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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 III - CAHtalyst; BRIEF: This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years). ; DRUG USED: NBI-74788; DRUG CLASS: New Molecular Entity (NME); INDICATION: Congenital Adrenal Hyperplasia (CAH); TARGET: Corticotropin Releasing Factor -Receptor1 (CRF-R1), Corticotropin Releasing Factor -Receptor2 (CRF-R2); THERAPY: Monotherapy; LEAD SPONSOR: Neurocrine Biosciences; CRITERIA: Inclusion Criteria: 1. Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit. 2. Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH. 3. Be on a stable regimen of steroidal treatment for CAH. 4. Participants of childbearing potential must agree to use an acceptable method of contraception during the study. Exclusion Criteria: 1. Have a diagnosis of any of the other known forms of classic CAH. 2. Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy. 3. Have a clinically significant unstable medical condition or chronic disease other than CAH. 4. Have a history of cancer unless considered cured. 5. Are pregnant. 6. Have a known history of clinically significant arrhythmia or abnormalities on ECG. 7. Have a known hypersensitivity to any corticotropin releasing hormone antagonists. 8. Have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study. 9. Have current substance dependence, or current substance (drug) or alcohol abuse. 10. Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study. ; PRIMARY OUTCOME: Percent change from baseline in glucocorticoid daily dose at Week 24; SECONDARY OUTCOME 1: Change from baseline in serum androstenedione at Week 4[/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 - Phosphate Binder Switch Study (Japan); BRIEF: To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD. ; DRUG USED: Ibsrela; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Sodium-hydrogen exchanger 3 (NHE3) ; THERAPY: Monotherapy; LEAD SPONSOR: Kyowa Kirin Co., Ltd.; CRITERIA: Inclusion Criteria: - Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination. - Met certain conditions for dialysis excluding Dry Weight (Dialysate, Dialyzer, Frequency of Dialysis per Week, Dialysis Time, Blood Flow Rate, and Dialysate and Substitution Fluid Flow Rate) 2 weeks before screening examination. - Taking at least 2 tablets of phosphate binder 3 times per day. The prescribed dosage regimen should have been unchanged for the period from 2 weeks before screening examination through pre-enrollment. - Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening examination. - If on any vitamin D or calcimimetics regimen, the dosage regimen should have been unchanged for the last 2 weeks before screening examination. Exclusion Criteria: - iPTH > 600 pg/mL (should be based on the most recent value from patients medical records before pre-enrollment) - History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome - History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination. - Severe heart disease (including congestive heart failure, defined as New York Heart Association [NYHA] cardiac functional classification of Class III or IV, and vascular lesions requiring hospitalization such as myocardial infarction), hepatic impairment (including AST/ALT ≥ 100 U/L before the start of observation period), or concurrent cirrhosis. - Developed cerebrovascular disease (such as cerebral infarction and cerebral hemorrhage) or cardiovascular disease (such as acute myocardial infarction and unstable angina) requiring hospitalization within 6 months before screening examination. - Uncontrollable hypertension or diabetes - Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period. - Any diagnosis of or treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix). ; PRIMARY OUTCOME: Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.; SECONDARY OUTCOME 1: Serum phosphorus levels at each time point after the start of treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ic/IIa - PXS5505-MF-101; BRIEF: This study will be an open-label phase 1/2a study to evaluate the safety and tolerability of PXS-5505 in patients with primary, postpolycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis. ; DRUG USED: PXS-5505; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: Lysyl Oxidase (LOX); THERAPY: Monotherapy; LEAD SPONSOR: Pharmaxis; CRITERIA: Inclusion Criteria: - Have a pathologically confirmed established diagnosis of primary myelofibrosis or post-essential thrombocythemia/polycythemia vera myelofibrosis as per the World Health Organization 2016 diagnostic criteria (must include at least Grade 2 marrow fibrosis) - Patients who are not eligible for stem cell transplantation - a) Dose escalation / Cohort expansion phase only: Patients not currently on ruxolitinib or fedratinib (where available) treatment due to ineligibility, or previously treated patients who have been discontinued for at least 2 weeks prior to first dose of study drug due to any of the following criteria: - Ineligible: Platelets <50 x 10^9/L - Intolerant: Development of red blood cell transfusion dependence of at least two units/month for 2 months OR ≥Grade 3 adverse events of thrombocytopenia, anemia, hematoma, and/or hemorrhage while on treatment with ruxolitinib or fedratinib for at least 28 days - Refractory: < 10% spleen volume reduction by MRI or CT, or < 30% decrease from baseline in spleen volume by palpation after at least 3 months treatment with ruxolitinib or fedratinib - Relapsed: Regrowth to < 10% spleen volume reduction by MRI or CT, or < 30% decrease from baseline in spleen volume by palpation, following an initial response to ruxolitinib or fedratinib and after at least 3 months treatment - b) Add-on phase only: Are being treated with ruxolitinib for at least 12 weeks prior to first administration of study treatment. The patient must be on a stable dose (no dose adjustments) of ruxolitinib for ≥ 8 weeks prior to study treatment and have not achieved complete remission (CR) by International Working Group (IWG) criteria. - Have intermediate -2, or high-risk disease according to the International Working Group prognostic scoring system (DIPSS); - a) Dose escalation / Cohort expansion phase only: Have symptomatic disease according to the MFSAF v4.0; Symptomatic disease is defined as a score of at least one in at least two items of the MFSAF v4.0; b) Add-on phase only: have a score of ≥ 10 on the MFSAF v4.0; - Have symptomatic disease according to the MFSAF v4.0; - Life expectancy of six months or greater; - Must have adequate organ function as demonstrated by the following (within last 2 weeks): - Alanine aminotransferase and/or aspartate aminotransferase ≤ 2.5x upper limit of normal (ULN), or ≤ 4 x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF); - Direct bilirubin ≤ 1.5 x ULN; or ≤ 2 x ULN (if upon judgment of the treating physician, it is believed to be due to EMH related to MF); - Estimated glomerular filtration rate (eGFR) > 50 mL/min - Eastern Cooperative Oncology Group performance status ≤ 2; - Men must agree to using one medically approved contraceptive measure and have their partners agree to an additional barrier method of contraception for the duration of the study and for 90 days after the last administration of study drug; women of childbearing potential must use effective contraception - Cohort Expansion and Add-on Phase only: A bone marrow biopsy must have been performed within 3 months prior to Day 1 treatment to establish the baseline fibrosis score or within 5 months of the re-initiation of treatment with PXS-5505 if subject participated in dose escalation phase of the trial Exclusion Criteria: - Greater than (>) 10% blasts in peripheral blood (determined within last two weeks); - Prior splenectomy, or planning to undergo splenectomy, or splenic irradiation within 3 months prior to the first dose of study treatment - Any serious medical condition or psychiatric illness that would prevent (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study - Known history of human immunodeficiency virus, active hepatitis C, or active hepatitis B - History or presence of any form of cancer within the three years prior to enrolment, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis - Participation in an investigational drug or device trial within two weeks prior to study Day 1 or within five times the half-life of the investigational agent in the other clinical study, if known - Use of any cytotoxic chemotherapeutic agents, including hydroxyurea, corticosteroids (prednisone ≤ 10 mg/day or corticosteroid equivalent is allowed), or immune modulators (e.g., thalidomide) within two weeks and interferon use within four weeks prior to study Day 1 - Symptomatic congestive heart failure (New York Heart Association Classification Class II), unstable angina, or unstable cardiac arrhythmia requiring medication - Pregnancy - History of surgery within two weeks prior to enrolment or anticipated surgery during the study period or two weeks post-study - History of aneurysm - Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent. ; PRIMARY OUTCOME: Number of subjects with serious and non-serious adverse events; SECONDARY OUTCOME 1: Maximum plasma concentration (C1hr=Cmax)[/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 - CL-003 (Castration-Resistant); BRIEF: The goal of this clinical study is to determine the efficacy and safety of Seviteronel, a lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with enzalutamide and/or abiraterone. ; DRUG USED: Seviteronel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Cytochrome P450c17; THERAPY: Monotherapy; LEAD SPONSOR: Innocrin Pharmaceutical; CRITERIA: Inclusion Criteria 1. Subjects must be ≥18 years of age. 2. Subjects or their legal representatives must be able to provide written informed consent. 3. Subjects must have documented histological or cytological evidence of adenocarcinoma of the prostate. 4. Subjects must have an ECOG Performance Score of 0-1. 5. Subjects must have undergone orchiectomy, or have ongoing LHRH analogue therapy prior to drug initiation. Subjects on LHRH analogues must remain on these agents for the duration of the study. 6. Subjects must have castrate levels of testosterone (≤50 ng/dl [1.7 nmol/L]) and have progressive disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values ≥1 week between each assessment. The PSA value at the Screening visit must be ≥2ng/mL with or without: - Soft tissue disease progression defined by RECIST 1.1 at Screening or ≤ 28 days of C1D1. Measurable disease is not required for entry. Lymph nodes ≥ 1.5cm (short axis) are considered measurable disease (PCWG3) - Bone disease progression defined by ≥2 new lesions on bone scan at Screening, or ≤28 days of C1D1 7. Subjects must have received abiraterone and/or enzalutamide. Subject must have received either abiraterone or enzalutamide for ≥12 weeks. Other second generation CYP17 inhibitors/androgen receptor antagonists including but not limited to TAK-700 (orteronel), TOK-001 (galeterone) may have been taken in place of abiraterone and ARN-509 (apalutamide) may have been taken in place of enzalutamide. 8. Subjects must have adequate hematopoietic function as evidenced by: - WBC ≥3,000/µl - ANC ≥1,500/µl - Platelet count ≥100,000/µl - HGB ≥10 g/dl and not transfusion dependent 9. Subjects must have adequate liver function, including all of the following: - Total serum bilirubin ≤2.0 x ULN unless the subject has documented Gilbert syndrome; - Aspartate and alanine aminotransferase (AST & ALT) ≤3.0 x ULN or ≤5.0 x ULN if subject has liver metastasis; - Alkaline phosphatase ≤2.0 x ULN or ≤5 x ULN in case of bone metastasis and/or hepatic metastasis 10. Subjects must have adequate renal function as evidenced by a serum creatinine of <2.0 mg/dl. 11. Subjects must have potassium (K+) >3.5 mEq/l. 12. Subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting a Screening and continuing throughout the study period and for 3 months after final study drug administration • Two acceptable forms of birth control include: 1. Condom (barrier method of contraception), and 2. One of the following: 1. Oral, injected or implanted hormonal contraception 2. Placement of an intrauterine device (IUD) or intrauterine system (ISU) 3. Additional barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. 4. Vasectomy or surgical castration ≥ 6 months prior to Screening. 13. Subjects able to swallow study medication 14. Subjects able to comply with study requirements Exclusion Criteria 1. Subjects who have completed sipuleucel-T (Provenge ®) treatment within 28 days of study drug initiation. 2. Subjects on 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of study drug initiation. 3. Subjects who received any investigational agent ≤28 days of study drug initiation. 4. Subjects who received palliative radiotherapy ≤2 weeks of study drug initiation. 5. Subjects with symptomatic CNS metastases. 6. Subjects with a history of another invasive malignancy ≤3 years of study drug initiation. 7. Subjects with a QTcF interval of >470 msec; if the Screening ECG QTcF interval is >470 msec, it may be repeated, and if repeat <470 msec, the subject may be enrolled. 8. Subject with clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place) 9. Subject that started a bone modifying agent (e.g. bisphosphonates, denosumab) ≤ 28 days of study drug initiation (note: ongoing bone modifying agents administered > 28 days are allowed). 10. Subject with any medical condition that could preclude subject participation in the study, pose an undue medical hazard, or which could interfere with study results. 11. Subject with Class III or IV Congestive Heart Failure as defined by the New York Heart Association (NYHA) functional classification system within the previous 6 months. 12. Subject with a history of loss of consciousness or transient ischemic attack ≤ 12 months of study drug initiation. 13. Subject with known active HIV, Hepatitis B, or Hepatitis C infections. 14. Subject with known or suspected hypersensitivity to seviteronel, or any components of the formulation 15. Subject with any other condition which in the opinion of the investigator would preclude participation in the study. ; PRIMARY OUTCOME: Proportion of patients who have a PSA response by while on study from starting treatment with seviteronel; 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 IIa - w/PegIntron/RBV (Japan); BRIEF: The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care ; 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: Key Inclusion Criteria: - Patients chronically infected with hepatitis C virus (HCV) genotype 1 - HCV RNA viral load ≥10*5* IU/mL at screening - Naïve or nonresponsive to the current standard of care Key Exclusion Criteria: - Cirrhosis - Hepatocellular carcinoma - Coinfection with hepatitis B virus, HIV-1 or HIV-2 ; PRIMARY OUTCOME: Percentage of Participants With Extended Rapid Virologic Response (eRVR); SECONDARY OUTCOME 1: Percentage of Participants With Rapid Virologic Response (RVR)[/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 - w/Venetoclax; BRIEF: The study is a multicenter, open label Phase I/II trial. 1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapsed/refractory AML. (Phase 1 portion) 2. To assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to 6 months after the start of treatment without receiving other AML therapies. (Phase 2 portion) ; DRUG USED: Actimab-A; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Cluster of Differentiation 33 (CD33/SIGLEC-3), Radiopharmaceutical; THERAPY: Combination; LEAD SPONSOR: Actinium Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Refractory or relapsed AML which will include: 1. Refractory disease will be defined as at least 1 prior treatment with no remission. 2. Relapsed disease will be defined as 5% or more blasts in bone marrow seen after remission. 3. Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, ts-AML) are also eligible. 2. Circulating blast count ≤ 200/μL within 10 days prior to first cycle of treatment. Hydroxyurea should be used to keep the peripheral blast count ≤ 200/μL until the first day of protocol treatment, to the extent that this is possible 3. ECOG ≤ 2 4. Estimated creatinine clearance ≥ 50 mL/min 5. AST and ALT ≤ 3.0 x ULN 6. Bilirubin ≤ 3.0 x ULN Exclusion Criteria: 1. Active CNS Leukemia. 2. Known HIV infection or known hepatitis B or hepatitis C infection (with a detectable viral load). 3. Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment. 4. Secondary refractory AML (e.g., treated for current relapse without achieving remission); a. With the exception that single agent FLT3 inhibitors, IDH1/IDH2 inhibitors are allowed for current relapse without achieving remission. 5. Have received prior radiation to maximally tolerated levels to any critical normal organ. 6. Clinically significant cardiac disease. 7. Active, uncontrolled serious infection. 8. Have other non-myeloid malignancy within 2 years of entry (with exceptions). 9. Psychiatric disorder that would preclude study participation 10. Previous solid organ transplant (prior treatment with SCT is allowed but not if patient has GVHD or is still receiving immunosuppression/GVHD therapy). ; PRIMARY OUTCOME: Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225; SECONDARY OUTCOME 1: Phase I: Overall Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - 1812VA323; BRIEF: The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo. ; DRUG USED: S-600918; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Cough; TARGET: P2 (Purine) Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Shionogi; CRITERIA: Key Inclusion Criteria: - Having refractory chronic cough (including unexplained chronic cough) for at least 1 year. - If female and of childbearing potential, agreement to use one of the allowed contraceptive methods. - Capable of giving signed informed consent. Key Exclusion Criteria: - Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more. - Has chronic obstructive pulmonary disease or uncontrolled asthma. - Has a clinically unstable medical condition. - History of or ongoing significant psychiatric disorder. - History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks. - History of malignancy in the last 5 years. - History of severe drug allergy. - History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs. - Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year. - Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg. - Received S-600918 previously. - Received an investigational drug in the last 3 months. - Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment. - Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA). - If female, pregnant or trying to become pregnant or breastfeeding. ; PRIMARY OUTCOME: Change in Cough at Week 4 Calculated as the Ratio of Number of Coughs per Hour in 24 Hours at Week 4 to Baseline; SECONDARY OUTCOME 1: Percentage of Participants with a Reduction from Baseline in the Number of Coughs per Hour in 24 Hours by ≥ 30%[/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 - BC28034; BRIEF: This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks. ; DRUG USED: Aleglitazar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: PPAR alpha, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients, >/=18 years of age - Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening - Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past - HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit - Fasting plasma glucose </=240 mg/dL at pre-randomization visit - Agreement to maintain diet and exercise habits during the study Exclusion Criteria: - Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months - Any previous treatment with thiazolidinedione or a dual peroxisome proliferator activated receptor (PPAR) agonist - Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin) - Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening ; PRIMARY OUTCOME: Change from baseline in hemoglobin HbA1c; SECONDARY OUTCOME 1: Change in lipid profile[/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 - Japanese Patients; BRIEF: The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease. ; DRUG USED: LIK066; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with obesity disease and inadequately controlled body weight with diet and/or exercise - BMI ≥ 25 kg/m^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35 kg/m^2 at least one obesity-related comorbidity - Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0% - Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female - Visceral fat area ≥ 100 cm^2 - Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study Exclusion Criteria: - Pregnancy or lactating women - Use of pharmacologically active weight-loss medications - Bariatric surgery - Ketoacidosis, lactic acidosis, hyperosmolar coma - Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening - Gastro-intestinal (GI) disorders associated with chronic diarrhea - Congestive heart failure, New York Heart Association (NYHA) class III or IV ; PRIMARY OUTCOME: Percentage Change From Baseline in Body Weight at Week 12; SECONDARY OUTCOME 1: Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12[/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 - Compared with Botox (Republic of Korea); BRIEF: The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients. ; DRUG USED: Jeuveau; DRUG CLASS: Biosimilar; INDICATION: Wrinkles; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Daewoong Pharmaceutical Co. LTD.; CRITERIA: ; PRIMARY OUTCOME: At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigators live severity assessment; SECONDARY OUTCOME 1: At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigators live severity assessment[/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 - REFLECTIONS B327-04; BRIEF: The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant setting. The hypothesis to be tested in this study is the percentage of patients with steady state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to EU-approved trastuzumab, using a margin of -12.5%. ; DRUG USED: Trazimera; DRUG CLASS: Biosimilar; INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Histologically confirmed HER2 overexpressing invasive breast cancer. - Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND). - Plan for neoadjuvant chemotherapy. - Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm. Exclusion Criteria: - Bilateral breast cancer. - Inflammatory breast cancer. - Presence of known distant metastases. - Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer. ; PRIMARY OUTCOME: Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.; SECONDARY OUTCOME 1: Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ATS907-205; BRIEF: This single-site, dose-escalation study will evaluate safety and tolerability of increasing concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular Hypertension ; DRUG USED: ATS907; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Altheos, Inc.; CRITERIA: Inclusion Criteria: - 18 years of age or greater - Diagnosis of open angle glaucoma or ocular hypertension in both eyes - Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (EDTRS) in each eye (equivalent to 20/200) - Must be willing to discontinue the use of all ocular hypotensive medications in both eyes prior to and during the entire course of the study Exclusion Criteria: Ophthalmic (in either eye): - Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s). Refractive surgery in study eye - Cataract surgery and or other intraocular surgery within one month prior to Screening in either eye - History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis - Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented - Contact lens wear during the duration of the study - Clinically significant ocular disease (e.g., diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study ; PRIMARY OUTCOME: Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs; 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 III - Pediatric; BRIEF: This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (Idiopathic) thrombocytopenia purpura. This study is available to pediatric patients who have completed a previous romiplostim ITP study and meet the eligibility criteria of this study. ; DRUG USED: Nplate; DRUG CLASS: Biologic; INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subject or subjects legally acceptable representative has provided informed consent. - Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP. Exclusion Criteria: - Subject has or previously had any bone marrow stem cell disorder (any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study). - Subject has any new active malignancy diagnosed since enrollment in the previous romiplostim ITP study. - Subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study. - Other investigational medications are excluded. - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) (with the exception of romiplostim in a previous clinical study). - Female subject of child bearing potential (defined as having first menses) is not willing to use highly effective contraception during treatment and for 4 weeks after the end of treatment. - Female subject is pregnant or breast feeding, or planning to become pregnant within 4 weeks after the end of treatment. - Subject has known sensitivity to any of the products to be administered during dosing. - Subject previously has entered this study (this will depend on the type of study). - Subject will not be available for protocol required study visits, to the best of the subject and investigators knowledge. - Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. ; PRIMARY OUTCOME: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Percentage of Participants With a Platelet Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FAR-131; BRIEF: This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. ; DRUG USED: Farletuzumab; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Folate Receptor (FOLR1); THERAPY: Combination; LEAD SPONSOR: Morphotek; CRITERIA: Inclusion Criteria: - A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies - Must have measurable disease by CT or MRI scan - Must have relapsed radiologically with a randomization date within ≥6 and < 24 months of completion of first-line platinum chemotherapy - Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy. - Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed. - Must be a candidate for carboplatin and taxane therapy - Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1 Exclusion Criteria: - Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy - Subjects who have received other therapy to treat their ovarian cancer since relapse - Known central nervous system (CNS) tumor involvement - Evidence of other active invasive malignancy requiring treatment in the past 5 years - Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA - Previous treatment with MORAb-003 (farletuzumab) - Clinical contraindications to use of a taxane ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 102 OLE; BRIEF: The purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in male participants with DMD who have successfully completed the 96-week eteplirsen Study 4658-102. ; DRUG USED: Exondys 51; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Dystrophin gene (DMD); THERAPY: Monotherapy; LEAD SPONSOR: Sarepta Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Participant successfully completes 96 weeks of treatment in Study 4658-102. Exclusion Criteria: - Participant has a prior or ongoing medical condition that, in the Investigators opinion, could adversely affect the safety of the participant, or make it unlikely that the course of treatment or follow-up would be completed, or impair the assessment of study results. Other inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Number of Participants Experiencing Adverse Events (AEs); 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 - Breast Cancer Metastatic to Brain; BRIEF: The goal of the first part of this clinical research study is to find the highest tolerable dose of TPI-287 in patients with breast cancer that has spread to the brain. The goal of the second part of this study is to learn if TPI-287 can control breast cancer that has spread to the brain. The safety of this drug will also be studied. ; DRUG USED: TPI-287; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Secondary; Metastases); TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Patients must have histologically proven breast cancer with metastatic disease to the brain. 2. Patients must have measurable disease on MRI that has progressed after prior therapy. PD will be defined as a>/= 25% increase in the sum of the products of greatest perpendicular diameters of all measurable disease over the smallest sum observed (since treatment started) on Gd-MRI, the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans. 3. Patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease 4. Patients must be >/=18 years of age. 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. 6. Patients must have adequate bone marrow function as evidenced by an absolute neutrophil count >/=1,500/microliters and a platelet count >/=100,000/microliter, adequate renal function as evidenced by serum creatinine </=2.0 mg/dL, adequate hepatic function as evidenced by serum total bilirubin </=2.0 mg/dL, AST/serum glutamate oxaloacetate transaminase (SGOT) and ALT/serum glutamate pyruvate transaminase (SGPT) </= 3X the upper limit of normal (ULN). 7. Patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of white blood cell count (WBC) and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame. 8. Women of child-bearing potential (i.e. </= 50 years of age or has had menstrual cycle within the past 12 months, if > 50 years of age. If in doubt, check FSH, LH and estradiol level) must have a negative urine or serum pregnancy test at screening. 9. Sexually active patients must agree to use adequate contraception (abstinence or barrier contraceptives must be used throughout the trial and one month after end of treatment) for the duration of the study . 10. Patients or their legal representative must be able to read, understand and sign an informed consent form (ICF). 11. TPI 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their PT, PTT and international normalized ratio (INR). Exclusion Criteria: 1. Patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received EIAEDs within 2 weeks prior to the first dose of study drug. 2. Patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management). 3. Patients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollment 4. Patients who are taking bevacizumab or have taken bevacizumab within the past 2 weeks for treatment of their brain metastases 5. Patients with an active infection (i.e., clinical signs or symptoms, including, but not limited to: bleeding/pustulant skin infections; productive cough associated with fever) on antibiotics or with a fever >/=38.5°C within 3 days prior to registration (i.e. date when the patient signs the consent and/or the patient is registered in CORE). 6. Patients with New York Heart Association (NYHA) Class 3 or 4 congestive heart failure. 7. Patients with known HIV or Hepatitis B or C 8. Patients who are pregnant or lactating or not practicing adequate contraception 9. Patients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patients ability to sign the ICF or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results. 10. Patients who are receiving concomitant systemic therapy for breast cancer. 11. Patients with leptomeningeal disease (LMD) or with a history of LMD will be excluded. ; PRIMARY OUTCOME: Overall Response Rate (ORR); 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 Ib/II - w/Irinotecan; BRIEF: Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage. ; DRUG USED: Zepzelca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: DNA; THERAPY: Combination; LEAD SPONSOR: PharmaMar; CRITERIA: Inclusion Criteria: 1. Voluntarily signed and dated written informed consent prior to any specific-study procedure. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. 4. Life expectancy ≥ 3 months. 5. Histologically or cytologically confirmed diagnosis of advanced disease of any of the following tumor types: For the Lurbinectedin Escalation Group and the Irinotecan Escalation Group: 1. Glioblastoma. 2. Soft-tissue sarcoma (excluding gastrointestinal stromal tumors [GIST]). 3. Endometrial carcinoma. 4. Epithelial ovarian carcinoma (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas) regardless of platinum sensitivity. 5. Mesothelioma. 6. Gastroenteropancreatic neuroendocrine tumors (GEP-NET). 7. Small cell lung cancer (SCLC). 8. Pancreatic adenocarcinoma. 9. Gastric carcinoma. 10. Colorectal carcinoma (CRC). For the Intermediate Escalation Group: 1. Endometrial carcinoma. 2. SCLC. 3. Other solid tumors may be included, if appropriate, after discussion between the Investigators and the Sponsor. For the Phase II expansion stage: 1. Glioblastoma. 2. Soft tissue sarcoma (including synovial sarcoma), 3. Endometrial carcinoma. 4. SCLC. 5. Neuroendocrine tumors. - Group 1: NENs grade 3 (Ki-67 >20%) according to the 2019 WHO classification of tumors of the digestive system, of gastroenteropancreatic origin or unknown primary site (lung primary tumors will be excluded). - Group 2: Well differentiated pancreatic neuroendocrine tumors (P-NETs) grade 2 (Ki-67 3-20%) or low grade 3 (Ki-67 21-55%) according to the 2019 WHO classification of tumors of the digestive system. 6. The number of prior lines of therapy allowed per patient will be as follows: For the Phase I Escalation Stage: No more than two prior lines of cytotoxic-containing chemotherapy regimens for advanced disease For the Phase II Lurbinectedin Expansion Stage: - For SCLC, one prior line of platinum-containing chemotherapy with/without antibodies against programmed cell death protein-1 (PD-1) or programmed death ligand-1 (PD-L1). - For NENs, - In Group 1 (patients with NENs of gastroenteropancreatic origin or unknown primary site, excluding lung primary tumors), progression to first-line platinum-based chemotherapy; and - In Group 2 (patients with well differentiated P-NETs), no more than three prior lines of systemic therapy (that may include somatostatin analogues, chemotherapy, everolimus and/or sunitinib). - For all other tumor types, no more than two prior lines of cytotoxic-containing chemotherapy regimens for advanced disease. There is no limit for prior targeted therapy, hormonal therapy and immunotherapy (such as nivolumab). 7. Phase II expansion stage: Tumor-specific cohort(s) at the RD: 1. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. For patients with glioblastoma: Measurable disease according to RECIST v.1.1 and Response Assessment in Neuro-Oncology (RANO) criteria. 2. Documented disease progression per RECIST v.1.1 during or immediately after last therapy according to any of the aforementioned criteria. For patients with glioblastoma: Documented disease progression per RECIST v.1.1 and RANO criteria. 8. At least three weeks since the last anticancer therapy, (including immunotherapy, investigational drugs and radiotherapy), and at least six weeks since nitrosoureas and mitomycin C (systemic). For biological/investigational anticancer therapies given orally, the aforementioned period of at least three weeks could be changed for one of at least five half-lives (whichever occurred first), provided that the therapy is given as single agent and not combined with other drugs. If this is not the case, this exception will not be acceptable. For patients with glioblastoma: at least 12 weeks since the end of radiotherapy, except if: 1. The patient has a new lesion outside of the radiotherapy field, or 2. The patient has undergone brain surgery to remove the tumor before study entry, and progressive disease has been confirmed histologically. Note: washout periods will be referred to the day of first cycle administration (Day 1), not to the day of registration (Day 0). 9. Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ 7 days before inclusion in the trial): 1. Platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 9.0 g/dL and absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L. 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × the upper limit of normal (ULN), even in the presence of liver metastases. 3. Alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN if disease-related/in the case of liver metastases). 4. Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN. 5. International Normalized Ratio (INR) < 1.5 (except if patient is on oral anticoagulation therapy). 6. Calculated creatinine clearance (CrCL) ≥ 30 mL/minute (using Cockcroft-Gault formula). 7. Creatine phosphokinase (CPK) ≤ 2.5 × ULN. 8. Albumin ≥ 3.0 g/dL 10. Recovery to grade ≤ 1 or to baseline from any adverse event (AE) derived from previous treatment (excluding alopecia and/or cutaneous toxicity and/or peripheral neuropathy and/or fatigue grade ≤ 2). Exclusion Criteria: 1. Concomitant diseases/conditions: 1. History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within the previous year. 2. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment. 3. Myopathy or any clinical situation that causes significant and persistent elevation of CPK (> 2.5 × ULN in two different determinations performed one week apart). 4. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C. Known Gilbert disease. 5. Active uncontrolled infection. 6. Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B. 7. Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or sub-occlusion or paralysis. 8. Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days. 9. Any other major illness that, in the Investigators judgment, will substantially increase the risk associated with the patients participation in this study 10. Active Coronavirus disease (COVID-19) (this includes positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal/oropharyngeal swabs or nasal swabs by PCR). 11. Hypersensitivity to any of the study drugs or their excipients. 2. Prior treatment with lurbinectedin, trabectedin (Yondelis®) or topoisomerase I inhibitors (irinotecan, topotecan, etc.). Prior topoisomerase inhibitors (e.g., irinotecan) are only allowed in patients with colorectal carcinoma 3. Prior bone marrow or stem cell transplantation, or radiation therapy in more than 35% of bone marrow. 4. Known brain metastases or leptomeningeal disease involvement. Glioblastoma lesions (primary or locally advanced) are eligible. Exception: patients with brain metastases are eligible provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment (patients taking steroids in the process of already being tapered within two weeks prior to screening are allowed). Brain CT-scan or MRI results must be provided at baseline. 5. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception. Women of childbearing potential (WOCBP) must agree to use an effective contraception method to avoid pregnancy during the course of the trial (and for at least six months after the last infusion). Fertile male patients must agree to refrain from fathering a child or donating sperm during the trial and for four months after the last infusion. 6. Limitation of the patients ability to comply with the treatment or follow-up protocol. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Safety evaluation[/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 - CAFQ056A2299 (Long-Term Safety Extension); BRIEF: This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinsons disease L-dopa induced dyskinesias (PD-LID). ; DRUG USED: AFQ056; DRUG CLASS: New Molecular Entity (NME); INDICATION: Levodopa-Induced Dyskinesia; TARGET: Metabotropic Glutamate Receptor subtype 5 (mGluR5); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol - Outpatients - Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements Exclusion Criteria: - Atypical or secondary form of Parkinsons disease - History of surgical treatment for PD including deep brain stimulation - Advanced, severe, or unstable disease (other than PD) - History of malignancy - Evidence of dementia - Untreated/ineffectively treated mental disorders - Treatment with certain prohibited medications - Abnormal lab values or heart abnormalities - Pregnant or nursing women ; PRIMARY OUTCOME: Incidence rate of adverse events including serious adverse events; SECONDARY OUTCOME 1: Change in mAIMS (modified Abnormal Involuntary Movement Scale) total score from baseline to Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter.[/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 - SELECT-PsA-1; BRIEF: This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1. ; DRUG USED: Rinvoq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriatic Arthritis (PA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria. - Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits. - Presence of either at Screening: 1. >= 1 erosion on x-ray as determined by central imaging review or; 2. high-sensitivity C-reactive protein (hs-CRP) > laboratory defined upper limit of normal (ULN). - Diagnosis of active plaque psoriasis or documented history of plaque psoriasis. - Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator. - Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on <= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for >= 12 weeks and at stable dose for >= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study. i. Participants who need to discontinue DMARDs prior to the Baseline Visit to comply with this inclusion criterion must follow the procedure specified below or at least five times the mean terminal elimination half-life of a drug: 1. >= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label); 2. >= 4 weeks for all others. Exclusion Criteria: - Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib). - Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide. - History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly. ; PRIMARY OUTCOME: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12; SECONDARY OUTCOME 1: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12[/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 - 200911; BRIEF: GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the treatment of HIV-1 infection in combination with other antiretroviral therapy (ART). This study will be a 10-day monotherapy, open-label, adaptive, dose ranging, repeat-dose study. This study will be conducted in two Parts (Part A and Part B) consisting single daily doses of GSK2838232 and Cobicistat from Day 1 to Day 10. This proof of concept open-label study will be aimed to characterize the acute antiviral activity, pharmacokinetics (PK), the relationship between PK and antiviral activity, and safety of GSK2838232/cobi administered across a range of doses over 10 days in HIV-1 infected patients. A cohort of 10 subjects will be studied in Part I followed by interim (go/no-go) analysis of Part A data. On completion of an interim analysis of part A data, further cohorts of 8 subjects will then be studied in Part B in a parallel design in two or more cohorts (depending upon the data obtained in Part A). Approximately 34 HIV-1 infected treatment-naive subjects will be enrolled during the study. Subjects in both parts will have a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation will be approximately 6 Weeks. ; DRUG USED: GSK2838232; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Gag protein; THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Between 18 and 55 years of age inclusive, at the time of signing the informed consent. - Healthy (other than HIV infection) male or female as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring, defined as no other chronic medical conditions and taking no chronic medications. - A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the medical monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - A creatinine clearance >80 mL/minute as determined by Cockcroft-Gault equation creatinine clearance CLcr (mL/minute) = (140 - age) x weight (Wt) divided by (72 x serum creatinine [Scr]) (times 0.85 if female) where age is in years, Wt is in kilogram (kg), and Scr is in units of mg/decilitre (dL). - Confirmed HIV positive; CD4+ cell count >=350 cells/millimetre (mm)^3 and plasma HIV-1 RNA >=5000 copies/mL at screening. - No current and no prior ART. - Body weight >=50 kg (110 pound [lbs.]) for men and >=45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kg/meter^2 (inclusive) - A female subject of reproductive or non-reproductive potential is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin (hCG) test at screening and prior to first dose), not lactating, and at least one of the following conditions applies: females of reproductive potential may only be enrolled if they are using two forms of complementary contraception, which must include one barrier method. They will be counselled on safer sex practices; there is no definitive drug-drug interaction (DDI) information with GSK2838232 and an interaction with oral contraceptives is possible, so other (barrier, inter-uterine device etc.) methods of contraception will be required; fertile females, who have an established, long-term lifestyle of sexual abstinence, or only same sex partners, require no other means of birth control. Pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy; postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. - Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until one week after the last dose of study medication; vasectomy with documentation of azoospermia; male condom plus partner use of one of the contraceptive options as: Contraceptive sub dermal implant including a <1 percent rate of failure per year; intrauterine device or intrauterine system including a <1 percent rate of failure per year; oral contraceptive, either combined or progestogen alone or injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. - Capable of giving signed informed consent. Exclusion Criteria: - Alanine aminotransferase (ALT) and bilirubin (BIL) >1.5 x upper limit of normal (ULN), isolated BIL >1.5xULN is acceptable if BIL is fractionated and direct BIL <35 percent. - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones); hepatitis B virus (HBV) and/or hepatitis C virus (HCV) positive. - Subjects who have any other chronic medical condition, including cardiovascular (CV), respiratory, neurologic, psychiatric, renal, gastrointestinal (GI), oncologic, rheumatologic, or dermatologic. - Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. - Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK medical monitor the medication will not interfere with the study procedures or compromise subject safety. - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. - Smoking is an exclusion criteria for this study. Subject having urinary cotinine levels indicative of smoking at screening. - Chronic marijuana or use of other elicit medications (cocaine, heroin) is an exclusion criteria. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. - Screening or Baseline cardiac troponin I greater than the 99 percent cutoff (>0.045 nanogram [ng]/mL by the Dimension Vista cardiac troponin [CTN] I assay). - A positive pre-study drug/alcohol screen. - Prior history of receiving an HIV maturation inhibitor - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of study drug administration or anticipated need for such treatment within the study. - Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of study drug administration. - An active Center for Disease Control and Prevention (CDC) category C disease except cutaneous Kaposis sarcoma not requiring systemic therapy during the trial. - Treatment with any vaccine within 30 days prior to receiving study medication. - Exclusion criteria for 24-hour screening holter: any symptomatic arrhythmia (except isolated extra systoles); sustained cardiac arrhythmias (such as atrial fibrillation, flutter or supraventricular tachycardia [>=10 seconds]); non-sustained or sustained ventricular tachycardia (defined as >=3 consecutive ventricular ectopic beats); any conduction abnormality including but not specific to left or complete bundle branch block, atrioventricular (AV) block, high grade or complete heart block Wolff-Parkinson-White (WPW) syndrome etc.; sinus pauses >3 seconds. - Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): heart rate <45 and >100 beats per minute (bpm) for males, and <50 and >100 bpm for females; PR Interval <120 and >220 milliseconds (msec); QRS duration <70 and >120 msec; corrected QT (QTc) interval >450 msec; Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization); any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], WPW syndrome); sinus pauses >3 seconds; any significant arrhythmia which, in the opinion of the principal investigator or GSK medical monitor, will interfere with the safety for the individual subject; non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats). ; PRIMARY OUTCOME: Maximum Decline From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA); SECONDARY OUTCOME 1: Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 AUC (0 to Tau)[/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 - Postpartum Iron Deficiency Anaemia (Denmark); BRIEF: The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue ; DRUG USED: Monoferric; DRUG CLASS: Non-NME; INDICATION: Anemia; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Pharmacosmos A/S; CRITERIA: Inclusion Criteria: 1. PPH > 1000 mL 2. Hb ≥ 5.5 and ≤ 8.0 g/dL (≥ 3.5 and ≤ 5.0 mmol/L) 3. Willingness to participate and signed the informed consent form Exclusion Criteria: 1. Women aged < 18 years 2. Multiple births 3. Peripartum RBC transfusion 4. Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 5. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products 6. Women with a history of active asthma within the last 5 years or a history of multiple allergies 7. Known decompensated liver cirrhosis and active hepatitis 8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to Dansk Selskab for Obstetrik og Gynækologi guidelines) 9. Active acute infection assessed by clinical judgement 10. Rheumatoid arthritis with symptoms or signs of active joint inflammation 11. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) 12. Not able to read, speak and understand the Danish language 13. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline 14. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus ; PRIMARY OUTCOME: Physical Fatigue; SECONDARY OUTCOME 1: Change in Hb concentration[/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 - PERSIST-2 (PAC326); BRIEF: Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis. ; DRUG USED: Pacritinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , Interleukin-1 receptor-associated kinase 1 (IRAK1), JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: CTI BioPharma; CRITERIA: Inclusion Criteria: - Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010) - Thrombocytopenia (platelet count ≤ 100,000/µL) at any time after signing informed consent - Palpable splenomegaly ≥ 5 cm on physical examination - Total Symptom Score ≥ 13 on the MPN-SAF TSS 2.0, not including the inactivity question - Patients who are platelet or red blood cell transfusion-dependent are eligible - Adequate white blood cell counts (with low blast counts), liver function, and renal function - At least 6 months from prior splenic irradiation - At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent - Not pregnant, not lactating, and agree to use effective birth control - Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument Exclusion Criteria: - Prior treatment with more than 2 JAK2 inhibitors or with pacritinib - There is no maximum cumulative prior JAK2 inhibitor treatment - History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant - Ongoing gastrointestinal medical condition such as Crohns disease, Inflammatory bowel disease, chronic diarrhea, or constipation - Active bleeding that requires hospitalization during the screening period - Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction - Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers - Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study - Life expectancy < 6 months ; PRIMARY OUTCOME: Spleen Volume Reduction; 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 III - Paediatric (Secondary Prevention); BRIEF: This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate. ; DRUG USED: Pradaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent - Previously documented objective diagnosis of VTE, followed by completed course of initial VTE treatment for at least 3 months (in case of VKA - intended INR between 2 and 3) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial. Patients, who during the treatment phase of 1160.106 trial were switched from dabigatran etexilate to SOC arm for any reason, are not eligible for this study. - Presence of an unresolved clinical risk factor requiring further anticoagulation for secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia, etc.) - Written informed consent form (ICF) provided by the patients parent or legal guardian and assent provided by the patient (if applicable) at the time of ICF signature according to local regulations. - Further inclusion criteria apply Exclusion criteria: - Conditions associated with an increased risk of bleeding - Renal dysfunction (eGFR < 50 mL/min/1.73m^2 using the Schwartz formula) or requirement for dialysis. eGFR retesting during the screening period is allowed (once). - Active infective endocarditis - Subjects with a heart valve prosthesis requiring anticoagulation. - Hepatic disease: Active liver disease, including known active hepatitis A, B or C or Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline phosphatase (AP) > 3 × upper limit of normal (ULN) within 3 months of screening - Pregnant or breast feeding females. Females who have reached menarche and are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and / or do not agree to adhere to pregnancy testing required by this protocol - Patients in age group 0 to < 2 years with gestational age at birth < 37 weeks or with body weight lower than the 3rd percentile - Anemia (hemoglobin < 80g/L) or thrombocytopenia (platelet count < 80 x 109/L) at screening. Transfusions during the screening period are allowed, provided that a satisfactory hemoglobin or platelet level is attained prior to visit 2 - Patients who have taken restricted medication prior to first dose of study medication - Patients who have received an investigational drug in the past 30 days prior to screening, except patients who have completed the treatment period (up to Visit 8) in 1160.106 trial - Patients who are allergic/sensitive to any component of the study medication including solvent - Patients or parents/legal guardians considered unreliable to participate in the trial per investigator judgment or any condition which would present a safety hazard to the patient based on investigator judgment - Further exclusion criteria apply ; PRIMARY OUTCOME: Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months; SECONDARY OUTCOME 1: Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months[/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 - Extension Study; BRIEF: The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety and efficacy data obtained in this study will be included in regulatory product submissions as appropriate. ; DRUG USED: Brazikumab; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1.01 Male or female participants who: successfully completed or discontinued participation due to lack of efficacy after Week 10 in the lead-in Study D5272C00001 (Legacy #3151-201-008). AND Meets 1 of the following criteria for successful completion or early termination from Study D5272C00001 (Legacy #3151-201-008): 1. Participant completed Study D5272C00001 (Legacy #3151-201-008), received scheduled study interventions, completed scheduled visits, and completed Week 54 assessments. 2. Participant discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001 (Legacy #3151-201-008), received scheduled study interventions, and completed Early Termination Visit assessments. 1.02. Deleted Eligibility as part of Amendment 2 1.03. Deleted Eligibility as part of Amendment 3 1.04. Deleted eligibility as part of Amendment 2 2.01. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Nonsterilized men who are sexually active with a female partner of childbearing potential should use condom during treatment and for 18 weeks after the last dose of study intervention, must comply with the methods of contraception described in Criterion 2.02 below, and must not donate or bank sperm for fertilization purpose for the same time period. 2.02. Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from signing the ICF throughout the study duration and for at least 18 weeks after last dose of study intervention 2.03. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. 3.01. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Written informed consent from the participant has been obtained prior to any study related procedures. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]). 4.01. Demonstration of adequate compliance with the study procedures in Study D5272C00001 (Legacy #3151-201-008), in the opinion of the investigator and/or sponsor. 4.02. Willingness and ability to attend all study visits, comply with the study procedures, and be able to complete the study period. 5.01 Participant must be 18 to 80 years of age inclusive, at the time of signing the ICF. Complete inclusion criteria are in the study protocol Exclusion Criteria: 1.01. Any participant with an unresolved AE from the lead-in study that, in the investigators opinion, would limit the participants ability to participate in or complete this study. Any unresolved AE related to an infection will require further discussion with the study physician/designee prior to enrollment. 1.02. Current diagnosis of fulminant colitis, CD or indeterminate colitis, presence of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or toxic megacolon. Bile acid malabsorption and other conditions that may potentially confound assessments must be treated prior to baseline. 1.03. Organ or cell-based transplantation with the exception of corneal transplant. 1.04. Any other condition or finding that, in the investigators or sponsors opinion, would either confound proper interpretation of the study or expose a participant to unacceptable risk. 1.05. The following are exclusionary with regards to malignancy: 1. Evidence of intestinal epithelial dysplasia on endoscopy, and this is confirmed on biopsy, the participant must be excluded. 2. Any diagnosis of malignancy that requires discontinuation of study intervention from lead-in study. 3. Any new diagnosis of malignancy after completion of the lead-in study. d) Carcinoma in situ of the cervix, with apparent successful curative therapy within 12 months prior to Week 0. 1.06. Participant meets criteria for discontinuation of study intervention during prior lead-in study. 1.07. Deleted exclusion criterion as part of Amendment 3 1.08. Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, including HIV infection. 1.09. Prolonged QTcF interval or conditions leading to additional risk for QT prolongation. Participants with electrolyte abnormalities such as hypokalemia and hypomagnesemia that would increase the risk of QT prolongation are to be corrected prior to enrollment. 1.010. Clinically significant kidney disease including but not limited to: (a) Chronic kidney disease with an estimated glomerular filtration rate of less than 30 ml/min calculated by Modification of Diet in Renal Disease equation, asapplicable, by the central laboratory at screening are excluded. 2.01. Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication in the protocol), biological treatment or prohibited treatment 2.02. Deleted eligibility as part of Amendment 2 2.03. Participant received a prohibited medication during participation in the D5272C00001 (Legacy #3151-201-008) study. 2.04. Participant received a Bacille Calmette-Guérin vaccination within 12 months of Week 0 or any other live vaccine < 4 weeks prior to Week 0, or is planning to receive any such vaccine over the course of the study. 2.05. Participant has received an investigational product after discontinuation from Study D5272C00001 (Legacy #3151-201-008) and prior to enrolling in this study or participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study D5272C00002 (Legacy #3151-202-008). 3.01. Participant who discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001 and did not receive all 3 IV infusions of study interventions scheduled for Week 0 (Day 1), Week 2 (Day 15), and Week 6 (Day 43), and SC at Week 10 (Day 71) in accordance with the protocol for Study D5272C00001. 3.02. Participant who discontinued due to lack of efficacy after Week 10 in Study D5272C00001 (Legacy #3151-201-008) but currently demonstrates clinical response and/or meets endoscopic Mayo Score of 0 or 1 prior to Week 54 in Study D5272C00001 (Legacy #3151-201-008): Clinical Response defined as: Reduction in mMS ≥ 2 points from baseline AND ≥ 30% from baseline, AND a decrease in the rectal bleeding score ≥ 1 point from baseline or a score of 0 or 1, in Study D5272C00001 (Legacy #3151-201-008). Note: Participants are encouraged to remain in the lead-in Study D5272C00001 (Legacy #3151-201-008) if the participant is demonstrating evidence of clinical response. Participants should not early terminate that study due to lack of efficacy if this exclusion is met. 4.01. Abnormal laboratory results at screening as described in the protocol. 5.01. Females who are pregnant, breast feeding, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use contraception consistently and correctly as required by the study protocol. 5.02. Participant is directly or indirectly involved in the planning and/or conduct and administration of this study as study staff member, or employee of the sponsor, or the participant is a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or the participant is enrolled in this study at another clinical study site. 5.03. Judgment that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 5.04. Previous enrollment in the present study. Complete exclusion criteria are in the study protocol ; PRIMARY OUTCOME: Number and percentage of patients with adverse events; 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 III - 3582 - BEGIN (BB); BRIEF: This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone. Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582. The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667. ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - For MAIN period (NN1250-3582): - Type 2 diabetes mellitus for at least 6 months - Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start - HbA1c 7.0-10.0 % (both inclusive) - Body Mass Index (BMI) below or equal to 40.0 kg/m^2 - For EXTENSION period (NN1250-3667): - Completion of the 52 week treatment period in NN1250-3582 Exclusion Criteria: - For MAIN period (NN1250-3582): - Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months - Cardiovascular disease within the last 6 months - Uncontrolled treated/untreated severe hypertension - Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures - Cancer and medical history of cancer ; PRIMARY OUTCOME: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment; SECONDARY OUTCOME 1: Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CL02-204; BRIEF: A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain. ; DRUG USED: CL-H1T; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Charleston Laboratories, Inc; CRITERIA: Inclusion Criteria: 1. Able to understand and willing to give written informed consent and authorize the Health Insurance Portability and Accountability Act (HIPAA) prior to entering the study. 2. Men and women with episodic migraine who meet the criteria of the International Headache Societys Headache Classification Committee for migraine with or without aura. 3. Between the ages of 18 and 75 years of age, inclusive. 4. A history of episodic migraine for at least 1 year. 5. Maximal frequency of 8 migraine attacks per month; minimum frequency of 2 migraine attacks per month; at least 48 hours of headache-free time between migraine attacks. 6. Maximum total headache days of 14 per month. 7. History of migraine headache with nausea ≥ 50% of the time. 8. Able and willing to complete an electronic diary (eDiary) to record the details of a migraine attack treated with investigational treatment. 9. Able to swallow a capsule whole. 10. Report headache on the Headache Pain Scale at Baseline before treatment. 11. Report the presence of nausea on the Nausea Scale at Baseline before treatment. 12. Women of childbearing potential (WOCBP) must practice an acceptable method of birth control (acceptable methods of birth control in this study include: surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partners vasectomy, or a double-barrier method [condom or diaphragm with spermicide]). Use of intrauterine devices and hormonal contraceptives must begin at least 8 weeks prior to Screening. 13. Willing and able to comply with the protocol requirements for the duration of the study. Exclusion Criteria: 1. A clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation. Such conditions may include cardiac, respiratory, hepatic, renal or metabolic diseases, peripheral vascular disease, any systemic disease, acute infection, or neurological disease (including Parkinsons Disease or other condition associated with a movement disorder), current malignancy or recent history (within 5 years) of malignancy (other than squamous cell or basal cell carcinoma) or any medical condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study. 2. A positive saliva screen for alcohol or a positive urine drug screen for cocaine, narcotics, benzodiazepines, opioids, tetrahydrocannabinol (THC), barbiturates, amphetamines, or any prescription drugs unless such a positive result can be explained by stated concomitant medications. 3. Regularly smoke cigarettes or use opiate analgesic drugs, benzodiazepines, ergot containing drugs, alcohol, THC, or other drugs of abuse that, at the discretion of the Investigator, may interfere with the evaluation of the endpoints in the trial. 4. Unstable use of prophylactic migraine medication (eg, change of dose or type of medication) during the 30 days prior to Screening Visit. 5. Subjects using monoamine oxidase-A (MAO-A) inhibitors and who cannot be washed out. 6. Subjects using selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, THC, or systemic corticosteroids over the past month prior to the Screening Visit. 7. Daily use of antipsychotics at least 15 days prior to randomization. 8. Medication overuse: 1. Opioids for headache ≥ 10 days during the 90 days prior to Screening Visit; 2. Combination medications that contain an opioid and/or barbiturate (eg, Fiorinal®) ≥ 10 days during the 90 days prior to Screening Visit. 3. Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications ˃ 14 days a month during the 90 days prior to Screening Visit. 4. Triptans or ergots ≥ 10 days a month during the 90 days prior to Screening Visit. 9. Use of mini prophylaxis for menstrual migraine. 10. History of allergic reaction or drug sensitivity to any triptans. 11. History of allergic reaction or drug sensitivity to promethazine. 12. History of allergic reaction or drug sensitivity to acetaminophen. 13. History of extrapyramidal reaction (eg, akathisia or dystonia) to neuroleptic treatments. 14. Subjects who are pregnant (positive urine hCG: Human chorionic gonadotropin test at Screening Visit) or breastfeeding. 15. Use of experimental or investigational treatments and/or participation in drug clinical studies within the 6 months before the Screening Visit. 16. Subjects who are employees of the Sponsor. 17. Relatives of, or staff directly reporting to, the Investigator. ; PRIMARY OUTCOME: Percentage of subjects who are pain-free 2 hours after taking investigational treatment; SECONDARY OUTCOME 1: Percentage of subjects with no vomiting 2 hours after taking the investigational 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 II - PDAC (UCSF); BRIEF: We will be conducting a Phase II study investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) at the Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco (UCSF). There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable PDAC cases will be identified per the definition developed in the currently running inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this trial, borderline resectable PDAC is defined as presence of any one or more of the following on CT: - An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring ≥ 180° of the circumference of the vessel wall - Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction - Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction. - An interface between the tumor, and Superior mesenteric artery (SMA) measuring < 180º of the circumference of the vessel wall. This trial will be conducted in two parts. In Part I, pre-treatment endoscopic ultrasound (EUS)-guided core biopsies of the pancreatic tumor, CA 19-9 levels and functional MRIs including Dynamic contrast-enhanced (DCE)-MRI and Diffusion-weighted magnetic resonance imaging (DWI-MRI) will be obtained for the first fifteen patients enrolled. After a 1-week run-in period with PEGPH20 on days 1 and 4, patients will have repeat EUS-guided core biopsies, functional MRI, CA 19-9 level and baseline CT chest, abdomen and pelvis. Subsequently, patients will be started on treatment with PEGPH20, gemcitabine and nab-paclitaxel given weekly for 3 weeks, every 28 days. To evaluate the disease response to treatment, CA 19-9 levels will be checked monthly and restaging CT chest, abdomen and pelvis will be obtained every 8 weeks. If there is disease progression at any point in the study, patients will be taken off of study and alternative treatments will be offered. At the completion of 4 cycles of therapy, restaging CT scans will be obtained to determine resectability. If the patients are found to have resectable disease, an additional functional MRI will be obtained to evaluate the PDAC stroma. If the patients are able to have successful surgeries, tissue analyses will be performed on the resected pancreatic tumor. These patients will then proceed to get 2 cycles of adjuvant chemotherapy with gemcitabine and nab-paclitaxel. If the patients are deemed to be surgical candidates but are found to have unresectable disease in the operating room, an intraoperative core biopsy of the pancreatic tumor will be obtained for tissue analyses. At the time of initiation of therapy with PEGPH20, patients will be started on prophylactic dose of enoxaparin 1 mg/kg subcutaneous daily. This will be continued throughout the study participation. In Part II, an additional 21 patients will be enrolled, and will begin neoadjuvant therapy with PEGPH20, gemcitabine and nab-paclitaxel without the 1 week run-in of PEGPH20-only or the pre- and post-run-in EUS-guided biopsies. ; DRUG USED: PEGPH20; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Hyaluronic acid; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Andrew Ko; CRITERIA: Inclusion Criteria: - Greater than or equal to 18 years old - Histologically confirmed pancreatic adenocarcinoma - Borderline resectable disease - Performance status of Eastern Cooperative Oncology Group (ECOG) of 0-1 - Therapy naïve - Evaluable disease with either: - RECIST-defined measurable disease - An elevated serum CA19-9 >100 u/ml - Adequate organ function including: - Bone marrow: Absolute Neutrophil Count (ANC) ≥1500/mm3, platelets ≥100,000/mm3 and hemoglobin ≥ 9 g/dL - Hepatic: Serum total bilirubin ≤1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) and aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5 x ULN. - Renal: Serum creatinine (sCr) ≤ 1.5 x ULN, or creatinine clearance (Ccr) ≥ 40 mL/min as calculated by the Modified Cockcroft-Gault formula. - Peripheral neuropathy < grade 2 - Alkaline phosphatase ≤ 2 times the ULN unless bone metastasis is present in the absence of liver metastasis Exclusion Criteria: - Age younger than 18 years old - Locally advanced or metastatic disease - Known allergy to hyaluronidase - Contraindications to prophylactic dose low molecular weight heparin (LMWH) , including - Patients with recent gastrointestinal bleeding - History of heparin induce thrombocytopenia on LMWH - Subjects with previous severe hemorrhagic events on LMWH - Known contraindications to heparin including: - Recent central nervous system bleed, intracranial or spinal lesion at high risk for bleeding - Active bleeding (major): more than 2 units transfused in 24 hours - Spinal anesthesia/lumbar puncture within the past month - Chronic, clinically significant measurable bleeding > 48 hours - Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis) - Recent major operation at high risk for bleeding - Underlying hemorrhagic coagulopathy High risk for falls (head trauma) - Presence of metal biliary stents (plastic biliary stents are not an exclusion) - Known status of HIV which is not well-controlled at the time of study eligibility - Untreated Hepatitis B infection - Active infection or antibiotics within 48 hours prior to study - Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation). - Serious medical comorbidities such as New York Heart Association Class III/IV cardiac disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12 months. - Patients with aneurysm clips, ear implants, spinal nerve stimulators, pacemaker, shrapnel or any other metal in their body (contraindication for MRI scans) - Known, existing uncontrolled coagulopathy. Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately anticoagulated and have not had a Grade 2 or greater bleeding episode in the 3 weeks before Day 1. - Current use of warfarin (patients will be eligible if warfarin is discontinued and low-molecular weight heparin is used instead). - Intolerance to dexamethasone - Prior history of cerebrovascular accident or transient ischemic attack, or pre-existing carotid artery disease. - Known pregnancy, nursing women or positive pregnancy test. - Any condition that would preclude informed consent, consistent follow-up and compliance for the study participation. ; PRIMARY OUTCOME: Incidence of Clinically Relevant Pancreatic Fistula; SECONDARY OUTCOME 1: Percent Change of CA19-9 Response Rate[/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/Rituxan - MCL; BRIEF: The purpose of this study is to determine the efficacy and safety of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma. ; DRUG USED: Treanda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: DNA, p53; THERAPY: Combination; LEAD SPONSOR: Cephalon; CRITERIA: Inclusion Criteria: - histopathologically confirmed diagnosis of typical or atypical mantle cell lymphoma, except for blastoid type. - documented relapsed/refractory mantle cell lymphoma. - CD20 positive B cells in the lymph node biopsy or other lymphoma pathology specimen. - adequate hematologic function according to specific trial parameters. - bidimensionally measurable disease with at least 1 lesion measuring 2.0 cm or more in a single dimension, or the patient is in the leukemic phase of the disease. - patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. - patient has an estimated life expectancy of at least 3 months. - women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. - men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of study drug treatment and for 30 days after participation in the treatment period. Exclusion Criteria: - has received more than 3 previous standard chemotherapy regimens. - has the blastoid subtype of mantle cell lymphoma. - documented history of central nervous system (CNS) lymphomatous involvement. - a history of previous high-dose chemotherapy with allogeneic stem cell transplantation (history of autologous stem cell transplantation is allowed). - previous treatment with bendamustine. - has an active malignancy other than MCL, or has had a malignancy other than MCL within the past 3 years, except for controlled prostate cancer without evidence of bone metastases, localized bladder cancer, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer. - has New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months. - has serum creatinine of more than 2.0 mg/dL or creatinine clearance of less than 30 mL/min based on the Cockcroft-Gault method or from a 24-hour urine collection. - does not have adequate hepatic organ function as evidenced by specific trial parameters. - has known human immunodeficiency virus (HIV) infection. - has active hepatitis B infection. Hepatitis B surface antigen must be tested. - a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.) - has received corticosteroids within 28 days of study entry unless chronically administered (prednisone ≤20 mg/day) for indications other than lymphoma or lymphoma-related complications. - any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to participate in or complete this study. - any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data. - patient has received other investigational agent(s) within 28 days of study entry. - patient has received chemotherapy within the prior 28 days. - patient has a known hypersensitivity to bendamustine, mannitol, or rituximab. ; PRIMARY OUTCOME: Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria; SECONDARY OUTCOME 1: Kaplan-Meier Estimate for Duration of 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 - ARS-103; BRIEF: The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode. ; DRUG USED: Plumiaz; DRUG CLASS: Non-NME; INDICATION: Seizure Disorders (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Acorda Therapeutics; CRITERIA: Inclusion Criteria: - Provide signed informed consent for study participation. - General good health with no clinically significant unstable abnormalities. - Diagnosis of epilepsy. Exclusion Criteria: - Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®). - Use of any investigational drug within 30 days. - Blood or plasma donation within 30 days. - Not willing or unable to tolerate blood draws. ; PRIMARY OUTCOME: Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),; SECONDARY OUTCOME 1: Number of Patients With 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/III - RINGSIDE (Desmoid Tumors); BRIEF: The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors. ; DRUG USED: AL102; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Gamma-secretase, Notch Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Ayala Pharmaceuticals, Inc,; CRITERIA: Inclusion Criteria Part A: 1. At least 18 years of age (inclusive) at the time of signing the ICF. 2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent). 3. Disease progression, assessed locally by the investigator, defined as having at least one of the following: - Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest diameters of target lesion(s), within 18 months of the screening MRI - Having desmoid tumor-related pain that is not adequately controlled with nonopioid medication 4. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only) 5. One of the following: - Treatment naïve subjects for whom, in the opinion of the investigator, the IP is deemed appropriate, OR - Recurrent/refractory disease following at least one line of therapy (including surgery, radiation, or systemic therapy) 6. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for re- confirmation of disease. 7. Must be able to swallow whole capsules with no GI condition affecting absorption; nasogastric or G-tube administration is not allowed. Exclusion Criteria Part A: 1. Diagnosed with a malignancy in the past 2 years with some exceptions. 2. Current or recent (within 2 months of IP administration) GI disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohns disease. 3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at Screening. 4. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, , symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsades de Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of acute ischemia. 5. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigators judgment, increase the risk to the subject associated with his or her participation in the study. 6. Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study. 7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2 8. Abnormal organ and marrow function at Screening defined as: 1. Neutrophils <1000/mm3, 2. Platelet count <100,000/mm3, 3. Hemoglobin <9 g/dL, 4. Total bilirubin >1.5x upper limit of normal (ULN) (except known Gilberts syndrome), 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x ULN, 6. Serum creatinine > ULN and creatinine clearance (CrCl) <60 mL/min (calculation of CrCl will be based on acceptable institution standard) 7. Uncontrolled triglyceride ≥Grade 2 elevations per common terminology criteria for adverse events (CTCAE) v5.0 (>300 mg/dL or >3.42 mmol/L). 9. ECG Exclusions (Part A only) 1. Mean QT interval corrected for heart rate using Fridericias formula (QTcF) ≥450 msec. 2. QRS duration > 110 ms 3. PR interval > 240 ms 4. Marked ST-T wave abnormalities which would make it difficult to measure the QT interval 10. Any treatments for desmoid tumors within 4 weeks prior to first dose of investigational therapy; subject must have recovered from therapy related toxicity to < CTCAE Grade 2 or clinical baseline. Therapy includes: 1. Locoregional tumor directed therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery 2. Systemic therapy including chemotherapy, biologic (anti-neoplastic agent, antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or investigational therapy 11. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP; Inclusion Criteria Part B 1. ≥12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF. 2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1 within 12 months of the screening visit scan. 3. Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined according to RECIST v1.1. 4. Subject and/or legally authorized representative (i.e. parent/guardian) must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. 5. Minor subjects must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements). For all other inclusion criteria refer to Part A inclusion criteria. Exclusion Criteria Part B The subjects must be excluded from participating in the study if they meet any of the exclusion criteria for Part A, except where otherwise noted. ; PRIMARY OUTCOME: Progression free survival; SECONDARY OUTCOME 1: Overall response rate[/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 - ZUMA-3 (r/r Adults); BRIEF: The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). ; DRUG USED: Tecartus; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Combination; LEAD SPONSOR: Kite, A Gilead Company; CRITERIA: Key Inclusion Criteria: 1. Relapsed or refractory B-precursor ALL defined as one of the following: - Primary refractory disease - First relapse if first remission ≤ 12 months - Relapsed or refractory disease after 2 or more lines of systemic therapy - Relapsed or refractory disease after allogeneic transplant provided individuals is at least 100 days from stem cell transplant at the time of enrollment 2. Morphological disease in the bone marrow (≥ 5% blasts) 3. Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs 4. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 5. Adequate renal, hepatic, pulmonary and cardiac function defined as: - Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min - Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) - Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilberts syndrome. - Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion, and no clinically significant arrhythmias - Baseline oxygen saturation > 92% on room air 6. In individuals previously treated with blinatumomab, cluster of differentiation 19 (CD19) tumor expression in bone marrow or peripheral blood. Key Exclusion Criteria: 1. Diagnosis of Burkitts leukemia/lymphoma according to World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis 2. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years 3. Isolated extramedullary disease 4. Central nervous system (CNS) abnormalities - Presence of CNS-3 disease or CNS-2 disease with neurological changes - History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement 5. History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome 6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment 7. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment. 8. Primary immunodeficiency 9. Known infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg positive) or hepatitis C virus. 10. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. 11. Prior medication: - Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment - Prior CD19 directed therapy other than blinatumomab - Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis - Donor lymphocyte infusion (DLI) within 28 days prior to enrollment - Any drug used for graft-versus-host disease (GVHD) within 4 weeks prior to enrollment - At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy prior to enrollment - Corticosteroid therapy for 7 days prior to enrollment 12. Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted 13. Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment 14. Live vaccine ≤ 4 weeks prior to enrollment 15. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential 16. Individuals of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of brexucabtagene autoleucel (KTE-X19) 17. In the investigators judgment, the individuals is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation 18. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate[/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/IIa - 003; BRIEF: This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated relative to placebo. ; DRUG USED: NDV-3; DRUG CLASS: Vaccine; INDICATION: Fungal Infections - Non-Systemic; TARGET: Candida, Staphylococcus; THERAPY: Monotherapy; LEAD SPONSOR: NovaDigm Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Has been informed of the nature of the study and has agreed to and is able to read, review, and sign the informed consent document prior to Screening. - Is a female between 18-50 years of age, inclusive, at the time of vaccination on an acceptable form of birth control. - Has a current episode of VVC (at Screening/Day -14) that can be confirmed with acute signs and symptoms of VVC (Composite Questionnaire score of ≥3) and a positive vaginal mycological culture for C. albicans. - Has a history of 2 or more documented episodes of VVC in the 12 months prior to Screening, including at least one of the previous episodes confirmed by positive results from a diagnostic lab test specific for the presence of Candida. Additional episodes may be self-reported. - Has a normal Papanicolaou (Pap) smear from the previous 12 months, or has no clinically significant abnormalities on a Pap smear taken at study entry as judged and documented by the investigator(s). - Is in general good health as judged and documented by the investigator(s) Exclusion Criteria: - Reports receiving any systemic or topical vaginal antifungal therapy for 4 weeks prior to study entry. - Mycological results from Study Day -14 or earlier cultures taken within 4 weeks prior to vaccination that show other yeast species (e.g., C. glabrata, C. tropicalis, etc.) as the cause of vaginitis. - Has other active infectious cause(s) of vulvovaginitis (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, symptomatic Herpes Simplex Virus-1 (HSV-1), symptomatic HSV-2, or symptomatic human papilloma virus) at Screening or other vaginal or vulvar conditions that would confound the interpretation of clinical response as judged by the investigator(s). - Will be under treatment or surgery at the start of the study for cervical intraepithelial neoplasia (CIN) or cervical carcinoma. - Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s), diagnosed diabetes mellitus (controlled or not) or psychiatric disease that would confound the interpretation of clinical response as judged by the investigator(s). - Reports a history of allergic response(s) or other serious reactions to nickel, aluminum, or yeast products - Reports a history of clinically significant allergies including food or drug allergies, anaphylaxis (or other serious reaction) to vaccines. - Has a known history of or active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). - Reports receiving or planning to receive any investigational drug, investigational vaccine, or investigational device within 4 weeks prior to vaccination, and at any other time during their participation in the study. - Reports receiving or planning to receive any other live vaccine within 3 weeks prior to vaccination and for 3 weeks after vaccination. - Reports having or shows evidence of a recent history of drug or alcohol abuse. - Reports the use or planned use of any immunosuppressive drugs, including systemic or topical vaginal corticosteroids, within 4 weeks prior to vaccination, with the exception of topical steroids (e.g., Over-The-Counter hydrocortisone) used elsewhere on the body. - Reports the use or planned use of any medications or treatments that may alter immune responses to the study vaccine within 3 weeks prior to vaccination - Reports receiving any blood products within 3 months prior to vaccination and throughout the study. - Reports donating blood/plasma within 4 weeks prior to vaccination. - Is pregnant or intends to become pregnant over the course of the study, breastfeeding, or has any other medical and/or social (e.g., non-compliant) reason which, in the opinion of the investigator(s), would prevent participation in the study. ; PRIMARY OUTCOME: Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period; SECONDARY OUTCOME 1: Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period[/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 - European (Pierre Fabre); BRIEF: Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome. ; DRUG USED: Savella; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fibromyalgia; TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Pierre Fabre Medicament; CRITERIA: Inclusion Criteria: - patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria Exclusion Criteria: - psychiatric illness - depression of generalised anxiety disorder - suicidal risk - substance abuse - active cardiac disease - pulmonary dysfunction - liver disease - renal impairment - autoimmune disease - chronic inflammatory rheumatoid disease - current systemic infection - epileptic - active cancer - sleep apnea - active peptic ulcer - inflammatory bowel disease - unstable endocrine disease - for men : prostatic enlargement of genito-urinary disorders - for women : pregnancy or breast feeding ; PRIMARY OUTCOME: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion; SECONDARY OUTCOME 1: comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria[/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 IIa - Social Anxiety Disorder; BRIEF: The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of treatment in participants with Social Anxiety Disorder (SAD). ; DRUG USED: JNJ-42165279; DRUG CLASS: New Molecular Entity (NME); INDICATION: Generalized Anxiety Disorder (GAD); TARGET: Fatty Acid Amide Hydrolase (FAAH); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Must have a primary DSM-5 diagnosis of Social anxiety disorder (SAD) except those with performance only as a specifier. Participants with a diagnosis of comorbid Generalized Anxiety Disorder (GAD) or Major Depressive Disorder (MDD) may be included if the Investigator considers SAD to be the predominant diagnosis. Participants with current or lifetime history of Attention deficit hyperactivity disorder (ADHD) and specific phobia may be included as well - Must have a Liebowitz Social Anxiety Scale score greater than or equal (>=) 70 at Screening and Baseline - Participants with a current episode of MDD must have a HDRS17 total score less than or equal to (<=) 18 - Must have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2), inclusive, at screening - Female participants must be either postmenopausal or surgically sterile Exclusion Criteria: - Participants who have performance only SAD are excluded. Participants with other current significant psychiatric condition(s) (Axis 1 under DSM-IV), including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), autism spectrum disorders, post-traumatic stress disorder (PTSD) or schizophrenia are excluded. Participants with a diagnosis of comorbid GAD or MDD may be included - Participants is currently receiving specific psychotherapy for SAD - Has a history of more than two unsuccessful adequate pharmacological treatment trials for SAD, defined as lack of response to at least 10 weeks of treatment at adequate doses (e.g., paroxetine >= 40 milligram per day (mg/day) or its equivalent; or clonazepam >= 2.5 mg/day or its equivalent) - Concurrent use of psychotropic medications - has a history of or current thyroid disease, thyroid dysfunction and is currently untreated for it ; PRIMARY OUTCOME: Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score; SECONDARY OUTCOME 1: Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales[/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/Atezolizumab +/- Vemurafenib (BRAFV600 Mutation; EU); BRIEF: This study will evaluate the efficacy and safety of cobimetinib plus atezolizumab in participants with BRAFV600 wild-type melanoma with central nervous system (CNS) metastases and of cobimetinib plus atezolizumab and vemurafenib in BRAFV600 mutation-positive melanoma patients with CNS metastases. ; DRUG USED: Cotellic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: Disease-specific inclusion criteria: - Histologically confirmed melanoma with radiologically confirmed brain metastases - Documented BRAFV600 mutation status of melanoma tumour tissue using a validated genetic test. - Measurable brain metastases - Prior systemic therapy for metastatic melanoma is allowed with exceptions as detailed in the exclusion criteria - Prior SRT or surgical therapy of ≤ 10 brain metastases is allowed but prior WBRT is not allowed - Adverse effects of all prior systemic or local treatment must have either returned to baseline or become stable and manageable prior to initiation of study treatment. General inclusion criteria: - Age ≥18 years - Able to comply with the study protocol, in the investigators judgment - ECOG Performance Status ≤ 2 - Life expectancy of > 3 months - Willing and able to complete health and quality of life questionnaires required by the protocol - Adequate hematologic and end-organ function - Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two effective forms of contraception during the course of this study and for at least six months after completion of study therapy. - Male patients must agree to refrain from donating sperm for at least six months after the last dose of cobimetinib Exclusion criteria: Disease-specific exclusion criteria: - Ocular melanoma - Leptomeningeal involvement - Uncontrolled tumour-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days. - Prior WBRT treatment for CNS disease - Increasing corticosteroid dose during the seven days prior to initiation of study treatment or current dexamethasone or equivalent dose of > 8 mg/day - Prior treatment with a BRAF or MEK inhibitor - For patients assigned to Cohort 1 only: prior immunotherapy in the metastatic setting is not allowed. Prior immunotherapy is allowed in the adjuvant setting, provided it is completed ≥ 90 days prior to study treatment initiation. For patients assigned to Cohort 2 only: prior immunotherapy in either the adjuvant or metastatic setting is not allowed. - Major surgical procedure other than for diagnosis within four weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study - Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or to any formulation component of cobimetinib or atezolizumab or, for patients assigned to Cohort 2 only, vemurafenib - Any anti-cancer therapy, including chemotherapy, hormonal therapy and radiotherapy, within two weeks prior to initiation of study treatment - Patients assigned to Cohort 2 only: Concomitant treatment with anticonvulsants other than gabapentin, vigabatrin and levetiracetam - Patients assigned to Cohort 2 only: acetaminophen is prohibited within seven days prior to initiation of study treatment unless the patient has an absolute contraindication to the to the use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin - Active malignancy (other than melanoma) or a prior malignancy within the past three years General exclusion criteria: - Known risk factors for ocular toxicity - History of clinically significant cardiac dysfunction - Inability to swallow medications - Malabsorption condition that would alter the absorption of orally administered medications - Traumatic injury within two weeks prior to initiation of study treatment - Prior allogeneic stem cell or solid organ transplantation - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - Uncontrolled diabetes or symptomatic hyperglycaemia - Any Grade ≥ 3 haemorrhage or bleeding event within 28 days of study treatment initiation - History of stroke, reversible ischemic neurological defect, or transient ischemic attack within six months prior to study treatment initiation - Positive human immunodeficiency virus (HIV) test at screening - Hepatitis B virus (HBV) infection (chronic or acute) - Active hepatitis C virus (HCV) infection - Active tuberculosis - History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Severe infection within four weeks prior to initiation of study treatment - Signs or symptoms of infection within two weeks prior to initiation of study treatment - Any serious medical condition or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the patients safe participation in, and completion of, the study - Any psychological, familial, sociological, or geographical condition that may hamper compliance with the protocol and follow-up after treatment discontinuation - Pregnancy, breastfeeding, or intention of becoming pregnant during the study. Women of childbearing potential must have a negative serum pregnancy test result within seven days prior to initiation of study treatment. - Treatment with therapeutic oral or IV antibiotics within two weeks prior to initiation of study treatment - Administration of a live, attenuated vaccine within four weeks prior to initiationof study treatment or anticipation of need for such a vaccine during the study - Treatment with systemic immunostimulatory agents within 28 days or 5 half-lives of the drug, whichever is shorter, prior to study treatment initiation - Treatment with systemic immunosuppressive medications within two weeks prior to study treatment initiation - Treatment with investigational drug within 28 days or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment - For patients to be assigned to Cohort 2 only: anticipated use of any concomitant medication during or within seven days prior to initiation of study treatment that is known to cause QT prolongation - Consumption of foods, supplements, or drugs that are strong or moderate CYP3A4 enzyme inducers or inhibitors at least seven days prior to initiation of study treatment. ; PRIMARY OUTCOME: Intracranial Objective Response Rate (ORR); SECONDARY OUTCOME 1: Extracranial 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 II - SOV06 (First Relapse; Platinum-Sensitive); BRIEF: The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer) ; DRUG USED: DCVAC/OvCa; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Immune System, Stem Cells/Other Cell Therapies; THERAPY: Combination; LEAD SPONSOR: SOTIO a.s.; CRITERIA: Inclusion Criteria: - Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy - Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer) - Laboratory parameters per protocol Exclusion Criteria: - FIGO I, II epithelial ovarian cancer - FIGO III, IV clear cells epithelial ovarian cancer - Non-epithelial ovarian cancer - Borderline tumors ( tumors of low malignant potential) - Prior or current systemic anti-cancer therapy for ovarian cancer (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab) - fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods - Pregnant of lactating women - Pre-defined co-morbidities - Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds ; PRIMARY OUTCOME: Progression Free Survival by modifications to the RECIST 1.1; SECONDARY OUTCOME 1: Overall survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EQUATOR (Maintenance Treatment); BRIEF: The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia. ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Patients age 18 years or older to less than 65 years, inclusive (at time of informed consent) - Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records). - Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s). - Subjects who showed previous response to antipsychotic treatment in the past year. - Subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization. - Subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization - Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment. Exclusion Criteria: - Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product - Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator - Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial) - Subjects experiencing acute depressive symptoms within the past 30 days - Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history - Subjects with a significant risk of violent behavior; who represent a risk of committing suicide - Subjects with clinically significant tardive dyskinesia - Subjects currently treated with insulin for diabetes. ; PRIMARY OUTCOME: Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C.; SECONDARY OUTCOME 1: Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria in the Double-blind Maintenance Phase[/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 - GALAHAD; BRIEF: The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies. ; DRUG USED: Zejula; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is excluded) - Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event - Received a second-generation or later androgen receptor (AR)-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis - Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing) - Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry Exclusion Criteria: - Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor - Prior platinum-based chemotherapy for the treatment of prostate cancer - Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) - Symptomatic or impending cord compression - Symptomatic brain metastases ; PRIMARY OUTCOME: Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation; SECONDARY OUTCOME 1: Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation[/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/III - IIT (Existing); BRIEF: The purpose of this study is to determine if oral Cyclosporine A and oral Lansoprazole are effective in rendering patients with existing type 1 diabetes, insulin independent. This two-arm study was designed to evaluate the safety and efficacy for insulin independence by utilizing the FDA-approved oral immune tolerance agent, Cyclosporine A, and the FDA-approved proton-pump inhibitor, Lansoprazole. Lansoprazole and other proton-pump inhibitors increase gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23). Studies with the immune tolerance agent, Cyclosporine A, previously demonstrated that among recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as 67.5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med. 1988:17;318(11):663-70). Cyclosporine A protected the remaining beta cells from further autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was ultimately required by all patients. Therefore, this study proposes the usage of Cyclosporine A with a beta regeneration agent. Follow-up studies for up to 13 years among 285 type 1 patients utilizing Cyclosporine A for 20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor demonstrated reductions in daily insulin requirements by much as 75% within 3 months following four weeks of therapy among existing type 1 diabetes patients (Transition Therapeutics, March 5, 2007 http://www.transitiontherapeutics.com/media/archive.php Accessed January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth factor in in vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409). Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci. 2007;1103:19-32). The distinctions and complexities of islets in man are far different than that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27:1-36 Epub ahead of print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration agent are required to sustain insulin independence. Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to 10-fold, this clinical trial utilizes the oral proton-pump inhibitor, Lansoprazole. This study will determine the safety and efficacy of Cyclosporine A used with and without Lansoprazole to determine the impact on insulin independence among patients with existing type 1 diabetes. Cyclosporine A is utilized to protect the new beta cells formed by Lansoprazole. The combination of the two therapies may render reductions in insulin requirements and have a greater impact on sustained insulin independence than previously reported with Cyclosporine A or gastrin alone among type 1 patients.A This 52-week study consists of two treatment arms designed to assess the safety and efficacy of achieving insulin independence using: - Oral Lansoprazole/Oral Cyclosporine A - Oral Placebo/Oral Placebo It is hypothesized that the combination of oral Cyclosporine A and oral Lansoprazole will safely render significantly more patients with existing type 1 diabetes, insulin independent and may serve as a novel and innovative treatment approach for patients with type 1 diabetes utilizing two FDA-approved therapies. ; DRUG USED: PRL001; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Calcineurin phosphatase , Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Perle Bioscience, Inc.; CRITERIA: Inclusion Criteria: 1. They are male or female, 8-60 years of age 2. They have a history of onset of type 1 Diabetes Mellitus at or before 20 years of age; or have documentation of autoimmunity testing to the pancreas to include one of more of the following tests - Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2), - Glutamic Acid Decarboxylase (GAD) autoantibodies, or - Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive) 3. They have a C-peptide of greater than or equal to to 0.6 ng/mL (0.2 nmol/L) 4. They have a Hemoglobin A1C levels of less than 9% 5. They are able and willing to participate in the study, as evidenced by providing written informed consent 6. Females must be post-menopausal (at least 1 year without spontaneous menses) or surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or to have a negative pregnancy test and practice acceptable contraception [e.g., oral, intramuscular, or implanted hormonal contraception, sexual partner with nonreversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intrauterine device]. Females of childbearing potential must undergo pregnancy testing within 24 hours prior to administration of the first dose of study drug. Exclusion Criteria: 1. Prior administration of immune tolerance therapy or immune tolerance clinical trial for type 1 diabetes 2. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0 3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial 4. Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study 5. Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion 6. Current treatment with oral antidiabetic agents 7. Evidence of active or latent tuberculosis 8. Vaccination with a live virus or organism within the 8 weeks before randomization continuing through week 52 of the study - Influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle - Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle 9. Systolic or diastolic blood pressure >150 mmHg and 90 mmHg, respectively, as measured by an appropriately sized cuff; 10. A body mass index (BMI) >28 kg/m2 11. Worsening retinopathy, angina, or congestive heart failure 12. A history or presence of acute or chronic pancreatitis 13. A history or presence of any illness, disease, or condition that could impact patient safety or evaluability of drug effect, in the Investigators opinion 14. An episode of severe hypoglycemia (defined as a change in mental status requiring assistance) during the prior 30 days 15. An episode of diabetic ketoacidosis during the prior 6 months 16. Received any new hypoglycemic medications within the past 3 months 17. An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level >2 times the upper limit of normal (ULN) 18. A blood urea nitrogen (BUN) level >50 mg/dL or a serum creatinine level >1.4 mg/dL 19. A serum amylase level >1.5 times the ULN or a serum lipase level >2 times the ULN 20. A history of substance abuse or dependence in the past year as defined by the Diagnostic and Statistical Manual of Mental Disorders, (DSM V) criteria ; PRIMARY OUTCOME: Insulin Requirements Among Patients Treated with Oral Cyclosporine and Oral Lansoprazole; SECONDARY OUTCOME 1: Glucagon C-peptide (under the curve) and Hemoglobin A1C levels among patients with existing type 1 diabetes treated with Cyclosporine and Lansoprazole[/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 - 2nd Line; BRIEF: The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival. ; DRUG USED: Sutent; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented - Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion - Evidence of measurable disease by radiographic technique - Adequate organ function. Exclusion Criteria: - Clinically relevant ascites (i.e. requiring paracentesis) - Severe weight loss - NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment - Diagnosis of second malignancy within last 3 years - History of or known brain metastases, spinal cord compression, or carcinomatous meningitis - Known HIV - Serious acute or chronic illness - Current treatment on another clinical trial - Pregnant or breastfeeding ; PRIMARY OUTCOME: Best Overall Response; SECONDARY OUTCOME 1: Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks[/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 - BC-CO-2; BRIEF: Current therapies for metastatic or unresectable Colon Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of metastatic or unresectable Colon Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with metastatic or unresectable Colon Cancer ; DRUG USED: Antineoplastons; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Burzynski Research Institute; CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists - Metastatic or unresectable disease - Measurable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal - No hepatic failure Renal: - Creatinine no greater than 2.5 mg/dL - No renal failure - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No chronic heart failure - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease, such as chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No active infection - No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulatory agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier) Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agent allowed - No prior antineoplaston therapy ; PRIMARY OUTCOME: ; 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 III - STELLAR 3 (F3 Fibrosis); BRIEF: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis. ; DRUG USED: Selonsertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Apoptosis Signal Regulating Kinase 1 (ASK1); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH Clinical Research Network (CRN) classification in the opinion of the central reader - Has the following laboratory parameters at the screening visit: - Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN) - Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation - Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted) - Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilberts syndrome or hemolytic anemia is present) Key Exclusion Criteria: - Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding - Child-Pugh (CP) score > 6, as determined at screening, unless due to therapeutic anti-coagulation - Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation - Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/ or centralized review of liver histology. - History of liver transplantation - Current or history of hepatocellular carcinoma (HCC) Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48; SECONDARY OUTCOME 1: Percentage of Participants Who Had Progression to Cirrhosis 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 - P06060; BRIEF: This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception. The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®. ; DRUG USED: MK-8342; DRUG CLASS: New Molecular Entity (NME); INDICATION: Contraception; TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion Criteria: - Healthy female subjects in need for contraception will be selected to participate in the trial; - Each subject must be >=18 to <=40 years of age at screening and in need for contraception; - Each subject must have given birth to at least one child (gestational age >=28 weeks); - Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri. Exclusion Criteria: - A subject must not be pregnant or suspected to be pregnant; - A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis; - A subject must not have a history or presence of any malignancy; - A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies; - A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism); - A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of >=3 times the upper normal limit; - A subject must not have congenital or acquired malformations or distortions of the uterus or cervix; - A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator; - A subject must not have vaginal bleeding of undiagnosed etiology; - A subject must not have dysmenorrhea interfering with daily activities or menorrhagia ; PRIMARY OUTCOME: The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subjects satisfaction with the ENG-MIUS; SECONDARY OUTCOME 1: Vaginal bleeding pattern[/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 - SGN33A-004 (w/Azacitidine); BRIEF: This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS). ; DRUG USED: Vadastuximab Talirine; DRUG CLASS: Biologic; INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 33 (CD33/SIGLEC-3), DNA; THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification. - Previously untreated for Myelodysplastic Syndrome (MDS) - Age ≥18 years of age. - Eligible for therapy with azacitidine. - Life expectancy of at least 12 weeks. - Eastern Cooperative Oncology Group (ECOG) performance status ≤2. - Adequate baseline laboratory parameters. Exclusion Criteria: - Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs). - History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis. - Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer). - Candidates for allogeneic stem cell transplant at the time of screening. ; PRIMARY OUTCOME: Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study; SECONDARY OUTCOME 1: Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities[/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 - Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS); BRIEF: The primary objectives of this study are to evaluate the effect of burosumab treatment on: - Increasing serum phosphorus levels in adults with TIO or ENS-associated osteomalacia - Improvement in TIO/ENS-associated osteomalacia as determined by osteoid thickness (O.Th), osteoid surface/bone surface (OS/BS), osteoid volume/bone volume (OV/BV) and mineralization lag time (MLt). ; DRUG USED: Crysvita; DRUG CLASS: Biologic; INDICATION: Bone Complications (Including Bone Metastases); TARGET: Fibroblast Growth Factor (FGF); THERAPY: Monotherapy; LEAD SPONSOR: Kyowa Kirin, Inc.; CRITERIA: Inclusion Criteria: 1. Have a clinical diagnosis of TIO/ENS-associated osteomalacia based on evidence of excessive fibroblast growth factor 23 (FGF23) that was not amenable to cure by surgical excision of the underlying tumor/lesion (documented by Investigator). 2. Be ≥ 18 years of age 3. Have a fasting serum phosphorus level < 2.5 mg/dL 4. Have an FGF23 level ≥ 100 pg/mL by Kainos assay 5. Have a ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) < 2.5 mg/dL 6. Have an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min (using Cockcroft-Gault formula). Subjects with eGFR ≥ 30 but < 60 mL/min will be considered eligible as long as in the opinion of the investigator the decline in renal function is not related to nephrocalcinosis. 7. Have a corrected serum calcium level < 10.8 mg/dL 8. Females of child-bearing potential must have a negative urine pregnancy test at Screening and Baseline and be willing to have additional pregnancy tests during the study. Females considered not to be of childbearing potential include those who have not experienced menarche, are post-menopausal (defined as having no menses for at least 12 months without an alternative medical cause) or are permanently sterile due to total hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. 9. Be willing to use 2 forms of effective methods of contraception while participating in the study (sexually active subjects) and for 12 weeks after last dose of study drug. 10. Be willing to provide access to prior medical records to determine eligibility including imaging, biochemical, and diagnostic, medical, and surgical history data 11. Provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures 12. Be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments (in the opinion of the investigator) Exclusion Criteria: 1. Have a prior diagnosis of human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C 2. Have a history of recurrent infection, a predisposition to infection, or a known immunodeficiency 3. Are pregnant or breastfeeding at Screening or are planning to become pregnant (self or partner) at any time during the study 4. Have participated in an investigational drug or device trial within 30 days prior to Screening or are currently enrolled in another study of an investigational product or device 5. Have used a therapeutic monoclonal antibody (mAb), including KRN23, within 90 days prior to Screening or have a history of allergic or anaphylactic reactions to any mAb 6. Have or a have a history of any hypersensitivity to KRN23 excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects 7. Have used a pharmacologic vitamin D metabolite or its analog (e.g., calcitriol, doxercalciferol, and paricalcitol), phosphate, or aluminum hydroxide antacids (e.g., Maalox® and Mylanta®) within 2 weeks prior to Screening or during the study 8. Have used medication to suppress parathyroid hormone (PTH) (e.g., Sensipar®, cinacalcet, calcimimetics) within 2 months prior to Screening 9. Have a history of malignancy within 5 years of study entry with the exception of phosphaturic mesenchymal tumors (PMTs) of the mixed connective tissue type or non-melanoma skin cancers such as basal cell skin cancer 10. Have donated blood or blood products within 60 days prior to Screening 11. Have a history of allergic reaction to or have shown adverse reactions to a tetracycline (e.g., tetracycline hydrochloride [HCl] and demeclocycline), benzodiazepines, fentanyl or lidocaine 12. Have any condition, which in the opinion of the investigator and sponsor, could present a concern for either subject safety or difficulty with data interpretation ; PRIMARY OUTCOME: Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the Mid-Point of the Dose Intervals Between Baseline and Week 24; SECONDARY OUTCOME 1: Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the End of the Dose Intervals Between Baseline 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 - TAURUS (Patient Preference vs. Sutent); BRIEF: Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC). ; DRUG USED: Fotivda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: AVEO Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Unresectable mRCC - Histologically or cytologically confirmed RCC of any histology - Subjects with or without prior nephrectomy - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Any prior systemic therapy for treatment of mRCC (including investigational or licensed drugs that target VEGF or VEGF receptors/pathway, or are mammalian target of rapamycin [mTOR] inhibitors) - Central nervous system malignancies or metastases - Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders - Significant serum chemistry or urinalysis abnormalities - Significant cardiovascular disease, including symptomatic left ventricular ejection fraction or baseline LVEF of ≤ institutional lower limit of normal, uncontrolled hypertension, myocardial infarction or severe angina within 6 months prior to administration of first dose of study drug, history of class III or IV congestive heart failure, or history of serious ventricular arrhythmia, cardiac arrhythmias, or coronary or peripheral bypass graft within 6 months of screening - Corrected QT interval (QTc) of >480 msec using Bazetts formula - Currently active second primary malignancy ; PRIMARY OUTCOME: Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib; SECONDARY OUTCOME 1: Number of Subjects With AEs and SAEs[/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 - Malignant Thymoma; BRIEF: The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy. ; DRUG USED: Milciclib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thymic Carcinoma; TARGET: Cyclin Dependent Kinase (CDK), Nerve growth factor (NGF)/receptor, Trk (Tropomyosin Receptor Kinase) Receptors, Tyrosine Kinases; THERAPY: Monotherapy; LEAD SPONSOR: Tiziana Life Sciences LTD; CRITERIA: Inclusion Criteria: - Signed and dated IRB/Approved Informed Consent - Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease - Presence of measurable disease - Age >=18 years old - ECOG performance status 0-1 - Negative pregnancy test (if female in reproductive years) - Use of effective contraceptive methods if men and women of child producing potential - Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is allowed) - Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gaults formula > 60 mL/min - Adequate hematologic status ANC >=1,500cells/mm3 Platelet Count >= 100,000cells/mm3 Hemoglobin >=9.0g/dL - Two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated) - Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade <=1 Exclusion Criteria: - Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis - Grade >1 retinopathy - Known brain metastases - Known active infections - Pregnant or breast feeding women - Diabetes mellitus uncontrolled - Gastrointestinal disease that would impact on drug absorption - Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline - Patients with previous history or current presence of neurological disorders (with the exception of myasthenia gravis), including epilepsy (although controlled by anticonvulsant therapy), Parkinsons disease and extra-pyramidal syndromes. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study ; PRIMARY OUTCOME: Progression-free Survival Rate at 3 Months; SECONDARY OUTCOME 1: Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters[/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 - OLE; BRIEF: The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). ; DRUG USED: Rozanolixizumab; DRUG CLASS: Biologic; INDICATION: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); TARGET: Neonatal Fc Receptor; THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma SRL; CRITERIA: Inclusion Criteria: - Subject who has completed one of the previous rozanolixizumab study(ies) that allow access to the present study (e.g. study CIDP01) - Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their final dose of investigational medicinal product (IMP) - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the final administration of IMP Exclusion Criteria: - Subject has any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the subject or would compromise the subjects ability to participate in this study - Subject has a clinically relevant active infection (eg, sepsis, pneumonia, abscess) - Subject has a known hypersensitivity to any components of rozanolixizumab - Subject intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of rozanolixizumab - Subject has an ongoing serious adverse event (SAE) or a medical condition in the parent study that the investigator considers to put the subject at a significantly increased risk of participating in CIDP04 - Subject has any planned elective surgery due to occur during the study dosing period which in the opinion of the investigator could interfere with study procedures ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Event (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 III - 303 (Adjunctive); BRIEF: The studys purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD) ; DRUG USED: Troriluzole; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obsessive-Compulsive Disorder (OCD); TARGET: Glutamine; THERAPY: Monotherapy; LEAD SPONSOR: Biohaven Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: 1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at screening; the duration of the subjects illness must be ≥ 1year 2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response too current standard of car base on the YBOCS score. 3. Determined by the investigator to be medically stable at baseline/ randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trail as designed. Key Exclusion Criteria: 1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD. 2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourettes disorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results. 3. Previous treatment in a study with troriluzole ; PRIMARY OUTCOME: The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS); SECONDARY OUTCOME 1: Frequency of SAEs and AEs leading discontinuation[/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 - SAP301 (Post-Operative); BRIEF: The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery. ; DRUG USED: Dsuvia; DRUG CLASS: Non-NME; INDICATION: Moderate to Severe Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: AcelRx Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria (additional criteria not specified here): 1. Patients who are scheduled to undergo one of the following procedures with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation: - abdominoplasty - open tension-free inguinal hernioplasty (Lichenstein repair with mesh) - laparoscopic abdominal surgery 2. Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I). 3. Female patients of childbearing potential must be using an effective method of birth control at the time of screening visit 4. Patients who are expected to have moderate-to-severe post-operative pain for at least 24 hours. Exclusion Criteria (additional criteria not specified here): 1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery 2. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug. 3. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP). 4. Patients who previously have had abdominoplasty or have had an inguinal hernia repair on the same side. ; PRIMARY OUTCOME: Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).; SECONDARY OUTCOME 1: Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).[/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 - BIA-51058-201; BRIEF: This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease ; DRUG USED: BIA 5-1058; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Dopamine beta-hydroxylase (DBH); THERAPY: Monotherapy; LEAD SPONSOR: Bial - Portela C S.A.; CRITERIA: Inclusion Criteria: For inclusion in the study, patients must fulfil all of the following criteria: 1. Male or female patients aged 18 to 65 years. 2. Able to comprehend and willing to sign an informed consent form. 3. Diagnosis of PAH (pulmonary arterial hypertension WHO Group 1), documented by right heart catheterisation with a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, a pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) > 3 WU [Galie N, et. al 2015; Lau EMT, et. al. 2017]: 1. Idiopathic, in non-vasoreactive patients 2. Heritable: Bone morphogenetic protein receptor type II (BMPR2) mutation and other mutations, in non-vasoreactive patients 3. Drugs and toxin induced, in non-vasoreactive patients 4. Associated with connective tissue disease 5. Associated with simple congenital defects (atrial septal defect and/or ventricular septal defect) if closed > 12 months before inclusion. 4. WHO functional class II or III as judged by the investigator. 5. Stable treatment with at least one of the following approved PAH therapies for at least 90 days prior to V1: Ambrisentan, Bosentan, Macitentan, Riociguat, Selexipag, Sildenafil, Tadalafil, Epoprostenol intravenous, Iloprost inhaled or Treprostinil intravenous or subcutaneous. Exclusion Criteria: Patients having or being any of the following are to be excluded from the study: 1. Contraindication to zamicastat, i.e. known hypersensitivity to ingredients of zamicastat formulation. 2. Two or more consecutive measurements of SBP < 95 mmHg or DBP < 50 mmHg. 3. Uncontrolled diabetes mellitus with HbA1c ≥ 8.5% within the last three months or at screening. 4. PAH WHO Group 1 due to portal hypertension, human immunodeficiency virus (HIV) infection and schistosomiasis. 5. Any disease known to cause pulmonary hypertension other than PAH WHO Group 1. 6. Obstructive lung disease: Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) < 60% and FEV1 < 60% of predicted value after bronchodilator administration. 7. Restrictive lung disease: Total Lung Capacity (TLC) < 70% of predicted value. 8. History of moderate to severe hepatic impairment (Child-Pugh B and C). 9. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at V1). 10. Use of the following prohibited medication or treatments during study participation: calcium channel blockers (CCBs) if used for the treatment of PAH in vasoreactive patients; drugs containing a catechol group that is metabolised by DβH e.g. rimiterole, isoprenaline, dopamine, dopexamine or dobutamide or α- and/or β-blockers. 11. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine. 12. Presence of any other significant or progressive/unstable medical condition that, in the opinion of the investigator, would compromise evaluation of the study treatment or may jeopardise the patients safety, compliance or adherence to protocol requirements. 13. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice acceptable contraceptive measures from the time of informed consent until 30 days after last IMP intake. Acceptable methods for women are surgical intervention (e.g. bilateral tubal occlusion), non-hormonal implantable intrauterine device, double-barrier methods, true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient) and vasectomised partner (provided that the partner is the sole sexual partner of the patient and the partner has received medical assessment of the surgical success). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), hormonal contraceptives and withdrawal are not acceptable methods of contraception. For men: Male patients who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved acceptable contraceptive measure from the time of informed consent until 90 days after the last IMP intake. The following methods are acceptable methods of contraception: partners use of combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); partners use of progestogen-only hormonal contraception (oral, injectable/implantable, intrauterine hormone-releasing system); partners use of implantable intrauterine device; surgical sterilisation (for example, vasectomy or bilateral tubal occlusion). 14. Previous participation in any other drug investigational study within the past 30 days (or five half-lives of investigational medicinal product [IMP] whichever is longer) prior to V1. 15. Vulnerable patients according to Section 1.61 of the ICH guideline for Good Clinical Practice E6. ; PRIMARY OUTCOME: Area under the curve 0-24h (AUC0-24h) - 50 mg; 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 - vs. Menactra (Aged 10-25; US); BRIEF: The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment. ; DRUG USED: Nimenrix; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects whom the investigator believes can and will comply with the requirements of the protocol. - A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination. - Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. - Healthy subjects as established by medical history and clinical examination before entering into the study. - If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. - Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). - Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y. - Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month). - History of meningococcal disease due to serogroup A, C, W-135, or Y. - Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required). - A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - Hypersensitivity to latex. - Major congenital defects or serious chronic illness. - History of any neurologic disorders or seizures. - Previous history of Guillain-Barré Syndrome. - Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy. - Acute disease at the time of enrollment. - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. - Pregnant or lactating female. - History of chronic alcohol consumption and/or drug abuse. - Female planning to become pregnant or planning to discontinue contraceptive precautions. ; PRIMARY OUTCOME: Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value; SECONDARY OUTCOME 1: Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value[/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 - w/Peg-IFN/RBV vs. Boceprevir; BRIEF: This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection. ; DRUG USED: Debio 025; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Cyclophilin; THERAPY: Combination; LEAD SPONSOR: Debiopharm International SA; CRITERIA: Inclusion criteria: - Chronic HCV genotype 1 infection - No previous treatment for HCV infection - African American ethnicity - Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit - A liver biopsy within 3 years prior to baseline Exclusion criteria: - HCV genotype different from genotype 1 or co-infection with other HCV genotype - Co-infection with Hepatitis B or HIV - Any other cause of relevant liver disease other than HCV - Presence or history of hepatic decompensation - Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (> ULN) in past 6 months Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events; SECONDARY OUTCOME 1: Percentage of Participants With Emergence of Resistant Mutations[/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 - VELOUR - w/FOLFIRI; BRIEF: The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms. ; DRUG USED: Zaltrap; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Participants who met the following main selection criteria were included in the study. Inclusion Criteria: - Histologically or cytologically proven adenocarcinoma of the colon or rectum - Metastatic disease that is not amenable to potentially curative treatment - One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible) - Prior treatment with bevacizumab is permitted. Exclusion Criteria: - Prior therapy with irinotecan - Eastern Cooperative Oncology Group performance status >2 The above information is not intended to contain all considerations relevant to participation in a clinical trial. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)[/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 - LIBRA (Beta Cell); BRIEF: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). We propose a double-blind, randomized controlled study comparing the effect of liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM. This study may demonstrate an important beta-cell protective capacity of liraglutide. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Mount Sinai Hospital, Canada; CRITERIA: Inclusion Criteria: - men and women between the ages of 30 and 75 years inclusive - physician-diagnosed type 2 diabetes of </= 7 years duration - negative for anti-GAD antibodies - on 0-2 oral anti-diabetic medications - A1c at screening between 5.5% and 9.0% inclusive, if on oral anti-diabetic medications, or between 6.0% and 10.0% inclusive, if not on oral anti-diabetic medications Exclusion Criteria: - use of insulin, GLP-1 agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitor - type 1 diabetes or secondary forms of diabetes - major illness with life expectancy < 5 years - involvement in another study requiring drug therapy - hypersensitivity to insulin, liraglutide, or metformin - renal dysfunction - hepatic dysfunction - history of pancreatitis - family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma - personal history of non-familial medullary thyroid carcinoma - malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer) - excessive alcohol consumption - unwillingness to undergo multiple daily insulin injection therapy - unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy - congestive heart failure - pregnancy ; PRIMARY OUTCOME: Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2); SECONDARY OUTCOME 1: Glycemic Control[/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 - ESTIMABL1; BRIEF: In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff. Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked. ; DRUG USED: Thyrogen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thyroid Cancer; TARGET: Thyroid stimulating hormone receptor (TSHR); THERAPY: Monotherapy; LEAD SPONSOR: Gustave Roussy, Cancer Campus, Grand Paris; CRITERIA: Inclusion Criteria: - 18 year or older - Newly diagnosed differentiated papillary or follicular thyroid carcinoma who underwent total thyroidectomy between 30 and 60 days before randomization and treated by LT4 for at least one month. - Patients are all staged pT1<1cm N1 or pT1>1cm N0 N1 Nx or pT2 N0 - The performance status is 0 or 1. - All patients will provide written consent to participate. Exclusion Criteria : - partial thyroidectomy - patients treated by LT4 less than one month - time from thyroidectomy superior to 60 days at randomization - patients with Hurtle cancer or aggressive histology - Patients staged pT1<1cm N0 or T2 N1 or T3 or T4 or M1 - patients for which the use of rhTSH is required for medical reasons - patients with major concurrent medical disorder (cardiac, renal, liver, respiratory) - patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission for at least 2 years) - patients with recent history of drugs affecting thyroid function, including iodine containing medications or radiocontrast agents - patients with recent history of 131I whole body scan - pregant women or breast-feeding ; PRIMARY OUTCOME: the rate of successful postoperative thyroid ablation; SECONDARY OUTCOME 1: the rate of long-term complications[/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 - AdvanTIG-302 (w/Tislelizumab); BRIEF: The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B. ; DRUG USED: BGB-A1217; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, TIGIT; THERAPY: Combination; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC. 2. No prior systemic treatment for metastatic NSCLC. 3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available). 4. Tumors with PD-L1 expressed in ≥ 50% tumor cells. 5. At least 1 measurable lesion as defined per RECIST v1.1. 6. ECOG Performance Status ≤ 1. Key Exclusion Criteria: 1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1. 2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Progression-free Survival (PFS) As Assessed By Investigators; SECONDARY OUTCOME 1: PFS As Assessed By A Blinded 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 - 13665; BRIEF: The purpose of this study is to estimate the median time to progression in participants with hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination with sorafenib or ramucirumab. ; DRUG USED: Galunisertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Transforming Growth Factor-beta (TGF-beta) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have histological evidence of a diagnosis of HCC not amenable to curative surgery - Part A: Serum alpha fetoprotein greater than or equal to 1.5 Upper Limits of Normal, Part B: Serum alpha fetoprotein less than 1.5 Upper Limits of Normal. Not applicable for Part C or D - Child-Pugh Stage: A or B7 for Parts A & B, A for Part C, and D - Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). A lesion that has been previously treated by local therapy will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy - Have given written informed consent prior to any study-specific procedures - Have adequate hematologic, hepatic and renal function - Have a performance status of equal to or less than 1 on the Eastern Cooperative Oncology Group (ECOG) scale - For Parts A & B: Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment. For Part C: not received previous systemic treatment. For Part D: have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment or have not received prior systemic treatment. - For Parts A, B, and D: have discontinued sorafenib for at least 2 weeks - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures - Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug - Females with childbearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug - Are able to swallow capsules or tablets Exclusion Criteria: - Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - Known HCC with fibro-lamellar or mixed histology - Presence of clinically relevant ascites - History of liver transplant requiring increased immunosuppressive therapy. (Participants on maintenance immunosuppressive therapy after liver transplant are eligible for Part A & B) - Have received more than 1 line of systemic treatment in Parts A, B and D - Have moderate or severe cardiac disease: 1. Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension 2. Have documented major electrocardiogram (ECG) abnormalities at the investigators discretion 3. Have major abnormalities documented by echocardiography with Doppler 4. Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress - Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study - Females who are pregnant or lactating - Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years. At the discretion of the investigator, hormone-refractory prostate cancer participants who are stable on GnRH agonist therapy and breast cancer participants who are stable on antiestrogen therapy may have that treatment continued - Have active infection that would interfere with the study objectives or influence study compliance - For Part C, have a known hypersensitivity to sorafenib or its excipients - For Part D, have a serious illness or medical condition(s), including but not limited to the following: 1. The participant has undergone major surgery within 28 days prior to randomization or has undergone central venous access device placement within 7 days prior to randomization 2. The participant has uncontrolled arterial hypertension ≥150 / ≥90 millimeters of mercury (mm Hg) despite standard medical management ; PRIMARY OUTCOME: Change From Baseline in Relationship of Biomarker Alpha-fetoprotein (AFP) to Overall Survival (OS); SECONDARY OUTCOME 1: Population Pharmacokinetics (PK) Mean Population Clearance of Galunisertib[/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 - Non-Resectable (BP-012); BRIEF: The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells in participants with previously treated advanced solid tumors (prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants T cells are modified to recognize and target the PSCA tumor marker on cancer cells. ; DRUG USED: BPX-601; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Immune System, Prostate Stem Cell Antigen (PSCA), Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Combination; LEAD SPONSOR: Bellicum Pharmaceuticals; CRITERIA: Inclusion Criteria: - Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy. - Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA. - Age ≥18 years. - Life expectancy > 12 weeks. - ECOG 0-1 - Adequate organ function. Exclusion Criteria: - Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months. - Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable. - Symptomatic, untreated, or actively progressing central nervous system metastases. - Impaired cardiac function or clinically significant cardiac disease. - Pregnant or breastfeeding. - Participant requires chronic, systemic steroid therapy. - Severe intercurrent infection. - Known HIV positivity. ; PRIMARY OUTCOME: Dose Limiting Toxicity; SECONDARY OUTCOME 1: Pharmacodynamics (PD) of BPX-601[/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 - Study 201; BRIEF: The ability of a new recombinant porcine coagulation factor VIII, B-domain deleted (called OBI-1), to control the non-life- or limb-threatening bleeding episodes patients with hemophilia A commonly develop is being evaluated. Patients with congenital hemophilia A and a low-titer (<20 Bethesda units [Bu]) inhibitory antibody to OBI-1, who meet the inclusion/exclusion criteria, will receive OBI-1 to treat their soft tissue or joint bleeding episode. At least the first two treatment episodes will be performed in the controlled setting of the hemophilia center/clinic/office, where any side effects can be observed. If the patient continues to meet the inclusion/exclusion criteria, has had no serious or severe adverse reactions to OBI-1, and has been in a home care program, the investigator may permit the patient to self-administer OBI-1 at home to treat subsequent bleeding episodes. The study will continue at least until 12 or more patients have received at least 24 treatment episodes in the aggregate. ; DRUG USED: Obizur; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Octagen Corporation; CRITERIA: Inclusion Criteria: Patients must meet at least the following criteria to participate in the trial: - Age at least 12 years. - Clinical diagnosis of congenital hemophilia A with current inhibitor to human fVIII OR the patient is known to have developed an anti-human fVIII inhibitor antibody anamnestic response to human fVIII in the past. - OBI-1 inhibitor antibody titer < 20 Bethesda Units at screening. - Uncomplicated joint or soft tissue bleed, or other non-life threatening or non-limb threatening bleeding episode. Exclusion Criteria: Patients will be ineligible to participate if any of the following are present: - Current treatment plan for any acute bleeding episode incorporates the use of human fVIII (recombinant or plasma-derived). - Presence of any life- or limb-threatening bleeding episode (defined) - Patient has received any human fVIII or prothrombin complex concentrate (PCC), within 7 days prior to Screening, OR received any PCC within 7 days prior to treatment with OBI-1. - Patient has received recombinant human fVIIa (rVIIa) within 3 days prior to Screening OR within 3 days prior to treatment with OBI-1. - Significant liver disease or renal disease ; PRIMARY OUTCOME: The percentage of successful treatment episodes, defined as having achieved control of the bleeding episode within One Loading Dose and 8 or fewer Treatment Doses, with a dose limit of 1000 U/kg in 24 hours; SECONDARY OUTCOME 1: Adverse events and serious adverse events observed throughout course of study[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - ORIGIN; BRIEF: A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3) ; DRUG USED: Atacicept; DRUG CLASS: Biologic; INDICATION: Immunoglobulin A (IgA) Nephropathy (Bergers Disease); TARGET: APRIL, B-cell activating factor (BAFF); THERAPY: Monotherapy; LEAD SPONSOR: Vera Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Must have the ability to understand and sign a written informed consent form - Male or female of ≥18 years of age - Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period - Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years - eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. - On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening - Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg Key Exclusion Criteria: - IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis - Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period - Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening) - Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg - Renal or other organ transplantation prior to, or expected during the study - Concomitant chronic renal disease in addition to IgAN - Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening - History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test - Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept ; PRIMARY OUTCOME: Change from baseline in urine protein to creatinine ratio (UPCR); SECONDARY OUTCOME 1: Annualized rate of change in estimated glomerular filtration rate (eGFR)[/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 - Primary DCM; BRIEF: The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities. ; DRUG USED: Danicamtiv; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiomyopathy - Dilated; TARGET: Myosin; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - For MYH7 and TTN cohorts, must have diagnosis of primary DCM (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of MYH7 or TTN - Has adequate acoustic windows for echocardiography - Maximum of 3 family members with same variant can be enrolled - For the cohort of primary DCM due to causalities other than MYH7 and TTN, participant must have diagnosis of primary DCM with a cause not related to MYH7 or TTN variants Exclusion Criteria: - Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s) - Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics) - Presence of protocol specified laboratory abnormalities at Screening - Recent acute coronary syndrome or angina pectoris (<90 days) - Recent hospitalization for heart failure (<90 days) ; PRIMARY OUTCOME: Frequency and severity of treatment-emergent adverse events and serious adverse events.; SECONDARY OUTCOME 1: Change in pharmacodynamic (PD) parameters assessed by transthoracic echocardiography (TTE)[/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 - M001-222; BRIEF: The primary objective of this study is to assess the safety and tolerability of subsequent systemic treatment of physicians choice (TPC) following the first-line lenvatinib treatment in unresectable hepatocellular carcinoma (uHCC) participants. ; DRUG USED: Lenvima; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Key Inclusion Criteria: - Participants must have confirmed diagnosis of unresectable Hepatocellular Carcinoma (uHCC) with any of the following criteria: 1. Histologically or cytologically confirmed diagnosis of uHCC 2. Clinically confirmed diagnosis of uHCC according to American Association for the Study of Liver Diseases criteria, including cirrhosis of any etiology or with chronic hepatitis B or C infection criteria - At least one measurable target lesion regardless if hepatic or non-hepatic according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) meeting the following criteria: 1. Hepatic lesion - The lesion can be accurately measured in at least one dimension as ≥1.0 centimeters (cm) (viable tumor for typical; and longest diameter for atypical), and - The lesion is suitable for repeat measurement, 2. Nonhepatic lesion - Lymph node lesion that measures at least one dimension as ≥1.5 cm in the short axis - Non-nodal lesion that measures ≥1.0 cm in the longest diameter Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion. - Participants categorized on the Barcelona Clinic Liver Cancer staging system to Stage B (not applicable for transarterial chemoembolization) or Stage C - Adequate bone marrow function, liver function, blood coagulation function, renal function, and pancreatic function as assessed by laboratory tests. - Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP ≤150/90 millimeters of mercury (mmHg) at Screening and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1 - Child-Pugh A - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Survival expectation of 12 weeks or longer before starting study drug Key Exclusion Criteria: - Imaging findings for HCC corresponding to any of the following: 1. HCC with ≥50% liver occupation 2. Clear invasion into the bile duct 3. Portal vein invasion at the main portal branch (Vp4) - Participants who have received any systemic chemotherapy, including sorafenib, regorafenib or other anti-vascular endothelial growth factor therapy, nivolumab, or any systemic investigational anticancer agents, including lenvatinib, for advanced/uHCC. - Participants who have received any anticancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, e.g., granulocyte colony-stimulating factor) within 28 days prior to the first dose of lenvatinib study treatment. - Participants who have not recovered from toxicities as a result of prior anticancer therapy such as the local hepatic injection chemotherapy or any prior therapy for other cancer types. - Significant cardiovascular impairment within 6 months of the first dose of study drug - Prolongation of QT interval corrected for heart rate using Fridericias correction (QTcF) to >480 milliseconds (ms) - Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib in the opinion of the investigator - Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio monitoring - Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least half teaspoon) within 28 days prior to the first dose of lenvatinib study treatment - Gastric or esophageal varices that require treatment - Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months - Any history of or current brain or subdural metastases - Participants having >1+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 grams/24 hour will be ineligible - Arterial-portal venous shunt or arterial-venous shunt preventing proper diagnosis of tumor - Any medical or other condition that in the opinion of the investigator would preclude the participants participation in a clinical study - Known intolerance to lenvatinib or any of the excipients - Human immunodeficiency virus positive or active infection requiring treatment (except for hepatitis virus) - Any history of drug or alcohol dependency or abuse within the prior 2 years - Major surgery within 3 weeks prior to the first dose of lenvatinib study treatment or scheduled for surgery during the study - Participant has had a liver transplant - Females who are breastfeeding or pregnant at Screening or Baseline - Females of childbearing potential who within 28 days before study entry did not use a highly effective method of contraception or do not agree to use a highly effective method of contraception throughout the entire study period ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ORESA; BRIEF: This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group phase 3 clinical study to confirm the safety and efficacy of T89 in patients with stable angina pectoris, with an extended open-label period to evaluate the long-term safety of T89. This study includes three main periods: the first study period is a 3-week single-blind qualifying run-in period to screen eligible stable angina patients by exercise tolerance test (ETT). The second study period is a 8-week double-blind treatment period to evaluate the efficacy and safety of T89 in patients with stable angina by ETT. And, the last study period is a 44-week open-label period to observe long-term use safety of T89. ; DRUG USED: Dantonic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Angina; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Tasly Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Willing to participate and sign a written informed consent 2. Males and females ≥ 18 and ≤90 years old. 3. Medical history of chronic stable angina triggered by physical effort and relieved by rest or sublingual nitroglycerin. 4. Patients who agree and in the opinion of the investigator are able to withdraw all non-beta blocker and all non-calcium channel blocker anti-anginal medications. For those subjects who are on beta blockers and/or calcium channel blockers, they are able to keep only one beta blocker or one calcium channel blocker (acceptable calcium channel blocker: amlodipine, diltiazem, verapamil or nicardipine), but not both, and subjects agree and are expected to be able to remain on this treatment regimen from Day -21 until the completion of the double-blind period in the opinion of the investigator. 4.1) For patients who have to modify their anti-anginal treatment regimen to meet the above qualification criteria, health care provider who is responsible for the patients cardiac care (if this is not the study doctor) must provide a form of agreement (verbal conversation, phone call, in writing or shown as referral) to the PI before the treatment modification. 4.2) For patients who are not on beta blocker or calcium channel blocker or other antianginal medications, there is no requirement to start on antianginal medication. *nitroglycerin tablets, only those provided by sponsor, are allowed to be used for on-demand symptomatic relief of angina during the qualifying and treatment periods to ensure an accurate calculation of consumption. 5. Documented history of coronary artery disease with one or more of the following conditions: 5.1) History of previous myocardial infarction (previous MI that occurred and was diagnosed at least 3 months prior to start of screening). 5.2) Ischemic heart disease determined by stress myocardial imaging examination (including nuclear stress test, cardiac stress MRI and echocardiography stress test). 5.3) Clinically significant coronary stenosis ≥50% in any vessel detected by coronary angiography (or coronary CT angiography). 6. Understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the Seattle Angina Questionnaire rating scales and diary cards. 7. Women of child bearing potential: Female patients of child-bearing potential or male patients with partners of child-bearing potential must use appropriate birth control from the start of screening, until 3 months after the last dose of study medication. Female patients of child bearing potential must have negative pregnancy tests at screening visit [Day -21, quantitative serum human chorionic gonadotropin (β-hCG test)] and randomization visit (Day 1, urine pregnancy test). 8. Patient must experience two or more angina episodes from Day-14 to Day 1, as the baseline frequency of angina. At least two of the angina episodes must be recorded by WCM (Other written forms of recording/reporting angina episodes may be acceptable only in situations and times that recording by WCM is impractical. In addition, patients are allowed to use short acting nitroglycerin for relief of angina). 9. To be qualified, patients must have two qualifying ETTs on standard Bruce protocol on Day- 7 and Day 1. The qualifying ETTs are: 1. ETTs must meet the positive ETT criteria; 2. Total exercise duration (TED) of the positive ETT is between 3-12 minutes of exercise; 3. The difference in TED between the two ETTs must not exceed 15% of the longer one. - For the qualifying ETTs, in patients with permitted baseline ST-segment depression at rest (<1 mm at 80 msec after the J point), qualifying ST-segment depression during ETT will be defined as additional ST-segment depression ≥1 mm (at 80 msec after the J point) below the resting value. Exclusion Criteria: 1. Patients with only non-cardiac chest pain or cardiac chest pain not related to angina. 2. Patients with contraindication to, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform ETT, in the opinion of investigator, including but not limited to: hospitalization for acute exacerbation of chronic lung disease within 4 weeks prior to the start of screening, current home oxygen use, needs for cardiac glycoside therapy, functionally limiting peripheral arterial disease, physical disability or other intercurrent illness such as acute respiratory infection/illness that, in the opinion of the Investigator or Sub-investigator, may interfere with the ability to perform ETT. 3. Patients with presence of electrographic or other abnormalities/factors that could interfere with exercise ECG interpretation or may lead to a false positive stress test (including but not limited to, Lown-Ganong-Levine Syndrome (LGL), Wolff-Parkinson-White Syndrome (WPW), left bundle branch block, ≥1 mm ST segment depression at rest, pacemaker rhythm etc.). *Left ventricular hypertrophy (LVH) without repolarization abnormalities is not considered an exclusion criterion. 4. Patients with history of any coronary revascularization procedure (e.g. PCI or CABG) within 2 months prior to the start of screening. 5. Patients who had unstable angina, or myocardial infarction within the recent 3 months prior to the start of screening. 6. Patients with ongoing NYHA Classes III-IV congestive heart failure. 7. Patients with angina pectoris at rest at screening. 8. Patients with rapid atrial fibrillation at screening (rest heart rate >120/min) or any time prior to randomization from Day -21. 9. Patients with ongoing myocarditis, pericarditis, thrombophlebitis or pulmonary embolism or who have recovered from these conditions <1 month prior to screening. Note: Patients who are on anticoagulant prophylaxis just for a pulmonary embolism or thrombophlebitis will not be subject to the one-month restriction. 10. Patient with uncontrolled hypertension characterized by seated systolic blood pressure >180mm Hg or diastolic blood pressure >100mm Hg, within 2 months prior to, or during, the Single Blind Qualifying Period. Or patients with severe congenital cardiac defects, severe valvular disease, suspected or known dissecting aortic aneurysm and hypertrophic cardiomyopathy should be excluded. 11. Patients with hemoglobin (HGB) <10 g/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2×upper limit of normal (ULN), hemoglobin A1C (HbA1C) >10%, or glomerular filtration rate (GFR) <30cc/min, in any of the single blind qualifying lab tests. 12. Patient with history of bleeding diathesis or cerebral hemorrhage or seizure disorder that need anticonvulsant. 13. Patients who have to be on ranolazine, ivabradine or calcium channel blockers other than, amlodipine, verapamil, nicardipine or diltiazem, and patients who have to be on more than one beta blockers and/or calcium channel blockers, or other anti-anginal agent other than only sublingual nitroglycerin for on-demand angina relief. 14. Patients who have to be on digoxin, digitalis, or other herbal products containing Danshen (Radix Salviae Miltiorrhizae, RSM), Sanqi (Radix Notoginseng, RN) or Ginkgo biloba during the single-blind screening and/or double-blind treatment period. 15. Patients on antiplatelet drugs (except aspirin or clopidogrel), statins, ACE inhibitor, angiotensin II receptor blocker (ARB), warfarin or other direct acting oral anticoagulants (DOACs) need to be stable at current dose for at least 2 weeks prior to the start of screening. 16. Clinical trials/experimental medication: participation in any other clinical trial or receipt of an investigational drug or device within 30 days prior to the start of screening. 17. Female patients with known, suspected or planned pregnancy, or lactation. 18. Patients with a recent (within the last 2 years) history of substance abuse (alcohol, marijuana, or known drug dependence). Or patients who have a positive urine substance screening test at the Day -21 initial visit. 19. Any family member or relative of the study site staff, sponsor or CRO. 20. Patients with any other severe or serious condition that, in the opinion of the investigator is likely to prevent compliance with the study protocol or pose a safety concern if the patient participates in the study. 21. Patients whose QTcF (Fridericias method corrected QT interval) is >460 ms in male and >470 ms in female during supine 12-lead ECG at rest at screening or any time prior to randomization from Day -21. And patients who are currently taking any medication that are known to prolong the QTcF interval at screening or any time prior to randomization from Day -21. ; PRIMARY OUTCOME: Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 57; SECONDARY OUTCOME 1: The trend of TED changes over time (Slop) from Day 1 to Day 57[/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 - KRT-232-103; BRIEF: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC. ; DRUG USED: KRT-232; DRUG CLASS: New Molecular Entity (NME); INDICATION: Merkel Cell Carcinoma; TARGET: Mdm2; THERAPY: Monotherapy; LEAD SPONSOR: Kartos Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - For Cohort 1, 3 and 4 patients must have failed treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for metastatic MCC - For Cohort 2, patients must not have received any anti-PD-1 or anti-PD-L1 therapy - For Cohort 3, patients must not have received any prior chemotherapy - For Cohort 4, patients must have received at least one prior line of chemotherapy - ECOG performance status of 0 to 1 - Histologically confirmed MCC. Disease must be measurable, with at least 1 measurable lesion by RECIST 1.1 - MCC expressing p53WT based on any CLIA or test approved by local health authority or a validated test (Cohort 1 and 2) - MCC expressing p53WT based Central Lab test (Cohort 3 and 4) - Adequate hematological, hepatic, and renal functions Exclusion Criteria: - For Cohort 2, subjects must not have autoimmune disease, medical conditions requiring systemic immunosuppression, prior stem cell transplant, or active infection with HBV or HCV. - Patients previously treated with MDM2 antagonist therapies or p53-directed therapies - History of major organ transplant - Patients with known central nervous system (CNS) metastases that are previously untreated - Grade 2 or higher QTc prolongation (>480 milli-seconds per NCI-CTCAE criteria, version 5.0) ; PRIMARY OUTCOME: Cohort 1 Part 1: To determine the KRT-232 RP2D.; SECONDARY OUTCOME 1: To determine the confirmed ORR based on 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 IIb - Reversal (Aged 50-80); BRIEF: This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of bentracimab (PB2452) in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of bentracimab (PB2452) in subjects aged 50-80 years old. A total of 205 subjects between 50-80 years old will be enrolled in the US or other countries at the discretion of the Sponsor across 5-15 sites. The subjects will be randomized at a ratio of 3:1 receiving either the bentracimab (PB2452) investigational study drug or placebo. Hence, a total of 154 subjects will be receiving bentracimab (PB2452) and approximately 51 subjects will be receiving placebo. ; DRUG USED: PB2452; DRUG CLASS: Biologic; INDICATION: Drug Toxicity; TARGET: Anti-platelet drugs; THERAPY: Monotherapy; LEAD SPONSOR: SFJ Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - The subject provides written or verbal informed consent (in-person or remotely) and agrees to comply with all protocol requirements throughout study participation. - The subject is male or female between ≥50 and ≤80 years of age. - The subject has a body mass index between 18 and 35 kg/m2 and a weight of ≥ 50 kg but ≤ 120 kg, inclusive, at screening. - The subject is considered by the Investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination findings at screening and Check-in. Subjects with chronic, stable, and well-controlled medical conditions, are eligible provided they meet all other inclusion/exclusion criteria. - The subject has specific inclusionary laboratory values at screening and check-in: white blood cell (WBC) count, platelet count, haemoglobin level, thyroid-stimulating hormone (TSH) level, and prothrombin time (PT) and partial thromboplastin time (PTT) levels within the normal range. - Subjects taking medications for well-controlled medical conditions must have been on a stable dose for at least 30 days prior to screening visit. - Subjects entering the study must be willing to start and/or document an 81 mg daily dose of aspirin on Day -7 and must document daily dosing until the final dose is administered on the morning of Day 1. Subjects already taking daily aspirin must suspend aspirin dosing after Day 1 until discharge from the clinical facility. - Female subjects of childbearing potential must not be pregnant, lactating, or planning to become pregnant for 3 months after the last dose of study drug. Female subjects of childbearing potential must use two effective methods of birth control from screening and before study drug administration through to the end of the study. Exclusion Criteria: - In the opinion of the Investigator there are concern(s) regarding the inability of the subject to comply with study procedures and/or follow up, or, if the subject is not suitable for entry into the study. - History of any acute or chronic medical disorder expected to decrease the life expectancy of the subject to an extent where the subjects study participation is affected. - Any clinically significant acute illness, medical/surgical procedure, or trauma within 4 weeks of the administration of study drug or any planned surgical procedure that will occur during the study. - Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments, and ECG parameters identified during screening or check-in. - Any specific contraindication to ticagrelor as described in the ticagrelor prescribing information. - Receiving chronic treatment with nonsteroidal anti-inflammatory drugs [including aspirin (>100 mg daily), anticoagulants, or other antiplatelet agents that cannot be discontinued 14 days prior to screening including clopidogrel, prasugrel, ticlopidine, dipyridamole, or cilostazol]. - First positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening. - Has received another investigational drug within 30 days of the administration of study drug in this study or within 5 half-lives of the experimental medication, whichever is longer. - History of severe or ongoing allergy/hypersensitivity to any biologic therapeutic agent. - Involvement with any PhaseBio or study site employee or their close relatives (e.g., spouse, parents, siblings, or children whether biological or legally adopted). - Previously received Bentracimab (PB2452) or had been randomized to receive study drug in an earlier cohort for this study ; PRIMARY OUTCOME: Reversal effect of intravenous infusion of bentracimab (PB2452) compared to baseline - Minimum % inhibition of PRU (VerifyNow); SECONDARY OUTCOME 1: Safety - Incidence and severity of AEs[/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 3001 - Rest of World (IV); BRIEF: This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patients participation will last approximately 1.5 years. ; DRUG USED: Bapineuzumab (IV and SQ); DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Diagnosis of probable AD, with MMSE score of 16-26, and brain MRI consistent with the diagnosis of AD - Concurrent use of cholinesterase inhibitor or memantine allowed, if stable. - Caregiver will participate and be able to attend clinic visits with patient. Exclusion Criteria: - Significant neurological disease other than AD, or a major psychiatric disorder - Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body) - Woman of childbearing potential ; PRIMARY OUTCOME: Change From Baseline in Alzheimers Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78; SECONDARY OUTCOME 1: Change From Baseline in Brain Amyloid Burden at Week 71[/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 - LAPLACE-TIMI 57 (w/Statin); BRIEF: To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia. ; DRUG USED: Repatha; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Male or female ≥ 18 to ≤ 80 years of age - On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks - Fasting LDL-C ≥ 85 mg/dL - Fasting triglycerides ≤ 400 mg/dL Exclusion Criteria: - Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization - Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%) - Uncontrolled hypertension - New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30% - Uncontrolled cardiac arrhythmia ; PRIMARY OUTCOME: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12; SECONDARY OUTCOME 1: Change From Baseline in LDL-C at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Fluarix - Children 6-35 Months; BRIEF: The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age. ; DRUG USED: FluLaval; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - A male or female between, and including, 6 and 35 months of age at the time of the first vaccination. - Written informed consent obtained from the parent(s)/LAR(s) of the subject. - Subjects in stable health as determined by the investigators clinical examination and assessment of subjects medical history. - Subjects are eligible regardless of history of administration of influenza vaccine in a previous season. Exclusion Criteria: - Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted. - Child in care. - Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dosed. - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. - History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine. - Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. - Acute disease and/or fever at the time of enrolment. - Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study. ; PRIMARY OUTCOME: Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.; SECONDARY OUTCOME 1: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains[/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 - vs. Regranex; BRIEF: This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study. Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer. Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks. ; DRUG USED: PDGF-BB; DRUG CLASS: Biologic; INDICATION: Diabetic Foot and Other Ulcers; TARGET: Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Virchow Group; CRITERIA: Inclusion Criteria: - Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus. - Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification). - Chronic ulcer of at least six weeks despite appropriate wound care. - Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive. - Well controlled infection or cellulitis (systemic antibiotherapy). - Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold). - Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index > 0.60, or ankle systolic pressure > 70 mmHg or toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification. - Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing. - Signed informed consent before any study procedure. Exclusion Criteria: - Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers. - Active ulcer infection assessed by clinical examination and radiographic if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement. - Active osteomyelitis affecting the area of the target ulcer. - Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL). - Known connective tissue or malignant disease. - Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy. - Use of investigational drug/device within 30 days. - Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days. - Vascular reconstruction within 8 weeks. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason. ; PRIMARY OUTCOME: Incidence of complete wound closure; SECONDARY OUTCOME 1: Time to achieve complete wound closure[/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 - 1311.5 Ext.; BRIEF: This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA). ; DRUG USED: Skyrizi; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participants who have completed all doses of study drug and Week 24 visit of the lead-in study. - Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study, including 20 weeks after last dose of study drug is given. - Women of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1). - Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study specific procedures. - Participant is judged to be in good health as determined by the Investigator. Exclusion Criteria: - Female participant who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including 20 weeks after the last dose of study drug is given. - Premature discontinuation of the study drug in the lead-in study for any reason. - Use of a biologic treatment other than risankizumab since first dose of study drug in the lead-in study. - Time elapsed is > 8 weeks since the Week 24 visit in the lead-in study. - Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator. ; PRIMARY OUTCOME: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - DARWIN 2 (Monotherapy); BRIEF: - Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks. - During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants disability, fatigue and quality of life were evaluated. ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - male or female subjects who are ≥18 years of age on the day of signing informed consent, - have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III, - have ≥6 swollen joints (from a 66-joint count) and ≥8 tender joints (from a 68-joint count) at Screening and at Baseline, - Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range (ULN), - have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX, - have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period. Exclusion Criteria: - current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening, - current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy, - previous treatment at any time with a cytotoxic agent, other than MTX, before Screening. ; PRIMARY OUTCOME: Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12; SECONDARY OUTCOME 1: Percentage of Participants Achieving an ACR20 Response at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Persistent (Adults/Adolescents); BRIEF: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids. ; DRUG USED: Arnuity Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Signed informed consent - Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior to first visit - Both genders; females of child bearing potential must be willing to use appropriate contraception - Pre-bronchodilator FEV1 of 40-90% predicted - Reversibility FEV1 of at least 12% and 200mLs - Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit Exclusion Criteria: - History of life threatening asthma - Respiratory infection or candidiasis - Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months - Concurrent respiratory disease or other disease that would confound study participation of affect subject safety - Allergies to study drugs, study drug excipients, medications related to study drugs - Taking another investigational medication or medication prohibited for use during the study - Previous treatment with FF or FF/VI in a phase II or III study - Night shift workers - Children in care ; PRIMARY OUTCOME: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period; SECONDARY OUTCOME 1: Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period[/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 - SIRROUND-T; BRIEF: The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents. ; 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 3 months before screening - Have moderately to severely active RA with at least 4 of 68 tender joints and 4 of 66 swollen joints, at screening and at baseline - Have had anti-tumor necrosis factor (TNF)-alpha therapy and were unresponsive by 1 of the following 2 reasons: Lack of benefit to at least 1 anti-TNF-alpha biologic therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, yisaipu, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab; Intolerance to at least 2 anti-TNF-alpha biologic therapies, as assessed by the treating physician, to etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol, or infliximab or have documented intolerance to an anti-TNF-alpha agent as described above that precludes further administration of anti-TNF-alpha agents - If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent - If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent - If using non-biologic disease modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the DMARD - C-reactive protein (CRP) 8.00 mg/L or more or erythrocyte sedimentation rate (ESR) 28 mm/hr or more at screening Exclusion Criteria: - Has received infliximab, infliximab biosimilar, or golimumab intravenous (IV) within 8 weeks of the first study agent administration - Has received subcutaneously (SC) golimumab, adalimumab, or certolizumab pegol within 6 weeks of the first study agent administration - Has received etanercept or yisaipu within 4 weeks of the first study agent administration - Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy. Has used tocilizumab within 8 weeks of the first study agent administration - Has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy - Has used anakinra within 1 week of first study agent administration - Has used abatacept or any other biologic therapy for the treatment of RA within 8 weeks of the first study agent administration - Has received intra-articular (IA), intramuscular (IM), 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 - Has a history of cyclophosphamide or cytotoxic agent use - Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent administration - Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before the first study agent administration ; PRIMARY OUTCOME: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16; SECONDARY OUTCOME 1: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score 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 II - OLE to M11-793 (28 wks); BRIEF: This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimers disease on stable doses of acetylcholinesterase inhibitors. ; DRUG USED: ABT-126; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subjects representative and assent must be obtained from the subject. - The subject was randomized into Study M11-793 and completed dosing through Week 24 in that study. - With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG. - If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository for the duration of the study and for 30 days following the last dose of study drug. However, if the male subjects partner has been postmenopausal for at least two years or is surgically sterile, then use of a barrier method of birth control is not required. - The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subjects status during the study. - The subject and caregiver must have sufficient visual, hearing and graphomotor skills to complete the study procedures. Exclusion Criteria: - The subject experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M11-793 that indicates the subject could become medically unstable during the current study. - The subject is currently taking or is expected to be prescribed any excluded medications without the approval of Abbott medical monitor. - The subject was noncompliant with donepezil or rivastigmine during Study M11-793 or is expected to discontinue these medications prior to conclusion of this study. - The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals. - The subject is currently enrolled in, or plans to participate in, another experimental study during the course of this trial. - The subject developed any significant medical or psychiatric condition that, in the opinion of the investigator, renders the subject an unsuitable candidate to participate in this study. - For any other reason the investigator considers the subject to be an unsuitable candidate to receive ABT-126 or to participate in this study. ; PRIMARY OUTCOME: Adverse Events; 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 III - SNT-III-011; BRIEF: The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON. ; DRUG USED: Catena; DRUG CLASS: New Molecular Entity (NME); INDICATION: Lebers Hereditary Optic Neuropathy (LHON) (Ophthalmology); TARGET: Mitochondrial Electron Transport Chain, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Santhera Pharmaceuticals; CRITERIA: Inclusion Criteria: - Age > or equal 10 years and < 65 years - Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR - No explanation for visual loss besides LHON Exclusion Criteria: - Any previous use of idebenone - Participation in another clinical trial of any investigational drug within 3 months prior to Baseline - Previous participation in Study SNT-II-003 (RHODOS) for idebenone. ; PRIMARY OUTCOME: ; 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 - SS; BRIEF: The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögrens Syndrome (SS). ; DRUG USED: VIB4920; DRUG CLASS: Biologic; INDICATION: Sjogrens Syndrome; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Monotherapy; LEAD SPONSOR: Viela Bio (acquired by Horizon Therapeutics); CRITERIA: Inclusion Criteria: - Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria. - Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min (only for Population 2). - Have an ESSDAI score of >= 5 at screening; (not including the peripheral nervous system, central nervous system, and pulmonary domains) (only for Population 1). - Have an ESSPRI score of >= 5 at screening (only for Population 2). - Have an ESSDAI score of < 5 at screening (only for Population 2). - Positive for either anti-Ro autoantibodies or rheumatoid factor, or both at screening. - Male and female participants who agree to follow protocol defined contraceptive methods. - No active or untreated latent tuberculosis (TB). Exclusion Criteria: - Medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of signing the informed consent form (ICF). - Risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status. - Concomitant polymyositis or dermatomyositis or systemic sclerosis. - Active malignancy or history of malignancy, except in situ carcinoma of the cervix and cutaneous basal cell carcinoma. - Hepatitis B, hepatitis C, or human immunodeficiency virus infection. - More than one episode of herpes zoster and/or an opportunistic infection in the last 12 months. - Active viral, bacterial, or other infections or history of more than 2 infections requiring intravenous antibiotics within 12 months prior to signing the ICF. - Participants with corona virus disease 2019 (COVID-19) infection or who, in the judgment of the investigator, are at unacceptable risk of COVID-19 or its complications. - A documented positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 2 weeks prior to randomization. - Received live (attenuated) vaccine within the 4 weeks prior to ICF signature. - Treated with any biologic B-cell-depleting therapy within 12 months or other B-cell targeting therapy < 3 months before randomization. - Injectable corticosteroids (including intraarticular) or treatment with > 10 mg/day dose oral prednisone or equivalent within 6 weeks prior to randomization (only for Population 1). - Treated with systemic corticosteroids for indications other than SS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) for more than a total of 2 weeks within 24 weeks prior to screening visit (only for Population 1). - Received previous treatment with anti-CD40L compounds at any time before screening. - Pregnant or lactating or planning to get pregnant during the duration of the study. ; PRIMARY OUTCOME: Change From Baseline in European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index (ESSDAI) at Day 169 in Population 1; SECONDARY OUTCOME 1: Change From Baseline in ESSPRI at Day 169 in Population 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 IIa - Keloid Removal (1401); BRIEF: To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision. ; DRUG USED: RXI-109; DRUG CLASS: New Molecular Entity (NME); INDICATION: Wound Healing; TARGET: Connective Tissue Growth Factor (CTGF); THERAPY: Monotherapy; LEAD SPONSOR: RXi Pharmaceuticals, Corp.; CRITERIA: Inclusion Criteria: - Adults, 21-55 years of age. - Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso. - Keloids to be excised must have been present for > 1 year. Exclusion Criteria: - Use of tobacco or nicotine-containing products - Pregnant or lactating - Post-menopausal or full hysterectomy ; PRIMARY OUTCOME: Reduction in the recurrence of a keloid after keloid excision; SECONDARY OUTCOME 1: Safety of RXI-109[/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 IIIb - w/Travel Vaccines; BRIEF: This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults. ; DRUG USED: Menveo; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Novartis; CRITERIA: Inclusion Criteria: Female and male subjects who must be healthy and must be: 1. Between 18 and 60 years of age inclusive and who have given their written informed consent; 2. Available for all visits and telephone calls scheduled for the study; 3. In good health as determined by medical history, physical examination and clinical judgment of the investigator; 4. For female subjects, having a negative urine pregnancy test. Exclusion Criteria: Individuals not eligible to be enrolled in the study are those: 1. who are breastfeeding; 2. who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection); 3. who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card; 4. who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study; 5. who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period. (Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization); 6. who have received an anti-malaria drug, up to 2 months prior to the study; 7. who have experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment; 8. who have any serious acute, chronic or progressive disease such as: - history of cancer - complicated diabetes mellitus - advanced arteriosclerotic disease - autoimmune disease - HIV infection or AIDS - blood dyscrasias - congestive heart failure - renal failure - severe malnutrition (Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment); 9. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome; 10. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy, egg allergy, antibiotic allergy, chicken proteins or gelatin allergy; 11. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): - receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy); - receipt of immunostimulants; - receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study; 12. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 13. who have myasthenia gravis; thyroid or thymic disorders, 14. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 15. who are part of the study personnel or close family members of those conducting this study. 16. for whom a long-term stay (≥ 1 month) was planned in Africa, Latin America, or Asia. ; PRIMARY OUTCOME: Geometric Mean Anti-typhoid Vi Antibody Concentrations; SECONDARY OUTCOME 1: Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone[/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 - MF; BRIEF: The study consists of two phases: The first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase 2 study to define the efficacy and safety profile of single agent SB1518 at the recommended dose in subjects with CIMF. ; DRUG USED: Pacritinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , Interleukin-1 receptor-associated kinase 1 (IRAK1), JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: S*BIO; CRITERIA: Inclusion Criteria - Subjects with CIMF (including post ET/PV MF) requiring therapy, including: - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Men of reproductive potential who can agree to practice effective contraception during the entire study period and for one month after the last study treatment - Women of child-bearing potential who have a negative pregnancy test within 14 days prior to the first dose of study drug and can agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists - Subjects who are able to understand and willing to sign the informed consent form Exclusion Criteria - Subjects with uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study unless the antibiotic is a CYP3A4 inducer/inhibitor - Subjects known to be HIV-positive - Subjects with known active hepatitis A, B, or C, or latent hepatitis B - Women who are pregnant or lactating - Subjects with prior radiation therapy to more than 20% of the hematopoietic marrow (prior radiation to spleen is allowed) ; PRIMARY OUTCOME: Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily; SECONDARY OUTCOME 1: Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF[/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 - PRO₂TECT Correction; BRIEF: A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) ; DRUG USED: Vadadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Independent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Akebia Therapeutics; CRITERIA: Inclusion Criteria: - ≥18 years of age - Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at Screening and not expected to start dialysis within 6 months of Screening - Mean Screening hemoglobin <10.0 grams per deciliter (g/dL) - Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening Exclusion Criteria: - Anemia due to a cause other than CKD or participants with active bleeding or recent blood loss - Red blood cell transfusion within 8 weeks prior to randomization. - Any erythropoietic stimulating agent within 8 weeks prior to randomization - Uncontrolled hypertension - Severe heart failure at Screening (New York Heart Association Class IV) - Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening - Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36); SECONDARY OUTCOME 1: Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 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 - COVERS Exp; BRIEF: The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections. ; DRUG USED: Teflaro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female, aged 18 years or older - Complicated skin and skin structure infection (cSSTI) - Infection of sufficient severity to warrant hospitalization - Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy. patients must have a positive culture for MRSA that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose. Exclusion Criteria: - Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug - Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens - Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease - Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb - Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock ; PRIMARY OUTCOME: Clinical Response at TOC; 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/II ; BRIEF: The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2). ; DRUG USED: VCL-HB01; DRUG CLASS: Vaccine; INDICATION: Herpes Simplex Virus (HSV) (Antiviral); TARGET: Herpes Simplex Virus (HSV); THERAPY: Monotherapy; LEAD SPONSOR: Vical; CRITERIA: Inclusion Criteria: - HSV-2 seropositive - A minimum of 1 year of reported history of genital herpes and either 2 to 9 recurrences within the year prior to screening or 2 to 9 recurrences per year prior to starting suppressive therapy Exclusion Criteria: - History of receiving an investigational HSV vaccine - Chronic illness for which a subjects immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes - Pregnant or breastfeeding ; PRIMARY OUTCOME: Number of participants with adverse events; SECONDARY OUTCOME 1: Genital lesion rate change from baseline[/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 - CAL-C13-001; BRIEF: This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor antagonist) on activating mutations of the Calcium-sensing receptor in patients with Autosomal Dominant Hypocalcemia. Patients with ADH have low blood calcium levels and an inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and hyperphosphatemia. PTH and blood calcium levels will be tested during and after the IV infusion of NPSP795. Concentrations of NPSP795 and length of time of IV infusion will vary depending on measured levels of ionized calcium. ; DRUG USED: SHP635; DRUG CLASS: New Molecular Entity (NME); INDICATION: Autosomal dominant hypocalcemia with hypercalciuria (ADHH); TARGET: Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Subjects with a heterozygous activating mutation of the CaSR gene (ADH); if not previously confirmed, genetic testing will be performed at the screening visit - At least 18 years of age - Body mass index (BMI) ≥ 18.5 to < 39 kg/m2 Exclusion Criteria: - Diseases or conditions that might compromise any major body system or interfere with the pharmacokinetics of NPSP795 - History of treatment with PTH 1-84 or 1-34 within the previous 6 months - History of hypocalcemia requiring frequent IV calcium infusions - History of hypocalcemic seizure within the past 3 months - Blood 25-hydroxy vitamin D level < 25 ng/mL. If subjects have a blood 25-hydroxy vitamin D level < 25 ng/mL at the outpatient screening visit, they will be prescribed vitamin D replacement. Once the 25-hydroxy vitamin D level is > 25 ng/mL, the subject will be eligible to continue on to the treatment phase of the study - Estimated glomerular filtration rate (GFR) < 25 mL/minute, and/or abnormal hepatic, hematologic, and/or clotting function - 12 lead resting electrocardiogram (ECG) with clinically significant abnormalities - Concomitant medications with the potential to interfere with NPSP795 metabolism - History of thyroid or parathyroid surgery ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs); SECONDARY OUTCOME 1: Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795[/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 - Uganda; BRIEF: The study will recruit up to 290 healthy adult males and non-pregnant females into a two-part clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the Sm-TSP-2 vaccine will be tested: one using Alhydrogel® only, and one using Alhydrogel® plus AP 10-701, each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg. The first part of the study will be a Phase I dose-escalation safety and immunogenicity study followed by a Phase IIb trial in which a larger number of adults will be enrolled to assess the impact of the vaccine on infection with S. mansoni. The impact of the vaccine on infection with S. haematobium will also be assessed although this will be exploratory given that potential cross-protection against this species is only hypothetical at this point. ; DRUG USED: Sm-TSP-2; DRUG CLASS: Vaccine; INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: Schistosoma mansoni Tetraspanin-2 (Sm-TSP-2); THERAPY: Monotherapy; LEAD SPONSOR: Baylor College of Medicine; CRITERIA: Inclusion Criteria: 1. Provide written informed consent prior to any study procedures. 2. Able to understand and comply with planned study procedures and be available for all study visits. 3. Male or non-pregnant female aged 18 to 45, inclusive at the time of enrollment. 4. Are in good health, as determined by vital signs (oral temperature, pulse, and blood pressure), medical history, and brief physical examination at screening. 5. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges. 6. Laboratory tests (alanine aminotransferase [ALT], creatinine, white blood cell count (WBC), hemoglobin, and platelets) are all within protocol-defined reference ranges. 7. Urinalysis with no greater than trace protein and negative for glucose. 8. Female subjects of childbearing potential must agree to practice highly effective contraception for a minimum of 30 days prior to first vaccination and for 30 days after last vaccination. 9. Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccination. 10. Able to correctly answer all questions on the informed consent comprehension questionnaire. Exclusion Criteria: 1. Has the intention to become pregnant within 5 months after enrollment in this study. 2. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after their last study vaccination. 3. Has an acute illness, including a documented oral temperature of 38.0°C or greater, within 72 hours prior to vaccination. 4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies. 5. Is immunosuppressed as a result of an underlying illness or treatment. 6. Using or intends to continue using oral or parenteral steroids, high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs. 7. Positive test for HIV infection. 8. Volunteer has had a history of alcohol or illicit drug abuse during the past 23 months. 9. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination. 10. History of a severe allergic reaction or anaphylaxis to known components of the study vaccines. 11. Has an acute or chronic medical condition that, in the opinion of the investigator, would render participation in this study unsafe or would interfere with the evaluation of responses. 12. History of splenectomy. 13. Is participating or plans to participate in another clinical trial with an interventional agent during the duration of the study. 14. Received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to the first study vaccination. 15. Planned receipt of any vaccine from the first study vaccination through 28 days after the last study vaccination. 16. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. 17. Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. 18. Anti-Sm-TSP-2 IgE antibody level above ELISA reactivity threshold. Part A Only: 19. Positive hepatitis B surface antigen (HBsAg). 20. Positive confirmatory test for hepatitis C virus (HCV) infection. Part B Only: 21. Negative for Schistosoma mansoni eggs, as assessed by the Kato Katz fecal thick smear during screening. ; PRIMARY OUTCOME: Safety and Tolerability: frequency of local and systemic reactogenicity events; SECONDARY OUTCOME 1: Immunogenicity: peak anti-Sm-TSP-2 IgG 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 IIa - Monotherapy; BRIEF: To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine. ; DRUG USED: AMG-301; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Pituitary adenylate cyclase-activating polypeptide (PACAP)/PACAP-specific receptor (PAC1); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form. - History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013) - Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening. - Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy Exclusion Criteria: - Older than 50 years of age at migraine onset. - History of cluster headache, hemiplegic migraine headache. - Unable to differentiate migraine from other headaches. - Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period. - History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. ; PRIMARY OUTCOME: Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period; SECONDARY OUTCOME 1: Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period[/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/Emtricitabine/TAF vs. Dolutegravir/Emtricitabine/TAF; BRIEF: This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF. ; DRUG USED: Biktarvy; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent) - Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening - Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC) - Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula - CD4+ cell count ≥ 200 cells/µL at screening Key Exclusion Criteria: - A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol - Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP) - Chronic hepatitis B virus (HBV) infection - Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible) - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline - Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.; SECONDARY OUTCOME 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12[/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/Atezolizumab/Bevacizumab; BRIEF: This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol. ; DRUG USED: TPST-1120; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: PPAR alpha; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: Stage 1 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization - Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of - Liver Diseases criteria in cirrhotic patients - Child-Pugh class A within 7 days prior to randomization - Disease that is not amenable to curative surgical and/or locoregional therapies - No prior systemic treatment for HCC - Life expectancy >= 3 months - Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status via central testing Stage 1 and Stage 2 - Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 - Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment - Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) - Negative HIV test at screening - For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 - ECOG Performance Status of 0, 1, or 2 - Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment - Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible) Exclusion Criteria: Stage 1 - Prior treatment with CD137 agonists or immune checkpoint inhibitors - Treatment with investigational therapy within 28 days prior to initiation of study - Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure - Untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk for bleeding - Prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study - AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade - Inadequately controlled hypertension - History of hypertensive crisis or hypertensive encephalopathy - Significant vascular disease - History of hemoptysis within 1 month prior to initiation of study - Evidence of bleeding diathesis or significant coagulopathy - Current or recent use of asprin (>325 mg/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol - Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose - Core biopsy or other minor surgical procedure within 3 days prior to initiation of study - History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and/or clinical signs/symptoms of GI obstruction - Evidence of abdominal free air not explained by paracentesis or recent surgery - Serious, non-healing/dehiscing wound, active ulcer, or untreated bone fracture - Grade >=2 proteinuria - Metastatic disease involving major airways/blood vessels, or centrally located mediastinal tumor masses of large volume - History of intra-abdominal inflammatory process - Radiotherapy within 28 days or abdominal/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study - Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure - Chronic daily treatment with NSAID - Eligible only for control arm Stage 1 and 2 - Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - History of hepatic encephalopathy - Moderate or severe ascites - HBV and HCV coinfection - Symptomatic, untreated, or actively progressing CNS metastases - History of leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled or symptomatic hypercalcemia - Active or history of autoimmune disease or immune deficiency - History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan - Active TB - Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina - Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study - History of malignancy other than HCC within 5 years prior to screening - Severe infection within 4 weeks prior to initiation of study - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study - Prior allogeneic stem cell or solid organ transplantation - Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins - Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study - Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/high-dose IL-2; BRIEF: The purpose of this study is to test the safety of an investigational vaccine called TroVax when given in conjunction with Interleukin-2 (IL-2) treatment. TroVax is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is standard treatment for your cancer, which means that you could receive it even if you choose not to participate in this study. TroVax is being studied as a possible treatment for patients with cancer of the kidney. TroVax belongs to a class of medicines called a vaccine. A vaccine helps the bodys immune system to recognize and kill foreign invading organisms effectively. It is believed that one of the reasons why cancer can spread through the body is that the immune system cannot recognize them as being different from normal tissues and therefore cannot kill the cancer cells. A vaccine that alerts the immune system to the presence of cancer cells in the body could lead to the immune system being able to target and kill those cancer cells effectively. This trial is of a completely new way of trying to treat cancer in the future by the use of vaccination injections. TroVax consists of a virus that has been changed so that it is no longer infectious and carries a gene for a protein called 5T4. This protein is carried by many kidney cancer calls. When the virus is injected, it makes the protein, and the bodys immune system is then able to recognize this protein and kill the cells that have it (i.e. the cancer cells). The purpose of this study is to assess the safety and tolerability of TroVax injections and to understand whether TroVax could make such an immune response happen in patients with renal cell cancer while receiving Interleukin-2 (IL-2). This study will also observe and monitor any side effects experienced in patients who receive TroVax while being treated with IL-2. ; DRUG USED: TroVax; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: 5T4 tumor antigen , Immune System; THERAPY: Combination; LEAD SPONSOR: Oxford BioMedica; CRITERIA: Inclusion Criteria: - Metastatic renal clear cell adenocarcinoma, histologically proven by biopsy of the primary tumour and/or a metastasis. If a fresh specimen is obtained for diagnostic purposes, it may be frozen and stained for 5T4. Prior nephrectomy is not required. - Requiring treatment with IL-2 and able to tolerate a high dose schedule per institutional standards. - Aged 18 years or more. - Performance status (ECOG) 0 or 1. - Expected survival longer than three months. - No clinically active autoimmune disease. - Total white cell count greater than or equal to 3 x 109/l. - Platelet count greater than or equal to 90,000/mm3. - Serum creatinine 1.6 mg/dl or less. - Total bilirubin 1.6 mg/dl or less. - Serum AST/ALT greater than or equal to three times the upper limit of normal or 5 times upper limit of normal if liver metastases are present. - Able to give written informed consent and to comply with the protocol. - Women must be either post menopausal, rendered surgically sterile or practising a reliable form of contraception (hormonal, intrauterine device or barrier). Men must practise an effective form of birth control, such as barrier protection. - Normal cardiac stress test if the patients are older than 50 years of age or have symptoms of cardiac disease. - Normal pulmonary function tests if the patient is a smoker or is known to have primary lung disease. Exclusion Criteria: - Pregnancy, lactation or lack of effective contraception in fertile men and women of childbearing potential. - Intercurrent serious infections within the 28 days prior to entry to the trial. - Known to be HIV positive because HIV infection can lead to serious adverse events with vaccination and/or high-dose IL-2. - Life threatening illness unrelated to cancer. - Cerebral metastases. - History of allergic response to previous vaccinia vaccinations. - Participation in any other clinical trial within the previous 30 days . - Previous malignancies within the last two years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy. - Previous history of major psychiatric disorder requiring hospitalisation or any current psychiatric disorder that would impede the patients ability to provide informed consent or to comply with the protocol. - Corticosteroids unless used as an antiemetic. - Family contact with active eczema, exfoliative skin disorder, pregnancy or other cause of immunocompromise. ; PRIMARY OUTCOME: To assess safety and tolerability of TroVax; 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 IIa - Study 202; BRIEF: The following study is being conducted to explore the safety and effectiveness of a new chemical entity called NXN-188 in subjects with a history of migraine with aura. In this study subjects will treat two attacks of migraine with aura during the aura phase - once with placebo and once with NXN-188. ; DRUG USED: NXN-188; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Nitric Oxide Synthase, Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Danish Headache Center; CRITERIA: Inclusion Criteria: 1. Male or female migraineurs with aura between 18 and 65 years old, inclusive 2. Meets the following criteria for migraine headache with aura: - Diagnosed with a history of migraine with aura - Aura consisting of at least one of the following, but no muscle weakness or paralysis: - Fully reversible visual symptoms (e.g. flickering lights, spots, lines, loss of vision) - Fully reversible sensory symptoms (e.g. pins and needles, numbness) - Fully reversible dysphasia (speech disturbance) - Aura has at least two of the following characteristics: - Visual symptoms affecting just one side of the field of vision and/or sensory symptoms affecting just one side of the body - At least one aura symptom develops gradually over more than 5 minutes and/or different aura symptoms occur one after the other over more than 5 minutes - Each symptom lasts from 5-60 minutes 3. At least one migraine headache with aura every 8-weeks and resulting in moderate to severe pain (on a 4-point categorical scale) within 2 hours of the onset of aura. 4. Migraine pain following aura in at least 75% of occurrences 5. The subject has a body mass index (BMI) within the range of 18 to 32 6. The subject is in general good health as determined by the medical history, physical exam, clinical laboratory tests, vital signs [heart rate (HR) and blood pressure (BP; after a 3-minute sitting period)] and ECG • ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within normal limits 7. The subject must be able to speak, read, and understand Danish sufficiently to understand the nature of the study, to provide written informed consent, and complete all study assessments 8. The subject is willing and able to comply with all testing requirements defined in the protocol 9. All females will avoid pregnancy at least 10 days before Visit 1, during the study and up until 3 months after Visit 2 10. Women of childbearing potential must be using a reliable form of contraception. A reliable form of contraception is defined as follows: - sterilisation (via hysterectomy or bilateral tubal ligation) - sterilisation of partner - IUD, - birth control pills on stable dose for at least three months before Visit 1, and one month after visit 2. - Medroxyprogesterone acetate (Depo-Provera) or etonogestrel (implanon) active for at least three months prior to the study and with continued administration at intervals sufficient to maintain contraceptive efficacy throughout the study period and at least one month after visit 2. Males must use condoms as contraception. Exclusion Criteria: 1. Presence of any clinically significant condition that would preclude study participation, as evaluated by the investigator 2. Are pregnant or lactating 3. History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease 4. Receiving any medication that, in the opinion of the Investigator or designee, may pose a risk of compromising tolerance or compliance 5. Are known to or suspected to be currently abusing alcohol or drugs, or have a history (within the past 12 months) of active alcohol or drug abuse 6. Participation in another drug or biologic study within 30 days preceding randomization into this study or during participation in this study 7. Subjects who are unable or unwilling, in the opinion of the Investigator, to comply with all study procedures and cooperate fully with study center staff ; PRIMARY OUTCOME: The severity of headache measured with a 4 point scale (The Headache Severity Score (HSS)); SECONDARY OUTCOME 1: The occurence of any type(s) of adverse events(s)[/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 - GUARDS-1; BRIEF: The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19. ; DRUG USED: Cinvanti; DRUG CLASS: Non-NME; INDICATION: COVID-19 Treatment; TARGET: Neurokinin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Heron Therapeutics; CRITERIA: Inclusion Criteria: - Is hospitalized for ≤48 hours with SARS-CoV-2 infection. Confirmed by polymerase chain reaction (PCR), antigen or immunoglobulin M (IgM) antibody test. - Has at least 1 of the following: Radiographic infiltrates by imaging, or oxygen saturation of <94% by pulse oximetry on room air or requiring supplemental oxygen. - Not anticipated to require mechanical ventilation within 48 hours. Exclusion Criteria: - Is taking high-dose hydroxychloroquine or chloroquine. - Is taking pimozide or strong or moderate CYP3A4 inhibitors. - Is currently receiving treatment with products intended to modify immune response to COVID-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed), chemotherapy or on hemodialysis or peritoneal dialysis. - Has known hypersensitivity to any components of aprepitant injectable emulsion. - Has evidence of ARDS. - Is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask, noninvasive positive pressure ventilation, or ECMO. - Has multiple organ failure. - Has current confirmed Influenza A or B infection, or a a history of organ or hematologic transplant, HIV, or active hepatitis B or hepatitis C infection. ; PRIMARY OUTCOME: Proportion of Subjects Alive and Discharged From the Hospital.; SECONDARY OUTCOME 1: Time to Death or Respiratory Failure, Defined as Any of the Following: Endotracheal Intubation and Mechanical Ventilation; Oxygen Delivered by High-flow Nasal Cannula; Noninvasive Positive Pressure Ventilation; Extracorporeal Membrane Oxygenation (ECMO).[/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 - NAV03-12; BRIEF: The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single center, open-label, within-subject study. ; DRUG USED: Lymphoseek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Kaposis Sarcoma - Imaging; TARGET: Macrophages, Mannose, Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Navidea Biopharmaceuticals; CRITERIA: Inclusion Criteria: 1. The subject has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures. 2. The subject is at least 18 years of age at the time of consent. 3. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 2. 4. The subject has a KS stage of T(0), I(0), S(0). 5. The subject has a marker lesion with a confirmed diagnosis of KS (CD 206-expressing cutaneous KS) via punch biopsy. The location of the marker KS lesion will be limited to locations on the extremities: from the shoulder to the metacarpal region or from the groin to the metatarsal region. 6. The subject has a marker KS lesion that is ≥ 1cm in diameter. Exclusion Criteria: 1. The subject is pregnant or lactating. 2. The subject has had prior chemotherapy, immunotherapy, or radiation therapy to the local KS site or regional lymphatic system within one year of enrollment. 3. The subject has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the marker KS lesion. 4. The subject has known sensitivity to dextran. ; PRIMARY OUTCOME: Localization; SECONDARY OUTCOME 1: Time to Localization[/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 - BELINDA (Aggressive B-cell NHL); BRIEF: This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy. ; DRUG USED: Kymriah; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Histologically confirmed, aggressive B-cell NHL at relapse/progression or PR after front line therapy. Aggressive B-cell NHL is heretofore defined by the following list of subtypes (Swerdlow et al 2016): 1. DLBCL, NOS, 2. FL grade 3B, 3. Primary mediastinal large B cell lymphoma (PMBCL), 4. T cell rich/histiocyte rich large B cell lymphoma (T/HRBCL), 5. DLBCL associated with chronic inflammation, 6. Intravascular large B-cell lymphoma, 7. ALK+ large B-cell lymphoma, 8. B-cell lymphoma, unclassifiable, (with features intermediate between DLBCL and classical Hodgkins Lymphoma (HL)), 9. High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, 10. High-grade B-cell lymphoma, NOS 11. HHV8+ DLBCL, NOS 12. DLBCL transforming from follicular lymphoma 13. DLBCL transforming from marginal zone lymphoma 14. DLBCL, leg type 2. Relapse or progression within 365 days from last dose of anti CD20 antibody and anthracycline containing first line immunochemotherapy or refractory (have not achieved a CR). 3. Patient is considered eligible for autologous HSCT as per local investigator assessment. Note: Intention to transplant and type of high dose chemotherapy (HDCT) regimen will be documented at the time of study entry 4. Disease that is both active on PET scan (defined as 5-Deauville scorepoint-scale of 4 or 5) and measurable on CT scan, defined as:: 1. Nodal lesions >15 mm in the long axis, regardless of the length of the short axis, and/or 2. Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) >10 mm in long AND short axis 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Adequate organ function: Renal function defined as: 1. Serum creatinine of ≤1.5 x upper limit of normal (ULN), OR estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 Hepatic function defined as: 2. Alanine Transaminase (ALT) and Aspartate Transiminase (AST) ≤ 5 × ULN 3. Total bilirubin ≤ 1.5 x ULN with the exception of patients with Gilbert syndrome who may be included if their total bilirubin is ≤3.0 × ULN and direct bilirubin ≤1.5 × ULN Hematologic Function (regardless of transfusions) defined as: 4. Absolute neutrophil count (ANC) >1000/mm3 5. Absolute lymphocyte count (ALC) >300/mm3 OR Absolute number of CD3+ T cells >150/mm3 (only for patients with non-historical apheresis) 6. Platelets ≥50000/mm3 7. Hemoglobin >8.0 g/dl Adequate pulmonary function defined as: 8. No or mild dyspnea (≤ Grade 1) 9. Oxygen saturation measured by pulse oximetry > 90% on room air 10. Forced expiratory volume in 1 s (FEV1) ≥ 50% and/or carbon monoxide diffusion test (DLCO) ≥50% of predicted level 7. Must have a leukapheresis material of non-mobilized cells available for manufacturing. Exclusion Criteria: 1. Prior treatment with anti-CD19 therapy, T cell therapy, or any prior gene therapy product 2. Treatment with any systemic lymphoma-directed second line anticancer therapy prior to randomization. Only steroids and local irradiation are permitted for disease control 3. Patients with active central nervous system (CNS) involvement by disease under study are excluded, except if the CNS involvement has been effectively treated and local treatment was >4 weeks before randomization 4. Prior allogeneic HSCT 5. Clinically significant active infection 6. Any of the following cardiovascular conditions: - Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening, - Left ventricle ejection fraction (LVEF) <45% as determined by echocardiogram (ECHO) or magnetic resonance angiography (MRA) or multigated acquisition (MUGA) at the screening assessment. - New York Heart Association (NYHA) functional class III or IV (Chavey et al 2001), within the past 12 months. - Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II) and third degree AV block unless adequately controlled by pacemaker implantation. - Resting QTcF ≥450 msec (male) or ≥460 msec (female) at screening or inability to determine the QTcF interval - Risk factors for Torsades de Pointes (TdP), including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/ symptomatic bradycardia, or any of the following: - Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome - Concomitant medication(s) with a Known Risk of Torsades de Pointes per crediblemeds.org that cannot be discontinued or replaced by safe alternative medication. 7. Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré Syndrome (GBS), Amyotrophic Lateral Sclerosis (ALS)) and clinically significant active cerebrovascular disorders (e.g. cerebral edema, posterior reversible encephalopathy syndrome (PRES)) Other protocol-defined inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Event-free survival (EFS); SECONDARY OUTCOME 1: EFS as assessed by local 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 IIa - Alchemilla; BRIEF: Primary Objective: To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS). Secondary Objectives: - To compare the effects of SAR292833 with placebo on the change of neuropathic pain symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI); - To evaluate the effects of SAR292833 in comparison to placebo on the change in pain intensity of mechanical allodynia; - To investigate the safety and tolerability of SAR292833 in comparison to placebo; - To investigate the pharmacokinetics (PK) and the relationships between main efficacy parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in patients with chronic peripheral neuropathic pain. ; DRUG USED: GRC 15300; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuropathic Pain; TARGET: TRPV3, transient receptor potential vanilloid receptor 3, VR-3; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: -The study will include adult patients of either gender, 18 - 85 of age, who have signed the informed consent form, and presenting with chronic peripheral neuropathic pain associated with: diabetic polyneuropathy, post-herpetic neuralgia. - The neuropathic pain must have a distinct neuroanatomically plausible distribution with sensory signs and symptoms confirmed by DN4 (Douleur Neuropathique en 4 questions) score of ≥4 and being present for more than 3 months. - SAR292833 should be taken in fed condition. Therefore, only patients who were judged to be reliable to fulfill this condition (used to having breakfast and dinner) will be included in the study. Exclusion criteria: - Patients with a baseline average daily pain intensity for their neuropathic pain < 5 on the 11-point NRS over the last 7 days before randomization; - Patients with a pain intensity of ≥ 9 on the 11-point NRS at Visit 1; - Any pain other than the neuropathic pain of equal or greater severity; - Sensory polyneuropathy post chemotherapy or in the context of cancer or AIDS; - Patients with complex regional pain syndrome; - Trigeminal neuralgia; - Patients with clinically significant or uncontrolled hepatic, metabolic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that might interfere with the evaluation of study medication according to Investigators medical judgment; - Patients on statins metabolized by CYP3A4, (e.g. simvastatin, atorvastatin) and abnormal CPK level; - Major depression; - Serum creatinine >150 μmol/L; - ALT 3 x ULN; - Total bilirubin > 1.5 x ULN except known Gilbert syndrome; - Presence of signs of clinically significant abnormalities on a standard electrocardiogram (ECG) recording at the screening visit according to Investigators medical judgment; - Pregnant or breastfeeding women; - Women of childbearing potential (WOCBP), not protected by highly effective contraceptive method of birth control; - Patients with diabetes mellitus and time between diagnosis of diabetes and enrolment <6 months; - Patients with diabetes mellitus and HbA1c >10% or fasting plasma glucose >250 mg/dL; - Use of the following drugs within 7 days prior to start with the pain intensity assessment (Visit 2): - Antidepressants (except for stable [>30 days] regimens of Selective serotonin reuptake inhibitors (SSRIs) for treatment of anxiety or depression), anticonvulsants or mexiletine for the treatment of pain; - Opioids or morphinomimetics; - Fatty acid supplements, primrose oil, myoinositol, chromium picolinate that are known to be used in neuropathic pain; - Acetyl salicylic acid (ASA) except up to 325 mg/d for myocardial infarction or transient ischemic attack prophylaxis; - Benzodiazepines other than indicated at low doses for sleep disorders; - Capsaicin patch; - Lidocaine patch; - Electroconvulsive therapy within 30 days of baseline evaluation; - CYP3A4 potent and moderate inhibitors; - CYP3A4 potent and moderate inducers; - Substrates of CYP3A4 with narrow therapeutic window. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Change from baseline in the average daily pain intensity as measured by the 11-point NRS;; SECONDARY OUTCOME 1: Percentage of patients with reduction in pain intensity of at least 30% and 50% at endpoint compared to baseline derived from the primary efficacy endpoint;[/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 - CLAVIER (biomarker study); BRIEF: This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks. ; DRUG USED: Lebrikizumab; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1 - Bronchodilator response demonstrated within the 12 months before Visit 1 or at Visit 1, 2, or 3 of screening - Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3 - On ICS therapy at a total daily dose of 500-2000 mcg of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study - On an eligible second controller medication (long-acting Beta-agonist [LABA), leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonists [LAMAs] or theophylline) for 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study - Uncontrolled asthma at Visit 1 and/or 2 and at Visit 3 - Chest X-ray or computed tomography (CT) scan within 12 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) that confirms the absence of other clinically significant lung disease - Demonstrated adherence with controller medication during the screening period Exclusion Criteria: - Maintenance oral corticosteroid therapy, defined as daily alternate-day oral corticosteroid maintenance therapy within 3 months prior to Visit 1 - Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event - Any infection requiring hospital, intravenous (IV) or intramuscular (IM) antibiotic treatment or any respiratory infection within 4 weeks prior to Visit 1 or during screening. Any infection requiring oral antibiotic treatment with 2 weeks prior to Visit 1 or during screening, or any parasitic infection within 6 months prior to Visit 1 or during screening - Active tuberculosis requiring treatment within 12 months prior to Visit 1 - Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection - History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma - Known current malignancy or current evaluation for a potential malignancy - Unable to safely undergo elective flexible fiberoptic bronchoscopy - Clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigator, to impact the participants ability to participate in the study, or to impact the study assessments - History of alcohol or drug abuse that would impair or risk the participants full participation in the study, in the opinion of the investigator - Current smoker or history of smoking (greater than [>] 10 pack-years), or unwillingness to abstain from smoking for the duration of the study - Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab - Use of a licensed or investigational monoclonal antibody other than anti-IL-13, or anti IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening - Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening - Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening - Initiation of or increase in allergen immunotherapy within 3 months prior to Visit 1 or during screening - Body mass index >38 kilograms per square meter (kg/m^2) - Body weight <40 kilograms (kg) - History of bronchial thermoplasty ; PRIMARY OUTCOME: Relative Change From Baseline in the Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells per Square Millimeter [Cells/mm^2]); SECONDARY OUTCOME 1: Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)[/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/Bendamustine; BRIEF: The objective of the first part of the study is to determine a safe dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The objectives of the second part of the study are to compare the safety and efficacy of TRU-016 in combination with bendamustine to bendamustine alone in patients with relapsed CLL. ; DRUG USED: Otlertuzumab; DRUG CLASS: Biologic; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Cluster of Differentiation 37 (CD37); THERAPY: Combination; LEAD SPONSOR: Aptevo Therapeutics; CRITERIA: Inclusion Criteria: - Diagnosis of relapsed CLL with 1 to 3 prior treatments - Demonstrated active disease requiring treatment - No prior bendamustine treatment - Not refractory to fludarabine or other purines, either as a single agent or in combination - Age >/=18 years; male or female - Eastern Cooperative Oncology Group (ECOG) performance status of </= 2 - Creatinine clearance > 40 mL/min - Absolute neutrophil count (ANC) >/= 1,200/mm3 - Platelets >/= 75,000/mm3 - Lymphocytes >/= 5,000/mm3 in Phase 1b Exclusion Criteria: - Treatment with rituximab or other B-cell depleting agent within 30 days or alemtuzumab within 12 weeks - Previous anticancer therapy within 30 days - Refractory to prior fludarabine or other purine analog therapy either as a single agent or in combination - Receipt of prior bendamustine or TRU-016 - Receipt of an investigational therapy or major surgery within 30 days - Previous or concurrent additional malignancy (some exceptions apply) - Any significant concurrent medical diseases or conditions - Positive serology for HIV or hepatitis C, hepatitis B surface antigen positive or hepatitis B core antibody positive. - Pregnant or breast feeding - Drug or alcohol abuse - Allergic to mannitol ; PRIMARY OUTCOME: Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria; SECONDARY OUTCOME 1: Response Per NCI 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 II - (Japan); BRIEF: The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis. ; DRUG USED: Tralokinumab; DRUG CLASS: Biologic; INDICATION: Idiopathic Pulmonary Fibrosis (IPF); TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of informed consent prior to any study specific procedures - Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF - Mild to moderate IPF to include all of the following at Visit 1 1. FVC ≥ 50% and ≤ 90% predicted normal 2. Partial pressure of oxygen in arterial blood (PaO2) of ≥ 55 mmHg on room air, or oxygen saturation by pulse oximetry (SpO2) of ≥ 90% on room air at rest 3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% and ≤ 90% predicted normal Exclusion Criteria: - History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis - Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease - A suspected IPF exacerbation not fully resolved and treatment completed ≤ 14 days prior to Visit 1 - A suspected IPF exacerbation during the screening period - A FEV1/FVC ratio < 0.70 at the time of Visit 1 (postbronchodilator) - The extent of emphysema on the HRCT is greater than the extent of fibrosis ; PRIMARY OUTCOME: Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events; SECONDARY OUTCOME 1: Serum Tralokinumab Concentration Data[/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 - DREAM-T2D; BRIEF: In Phase 1 and 2 studies already conducted, Metformin DR, with its targeted delivery to the distal small intestine, has shown the potential to be a safe and effective way to improve glycemic control in patients with T2DM and CKD with less systemic metformin exposure. The primary purpose of this Phase 3 clinical study is to collect pivotal data confirming the safety and efficacy of Metformin DR in T2DM patients with varying renal function from normal up to CKD3B. ; DRUG USED: NewMet; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK); THERAPY: Monotherapy; LEAD SPONSOR: Anji Pharma; CRITERIA: Inclusion Criteria: 1. Is male or female and at least 18 years old 2. Has body mass index 20.0 to 45.0 kg/m2 (inclusive) 3. Has T2DM 4. Has HbA1c of 7.0% to 9.5%, inclusive, at Visit 1A and HbA1c value of 7.0% to 10.5%, inclusive, at Week -2 (Visit 3/3A as applicable) 5. Has an eGFR value of ≥30 mL/min/1.73 m2 based on the CKD-EPI equation at Visit 1A and Visit 3/3A (Week -2) 6. Stable treatment with a metformin preparation or a combination product containing metformin for 8 weeks prior to Visit 1A 7. If treated with the following medications, must be on a stable regimen for a minimum of 6 weeks prior to Visit 1B 1. Drugs known to affect body weight, including prescription medications (e.g., phentermine, phentermine/topiramate, orlistat, lorcaserin, bupropion/naltrexone) and over-the-counter anti-obesity agents 2. Hormone replacement therapy (female patients) and testosterone (male patients) 3. Oral contraceptives (female patients) 4. Antihypertensive agents including ACEi/ARB 5. Lipid-lowering agents 6. Thyroid replacement therapy 7. Antidepressant agents 8. Ability to understand and willingness to adhere to protocol requirements Exclusion Criteria: 1. Is currently on dialysis, has been on any dialysis within 1 year of Visit 1B, or is expected to undergo dialysis during the study period 2. Has a history of lactic acidosis 3. Has a fasting plasma glucose (FPG) value >240 mg/dL (>13.3 mmol/L) at Week -2 (Visit 3/3A as applicable) 4. An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN at Visit 1B or Visit 3/3A (Week -2) (except in case of documented Gilberts syndrome) 5. Has a fasting plasma lactate value >2 mol at Visit 1B 6. Has a bicarbonate value ≤20 mEq/L at both Visit 1A and 1B. If bicarbonate value is <20 at Visit 3/3A or 4, patient may be excluded if the investigator considers this clinically significant 7. A history of >5% weight change within 12 weeks prior to Visit 1A 8. Has mean BP measurements >180 mmHg (systolic BP) or >100 mmHg (diastolic BP) at Visit 1A or Visit 3/3A, which can be rechecked within 1 week (Note: re-screening is allowed 6 weeks after initiation/modification of antihypertensive agents if the patient is screen failed due to BP only) 9. Oral antidiabetic agent or insulin use that is not stable for 8 weeks prior to randomization (i.e., change in oral medication dose or basal insulin dose increased or decreased by more than 20% during the 8 weeks prior to Visit 4 [Day 1]) 10. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications: 1. Prescribed metformin preparation after initiation of metformin washout following Visit 1B 2. Greater than 10 consecutive days of systemic corticosteroids by oral, intravenous, or intramuscular route within 12 weeks of Visit 1B; inhaled, intranasal, ophthalmic, topical, or intra-articular corticosteroids are not exclusionary 3. Planned use of proton pump inhibitors after Visit 2 (Week -6); such use could potentially affect the DR and PK of Metformin DR. Proton pump inhibitor treatment may be replaced by other treatment (such as H2 receptor antagonists [excluding ranitidine], or calcium carbonate antacids) prior to Visit 4 (Day 1), if appropriate per the judgment of the Investigator 4. Cationic drugs that are eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, flecainide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) within 1 week of Visit 3 (Week 2) 5. Iodinated contrast dye within 1 week prior to Visit 3 (Week -2) 6. Investigational drug within 8 weeks (or 5 half-lives of the investigational drug, whichever is greater) of the date of the first dose of randomized study medication 7. Metformin DR or double-blind matching placebo for Metformin DR at any time prior to Visit 1B 11. Has a clinically significant medical condition as judged by the Investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions: 1. Hepatic disease 2. Gastrointestinal disease, including but not limited to: i. History or presence of inflammatory bowel disease or other severe gastrointestinal disease, particularly those that may impact gastric emptying, such as gastroparesis and pyloric stenosis ii. Prior or expected surgical gastrointestinal procedure that may impact the gut hormonal response to study medication such as gastric bypass surgery or gastric banding surgery iii. Active diagnosis of pancreatitis c. Endocrine disorder other than T2DM or hypothyroidism on replacement therapy d. Cardiovascular disease, including history of stroke, decompensated heart failure New York Heart Association Class III or IV, myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft or angioplasty within 3 months prior to Visit 1A (screening) e. Central nervous system diseases such as epilepsy f. Psychiatric or neurological disorders that in the Investigators opinion would cause the patient to be noncompliant with study procedures g. Organ transplantation h. Chronic or acute infection requiring systemic antibiotic treatment i. Orthostatic hypotension or syncope j. Active malignancy within the past 5 years with exception of basal cell and squamous cell carcinoma 12. Known allergy or hypersensitivity to Metformin DR, Metformin IR, or placebo or any inactive component of study medication, active comparator, or placebo, unless the reaction is deemed irrelevant to the study by the Investigator (prior history of gastrointestinal intolerance to metformin is not exclusionary) 13. Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within 1 year prior to Visit 1B 14. A physical, psychological, or historical finding that, in the Investigators opinion, would make the patient unsuitable for the study 15. Any verified clinically significant abnormality identified on physical examination, laboratory tests, ECG, vital signs, or any adverse event (AE) at the time of Visit 1B through Visit 4 that, in the judgment of the Investigator or any Sub-investigator, would preclude safe completion of the study or constrains efficacy assessment 16. Currently abuses drugs or alcohol or has a known history of abuse that in the Investigators opinion would cause the patient to be noncompliant with study procedures 17. Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 8 weeks prior to Visit 1B, or is planning to donate blood or have a blood transfusion during the study 18. Prior or planned major surgery of any kind (requiring overnight hospitalization) within 6 months of Visit 1B 19. Patients insufficiently compliant with study medication during the placebo run-in phase (<85% or >115%) as assessed at Visit 4 20. Is screening for the study at more than one clinical site or is participating in any other clinical study 21. Is currently pregnant (confirmed by serum pregnancy test at Visit 1B) or breastfeeding or plans to become pregnant during the course of the study 22. Women of childbearing potential not willing to use highly effective method(s) of birth control during the entire study, or who are unwilling or unable to be tested for pregnancy 23. If the patient has evidence of coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection), the patient cannot be enrolled in the study 24. Is employed by Anji Pharma (that is an employee, contract worker, or designee of the company). ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: HbA1c response (Metformin DR vs. placebo)[/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 - vs. Liraglutide; BRIEF: This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening - HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive) - BMI: 25.0 - 40.0 kg/m^2 (both inclusive) Exclusion Criteria: - Simultaneous participation in any other clinical trial of an investigational medicinal product - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids) - History of pancreatitis (acute or chronic) - Screening calcitonin above or equal to 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC) - Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology) - Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack - Currently planned coronary, carotid or peripheral artery revascularisation - Patients presently classified as being in New York Heart Association (NYHA) Class III or IV ; PRIMARY OUTCOME: Change in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change in Fasting Plasma Glucose (FPG)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PRIMO; BRIEF: This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of PI3K-δ,γ, in patients with relapsed/refractory Peripheral T-cell Lymphoma (PTCL). ; DRUG USED: Copiktra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral T-Cell Lymphoma (PTCL) - NHL; TARGET: p110 delta/PIK3CD, p110 gamma/PIK3CG, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: SecuraBio; CRITERIA: Inclusion Criteria: 1. Age ≥ 18 years of age 2. Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the World Health Organization: 1. Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS); 2. Angioimmunoblastic T-cell lymphomas (AITL); 3. Anaplastic large cell lymphoma (ALCL); or 4. Natural-killer/T-cell lymphoma (NKTL) 3. Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following: 1. failed to achieve at least a PR after 2 or more cycles of standard therapy; 2. failed to achieve a CR after completion of standard therapy; and/or 3. persistent or progressive disease after an initial response 4. For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin 5. Measurable disease as defined by Lugano for PTCL, that is, at least 1 measurable disease lesion > 1.5 cm in at least one dimension by conventional techniques (18FDG-PET-CT, CT with contrast, MRI) Exclusion Criteria: 1. Primary leukemic PTCL subtypes (that is, T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, adult T-cell leukemia/lymphoma and aggressive NK-cell leukemia) or transformed mycosis fungoides 2. Received prior allogeneic transplant 3. Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor 4. Known central nervous system involvement by PTCL 5. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) once daily (QD) 6. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening 7. Known hypersensitivity to duvelisib and/or its excipients ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Number of Participants with Treatment-emergent Adverse events (TEAEs) as Assessed by CTCAE v4.0[/INST]No</s>