. 2. Has any chronic pain or frequently recurring pain condition, other than endometriosis that is treated with opioids or requires analgesics for ≥ 7 days per month. 3. Has had surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit. 4. Has a history of or currently has osteoporosis or other metabolic bone disease. 5. Has a clinically significant gynecologic condition, other than endometriosis, identified during Screening or Run-In period transvaginal ultrasound or endometrial biopsy. ; PRIMARY OUTCOME: Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT); SECONDARY OUTCOME 1: Change From Baseline In The Endometriosis Health Profile (EHP)-30 Pain Score At Week 24[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - China; BRIEF: The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin). ; DRUG USED: Nesina; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Combination; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Has a historical diagnosis of Type 2 Diabetes Mellitus. - Has a body mass index between acceptable range. - Is experiencing inadequate glycemic control. - Body weight keeps constant. - Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose. Exclusion Criteria: - Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization. - Has a systolic blood pressure beyond the acceptable range at Screening visit. - Has New York Heart Association Class III or IV heart failure regardless of therapy. - Has any major illness or debility that in the investigators opinion prohibits the subject from completing the study. - Has a history of hypersensitivity or allergies to any DPP-4 inhibitor. ; PRIMARY OUTCOME: Change From Baseline in Glycosylated Hemoglobin (HbA1c); SECONDARY OUTCOME 1: Change From Baseline in HbA1c Over Time[/INST]Yes</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMPOWER 22; BRIEF: This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenofovir disoproxil (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections. ; DRUG USED: Islatravir; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV Prevention; TARGET: Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization. - Sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 days prior to screening. - High risk for HIV-1 infection. - Not pregnant or breastfeeding, and one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or is a WOCBP and is using an acceptable contraceptive method during the intervention period and for at least 42 days after the last dose. - A WOCBP must have a negative pregnancy test within 24 hours prior to the first dose of study intervention. Exclusion Criteria: - Hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. - Findings of chronic hepatitis B virus (HBV) infection or past HBV. - Current or chronic history of liver disease. - History of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer. - Past or current use of cabotegravir, lenacapavir, or any other long-acting HIV prevention product. - Currently participating in or has participated in an interventional clinical study with an investigational compound or device, within 30 days prior to Day 1. - Expecting to conceive or donate eggs at any time during the study. ; PRIMARY OUTCOME: Incidence Rate Per Year of Confirmed HIV-1 Infections; SECONDARY OUTCOME 1: Incidence Rate per Year of Confirmed HIV-1 Infections Among Participants[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - STRETTO (Adult mild-moderate); BRIEF: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks. ; DRUG USED: Lebrikizumab; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Age 18-75 years old at study start - Asthma diagnosis for >/= 12 months prior to study start - Bronchodilator response at screening - Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3 - No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan - Stable and symptomatic asthma during the screening period - Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose Exclusion Criteria: - Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start - Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event - Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start - Documented prior treatment failure with Montelukast - Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study - Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start - Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patients ability to participate in the study, or impact the study assessments - History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma - History of alcohol or drug abuse that would impair or risk the patients full participation in the study, in the opinion of the investigator - Current or history of smoking (> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study - Past and/or current use of any anti-IL-13 or anti- IL4/IL-13 therapy, including lebrikizumab - Use of a licensed or investigational monoclonal antibody other than anti IL-13 or anti-IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening - Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start or during screening - Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening - Initiation of or change in allergen immunotherapy within 3 months prior to study start or during screening - Receipt of a live attenuated vaccine within 4 weeks prior to study start of during screening - Pregnancy or breast feeding - Body mass index > 38 kg/m2 - Body weight < 40 kg - History of bronchial thermoplasty ; PRIMARY OUTCOME: Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1); SECONDARY OUTCOME 1: Relative change in morning pre-bronchodilator peak expiratory flow (PEF)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs Erlotinib (After 1st or 2nd Line) ; BRIEF: This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib. ; DRUG USED: Tesevatinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), EPH receptor B4 (EPHB4), HER2/neu or ErbB-2, Src Kinase Family, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Kadmon Corporation, LLC; CRITERIA: For Eligibility subjects must have: - failed one or two previous courses of therapy. - have no active brain metastasis. Treated non-active brain metastasis are acceptable. - cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva [erlotinib] or Iressa [gefitinib]) in the past. - has demonstrated progressive disease. ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Progression-free survival[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RE-AFFIRM; BRIEF: The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. ; DRUG USED: Tonmya; DRUG CLASS: Non-NME; INDICATION: Fibromyalgia; TARGET: Alpha 2 Adrenergic Receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Tonix Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of Primary Fibromyalgia (2010 ACR criteria) - Male or female 18-75 years old - Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame. - Willing and able to withdraw specific therapies (ask PI) - If female, medically acceptable form of contraception or not of child bearing potential. - Provide written informed consent to participate. - Willing and able to comply with all protocol specified requirement. Exclusion Criteria: - Arthritis, lupus and other systemic auto-immune diseases - Regional or persistent pain that could interfere with assessment of fibromyalgia pain - Bipolar and psychotic disorders - Increased risk of suicide - Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities. - Inability to wash-out specific medications (ask PI) - Known hypersensitivity to cyclobenzaprine - Others: seizure disorders, severe/untreated sleep apnea, BMI>45 ; PRIMARY OUTCOME: Weekly mean pain score; SECONDARY OUTCOME 1: Patients Global Impression of Change (PGIC)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COG AALL1331 (1st Relapse); BRIEF: This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the bodys immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia. ; DRUG USED: Blincyto; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Cluster of Differentiation 19 (CD19), Cluster of Differentiation 3 (CD3), Immune System; THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients >= 1 year and < 31 years of age at the time of relapse will be eligible - First relapse of B-ALL, allowable sites of disease include isolated bone marrow, combined bone marrow and CNS and/or testicular, and isolated CNS and/or testicular; extramedullary sites are limited to the CNS and testicles - No waiting period for patients who relapse while receiving standard maintenance therapy - Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study - Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy, or maintenance chemotherapy, or intrathecal chemotherapy (methotrexate strongly preferred) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status - Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur - Stem cell transplant or rescue: patient has not had a prior stem cell transplant or rescue - Patient has not had prior treatment with blinatumomab - With the exception of intrathecal chemotherapy (methotrexate strongly preferred; cytarabine is permissible) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status, patient has not received prior relapse-directed therapy (i.e., this protocol is intended as the INITIAL treatment of first relapse) - Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: - 1 to < 2 years: =< 0.6 mg/dL - 2 to < 6 years: =< 0.8 mg/dL - 6 to < 10 years: =< 1 mg/dL - 10 to < 13 years: =< 1.2 mg/dL - 13 to < 16 years: =< 1.5 mg/dL (males) and =< 1.4 mg/dL (females) - >= 16 years: =< 1.7 mg/dL (males) and =< 1.4 mg/dL (females) - Direct bilirubin < 3.0 mg/dL - Shortening fraction of >= 27% by echocardiogram, or - Ejection fraction of >= 50% by radionuclide angiogram - All patients and/or their parent or legal guardian must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: - Patients with Philadelphia chromosome positive/breakpoint cluster region protein (BCR)-Abelson murine leukemia viral oncogene homolog 1 (ABL1)+ ALL are not eligible - Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible - Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL) are not eligible - Patients with B-lymphoblastic lymphoma (B-LL) are not eligible - Patients with known optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to determine optic nerve or retinal involvement - Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome - Patients with known human immunodeficiency virus (HIV) infection - Patients with known allergy to mitoxantrone, cytarabine, or both etoposide and etoposide phosphate (Etopophos) - Lactating females who plan to breastfeed - Patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential - Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation - Patients with pre-existing significant central nervous system pathology that would preclude treatment with blinatumomab, including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement are not eligible; patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible; (patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved) - Patients with uncontrolled seizure disorder are not eligible; (patients with seizure disorders that do not require antiepileptic drugs, or are well controlled with stable doses of antiepileptic drugs remain eligible) ; PRIMARY OUTCOME: Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients; SECONDARY OUTCOME 1: Overall Survival (OS) of HR and IR Relapse Patients[/INST]No</s> |
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