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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 II - Study 206; BRIEF: Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria ; DRUG USED: Reloxaliase; DRUG CLASS: Biologic; INDICATION: Hyperoxaluria; TARGET: Oxalate; THERAPY: Monotherapy; LEAD SPONSOR: Allena Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Signed a informed consent form or an assent 2. Aged 12 or older with body weight ≥ 35kg 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohns disease, short bowel syndrome, or other malabsorption syndrome) 4. Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening 6. In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening 7. Patients on dialysis, must be stable for greater than 3 months Exclusion Criteria: 1. Unable or unwilling to discontinue Vitamin C supplementation ; PRIMARY OUTCOME: Change in plasma oxalate; SECONDARY OUTCOME 1: Change in 24-hr urinary oxalate excretion[/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 - MOVE-PD (Parkinson); BRIEF: The purpose of this study, called MOVE-PD, is to investigate how individuals with Parkinsons disease (PD) and chronic constipation (CC) respond to RM-131 as compared to placebo. The study will look at how well RM-131 affects the frequency of spontaneous bowel movements over a 14-day period. The study will also evaluate the safety and tolerability of the study drug and evaluate whether the study drug relieves the uncomfortable GI symptoms related to chronic constipation in patients who are unsatisfied with other therapies they have tried for constipation. ; DRUG USED: Relamorelin; DRUG CLASS: Biologic; INDICATION: Chronic Idiopathic Constipation; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Motus Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Able to provide written informed consent and be willing and able to comply with study procedures. - Diagnosis of Parkinsons disease - Diagnosis of chronic constipation (CC), including experiencing constipation for ~12 or more weeks in the preceding 12 months. - Regular treatment for chronic constipation during the last 6 months, and dissatisfaction with current treatment for CC, after treatment with at least 2 regimens for constipation (see note at end of this section). - Stable medication history defined as no changes in regimen for at least 2 weeks prior to the baseline period - Body mass index of 18-40 kg/m2 - Mini-mental status exam (at screening) ≥26 - Female patients must have negative serum or urine pregnancy tests and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. A vasectomized partner will be allowed as one in conjunction with another single-barrier method. - Female patients unable to bear children must have this documented in the case report form(i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). Post-menopausal status will be confirmed by follicle stimulating hormone (FSH) in women less than 60 years of age Note the following medications are allowed: - Selective serotonin reuptake inhibitor (SSRI), SNRI, and tricyclic antidepressants are permissible at stable doses. All medications shall be reviewed and dis/approved by the investigator on a case-by-case basis. - Benzodiazepines are permissible at stable doses - Stable doses of antacids, NSAIDS, Cox-2 inhibitors, calcium supplements, thyroid replacement, estrogen replacements, low-dose aspirin for cardioprotection, and birth control (but with adequate back up contraception as drug interactions with birth control have not been conducted) are permissible - Dopamine agonists and amantadine allowed if on a stable dose - Deep brain stimulation is allowed. Exclusion Criteria: - Unable or unwilling to provide informed consent or to comply with study procedures - Diagnosis of secondary constipation beyond that of Parkinsons disease - Structural or metabolic diseases that affect the GI system - Unable to withdraw the following medications 48 hours prior to the baseline period and throughout the study (except as protocol defined rescue medications; see below): - Medications that alter GI transit including laxatives, prokinetics, erythromycin, narcotics, and anti-cholinergics (except as protocol defined rescue medications). - GABAergic agents - Drugs with a low therapeutic index, such as warfarin, digoxin, anti-seizure medications - NOTE: Parkinsons disease therapies are allowed. Exceptions for Parkinsons disease medications include: - Cogentin (benztopine), Artane (trihexyphenidyl), and apomorphone are excluded - History of recent major surgery (within 60 days of screening) - Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc. - History of symptomatic orthostatic hypotension or significant history of dizziness - History of hypersensitivity to mannitol which is an ingredient of both active and placebo study medications - Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator - Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities (including prolonged QTc > 500 msec) or abnormal blood pressure at screening except minor deviations deemed to be of no clinical significance by the Investigator - Acute GI illness within 48 hours of the baseline period - History of major GI surgery, except that patients with uncomplicated appendectomy or cholecystectomy are allowed. - ALT or AST > 1.5 X upper limit of normal (ULN) during screening - Females who are pregnant or breastfeeding - History of excessive alcohol use or substance abuse - Patient or caregiver unable to administer daily SC injections - Participation in an investigational clinical study within the 30 days prior to dosing in the present study - Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study ; PRIMARY OUTCOME: Investigate the effects of treatment with RM-131 for 14 days on the frequency of spontaneous bowel movements (SBMs) when administered to patients with Parkinsons Disease (PD) and Chronic Constipation (CC); SECONDARY OUTCOME 1: Evaluate the safety and tolerability of multiple doses of RM-131 when administered to patients with PD and CC[/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 I/II/III - Children (6 Months to 11 Years Old); BRIEF: This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated. ; DRUG USED: Comirnaty; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: BioNTech SE; CRITERIA: Inclusion Criteria 1. Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and <16 years of age. 2. Participants parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. 4. Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation. 5. Negative urine pregnancy test for female participants who are biologically capable of having children. 6. Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 7. The participant or participants parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written). Exclusion Criteria 1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19. 2. Phase 1 only: Known infection with HIV, HCV, or HBV. 3. Receipt of medications intended to prevent COVID-19. 4. Previous or current diagnosis of MIS-C. 5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigators judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results 6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 7. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 8. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted. 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 10. Female who is pregnant or breastfeeding. 11. Previous vaccination with any coronavirus vaccine. 12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study. 14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. 15. Previous participation in other studies involving study intervention containing LNPs. 16. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. ; PRIMARY OUTCOME: Percentage of participants in Phase 1 reporting local reactions; SECONDARY OUTCOME 1: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs[/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 - RP-001 (River Plate); BRIEF: The study is designed to assess the safety and efficacy of Vismed®, a special eye drop containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being compared to another eye drop, identical in composition except that it does not contain the active ingredient, sodium hyaluronate. This eye drop is designed as the vehicle. Some subjects are to receive Vismed® treatment, while others are to receive the vehicle; the assignment of subjects to receive either Vismed or vehicle is to be random. The two-week treatment phase is followed by a one week follow-up period to evaluate safety of Vismed®. ; DRUG USED: AL-2354A; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Eye (Ophthalmology); TARGET: Hyaluronic acid; THERAPY: Monotherapy; LEAD SPONSOR: Lantibio; CRITERIA: Inclusion Criteria: - Male and female adults aged 18 years and over. - Subjects should have at least a 3-month documented history of dry eye in both eyes diagnosed as dry eye syndrome, keratoconjunctivitis sicca (KCS), or due to Sjögren syndrome (immune exocrinopathy). - Subjects must agree to discontinue all artificial tears from Screening through the duration of the treatment period (Screening to Day 14). - Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening. - Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study. - Subjects must provide signed informed consent prior to participation in any study-related procedures. Exclusion Criteria: - Pregnancy or lactation. - Females of childbearing potential who are not using systemic contraception, are not postmenopausal (≥ 1 year), or are not surgically sterilized. - Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening. - Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication. - Any active inflammation of the eye not due to KCS (eg, iritis, scleritis, etc.). - Participation in any other clinical trial within 30 days prior to Screening. - Prior participation in a previous clinical trial of Vismed®. ; PRIMARY OUTCOME: staining of the cornea and conjunctiva; SECONDARY OUTCOME 1: staining of the cornea and conjunctiva[/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 - Study 402; BRIEF: The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes. The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine. ; DRUG USED: Bexagliflozin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Theracos; CRITERIA: Inclusion Criteria: - Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes. - Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive). - HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%. - Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications. - Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L). - If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study. - Female subjects must be surgically sterilized or postmenopausal. Exclusion Criteria: - Type 1 diabetes or diabetes treated with insulin injection. - Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these. - Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening. - Positive results on screen for drugs of abuse. - Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer. - Previous treatment with EGT0001474 or EGT0001442. ; PRIMARY OUTCOME: Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study; SECONDARY OUTCOME 1: Change in the Body Weight From Baseline at Week 4[/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 - PHOTON (8mg Dosage); BRIEF: The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: - To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response - To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Diabetic macular edema (DME) with central involvement in the study eye - Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME - Willing and able to comply with clinic visits and study-related procedures - Provide informed consent signed by study participant or legally acceptable representative Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment. Key Exclusion Criteria: - Evidence of macular edema due to any cause other than diabetes mellitus in either eye - Active proliferative diabetic retinopathy in the study eye - IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye - Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time - Treatment with ocriplasmin (JETREA®) in the study eye at any time NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply ; PRIMARY OUTCOME: Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48; SECONDARY OUTCOME 1: Percentage of Participants With a ≥2 Step Improvement From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Score at Week 48[/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 - MATRIX EG; BRIEF: The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach. ; DRUG USED: Matuzumab; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: - Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus - Metastatic disease - Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from archived tissues - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 - At least 1 measurable lesion (modified World Health Organization criteria) Exclusion Criteria: - Previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed greater than (>) 12 months prior to study treatment - Radiotherapy or major surgery within 4 weeks prior to treatment - Brain metastases - Peripheral neuropathy or ototoxicity greater than or equal to (>/=) Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events Version 3 [NCICTC V3]) - Abnormal electrocardiogram (ECG) ; PRIMARY OUTCOME: Percentage of Participants With Objective Response Assessed by Independent Review Committee; SECONDARY OUTCOME 1: Duration of Objective Response Assessed by Independent Review Committee[/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 - w/RCHOP or RCHP; BRIEF: This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b. ; DRUG USED: Denintuzumab Mafodotin; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 19 (CD19), Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b; - patients must have high intermediate or high risk disease - Tumor tissue available from most recent biopsy to determine cell of origin - Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter - Eastern Cooperative Oncology Group performance status ≤2 - Age 18 years or older - Adequate study baseline laboratory parameters Exclusion Criteria: - Previous history of treated indolent lymphoma - History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years - History of progressive multifocal leukoencephalopathy - Cerebral/meningeal disease related to the underlying malignancy - Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment ; PRIMARY OUTCOME: Part B Outcome Measure: Complete Response Rate (CR); SECONDARY OUTCOME 1: Event-free Survival (EFS) Between Study Arms in Part B[/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 Ib/II - w/Etoposide & Cisplatin; BRIEF: M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED. ; DRUG USED: MSC2490484A; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: DNA-PK; THERAPY: Combination; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: To be eligible for the study (Phase Ib and Phase II) the participant must fulfill all of the following criteria: - Male or female participants at least 18 years of age - Histological or cytological diagnosis of SCLC - Extensive disease (ie, disease beyond ipsilateral hemithorax, which may include malignant pleural or pericardial effusion or hematogenous metastases [Tany, Nany, M1a/b; T3-T4, Nany, M0, due to multiple lung nodules or extent of disease that precludes a tolerable radiation field, as judged by the Investigator]) - Participants eligible for first line platinum-based chemotherapy - Measurable or evaluable disease according to RECIST v1.1 - Eastern Cooperative Oncology Group performance status (ECOG PS) less than equals to (<=) 2 - Life expectancy of greater than equals to (≥) 3 months - Female participants of childbearing potential and male participants with female partners of childbearing potential must be willing to avoid pregnancy Note: Other protocol defined criteria could apply. Exclusion Criteria: Participants are not eligible for the study if they fulfill any of the following exclusion criteria: - Prior anticancer therapy for extensive disease (ED) SCLC including experimental agents. - Concurrent use of other anticancer therapy including any investigational agent within 28 days prior to the first dose of the investigational drug M3814. - Extensive prior radiotherapy (RT) on more than 30% of bone marrow reserves (by Investigator judgment) - Prior bone marrow/stem cell transplantation within 5 years before study start (Phase II only) - Major surgical intervention within 28 days prior to the first dose of investigational drug administration. Intervention(s) to establish the diagnosis for SCLC is permitted within 28 days as long as participants are cleared by the medical and surgical teams. - Poor vital organ functions defined as: - Bone marrow impairment as evidenced by hemoglobin less than (<) 9.0 gram per deci liter (g/dL) (5.7 micromole per liter (μmol/L)), absolute neutrophil count < 1.5 × 109/L, platelets < 100 × 109/L - Renal impairment as evidenced by calculated creatinine clearance < 60 mL/minutes (min) (according to the Cockcroft-Gault formula) - Liver function abnormality as defined by total bilirubin greater than (>) 1.5 × upper limit of normal (ULN) or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 × ULN (participants with liver involvement: a maximum of AST/ALT 5 × ULN) - Contraindication to the use of etoposide or cisplatin - Participants currently receiving (or unable to stop using prior to receiving the first dose of investigational drug) medications or herbal supplements known to be potent inhibitors of cytochrome P450 (CYP) 3A and CYP2C19 (unless treatment can be discontinued at least 1 week prior to receiving the first dose of investigational drug) or potent inducers of CYP3A and CYP2C19 (unless treatment can be discontinued at least 3 weeks prior to receiving the first dose of investigational drug). Note: Other protocol defined criteria could apply. ; PRIMARY OUTCOME: Phase Ib: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.; SECONDARY OUTCOME 1: Phase Ib: Number of Subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths[/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 I - w/Ipilimumab/Nivolumab (Emory); BRIEF: This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread. ; DRUG USED: Pepinemab; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Semaphorin 4D/CD100; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Emory University; CRITERIA: Inclusion Criteria: - Stage I-IVA cytologically or histologically-proven head and neck squamous cell carcinoma (HNSCC), p16 positive and negative allowed - Oropharyngeal tumors must have p16 testing done - Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection - Archival tissue prior to treatment available from at most 6 months prior to study enrollment. Otherwise new pre-treatment biopsy mandatory - No prior treatment for HNSCC - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Absolute neutrophil count ≥ 1,500 cells/µL - Platelets ≥ 100,000/µL - Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell [prbc] transfusion) - Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN - Albumin ≥ 3.0 g/dL - Serum creatinine ≤ 1.5 x ULN - Calculated creatinine clearance of ≤ 50 mL/min - International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level < 1.1 units/mL (U/mL) are allowed on the trial - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures - Ability to understand and willingness to sign a written informed consent document - Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion - Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion - Female subjects of childbearing age must have a negative serum pregnancy test at study entry Exclusion Criteria: - Poor venous access for study drug administration - Nasopharynx cancer, cancer of unknown primary, sinonasal cancer - Determined not to be a surgical candidate due to medical co-morbidities - Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation) - Prior organ allograft or allogeneic bone marrow transplantation - Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll - Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease - Women who are pregnant or lactating - Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study - Clinical evidence of bleeding diathesis or coagulopathy - Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma fully resected) unless disease free for a minimum of one year - Patients that have had prior treatment for HNSCC are not eligible - Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment - Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration - History of severe hypersensitivity reactions to other monoclonal antibodies - Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab - No archival tissue available pre-study treatment, and repeat biopsy not feasible ; PRIMARY OUTCOME: Change in immune profile in the tumor microenvironment; SECONDARY OUTCOME 1: Incidence of adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0[/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 - EMPOWER-CSCC 1; BRIEF: Groups 1 to 4 To estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced treated with cemiplimab ; DRUG USED: Libtayo; DRUG CLASS: Biologic; INDICATION: Skin Cancer - Squamous Cell Carcinoma (SCC) ; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - At least 1 measurable lesion - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - Adequate bone marrow function - Adequate renal function - Adequate hepatic function - Archived or newly obtained tumor material - Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6) - Surgical or radiological treatment of lesions contraindicated Key Exclusion Criteria: - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events - Prior treatment with an agent that blocks the PD-1/PD-L1pathway - Prior treatment with a BRAF inhibitor - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40. - Untreated brain metastasis(es) that may be considered active - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus - History of non-infectious pneumonitis within the last 5 years - Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments - Known allergy to doxycycline or tetracycline - Patients with a history of solid organ transplant - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Investigator Assessments of 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 II - TARMAC (w/Tisagenlecleucel); BRIEF: This is an open label, multi-center, single-arm, phase II study investigating the efficacy and safety of the combination of ibrutinib and Tisagenlecleucel in twenty patients with relapsed or refractory Mantle Cell Lymphoma (MCL) or who had sub-optimal response to standard therapy in the presence of TP53 mutation. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Combination; LEAD SPONSOR: Peter MacCallum Cancer Centre, Australia; CRITERIA: Inclusion Criteria: - Patients must meet all the following criteria for study entry: 1. Written informed consent prior to screening procedures 2. Be ≥18 years of age on the day of signing informed consent 3. Have a confirmed diagnosis of MCL according to World Health Organization (2016) criteria 4. Have sufficient fresh or archival material available for central review 5. At least one site of radiographically assessable disease not previously irradiated (lymph node with largest diameter ≥1.5cm, or unequivocal evaluable hepatomegaly/splenomegaly or marrow phase disease) 6. Meet at least one of the following disease criteria: - Have relapsed, or progressed following at least 1 prior line of systemic chemoimmunotherapy for MCL (may include ibrutinib or other BTK-inhibitor in combination) - Be refractory to at least one prior line of chemoimmunotherapy (refractory is defined as less than a conventional PR following 2 cycles of anthracycline or cytarabine-containing therapy) - Have achieved <CR on PET imaging following 2 cycles of anthracycline or cytarabine-containing therapy in the presence of aberrations of p53; or <CR post autologous stem cell transplantation - Failure to achieve CR following at least 6 months of an ibrutinib or BTK inhibitor -containing front-line regimen, or failure to achieve PR following 8 weeks of a BTK inhibitor 7. Have a life expectancy of ≥ 3 months, as judged by the investigator 8. Have acceptable haematological function within 7 days prior to registration, defined as: - Absolute neutrophil count ≥1x10^9/L (may be supported by growth) - Absolute lymphocyte count ≥0.3x10^9/L or absolute CD3+ fraction > 0.15x 10^9/L - Platelets >50x 10^9/L unless explained by lymphoma at the discretion of the CPI - Haemoglobin ≥ 80 g/L (may be transfusion supported) 9. Have acceptable organ function within 7 days prior to registration, defined as: - Serum creatinine ≤1.5 x ULN, or a calculated creatinine clearance of at least 50 mL/min using the Cockcroft-Gault equation (see appendix 1) or a 24-hour urine collection - AST or ALT ≤3.0 x ULN - Bilirubin ≤ 1.5 x ULN (with the exception of patients with Gilberts syndrome. Patients with Gilberts syndrome may be included if their total bilirubin is ≤3.0 x ULN and direct bilirubin ≤1.5 x ULN). - aPTT and PT ≤ 1.5x ULN - Adequate pulmonary function defined as: - No or mild dyspnea (≤ grade 1) - Oxygen saturation measured by pulse oximetry ≥ 90 percent on room air 10. Female patients of childbearing potential and non-sterile male patients (with partners of childbearing potential) must agree to use highly effective methods of contraception from registration on the study to 30 days after the last dose of ibrutinib and 12 months after Tisagenlecleucel infusion and until Tisagenlecleucel is no longer present by qPCR on two consecutive tests (whichever is later): - Total abstinence from sexual intercourse when this is in line with the preferred and usual life style of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception - Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks prior to registration. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment - Male sterilisation (at least 6 months prior to screening). For female patients on the study, the vasectomised male partner should be the sole partner for that patient - Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before enrolment into this study. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential. 11. Female patients of childbearing potential must have a negative serum (beta-human chorionic gonadotropin (β-hCG) or urine pregnancy test within 7 days of registration 12. Sexually active male patients must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 30 days after the last dose of ibrutinib or 12 months after Tisagenlecleucel infusion and until Tisagenlecleucel is no longer present by qPCR on two consecutive tests Exclusion Criteria: - Patients who meet any of the following criteria will be excluded from study entry: 1. Prior allogeneic transplantation 2. Autologous transplantation within 6 weeks prior to registration 3. Active and uncontrolled autoimmune cytopenias 4. Active central nervous system involvement with MCL 5. Previous treatment with adoptive T-cell therapy 6. Receipt of a non BTK-inhibitor investigational medical product within the last 30 days prior to planned leukapheresis 7. Receipt of a non-anti CD20- monoclonal antibody with anti-neoplastic intent within 30 days prior to planned leukapheresis 8. Receipt of steroids >20mg prednisolone or equivalent in the fortnight prior to planned leukapheresis 9. Requirement for ongoing therapy with: - Potent CYP3A inhibitors (e.g. indinavir, ketoconazole, clarithromycin) - Potent CYP3A inducers (e.g. rifampin, phenytoin, carbamazepine) - Vitamin K antagonists (e.g. warfarin or equivalent) - Antiretroviral medications 10. Consumption within 3 days prior to registration: - Grapefruit or grapefruit products - Seville oranges - Star fruit 11. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of screening or class III to IV cardiac disease as defined by the New York Heart Association Functional Classification 12. Active neurological disorders of clinical relevance (e.g. epilepsy, severe brain injury, dementia, Parkinsons disease or autoimmune/inflammatory disorders (e.g. Guillain-Barre syndrome, motor neurone disease, chronic inflammatory demyelinating polyneuropathy) 13. Other significant life-threatening illness or medical condition which, in the investigators opinion, could compromise the subjects safety, interfere with absorption or metabolism of study drug, or put the study outcomes at undue risk 14. History of other active malignancy, with the exception of: - Adequately treated in situ carcinoma of the cervix or breast - Adequately treated basal cell carcinoma of skin or localised squamous cell carcinoma of the skin - Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and without evidence of recurrence for at least 2 years prior to registration 15. History of human immunodeficiency (HIV) or active hepatitis C virus or active hepatitis B virus. NOTE: Serology must be repeated at the pre-conditioning stage prior to infusion with Tisagenlecleucel. 16. Clinically significant active infection confirmed by clinical evidence, imaging or positive laboratory tests (e.g. blood cultures, viral DNA/RNA by PCR) 17. Receipt of live, attenuated vaccines within 4 weeks of registration 18. Major surgery within 4 weeks prior to registration 19. Pregnant or nursing (lactating) women. Note: Women of child-bearing potential must have a negative serum pregnancy test performed within 24 hours before leukapheresis, lymphodepletion (if performed) and prior to Tisagenlecleucel infusion. 20. Known hypersensitivity to the excipients of Tisagenlecleucel or to any product to be given to the patient as per the study protocol (e.g. tocilizumab and lymphodepleting agents) ; PRIMARY OUTCOME: Estimate complete response (CR) rate at month 4 following the infusion of Tisagenlecleucel using the Lugano criteria; SECONDARY OUTCOME 1: Evaluate safety of combination therapy with Tisagenlecleucel and ibrutinib through monitoring of the incidence, nature and severity of adverse events (graded according to NCI CTCAE v5.0), SAEs, dose interruptions and dose reductions of ibrutinib[/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 - 2203; BRIEF: multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome ; DRUG USED: Signifor; DRUG CLASS: Non-NME; INDICATION: Dumping Syndrome; TARGET: Somatostatin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria:. - Male or female patients ≥ 18 years of age. - Post-gastric or esophageal bypass surgery, matching one of the criteria below: - Bariatric surgery: more than 6 months before signing the informed consent - Esophageal cancer surgery: were disease free at study entry - Gastric cancer surgery: were at stage 0 or I and were disease free at study entry - Patient with a documented diagnosis of Dumping Syndrome defined as having: - History of/or active symptoms associated with dumping syndrome (e.g. post-prandial tachycardia, bloating, diarrhea) and - Documented history of hypoglycemia based on either: - glucose <50 mg/dL or 2.8 mmol/L on a sporadic or scheduled blood analysis -or - glucose value <60 mg/dL or ≤ 3.3 mmol/L at 90, 120, 150 or 180 min during an OGTT - Patients had at least one glucose level <60 mg/dL (or ≤ 3.3 mmol/L) at 90, 120, 150 or 180 min during the 3-hour OGTT at screening. - Patients with esophageal cancer with a negative computed tomography (CT) or Magnetic resonance imaging (MRI) scan (neck, thoracic, and upper abdominal) and albumin ≥ 3.5 g/dl at baseline. - Patients with gastric cancer with a negative CT or MRI scan (total abdomen). - Karnofsky Performance Status ≥ 60 (i.e. required occasional assistance, but was able to care for most of their personal needs) - Patients who received other therapies for dumping syndrome (such as acarbose, gama guar, pectin) must have stopped all treatments and had a wash out period prior to signing the informed consent (i.e. at least 2 weeks between last previous therapy and first dose of study medication in this study). - Patients who had provided signed written informed consent prior to study participation. Exclusion Criteria: - Bariatric patients who had lap band. - Patients with a current diagnosis of diabetes mellitus. - Patients who had failed treatment with somatostatin analogues for dumping syndrome in the past. - Patients who had been treated with somatostatin analogues in the past, must have had an appropriate interval between the last administration of somatostatin analogues treatment and the study drug as follows - Octreotide sc for ≥ 72 hours - Octreotide LAR for ≥ 56 days (8 weeks) - Lanreotide Autogel for ≥ 98 days (14 weeks) - Lanreotide SR ≥ 28 days (4 weeks) - Patients who were already treated with pasireotide. - Patients who had a known hypersensitivity to somatostatin analogues. - Patients who were receiving anti-cancer therapy (chemotherapy and/or radiotherapy). - Patients who had any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: - Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot). An HIV test was not required; however, previous medical history was reviewed. - Non-malignant medical illnesses that were uncontrolled or whose control may have been jeopardized by the treatment with this study treatment. - Life-threatening autoimmune and ischemic disorders. - Patients with the presence of active or suspected acute or chronic uncontrolled infection. Inadequate end organ function as defined by: - Inadequate bone marrow function: - White blood cells (WBC) <2.5 x 109/L - Absolute neutrophil count <1.5 x 109/L - Platelets <100 x 109/L - Hemoglobin <9 g/dL - International normalized ratio (INR) ≥ 1.3 - Serum creatinine >2.0 mg/dL - Alkaline phosphatase (ALP) >2.5 x upper limit of normal (ULN) - Serum total bilirubin >1.5 x ULN - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 x ULN - History of liver disease, such as cirrhosis or chronic active hepatitis B and C. - Presence of Hepatitis B surface antigen (HbsAg) and/ or presence of Hepatitis C antibody test (anti-Hepatitis C Virus). ; PRIMARY OUTCOME: Response Rate in Plasma Glucose Level; SECONDARY OUTCOME 1: Response Rate in Plasma Glucose Level[/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 - CHIME 4 (OLE); BRIEF: Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study are invited to participate in this study. This is a Phase 3 open label extension (OLE) study with the objective of collecting long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD, when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects will be treated with SPN-810.Subjects will be given a choice to extend participation in this study every 6 months for up to 36 months. ; DRUG USED: SPN-810; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine 2 (D2) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301or 810P302 or discontinued early from the previous study during the maintenance phase and allowed to enroll only after consultation between the Investigator, the Medical Monitor and the Sponsor. 2. Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs). 3. Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302. 4. Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants). 5. Weight of at least 20 kg. 6. Written Informed Consent obtained from the subjects parent or LAR, and written Informed Assent obtained from the subject if appropriate. Exclusion Criteria: 1. Body Mass Index (BMI) in 99th percentile or above. 2. Clinically significant change in health status, safety concern or any other reason that, in the opinion of the Sponsor or the Investigator, would prevent the subject from participating in this study or successfully completing this study. 3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males). 4. Current substance or alcohol use. 5. Suicidal thoughts or behaviors confirmed at last visit in the previous double-blind randomized study. ; PRIMARY OUTCOME: Adverse Events will be summarized at the subject and event level. Treatment Emergent Adverse Events (TEAEs) will be summarized by severity and relationship. TEAE incidence table will be listed and summarized by group of optimized doses.; SECONDARY OUTCOME 1: [/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 IIb/III - SOLUTION; BRIEF: The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails. ; DRUG USED: Luliconazole 10%; DRUG CLASS: Non-NME; INDICATION: Fungal Infections - Non-Systemic; TARGET: Ergosterol biosynthesis; THERAPY: Monotherapy; LEAD SPONSOR: Topica Pharmaceuticals; CRITERIA: Inclusion Criteria: - Subjects of either gender, any race and between the ages of 18 and 70 inclusive - Subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (DSO) - Subjects must be free of any disease that in the Investigators opinion might interfere with the study evaluations or jeopardize the subjects safety Exclusion Criteria: - Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution - Subjects who are currently participating or have recently participated in another investigational medication or device study ; PRIMARY OUTCOME: The proportion of subjects who achieve complete cure of the target great toenail; SECONDARY OUTCOME 1: [/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 - Long Term Safety Study; BRIEF: This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD). ; DRUG USED: ASN002; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: JAK/STAT , Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: Asana BioSciences; CRITERIA: Inclusion Criteria - Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study - Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigators judgment. - Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study. - Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse - Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. - Subjects must be willing to comply with all study procedures and must be available for the duration of the study. - Subject has a body mass index (BMI) ≤ 38 kg/m2. Exclusion Criteria - Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. - Subject has clinically infected atopic dermatitis. - A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer - Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments. - Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past. - Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator. ; PRIMARY OUTCOME: Change From Baseline in Eczema Area Severity Index (EASI) Score; SECONDARY OUTCOME 1: Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)[/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 - STRIDE-1 (TRD); BRIEF: To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD. Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period. ; DRUG USED: AXS-05; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine Reuptake, Nicotinic Acetylcholine Receptors (nAChR) , NMDA Glutamate Receptor, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Receptors - Unspecified, Sigma-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Axsome Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Currently meets DSM-V criteria for MDD - History of inadequate response to 1 or 2 adequate antidepressant treatments - Body mass index (BMI) between 18 and 40 kg/m2, inclusive - Agree to use adequate method of contraception for the duration of the study - Additional criteria may apply Key Exclusion Criteria: - Suicide risk - Treatment with any investigational drug within 6 months - History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study - Additional criteria may apply ; PRIMARY OUTCOME: Montgomery-Åsberg Depression Rating Scale (MADRS) total score; SECONDARY OUTCOME 1: Clinical Global Impressions-Severity (CGI-S)[/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 - CEDAR; BRIEF: This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration. ; DRUG USED: Darpin; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Diagnosis of age-related macular degeneration in at least 1 eye - Best corrected visual acuity of 20/40 to 20/320 in the study eye - Best corrected visual acuity of 20/200 or better in the non-study eye Exclusion Criteria: - History of vitrectomy, macular surgery, or glaucoma surgery in the study eye - Cataract or refractive surgery in the study eye within the last 3 months ; PRIMARY OUTCOME: Percentage of Participants With Stable Vision at Week 52; SECONDARY OUTCOME 1: Mean Change From Baseline in BCVA in the Study Eye at Week 52[/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 307 (Symptomatic GERD); BRIEF: The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD). ; DRUG USED: AcipHex ER; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: KEY INCLUSION CRITERIA: Male or female, ages 18 through 75 years will be included in the study. Females should be either of nonchildbearing potential or of childbearing potential. Females of childbearing potential must have negative serum and urine pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Women using hormonal contraceptives must also be using an additional approved method of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Pregnant or lactating females are excluded. Subjects must have a history of heartburn, identified as their main complaint, for 6 months or longer.Subjects must have documentation of a minimum of 5 moderate to severe heartburn episodes, 3 of which occur during the daytime and 1 of which occurs during the nighttime, during the last 7 days before randomization. Subjects must be able to read, write, and understand the language of the symptom dairy. KEY EXCLUSION CRITERIA: Subjects will be excluded from the study if they are found to have erosive esophagitis during esophagogastroduodenoscopy (EGD) at Screening, current or a history of esophageal motility disorders, current or a history of Barretts esophagus, current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications), current or a history of Zollinger-Ellison syndrome and acid hypersecretory conditions, or current gastric or duodenal ulcer. Subjects will be excluded if they are found to have current or a history of cancer, with the exception of fully excised skin basal cell carcinoma, inflammatory bowel disease, a history of esophageal, gastric and duodenal surgery, except simple closure of a perforated ulcer. Subjects will be excluded who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>=20 mg/day prednisone or equivalent), or aspirin (>325 mg/day). Female subjects will be excluded who are pregnant, lactating, or have a positive B-human gonadotropin test at Screening/Baseline. Subjects will be excluded who are known to be human immunodeficiency virus (HIV) positive, have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial. Subjects who are unwilling to provide informed consent will be excluded. ; PRIMARY OUTCOME: Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4; SECONDARY OUTCOME 1: Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4[/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 - LP0105-1020; BRIEF: This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel ; DRUG USED: Picato Gel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Mitochondria, Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities Exclusion Criteria: - Location of the treatment area (trunk (except chest) or extremities) - within 5 cm of an incompletely healed wound, - within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) - Prior treatment with ingenol mebutate within the selected treatment area - Lesions in the treatment area that have: - atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous horns) and/or, - recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions) ; PRIMARY OUTCOME: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs); SECONDARY OUTCOME 1: Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation)[/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 - RESPONSE 2; BRIEF: This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polycythemia Vera (PV); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, Non-palpable spleen, Phlebotomy dependent, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2. Exclusion Criteria: Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, excluding specific skin cancers, Previously received treatment with a JAK inhibitor, Being treated with any investigational agent, Women who are pregnant or nursing. Other inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Number of Participants Achieving Hematocrit (Hct) Control at Week 28; SECONDARY OUTCOME 1: Number of Participants Achieving a Complete Hematological Remission at Week 28[/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 - B7471008 (18-49 y/o); BRIEF: This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC. ; DRUG USED: Prevnar 20; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: 1. Male or female adults ≥18 and <50 years of age. 2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product. 3. Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children. Exclusion Criteria: 1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigators opinion, excludes the subject from participating in the study. 3. History of microbiologically proven invasive disease caused by S pneumoniae. 4. Pregnant female subjects or breastfeeding female subjects (known or suspected). ; PRIMARY OUTCOME: Percentage of Participants With Local Reactions Within 10 Days After Vaccination; SECONDARY OUTCOME 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination[/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 I/Ib - IVY; BRIEF: This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy. ; DRUG USED: Pegilodecakin; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: IL-10 (Interleukin-10) and IL-10 Receptor (IL-10R); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: Part A Escalation Cohorts: o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts: - Tumors with all histological diagnosis or tissue origin may be enrolled - Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease. - Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC) - At least 18 years of age - Performance Status of 0 or 1 - Adequate organ function Exclusion Criteria: - Hematologic malignancies - Pregnant or lactating - Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders - Myocardial infarction within the last 6 months - Unstable angina, or unstable cardiac arrhythmia requiring medication - Surgery within the last 28 days - Systemic fungal, bacterial, viral, or other infection - History of bleeding diathesis within the last 6 months - Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B ; PRIMARY OUTCOME: Safety and tolerability as measured by incidence of adverse events; SECONDARY OUTCOME 1: Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)[/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 IIb - Abdominoplasty; BRIEF: The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty. ; DRUG USED: Olinvyk; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Trevena Inc.; CRITERIA: Inclusion Criteria: - >=18 and <=65 years of age. - Plans to undergo an abdominoplasty procedure with no additional collateral procedures. - Is able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure. Exclusion Criteria: - ASA Physical Status Classification System classification of P3 or worse. - Has surgical or post-surgical complications. - Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs. - Has previously participated in another TRV130 clinical study. ; PRIMARY OUTCOME: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo; SECONDARY OUTCOME 1: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine[/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 - 202; BRIEF: The purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy. ; DRUG USED: Efpeglenatide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Hanmi Pharmaceutical Company Limited; CRITERIA: Inclusion Criteria: - Is male or female and 18 to 65 years of age, inclusive, at screening - Has a history of T2DM and a stable dose of metformin - Has HbA1c levels at screening between 7% and 10% Exclusion Criteria: - Is pregnant or lactating - Has type 1 diabetes - Has a significant change in body weight in the 3 months before screening - Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening - Has an estimated glomerular filtration rate rate <75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 <estimated glomerular filtration rate <90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio >30 mg/g. - Has alanine aminotransferase or aspartate aminotransferase values >2.0 × upper limit of normal or total bilirubin >1.5 × upper limit of normal unless the subject has a known history of Gilberts syndrome - Has fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) or >250 mg/dL (>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredricksons Type I, IV or V hyperlipidemia will be excluded. - Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding - Has any acute illness within 5 days before first study drug administration - Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis - Is a heavy tobacco user(more than 10 cigarettes a day) - Is a heavy alcohol user - Has a positive screen for drugs of abuse ; PRIMARY OUTCOME: Number of subjects with adverse events as a measure of safety and tolerability; SECONDARY OUTCOME 1: The pharmacokinetics in repeat-dose[/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 - PEP0208; BRIEF: The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer. ; DRUG USED: Onivyde; DRUG CLASS: Non-NME; INDICATION: Pancreatic Cancer; TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: PharmaEngine; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas - Metastatic disease - Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen - Karnofsky performance status equal or more than 70 Exclusion Criteria: - With active CNS metastases - With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1) - Major surgery or radiotherapy within 4 weeks - Prior participation in any investigational drug study within 4 weeks - With prior irinotecan treatment ; PRIMARY OUTCOME: Survival Rate; SECONDARY OUTCOME 1: other efficacy endpoints[/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 I/II - ACE-CL-001; BRIEF: This study is evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). ; DRUG USED: Calquence; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Acerta Pharma BV; CRITERIA: Inclusion Criteria: 1. Men and women ≥ 18 years of age with a confirmed diagnosis of CLL/SLL, which has relapsed after, or been refractory to, ≥ 2 previous treatments for CLL/SLL. 2. Must have measurable CLL/SLL defined as ≥ 1 lymph node ≥ 2 cm as measured in the longest diameter. 3. Active disease meeting ≥ 1 of the following International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for requiring treatment: 1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL). 2. Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly. 3. Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy. 4. Progressive lymphocytosis with an increase of > 50% over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. The LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In participants with initial blood lymphocyte counts of < 30 X 10^9/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded. 5. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy. 6. Constitutional symptoms documented in the participants chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs: i. Unintentional weight loss ≥ 10% within the previous 6 months before screening. ii. Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before screening without evidence of infection. iii. Night sweats for > 1 month before screening without evidence of infection. 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 5. Agreement to use highly effective methods of contraception during the study and for 2 days after the last dose of study drug if sexually active and able to bear or beget children (see Section 3.7.9 for list of highly effective methods of contraception). 6. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty. 7. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local participant privacy regulations). Inclusion Criteria for Treatment Subgroups 1. Treatment Naive only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL, who require treatment per National Cancer Institute (NCI) or International Working Group guidelines and a) do not want to receive chemoimmunotherapy or b) have comorbidities that would preclude chemoimmunotherapy. 2. Ibrutinib Intolerant only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL who are not tolerating ibrutinib due to ibrutinib-related AEs. 3. Richters Syndrome/Prolymphocytic Leukemia Transformation only: Men and women ≥ 18 years of age and biopsy proven diffuse large B cell lymphoma (DLBCL) Richters transformation or prolymphocytic leukemia transformation. 4. Ibrutinib relapsed/refractory (R/R) only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL whose best response after 2 cycles of ibrutinib therapy was stable disease or nonresponse or who initially responded to ibrutinib therapy and now have signs of clinical progression. Exclusion Criteria: 1. Prior malignancy, except for adequately treated basal cell, squamous cell skin cancer or in situ cervical cancer. Participants with other prior malignancies from which the participant has been disease free for ≥ 2 years may be included if approved by the medical monitor. 2. A life-threatening illness, medical condition or organ system dysfunction which, in the investigators opinion, could compromise the participants safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk. 3. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) ≤ 40%. 4. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. 5. Any immunotherapy within 4 weeks of first dose of study drug. 6. For participants with recent chemotherapy or experimental therapy the first dose of study drug must occur after 5 times the half-life of the agent(s). 7. Relapsed after, or refractory to, prior BTK inhibitor therapy (Note: Does not apply to Ibrutinib R/R or Richters Syndrome Group). 8. Any history of Richters transformation (Note: Does not apply to Richters Syndrome Group). 10. Central nervous system (CNS) involvement by lymphoma. 11. Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation. 12. Known history of human immunodeficiency virus (HIV) or serologic status indicating active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection or any uncontrolled active systemic infection. Participants with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before enrollment. Those who are hepatitis B surface antigen positive or hepatitis B PCR positive and those who are hepatitis C PCR positive will be excluded. 13. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenic purpura (ITP) defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (> 20 mg daily of prednisone daily or equivalent). 14. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug. 15. Requires treatment with proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). 16. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug. 17. Major surgery within 4 weeks before first dose of study drug. 18. ANC < 0.75 x 10^9/L or platelet count < 50 x 10^9/L unless there is bone marrow involvement. 19. Total bilirubin > 1.5 x upper limit of normal (ULN) (total bilirubin ≤ 2.5 x ULN allowed in participants with autoimmune hemolytic anemia that is otherwise controlled); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN unless disease related. 20. Serum amylase > 1.5 x ULN or serum lipase > 1.5 x ULN. 21. Significant screening electrocardiogram (ECG) abnormalities including, 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, or QTc ≥ 480 ms. 22. Cardiac troponin I levels above the limit of normal as specified by the manufacturer. 23. Breast feeding or pregnant. 24. History of bleeding diathesis (eg, hemophilia, von Willebrand disease). 25. Concurrent participation in another therapeutic clinical trial. 26. Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault [(140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female]. 27. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening. ; PRIMARY OUTCOME: Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1; SECONDARY OUTCOME 1: Percentage of Participants With Objective Response (OR) as Assessed by the Investigator[/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 Ia/Ib - Canada; BRIEF: This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals ; DRUG USED: CC-31244; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Monotherapy; LEAD SPONSOR: Cocrystal Pharma, Inc.; CRITERIA: Main Inclusion Criteria: HV and HCV INFECTED SUBJECTS: - Male or female aged ≥ 18 to ≤ 65 years; - Body mass index ≥ 18.5 to ≤ 35.0 kg/m2; - Body weight ≥ 50 kg; - Negative screening for alcohol and drugs of abuse; - Normal results on 12-lead electrocardiogram (ECG); - For females, negative result on a pregnancy test. HCV INFECTED SUBJECTS: - HCV treatment-naïve subjects must have not received prior direct acting agent (DAA) treatment for hepatitis C infection; - Documented clinical history compatible with chronic hepatitis C; - HCV Genotype 1 by HCV genotyping performed at Screening; - Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening; - Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest, F2 or lower) within one year prior to study), if these are not available, do a FibroTest at screening, which must be F2 or lower. Main Exclusion Criteria: HV and HCV INFECTED SUBJECTS: - Females who are pregnant or are lactating; - Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV); - Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator; - Positive screen result for drugs of abuse or alcohol on Day -1. Use of other investigational drugs within 60 days of dosing; - Subject with intestinal malabsorption; - Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities; - Serum creatinine > upper limit of normal (ULN); - Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. HEALTHY VOLUNTEERS: - Positive screen for anti-HCV antibody HCV INFECTED SUBJECTS: - Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis; - History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency; - History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC; - Active clinically significant diseases. ; PRIMARY OUTCOME: Number of treatment emergent adverse events (AE); SECONDARY OUTCOME 1: Measure plasma levels of CDI-31244 after SD[/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 Ib/II - w/Carboplatin; BRIEF: This study seeks to (i) determine the safe dose of CYT997 when given in combination with carboplatin in patients with relapsed glioblastoma multiforme (glioma) and (ii) to determine whether the combination of CYT997 with carboplatin is a useful treatment for glioma. ; DRUG USED: CYT997; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Angiogenesis, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Patients must have histologically-confirmed glioblastoma multiforme that has progressed after initial surgery, radiation therapy and temozolomide chemotherapy. - Measurable tumour must be present on gadolinium-enhanced MRI - At least 3 months must have elapsed from completing radiation to minimize the possibility of pseudo-progression. - At least 4 weeks since prior chemotherapy (6 weeks if the last regimen included bischloroethylnitrosourea (BCNU) or Chloroethyl-Cyclohexyl-NitrosoUrea (CCNU)). - Age ≥ 18 years. - If patients are taking steroids, the dose must be stable for = 7 days. - Eastern Cooperative Oncology Group (ECOG) performance status = 2. - Life expectancy of greater than 2 months. - Patients must have adequate organ and marrow function as defined below: - Absolute neutrophil count = 1.5 × 109/L - Platelet count = 100 × 109/L - Total bilirubin within normal limits - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 5 × upper limit of normal (ULN) - Creatinine within normal limits OR creatinine clearance = 60 mL/min/1.73 m2 for patients with creatinine levels above normal - Normal left ventricular ejection fraction on a gated blood pool scan or echocardiogram - Must agree to use adequate contraceptive measures if indicated - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have received any other investigational agent in the preceding four weeks prior to commencing therapy in this study. - Patients who have been previously treated with carboplatin. - Patients who have been previously treated with bevacizumab or other anti-angiogenesis or vascular-disrupting agents - Patients who are receiving enzyme-inducing anticonvulsant drugs (EIACD) such as phenytoin or carbamazepine. - Patients with a history of allergic reactions attributed to compounds of similar chemical composition to CYT997 or other agents used in the study. - Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant or lactating women. - Patients with immune deficiency, including HIV-positive patients. - Patients with uncontrolled diarrhoea despite optimal medication and those with any history of acute gastrointestinal bleeding. - Patients who are unable or unwilling to undergo MRI scanning - Patients with the following conditions/treatments will be excluded: - Myocardial infarction (MI) or stroke within 6 months - History of stroke or transient ischemic attacks (TIAs) - Unstable angina pectoris or acute ischemic changes on ECG - History of diabetic retinopathy - Symptomatic peripheral arterial disease o Major surgery in the last 4 weeks - Evidence of intra-tumoural haemorrhage on imaging, except for stable grade-1 post-operative haemorrhage. - Current therapeutic anti-coagulation with warfarin or a heparin (excludes lowdose prophylactic heparin). - Uncontrolled hypertension - The need for any anti-arrhythmic drugs - Presence of luminal stenosis of 50% or more in any of the extracranial or intracranial arteries supplying the brain, as measured by magnetic resonance angiography (MRA) at baseline. - Patients with a baseline prolongation of the QTc interval of Common Terminology Criteria (CTC) grade 1 (QTc > 0.45- 0.47 sec) or greater. - Patients with impaired cardiac function or clinically significant cardiac diseases, including any one of the following: - Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram; - complete left bundle branch block; - obligate use of a cardiac pacemaker; - congenital long QT syndrome; - history or presence of ventricular tachyarrhythmia; - presence of unstable atrial fibrillation (ventricular response > 100 bpm) Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria; - clinically significant resting bradycardia (< 50 bpm); - right bundle branch block + left anterior hemiblock (bifascicular block); - angina pectoris = 3 months prior to starting study drug; - acute MI = 3 months prior to starting study drug; or - other clinically significant heart disease (e.g., congestive heart failure (CHF), uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen). - Patients currently receiving treatment with medications known to prolong the QTc interval and/or to induce Torsades de Pointes arrhythmia. ; PRIMARY OUTCOME: Safety and tolerability of escalating doses of CYT997 when given in combination with standard carboplatin therapy (Phase Ib component); SECONDARY OUTCOME 1: Objective response rate (ORR)[/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 Ib - MAD; BRIEF: Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose production characteristic of type 2 diabetes mellitus that is a major contributor to hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with type 2 diabetes mellitus. ; DRUG USED: RVT-1502; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ligand Pharmaceuticals; CRITERIA: INCLUSION CRITERIA: Part 1 1. Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment. 2. Willing and able to provide written informed consent. 3. Not diabetic and has a fasting plasma glucose (FPG) between 70 mg/dL and 105 mg/dL, inclusive. 4. Good health with no significant concomitant pathology based on medical history, physical examination, electrocardiogram (ECG), routine laboratory tests (chemistry, hematology, lipid profile, international normalized ratio, and urinalysis), and vital signs. Part 2 1. Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment. 2. Willing and able to provide written informed consent. 3. Has T2DM according to American Diabetes Association criteria. 4. Currently on stable metformin therapy (unchanged dose for greater than or equal to 12 weeks prior to screening). At the discretion of the investigator, subjects who are drug naïve or whose metformin dose has not been stable for at least 12 weeks at screening, may be started on metformin or have their metformin dose stabilized. Following 12 weeks of stable metformin, they may undergo re screening including assessment of HbA1c and FPG (inclusion criteria 5 and 6). 5. Has an HbA1c level between 6.5% and 10.5% at screening. One retest is permitted. 6. Venous FPG is 125 mg/dL and 260 mg/dL at screening and either the Day -1 venous FPG or the Day 1 capillary blood glucose (CBG) is 115 mg/dL and 260 mg/dL. One retest is permitted. 7. Has a body mass index between 20 and 45 kg/m2, inclusive. EXCLUSION CRITERIA: Part 1 1. Has a recent history of drug and/or alcohol abuse. 2. Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions as specified in the protocol. 3. Unwilling to comply with restrictions on strenuous exercise as specified in the protocol. 4. Has history of clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data. 5. Has liver transaminase levels (aspartate transaminase [AST] or alanine transaminase [ALT]) >10% of the upper limit of normal (ULN), or has creatine kinase (CK) levels >2 × ULN at screening or admission to clinic (Day -1). 6. Has a plasma triglyceride level >400 mg/dL. If triglyceride level is between 400 mg/dL and 500 mg/dL. 7. Has a recent history of uncontrolled high blood pressure or has systolic blood pressure <90 mmHg or >140 mmHg or diastolic blood pressure <60 mmHg or >90 mmHg at screening. 8. Is taking prescription or non-prescription drugs, vitamins, herbal, and dietary supplements, within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, or is unwilling to refrain from taking any such medication until after the last protocol-specified blood sample. The use of acetaminophen, not to exceed a total daily dose of 1 g, is permitted up to 24 hours prior to admission to the investigational site and then prohibited until after the last protocol-specified blood sample. The use of stable hormone replacement medication by women, topical steroids, and stable thyroid medication is permitted. Part 2 1. Has a history of hypoglycemic unawareness or recurrent hypoglycemia requiring assistance. 2. Has liver transaminase levels (AST or ALT) >10% × ULN, or has CK levels >1.5 × ULN at screening or admission to clinic (Day -1). 3. Has history of clinically significant cardiovascular, pulmonary, renal, endocrine (other than T2DM), hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data. 4. Has a recent history of uncontrolled high blood pressure or has systolic blood pressure <90 mmHg or >140 mmHg or diastolic blood pressure <60 mmHg or >90 mmHg at screening. One retest of blood pressure within 24 hours is permissible at the discretion of the Investigator. Therapy for hypertension (beta blockers excluded) that has been stable for at least one month prior to screening is permitted. At the Investigators discretion, one anti-hypertensive medication (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, hydrochlorothiazide, or dihydropyridine calcium-channel blocker) may be initiated, or the dosage of a current antihypertensive medication up titrated, in a subject with blood pressure slightly above the eligibility criterion at screening. After at least 4 weeks of stable blood pressure treatment, if the subjects blood pressure has decreased to within the 140/90 mmHg limit, the subject will be fully reassessed for eligibility. 5. Has received insulin for more than 6 consecutive days within 6 months prior to screening or has received insulin within 3 months prior to screening. 6. Has been treated with peroxisome proliferator-activated receptor gamma agonist, incretin therapy, amylin mimetics, or sodium-glucose linked transporter-2 inhibitor therapy within 12 weeks prior to screening; treatment with other diabetic medications (excluding metformin) within 3 weeks prior to screening. 7. Is taking concomitant medications. At least 3 months of stable therapy for thyroid replacement and hypercholesterolemia (gemfibrozil, Welchol, and cholestyramine are not permitted) and at least 4 weeks of stable hypertension medications (as described above) and low dose aspirin are permitted. ; PRIMARY OUTCOME: Number of participants with one or more drug related adverse events or serious adverse events; SECONDARY OUTCOME 1: Pharmacokinetic (PK) profile (area under the concentration curve (AUC) of LGD-6972 after repeat oral doses in NHS and in subjects with T2DM[/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 - Dose-finding (Brazil); BRIEF: A Phase II open-label, randomized, parallel group, 2 sites (Brazil), designed to evaluate the safety and efficacy of 3 doses of study drug for the treatment of the MPS II. ; DRUG USED: JR-141; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis II (MPS II; Hunter Syndrome); TARGET: Sulfated alpha-L-iduronic acid; THERAPY: Monotherapy; LEAD SPONSOR: JCR Pharmaceuticals Co., Ltd.; CRITERIA: Inclusion Criteria: - Males with confirmed diagnosis of MPS II, based on deficient activity of IDS in leucocytes or fibroblasts and/or pathogenic mutations identified in the IDS gene (if enzyme diagnosis was in dried blood spots or plasma, molecular genetics confirmation is mandatory). - One of the following age groups: 1. 0 to 3 years and 11 months old (6 patients, 2 in each dose) 2. 4 years to 7 years and 11 months old (6 patients, 2 in each dose) 3. 8 years or older (6 patients, 2 in each dose) - Capable of providing written consent by himself, unless the patient is under the age of 18 years at the time of informed consent process, or it is not possible to obtain consent from the patient himself due to his intellectual disabilities associated with MPS II. - In the case of a patient who is under the age of 18 years or from whom it is not possible to obtain consent due to his intellectual disabilities associated with MSP II, he may be included if written consent can be provided by legal representative; however written consent should be obtained from the patient himself too, wherever possible. - Naïve patients or patients who are receiving enzyme replacement therapy with idursulfase could be included if provided treatment has been stable in the last 6 months and agree to interrupt the treatment at least one week before the first study drug infusion, and agree in suspending this treatment for the duration of the trial. Exclusion Criteria: - Refusal to sign the informed consent form. - Unable to perform the study procedures, except for neurocognitive testing. - Previous engrafted BMT/HSCT. - Surgical or other major medical intervention planned to occur before week 26. - Participation in a clinical trial with an investigational drug in the last 12 months. - Judged by the investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking a position for lumber puncture due to joint contracture or those who are likely to experience difficulty breathing during the lumbar puncture process. - Judged by the investigator or subinvestigator to be ineligible to participate in the study due to a history of a serious drug allergy or sensitivity. - Otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study out of consideration for the subject safety. ; PRIMARY OUTCOME: Number of participants with Adverse Events; SECONDARY OUTCOME 1: Plasma Pharmacokinetic parameter [Maximum Plasma Concentration [Cmax]][/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 I - Healthy Volunteers; BRIEF: Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects. After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28. Subjects will return on day 56 for the final visit. ; DRUG USED: Zika Vaccine (Themis); DRUG CLASS: Vaccine; INDICATION: Zika Virus Disease; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Themis Bioscience GmbH; CRITERIA: Inclusion Criteria: - healthy volunteers aged 18 to 55 - subjects of child bearing potential must perform reliable method of contraception Exclusion Criteria: - immune deficiency, history of HIV, HBV, HCV - drug addiction - vaccination within 4 weeks prior to study or planned vaccination during study - prior receipt of any Zika vaccine - recent infection 1 week prior to screening - relevant medical history interfering with aim of study - neoplastic disease, hematological malignancy - history of autoimmune disease - psychological condition that affects ability to participate in the study - history of severe adverse reactions to vaccine administration - history of anaphylaxis - allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator - use of immunosuppressive drugs within 30 days before screening or planned use during study - receipt of blood products within 120 days before screening or planned use during study - pregnancy, unreliable contraception method - decision of the investigator - regular blood plasma donor ; PRIMARY OUTCOME: Immunogenicity: Functional anti-Zika antibodies as measured by PRNT; SECONDARY OUTCOME 1: [/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 I - 101; BRIEF: In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated 2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses. ; DRUG USED: VLA1601; DRUG CLASS: Vaccine; INDICATION: Zika Virus Disease; TARGET: Immune System, Viral Antigens; THERAPY: Monotherapy; LEAD SPONSOR: Valneva Austria GmbH; CRITERIA: Inclusion Criteria: 1. Subject is 18 to 49 years of age on the day of screening (Visit 0); 2. Subject has a Body Mass Index (BMI) of ≥18.5 and <30 kg/m2 on the day of screening (Visit 0); 3. Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures; 4. Subject is generally healthy as determined by the Investigators clinical judgment based on medical history, physical examination and screening laboratory tests; 5. If subject is of childbearing potential: i. Subject has a negative serum pregnancy test at screening (Visit 0); ii. Subject agrees to employ adequate birth control measures for the duration of the study. This includes one of the following measures: 1. Hormonal contraceptives (e.g. implants, birth control pills, patches) since ≥30 days prior to first vaccination; 2. Intrauterine device; 3. Barrier type of birth control measure (e.g. condoms, diaphragms, cervical caps); 4. Vasectomy in the male sex partner ≥3 months prior to first vaccination; Exclusion Criteria: 1. Subject has a history of known flavivirus infection, or vaccination with a licensed or investigational flavivirus vaccine; 2. Subject has plans to receive a licensed flavivirus vaccine during the course of the study; 3. Subject has plans to travel to areas (including within the US) with active ZIKV, Japanese Encephalitis Virus (JEV), Dengue Virus (DENV) or Yellow Fever Virus (YFV) transmission during the course of the study or has travelled to a flavivirus-endemic area within 4 weeks prior to study enrollment; 4. Subject is seropositive to ZIKV, JEV, DENV or West Nile virus (WNV); 5. Subject has received an inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to vaccination in this study; 6. Subject has clinically significant abnormal laboratory values, as determined by the Investigator, at screening (Visit 0); 7. Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); 8. Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological (including Guillain-Barré syndrome), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder; 9. Subject has a disease or is undergoing a form of treatment or was undergoing a form of treatment within 4 weeks prior to study enrollment (i.e. subject randomized) that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled (low dose), intranasal or topical steroids is permitted); 10. Subject has a history of severe hypersensitivity reactions or anaphylaxis; 11. Subject has a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications); 12. Subject had acute febrile infections within two weeks prior to vaccination in this study; 13. Subject has donated blood within 30 days or received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or plans to donate blood or use blood products during the course of the study; 14. Subject has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating; 15. Subject is currently enrolled or has participated in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IMP or investigational device during the course of this study; 16. Subject has plans to become pregnant during the course of the study, or is pregnant (positive serum pregnancy test at screening) or lactating at the time of study enrollment; 17. Subject has a known or suspected problem with alcohol or drug abuse as determined by the Investigator; 18. Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities); 19. Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study; 20. Subject has any condition that, in the opinion of the Investigator, may compromise the subjects well-being, might interfere with evaluation of study endpoints, or would limit the subjects ability to complete the study. ; PRIMARY OUTCOME: Rate of subjects with solicited adverse events including injection site and systemic reactions; SECONDARY OUTCOME 1: Rate of subjects with solicited adverse events including injection site and systemic reactions[/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 - MERIT (EU) (MT-06); BRIEF: The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits. Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet. Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications. ; DRUG USED: Odactra; DRUG CLASS: Biologic; INDICATION: Allergic Rhinitis; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: ALK-Abelló A/S; CRITERIA: Inclusion Criteria: - A history of house dust mite allergy - Use of symptomatice medication for treatment of house dust mite allergy - Positive skin prick test to mites - Positive specific IgE Exclusion Criteria: - History of uncontrolled asthma - Overlapping symptomatice allergies - Previous treatment with immunotherapy ; PRIMARY OUTCOME: Evaluation of allergy symptoms and use of symptomatic medication; 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 - N-MOmentum; BRIEF: To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD. ; DRUG USED: Uplizna; DRUG CLASS: Biologic; INDICATION: Neuromyelitis Optica (Devics Syndrome, NMO); TARGET: Cluster of Differentiation 19 (CD19); THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: 1. Men and women 18 years or older with diagnosis of NMO/NMOSD 2. Confirmation of NMO/NMOSD status: 1. AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years 2. AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years 3. Able and willing to give written informed consent and comply with the requirements of the study protocol. 4. EDSS <= 7.5 (8 in special circumstances) 5. Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product. Exclusion Criteria: 1. Lactating and pregnant females 2. Treatment with any investigational agent within 4 weeks of screening 3. Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy. 4. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization. 5. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization 6. Receipt of the following at any time prior to randomization: 1. Alemtuzumab 2. Total lymphoid irradiation 3. Bone marrow transplant 4. T-cell vaccination therapy 7. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal. 8. Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization. 9. Receipt of any of the following within 3 months prior to randomization: 1. Natalizumab (Tysabri®). 2. Cyclosporin 3. Methotrexate 4. Mitoxantrone 5. Cyclophosphamide 6. Tocilizumab 7. Eculizumab 10. History of Hepatitis B and/or Hepatitis C (Hep B/C at screening) 11. Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection 12. History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization 13. Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days ; PRIMARY OUTCOME: Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP; SECONDARY OUTCOME 1: Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP[/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 - Pediatric (FA-A); BRIEF: The objective of this study is to assess the therapeutic efficacy of a hematopoietic cell-based gene therapy for patients with Fanconi anemia, subtype A (FA-A). Hematopoietic stem cells from mobilized peripheral blood of patients with FA-A will be transduced ex vivo (outside the body) with a lentiviral vector carrying the FANCA gene. After transduction, the corrected stem cells will be infused intravenously back to the patient with the goal of preventing bone marrow failure. ; DRUG USED: RP-L102; DRUG CLASS: Biologic; INDICATION: Fanconi Anemia; TARGET: Fanconi anemia, complementation group A (FAA, FACA, FANCA); THERAPY: Monotherapy; LEAD SPONSOR: Rocket Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Fanconi anemia as diagnosed by chromosomal fragility assay of cultured lymphocytes in the presence of DEB or a similar DNA-crosslinking agent 2. Patients of the complementation group FA-A 3. Minimum age: 1 year and a minimum weight of 8 kg 4. At least 30 CD34+ cells/μL are determined in one bone marrow (BM) aspiration within 3 months prior to CD34+ cell collection OR (see subsequent criterion) 5. If the number of CD34+ cells/ μL in BM is in the range of 10-29, peripheral blood (PB) parameters should meet two of the three following criteria: - Hemoglobin: ≥11g/dL - Neutrophils: ≥900 cells/μL - Platelets: ≥60,000 cells/μL 6. Provide informed consent in accordance with current legislation 7. Women of childbearing age must have a negative urine pregnancy test at the baseline visit, and accept the use of an effective contraception method during participation in the trial Exclusion Criteria: 1. Subjects with an available and medically eligible HLA-identical sibling donor. 2. Evidence of myelodysplastic syndrome or leukemia, or cytogenetic abnormalities other than those reported as variant(s) of normal in BM aspirate analysis. This assessment should be made by valid studies conducted within the 3 months before the subject commences the stem cell mobilization/collection procedures of the clinical trial. 3. Subjects with somatic mosaicism associated with stable or improved counts in all PB cell lineages. (If T-lymphocyte chromosomal fragility analysis indicates potential mosaicism, a medically significant decrease (≥1 NCI CTCAE grade) in at least one blood lineage over time must be documented to enable eligibility, as should <5% resistance of bone marrow colony forming cells (CFCs) to 10nM MMC; whenever possible potential mosaicism should also be evaluated by gene sequencing of MMC-resistant CFCs). 4. Lansky performance status ≤60%. 5. Any concomitant disease or condition that, in the opinion of the Principal Investigator, renders the subject unfit to participate in the study. 6. Pre-existing sensory or motor impairment ≥grade 2 according to the criteria of the NCI. 7. Pregnant or breastfeeding women. 8. Hepatic dysfunction as defined by either: - Bilirubin >3.0 × the upper limit of normal (ULN) or - Alanine aminotransferase (ALT) > 5.0 × ULN or - Aspartate aminotransferase (AST) > 5.0 × ULN For subjects with bilirubin, ALT or AST above ULN, a workup to identify the etiology of liver abnormality should be conducted prior to confirmation of eligibility as stipulated in exclusion criterion 5, including evaluation of viral hepatitis, iron overload, drug injury or other causes. 9. Renal dysfunction requiring either hemodialysis or peritoneal dialysis. 10. Pulmonary dysfunction as defined by either: - Need for supplemental oxygen during the prior 2 weeks in absence of acute infection or - Oxygen saturation by pulse oximetry <90%. 11. Evidence of active metastatic or locoregionally advanced malignancy for which survival is anticipated to be less than 3 years. 12. Subject is receiving androgens (i.e. danazol, oxymetholone). 13. Subject is receiving other investigational therapy for treatment/prevention of FA-associated bone marrow failure. ; PRIMARY OUTCOME: Phenotypic correction of bone marrow colony forming units after infusion of RP-L102; SECONDARY OUTCOME 1: Phenotypic correction of T-lymphocytes in peripheral blood after infusion of RP-L102[/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 - CHEST-1; BRIEF: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). ; DRUG USED: Adempas; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery. Exclusion Criteria: - All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension. ; PRIMARY OUTCOME: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16; SECONDARY OUTCOME 1: Pulmonary Vascular Resistance (PVR) - Change From Baseline to 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 I - CD-003; BRIEF: To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohns disease who are refractory to one or more standard Crohns disease therapies. ; DRUG USED: PDA-001; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Celularity Incorporated; CRITERIA: Inclusion Criteria: - • Males and females 18 - 75 years of age at the time of signing the informed consent document. - Minimum weight of subject is 40 kg at screening. - Subject must have inflammatory Crohns Disease (CD) diagnosed at least 6 months but no greater than 15 years prior to treatment with Investigational Product (IP). - Subject must have confirmation of ongoing CD by ileocolonoscopy at screening. - Subject must have a Crohns Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 as assessed between Visit 1 and Visit 2. Exclusion Criteria: - Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study including but not limited to - Liver Function Tests Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 2.5 x the upper limit of normal at screening. - Serum creatinine concentration > 2.0 mg/dl at screening. Alkaline phosphatase > 2.5 x the upper limit of normal at screening. - Bilirubin level > 2 mg/dL (unless subject has known Gilberts disease). - Pregnant or lactating females. - Morbidly obese subjects Body Mass Index (BMI) > 35 at screening). - Subject has untreated chronic infection including Clostridium difficile toxin positive at screening or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP (other than a treated urinary tract infection or drained perianal abscess). Note: Stable doses of antibiotics used to treat Crohns Disease are allowed. - Subject has organic heart disease (eg, congestive heart failure), clinically significant arrhythmia or clinically significant abnormal findings on Electrocardiograms (ECG). - Subject has a history of other malignancies within 5 years (except basal cell carcinoma of the skin that is surgically cured, remote history of cancer now considered cured or positive Pap smear with subsequent negative follow up). - Subject has had a stricture of the bowel requiring hospitalization within 182 days prior to treatment with IP. - Subject has had bowel surgery other than perianal (for example, fistulotomy, seton placement, or abscess drainage) or previous abscess drainage within 182 days prior to treatment with IP. - Subject has had any surgery within 28 days prior to treatment with IP. - Subject has a colostomy, ileostomy or ileal pouch anal anastomosis. - Subject has received an investigational agent -an agent or device not approved by FDA for marketed use in any indication-within 90 days (or 5 half-lives, whichever is longer) prior to treatment with investigational product. - Subject has received previous cell therapy. - Subject is expecting to have elective surgery at any time between Visit 1 (screening) and Visit 7 (end of induction phase). - Subject has concurrent diagnosis of ulcerative colitis. - Subjects with protein C or S deficiency. - Subjects with prior history of thrombophlebitis or other pathological arterial or venous thrombosis. ; PRIMARY OUTCOME: Adverse Events; SECONDARY OUTCOME 1: Clinical 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 II - LUTS; BRIEF: The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH. ; DRUG USED: Udenafil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Benign Prostatic Hyperplasia (BPH); TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Monotherapy; LEAD SPONSOR: Warner Chilcott; CRITERIA: Inclusion Criteria: - History of LUTS for ≥6 months secondary to BPH - Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening Exclusion Criteria: - ; PRIMARY OUTCOME: Change from Baseline in Total IPSS (International Prostate Symptom Score); SECONDARY OUTCOME 1: Change from Baseline Total IPSS[/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 IIb - w/Standard Induction Therapy; BRIEF: This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, 7+3) and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone. ; DRUG USED: DSTAT; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Chemokine (C-X-C motif) Ligand 12 (CXCL12)/Stromal Cell-Derived Factor 1 (SDF-1), Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Combination; LEAD SPONSOR: Chimerix; CRITERIA: Inclusion Criteria: Subjects had to meet all the following criteria to be eligible for enrollment in this study: 1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML). 2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: Subjects who met any of the following criteria were not eligible for enrollment in this study: 1. Had acute promyelocytic leukemia 2. Had prior chemotherapy for AML. 3. Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome. 4. Had central nervous system (CNS) leukemia. ; PRIMARY OUTCOME: Number of Subjects Who Achieved Morphologic Complete Remission; SECONDARY OUTCOME 1: Duration of Event-free 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 I/II - TIGER-X (US); BRIEF: Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation. ; DRUG USED: Rociletinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Clovis Oncology, Inc.; CRITERIA: Inclusion Criteria - All patients must meet the following inclusion criteria: 1. Metastatic or unresectable locally advanced NSCLC 2. Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion 3. Biopsy of either primary or metastatic tumor tissue within 60 days of dosing 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 5. Minimum age of 18 years 6. Adequate hematological and biological function 7. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation Phase 2 Cohorts must also meet the following inclusion criteria: - Disease progression confirmed by radiologic assessment while on treatment with EGFR- TKI Or - Disease progression confirmed by radiologic assessment while on treatment with the first single agent EGFR TKI and - Documented evidence of T790M mutation in EGFR following disease progression on the first single agent EGFR TKI. - Measureable disease according to RECIST Version 1.1 Exclusion Criteria - Any of the following criteria will exclude patients from study participation: 1. Documented evidence of an Exon 20 insertion activating mutation in the EGFR gene 2. Active second malignancy 3. Known pre-existing interstitial lung disease 4. Patients with Leptomeningeal carcinomatosis are excluded. Other CNS metastases are only permitted if treated, asymptomatic and stable (not requiring steroids for at least 4 weeks prior to start of study treatment). 5. Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib 6. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib 7. Prior treatment with rociletinib or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR 8. Certain cardiac abnormalities or history 9. Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib 10. Females who are pregnant or breastfeeding 11. Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib 12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study 13. Any other reason the investigator considers the patient should not participate in the study ; PRIMARY OUTCOME: Percentage of T790M Positive Patients With Confirmed Response Per Investigator; SECONDARY OUTCOME 1: Overall Survival (OS) Determined by Investigator Assessment[/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 - Critical Limb Ischemia; BRIEF: The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia. ; DRUG USED: Engensis; DRUG CLASS: Biologic; INDICATION: Peripheral Arterial Disease (PAD); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy; LEAD SPONSOR: Helixmith Co., Ltd.; CRITERIA: Inclusion Criteria: - Male or female, between 18 and 90 years of age; - Diagnosis of critical limb ischemia (Rutherford Class 4 or 5), including: - A resting ankle systolic pressure (in either the dorsalis pedis or posterior tibial arteries) of ≤ 70 mmHg in the affected limb; or - A resting toe systolic pressure of ≤ 50 mmHg in the affected limb; or - For patients in which measurement of ankle systolic pressure is not feasible (e.g. vessel calcification and non-compressibility); TcPO2 ≤ 30 mmHg; - Poor or suboptimal candidate for bypass graft surgery or percutaneous angioplasty; - Pain at rest, and/or ischemic ulcers, and/or focal gangrene (< 3 cm2) for a minimum of 2 weeks, - Significant stenosis (≥ 75%) of one or more of the following arteries: superficial femoral, popliteal, or two or more infra-popliteal arteries as verified by angiography within 12 months prior to enrollment; - Be willing to maintain current drug therapy for peripheral arterial disease throughout the course of the study including an anti-platelet and statin treatment unless not tolerated; - Clinically stable on optimized medical regimen for >30 days - Be capable of understanding and complying with the protocol and signing the informed consent document prior to being subjected to any study related procedures; - Women who are surgically sterile or at least 1 year postmenopausal or who have been practicing adequate contraception for at least 12 weeks prior to entering the study. If the subject is of child-bearing potential, she must have a negative urine pregnancy test result prior to study enrollment and must agree to repeat pregnancy screening tests during the study. If the subject or the subjects partner(s) is of child bearing potential, the subject and the subjects partner(s) must agree to use a double barrier method of birth control while participating in this study. Exclusion Criteria: - Subjects who have undergone a successful revascularization procedure or sympathectomy within 12 weeks prior to study entry. A clinically unsuccessful revascularization procedure is defined as one in which: - the target vessel re-occludes (≥50%, as verified by a second angiogram. Duplex ultrasonography can be used to determine vessel patency if the patient cannot tolerate a second angiogram), or - the target vessel remains patent, but there is no resolution of symptoms 6 weeks after the procedure (e.g. no evidence of ulcer healing, no improvement in pressures, no reduction in resting pain); - Subjects that will require an amputation in the target leg within 4 weeks of randomization; - Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon in the extremity planned for treatment; - Heart Failure with a NYHA classification of III or IV; - Stroke (NIH scale >2) or myocardial infarction within last 3 months; - Unstable angina - Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) > 200 mmHg or diastolic BP (DBP) > 110 mmHg at baseline/screening evaluation; - Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination; - Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buergers disease); - Subjects with advanced liver disease including decompensated cirrhosis, jaundice, ascites or bleeding varices; - Subjects currently receiving immunosuppressive medications chemotherapy, or radiation therapy; - Positive HIV or HTLV at screening; - Active Hepatitis B or C infection as determined by Hepatitis B surface antibody (HBsAb), Hepatitis B core antibody (IgG and IgM; HBcAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV), at Screening; - Specific laboratory values at Screening including: Hemoglobin < 8.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, AST and/or ALT > 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary; - Patients with a recent history (< 5 years) of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings; - Elevated PSA unless prostate cancer has been excluded; - Subjects with any co- morbid conditions likely to interfere with assessment of safety or efficacy or with an estimated life expectancy of less than 6 months - Subjects requiring > 81 mg daily of acetylsalicylic acid; If > 81 mg are taken at screening, subjects may be enrolled if willing/able to switch to another medication; - Subjects requiring regular COX-2 inhibitor drug(s) or high dose steroids (excepting inhaled steroids); - Major psychiatric disorder in past 6 months; - History of drug or alcohol abuse / dependence in the past 2 years; - Use of an investigational drug or treatment in past 12 months; concurrent participation in investigational protocol or unapproved therapeutics and - Unable or unwilling to give informed consent. ; PRIMARY OUTCOME: The primary study endpoint is to assess the safety of IM administration of VM202 in subjects with moderate or high-risk CLI; SECONDARY OUTCOME 1: Change in tissue oxygenation (TcPO2) from baseline to 9 months and 12 months following the first 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 IIb - IFN-Free w/BMS-650032/BMS-791325; BRIEF: The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Men and women, ages ≥18 years of age - Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment - Subjects should have chronic hepatitis C (CHC) as documented by: 1. Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or 2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis) - HCV genotype 1a, 1b or 4 only - HCV RNA viral load of ≥10,000 IU/mL at screening - Have one of the following: 1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR 2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR 3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis - Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive - Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening Exclusion Criteria: - Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures) - History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis - Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment - Documented or suspected hepatocellular carcinoma (HCC) - Positive for hepatitis B surface antigen (HBsAg) - Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies - Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN) - Total Bilirubin ≥2 mg/dL ; PRIMARY OUTCOME: Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12); SECONDARY OUTCOME 1: Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)[/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 - Pre-Treated Stage Ib-IVa; BRIEF: The purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria. ; DRUG USED: Quisinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cutaneous T-Cell Lymphoma (CTCL) - NHL; TARGET: Histone Deacetylase (HDAC); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Histopathologically confirmed cutaneous T-cell lymphoma (CTCL), either mycosis fungoides or sezary syndrome Stage Ib-IVa - Relapsed or refractory (unresponsive) disease following at least 1 prior systemic therapy for CTCL, except psoralen and long-wave ultraviolet radiation (it is considered skin-directed therapy and not systemic therapy) - Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 28 days - Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) 1 cm or greater than 1 cm in the longest diameter laboratory function tests and bone marrow test - Agrees to protocol defined use of effective contraception - Adequate laboratory function tests and bone marrow test Exclusion Criteria: - Prior histone-deacetylase inhibitor therapy for CTCL - Concurrent systemic corticosteroid dose greater than 10 mg per day of prednisone or equivalent (stable use of 10 mg or less than 10 mg per day of prednisone for 1 month or more before study entry is allowed) - Major surgery or radiotherapy within 3 weeks before the start of the study medication - Unstable angina or heart attack within the preceding 12 months, congestive heart failure New York Heart Association Class II-IV, known presence of dilated, hypertrophic, or restrictive cardiomyopathy - Inadequate gastrointestinal absorption status - Use of potent inhibitors of CYP3A4/A5 - Positive human immunodeficiency virus ; PRIMARY OUTCOME: Number of participants who will achieve overall cutaneous Response Rate (RR) based on modified Severity Weighted Assessment Tool (mSWAT) criteria; SECONDARY OUTCOME 1: Number of participants who will achieve global Response Rate (RR) based on based on consensus global response 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 II - STAYCIS (NIAID Sponsored); BRIEF: Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients. Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance. ; DRUG USED: Lipitor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: HMG CoA Reductase (HMGR); THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Allergy and Infectious Diseases (NIAID); CRITERIA: Inclusion Criteria: - Clinically isolated syndrome (CIS) as defined by an acute or subacute well-defined neurological event lasting at least 48 hours and consistent with MS (i.e., optic neuritis, spinal cord syndrome, brainstem/cerebellar syndromes). Other causes for optic neuritis other than CIS must be ruled out by an ophthalmologist. Patients with other clinically silent abnormal findings found upon neurological examination that are not attributable to the presenting symptom are not excluded. - Onset of CIS symptoms occurring within 90 days of randomization - Abnormal, unenhanced brain MRI with 2 or more clinically silent T2 lesions greater than or equal to 3 mm in diameter, at least one of which is periventricular in location or ovoid in shape - Willing to use acceptable methods of contraception - Have received 3 to 5 days of corticosteroid therapy within 60 days of CIS onset Exclusion Criteria: - Definite diagnosis of MS according to McDonald criteria - Previous history of neurological symptoms lasting more than 48 hours. Patients with a history of neurological symptoms lasting less than 48 hours will not be excluded. - Prior use of interferon, glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis anytime prior to study entry - Use of interferon preparations (unless as specified by the protocol), glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis during the study - Use of cyclosporine, fibric acid derivatives, niacin, erythromycin, or azole antifungal during the study - Received more than 5 g of methylprednisolone (or the equivalent of other IV corticosteroid) prior to study screening - Use of a cholesterol-lowering agent during the 3 months prior to study screening or need for such agents during the study - Previous history of severe side effects with statin therapy - Prior exposure to total lymphoid irradiation - History of substance abuse in the 12 months prior to study screening - History of systemic illness or medical condition that would limit the likelihood of completing the MRI procedures or would interfere with the measurement of a therapeutic effect - Implanted pacemakers, cochlear implants, defibrillators, or metallic objects on or inside the body - Uncontrolled hypertension, asthma, known malignancy other than skin cancer, symptomatic cardiac disease, epilepsy, insulin-dependent diabetes, or symptoms that can only be explained by systemic lupus erythematosus (SLE) or other autoimmune diseases - Active liver disease - Major medical illnesses or psychiatric impairment that in the investigators opinion could interfere with the study - History of severe depression or suicidal ideation within 1 year of study entry - Pregnancy or breastfeeding ; PRIMARY OUTCOME: The Occurrence of ≥ 3 New T2 Lesions With or Without Gd+ Enhancement or Clinical Exacerbation Through 12 Months.; SECONDARY OUTCOME 1: Proportion of Participants Who Are Diagnosed With Multiple Sclerosis According to the McDonald Criteria[/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 Ia/Ib - AB-836-001; BRIEF: This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects. ; DRUG USED: AB-836; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Hepatitis B/HBV; THERAPY: Monotherapy; LEAD SPONSOR: Arbutus Biopharma Corporation; CRITERIA: Inclusion Criteria: - Healthy Subjects 1. Male and Female (not of childbearing potential in Part 1 and 2a) subjects between 18 and 45 years old 2. Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results. 3. BMI of 18-32 kg/m2. - CHB Subjects: 1. Male or female between 18 and 65 years old. 2. Chronic HBV infection documented as a positive HBsAg, HBV DNA, or HBeAg test at least 6 months prior to the Screening Visit, or a historical liver biopsy consistent with chronic HBV infection 3. For cohort F, G, H: 1. HBV DNA ≥2,000 IU/mL at Screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment). 2. ALT ≤ 5x ULN 4. For Cohort I: 1. HBV DNA <LLOQ at Screening 2. Subjects must have been receiving either TAF, TDF, or ETV consistently for ≥6 months prior to Day 1 and are willing to continue with the same NA treatment through the final study visit. 3. ALT ≤ 2.5 x ULN 5. HbsAg ≥250 IU/mL at screening Exclusion Criteria: - CHB Subjects 1. Advanced fibrosis, cirrhosis or other signs of advanced liver disease as assessed by clinical history, ultrasound or FibroScan, or history of cirrhosis or any clinically significant medical condition associated with chronic liver disease. 2. Co-infection with HIV or other non-B hepatitis viruses. 3. Any clinically significant or unstable medical condition or illness that could confound study findings. 4. Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are pregnant or breastfeeding. 5. Previous treatment with a capsid inhibitor, core inhibitor, or core protein assembly modifier [CpAM or CAM]) within 6 months of the Day 1 visit, or prior treatment with an HBV-targeted siRNA or antisense oligonucleotide compound at any time. ; PRIMARY OUTCOME: Incidence of TEAEs; SECONDARY OUTCOME 1: [/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 - CERTAIN; BRIEF: To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years Exclusion Criteria: - All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient - Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial - Patients must not have received any previous biological therapy for rheumatoid arthritis (RA) ; PRIMARY OUTCOME: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24; SECONDARY OUTCOME 1: 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and 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 II - NOMID (NAIMS); BRIEF: This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological, cutaneous and arthropathy (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, eye problems, and learning difficulties. Immune suppressing medicines commonly used to treat other pediatric rheumatologic diseases do not suppress NOMID symptoms and, if used long-term and in high doses, can cause harmful side effects. Anakinra, approved by The Food and Drug Administration for treating rheumatoid arthritis in adults, blocks a substance called IL-1 that may be an important factor in causing the inflammation in NOMID. ; DRUG USED: Kineret; DRUG CLASS: Biologic; INDICATION: Cryopyrin (CIAS1)-Associated Periodic Syndromes (CAPS); TARGET: IL-1 Receptor (IL-1R); THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); CRITERIA: -INCLUSION CRITERIA: 1. There is no age limitation. 2. Patients fulfill at least 2 of the following 3 clinical manifestations: - Typical NOMID rash - CNS involvement (papilledema, CSF pleocytosis, sensorineural hearing loss) - Typical arthropathic changes on radiograph (epiphyseal and/or patellar overgrowth. 3. Onset of manifestations of NOMID/CINCA at less than or equal to 6 months of age. 4. Stable dose of steroids, NSAIDs, DMARDs for 4 weeks prior to enrollment visit. 5. Washout period for biologics: 6 half-lives before anakinra administration for all drugs with anti TNF properties. For etanercept (6 half-lives=24 days) this calculates to drug discontinuation 3 days before enrollment into the observation period, for infliximab and adalimumab (6 half-lives=48 days) drug will be discontinued 27 before the observation period, and for thalidomide (6 half-lives=3 days) drug will be discontinued for 3 days prior to anakinra administration. 6. Patients or legal guardians ability and willingness to give informed consent. 7. Females of childbearing potential (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication. Women of childbearing age and men able to father a child, who are sexually active, will be asked to use a form of effective birth control, including abstinence. 8. Negative PPD test using 5 T.U. intradermal testing per CDC guidelines with exception of inclusion criteria #9 below. 9. Patients with latent TB (positive PPD test) must have adequate therapy for TB initiated prior to first dose of study medication as recommended in published guidelines. EXCLUSION CRITERIA: 1. Having received live virus vaccine during 3 months prior to baseline visit (1st visit to NIH). 2. Patients with active infections or a history of pulmonary TB infection with or without documented adequate therapy, Patients with current active TB, or recent close exposure to an individual with active TB are excluded from the study. 3. Positive testing for HIV, Hepatitis B or C known or documented at screening, enrollment or baseline visit. 4. Have a history of or concomitant diagnosis of congestive heart failure. 5. History of malignancy. 6. Recent use of IL-1 antagonist within the last three months or prior use of anti CD4 antibody. 7. Known hypersensitivity to E. coli derived products or any components of anakinra. 8. Presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, SLE in addition to NOMID/CINCA). 9. Presence of the following at enrollment visit: ALT or AST greater than 2.0 x upper limit of normal (ULN) of the local laboratories values, creatinine greater than 1.5 xULN, WBC less than 3.6x10(9)/l; platelet count less than 150,000 mm(3). 10. Enrollment in any other investigational clinical study or receiving an investigational agent, or has not yet completed at least 4 weeks since ending another investigational device or drug trial. 11. Subjects for whom there is concern about compliance with the protocol procedures by subject and/or parent/s and legally acceptable representative/s. 12. Lactating females or pregnant females. 13. Patients with asthma will only be included after evaluation by a pulmonary and infectious disease consultation. ; PRIMARY OUTCOME: Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches); SECONDARY OUTCOME 1: [/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 - SWOG-S0910; BRIEF: RATIONALE: Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving epratuzumab together with cytarabine and clofarabine may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab together with cytarabine and clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia. ; DRUG USED: Epratuzumab; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Cluster of Differentiation 22 (CD22); THERAPY: Combination; LEAD SPONSOR: SWOG Cancer Research Network; CRITERIA: DISEASE CHARACTERISTICS: - Morphologically confirmed precursor B-cell acute lymphoblastic leukemia (ALL) (non T-cell) - Must have evidence of disease in bone marrow or peripheral blood - Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T cell, or mixed B/T cell) - Must have ≥ 5% lymphoblasts present in the blood or bone marrow - At least 20% of marrow and/or peripheral blood lymphoblasts must be CD22+ by flow cytometry - Co-expression of myeloid antigens (CD13 and CD33) allowed - Patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible - Philadelphia (Ph) chromosome-negative disease - Patients with unknown Ph status by cytogenetics or FISH and unknown BCR/ABL status by PCR are eligible for study registration, but must be removed from study therapy if found to be Ph+ or BCR/ABL+ after study registration - Refractory to a standard induction regimen that included vincristine and prednisone or high-dose cytarabine or mitoxantrone OR relapsed after successful prior induction therapy - Any number of prior induction therapies or any number of remissions achieved are allowed - No M0 acute myeloid leukemia, mixed lineage leukemia, or L3 (Burkitt) leukemia - No active CNS involvement by clinical evaluation - Patients with a documented history of CNS involvement of ALL or with clinical signs or symptoms consistent with CNS involvement of ALL must undergo a lumbar puncture that is negative for CNS involvement of ALL - Patients < 22 years of age must be willing to receive prophylactic intrathecal chemotherapy - Must be registered on SWOG-9007 Cytogenetic Studies in Leukemia Patients (closed as of 07/01/2010) PATIENT CHARACTERISTICS: - Zubrod performance status 0-2 - Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 60 mL/min - AST and ALT ≤ 2.5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 times ULN - Bilirubin ≤ 1.5 times ULN - Not pregnant or nursing - Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment - HIV-positive patients are eligible (at the discretion of the investigator) provided the following criteria are met: - No history of AIDS-defining conditions - CD4 cell count > 350/mm³ - If on antiretroviral agents, must not include zidovudine or stavudine - Willing to receive prophylaxis for pneumocystis jirovecii pneumonia during study therapy (regardless of CD4 cell count) until the CD4 cell count is > 200/mm³ after completion of study treatment - Prior malignancy (other than ALL) allowed provided it is in remission and there are no plans to treat the malignancy at the time of study registration - No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs or symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment - No neuropathy (cranial, motor or sensory) ≥ grade 2 PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Any number of prior therapies allowed - More than 90 days since prior allogeneic bone marrow transplant (BMT) - No concurrent immunosuppression therapy for the treatment of graft-vs-host disease (GVHD) - No acute GVHD ≥ grade 2, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity - Prior autologous BMT allowed - No concurrent immunosuppression therapy for the treatment of GVHD - More than 14 days since prior chemotherapy, investigational agents, or major surgery and recovered - Maintenance therapy with steroids, vincristine, and/or anti-metabolite agents, including but not limited to, mercaptopurine, thioguanine, and methotrexate allowed - Concurrent hydroxyurea to reduce WBC to a reasonable level (as deemed by the treating physician) allowed - No prior clofarabine or epratuzumab - No other concurrent cytotoxic therapy or investigational therapy - No concurrent alternative medications (e.g., herbal or botanical medications for anticancer purposes) - Concurrent participation on SWOG-S9910 Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary allowed (closed as of 07/01/2010) ; PRIMARY OUTCOME: Complete Remission; SECONDARY OUTCOME 1: Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events[/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 IIb - Kinect Study; BRIEF: The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) 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: - Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening. - Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status. - Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study. - Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. - Female subjects must not be pregnant. - Be in good general health and expected to complete the clinical study as designed. - Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive). - Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine. - Have a negative alcohol breath test at screening and study start. Exclusion Criteria: - Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening. - Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary). - Have a known history of neuroleptic malignant syndrome. - Have a significant risk of suicidal or violent behavior. - Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine. - Receiving medication for the treatment of tardive dyskinesia. - Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result. - Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study. - Have an allergy, hypersensitivity, or intolerance to tetrabenazine. - Have had previous exposure with NBI-98854. ; PRIMARY OUTCOME: Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6; SECONDARY OUTCOME 1: Clinical Global Impression - Global Improvement of TD (CGI-TD)[/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 - Long-Term Study; BRIEF: This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste). ; DRUG USED: Plumiaz; DRUG CLASS: Non-NME; INDICATION: Seizure Disorders (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Acorda Therapeutics; CRITERIA: Inclusion Criteria: - Diagnosis of drug-resistant epilepsy - Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED) - Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit - A caregiver must consent to participate together with the subject for purposes of observation and data collection - The caregiver must be present when the investigational product is administered - Screening body weight between 26 to 111 kg, inclusive Exclusion Criteria: - Female subject who is pregnant, breastfeeding, or planning to become pregnant - Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam - Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components - Positive screening test for ethanol or other drugs of abuse - Unable to receive medications intranasally ; PRIMARY OUTCOME: Olfactory Changes as Measured by the Smell Identification Test (SIT); SECONDARY OUTCOME 1: [/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 I - Healthy Volunteers (US); BRIEF: The primary objective of this study is to evaluate the effect of filgotinib on a mixed organic anion transporting polypeptide/cytochrome P450 3A (OATP/CYP3A), OATP/ breast cancer resistance protein (BCRP), and OATP substrates using phenotypic probes. ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug. - Have a calculated body mass index (BMI) of greater than or equal to (≥) 19.0 and less than or equal to (≤) 30.0 kilogram per meter square (kg/m^2) at screening. - Have a creatinine clearance (CLcr) ≥ 90 milliliters per minute (mL/min) (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening and upon admission. - Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at clinic admission. - Male participants must be surgically sterile. - Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. - Screening laboratory evaluations and 12-lead electrocardiogram (ECG) evaluations must be without clinically significant abnormalities as assessed by the investigator. - Have liver biometric tests such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin below the upper limit of normal at screening. - Must be willing and able to comply with all study requirements. - Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs. - Participants must not have donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug. Key Exclusion Criteria: - Positive serum pregnancy test (Female participants). - Lactating female. - Have received any investigational drug/device within 30 days prior to study dosing (or within 5 half-lives of the drug, whichever is longer). - Have current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance or participant safety, or a positive drug or alcohol test at screening or admission. - Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening. - Have positive Coronavirus Disease 2019 (COVID-19) Real-Time Reverse. - Transcriptase-Polymerase Chain Reaction (RT-PCR) testing on screening and admission. - Have poor venous access that limits phlebotomy. Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS; SECONDARY OUTCOME 1: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)[/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 - TNBC; BRIEF: This study is designed to evaluate the preliminary anti-tumor activity and tolerability of PF-03084014 when administered as a single agent in the treatment of patients with advanced triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for genomic alterations in Notch receptors (NA-) ; DRUG USED: Nirogacestat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Gamma-secretase; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Histological or cytological diagnosis of triple negative breast cancer (TNBC) with evidence of a) metastatic or b) locally recurrent advanced disease that is not amenable to resection or radiotherapy with curative intent. - Availability of an original diagnostic tumor tissue or the most recent metastatic tumor biopsies (archival biopsy or de novo biopsy) and a peripheral blood sample for Notch receptors genomic profiling Exclusion Criteria: - Known brain metastases. - Prior treatment with gamma secretase inhibitor or other Notch signaling inhibitor. ; PRIMARY OUTCOME: Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+); SECONDARY OUTCOME 1: OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)[/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 IIa - 20100761 - Dose Effect; BRIEF: This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. ; DRUG USED: ARRY-403; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Hexokinase/Glucokinase; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Age 18 to 75 years, inclusive - Diagnosis of type 2 diabetes mellitus - HbA1c levels 7.5% to 11.0%, inclusive, at screening - Fasting C-peptide levels ≥ 0.2 nmol/L at screening - BMI ≥ 25 to < 45 kg/m2 at screening - Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization - If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization - Subject has provided informed consent. Exclusion Criteria: - History of type 1 diabetes - History of significant weight gain or loss (> 10%) during the 4 weeks before randomization - Use of any weight loss medication (over the counter or prescription) within 60 days of randomization - Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization - Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization - Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months - Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness - Evidence of active infections that can interfere with the study - Presence of clinically significant organ system disease that is not stabilized or may interfere with the study - Currently receiving immunosuppressive therapy - History of positive HIV, chronic hepatitis B or C, or cirrhosis - Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening. - History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption - Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation - Poorly controlled hypertension defined as diastolic pressure > 100 mm Hg or systolic pressure > 160 mm Hg (assessed on two separate occasions during the screening period) - Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease-free state since treatment) - Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization ; PRIMARY OUTCOME: To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin; SECONDARY OUTCOME 1: To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test[/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 - Arteriovenous Graft Surgery; BRIEF: A study to evaluate the efficacy of SRM003 treatment versus participating sites standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease. It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury. ; DRUG USED: SHP613; DRUG CLASS: Biologic; INDICATION: End-Stage Renal Disease (ESRD); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: 1. Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female. 2. Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization. 3. Subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent prosthetic expanded polytetrafluoroethylene AVG placed in the upper extremity. 4. Subject must have a life expectancy of at least 78 weeks after randomization. 5. Subject must be able to understand and be willing to complete all study requirements. Exclusion Criteria: 1. Subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 78 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 78 weeks and is unwilling to change transplant list status to hold for 3 months after randomization. 2. Subject has had more than 3 access placement surgeries (defined as a new access, not a revision) in the target limb. 3. Subject has medical conditions and diseases that may cause non-compliance with the protocol 4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products. 5. Subject has a history of intravenous drug use within 6 months prior to screening 6. Subject is morbidly obese, defined as having a body mass index >40. 7. Pregnant or nursing woman, or plans to become pregnant during the study. ; PRIMARY OUTCOME: Percentage of Participants With Loss of Unassisted Primary Patency; SECONDARY OUTCOME 1: Percentage of Participants With Loss of Assisted Primary Patency[/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 - SIRROUND-H; BRIEF: The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening - Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline - Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate - Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent - C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening Exclusion Criteria: - Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept - Has ever used tofacitinib therapy or any other JAK inhibitor - Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration - Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable ; PRIMARY OUTCOME: Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24[/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 I/II - B-cell Lymphomas (w/Revlimid); BRIEF: The purpose of this study is to determine whether ublituximab in combination with lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies who have relapsed or are refractory after CD20 directed antibody therapy. ; DRUG USED: Ublituximab; DRUG CLASS: Biologic; INDICATION: Marginal Zone Lymphoma - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: TG Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Relapsed or refractory B-cell non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) - Participants must have received at least one prior line of therapy with an anti-CD20 antibody (i.e. rituximab, ofatumumab, etc.) or an anti-CD20 antibody containing regimen - Measurable or evaluable Disease - Eastern Cooperative Oncology Group performance status 0, 1 or 2 - Participants ineligible for high dose or combination chemotherapy + stem cell transplant - No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology - All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® Exclusion Criteria: - Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry - Prior autologous or allogeneic stem cell transplantation within 6 months of study entry - History of severe hypersensitivity or anaphylaxis to prior murine or mouse/human chimeric antibodies, or to any component of ublituximab, or with prior lenalidomide or thalidomide - Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements - History of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to Day 1 of Cycle 1 - Pregnant women ; PRIMARY OUTCOME: Maximum Tolerated Dose acceptable for participants; SECONDARY OUTCOME 1: Efficacy[/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 - AcSé; BRIEF: This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of nivolumab monotherapy in 6 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available. ; DRUG USED: Opdivo; 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: UNICANCER; CRITERIA: Inclusion Criteria: 1. Patient information sheet and written informed consent form signed. 2. Histologically confirmed diagnosis of a pathology corresponding to one of the following selected cancer types: - Non-clear cell renal-cell carcinomas: papillary renal cell carcinoma (pRCC, type I, type II and non-classified pRCC), chromophobe RCC (ChRCC), renal medullary carcinoma (RMC), collecting duct/Bellini duct carcinoma (CDC), microphthalmia-associated transcription (MiT) family translocation renal cell carcinoma (tRCC), renal cell carcinoma with a prominent sarcomatoid component (sarcRCC).From the 51st patient included in this cohort, only the following histological type will be selected: collecting duct/Bellini duct carcinoma (CDC). - Rare head and neck cancers: principal and accessory salivary gland tumours, facial tissue tumours. - Rare skin cancers: adnexal carcinomas, basal cell carcinoma resistant to vismodegib.From the 51st patient included in this cohort, only the following histological type will be selected: Basal Cell carcinoma. - Non-colorectal cancers with microsatellite instability determined locally by immunohistochemistry or polymerase chain-reaction (PCR) - Squamous cell carcinoma of penis. - Any non MSI-high cancer with POLE exonucleasic domain mutation (somatic or germline) in hotspots (codons 286, 411, 424 and 459) or other germline or somatic variants with high probability of pathogenesis according to in silico assessment by the INCa ad hoc biology group. 3. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator. 4. Aged ≥18 years old. 5. Measurable disease according to RECIST v1.1 guidelines for solid tumours. 6. Able to provide a formalin fixed/paraffin embedded (FFPE) biopsy sample of a metastatic site or primitive tumour tissue. Note: Patients for whom suitable archived biopsy material is not available must be willing to undergo a biopsy of a tumour lesion prior to study entry, unless this is medically contraindicated (e.g. site inaccessible or patient safety concerns). 7. Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments. 8. Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to NCI-CTCAE criteria, v 4.0) with the exception of Grade 2 alopecia. 9. Adequate hematologic function (absolute neutrophil count (ANC) ≥1.0 x10⁹/L, platelets ≥100 x10⁹/L, haemoglobin (Hb) ≥9 g/L) measured within 14 days of treatment initiation. 10. Adequate renal function (creatinine clearance ≥50 mL/min using the glomerular filtration rate (MDRD) or CKI EPI method) measured within 14 days of treatment initiation. 11. Adequate hepatic function (serum bilirubin ≤1.5 x the reference upper limit of normal (ULN) unless due to Gilberts syndrome; aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 x ULN) measured within 14 days of treatment initiation. For patients with documented liver metastasis ASAT/ALAT ≤5 x ULN is acceptable. 12. Strictly normal blood levels of calcium and magnesium, measured within 14 days of treatment initiation. 13. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤1. 14. Estimated life expectancy ≥90 days. 15. Patients who are sexually active must agree to use a medically accepted method of contraception (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner, for participating women; condoms for participating men) or practice complete abstinence, beginning 14 days before the first administration of investigational product (IP), while on treatment and for at least 5 months after the last administration of IP for female patients, and 7 months after the last administration of IP for male patients. 16. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to the first administration of IP. If urine test results are positive or cannot be confirmed as negative, a serum pregnancy test will be required. 17. Women who are breastfeeding should discontinue nursing prior to the first administration of IP and for at least 90 days after the last administration of IP. 18. Patients must be affiliated to a Social Security System or equivalent. Exclusion Criteria: 1. Prior treatment with an anti-PD1 or anti-PD-L1 antibody 2. Eligible, and willing, to participate in a clinical trial of an alternative anticancer therapy targeting their disease which is open to accrual in France. 3. Concurrent steroid medication at a dose greater than prednisone 10 mg/day or equivalent. 4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 5. History of (non-infectious) pneumonitis that required steroids, or current pneumonitis. 6. History of severe hypersensitivity reaction to any monoclonal antibody therapy 7. Radiotherapy (except for brain and extremities) within 21 days prior to the first administration of IP. 8. Treatment with other investigational drugs or participation in another clinical trial within 21 days prior to the first administration of IP or concomitantly with the trial. 9. Has known symptomatic central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. 10. Has known carcinomatous meningitis or a history of leptomeningeal disease. 11. Serum creatinine >1.5 x ULN or glomerular filtration rate (GFR) <50 mL/min. 12. Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix. 13. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy. 14. Active or chronic hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies), or a known history of active Tuberculosis bacillus. 15. Has received a live vaccine within 30 days of planned start of study treatment. Note: Seasonal influenza vaccines for injection are generally inactivated vaccines and are allowed. 16. Active alcohol or drug abuse. 17. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule. 18. Any condition which in the Investigators opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol. ; PRIMARY OUTCOME: Objective response rate; SECONDARY OUTCOME 1: Progression-free survival[/INST]No</s>