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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 - TACT; BRIEF: TACT is a real world randomized controlled trial of tecarfarin, a novel vitamin K antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two groups of subjects who require chronic oral anticoagulation for a broad panel of indications. ; DRUG USED: Tecarfarin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anticoagulation; TARGET: Vitamin K Epoxide Reductase (VKOR); THERAPY: Monotherapy; LEAD SPONSOR: Espero Biopharma; CRITERIA: General Screening Inclusion Criteria 1. Is male or female and at least 18 years of age. 2. Is able and willing to sign an IRB-approved written informed consent. 3. Is able and willing to follow instructions, to comply with protocol requirements, and to attend required study visits. 4. Is taking a CYP2C9-interacting medication (inhibitor, substrate, or inducer; see list in Appendix A) at the time of randomization and is expected to receive this medication chronically for the duration of the trial. 5. Has either 1. Chronic kidney disease stage 3 or 4 (eGFR ≥ 15 to <60 mL/min/1.73 m2 at Screening based on central laboratory) and/or 2. A CYP2C9 genotype variant allele 6. (Only for warfarin experienced patients) Patient is considered poorly controlled on warfarin therapy as judged by the investigator, e.g. has at least 2 INR values out of target range within previous 12 months Anticoagulation-Related Inclusion Criteria 7. Requires chronic anticoagulation therapy. 8. Is willing to receive chronic anticoagulation investigational therapy for the duration of the study or, for warfarin-naïve DVT subjects, treating physician prescribed at least a 6-month treatment period with an oral anticoagulation agent. 9. Has one or more of the following indications for chronic oral anticoagulation: 1. Atrial fibrillation/flutter (paroxysmal, persistent or permanent), not due to a reversible cause, documented by electrocardiography (ECG) 2. Aortic and/or mitral prosthetic HV 3. History of venous thromboembolic disease 4. History of myocardial infarction or cardiomyopathy 5. Any another indication for which warfarin is approved or recommended, with Sponsor approval 10. Conforms to the following restrictions regarding vitamin-K containing dietary supplements: 1. If taking at Baseline (Visit 2), is willing to continue with consistent doses throughout the study 2. If not taking at Baseline (Visit 2), is willing to abstain from such supplements throughout the study General Exclusion Criteria 1. Is pregnant, nursing, or a woman of childbearing potential who cannot assure that they will not become pregnant for the duration of the study. 2. Has been treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, at time of screening. Safety-Related Exclusion Criteria 3. Has a life expectancy <1 year 4. Is age >85 years 5. Has severe end-organ disease, such as: 1. Estimated GFR (eGFR) < 15 mL/min/1.73 m2 at Screening per the central laboratory 2. Is on dialysis 3. Is expected to be on dialysis or receive kidney transplant within 6 months of screening 4. Advanced pulmonary disease requiring home oxygen 5. NYHA class IV heart failure 6. Severe psychiatric disorder such as advanced dementia 6. Has a history of ischemic stroke without residual neurologic deficit within the last 3 months, prior major ischemic stroke with residual neurologic deficit, or any history of intracranial bleeding 7. Is an ongoing alcohol or substance abuser 8. Has anemia (screening hemoglobin <9 g/dL) For subjects who have received a MHV within 4 weeks of Screening, who have no active bleeding, and whose hemoglobin is stable, a Screening hemoglobin as low as 8 g/dL is allowed. For subjects with severe CKD (eGFR ≥ 15 to <30 mL/min/1.73 m2), who have no active bleeding, and whose hemoglobin is stable, a Screening hemoglobin as low as 8 g/dL is allowed. 9. Has thrombocytopenia (screening platelet count <90,000 x 103/microL) 10. Has a history of or presence of any illness or condition, which, in the judgment of the Investigator, may compromise the safety of the subject during Study Drug administration. Anticoagulation-related Exclusion Criteria 11. Has active bleeding or lesions at risk of bleeding such as gastric ulceration, colonic or cerebral arterio-venous malformations, cerebral or aortic aneurysms, pericarditis or endocarditis 12. Except for MHV replacement surgery and related or concurrent procedures, has recently (<14 days from Screening) undergone non-thromboembolic surgery or other invasive procedures such as lumbar puncture. 13. Has blood dyscrasias or inherited disorders of hemostasis. 14. Has a history of hemorrhagic tendencies or prior serious hemorrhagic events such as hemorrhage within the cranium, eye, spinal cord, retroperitoneum. 15. Has active gross hematuria or gastrointestinal bleeding 16. Has a history of gross hematuria or gastrointestinal bleeding within the past 6 months prior to Screening. (Note: Investigators may enroll patients with such bleeding episodes if they are resolved at least 4 weeks prior to screening and if the benefits of anticoagulation outweigh the risks using accepted risk stratification methods such as HASBLED.) 17. Has received concomitant therapy with other anticoagulant or antiplatelet agents, such as clopidogrel, prasugrel, ticlopidine, dipyridamole, heparin or low molecular weight heparin (LMWH), or nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued prior to initiating tecarfarin/warfarin dosing, unless use of such drugs is necessary as part of bridging/transitioning during the first several days of Study Drug administration. Daily use of 81 - 100 mg aspirin and intermittent or chronic use of the selective COX-2 inhibitors celecoxib and valdecoxib is allowed. 18. Has congenital or acquired coagulant inhibitors present which would interfere with the use of the INR, eg: 1. Antiphospholipid antibody syndrome or positive lupus anticoagulant 2. Abnormally prolonged prothrombin time, in the absence of therapeutic anticoagulation, due to an endogenous inhibitor ; PRIMARY OUTCOME: Percentage of time in the therapeutic range (TTR) for tecarfarin vs. warfarin for each treatment group in the randomized population; SECONDARY OUTCOME 1: Percentage TTR for tecarfarin vs. warfarin in the sub-population of patients who are taking a CYP2C9-interacting medication and have a CYP2C9 genotype variant allele[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ALIVE; BRIEF: This is a randomized, controlled multi-site, multi-national clinical trial conducted in Thailand and Malaysia for naïve Asian adults (males or females), 18 years of age and older presenting with advanced HCC (BCLC stage C) including subjects with vascular involvement and/or extrahepatic spread (not eligible for TACE, surgery or locoregional treatment) with Child-Pugh stage A or B liver function. 150 subjects will be randomized 2:1 to AlloStim® immunotherapy vs Physicians Choice of Sorafenib, Levantinib or FOLFOX4. ; DRUG USED: AlloStim; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Immunovative Therapies, Ltd.; CRITERIA: Inclusion Criteria: 1. Males and females who are at least 18 years of age at time of enrollment 2. Histologically or cytologically documented advanced HCC (BCLC stage C) disease at diagnosis. 3. No prior treatment for BCLC class C disease. 4. Child-Pugh Class A or subset of Child-Pugh Class B 5. Performance status: ECOG < 2 with no deterioration over the previous 2 weeks 6. With or without positive HBV and/or HCV 7. With or without extrahepatic disease and with or without macrovascular invasion 8. Measurable enhancing disease in liver with at least one target lesion evaluable by mRECIST 9. Adequate hematological, liver and renal function as assessed by the following: - Hemoglobin > 10.0 g/dl - Platelet count > 75,000/μl - ALT and AST < 5.0 x ULN - Serum creatinine < 1.5 10. Women of child-bearing potential: negative pregnancy test 11. Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study 12. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate Exclusion Criteria: 1. Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma). 2. Child-Pugh liver function combined score >9 (Class C or Class D) 3. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator) 4. Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy 5. Severe stomach/esophageal varices requiring interventional treatment. 6. Unable to tolerate radiological contrast dye 7. Any prior experimental, approved or off-label treatment for HCC (including levantinib, nivolumab, duvalumab, tremelimumab, brivananib, cabozantinib or ramucircumab) or any approved or experimental procedures such as surgery, radiation or ablation. 8. Enrollment in any previous clinical trial for HCC 9. Any history of autoimmune disorder (type I, insulin-dependent diabetes allowed) 10. History of COPD or oxygen saturation <92% at room air 11. Any clinical condition requiring systemic steroids (inhaled steroids allowed) or any current immunosuppressive therapy or anti-epileptic drug therapy. 12. Known history of HIV infection 13. Clinically significant gastrointestinal bleeding within 30 days prior to study entry 14. History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) 15. Uncontrolled hypertension (SBP >150 or DBP>90). 16. Active clinically serious infections (> grade 2 CTCAE version 5.0) 17. History of organ transplant or tissue allograft 18. Uncontrolled concurrent serious medical or psychiatric illness 19. Clinically apparent central nervous system metastases or carcinomatous meningitis 20. History of drug abuse or current alcohol abuse 21. History of blood transfusion reactions 22. Pregnant or lactating women ; PRIMARY OUTCOME: overall survival; SECONDARY OUTCOME 1: Quality of Life Survey[/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 - HER2+ Tumors; BRIEF: This study is an open-label, dose-escalation study of MM-111 with five different combination treatments with the main goal of determining the safety of MM-111 with each combination. ; DRUG USED: MM-111; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: ErbB3/HER3, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Merrimack Pharmaceuticals; CRITERIA: Inclusion Criteria - Patients must have histologically or cytologically confirmed advanced cancer that is positive for HER2, either: - At least 3+ positive by immunohistochemistry, or - Gene amplified positive by fluorescence in situ hybridization (FISH). Chromogenic in situ hybridization (CISH) is acceptable to confirm HER2 positivity if FISH results are not available. - The patients cancer must have recurred or progressed following standard therapy or have not responded to standard therapy. (Patients with previously untreated HER2+ metastatic gastric or gastro-esophageal junction cancer can be enrolled onto the cisplatin, capecitabine, and trastuzumab + MM-111 arm of the study.) - Patients must be ≥ 18 years of age. - Patients or their legal representatives must be able to understand and sign an informed consent. - Patients should have evaluable or measurable disease ≥ 1 cm. - Patients must have ECOG PS ≤ 1 or Karnofsky performance score of ≥ 70. - Patients must have adequate hematologic status as evidenced by: - Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 - Platelet count ≥ 100,000 platelets/mm3 - Hemoglobin ≥ 9 g/dL - For arms 1, 2, 3 and 4 patients must have adequate hepatic function as evidenced by: - Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN) - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 x ULN (5 × ULN is acceptable if liver metastases are present) - For arm 5 (Docetaxel) patients must have adequate hepatic function as evidenced by: - Serum bilirubin within normal limits, - AST and/or ALT < 1.5 X ULN and alkaline phosphatase < 2.5 X ULN if concomitantly elevated - Patients must have adequate renal function as evidenced by: - Serum creatinine ≤ 1.5 × ULN - Calculated clearance 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal - Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.4.0) up to Grade 1 is acceptable for patients with pre-existing peripheral neuropathy. - Patients must have a life expectancy of at least 3 months. Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 60 days following the last dose of MM-111. Exclusion Criteria: - Patients for whom potentially curative antineoplastic therapy is available - Patients who are pregnant or lactating - Patients with an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing. (At the discretion of the Investigator, patients with tumor fever may be enrolled.) - Patients with untreated and/or symptomatic primary or metastatic central nervous system (CNS) malignancies (Patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial.) - Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies. - Patients with a known history of hypersensitivity to any of the drug components of a particular regimen. - Patients who have received other recent antitumor therapy including: - Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111. Dosing in < 28 days since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent have passed. - Any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of MM-111. There is no necessary washout for trastuzumab. Patients enrolled to the lapatinib-containing arms of the study do not need to have a washout period for lapatinib. - Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50% - History of myocardial infarction within 12 months of enrollment - Uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg) - Known angina pectoris requiring medication - Known clinically significant valvular heart disease - Known history of high-risk arrhythmias - Known history of congestive heart failure - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome - Active gastrointestinal bleedingPatients who have received prior maximum cumulative anthracycline doses: - doxorubicin or liposomal doxorubicin doses > 360 mg/m2 - mitoxantrone > 120 mg/m2 and idarubicin > 90 mg/m2 - epirubicin doses higher than 720 mg/m2 - Other (e.g., liposomal doxorubicin or other anthracycline equivalent of 360 mg/m2 of doxorubicin) - If more than 1 anthracycline has been used, the cumulative dose must not exceed the equivalent of 360mg/m2 of doxorubicin - Patients with a history of allogeneic transplant. (Patients with a history of autologous bone marrow or stem cell transplant may be enrolled.) - Patients with known human immunodeficiency virus (HIV), hepatitis B or C. (If patients have previously been treated for hepatitis C and have undetectable viral loads, they can be considered eligible for the trial.) - Patients with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results ; PRIMARY OUTCOME: Determine patients safety (# of adverse events/serious adverse events) and tolerability of MM-111 in combination with multiple treatment regimens; SECONDARY OUTCOME 1: To characterize the pharmacokinetics (PK) profile of MM-111 when administered in combination with multiple treatment regimens. The PK profile will help to determine the phase 2 dose[/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 - TARGET (+/- Docetaxel); BRIEF: This study will test the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line Non Small Cell Lung Cancer (NSCLC) (adenocarcinoma, squamous, adenosquamous or adenocarcinoma with other NSCLC variants of the lung) in participants with all target lesions expressing the folate receptor [FR(++)]. ; DRUG USED: Vintafolide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Folate Receptor (FOLR1), Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Endocyte; CRITERIA: Inclusion Criteria: 1. Ability to sign an approved informed consent form (ICF). 2. Must be ≥ 18 years of age. 3. Histology confirmed diagnosis of non-small cell lung cancer (adenocarcinoma, squamous, adenosquamous, or adenocarcinoma with other NSCLC variants of the lung) (Stage IIIB or IV). 4. All (RECIST v1.1-defined) target lesions positive for the folate receptor [FR(++)] by SPECT scan. 5. Only one prior systemic therapy for advanced disease (e.g.,a platinum doublet or a maintenance regimen that includes a platinum doublet; in addition, the participant may have received an epidermal growth factor receptor [EGFR] inhibitor). 6. Radiological evaluation conducted no more than 28 days prior to beginning study therapy. If history of CNS metastasis baseline radiological imaging must include brain MRI or CT. 7. Radiologic evidence of disease progression following the most recent prior treatment. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 9. Must have recovered (to baseline/stabilization) from prior cytotoxic-therapy-associated acute toxicities. 10. Prior radiation therapy is allowed if the following criteria is met: - Radiation to < 25% of the bone marrow; whole pelvis radiation is excluded. - Prior radiotherapy must be completed at least 2 weeks before randomization. - Must have recovered from the acute toxic effects of the treatment before randomized. - Prior thoracic radiation must be completed 30 days before study enrollment. - Irradiated pulmonary lesions cannot be used as target or non-target lesions (and must be excluded) unless there is previous documented progression of these lesions. - Palliative extrathoracic radiotherapy can continue, but these lesions must be excluded as target and non-target lesions. 11. Adequate organ function: - Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelets ≥ 100 x 109/L. Hemoglobin ≥ 9 g/dL. - Hepatic: Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) and alkaline phosphatase ≤ 2.5 x ULN. - Renal: Serum creatinine ≤ 1.5 x ULN, or for participants with serum creatinine > 1.5 ULN, creatinine clearance ≥ 50 mL/min/1.73 m2 (50mL/min/1.73m2 is equivalent to 0.83 mL/s/m2). 12. Participants of childbearing potential: - Women who are capable of becoming pregnant must have a negative serum pregnancy test within 1 week prior to exposure to EC20 and within 1 week prior to exposure to treatment with EC145 and/or docetaxel. - Women who are capable of becoming pregnant and male participants who are sexually active must practice an effective method of birth control for the duration of their participation in the trial through 3 months following the last dose of EC145 and through 6 months following the last dose of docetaxel. Exclusion Criteria: 1. Prior therapy with docetaxel, vinorelbine, or vinca-containing compounds. 2. Known hypersensitivity to docetaxel or polysorbate 80. 3. Symptomatic central nervous system (CNS) metastases or metastases that result in midline shift, significant edema. 4. Malignancies other than NSCLC that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible. 5. Serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension. 6. Anti-folate therapy such as methotrexate for rheumatoid arthritis. 7. Baseline peripheral neuropathy CTCAE ≥ Grade 2. 8. Pregnant or lactating women. 9. Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy. 10. Active infections (e.g., hepatitis or HIV carriers) ; PRIMARY OUTCOME: Progression free survival(PFS)based on investigator assessment using RECIST v1.1; SECONDARY OUTCOME 1: Compare overall response rate of participants between treatment arms.[/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 - NI-AC002 (Healthy Volunteers); BRIEF: The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes). ; DRUG USED: SB204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acne; TARGET: Nitric Oxide/ Nitrogen Monoxide; THERAPY: Monotherapy; LEAD SPONSOR: Novan, Inc.; CRITERIA: Inclusion Criteria: - Healthy male and female volunteers - Age 18 or older - High degree of fluorescence of facial skin under Woods lamp Exclusion Criteria: - Acute or chronic skin disorders - Use of topical or systemic antibiotics within 4 weeks of study - Concomitant use of nitroglycerin or other nitric oxide donor drugs - Females who are pregnant, planning pregnancy or breast feeding ; PRIMARY OUTCOME: Cutaneous tolerability Evaluation; SECONDARY OUTCOME 1: Safety 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 - NIAGARA; BRIEF: A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion: - Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology - Patients must be planning to undergo a radical cystectomy - Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC - ECOG performance status of 0 or 1 - Must have a life expectancy of at least 12 weeks at randomization Exclusion: - Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening. - Prior pelvic radiotherapy treatment within 2 years of randomization to study - Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies. - Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) - Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. - Uncontrolled intercurrent illness - Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency ; PRIMARY OUTCOME: Pathologic complete response (pCR) rates at time of cystectomy; SECONDARY OUTCOME 1: Proportion of patients who achieve <P2 at time of cystectomy[/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 - PoC; BRIEF: To determine whether LFG316 can induce a hematological response, as measured by reduction in hemolytic activity, in patients with PNH. ; DRUG USED: Tesidolumab; DRUG CLASS: Biologic; INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female patients between the age of 18-75 (inclusive), or 18-65 (applicable in Czech Republic) with a diagnosis of PNH prior to screening - A documented PNH clone size of ≥10% by RBCs and/or granulocytes - Serum LDH levels at least 1.5-fold above the upper limit of normal (ULN) at screening - Negative pregnancy test for women of child bearing potential at screening - Previous vaccination against Neisseria meningitidis is required at least 2 weeks prior to first dosing. Exclusion Criteria: - Known or suspected hereditary complement deficiency - History of recurrent meningitis, history of meningococcal meningitis despite vaccination - Presence or suspicion (based on judgment of the investigator) of active bacterial infection within 2 weeks prior to first dose of LFG316, or recurrent bacterial infections - Under active therapy with other agents interfering with the complement system - Severe concurrent co-morbidities that are a likely caused by underlying autoimmune diseases other than PNH - Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 50 days after the last dose of LFG316. ; PRIMARY OUTCOME: Serum lactate dehydrogenase (LDH) levels; SECONDARY OUTCOME 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)[/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 - BIOV-121 - Non-intensive, Elderly; BRIEF: The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine. ; DRUG USED: Clolar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA polymerase, DNA synthesis, Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion Criteria: - Provide signed, written informed consent - Have untreated AML according to World Health Organization (WHO) classification - Male or post-menopausal female ≥ 65 years of age - Unsuitable for intensive chemotherapy - Be able to comply with study procedures and follow-up examination - Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies - Have adequate liver and renal function as indicated by certain laboratory values Exclusion Criteria: - Received previous treatment with clofarabine - Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed) - Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine - Have a psychiatric disorder that would interfere with consent, study participation, or follow-up - Have an active, uncontrolled systemic infection - Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days - Have symptomatic central nervous system (CNS) involvement - Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)[/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 - AP-011 (Basal Thumb Joint); BRIEF: This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the basal thumb joint. ; DRUG USED: Ampion; DRUG CLASS: Biologic; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Ampio Pharmaceuticals. Inc.; CRITERIA: Inclusion Criteria: 1. Able to provide written informed consent to participate in the study. 2. Willing and able to comply with all study requirements and instructions of the site study staff. 3. Male or female, 40 years to 85 years old (inclusive). 4. Radiographic evidence of Basal joint arthritis (Eaton-Littler classification, stages 1 through 4). 5. Pain associated with basal joint arthritis, defined as a score ≥ 4 as evaluated by the Australian-Canadian OA Index (AUSCAN)-numeric rating score (NRS, 0-10). Exclusion Criteria: 1. As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study. 2. Previous Ampion™ injection. 3. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion). 4. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate). 5. Women who are currently pregnant or who could become pregnant. 6. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis, as assessed locally by the Principal Investigator. 7. Any other disease or condition interfering with the free use and evaluation of the index thumb for the duration of the trial (e.g., congenital defects, stricture). 8. Major injury to the index thumb within the 12 months prior to screening. 9. Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study. 10. Use of the following medications are exclusionary: - IA injected pain medications in the study thumb during the study; - Analgesics containing opioids; - NSAIDs (including but not limited to ibuprofen, aspirin, naproxen, diclofenac) acetaminophen is available as a rescue medication during the study from the provided supply; - Topical prescription treatment on osteoarthritis index thumb during the study; - Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin in the cardio-protective dose (81mg) and Plavix are allowed); - Systemic treatments that may interfere with safety or efficacy assessments during the study; - Immunosuppressants; - Use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable, defined as chronic use of the same dose for at least 1 month). 11. Any human albumin treatment in the 3 months before randomization. ; PRIMARY OUTCOME: Safety will be evaluated from Baseline to Week 4. monitoring incidence of AEs, thumb exam, vitals, and concomitant medication use; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ONU3704; BRIEF: The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy. ; DRUG USED: Targiniq ER; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Purdue Pharma LP; CRITERIA: Inclusion Criteria include: - Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period; - The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation; - Subjects must have a self-reported history of opioid induced constipation (OIC). Exclusion Criteria include: - Subjects with rheumatoid arthritis or other inflammatory arthritis; - Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months; - Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility; - Subjects with chronic constipation not related to opioid use; - Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study; - Subjects with a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated. Other protocol specific inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Overall complete spontaneous bowel movement (CSBM) responder rates; SECONDARY OUTCOME 1: CSBM Responder at least 50% of the weeks in the double-blind 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 I - India/Mexico/NZ/South Africa; BRIEF: This study intends to evaluate how safe and well tolerated the LY2405319 compound is when given to people for 7 days (in Part 1) and 28 days (in Part 2). This study intends to also determine if there is a positive effect on lowering the level of glucose in people with type 2 diabetes. ; DRUG USED: LY2405319; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Men and women without child bearing capability - Ages 35 to 70 years - Type 2 diabetic subjects, diagnosed for at least 3 months - Average body weight (relative to height) - Willing to be available for the duration of the study Exclusion Criteria: - Significant medical illnesses (except Type 2 diabetes) - Abnormal 12-lead electrocardiogram (ECG ) - Current or previous use of insulin for greater than 7 days for control of diabetes - Regular use of drugs of abuse - Excessive alcohol use ; PRIMARY OUTCOME: Safety labs, ECGs, vital signs, adverse events.; SECONDARY OUTCOME 1: Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples)[/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 - 3583 - BEGIN: BB T1 LONG; BRIEF: This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644. ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 1 diabetes mellitus for at least 12 months - Current treatment with any basal bolus insulin for at least 12 months - HbA1c below or equal to 10.0% - BMI (Body Mass Index) below or equal to 35.0 kg/m^2 - For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228) Exclusion Criteria: - Use of any other antidiabetic drug than insulin within the last 3 months - Cardiovascular disease within the last 6 months - Uncontrolled treated/untreated severe hypertension - Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months - Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements - 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 (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes[/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 - ONE (Safety); BRIEF: Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: - To evaluate the other safety aspects of sarilumab administered as monotherapy. - To assess the exposure of sarilumab administered as monotherapy. ; DRUG USED: Kevzara; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Diagnosis of rheumatoid arthritis (RA) ≥ 3 months. - Moderately to severely active rheumatoid arthritis. - Participants who per investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs). Exclusion criteria: - Participants < 18 years of age. - Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA. - History of juvenile idiopathic arthritis or arthritis onset prior to age 16. - Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Feltys syndrome. - Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies. - Treatment with prednisone > 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization. - New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovascular diseases. - Use of parenteral glucocorticoids or intra-articular glucocorticoids injection within 4 weeks prior to randomization. - Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib). - New treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 6 weeks prior to randomization. - Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first dose of study drug administration, whichever is longer. - Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. Non-malignant lymphoproliferative disorders are also excluded. - Participants with active tuberculosis or untreated latent tuberculosis infection. - Pregnant or breast feeding women. The above information is not intended to contain all considerations relevant to a Participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percentage of Participants With Incidence of Antidrug Antibodies (ADA); SECONDARY OUTCOME 1: Serum Sarilumab 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 II - X2201; BRIEF: This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma. ; DRUG USED: QBX258; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines. - Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2. - Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5. - FEV1 40 to 90% of predicted. Exclusion Criteria: - Diagnosed with COPD as defined by the GOLD guidelines - Subjects who have had a respiratory tract infection within 4 weeks prior to screening. - Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration ; PRIMARY OUTCOME: Change From Baseline in Asthma Control Questionnaire (ACQ) Score; SECONDARY OUTCOME 1: Change in Forced Expiratory Volume in One Second (FEV1)[/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 - Single and Multiple Doses; BRIEF: This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy subjects and in patients with T2DM. ; DRUG USED: LIK066; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Parts I and III: Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening. - Parts II and IV: Patients, age 18-65 years, must have been diagnosed with T2DM at least 8 weeks prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening. - Fasting plasma glucose ≤250mg/dL at screening and baseline. - If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study. Exclusion Criteria; all parts: - Patients with type 1 diabetes mellitus. - Patients with history of acute diabetic complications within the 6 months prior to screening. - Women of child-bearing potential. - Patients with signs or symptoms of significant diabetic complications. - Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing. - History of drug or alcohol abuse within the 12 months prior to dosing. - Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigators opinion, jeopardize the patient in case of participation in the study. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Safety and tolerability of single and multiple dose(s) of LIK066: number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).; SECONDARY OUTCOME 1: Change in fasting and post-challenge plasma glucose after 2 weeks of treatment[/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 - HIV/HCV; BRIEF: The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug. ; DRUG USED: Incivek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (>) 1000 international units per milliliter (IU/mL) - Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse - Population B: Peg-IFN/RBV prior null or partial responder - Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration - Participant must have positive HIV antibody at Screening - Participant must have a diagnosis of HIV-1 infection >6 months before Screening - Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening: - Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine) - Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components - Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components - Boosted atazanavir plus Epzicom®, or equivalent components - Raltegravir plus Truvada®, or equivalent components - Raltegravir plus Epzicom®, or equivalent components - Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol - Laboratory values within acceptable ranges at Screening as specified in the protocol Exclusion Criteria: - Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1 - Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides - Contraindications to any planned HAART component as per the respective drug labeling information - Contraindications to Peg-IFN or RBV - Evidence of hepatic decompensation - Clinical suspicion of acute hepatitis - Any other cause of liver disease in addition to hepatitis C - History of organ transplantation (except cornea and skin) - Autoimmune-mediated disease - Participated in any investigational drug study within 90 days before Day 1 - Previous treatment with an HCV protease inhibitor ; PRIMARY OUTCOME: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 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 - TROPHIMMUN (Gestational Trophoblastic Neoplasias (GTN)); BRIEF: Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole. GTN patients are commonly treated with single agent treatment (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens. Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life. There is a need for modern targeted agents with better benefit/toxicity profiles. There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is hijacked by GTN cell for proliferating : - Spontaneous regressions of metastasic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells. - Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center. - The case of complete and durable response to pembrolizumab was reported in a patient with multi chemo-resistant GTN. ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Uterine (Endometrial) Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Hospices Civils de Lyon; CRITERIA: Inclusion criteria for all patients : - Woman older than 18 years - Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Patients with adequate bone marrow function : - Absolute neutrophil granulocyte count ≥ 1.5 x 10 9 /L - Platelet count ≥ 100 x 10 9 /L - Haemoglobin ≥ 9.0 g/dL (may have been blood transfused). - Patients with adequate renal function : - Calculated creatinine clearance >= 30 ml/min according to the Cockcroft-Gault formula (or local institutional standard method) - Patients with adequate hepatic function - Serum bilirubin ≤ 1.5 x UNL and AST/ALT ≤ 2.5 X UNL (≤ 5 X UNL for patients with liver metastases) - Patients must have a life expectancy ≥ 16 weeks - Confirmation of non-childbearing status for women of childbearing potential. An evolutive pregnancy can be ruled out in the following cases: - in case of a previous hysterectomy - if serum hCG level ≥ 2 000 IU/L and no intra or extra-uterine gestational sac is detected on pelvic ultrasound - if serum hCG level < 2 000 IU/L on a first measurement and serum hCG increases <100% on a second measurement performed 3 days later - Highly effective contraception if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential must agree to use 2 highly effective contraceptions, defined as methods with a failure rate of less than 1 % per year. Highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after avelumab treatment. - Patients who gave their written informed consent to participate in the study - Patients affiliated to a social insurance regime - Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Cohort A specific inclusion criteria : - Patients with gestational trophoblastic disease resistant to mono-chemotherapy (methotrexate and/or actinomycine-D Cohort B specific inclusion criteria : - Patients with gestational trophoblastic disease resistant to polychemotherapy (such as EMA-CO; EMA-EP; BEP; … regimens) without limitation in the number of previous chemotherapy lines - Patients with limited risk of fast progression, according to Centre de reference des maladies trophoblastiques. In the case where a validated therapeutic alternative is available (platinum salt-based chemotherapy in case of resistance to polychemotherapy without platinum salt), the patient must have been informed and the therapeutic alternative will be proposed in priority. Exclusion Criteria: - Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- CTLA 4 (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways). - Illness, incompatible with avelumab, such as congestive heart failure; respiratory distress; liver failure; allergy. - Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. - All subjects with brain metastases, except those meeting the following criteria: - Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment - No on-going neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) - Subjects with brain metastases must be either off steroids except a stable or decreasing dose of <10mg daily prednisone (or equivalent) - Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug. - Persistent toxicities (>CTCAE grade 1) with the exception of alopecia and sensory neuropathy ≤ grade 2, caused by previous cancer therapy. - Treatment with other investigational agents - Bowel occlusive syndrome, inflammatory bowel disease, immune colitis or other gastro-intestinal disorder that does not allow oral medication such as malabsorption. - Clinically significant (i.e active) cardiovascular disease : cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication - Patients with severe acute or chronic medical conditions including immune pneumonitis, inflammatory bowel disease, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. - Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011). - Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. - Active infection requiring systemic therapy. - Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive) - Administration of a live vaccine within 4 weeks prior the first dose of avelumab. - Treatment with oral anticoagulant such Coumadin. - Current or prior use of immunosuppressive medication within 7 days prior to start of study treatment. The following are exceptions to this exclusion criterion: - Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection); - Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent; - Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible. - Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control - Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome. - Prior organ transplantation, including allogeneic stem cell transplantation (excluding autologous bone marrow transplant) - Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE Grade ≥ 3) - Patients under guardianship. ; PRIMARY OUTCOME: The rate of patients with successful normalization of hCG assays; SECONDARY OUTCOME 1: Resistance free survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PREVENT; BRIEF: The overall objective is to evaluate the efficacy, tolerability, and safety of a single dose of RBT-9 versus placebo in coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk of progression. ; DRUG USED: RBT-9; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Renibus Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female, ≥18 years of age at Screening. 2. Confirmed infection with SARS-CoV-2. 3. High risk of COVID-19 disease progression, defined as: 1. 18-69 years of age with lymphopenia AND 1 additional risk factor (described below) 2. 18-69 years of age without lymphopenia AND 2 risk factors (described below) 3. ≥70 years of age with lymphopenia OR 1 other risk factor (described below) Risk Factors: - Documented history of coronary artery disease - Heart failure (New York Heart Association Class 3 or 4) - Chronic lung disease (eg, asthma or chronic obstructive pulmonary disease) requiring treatment - Documented history of stroke - Diabetes mellitus, requiring at least 1 prescription medicine for management - Documented chronic kidney disease with an estimated glomerular filtration rate <30 mL/min, not on dialysis - Obesity (Class 2 or 3; body mass index >34.9 kg/m2) - On immunosuppressive therapy - Oxygen saturation between 90 and 95% with or without supplemental oxygen 4. Admitted to a hospital for observation and/or treatment (controlled facility may include an emergency room, urgent care facility, temporary/modular hospital, infusion center, clinical research unit, etc). 5. If female, must be postmenopausal, surgically sterile, or if of childbearing potential, must be practicing 2 effective methods of birth control during the study and through 30 days after completion of the study. 6. For females of childbearing potential, a urine pregnancy test must be negative at the Screening Visit. 7. If male, must be surgically sterile or willing to practice 2 effective methods of birth control during the study and through 30 days after completion of the study. 8. Must be willing and able to give informed consent and comply with all study procedures. Exclusion Criteria: 1. Anticipated need for ICU care and/or ventilatory support (invasive or noninvasive) within 24 hours. 2. Evidence of acute cardiac injury, as determined by the Investigator at the time of Screening. This may be based upon clinical signs and symptoms, ECG findings, or elevated troponin I levels. 3. Evidence of acute kidney injury not due to pre-renal azotemia or urinary tract obstruction at the time of Screening. 4. Oxygen saturation <90% on supplemental oxygen with a nasal cannula, including high-flow oxygen at the time of Screening. 5. Requires non-invasive ventilation at the time of Screening. 6. Requires dialysis at the time of Screening. 7. Has received or is receiving anti-IL-6 therapies (eg, Tocilizumab, Sarilumab, Siltuximab, etc) for the treatment of COVID-19; subjects receiving anti-IL-6 therapies for underlying medical conditions unrelated to COVID-19 are not excluded from eligibility. 8. Pregnant or lactating. 9. History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-9. 10. Known hypersensitivity or previous anaphylaxis to RBT-9 (stannous protoporphyrin) or any tin-based product. 11. Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug. 12. Inability to comply with the requirements of the study protocol. ; PRIMARY OUTCOME: Evaluate the Effect of RBT-9 Versus Placebo on Clinical Status of COVID-19 Patients as Measured Using the 8-point World Health Organization (WHO) Ordinal Clinical Scale; 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 - w/Clopidogrel/Prasugrel; BRIEF: The primary objective of this study is to assess the pharmacodynamic (PD) effects of clopidogrel, prasugrel, and ticagrelor when administered after a single subcutaneous (s.c.) dose of ACT-246475 in healthy male and female subjects ; DRUG USED: Selatogrel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Adenosine Diphosphate P2Y12 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Main Inclusion Criteria: - Signed informed consent - Healthy male and female subjects aged between 18 and 65 years (inclusive) at screening - Body mass index of 18.0 to 31.0 kg/m2 (inclusive) at Screening - Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls from screening up to at least 30 days after last study treatment administration - Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 beats per minute (bpm) (inclusive) at screening - Healthy on the basis of physical examination, cardiovascular assessments, and laboratory tests - Maximum (at peak) platelet aggregation ≥ 40% (light transmission aggregometry [LTA]) upon 20 μM adenosine diphosphate (ADP) activation at screening - Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for both cartridges of collagen/adrenaline and collagen/ADP below the upper limit of normal range at screening Main Exclusion Criteria: - Pregnant or lactating women - Known hypersensitivity to ACT-246475, clopidogrel, prasugrel, ticagrelor, any of their excipients, or drugs of the same class - Any contraindication to clopidogrel, prasugrel, or ticagrelor treatment - Known hypersensitivity or allergy to natural rubber latex - Platelet count < 120 × 109 L-1 at Screening and Day -1 - Known platelet disorders (e.g., Glanzmann thromboasthenia, von Willebrand disease, platelet release defect) - Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs, P2Y12 receptor antagonists, or any medication with blood-thinning activity (i.e., injectable or oral anticoagulants) within 3 weeks prior to study treatment administration - Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol ; PRIMARY OUTCOME: Time-matched comparisons of IPA% (MPA) between treatments (i.e., Treatment A1 vs A2, Treatment B1 vs B2, and treatment C1 vs C2, treatments are defined below) following administration of ACT-246475 and its matching placebo.; 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 - DIC2-08-03; BRIEF: The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain. ; DRUG USED: Zorvolex; DRUG CLASS: Non-NME; INDICATION: Mild to Moderate Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Iroko Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: - Patient is male or female between 18 and 50 years of age - For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control - Patient requires extraction of 2 or more third molars - Patient must be willing to stay at the study site overnight Exclusion Criteria: - Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs - Patient has a current disease or history of a disease that will impact the study or the patients well-being - Patient has used or intends to use any of the medications that are prohibited by the protocol - Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test - Patient has taken another investigational drug within 30 days prior to Screening ; PRIMARY OUTCOME: Total Patient Pain Relief Over 0 to 12 Hours.; 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 I - V160-003 (Healthy Japanese Adults); BRIEF: The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis. ; DRUG USED: V160; DRUG CLASS: Vaccine; INDICATION: Cytomegalovirus (CMV) Infection (Antiviral); TARGET: Human Cytomegalovirus (HCMV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Healthy based on medical history and physical examination - Serologically confirmed to be CMV seropositive or CMV seronegative at Visit 1 - If of reproductive potential, agrees to the following from randomization through at least 4 weeks after the last dose of V160-/placebo (from Day 1 through Month 7): 1) practice abstinence from heterosexual activity and remain abstinent, or 2) use contraception unless confirmed to be azoospermic as detailed in the protocol Exclusion Criteria: - History of any allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention - Plans donation of sperm any time from signing the informed consent through 1 month after receiving the last dose of study drug - Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition that requires immunosuppressive medication. - Has a condition in which repeated venipuncture or injections post more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access - Has major psychiatric illness including: any history or schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicidal ideation within 3 years. - Has previously received any CMV vaccine - Had any live virus vaccine administered or scheduled to be administered in the period from 4 weeks prior to, and 4 weeks following receipt of study drug - Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following study drug - Had administration of any immune globulin or blood product within 90 days prior to injection with study drug or scheduled within 30 days thereafter - Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry - Has received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d prednisone equivalent) within 14 days prior to the first vaccination (participants using inhaled, nasal, or topical steroids are considered eligible for the study) - Has received any anti-viral agent (e.g. letermovir, ganciclovir, valganciclovir, foscarnet, and valacyclovir) with proven or potential activity against CMV 14 days prior to vaccination or is likely to receive such an agent within 14 days after vaccination - Receiving or has received in the year prior to enrollment immunosuppressive therapies including but not limited to rapamycin (also sirolimus), tacrolimus (also FK-506), or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic immunotherapy, chemotherapy and other immunosuppressive therapies known to interfere with the immune response. Topical tacrolimus is allowed provided that it is not used within 14 days prior to, or 14 days following study drug - Has participated in another clinical trial in the past 4 weeks, or plans to participate in a treatment-based trial or a trial in which an invasive procedure is to be performed while enrolled in this trial. ; PRIMARY OUTCOME: Percentage of Participants With a Solicited Injection-site Adverse Event (AE); SECONDARY OUTCOME 1: Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb)[/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 - UCLA Fresh (ADA-SCID); BRIEF: The aim of this study is to assess the safety and efficacy of autologous transplantation of hematopoietic stem cells (CD34+ cells) from the bone marrow (BM) of ADA-deficient SCID infants and children following human ADA cDNA transfer by the EFS-ADA lentiviral vector. The level of gene transfer in blood cells and immune function will be measured as endpoints. ; DRUG USED: OTL-101; DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Adenosine Deaminase (ADA); THERAPY: Monotherapy; LEAD SPONSOR: University of California, Los Angeles; CRITERIA: Inclusion Criteria: -Children ≥ 1.0 months of age with a diagnosis of ADA-deficient SCID based on A. Decreased ADA enzymatic activity in erythrocytes, leukocytes, skin fibroblasts, or in cultured fetal cells to levels consistent with ADA-deficient SCID as determined by reference laboratory or confirmed ADA gene mutation(s) known to cause disease , AND B. Evidence of severe combined immunodeficiency based on either: 1. Family history of first order relative with ADA deficiency and clinical and laboratory evidence of severe immunologic deficiency, OR 2. Evidence of severe immunologic deficiency in subject prior to institution of immune restorative therapy, based on 1. lymphopenia (absolute lymphocyte count <400 cells/mcL) OR absence or low number of T cells (absolute CD3+ count <300 cells/mcL) OR 2. severely decreased T lymphocyte blastogenic responses to phytohemagglutinin (either <10% of lower limit of normal controls for the diagnostic laboratory, <10% of the response of the normal control of the day, or stimulation index <10) - Ineligible for matched sibling allogeneic bone marrow transplantation: absence of a medically eligible HLA-identical sibling, with normal immune function, who may serve as an allogeneic bone marrow donor - Signed written informed consent according to guidelines of the Institutional Review Board (IRB) (UCLA Office of Human Research Protection Program and National Human Genome Research Institute (NHGRI) IRB Exclusion Criteria: 1. Age ≤ 1.0 months Appropriate organ function as outlined below must be observed within 60 days of entering this trial. 2. Hematologic 1. Anemia (hemoglobin < 10.5 g/dl at < 2 years of age, or < 11.5 g/dl at > 2 years of age). 2. Neutropenia (absolute granulocyte count <500/mm3. 3. Thrombocytopenia (platelet count < 150,000/mm3, at any age). 4. International Normalised Ratio (INR) or Prothrombin Time (PT) > 2 times the upper limits of normal or Partial Thromboplastin Time (PTT) > 2.33 times the upper limit of normal (patients with a correctable deficiency controlled on medication will not be excluded). 5. Cytogenetic abnormalities on peripheral blood or bone marrow or amniotic fluid (if available). 6. Prior allogeneic Hematopoietic Stem Cell Transplant (HSCT) with cytoreductive conditioning 3. Infectious a. Evidence of infection with HIV-1, hepatitis B, Hepatitis C, or parvovirus B 19 by DNA Polymerase Chain Reaction (PCR) within 90 days prior to bone marrow harvest. If other infection is present, it must be under control (e.g. stable or decreasing viral load) at the time of screening 4. Pulmonary 1. Resting O2 saturation by pulse oximetry < 95% on room air. 2. Chest x-ray indicating active or progressive pulmonary disease. 5. Cardiac 1. Abnormal electrocardiogram (EKG) indicating cardiac pathology. 2. Uncorrected congenital cardiac malformation with clinical symptomatology. 3. Active cardiac disease, including clinical evidence of congestive heart failure, cyanosis, hypotension. 4. Poor cardiac function as evidenced by LV ejection fraction < 40% on echocardiogram. 6. Neurologic 1. Significant neurologic abnormality by examination. 2. Uncontrolled seizure disorder. 7. Renal 1. Renal insufficiency: serum creatinine >= 1.2 mg/dl, or >= 3+ proteinuria. 2. Abnormal serum sodium, potassium, calcium, magnesium, phosphate at grade III or IV by Division of AIDS Toxicity Scale. 8. Hepatic/GI: 1. Serum transaminases > 5 times the upper limit of normal (ULN). 2. Serum bilirubin > 2 times ULN. 3. Serum glucose > 1.5 times ULN. 4. Intractable severe diarrhea. 9. Oncologic 1. Evidence of active malignant disease other than dermatofibrosarcoma protuberans (DFSP) 2. Evidence of DFSP expected to require anti-neoplastic therapy within the 5 years following the infusion of genetically corrected cells 3. Evidence of DFSP expected to be life limiting within the 5 years following the infusion of genetically corrected cells 10. Known sensitivity to Busulfan 11. General 1. Expected survival < 6 months. 2. Pregnant. 3. Major congenital anomaly. 4. Ineligible for autologous HSCT by the criteria at the clinical site. 5. Other conditions which in the opinion of the principal investigator and/or co-investigators, contra-indicate the bone marrow harvest, the administration of busulfan, infusion of transduced cells or indicate the patient or patients parents/primary caregivers inability to follow protocol. ; PRIMARY OUTCOME: Overall Survival (OS) of Subjects Treated With Investigational Medicinal Product (IMP) (1 Year); SECONDARY OUTCOME 1: OS of Subjects Treated With Investigational Medicinal Product (IMP) (2 Years)[/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 - Eyebrow Alopecia Areata; BRIEF: This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows. ; DRUG USED: Corectim; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alopecia Areata; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: - Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis), on both scalp and eyebrows as assessed by the investigator. - Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening. - Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening. Exclusion Criteria: - Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator. - Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo. - Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation. - Any biologic medicinal product targeting the immune system within 5 half-lives and minimum 4 weeks prior to randomisation (e.g. anti-TNFα, anti-IL17, anti IL12/23, anti IL-4Rα targeting drugs). - Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation. ; PRIMARY OUTCOME: Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.; SECONDARY OUTCOME 1: Treatment emergent AEs (including AEs relating to local tolerability)[/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 -3004 (Japan); BRIEF: A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present. The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel. 2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, each participant will have the fistula cleaned and will receive an injection of darvadstrocel near the fistula, under anesthetic. For up to 1 year after treatment, participants will regularly visit the clinic for follow-up. The fistula will be examined and any side effects from the treatment will be recorded. Participants will have an MRI at one clinic visit (about 24 weeks after treatment). ; DRUG USED: Cx601; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Has a CD diagnosis based on accepted clinical, endoscopic, histological and/or radiologic criteria at least 6 months before the screening visit. 2. Has complex perianal fistula refractory to at least one of the following treatments: immunosuppressants or biologics (anti-TNFs, anti-integrin, anti-interleukin [IL] 12/23). Fistula(s) refractory to therapy is defined in this study as follows: Immunosuppressants: Inadequate response after 3 months, based on clinical assessment, or more treatment with azathioprine, 6-mercaptopurine or methotrexate. Biologics: Inadequate response after 14 weeks (16 weeks for anti-IL 12/23), based on clinical assessment, or more standard treatment for induction and maintenance. 3. A complex perianal fistula(s) that meets one or more of the following criteria, modified from the American Gastroenterological Association (AGA) technical review: High intersphincteric, transsphincteric, extrasphincteric, or suprasphincteric as assessed by MRI. Presence of 2 or 3 external openings (tracts) as assessed by clinical examination. Associated fluid (abscess) collections as determined by MRI. This study requires that the participant has complex perianal fistulas with a maximum of 2 internal openings and a maximum of 3 external openings, based on clinical assessment. Darvadstrocel treatment is targeted for fistulas that connect between internal and external openings. A central reading of a locally performed pelvic MRI will be performed to confirm the location of the fistula and potential associated perianal abscess(es). Fistulas must have been draining for at least 6 weeks before the screening visit. Participants with actively draining simple subcutaneous fistulas, at the time of the screening visit, are not allowed in this study. 4. Has inactive or mildly active luminal CD defined by meeting all of the following criteria: 1. Colonoscopy, flexible sigmoidoscopy or rectoscopy performed either at screening or within the 6 months before screening, demonstrating no rectal ulcers larger than 0.5 cm. A participant who has documented rectal ulcers larger than 0.5 cm within the 6 months before screening but has undergone subsequent treatment may be eligible if there are no rectal ulcers larger than 0.5 cm on a sigmoidoscopy or rectoscopy performed after treatment or at the time of screening. 2. The improvement of, or no worsening in stool frequency, sustained for 1 week or more, in the interval between the colonoscopy, flexible sigmoidoscopy or rectoscopy in inclusion criteria 4(a) and the screening visit. 3. No initiation or intensification of treatment with corticosteroids, immunosuppressants, or monoclonal antibody dose regimen between the colonoscopy, flexible sigmoidoscopy or rectoscopy in inclusion criteria 4(a) and the screening visit. Exclusion Criteria: 1. Has received any investigational compound within 12 weeks/84 days before screening. 2. Has received darvadstrocel/eASC in a previous clinical study or as a therapeutic agent. 3. The participant weighs <10 kg at screening. 4. Has concomitant perianal fistula(s) with only internal or external opening(s). 5. Has concomitant internal fistula(s) such as ileo-vesical, rectovaginal or ileo-colonic fistula(s). 6. Has an abscess >2 cm, unless resolved in the preparation procedure. 7. Has rectal and/or anal stenosis, and/or active proctitis, which would restrict the surgical procedure. 8. The participant underwent surgery for the fistula other than drainage or seton placement. 9. Has diverting stomas. 10. Has ongoing systemic corticosteroid treatment or has been treated with systemic corticosteroids within 4 weeks before screening. 11. The participant requires new treatment with immunosuppressants/anti-TNF agents during the screening period. 12. The participant has known or suspected COVID-19 by the investigator within the past 2 months (additional testing may be performed at the discretion of the investigator). Positive antibody testing for COVID without other evidence of current or recent active infection does not exclude participation. Participants who were in screening at the time that COVID-19-related factors resulted in discontinuation may also be rescreened with approval of the sponsor or designee. 13. The participant requires surgery in the perianal region for reasons other than fistulas at the time of screening or foreseen either during the study and/or during the 24 weeks after treatment administration. 14. Has malignant tumor or a prior history of any malignant tumor, including any type of fistula carcinoma. 15. Has current or recent (within 3 months before the screening) history of abnormal, severe, progressive, uncontrolled hepatic, hematologic, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease. 16. Has either congenital or acquired immunodeficiencies, including participants known to be HIV carriers or participants with, in the judgment of the investigator, are suspected to have monogenic inflammatory bowel disease. 17. Has previously received a bone marrow transplant. 18. Has a contraindication to MRI scan or other planned study procedures. 19. Has a contraindication to the anesthetic procedure. 20. Had major surgery or severe trauma within 6 months before the screening visit. ; PRIMARY OUTCOME: Percentage of Participants who Achieve Combined Remission; SECONDARY OUTCOME 1: Percentage of Participants who Achieve Clinical Remission[/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 - M12-921; BRIEF: The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinsons disease. ; DRUG USED: Duopa; DRUG CLASS: Non-NME; INDICATION: Parkinsons Disease (PD); TARGET: Aromatic L-amino acid decarboxylase (AADC), Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Diagnosis of idiopathic Parkinsons disease according to the United Kingdom Parkinsons Disease Society (UKPDS) Brain Bank Criteria. 2. Subjects have 4 or 5 in modified Hohn and Yahr (H & Y) classification of disease severity at Off state determined by the UPDRS Part V at Screening Visit 1. 3. The subjects advanced Parkinsons disease must be levodopa-responsive as judged by the Investigator. 4. Subjects have had optimal treatment with available Parkinsons disease medication as defined by local standards of care and, based upon the judgment of the Investigator, and their symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with available anti-parkinsonian pharmacological therapy when no further improvement is expected regardless of any additional manipulations of levodopa and/or other anti parkinsonian medication; this will be based on the Investigators best clinical judgment. 5. Presence of a recognizable Off and On state (motor fluctuations) as confirmed by UPDRS Part III (in both On and Off states), and by the Parkinsons Disease Diary© which must be observed and confirmed at Screening Visit 1. 6. Subjects must be experiencing a minimum of 3 hours per day of Off time, as estimated by the Investigator and supported by the UPDRS at Screening Visit 1 and the Parkinsons Disease Diaries at baseline. The Off time must occur during a continuous 16-hour interval, including the portion of the day during which the subject is awake the majority of the time (e.g., 5 AM to 9 PM, 7 AM to 11 PM). Exclusion Criteria: 1. Parkinsons disease diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinsons-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or the other neurodegenerative diseases that might mimic the symptoms of Parkinsons disease . 2. Subjects who have undergone neurosurgery for the treatment of Parkinsons disease . 3. Current primary psychiatric diagnosis of acute psychotic disorder or other uncontrolled primary psychiatric diagnoses, (e.g., bipolar disorder or major depressive disorder per Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria. 4. Alzheimers disease; or other significant cognitive impairment or dementia (defined as Mini-Mental State Examination (MMSE) total score < 24). 5. Subject has significant current suicidal ideation within the previous year as evidenced by answering yes to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening or any history of suicide attempts. 6. A low B12 level or low-normal B12 level (less than 300 pg/mL) with elevated methylmalonic acid (MMA). Note: Abnormal Vitamin B12 of questionable clinical significance (i.e., indeterminate or low normal results) prior to or at Screening Visit 2 require appropriate interpretation in conjunction with MMA and homocysteine laboratory values prior to proceeding further into the study. ; PRIMARY OUTCOME: Average Daily Normalized Off Time: Change From Baseline To The Final PEG-J Visit; SECONDARY OUTCOME 1: Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/Ib - 001; BRIEF: This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. ; DRUG USED: CPI-818; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral T-Cell Lymphoma (PTCL) - NHL; TARGET: Immune System, Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Monotherapy; LEAD SPONSOR: Corvus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Adult subjects age ≥18 years - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Histologically confirmed evidence of T-cell lymphoma - Measurable disease. - Adequate organ function. - At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy. Exclusion Criteria: - Treatment with systemic immunosuppressive medication. - History of allogeneic hematopoietic stem cell transplantation. - History of primary immunodeficiency, solid organ transplantation. - History of opportunistic infection within 180 days of starting study drug. - Females who are pregnant, lactating, or intend to become pregnant - History of invasive prior malignancy that required systemic therapy within last 3 years. - Concomitant use of strong inhibitors or inducers of CYP3A. ; PRIMARY OUTCOME: Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose; SECONDARY OUTCOME 1: Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818[/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 - hs-CRP; BRIEF: The purpose of this study is to assess the safety and tolerability of multiple doses of VB-201 administered for 4 weeks and its efficacy on biomarkers. ; DRUG USED: VB-201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Cluster of differentiation 14 (CD14), IL-12 (Interleukin-12) and IL-12 receptor, IL-23 (Interleukin-23) , Toll-Like Receptor 2 (TLR2); THERAPY: Monotherapy; LEAD SPONSOR: Vascular Biogenics Ltd. operating as VBL Therapeutics; CRITERIA: Inclusion Criteria: - Male or female patients, ≥18 to ≤75 years of age; Exclusion Criteria: - Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin; - Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, [including hepatitis B or C, HIV], bacterial infections, systemic fungal infections, or syphilis); - Subjects with a history of coronary events within the last 6 months; ; 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 II - 002; BRIEF: This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome. ; DRUG USED: LiRIS; DRUG CLASS: Non-NME; INDICATION: Interstitial Cystitis / Painful Bladder Syndrome; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Diagnosis of interstitial cystitis or bladder pain syndrome Exclusion Criteria: - Diagnosis of interstitial cystitis with Hunners lesions/ulcers - Previous treatment with LiRIS® ; PRIMARY OUTCOME: Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up; 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 - ENCHANTED; BRIEF: ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study addressing questions (2) and (4) concluded with a publication of the results in February 2019. ; DRUG USED: Activase; DRUG CLASS: Biologic; INDICATION: Ischemic Stroke; TARGET: Fibrin (Coagulation Factor Ia) , Plasminogen, Tissue Plasminogen Activator (TPA); THERAPY: Monotherapy; LEAD SPONSOR: The George Institute; CRITERIA: Inclusion Criteria: - Adult (age ≥18 years) - A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging - Able to receive treatment within 4.5 hours after the definite time of onset of symptoms - Have a systolic BP ≤185 mmHg - Provide informed consent (or via an appropriate proxy, according to local requirements) Specific criteria for arm [A] of low-dose vs standard-dose rtPA (Recruitment completed in August 2015.): - Able to receive either low-dose or standard-dose rtPA Specific criteria for arm [B] of intensive BP lowering vs guideline recommended BP control - Patient will or has received thrombolysis treatment with rtPA, either randomised dose within the trial or physician decided dose rtPA outside of the trial - Sustained elevated systolic BP level, defined as 2 readings ≥ 150 mmHg - Able to commence intensive BP lowering treatment within 6 hours of stroke onset - Able to receive either immediate intensive BP lowering or conservative BP management Exclusion Criteria: - Unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset. - Other medical illness that interferes with outcome assessments and follow-up [known significant pre-stroke disability (mRS scores 2-5)]. - Specific contraindications to rtPA (Actilyse) or any of the blood pressure agents to be used. - Participation in another clinical trial involving evaluation of pharmacological agents. - Need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors. ; PRIMARY OUTCOME: Combined death and disability; SECONDARY OUTCOME 1: Symptomatic intracerebral hemorrhage[/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 - Adults, R/R (US & EU); BRIEF: The purpose of this study is to confirm whether the bispecific T cell engager antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL). ; DRUG USED: Blincyto; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Cluster of Differentiation 19 (CD19), Cluster of Differentiation 3 (CD3), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Amgen Research (Munich) GmbH; CRITERIA: Inclusion Criteria: - Patients with Philadelphia chromosome (Ph)-negative B-precursor ALL, with any of the following: - relapsed or refractory with first remission duration less than or equal to 12 months in first salvage or - relapsed or refractory after first salvage therapy or - relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT) - 10% or more blasts in bone marrow - In case of clinical signs of additional extramedullary disease: measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Age ≥ 18 years Exclusion Criteria: - Patients with Ph-positive ALL - Patients with Burkitts Leukemia according to World Health organization (WHO) classification - History or presence of clinically relevant central nervous system (CNS) pathology - Active ALL in the CNS or testes - Current autoimmune disease or history of autoimmune disease with potential CNS involvement - Autologous HSCT within six weeks prior to start of blinatumomab treatment - Allogeneic HSCT within three months prior to start of blinatumomab treatment - Any active acute graft versus-host disease (GvHD), or active chronic GvHD Grade 2 - 4 - Any systemic therapy against GvHD within two weeks prior to start of blinatumomab treatment - Cancer chemotherapy within two weeks prior to start of blinatumomab treatment - Radiotherapy within two weeks prior to start of blinatumomab treatment - Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treat-ment - Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment - Treatment with any other investigational medicinal product (IMP) after signature of informed consent - Eligibility for allogeneic HSCT at the time of enrollment - Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation - Abnormal laboratory values indicative of inadequate renal or liver function - History of malignancy requiring treatment other than ALL within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix - Any concurrent disease or medical condition that is deemed to interfere with the conduct of the study - Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus - Pregnant or nursing women - Women of childbearing potential not willing to use an effective form of contraception. Male patients not willing to ensure not to beget a child - Previous treatment with blinatumomab ; PRIMARY OUTCOME: Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment; SECONDARY OUTCOME 1: Time to Hematological Relapse (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 I/II - Older Adults; BRIEF: The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years. As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B). ; DRUG USED: GSK3844766A; DRUG CLASS: Vaccine; INDICATION: Respiratory Syncytial Virus (RSV) Prevention; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: For all subjects: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject prior to performing any study specific procedure. For Part A: • A male or female between, and including, 18 and 40 years of age at the time of the first vaccination. For Part B: - A male or female between, and including, 60 and 80 years of age at the time of the first vaccination. - Subjects with residence status allowing free mixing with general community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Exclusion Criteria: For all subjects: - Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period. - Any medical condition that in the judgment of the investigator would make IM injection unsafe. - Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20 mg/day, or equivalent). Inhaled and topical steroids are allowed. - Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. - Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after each study vaccination. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. - Hypersensitivity to latex. - Serious or unstable chronic illness. Patients with chronic stable conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study. - Any other condition (e.g. chronic obstructive pulmonary disease or severe respiratory condition) that, in the opinion of the investigator, might interfere with the evaluations required by the study. - History of any neurological disorders or seizures. - Acute disease and/or fever at the time of enrolment. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by the investigator based on medical history, physical examination or laboratory screening tests. - Hepatomegaly, right upper quadrant abdominal pain or tenderness. - Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. - History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. - Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. - Previous vaccination with an RSV vaccine. - Lymphoproliferative disorder and malignancy within 5 years. - Body mass index > 40 kg/m². - Planned move to a location that will prohibit participating in the trial until study end. - At screening: Hematology parameters (complete blood cell count [red blood cells, white blood cells], white blood cells differential count [lymphocytes, neutrophils and eosinophils], platelets count or hemoglobin level) and/or biochemistry parameters (creatinine, blood urea nitrogen or liver enzymes [alanine aminotransferase or aspartate aminotransferase]) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator. For Part A: - Pregnant or lactating female. - Female subjects of childbearing potential, except if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination, and - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. For Part B: - Known previous administration of a vaccine containing MPL, QS-21 and/or MF59 (e.g. GSK Biologicals vaccine against human papillomavirus infection marketed as Cervarix, GSK Biologicals Herpes Zoster vaccine marketed as Shingrix, an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su], or MF59 adjuvanted influenza vaccines [e.g. Fluad]). - Planned administration of GSK Biologicals Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su] within 180 days after the second dose of the study vaccine. - Bedridden subjects. ; PRIMARY OUTCOME: Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose; SECONDARY OUTCOME 1: Number of Subjects With Any SAEs, up the End of Follow-up Period (Month 14) - Part B Groups[/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 - ATLAS; BRIEF: The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population. ; DRUG USED: BIIB023; DRUG CLASS: Biologic; INDICATION: Lupus Nephritis; TARGET: TWEAK/TWEAK receptor; THERAPY: Combination; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Documented diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti dsDNA antibody. - Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Participants are permitted to have co existing Class V lupus nephritis. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist. - Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as urinary protein:creatinine ratio (uPCR) >1.0 mg/mg. Key Exclusion Criteria: - Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening - Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m^2 (calculated using the abbreviated Modification of Diet in Renal Disease equation) or the presence of oliguria or end-stage renal disease requiring dialysis or transplantation - Subjects requiring dialysis within 12 months prior to Screening - History of renal transplant - Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/B-cell activating factor [e.g., briobacept, belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52; SECONDARY OUTCOME 1: Percentage of Participants Who Achieve Complete Renal Response at Week 52[/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/Tarceva (SUN1058); BRIEF: This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen ; DRUG USED: Sutent; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Patients with locally advanced/metastatic non-small cell lung cancer - Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen Exclusion Criteria: - Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors - History of or known brain metastases ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Percentage of Participants With Objective 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 - Dose Re-Escalation; BRIEF: RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to see how well it works in treating patients with advanced malignant solid tumors. ; DRUG USED: Nexavar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Raf kinase, RET, Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: University of California, Davis; CRITERIA: Inclusion Criteria - Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective or solid tumor for which sorafenib is considered acceptable therapy - Age > 18 years old - Performance Status 0 - 2 - Measurable or non-measurable disease. - Adequate bone marrow, liver and renal function - Any number of prior chemotherapy regimens are allowed. - Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy. - Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment - Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib. - Ability to understand and the willingness to sign a written informed consent. - International normalized ratio < 1.5 or a Prothrombin Time/Partial thromboplastin time within normal limits. Exclusion Criteria - Prior therapy with sorafenib or sunitinib. - Cardiac disease: Congestive heart failure > class II New York Heart Association. - Symptomatic or uncontrolled brain metastasis. - No component of squamous carcinoma can be present in any patient with non-small cell lung cancer - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. - Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management. - Known HIV infection or chronic Hepatitis B or C. - Active clinically serious infection > CTCAE Grade 2. - Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. - Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug. - Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug. - Serious non-healing wound, ulcer, or bone fracture. - Evidence or history of bleeding diathesis or coagulopathy - Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug. - Use of St. Johns Wort or rifampin - Known or suspected allergy to sorafenib or any agent given in the course of this trial. - Any condition that impairs patients ability to swallow whole pills. - Any significant malabsorption problem. - Therapy with bevacizumab < 3 months prior to first dose of study drug. ; PRIMARY OUTCOME: Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity; SECONDARY OUTCOME 1: Overall Response 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 I - CNS Effects; BRIEF: A Randomized, 4-Period, Crossover Study to characterize the effects of tolperisone 200 mg and 400 mg (supratherapeutic dose) three times a day (TID) over 3 days of dosing on measures of simulated driving performance, cognitive function and drowsiness and compared to placebo and cyclobenzaprine (single-day, residual effect, multiple-day). ; DRUG USED: Tolperisone; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuromuscular Spasm and Spasticity; TARGET: Calcium Channel, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Neurana Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Ambulatory male or female, between 21 and 65 years of age, inclusive, for the entire duration of the study (from Screening through Day 3 of last treatment period). - Body mass index (BMI) range between 18.5 and 30.0 kg/m2, inclusive. - Subject must possess a valid drivers license and be an active driver and have driven a minimum of 10,000 miles (about 16,000 km) per year for the previous 3 years. - Subject must demonstrate simulator sickness questionnaire scores that are not indicative of simulator sickness as defined in the driving simulation operations manual. - Subject must have a regular sleep pattern, not be engaged in shift-work, and in general, have at least 7 hours of sleep each night. Exclusion Criteria: - History of sleep disorders, including insomnia, sleep apnea, Restless Legs Syndrome (RLS), or narcolepsy, night-shift workers, routine daytime napping or oversleeping on weekends days (off work) or a score higher than 10 on the Epworth Sleepiness Scale (ESS) at Screening. - A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the Investigator. - Subject has traveled across 2 or more time zones (trans meridian travel) in the last 2 weeks prior to randomization or is expected to travel across 2 or more time zones during the study. - Subject has any physical condition (e.g., severe vision issues, hand use limitations) that would prevent the subject from performing the cognitive or drowsiness assessments. - Subject has a presence or history of any medically diagnosed, clinically significant psychiatric disorder, including depression, anxiety, insomnia, schizophrenia, or bipolar disorder. - Consumes more than 3 cups of coffee per day. - Female subjects who are pregnant or lactating. - Any clinically significant medical abnormality, any clinically significant chronic disease, or any clinically significant finding on physical examination. - Subject with a genotype status of poor-, ultrarapid-, or indeterminate- metabolizers of cytochrome CYP2D6. - Subject is unable to remain in the research unit for each of the treatment periods. - Subject has visual or auditory impairment which in the opinion of the Investigator would interfere with study related procedures or study conduct. ; PRIMARY OUTCOME: Driving Performance; SECONDARY OUTCOME 1: Karolinska Sleepiness Scale[/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/Cetuximab or w/Cetuximab/Alpelisib; BRIEF: This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer ; DRUG USED: Braftovi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Raf kinase; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Metastatic colorectal cancer - Progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens - Life expectancy ≥ 3 months - ECOG performance status ≤ 2 Exclusion Criteria: - Symptomatic or untreated leptomeningeal disease - Symptomatic brain metastasis - Patients with clinically manifested diabetes - Acute or chronic pancreatitis - Clinically significant cardiac disease Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1; SECONDARY OUTCOME 1: Number of Participants With Treatment - Emergent Adverse Events of Grade 3 or 4 Severity Based on National Cancer Institute of Common Terminology Criteria (NCI-CTCAE), Version 4.0[/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/Cytarabine; BRIEF: This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib 150 mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily in combination with cytarabine 20 mg subcutaneously for 10 days. Anticipated time on study treatment is until disease progression, intolerable toxicity, or patient withdrawal of consent. ; DRUG USED: Erivedge; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Hedgehog Signaling Pathway; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients, >/= 18 years of age - Patients with documented relapsed or refractory AML, except acute promyelocytic leukemia (APL [M3 subtype]), or relapsed or refractory high-risk MDS (high-risk MDS defined as International Prognostic Scoring System (IPSS) Int-2 or high and >/= 10% blasts in bone marrow) - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Negative serum pregnancy test for women of childbearing potential and use of two forms of contraception while enrolled in the study and for 7 months after the patient discontinues from study - Male patients with female partners of childbearing potential must agree to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 2 months after the last dose of vismodegib - All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade </= 2 prior to starting therapy - Adequate hepatic and renal function Exclusion Criteria: - Prior treatment with a Hh pathway inhibitor - Prior therapy for the treatment of malignancy within 14 days of Day 1, with the exception of: Hydroxyurea in patients who need to continue this agent to maintain white blood cell (WBC) counts </= 50,000/mL. Hydroxyurea must be discontinued by Day 14 of the study - Current evidence of active central nervous system (CNS) leukemia - Any other active malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix) - Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Unstable angina, symptomatic or otherwise uncontrolled arrhythmia requiring medication (does not include stable, lone atrial fibrillation), or myocardial infarction </= 6 months before study treatment start Any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study - Pregnant or breast-feeding women - Patients who refuse to potentially receive blood products and/or have a severe hypersensitivity to blood products ; PRIMARY OUTCOME: Percentage of Participants With a Complete Response (CR) or CR With Incomplete Blood Count Recovery (CRi) or Morphologic Leukemia Free State (MLFS) or Partial Response (PR) at Week 8; SECONDARY OUTCOME 1: Percentage of Participants With CR, CRi, MLFS or PR at Anytime During Study Treatment[/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 - w/Estradiol/Norethindrone Acetate; BRIEF: This is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label for the next three years. ; DRUG USED: Orilissa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine Fibroids; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participant is a premenopausal female at the time of Screening. - Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound [Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)]. - Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) > 80 mL during each of two screening menses as measured by the alkaline hematin method. - Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose. - Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology. Exclusion Criteria: - Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder. - Participant has history of osteoporosis or other metabolic bone disease. - Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. - Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). - Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed. ; PRIMARY OUTCOME: Change in Bone Mineral Density (BMD); 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 (Canada); BRIEF: This was a single center, proof-of-concept (PoC), Phase II study. Patients with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and scheduled to receive doxorubicin-based (neo)adjuvant therapy to be followed by paclitaxel or docetaxel as per clinical practice. The planned doxorubicin-based chemotherapy treatment consisted of doxorubicin 60 mg/m2 in combination with cyclophosphamide 600 mg/m2 (AC) intravenous (IV) every 2 or 3 weeks for 4 cycles. Patients were scheduled for CMRI and 99mTc-rhAnnexin V-128 imaging (planar and SPECT / CT) at the following visits: 1. Screening/baseline, i.e. 2 weeks prior to initiating AC treatment (Visit 1) 2. After the 2nd and before the 3rd cycle of AC treatment (Visit 2) 3. After the 4th cycle of AC treatment and within 2 weeks (Visit 3) 4. At 12 weeks after the 4th cycle of AC treatment (Visit 4). The imaging procedures were conducted and analyzed. Bloodwork for cardiotoxicity biomarkers (troponin, N terminal pro B-type natriuretic peptide [NT-proBNP]) was performed at each visit. ; DRUG USED: Annexin V-128; DRUG CLASS: Biologic; INDICATION: Cardiovascular Disease; TARGET: Phosphatidylserine; THERAPY: Monotherapy; LEAD SPONSOR: Advanced Accelerator Applications; CRITERIA: Inclusion criteria: 1. Females >= 18 years of age with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and planned for (neo)adjuvant doxorubicin-based chemotherapy (AC every 2 or 3 weeks x 4 cycles) 2. Eastern Cooperative Oncology Group Status (ECOG) ≤ 2 3. Able and willing to comply with the study procedures Exclusion criteria: 1. Pregnancy or lactation 2. Moderate or severe valvular stenosis or regurgitation 3. History of atrial fibrillation or flutter 4. History of any disease or relevant physical or psychiatric condition which may interfere with the study objectives at the investigator judgment 5. Know hypersensitivity to the investigational product (IP) or any of its components 6. Prosthetic valve or pacemaker 7. Claustrophobia or inability to lie still in a supine position 8. Contraindication(s) to the CMRI procedure 9. Participation in another clinical trial within 4 weeks before study inclusion, except for patients who have participated or who are currently participating in a study without any study drug administration 10. Unwillingness to provide consent ; PRIMARY OUTCOME: Part I / Proof of Concept (PoC): Number of Participants Evaluated for Imaging Feasibility; SECONDARY OUTCOME 1: 99mTc-rhAnnexin V-128 Myocardial Uptake[/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 - Dose Ranging Study; BRIEF: This study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ED) patients with acute pain. After screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician. Adverse events will be collected for five days after initial enrollment. ; DRUG USED: Subsys; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: INSYS Therapeutics Inc; CRITERIA: Inclusion Criteria: - Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study - Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender - Has a pain score within protocol-specified parameters Exclusion Criteria: - Has allergy to fentanyl or morphine - Has oxygen-dependent conditions or oxygen saturation <95% - Has planned or recent drug use outside protocol-specified parameters - Has any condition that, in the principal investigators opinion, would place the patient at risk or influence the conduct of the study or interpretation of results ; PRIMARY OUTCOME: Percentage of participants requiring additional doses of randomized pain medication; SECONDARY OUTCOME 1: Percentage of participants requiring additional doses of randomized pain medication at secondary time points[/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 - KEYNOTE-01A (Substudy 1); BRIEF: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) PLUS chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, or MK-0482 in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). ; DRUG USED: MK-7684; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, TIGIT; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC - Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy - Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation - Has not received prior systemic treatment for their metastatic NSCLC - Is able to complete all screening procedures within the 35-day screening window - Has adequate organ function within 10 days of initiation of study treatment - Male participants must agree to use contraception and should refrain from donating sperm during the treatment period and for at least 120 days after the last dose of pembrolizumab and for at least 180 days after the last dose of chemotherapy - Female participants must not be pregnant or breastfeeding, and at least one of the following conditions apply: 1. Not a woman of childbearing potential (WOCBP), OR 2. A WOCBP who agrees to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and for at least 180 days after the last dose of chemotherapy Exclusion Criteria: - Has a diagnosis of small cell lung cancer - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment - Has a known additional malignancy that is progressing or has required active treatment within the past 2 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has an active autoimmune disease that has required systemic treatment in the past 2 years - Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis - Has an active infection requiring systemic therapy - Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, or New York Heart Association Class III or IV congestive heart failure - Has a known history of HIV infection - Has a known history of Hepatitis B or known active Hepatitis C virus infection - Has had major surgery <3 weeks before the first dose of study treatment - Is expected to require any other form of antineoplastic therapy while on study - Has symptomatic ascites or pleural effusion (if receiving pemetrexed; Alimta®, Eli Lilly) - Has a history or current evidence of a gastrointestinal (GI) condition (e.g. inflammatory bowel disease, Crohns disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications - Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or peritoneal carcinomatosis - Has preexisting neuropathy that is moderate in intensity - Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease - Has received prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed cell death-ligand 1 (PD-L1), or anti-PD-L2 agent or prior therapy targeting other immunoregulatory receptors or mechanisms - Is currently receiving either strong or moderate inhibitors of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C8 (CYP2C8) that cannot be discontinued for the duration of the study - Is currently receiving strong or moderate inducers of CYP3A4 or CYP2C8 that cannot be discontinued for the duration of the study - Is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than aspirin dose less than or equal to 1.3 gm/day for a 5-day period (8-day period for long acting agents such as peroxicam), for participants who will receive pemetrexed - Is unable or unwilling to take folic acid or vitamin B12 supplementation, for participants who will receive pemetrexed - Has a known sensitivity to any component of carboplatin, paclitaxel, pemetrexed or any of their excipients - Has received prior radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study treatment - Has received a live vaccine within 30 days before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed - Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE) - Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs) - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment - Previously had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment - Has had an allogenic tissue/solid organ transplant ; PRIMARY OUTCOME: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); SECONDARY OUTCOME 1: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)[/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 - Vasomotor Symptoms; BRIEF: The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats. ; DRUG USED: AUS-131; DRUG CLASS: New Molecular Entity (NME); INDICATION: Menopause (including Hormone Replacement Therapy [HRT]); TARGET: Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Ausio Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: - 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) concentrations > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy, or hysterectomy with 2 (measured 14 days apart) serum FSH concentrations > 40 mIU/mL. - Is likely to experience at least 50 moderate to severe vasomotor symptoms ([MSVS] hot flushes and nocturnal sweating) per week while not receiving estrogen replacement therapy based on history of menopause, in the judgment of the investigator. - Documented experiencing at least 50 MSVS per week during the 14 day baseline period before the Randomization Visit (Visit 3), based on the patient diary entries (calculated mean MSVS/week for the 14 day baseline period). - If ≥ 40 years of age, has a documented negative mammogram and a normal clinical breast examination with no findings indicative of breast malignancy. - Has a body mass index (BMI) < 35.0 kg/m2. Exclusion Criteria: - Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug. - Received any of the following:oral or dermal estrogen/progestin or selective estrogen receptor modulator (SERM) containing drug product therapy within 8 weeks before Screening, injectable or implantable estrogen/progestin therapy within 3 months before Screening, hormone releasing intrauterine device - Had unexplained or otherwise abnormal vaginal bleeding within 6 months before Screening. - Has a history of, or currently has, any of the following conditions: thrombophlebitis, thromboembolic disease, estrogen dependent neoplasia, or carcinoma of the breast. - Has a history of any untreated or uncontrolled endocrine disorders (e.g., hyperparathyroidism, uncontrolled hyperthyroidism). - Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, hepatic, renal, endocrine, or gastric disease or any other condition that, in the opinion of the investigator, could compromise the patients welfare, ability to communicate with the study staff, or otherwise contraindicate study participation. - Has clinically significant depression or severe psychiatric disturbances. - Has active liver disease with aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN), alanine aminotransferase (ALT) > 3 times ULN, unexplained alkaline phosphatase > 3 times ULN, total bilirubin > 2 times ULN, renal insufficiency with creatinine > 1.7 mg/dL, or clinically significant abnormal hemoglobin, white blood cell count, or platelet count. - Has an endometrial thickness ≥ 4 mm. - Has a history indicative of endometrial hyperplasia or cancer. - Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma). - Has known or suspected history of alcoholism or drug abuse or misuse within the past 5 years. - Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg or < 60 mmHg at Screening. - Has a history of smoking more than 5 cigarettes daily within the year before Screening. - Has tested positive on the urine drug screen. Patients who test positive at Screening and can produce documentation from their physician for the medication that caused the positive test may be considered for study enrollment at the discretion of the investigator. - Has significant difficulties swallowing capsules or is unable to tolerate oral medication. - Has participated in another clinical trial or received any investigational drug or device or investigational therapy within 30 days before Screening. - Has a disorder that affects gastrointestinal absorption. ; PRIMARY OUTCOME: Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period); SECONDARY OUTCOME 1: Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week 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 Ib - ARCT- 810-02; BRIEF: Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in clinically stable patients (stable on standard of care treatment, e.g. diet ± ammonia scavengers) with ornithine transcarbamylase deficiency (OTCD). ; DRUG USED: ARCT-810; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urea Cycle Disorders and Derangements (UCD); TARGET: Ornithine transcarbamylase; THERAPY: Monotherapy; LEAD SPONSOR: Arcturus Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Adequate cognitive ability to consent and recall symptoms over a 1-week time period 2. Males and females ≥18 years of age with documented diagnosis of ornithine transcarbamylase deficiency (OTCD) confirmed with genetic testing, or willing to consent to OTC gene sequencing and deletion/duplication testing 3. Subjects ornithine transcarbamylase deficiency (OTCD) is stable as evidenced by 1. no clinical symptoms of hyperammonemia AND b, 2. an ammonia level <100 µmol/L (170 µg/dL) at the screening evaluation Subjects must remain free from symptoms of hyperammonemia throughout the screening period. 4. If using nitrogen ammonia scavenger therapy, must be on a stable regimen (no change in dose or frequency) for ≥ 28 days prior to providing informed consent and throughout the screening period 5. Must have maintained a stable protein-restricted diet (+/- amino acid supplementation) for at least 28 days prior to providing informed consent and continue to maintain a stable diet for the duration of the study 6. Good general health other than OTCD, in the opinion of the Investigator 7. Willing to refrain from strenuous exercise/activity and alcohol for 72 hours before study visits 8. Willingness to comply with procedures and visits 9. Willingness to follow contraception guidelines Exclusion Criteria: 1. History of clinically significant disease(s), in the opinion of the Investigator 2. Clinically significant screening laboratory values 3. Uncontrolled diabetes 4. Clinically significant anemia 5. Subjects who develop infection during screening must be asymptomatic for at least 7 days prior to dosing 6. Unwillingness to comply with study requirements 7. History of positive HIV, hepatitis C, or chronic hepatitis B 8. Uncontrolled hypertension 9. Malignancy within 5 years prior to study 10. Treatment with another investigational drug, biological agent, or device within 30 days of screening, or 5 half-lives of investigational drug 11. Treatment with any oligonucleotide or mRNA within 6 months of screening, with exceptions for some vaccinations and investigational treatments 12. History of gene therapy, hepatocyte or mesenchymal stem cell transplantation 13. Prior organ transplant 14. History of severe allergic reaction to a liposomal product 15. Recent history of, or current, drug or alcohol abuse 16. Dependence on inhaled (smoked or vaped) or oral cannabis products 17. Systemic corticosteroids within 6 weeks prior to screening 18. Blood donation of 50 to 499 mL within 30 days of screening or of .499 mL within 60 days of screening 19. Other conditions, in the opinion of the Investigator, that would make the subject unsuitable for participation ; PRIMARY OUTCOME: Incidence, severity and dose-relationship of adverse events (AEs); SECONDARY OUTCOME 1: Change in area under the curve after single dose of ARCT-810[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - AIM; BRIEF: The purpose of this study is to determine whether the administration of iduronate-2-sulfatase enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients with MPS II. ; DRUG USED: Elaprase; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis II (MPS II; Hunter Syndrome); TARGET: Sulfated alpha-L-iduronic acid; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: To be eligible to participate in this study, patients must meet the following inclusion criteria prior to enrollment: 1. The diagnosis of MPS II will be determined by the investigator based upon both clinical and biochemical criteria. 2. All patients must have at least one of the following Clinical Criteria considered by the investigator to be MPS II-related: - Hepatosplenomegaly - Radiographic evidence of dysostosis multiplex - Valvular heart disease - Evidence of obstructive pulmonary disease 3. In addition, patients must have the following Biochemical Criteria: - Documented deficiency in iduronate-2-sulfastase enzyme activity of less than or equal to 10% of the lower limit of the normal range as measured in plasma, fibroblasts, or leukocytes (based on normal range of measuring laboratory). - A normal enzyme activity level of one other sulfatase as measured in plasma, fibroblasts, or leukocytes (based on normal range of measuring laboratory). 4. Must be male, 5 to 25 years of age. 5. Forced vital capacity of <80% of predicted obtained at the baseline evaluation of this study. 6. Must be able to adequately perform the testing required in this study, including reproducible pulmonary function testing by spirometry, as judged by the investigator. 7. Patient, patients parent(s), or legally authorized guardian must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. Exclusion Criteria: Patients meeting any of the following criteria are not eligible for participation in this study: 1. Patient has received treatment with another investigational therapy within the past 60 days. 2. Patient, patients parent(s), or patients legal guardian is unable to understand the nature, scope, and possible consequences of the study. 3. Patient is unable to comply with the protocol (e.g., due to a medical condition such as cervical cord compression or uncooperative attitude) or is unlikely to complete the study, as determined by the investigator. 4. Patient has a tracheostomy. 5. Patient has received a bone marrow or cord blood transplant. 6. Patient with known hypersensitivity to any of the components of iduronate-2-sulfatase. ; PRIMARY OUTCOME: Ranked Adjusted 2-Component Composite Variable Score Based on Change From Baseline to Week 53; SECONDARY OUTCOME 1: Change From Baseline in Mean Global Joint Range of Motion (JROM) Score at Week 53[/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 - PTCEMF (Open-Label Safety); BRIEF: The primary objective of this study is to evaluate the safety of a 0.9 milligrams per kilogram (mg/kg) and 0.45 mg/kg daily dose of deflazacort with a comparable natural history control group after 52 weeks of treatment in males with DMD aged greater than or equal to (>=) 2 to lesser than (<) 5 years. The study will comprise of 2 periods (Period 1: 52-week safety and pharmacokinetics [PK], and Period 2: 52-week extension). Participants will be randomized in a 1:1 ratio to one of 2 treatment arms: 0.9 mg/kg deflazacort, and 0.45 mg/kg of deflazacort. A historic control group (which should match the study population as closely as possible) will be used as a comparator to characterize the safety and tolerability of deflazacort. ; DRUG USED: Emflaza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: PTC Therapeutics; CRITERIA: Inclusion Criteria: - In the opinion of the Investigator, the participant and parent(s)/caregiver are capable of complying with protocol requirements. - The participants legally acceptable representative signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures. - The participant must have a diagnosis of DMD defined by genetic or biopsy confirmation of DMD or have documented, increased serum creatine kinase more than 40 times the upper limit of normal (ULN) and shown phenotypic signs of DMD. - The participant weighs between 11 kilograms (kg) and 50 kg at screening visit. - Ability to comply with scheduled visits, oral drug administration, and study procedures. - The participant is current on childhood vaccinations according to the Center for Disease Control (CDC) recommended immunizations for children from birth through 6 years old. Note: The investigator should discuss timing of receipt of the varicella vaccine with the caregiver prior to initiation of chronic steroid treatment. Administration of live or live attenuated vaccines is not recommended in participants receiving immunosuppressive doses of corticosteroids. Participants whose caregivers decline vaccinations as a matter of personal belief may be included. - Baseline health is judged to be stable based on medical history, physical examination, laboratory profiles, and vital signs at screening, as deemed by the Investigator. - The participant is able to ingest the oral tablets either whole or crushed. Exclusion Criteria: - The participant has received 4 weeks or more of continuous corticosteroid therapy within 3 months of study screening visit. - The participant has, in the judgment of the Investigator, clinically significant abnormal clinical laboratory parameters at screening or baseline that may affect safety. - The participant has, in the judgment of the Investigator, a history or current medical condition that could affect safety including, but not limited to: 1. Major renal or hepatic impairment 2. Immunosuppression or other contraindications for corticosteroid treatment 3. History of chronic systemic fungal or viral infections 4. Diabetes mellitus or significant glucose intolerance 5. Idiopathic hypercalciuria 6. Symptomatic cardiomyopathy Note: Elective surgeries can be discussed with medical monitor. - The participant has a history of hypersensitivity or allergic reaction to steroids or their formulations including, but not limited to lactose, sucrose, etc. - The participant has received any drug, including prescription and non-prescription medications, and herbal remedies known to be significant inhibitors and/or inducers of cytochrome P3A4 (CYP3A4) enzymes and/or P glycoprotein (P-gp) 14 days prior to the first dose of study drug. - The participant has an indication that requires long-term use of strong CYP3A4 inhibitors and/or inducers that would interfere with the pharmacokinetics of deflazacort. - The participant has received any investigational compound and/or has participated in another clinical study within 30 days prior to study treatment with the exception of observational cohort studies or non-interventional studies. ; PRIMARY OUTCOME: Period 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Period 1: Peak Plasma Concentration (Cmax) of Deflazacort[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers; BRIEF: This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of orally-administered AMXT 1501 dicaprate in normal healthy male volunteers. The study is comprised of a total of 8 cohorts; 4 single ascending dose (SAD) cohorts, 1 Food Effect (FE) Crossover cohort, and 3 multiple ascending dose (MAD) cohorts. Tablets will be administered after an overnight fast (10 hours) with at least 250 mL water. No food will be administered (exception for fed subjects, see below) for one hour thereafter. Each cohort will have a total 6 subjects: SAD and MAD (2 subjects receiving placebo and 4 subjects receiving active AMXT 1501 dicaprate); and FE crossover (6 subjects receiving active AMXT 1501 dicaprate). ; DRUG USED: AMXT 1501; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Polyamine Metabolism; THERAPY: Monotherapy; LEAD SPONSOR: Aminex Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Adult males aged 18 to 55 years inclusive and between 18 to 30 kg/m2 body mass index (BMI). 2. Subjects who are healthy as determined by prestudy medical history, physical examination, and 12 Lead ECG. 3. Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator. 4. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening. 5. Subjects who are negative for drugs of abuse and alcohol tests at screening and admission. 6. Subjects who are non-smokers for at least 1 month preceding screening. 7. Subjects who are able and willing to give written informed consent. Exclusion Criteria: 1. History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subjects ability to participate in the study. 2. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. 3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug. 4. Subjects who have a history of relevant drug hypersensitivity to AMXT 1501. 5. Subjects who have a history of hearing loss. 6. Subjects who consume more than 21 units of alcohol a week. (unit = 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer) 7. Subjects who have a significant infection or known inflammatory process within 2 weeks of dosing or has febrile illness within 7 days of dosing. 8. Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhea, heartburn). 9. Subjects who have an acute infection such as influenza at the time of screening or admission. 10. Subjects who do not agree to use medically acceptable methods of contraception during the study and for 90 days after the last dose of study drug 11. Subjects who use any medication including antacids, analgesics (with the exception of occasional use of up to 3 g of acetaminophen a day), herbal remedies (e.g., St. Johns Wort), or vitamins and minerals from 2 weeks (for prescribed) or 1 week (for non-prescribed) prior to the first administration of study drug or longer if the medication has a long half-life. Occasional use of paracetamol/acetaminophen is allowed for minor pains and headache. 12. Subjects currently receiving medications or herbal supplements known to be potent inhibitors of CYP3A4 and potent inducers of CYP3A4 (from 2 weeks prior to the first administration of study drug). All subjects must avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4. 13. Any intake of grapefruit, grapefruit juice, or other products containing grapefruit within 14 days of the first administration of study drug. 14. Subjects who have used any investigational drug in any clinical trial within 60 days of the screening visit. 15. Subjects who are vegans or have medical dietary restrictions. 16. Subjects who cannot communicate reliably with the Investigator. 17. Subjects who are unlikely to co-operate with the requirements of the study. ; PRIMARY OUTCOME: Determine the maximum feasible dose (MFD); SECONDARY OUTCOME 1: To assess the effects of oral AMXT 1501 dicaprate on biomarkers to determine the appropriate dose level of the AMXT1501.[/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 0/II - Ivy Brain Tumor Center; BRIEF: This trial is an open-label, multicenter, Phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. In the lead-in cohort, a total of 20 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered infigratinib prior to surgical resection of their tumor. ; DRUG USED: Truseltiq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy; LEAD SPONSOR: Nader Sanai; CRITERIA: Inclusion Criteria: 1. Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard (Stupp regimen) therapy, which included maximal surgical resection, temozolomide, and fractionated radiotherapy. 2. Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI. 3. Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm, as per RANO criteria. 4. Sufficient archival tissue available to confirm eligibility. 5. Archival tissue must demonstrate: FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation from NGS sequencing or IHC and RT-PCR. 6. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable). 7. Has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. 8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures. 9. Age ≥18 at time of consent 10. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982) 11. Ability to swallow oral medications. 12. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility): 1. Adequate bone marrow function: - absolute neutrophil count ≥1,000/mcL - Platelets (at time of surgery) ≥100,000/mcL - hemoglobin ≥8.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. 2. Adequate hepatic and renal function: - total bilirubin ≤1.5 X ULN Participants with Gilberts syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted. - AST(SGOT) ≤3 X institutional ULN - ALT(SGPT) ≤3 X institutional ULN - Calculated or measured creatinine clearance ≥45 mL/min 3. Other Lab Values: - Amylase or lipase ≤2 X institutional ULN - calcium or phosphorus, or calcium-phosphorus product <55 mg2/dL2 1. Inorganic phosphorus within normal limits 2. Total corrected serum calcium within normal limits 13. Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant has had a hysterectomy. 14. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the end of treatment administration. 15. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 1 month after the end of treatment administration. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid. 16. Agreement to adhere to Lifestyle Considerations throughout study duration. 17. Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 21 days is required between last chemotherapy dose and Day 1 (provided the patient did not receive radiotherapy). 18. Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and Day 1. Exclusion Criteria: 1. Have a history of liver transplant. 2. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection). 3. Known active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment. 4. Have a history and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification. 5. Have current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, inflammation or ulceration, keratoconjunctivitis confirmed by ophthalmic examination. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study. 6. Have current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc. 7. Have had a recent (≤3 months prior to first dose of study drug) transient ischemic attack or stroke. 8. CTCAE (v5.0) Grade ≥2 hearing loss. 9. CTCAE (v5.0) Grade ≥2 neuropathy. 10. Have clinically significant cardiac disease including any of the following: 1. Known congestive heart failure requiring treatment (New York Heart Association Grade ≥2), LVEF <50% or local lower limit of normal as determined by MUGA scan or echocardiogram (ECHO), or uncontrolled hypertension (refer to the European Society of Cardiology and European Society of Hypertension guidelines [Williams et al 2018]). 2. Presence of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2 ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction abnormality. 3. Unstable angina pectoris or acute myocardial infarction ≤3 months prior to first dose of study drug. 4. QTcF >470 msec (males and females). Note: If the QTcF is >470 msec in the first ECG, a total of 3 ECGs separated by at least 5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤470 msec, the participant meets eligibility in this regard. 5. Known history of congenital long QT syndrome. 11. Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohns disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). 12. Prior therapy with any mitogen-activated protein kinase (MEK) or FGFR inhibitor. Prior therapy is defined as a therapeutic dosing, as determined by the Investigator. 13. Are currently receiving or are planning to receive during participation in this study, treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration. Participants are not permitted to receive enzyme-inducing anti-epileptic drugs, including carbamazepine, phenytoin, phenobarbital, and primidone. 14. Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed. 15. Have any known hypersensitivity to gemcitabine, cisplatin, calcium-lowering agents, infigratinib, or their excipients. 16. Treatment with another investigational drug or other intervention within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer. 17. Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges or products containing juice of these fruits within 7 days prior to first dose of study drug. 18. Have used medications known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes (TdP) 7 days prior to first dose of study drug. 19. Have used amiodarone within 90 days prior to first dose of study drug. ; PRIMARY OUTCOME: Phase 0: Concentration of infigratinib in enhancing and non-enhancing tumor tissue; SECONDARY OUTCOME 1: Phase 0: PD Analysis[/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 - C2N-8E12-WW-104 Ext.; BRIEF: The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP). ; DRUG USED: ABBV-8E12; DRUG CLASS: Biologic; INDICATION: Progressive Supranuclear Palsy; TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Subject completed Study C2N-8E12-WW-104 (NCT02494024) - Subject was not eligible to enroll in Study M15-562 (NCT02985879) Exclusion Criteria: - Subject weighs less than 35 kg at screening - Subject has any contraindication or inability to tolerate brain MRI - Subject has any significant change in his/her medical condition that could interfere with the subjects participation in the study, could place the subject at increased risk, or could confound interpretation of study results ; PRIMARY OUTCOME: Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DUAL (China, Republic of Korea, and Taiwan); BRIEF: Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen ; 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: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Males and females, ≥ 18 years of age - Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and either: 1. Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening or 2. Liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation) - Subjects who are intolerant to previous therapy with Interferon Alfa (IFNα) either with or without Ribavirin (RBV) (I±R)(independent of previous response to therapy) or ineligible for I±R and who meet one of the criteria below: 1. Anemia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in hemoglobin to < 8.5 g/dL during therapy (documented); the I±R ineligibles are subjects who have a screening hemoglobin < 10.0 g/dL and ≥ 8.5 g/dL OR 2. Neutropenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in absolute neutrophil count (ANC) to < 0.5 x 10(9) during therapy (documented); the I±R ineligibles are subjects who have a screening ANC < 1.5 x 10(9) cells/L and ≥ 0.5 x 10(9) cells/L OR 3. Thrombocytopenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in platelet counts < 25,000 cells/mm3 during therapy (documented); the I±R ineligibles are subjects who have a screening platelet count of < 90 x 10(9) cells/L and ≥ 50 x 10(9) cells/L - HCV RNA ≥ 10,000 IU/mL - Seronegative for Human Immunodeficiency Virus (HIV) and hepatitis B surface antigen (HBsAg) - Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI = weight (kg)/ [height(m)]2 at screening - Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 40%). If a subject does not have cirrhosis, a liver biopsy within three years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. For countries where liver biopsy is not required prior to treatment and where noninvasive imaging tests (Fibroscan® ultrasound) are approved for staging of liver disease, non-invasive imaging test results may be used to assess the extent of liver disease Exclusion Criteria: - Prior treatment with HCV direct acting antiviral (DAA) - Evidence of a medical condition contributing to chronic liver disease other than HCV - Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy - Diagnosed or suspected hepatocellular carcinoma or other malignancies - Uncontrolled diabetes or hypertension - History of moderate to severe depression. Well-controlled mild depression is allowed - Total bilirubin ≥ 34 µmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilberts disease - Confirmed alanine aminotransferase (ALT) ≥ 5 x upper limit of normal (ULN) - Confirmed albumin < 3.5 g/dL (35 g/L) - Alpha-fetoprotein (AFP) > 100 ng/mL OR ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of hepatocellular carcinoma (HCC) are excluded - Confirmed hemoglobin < 8.5 g/dL - Confirmed ANC < 0.5 x 10(9) cells/L - Confirmed platelet count < 50,000 cells/mm3 ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12)[/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 - MO25653; BRIEF: This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs. ; DRUG USED: Zelboraf; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Secondary; Metastases); TARGET: Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients, >/= 18 years of age - Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test) - Brain metastases for which surgical resection is not a treatment option - Patients must have failed at least one previous treatment for brain metastases - Requiring corticosteroids for symptom control - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: - Increasing corticosteroid dose during the 7 days prior to study entry - Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix - Concurrent administration of any anticancer therapies other than those administered in the study - Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug ; PRIMARY OUTCOME: Percentage of Participants With Adverse Events (AEs); SECONDARY OUTCOME 1: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site[/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 - Pediatric Extension Study (UC and Crohns); BRIEF: The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD. ; DRUG USED: Entyvio; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003. (Note: A participant remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.) 2. Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of >=2 points and >=25% from Baseline, or a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of >=20 points from baseline for participants with UC; or a reduction of the CDAI as defined by a >=70-point decrease from Baseline or a decrease of Pediatric Crohns Disease Activity Index (PCDAI) of >=15 points for participants with CD. 3. May be receiving a therapeutic dose of the following drugs: - Oral 5-aminosalicylic acid (5-ASA) compounds. - Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day]) provided the participant was receiving this medication during prior participation in MLN0002-2003. - Topical (rectal) treatment with 5-ASA or corticosteroids. - Probiotics (example, Saccharomyces boulardii). - Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea. - Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole). - Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003. 4. The participants vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003. Exclusion Criteria: 1. Is female and is lactating or pregnant. 2. Has hypersensitivity or allergies to vedolizumab or any of its excipients. 3. Has withdrawn from Study MLN0002-2003. 4. Has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety. 5. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug. 6. Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study. 7. Has other serious comorbidities that will limit his or her ability to complete the study. ; PRIMARY OUTCOME: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percentage of Participants With UC Meeting Clinical Response Based on Complete Mayo Score at Week 32[/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 - DR-ASC-201 (Duramed); BRIEF: This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary ; DRUG USED: Quartette; DRUG CLASS: Non-NME; INDICATION: Contraception; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta), Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Duramed Research; CRITERIA: Inclusion Criteria: - Premenopausal - Not pregnant or breastfeeding - Agree to use back-up non-hormonal contraception for study period Exclusion Criteria: - Any contraindication to the use of oral contraceptives - Pregnancy within the last 3 months - Smoking >10 cigarettes per day ; PRIMARY OUTCOME: Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84); SECONDARY OUTCOME 1: Days With Bleeding During Active Cycle 1 (Day 1-84)[/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 - MYTHIC (CCNE1/Other Alterations); BRIEF: The primary purpose of this study is to assess the safety and tolerability of RP-6306 alone and in combination with RP-3500 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity. ; DRUG USED: RP-6306; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Myt1 kinase (PKMYT1); THERAPY: Monotherapy; LEAD SPONSOR: Repare Therapeutics; CRITERIA: Inclusion Criteria: - Male or female and ≥12 years-of-age at the time of informed consent. - Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, or 2 for patients >16 years of age. - Locally advanced or metastatic resistant or refractory solid tumors. - Patients <18 years of age must weigh at least 40 kg. - Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible - Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker. - Measurable disease as per RECIST v1.1. - Ability to swallow and retain oral medications. - Acceptable hematologic and organ function at screening. - Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening. - Resolution of all toxicities of prior therapy or surgical procedures. - Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment. Exclusion Criteria: - Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, whichever is shorter, prior to first dose of study drug. - History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patients participation for the full duration of the study treatment. - Patients who are pregnant or breastfeeding. - Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigators opinion, could compromise the participating patients safety. - Major surgery within 4 weeks prior to first dose of RP-6306. - Uncontrolled, symptomatic brain metastases. - Uncontrolled hypertension. - Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol. ; PRIMARY OUTCOME: Safety and Tolerability of RP-6306 in patients with advanced solid tumors as assessed by NCI CTCAE v5.0; SECONDARY OUTCOME 1: To assess the plasma concentrations of RP-6306 monotherapy in the fasted and fed states.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - CONSONANCE; BRIEF: This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS). ; DRUG USED: Ocrevus; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS) - EDSS (Expanded Disability Status Scale) </ =6.5 at screening - Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physicians judgment - Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist - Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers - For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug Exclusion Criteria: - Relapsing-remitting multiple sclerosis (RRMS) at screening - Inability to complete an MRI - Gadolinium (Gd) intolerance - Known presence of other neurological disorders Exclusions Related to General Health: - Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening - Lactation - Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study - History or currently active primary or secondary immunodeficiency - Lack of peripheral venous access - Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study. - Active infections must be treated and resolved prior to the first infusion of ocrelizumab - Participants in a severely immunocompromised state until the condition resolves - Participants with known active malignancies or being actively monitored for recurrence of malignancy - Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML) Exclusions Related to Laboratory Findings: - Positive screening tests for hepatitis B - CD4 count <250/μL - ANC <1.0 × 103/μL - AST/SGOT or ALT/SGPT ≥3.0 × ULN in combination with either an elevated total bilirubin (>2 X ULN) or clinical jaundice Exclusions Related to Medications: - Hypersensitivity to ocrelizumab or to any of its excipients - Previous treatment with ocrelizumab - Previous treatment with B-cell targeted therapies (i.e., atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab). Note: previous treatment with rituximab is allowed as long as the last dose was administered more than 6 months before the ocrelizumab infusion AND if discontinuation was due to adverse events or immunogenicity AND if Bcell levels are above the lower limit of normal (LLN) prior to screening. - Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation - Previous treatment with natalizumab where PML has not been excluded according to specific algorithm - Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label - Systemic corticosteroid therapy within 4 weeks prior to screening - All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab, unless the local regulations allow for a shorter interval. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted - Previous treatment with daclizumab, ozanimod or figolimod in the last 8 weeks - Previous treatment with siponimod in the last 2 weeks - Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening - Previous treatment with natalizumab in the last 12 weeks. - Previous treatment with teriflunomide in the last 12 weeks. This washout period can be shortened if an accelerated elimination procedure is implemented before screening visit. One of the following elimination procedures can be used: - Cholestyramine 8 g administered 3 times daily for a period of at least 7 days (cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated) - Alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of at least 7 days. - Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks - Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS - Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks - Participants previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If above or not known, an accelerated elimination procedure should be implemented before screening visit ; PRIMARY OUTCOME: Proportion of Participants with No Evidence of Progression (NEP); SECONDARY OUTCOME 1: Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT)[/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 - ACT11705; BRIEF: The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS). Secondary Objectives are: - To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life; - To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain; - To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment; - To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain; - To assess endocannabinoid plasma concentrations. ; DRUG USED: SSR411298; DRUG CLASS: Vaccine; INDICATION: Cancer Pain; TARGET: Fatty Acid Amide Hydrolase (FAAH), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: Patient with moderate or severe, persistent cancer pain who is receiving the World Health Organization (WHO) Step 2 or 3 cancer pain treatment: - Pain generator (source of pain) must be primarily due to underlying cancer or cancer treatment; - Pain generator (source of pain) must be classified as either primarily nociceptive or primarily neuropathic; - Pain severity must be moderate or severe with an average NRS score ≥4 during the screening week. Exclusion criteria: - Instability of pain during the screening week; - Use of prohibited adjuvant pain treatment in the week prior to study entry or plan to use these medications during the study; - Current use of medication containing tetrahydrocannabinol (THC); - Chemotherapy within 4 weeks before study entry or chemotherapy planned during the study (a stable regiment of hormonal therapy is permitted); - Radiotherapy within 4 weeks before study entry or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted); - Cancer related surgery within 4 weeks before study entry or cancer-related surgery planned during the study. 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 average Numeric Rating Scale (NRS) pain intensity score; SECONDARY OUTCOME 1: Change from baseline in Brief Pain Inventory Short-Form (BPI-SF) scores[/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 - GLD-1875; BRIEF: The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (TG ≥250 mg/dL). The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461. ; DRUG USED: REGN4461; DRUG CLASS: Biologic; INDICATION: Lipodystrophy; TARGET: Leptin Receptor (LepR); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol - Presence of one or both of the following metabolic abnormalities at screening: 1. HbA1c ≥ 7% OR 2. Fasting TG ≥250 mg/dL - Generally stable diet (based on patients recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit Key Exclusion Criteria: - Treatment with metreleptin within 1 month of the screening visit - Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit - Treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day during the study period - History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit - Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening - Participation in any clinical research study evaluating an Investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit. - Pregnant or breast-feeding women NOTE: Other protocol defined inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Absolute change from baseline hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: Absolute change in composite endpoint comprising absolute change in either HbA1c or percent change in fasting TG[/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 - FLU-101; BRIEF: This is a Phase I, parallel design open label study to evaluate safety, tolerability and immunogenicity of nine different formulation of two individual H1 and one H5 HA plasmid administered intradermally followed by electroporation in healthy adults ; DRUG USED: INO-3510; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pandemic Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Inovio Pharmaceuticals; CRITERIA: Inclusion Criteria: - Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI); - Adults of either gender 18-55 years of age at entry; - Healthy subjects as judged by the Investigator based on medical history, physical examination, and normal results for an ECG, CBC, serum chemistries, and urinalysis done up to 4 weeks prior to enrollment and administration of vaccination ± EP; - Current nonsmoker; - Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) until 12 weeks after last vaccination; - Able and willing to comply with all study procedures. Exclusion Criteria: - Positive serological test for Human Immunodeficiency Virus, hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or Grade 3 or greater CPK at screening; - Pregnant or breastfeeding subjects; - Any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site (excluding inhaled and eye drop-containing corticosteroids) or the use of other immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 0 of study vaccine administration; - Administration of any blood product within 3 months of enrollment; - Prior receipt of any investigational or licensed H5N1 influenza vaccine at any time; - Subjects with contraindications to influenza vaccination other than egg allergy (such as a history of Guillain-Barre Syndrome after receiving influenza vaccine); - Administration of any vaccine within 6 weeks of enrollment; - Participation in a study with an investigational compound or device within 4 weeks of signing informed consent; - Subjects with cardiac pre-excitation syndromes (such as Wolff-Parkinson-White); - Subjects with a history of seizures (unless seizure free for 5 years); - Subjects with tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination ± EP; - Subjects with any implantable leads; - Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements; - Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study; - Any other conditions judged by the investigator that would limit the evaluation of a subject. ; PRIMARY OUTCOME: Safety and tolerability of nine different formulation of multiple combination of H1 and H5 HA plasmid administered ID followed by electroporation in healthy adult subjects; SECONDARY OUTCOME 1: Humoral and cellular immune responses[/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 - SAV005-02 (CF/MRSA); BRIEF: The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients. ; DRUG USED: AeroVanc; DRUG CLASS: Non-NME; INDICATION: Staphylococcal Vaccines and Other Staphylococcus-Specific Agents (Antibacterial); TARGET: Cell wall synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Savara Inc.; CRITERIA: Inclusion Criteria: 1. Adults ≥18 years old (and the legally authorized representatives of children ≥12 but <18 years old): Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form (ICF). Children ≥12 but <18 years old: Able to communicate with site personnel and to understand and voluntarily sign the Assent Form. 2. Able and willing to comply with the protocol, including availability for all scheduled study visits. 3. Have a confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following: a) Positive sweat chloride test (value ≥60 mEq/L), or b) Genotype with two mutations consistent with CF (ie, a mutation in each of the cystic fibrosis transmembrane conductance regulator [CFTR] genes). 4. Be ≥12 years old at time of ICF/Assent Form signing. 5. Have sputum culture positive for MRSA at Screening, with at least 10,000 CFUs/mL of MRSA. 6. In addition to the screening sample, have at least two historical respiratory tract cultures (i.e., sputum and/or throat swab) positive for MRSA prior to Screening and evidence that the MRSA lung infection has persisted for at least 6 months prior to Screening. 7. Have forced expiratory volume in 1 second (FEV1) ≥30% and ≤100% of predicted that is normalized for age, gender, and height at Screening. 8. Evidence, defined as one or both of the following, that the persistent MRSA lung infection is suspected to be causing health consequences. - Have had at least one episode of acute pulmonary infection treated with non-maintenance antibiotics within 12 months from Screening. Initiation of treatment with intermittent inhaled anti-Pseudomonas therapy will not qualify as treatment with non-maintenance antibiotics. - Requires anti-MRSA treatment as part of a maintenance regimen to prevent pulmonary exacerbations or other respiratory symptoms. 9. Be able to perform all the techniques necessary to use the AeroVanc inhaler and measure lung function. 10. Be able to produce expectorated sputum samples or be able and willing to undergo standardized sputum induction. 11. Agree not to smoke from Screening through the end of the study. 12. Female patients of child-bearing potential are eligible to participate in this study only if they are NOT pregnant or lactating, and if the patient is using a highly effective method of birth control. 13. Patients with P. aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the investigator, stable despite the lack of such treatment. Patients on a Cayston based therapy must have received at least 2 cycles of Cayston prior to Baseline (can be 2 consecutive months or 2 cycles over 4 months). Exclusion Criteria: 1. Administration of any investigational drug or device within 28 days prior to ICF/Assent Form signing. 2. Use of iv or inhaled anti-MRSA drugs within 28 days or oral anti-MRSA drugs within 14 days prior to Visit 2 (ie, randomization, Baseline and AeroVanc/placebo treatment initiation). 3. A history of previous allergies or sensitivity to vancomycin, or other component(s) of the study drug or placebo except for a history of red-man syndrome. 4. History of severe cough/bronchospasm upon inhalation of dry powder inhalation product, or nebulized vancomycin. 5. Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus [VRSA], or vancomycin intermediate resistant Staphylococcus aureus [VISA], with minimum inhibitory concentration [MIC] ≥4 mcg/mL). 6. Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone every other day, or equipotent doses of another corticosteroid. 7. History of sputum culture or throat swab culture yielding B. cepacia or gladioli in the previous two years, or nontuberculosis mycobacteria in the previous six months. 8. An acute upper or lower respiratory infection, or pulmonary exacerbation within 7 days prior to Randomization. 9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 7 days prior to ICF/Assent Form signing. 10. Current daily continuous oxygen supplementation or requirement for more than 2 L/min at night. 11. Changes in physiotherapy technique or schedule within 7 days prior to ICF/Assent Form signing. 12. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation. 13. A chest X-Ray at Screening with abnormalities indicating a significant acute finding (eg, pneumothorax, or pleural effusion). 14. Lactating female or female with a positive pregnancy test result. All women of childbearing potential will be tested. 15. Renal insufficiency, defined as creatinine clearance <50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation in children, at Screening. 16. Diagnosed with clinically significant hearing loss. 17. Abnormal liver function, defined as ≥4x upper limit of normal (ULN), of serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT), or known cirrhosis at the time of Screening. 18. Serum hematology or chemistry screening results which in the judgment of the Investigator would interfere with completion of the study. 19. Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). 20. Other findings or medical history at screening that, in the Investigators opinion, would compromise the safety of the patient or the quality of the study data. ; PRIMARY OUTCOME: Change From Baseline in MRSA Sputum Density.; SECONDARY OUTCOME 1: Change From Baseline in MRSA Sputum Density.[/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 - 001 (CIN/HPV); BRIEF: Phase I, open-label, sequential-cohort, ascending multiple-dose study to evaluate the safety and tolerability of escalating doses of PDS0101 in female subjects with high-risk HPV infection and biopsy-proven CIN1. The study will include 3 cohorts of 3 to 6 subjects each based on a modified 3 + 3 dose-escalation study design. The study will be initiated with Cohort 1 and progress through Cohort 3, with each subsequent cohort receiving a higher dose of PDS0101. Successive cohorts will receive a constant dose of HPV-16 E6 and E7 peptides. All subjects will receive 3 vaccinations SC given approximately 21 days apart. Dosing and dose escalation will be based on safety evaluation for determination of potential dose-limiting toxicity (DLT). ; DRUG USED: PDS0101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cervical Cancer; TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: PDS Biotechnology Corp.; CRITERIA: Inclusion Criteria: 1. Written informed consent prior to initiation of any study-related procedures; 2. Nonlactating female between the ages of 21 to 65 years, inclusive; 3. Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contraception (defined as 2 concurrent methods of contraception, 1 of which is a barrier method) and agrees to continue using effective contraception throughout the duration of the study; 4. Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits); 5. Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL) within 4 months prior to screening Visit 1; 6. History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy, within 12 weeks prior to administration of first study vaccination (CIN 2/3 subjects will not be eligible); 7. For the diagnosis of CIN1, has a documented satisfactory colposcopy, ie, the entire lesion as well as the entire squamocolumnar junction is visualizible by colposcopy; 8. Confirmed high-risk HPV infection by a commercially available high-risk DNA assay (eg, Hybrid Capture II [Qiagen]); 9. Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1): - Bone marrow function: absolute neutrophil count ≥1,500/µL, and platelets ≥ 100,000/ µL; - Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN); - Hepatic function: total bilirubin ≤ 1.5 x ULN (Common Terminology Criteria for AEs [CTCAE] v4.0 grade 1) except patients with Gilberts disease (up to 5.0 mg/dL). Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN. - Normal Cardiac function: as assessed by history and physical exam. Exclusion Criteria: 1. Atypical endometrial or glandular cells or evidence of invasive cervical carcinoma on cervical biopsy; 2. Previous history of cancer, other than adequately treated basal cell or Stage 1 squamous cell carcinoma of the skin; 3. Current recognized immunodeficiency disease, including infection with HIV, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies. 4. Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor]) within 30 days prior to administration of the first study vaccination; 5. Serious, concomitant disorder, including active systemic infection requiring treatment, in the opinion of the investigator; 6. Currently receiving or has received treatment with systemic steroids in the following dosages within 30 days prior to administration of the first study vaccination. - Chronic or long-term corticosteroids: ≥0.5 mg/kg/day of oral prednisolone or equivalent - Sporadic corticosteroids: ≥1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days - Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable; 7. Other condition or prior therapy that, in the opinion of the Investigator, compromises the subjects welfare or may confound study results; 8. Participation in another investigational study concurrently or use of another investigational drug within 6 months prior to administration of the first study vaccination; 9. Previously enrolled in this study. ; PRIMARY OUTCOME: Evaluation or determination of adverse events following vaccination; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 406 - w/Doxorubicin; BRIEF: The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma. ; DRUG USED: Evofosfamide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sarcoma; TARGET: DNA; THERAPY: Combination; LEAD SPONSOR: Threshold Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female ≥ 15 years of age - Ability to understand the purposes and risks of the study and has signed or, if appropriate, the subjects parent or legal guardian has signed a written informed consent form approved by the investigators IRB/Ethics Committee - Pathologically confirmed diagnosis of soft tissue sarcoma of the following histopathologic types: - Synovial sarcoma - High grade fibrosarcoma - Undifferentiated sarcoma; sarcoma not otherwise specified (NOS) - Liposarcoma - Leiomyosarcoma (excluding GIST) - Angiosarcoma (excluding Kaposis sarcoma) - Malignant peripheral nerve sheath tumor - Pleomorphic Rhabdomyosarcoma - Myxofibrosarcoma - Epithelioid sarcoma - Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (MFH) (including pleomorphic, giant cell, myxoid and inflammatory forms) - Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate. - Recovered from reversible toxicities of prior therapy - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy of at least 3 months - Acceptable liver, renal, hematological and cardiac function - All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception Exclusion Criteria: - Prior systemic therapy for advanced or metastatic disease (neoadjuvant therapy followed by surgical resection and adjuvant therapy permitted). Palliative radiotherapy to non-target lesions is allowed if completed at least two weeks prior to study entry - Low grade tumors according to standard grading systems - Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards - Prior therapy with an anthracycline or anthracenedione - Prior mediastinal/cardiac radiotherapy - Current use of drugs with known cardiotoxicity or known interactions with doxorubicin - Anti-cancer treatment with radiation therapy, neoadjuvant or adjuvant chemotherapy, targeted therapies, immunotherapy, hormones or other antitumor therapies within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Palliative radiotherapy to non-target lesions is allowed, is completed at least two weeks prior to study entry. - Significant cardiac dysfunction precluding treatment with doxorubicin - Seizure disorders requiring anticonvulsant therapy unless seizure-free for the last year - Known brain metastases (unless previously treated and well controlled for a period of ≥ 3 months) - Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years - Severe chronic obstructive or other pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia - Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery - Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy - Prior therapy with a hypoxic cytotoxin - Subjects who participated in an investigational drug or device study within 28 days prior to study entry - Known infection with HIV, hepatitis B, or hepatitis C - Subjects who have exhibited allergic reactions to a structural compound similar to TH-302,doxorubicin or their excipients - Females who are pregnant or breast-feeding - Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study - Unwillingness or inability to comply with the study protocol for any reason ; PRIMARY OUTCOME: Efficacy of TH-302 in combination with doxorubicin; SECONDARY OUTCOME 1: Safety of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma compared with doxorubicin alone[/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 - w/Pemetrexed; BRIEF: To determine the efficacy of ABT-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2. ; DRUG USED: ABT-751; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Pathologically documented NSCLC - Locally advanced (Stage III) or metastatic (Stage IV) NSCLC - Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy) - Only one prior anti-tumor treatment regimen in the curative setting - Progressive disease following the previous anti-tumor treatment regimen - Measurable disease by RECIST criteria - Brain metastasis must be stable and well-controlled - ECOG performance score 0-2 - All anti-tumor therapy discontinued at least 3 weeks prior to study entry - All adverse events from prior treatment are resolved or stable - Adequate hematologic, renal, and hepatic function - Females must not be pregnant - Willing to take adequate measures to prevent pregnancy - Life expectancy of at least 3 months - Able to complete the Quality of Life questionnaire - Voluntarily signed informed consent Exclusion Criteria: - Greater than Grade 1 neurological findings - Allergy to sulfa medications - Previous treatment with ABT-751 or pemetrexed - Receipt of more than one investigational agent for NSCLC - Significant weight loss (>10%) within 6 weeks of study entry - Glucose-6-phosphate dehydrogenase deficiency or porphyria - Significant systemic disease that would adversely affect participation - Class 3-4 New York Heart Association classification status - Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator ; PRIMARY OUTCOME: Progression-free Survival; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase 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 I - INCB 106385-102; BRIEF: This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) ; DRUG USED: INCB106385; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Adenosine A2a Receptor, Adenosine A2b Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Ability to comprehend and willingness to sign an ICF. - Willing and able to conform to and comply with all Protocol requirements. - Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable). - Willingness to undergo pre- and on-treatment tumor biopsy. - Have CD8 T-cell-positive tumors. - Presence of measurable disease according to RECIST v1.1. - ECOG performance status 0 to 1. - Life expectancy > 12 weeks. - Willingness to avoid pregnancy or fathering children based. - Acceptable laboratory parameters Exclusion Criteria: - Clinically significant cardiac disease. - Known or active CNS metastases and/or carcinomatous meningitis. - Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease.. - Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment. - Known additional malignancy that is progressing or requires active treatment,or history of other malignancy within 2 years of the first dose of study treatment. - Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment. - Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. - Immune-related toxicity during prior immune therapy for which permanent discontinuation of therapy is recommended, or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage. - Any prior chemotherapy, biological therapy, or targeted therapy to treat the participants disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. - Any prior radiation therapy within 28 days before the first dose of study treatment. - Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. - Concomitant treatment with strong CYP3A4 inhibitors or inducers. - Receipt of a live vaccine within 30 days of the first dose of study treatment. - Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of the first dose of study treatment. - Evidence of HBV or HCV infection or risk of reactivation. - Known history of HIV (HIV 1/2 antibodies). - History of organ transplant, including allogeneic stem-cell transplantation. - Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components. - Presence of a gastrointestinal condition that may affect drug absorption. - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study. - Any condition that would, in the investigators judgment, interfere with full participation in the study,pose a significant risk to the participant; or interfere with interpretation of study data ; PRIMARY OUTCOME: Number of treatment-emergent adverse events (TEAE); SECONDARY OUTCOME 1: Cmax of INCB106385 as a single agent or in combination with INCMGA00012[/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 - Post High Tibial Osteotomy (Korea); BRIEF: The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients ; DRUG USED: JointStem; DRUG CLASS: Biologic; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: R-Bio; CRITERIA: Inclusion Criteria: 1. Patients must consent in writing to participate in the study by signing and dating an informed consent document 2. Patients who can communicate (exclusion of anyone who cannot understand the questionnaire) 3. between 20 years and 80 years of age 4. BMI≤30 5. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4 6. Diagnosis of osteoarthritis by ACR(American College of Rheumatology Criteria) Global functional criteria : There is the pain of the knee and radiographic osteophyte and at least one of the following (1) age >50 years (2) Less than 30 minutes of morning stiffness (3) The friction When moving weighted the knee 7. Patients who agree with contraception 8. Patients who agree to stop the existing osteoarthritis treatment and to get enough washout periods until medication time 9. Patients scheduled for High tibial osteotomy due to medial gonarthrosis Exclusion Criteria: 1. patients with osteoporosis 2. Preparing for Pregnancy or Pregnant women or lactating mothers. 3. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), venereal disease research laboratory(VDRL) 4. Patients with hypersensitivity to investigator product or investigational product component or those with a history 5. Patients who had participated in other clinical trials within 12 weeks prior to this study 6. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment. 7. Patients who experienced as the knee joint cartilage and stem cell therapy or failure to treat 8. Patents who started or changed the physical therapy program established within 2 weeks before the start of the study or during the study(An established physical therapy program may continue for the duration of the trial, provided that it does not change in frequency and intensity) 9. Patents included in the following specific risk groups that may influence safety and efficacy assessments at the discretion of the investigator:: septic arthtritis, rheumatic disease, gout, recurrent pseudogout, paget disease, joint fracture, alcaptonuria, acromegaly, hemochromatosis, wilsons disease, primary osteochondrosis, hereditary disorder(ex: hyperkinesia), collagen gene abnormality ,etc 10. Patients who have clinically significant severe medical illnesses judged the principal investigator 11. Patients who have been diagnosed with malignancy within 5 years before screening (except for patients who were completely remissioned three years before screening criteria) 12. Patients who the principal investigator consider inappropriate for the clinical trial due to any other reasons 13. Patients who received concomitant contraindications and who have not passed the prescribed wash-out period before participating in the clinical trial ; PRIMARY OUTCOME: MRI scan; SECONDARY OUTCOME 1: MRI scan[/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 - Monotherapy (Cocaine Dependent Subjects); BRIEF: This study assessed whether AFQ056 had a beneficial effect by reducing cocaine use in Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report. ; DRUG USED: AFQ056; DRUG CLASS: New Molecular Entity (NME); INDICATION: Substance Use Disorder; TARGET: Metabotropic Glutamate Receptor subtype 5 (mGluR5); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Understand the study procedures and provide written informed consent before any assessment is performed. - Subjects diagnosed with Cocaine Use Disorder according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Ed.). - Must use cocaine through snorting (intranasally) as primary route of administration. - Recent cocaine use confirmed by positive urine screen for 1 or more benzoylecgonine (BE). - Must be seeking treatment for cocaine dependence and have a desire to reduce or cease cocaine use. Exclusion Criteria: - Has current diagnosis of Substance Use Disorder (according to the DSM 5) on alcohol, cannabis or other stimulants, except cocaine. - Meets current or lifetime DSM 5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder. - Have current treatment for Substance Use Disorder (e.g.: disulfiram, acamprosate, methyl phenidate, modafinil, topiramate, immediate release dexamfetamine,or baclofen). - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test - Have a history of any illness, condition, and use of medications that in the opinion of the investigator or designee might confound the results of the study or pose additional risk in administering the investigational agents to the subject or preclude successful completion of the study - Current or/and previous treatment with concomitant medications that are strong or moderate inducers/inhibitors of CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, etc.) - History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result. - Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). - Score yes on item 4 or item 5 of the Suicidal Ideation section of the CSSRS, if this ideation occurred in the past 6 months, or yes on any item of the Suicidal Behavior section, except for the Non-Suicidal Self-Injurious Behavior (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years. - Controlled hypertension ; PRIMARY OUTCOME: Proportion of Cocaine Use Days; SECONDARY OUTCOME 1: Proportion of Positive Urine Measurements of Benzoylecgonine (BE)[/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 - NP101-009; BRIEF: This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period. ; DRUG USED: Zecuity; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: NuPathe Inc.; CRITERIA: Inclusion Criteria: - Subject is an adult male or female, age range 18 years to 65 years. - Subject has a diagnosis of migraine headache, with or without aura, as defined in the ICHD-II and the diagnosis was made before the age of 50. - Subject experiences mild to severe headaches during a migraine attack based on subject testimony. - Subject has at least a one year history of migraine based upon subject testimony. - Subject typically experiences at least two migraine headaches per month based on subject testimony. - Subject will be judged to be in good health, based upon the results of a medical history, physical examination, vital signs, ECG and laboratory profile. Subjects will not have any clinically significant abnormal laboratory parameters, vital signs or ECG parameters in order to qualify for enrollment. - Female subject of childbearing potential (not surgically sterile or 2 years postmenopausal) must have a negative pregnancy test at screening and prior to enrollment. - Subject must have a negative drug screen. - Subject must be capable of reading and understanding either English or Spanish subject information materials. Be able to successfully apply a practice patch, carry-out all subject procedures, and be able to voluntarily sign and date an IC agreement approved by an IRB. - Subject has at least two acceptable patch application sites (upper arms or upper thighs) that are relatively hair free and has no scars, tattoos, scratches or bruises. - In the investigators opinion the subject is on a stable medication regimen. Exclusion Criteria: - Subject has more than 15 headache days per month for any of the three months prior to screening. - Subject has suspected or confirmed cardiovascular disease that contraindicates study participation. - Subject has a history of epilepsy or condition associated with a lowered seizure threshold. - Subject has Raynauds disease. - Subject has a history of basilar or hemiplegic migraines. - Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence. - Subject has taken non-triptan serotonergic drugs including SSRIs (including Wellbutrin), SNRIs, TCAs, MAOIs or preparations containing St. Johns Wort within 1 month prior to screening and/or is planning to start any of these medications during the study. - Subject is unwilling to discontinue use of a PD5 inhibitor (e.g. Viagra®, Levitra®, or Cialis®) through the Final Visit. - Subject has a history of a significant allergy or hypersensitivity to any component of the study patch used in this study. - Subject has any generalized skin irritation or disease including eczema, psoriasis, melanoma, or contact dermatitis that would affect transdermal absorption of sumatriptan and / or affect the subjects ability to assess skin irritation. - Subject has clinically significant abnormal laboratory parameters, vital signs or ECG parameters. - Subject is known to be hepatitis B, hepatitis C or HIV positive. - Subject has a diagnosis of bipolar disorder or current major depressive disorder, or has any other medical or psychiatric condition, that in the investigators opinion would make the subject unsuitable for enrollment / participation in the study. - Subject has hepatic dysfunction defined as SGOT/AST or SGPT/ALT ≥ 2 times the upper limit of normal (ULN) range, or alkaline phosphatase or total bilirubin ≥ 1.5 times the ULN range or if in the opinion of the Investigator the subjects history, physical examination or other laboratory tests suggest hepatic dysfunction. - Female subject who is pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception during the study and for a period of 30 days following dosing. - Subject has known history of failure to respond to sumatriptan (ineffective or poorly tolerated). - Subject has participated in a clinical study within 30 days of screening or is planning to participate in another clinical study. - Subject has been previously enrolled in NP101-008. - Subject is electrically sensitive (e.g., prior iontophoresis with adverse outcome related to the current delivered by the device) or who have electrically sensitive support systems (e.g., pacemaker) or other medical condition that in the investigators opinion would make the subject unsuitable for enrollment in the study. - Subject who is considered by investigator or NuPathe, for any reason, to be an unsuitable candidate for this study. ; PRIMARY OUTCOME: Subject Self-examination of Skin Irritation; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Crimson-1; BRIEF: The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC). ; DRUG USED: Marzeptacog alfa; DRUG CLASS: Biologic; INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Coagulation Factor IX, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Catalyst Biosciences; CRITERIA: Inclusion Criteria: - Diagnosis of congenital hemophilia A or B with inhibitors - Male or Female, age 12 or older - History of frequent bleeding episodes - Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities Exclusion Criteria: - Previous participation in a clinical trial evaluating a modified rFVIIa agent - Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect - Known hypersensitivity to trial or related product - Known positive antibody to FVII or FVIIa detected by central lab at screening - Have a coagulation disorder other than hemophilia A or B - Be immunosuppressed - Significant contraindication to participate ; PRIMARY OUTCOME: Bleeding episode treatment success; 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 - NEFERTT (HER2+); BRIEF: This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen. ; DRUG USED: Nerlynx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: Puma Biotechnology, Inc.; CRITERIA: Inclusion Criteria: - ErbB-2 positive locally recurrent or metastatic breast cancer - Eastern Cooperative Oncology Group (ECOG) 0-2 - Measurable disease - Availability of tumor tissue for HER2 status confirmation Exclusion Criteria: - Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease - Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting - Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy - History of heart disease - History of gastrointestinal disease ; PRIMARY OUTCOME: Progression-Free Survival; SECONDARY OUTCOME 1: Objective Response 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 II - Antidepressant Effects; BRIEF: The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo. ; DRUG USED: AZD6765; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features - Females must be of non-childbearing potential. Exclusion Criteria: - Treatment with Clozapine or ECT within 3 months prior to study - Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV ; PRIMARY OUTCOME: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.; SECONDARY OUTCOME 1: The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).[/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 - w/Ixazomib + Dexamethasone; BRIEF: ONC201 is a novel dopamine receptor D2 antagonist that is able to activate the integrated stress response pathway. It is active against multiple myeloma cells in vitro, both as a single agent and in combination with corticosteroids and proteasome inhibitors. In order to document superiority over the combination compared to the individual agents of ixazomib and ONC201 in a single arm study, there will initially be a run-in period of weekly ONC201 625 mg with dexamethasone 40 mg such that if there is progression of disease (25% increase) after 4 weeks or less than a minimal response (25% reduction) after 8 weeks then ixazomib will be added. Dexamethasone is dose-reduced to 20 mg at the same schedule for subjects ≥ 75 years old. If patients do achieve single-agent responses with ONC201 (minimal response or better), they will continue with weekly ONC201 and dexamethasone until progression, with response assessments after each 28-day cycle. Patients who have previously been treated on another clinical trial with weekly ONC201 625mg with dexamethasone with progression while receiving treatment do not need to complete the run-in phase of the study. At the time of progression, they will proceed to the 3 drug combination phase of the study. It is at the point of 3 drug initiation, that below phase I DLT principles or phase II disease control rate considerations apply. ; DRUG USED: ONC201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Dopamine 2 (D2) Receptor; THERAPY: Combination; LEAD SPONSOR: Ajai Chari; CRITERIA: Inclusion Criteria: - Signed Written Informed Consent: Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care - Target Population 1. Symptomatic MM having progressed on 2 prior therapies including proteasome inhibitor (i.e. bortezomib, carfilzomib ixazomib), immunomodulatory drug (i.e., thalidomide, lenalidomide, pomalidomide), and daratumumab or other CD38 targeting monoclonal antibody. Proteasome inhibitor refractory patients are eligible. Subjects must not be candidates for treatment regimens known to provide clinical benefit to be eligible for this study. 2. Male or female patients 18 years or older 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 4. Patients must have measurable disease defined by at least 1 of the following 3 measurements: i. Serum M-protein > 0.5 g/dL ii. Urine M-protein > 200 mg/24 hours iii. Serum free light chain assay: involved free light chain level >10 mg/dL (> 100 mg/L) provided the serum free light chain ratio is abnormal Exclusion Criteria: - Medical History and Concurrent Diseases 1. Peripheral neuropathy > Grade 2 or >Grade 1 with pain on clinical examination during the Screening period. 2. Significant cardiac disease as determined by the investigator including: i. Known or suspected cardiac amyloidosis ii. Congestive heart failure of Class III or IV of the NYHA classification iii. Uncontrolled angina, hypertension or arrhythmia iv. Myocardial infarction in the past 6 months v. Any uncontrolled or severe cardiovascular disease vi. QTc > 470 milliseconds (msec) on a 12-lead ECG obtained during the Screening period. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG. c. Known active hepatitis B (defined as most recent serum PCR or hepatitis B surface antigen positive) or active hepatitis C (note, hepatitis C in sustained virologic response defined as negative RNA PCR at least 12 weeks after any therapy is permitted). d. Any medical conditions that, in the investigators opinion, would impose excessive risk to the subject, e.g., any uncontrolled disease, such as pulmonary disease, infection, seizure disorder, uncontrolled hyperglycemia. e. Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent or limit compliance with study requirements. f. Prior or concurrent malignancy, except for the following: i. Adequately treated basal cell or squamous cell skin cancer ii. Cervical carcinoma in situ iii. Adequately treated Stage I or II cancer from which the subject is currently in complete remission. iv. Or any other cancer from which the subject has been disease-free for ≥ 3 years g. Diarrhea > Grade 1, based on the NCI CTCAE grading, in the absence of antidiarrheals. h. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of study drug, including difficulty swallowing. i. Males or females of childbearing potential who do not agree to practice 2 effective methods of contraception, at the same time through 90 days after the last dose of study drug j. Females who are pregnant or breastfeeding. k. Diagnosis of Waldenstroms macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, myeloproliferative syndrome, or primary amyloidosis (with the exception of patients whose amyloidosis has been documented as a complication of MM, who will be evaluated on a case-by-case basis for trial participation). l. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study drug administration. m. Parkinsons disease 4) Physical and Laboratory Test Findings a. Corrected serum calcium ≥ 14 mg/dl within 2 weeks of enrollment (despite appropriate measure such a short course of steroids, bisphosphonates, hydration, and calcitonin). b. Absolute neutrophil count < 1000 cells/mm3. No growth factors allowed within 1 week of enrollment. c. Platelets < 75,000 cell/mm3 (75 x 109/L). Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours prior to study drug administration. d. Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value e. Serum bilirubin ≥ 1.5 x ULN, patients with Gilberts syndrome and a total bilirubin of < 3 times ULN are permitted) f. AST or ALT ≥ 3 x ULN. g. CrCl < 30 ml/min/1.73m2. Creatinine clearance is estimated by the CKD-EPI formula. (Calculator available at https://www.kidney.org/professionals/kdoqi/gfr_calculator.) - Prior Therapy or Surgery 1. Major surgery or radiation therapy within 14 days before study drug administration. 2. Kyphoplasty or vertebroplasty within 1 week of enrollment. 3. Administration of chemotherapy, biological, immunotherapy, or investigational agent (therapeutic or diagnostic) within 3 weeks before enrollment (14 days for non-myelosuppressive therapy). Subjects should be 6 weeks from last dose of nitrosourea, nitrogen mustards or monoclonal antibody, 12 weeks from autologous SCT, and 16 weeks from allogeneic SCT. 4. Corticosteroids use exceeding a cumulative dose of 160 mg of dexamethasone during screening. 5. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GVHD). 6. Treatment with plasmapheresis within 4 weeks before enrollment. 7. NSAIDs, IV contrast, aminoglycosides, or other potentially nephrotoxic drugs within 2 weeks of enrollment. 8. Current use of a non-standard dialysis membrane. 9. Systemic treatment with strong inhibitors or inducers of CYP450 system should not be used on study including but not limited to fluvoxamine, enoxacin, ciprofloxacin, clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole, rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, buproprion, fluoxetine, paroxetine, ticlopidine, or St. Johns wort within 14 days before the first dose of study treatment. Ixazomib has significant drug-drug interactions with strong CYP3A inducers. No drug-drug interactions with the CYP450 screen have been found with ONC201, but the analysis of these studies is not complete, so during the study use of inhibitors or inducers of CYP450 system is excluded. 10. Failure to have fully recovered (i.e., Grade 1 toxicity or less, with the exception of alopecia) from clinically significant effects of prior chemotherapy regardless of interval since last treatment. - Allergies and Adverse Drug Reaction Known hypersensitivity to bortezomib, ixazomib, dexamethasone, ONC201 ; PRIMARY OUTCOME: Recommended phase II dose (RPTD); SECONDARY OUTCOME 1: Disease control 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 Ib - w/SAR245409; BRIEF: This research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR) inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary purpose of the study is to determine the maximum tolerated dose of the drug combination. ; DRUG USED: Pimasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: EMD Serono; CRITERIA: Inclusion Criteria: - Subject with advanced solid tumors for which there is no approved therapy: - Advanced solid tumor with diagnosed alteration in one or more of the following genes (PTEN, BRAF, KRAS, NRAS, PI3KCA, ErbB1, ErbB2, MET, RET, c-KIT, GNAQ, GNA11 and/or - A histologically or cytologically confirmed diagnosis of one of the following solid tumors: pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma and melanoma - Subject with archived tumor tissue available for transfer to the Sponsor - Subject enrolled at lower dose level cohorts and MTD expansion cohorts must have tumor available for biopsy and agree to pre-treatment and on-treatment tumor biopsies - Subject has measurable or evaluable disease by response evaluation criteria in solid tumors (RECIST) v1.1 - Subject is aged greater than or equal to (>=) 18 years - Subjects enrolled in disease specific expansion cohorts must fulfill all the inclusion/exclusion criteria listed above with the following restriction to the Inclusion Criterion number 1: - Relapsed or refractory Kirsten rat sarcoma viral oncogene homolog (KRAS) or neuroblastoma RAS viral oncogene homolog (NRAS) mutated metastatic non-small cell lung cancer (NSCLC) with no approved therapies, or - Relapsed or refractory metastatic triple negative breast cancer defined as estrogen, progesterone and HER2 negative carcinoma of the breast with no approved therapies, or - Relapsed or refractory metastatic colorectal cancer (CRC) with dual KRAS and PIK3CA mutation with no approved therapies, or - BRAF V600E/K mutated unresectable or metastatic melanoma after progression on B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitors - Other protocol-defined inclusion criteria could apply Exclusion Criteria: - Subject has been previously treated with a PI3K inhibitor or a MEK inhibitor and taken off treatment due to treatment related adverse events - Subject has received: - Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anti-cancer therapy within 28 days of trial drug treatment - Any investigational agent within 28 days of trial drug treatment - Extensive prior radiotherapy on more than 30% bone marrow reserves, or prior bone marrow/stem cell transplantation - Subject has not recovered from toxicity due to prior therapy - Subject has poor organ and marrow function as defined in the protocol - Subject has a history of central nervous system metastases, unless subject has been previously treated for CNS metastases - Subject has a history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease - Subject has a history of recent major surgery or trauma within the last 28 days. - Subject has participated in another clinical trial within the past 30 days - Other protocol-defined exclusion criteria could apply ; PRIMARY OUTCOME: Number of Subjects With Dose Limiting Toxicities (DLT); SECONDARY OUTCOME 1: Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)[/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 - LP0058-1442; BRIEF: This is a phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of 4 different oral formulations of LEO 32731 in healthy subjects. The trial will be conducted in 3 parts at a single site. Each eligible subject will be enrolled into 1 group only and will participate in 3 treatment periods. ; DRUG USED: Orismilast; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Key inclusion criteria: - Age 18 to 65 years, inclusive. - Body mass index of 18.5 to 29.9 kg/m2, inclusive. - In good health, at the discretion of the investigator, as determined by: medical history, physical examination, vital sign assessment (specifically, blood pressure must be within normal reference range), 12-lead ECG, clinical laboratory evaluations, aspartate aminotransferase and alanine aminotransferase not above the upper limit of normal (Gilberts syndrome is not acceptable). - Female subjects of childbearing potential must be willing to use a highly effective form of birth control in conjunction with a barrier method of contraception throughout the trial and for at least 90 days after final follow-up. - Male subjects with a female partner of childbearing potential must be willing to use a highly effective form of birth control in conjunction with male barrier method of contraception (i.e. male condom with spermicide) throughout the trial and for at least 90 days after final follow-up. Key exclusion criteria: - Systemic or topical treatment within 14 days prior to first dose administration unless in the opinion of the investigator the medication will not interfere with the trial procedures or compromise safety. - Any medications, including St. Johns wort, known to chronically alter drug absorption or elimination processes within 30 days prior to first dose administration. - Subjects who smoke more than an average of 10 cigarettes per day. - History of chronic alcohol or drug abuse within 12 months prior to screening. - Subjects with ≥3 bowel movements per day. - Any disorder which is not stable and could: Affect the safety of the subject throughout the trial; Influence the findings of the trial; Impede the subjects ability to complete the trial. Examples include but are not limited to cardiovascular, GI, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders and major physical impairment. ; PRIMARY OUTCOME: Part 1. AUC0-∞; SECONDARY OUTCOME 1: Part 1. Number of GI-related AEs and number of subjects with GI-related AEs during each combination of treatment and 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 I - Moderate to Severe (Japan); BRIEF: The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a single subcutaneous (SC, under the skin) dose administered to Japanese participants with moderate to severe plaque psoriasis. ; DRUG USED: Tremfya; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Pharmaceutical K.K.; CRITERIA: Inclusion Criteria: - Diagnosis of plaque-type psoriasis at least 6 months prior to screening (participants with concurrent psoriatic arthritis may be enrolled) - Having plaque-type psoriasis covering at least 10% of total body surface area (BSA) at baseline - Has a Psoriasis Area and Severity Index (PASI) score of 12 or greater at baseline - Is a candidate for systemic phototherapy or systemic treatment of psoriasis (either new to treatment or having had previous treatment) - Has at least 2 plaques suitable for repeat biopsy (Only participants who consent separately to participate in this assessment. Refusal to give consent for this component does not exclude an individual from participation in the clinical study). Exclusion Criteria: - Currently has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular) - Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g., secondary infection occurred on bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers - Has a history of latent, or active or opportunistic systemic infection with pathogens including, but not limited to, Klebsiella pneumoniae, Cryptococcus neoformans, Candida albicans, Toxoplasma gondii, and Pneumocystis jiroveci prior to screening - Has or has had a serious infection (e.g., sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to screening ; PRIMARY OUTCOME: The number and type of adverse events; SECONDARY OUTCOME 1: Blood levels of CNTO 1959[/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 - RLM 3071-305-020 (OLE); BRIEF: This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development. ; DRUG USED: Relamorelin; DRUG CLASS: Biologic; INDICATION: Diabetic Gastroparesis; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Successful completion of either Study RLM-MD-03 or Study RLM-MD-04 - Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures - Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator. Exclusion Criteria: - Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020 - Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigators opinion, would limit the participants ability to participate in or complete the study - Any other reason that, in the investigators opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease - Females who are pregnant, nursing, or planning a pregnancy during the study. ; PRIMARY OUTCOME: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (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 I - Tissue Substudy ; BRIEF: The purpose of this study is to gain a better understanding about how the study drug MGA271 works. No test drug will be given in this study. Patients with easily accessible tumors at the screening visit for participation in Study CP-MGA271-01 will be asked to participate in this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle biopsies. ; DRUG USED: Enoblituzumab; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: B7-H3; THERAPY: Monotherapy; LEAD SPONSOR: MacroGenics; CRITERIA: Inclusion Criteria: - Qualified, by meeting all inclusion and exclusion criteria, for participation in Study CP-MGA271-01. - Must have provided informed consent to participate in Study CP-MGA271-01. - Must have accessible tumors (generally speaking, metastatic deposits involving skin, subcutaneous tissue, or peripheral lymph node whose excision, punch biopsy, or core needle biopsy would not require general anaesthesia or the invasion of a body cavity). - Willing to undergo two minor surgical procedures with no expectation of personal benefit - Have provided Informed Consent for this substudy as indicated by a signature on an approved consent document obtained from the patient or his/her legally authorized representative Exclusion Criteria: - Any medical condition that would contraindicate the use of local or locoregional anaesthesia, or conscious sedation for the intended minor surgical procedure. - Any medical condition (eg. skin disease or bleeding diathesis) that would hinder wound healing following a minor surgical procedure. - Dementia or altered mental status that would preclude understanding and rendering of informed consent. ; PRIMARY OUTCOME: Mechanism of Action; 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 - Single Dose Escalation; BRIEF: The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a screening visit and if eligible and consenting, will attend to participate in the study within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing when each subject will receive a single intravenous dose of GSK3050002 or placebo, then remain in house under supervision until discharged on Day 3. Subjects will then return for 7 outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be 7-14 days following the last visit. ; DRUG USED: GSK3050002; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: Chemokine (C-C motif) ligand 20 (CCL20); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Male aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12- lead ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria may be included only if the Investigator in consultation with the GSK Medical Monitor [if required] agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - Body mass index (BMI) within the range 18 - 29 kilogram per meter square [kg/m^2] (inclusive). - Male subjects with female partners of child-bearing potential must agree to use one of the listed contraception methods. This criterion must be followed for 1 month prior to the first dose of study medication for 15 weeks post dose. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. - Suitable for cannulation and with adequate venous access. - Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <= 1.5xUpper limit of Normal [ULN] (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Based on a single ECG QTcF < 450 milliseconds (msec). Exclusion Criteria: - Criteria Based Upon Medical Histories - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. - 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 GSK Medical Monitor, contraindicates their participation. - History of severe drug allergies including type 1 hypersensitivity reaction to parental administration of contrast agents, human or murine proteins or monoclonal antibodies. - Subject has acne which requires prescription treatment - Criteria Based Upon Diagnostic Assessments - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening - A positive pre-study drug/alcohol screen. - A positive test for Human immunodeficiency virus (HIV) antibody. - Subject is a heavy smoker as defined by a positive smoking breath test of >10 parts per million (ppm) carbon monoxide (CO). - Other Criteria - Evidence of current or at risk of developing bacterial, fungal, or viral infection at screening or within 7 days before dosing. - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. - 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). - Subject is unable to refrain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements), within 7 days prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study. - Subject is unable to abstain from travelling to area which carry a high risk of infection for the duration of the study. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Subject is unable to abstain from being vaccinated or immunized for 4 weeks prior to dosing and for 19 weeks after the study. ; PRIMARY OUTCOME: Number of subjects with adverse events; SECONDARY OUTCOME 1: Chemokine (C-C motif) ligand 20 (CCL20) levels in blood[/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 - Solid Tumors/Lymphoma; BRIEF: A Phase 1 open-label, non-randomized dose escalation study to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711). ; DRUG USED: Birinapant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: IAPs (Inhibitor of apoptosis proteins); THERAPY: Monotherapy; LEAD SPONSOR: TetraLogic Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Advanced metastatic or unresectable malignancy that is refractory to currently available standard therapies or no effective therapy exists. The subjects malignancy must be confirmed by prior pathologic study. - Evaluable disease (measurable or non-measurable) by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) or Revised Response Criteria for Malignant Lymphoma (RRCML) (Cheson 2007). - Life expectancy greater than 3 months. - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. - Adequate renal function, defined as serum creatinine ≤ 1.5 X upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 ml/min. - Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 3 X ULN and total bilirubin < 1.5 X ULN. - Adequate bone marrow function, defined as absolute neutrophil (ANC) ≥ 1,500/mm3 (≥1.5 X106/L), platelet count ≥ 75,000/mm3 (≥ 75 X106/L), and hemoglobin ≥ 10 mg/dL in the absence of transfusion. Key Exclusion Criteria: - Recent anti-cancer treatment defined as: - Standard or investigational anti-cancer therapy within 4 weeks prior to first dose of TL32711. Exception: continued hormonal interventions for sensitive diseases. - Radiation therapy within 2 weeks prior to the first dose of TL32711. - Clinically significant pulmonary illness resulting in Grade ≥ 2 hypoxia (National Cancer Institute Common Terminology criteria for Adverse Events [NCI CTCAE, v4]) or any requirement for supplemental oxygen, or pulse oximetry less than 90% saturation on room air. - Symptomatic or uncontrolled brain metastases requiring current treatment (less than 4 weeks from last cranial radiation or 2 weeks from last steroids). - Impaired cardiac function or clinically significant cardiac disease. - Ongoing auto-immune disease or with history of an auto-immune disease within the past 5 years. Auto-immune disease include but are not limited to systemic lupus erythematosis, scleroderma, rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis and regional enteritis (Crohns disease). - Systemic or chronic topical corticosteroids or immunosuppressive therapy within 4 weeks prior to study entry or anticipated need of systemic corticosteroids or immunosuppressive therapy during study participation. - Skin lesions of Grade ≥ 2 severity (NCI CTCAE v4), except alopecia. - Lack of recovery of prior adverse events to Grade ≤1 severity (NCI CTCAE v 4) (except alopecia or neuropathy) due to medications administered prior to the first dose of TL32711. ; PRIMARY OUTCOME: Define the MTD; SECONDARY OUTCOME 1: Tumor burden according to Response Evaluation Criteria in Solid Tumors (RECIST)/Revised Response Criteria Malignant Lymphoma[/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 - XSGR-PBH-201; BRIEF: This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial hypoglycemia. Twelve eligible subjects will be randomly assigned to receive Glucagon RTU or placebo at the first of two clinical research center (CRC) visits, followed by the other treatment at the second CRC visit. Subjects will be randomly assigned to either Glucagon RTU or Placebo for the duration of a 12-week Outpatient Stage. A follow-up safety assessment visit will occur 14 to 28 days after a subjects last dose of study drug. ; DRUG USED: Gvoke RTU Micro; DRUG CLASS: Non-NME; INDICATION: Hyperinsulinemia/Hypoglycemia; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Xeris Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female 2. Aged 18 to 75 years of age, inclusive 3. Symptoms of hypoglycemia that developed after bariatric surgery (Roux-en-Y gastric bypass [RYGB] only) in the absence of antidiabetic medications 4. History of bariatric surgery (RYGB only), at least 6 months prior to screening 5. Whipples triad 1. Ability to both experience and recognize hypoglycemic awareness. 2. Documented glucose levels < 54 mg/dL when experiencing symptoms suggestive of hypoglycemia 3. Relief of hypoglycemia symptoms when the glucose is raised to normal 6. Diagnosis of post-bariatric hypoglycemia (PBH) by a physician, requiring intervention such as intake of oral carbohydrates. This diagnosis includes documentation of endogenous hyperinsulinism in the presence of low plasma glucose. 7. In subjects with medical history of diabetes, medical documentation of postoperative remission of diabetes mellitus (fasting glucose < 110 mg/dL), and HbA1c < 6% (or 42 mmol/mL) with all previous antidiabetic medication discontinued for at least 6 months before screening. 8. Body mass index (BMI) ≤ 40 kg/m2 9. Willingness to follow all study procedures, including attending all clinic visits and self-administering blinded study drug at home for 12 weeks 10. Understands the study procedures, alternative treatment available, and risks involved with the study, and he/she voluntarily agrees to participate by giving written informed consent 11. Women of childbearing potential must have a negative urine pregnancy test and agree to use contraception and refrain from breast-feeding during the study and for at least 15 days after participating in the study. Exclusion Criteria: 1. Documented hypoglycemia occurring in the fasting state (> 12 hours fast) within 12 months of study entry 2. Hypoglycemic unawareness as evidenced by a Gold Scale score > 4 at screening 3. Early Dumping Syndrome 4. Known insulinoma or adrenal insufficiency 5. Active treatment with any insulin/insulin secretagogues, or other diabetes medications except for acarbose and glucagon-like peptide 1 (GLP-1) analogues 6. Chronic kidney disease Stage 4 or 5 or an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 at screening 7. Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 3 times the upper limit of normal (ULN); hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL 8. Congestive heart failure, New York Heart Association Class III or IV 9. History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening. 10. History of a cerebrovascular accident within 6 months prior to screening or with major neurological deficits 11. Seizure disorder (other than with suspected or documented hypoglycemia). 12. Active malignancy, except for basal or squamous cell skin cancers 13. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease) 14. Major surgical operation within 30 days prior to screening 15. Hematocrit ≤ 30% 16. Bleeding disorder, treatment with warfarin, or platelet count < 50,000 /mm3 17. Active alcohol abuse or substance abuse (per investigator assessment) 18. Current chronic administration of oral or parenteral corticosteroids, however topical, intraarticular, and inhaled corticosteroids are allowed 19. Use of an investigational drug within 15 days or 5 half-lives, whichever is longer, prior to screening 20. Member of a special vulnerable populations such as pregnant women, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable 21. Any other medical condition or finding that in the opinion of the investigator or sponsor, would compromise the safety of the subject or compromise the integrity of the study data ; PRIMARY OUTCOME: Blood glucose recovery: CRC; SECONDARY OUTCOME 1: Symptomatic Recovery: CRC[/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 - 001; BRIEF: This is a clinical study for adult subjects with Post Traumatic Stress Disorder. ; DRUG USED: PRX-3140; DRUG CLASS: New Molecular Entity (NME); INDICATION: Post-Traumatic Stress Disorder (PTSD); TARGET: Serotonin 5-HT4 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ology Bioservices; CRITERIA: Inclusion Criteria: 1. Male and female subjects between ages 18-55 2. The subject has signed and dated the written informed consent to participate in the study 3. The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions 4. The subject meets criteria for PTSD as defined by the DSM-IV-TR 5. Stable use of clinically prescribed medications 6. Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation 7. Female subjects - not surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy). Exclusion Criteria: 1. Actively alcohol or drug dependent as defined by DSM-IV-TR Criteria 2. Patient actively suicidal within last 12-months or with current suicidal ideation 3. History of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview 4. Participation in a clinical drug research study within the past 30 days 5. Subject currently taking any SSRI or anti-depressant medication. 6. Pregnant or breastfeeding females 7. Subjects will be excluded based on lab values, ECG findings, or physical findings that the Investigators deems exclusionary. ; PRIMARY OUTCOME: Change in adverse events from baseline; SECONDARY OUTCOME 1: Change from baseline in PTSD and mood related symptoms[/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 - ENGAGE (Early AD); BRIEF: The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI]. ; DRUG USED: Aduhelm; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have: - A Clinical Dementia Rating (CDR)-Global Score of 0.5. - Objective evidence of cognitive impairment at screening - An MMSE score between 24 and 30 (inclusive) - Must have a positive amyloid Positron Emission Tomography (PET) scan - Must consent to apolipoprotein E (ApoE) genotyping - If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1 - Must have a reliable informant or caregiver Key Exclusion Criteria: - Any medical or neurological condition (other than Alzheimers Disease) that might be a contributing cause of the subjects cognitive impairment - Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year - Clinically significant unstable psychiatric illness in past 6 months - History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening - Indication of impaired renal or liver function - Have human immunodeficiency virus (HIV) infection - Have a significant systematic illness or infection in past 30 days - Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities - Any contraindications to brain magnetic resonance imaging (MRI) or PET scans - Alcohol or substance abuse in past 1 year - Taking blood thinners (except for aspirin at a prophylactic dose or less) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78; SECONDARY OUTCOME 1: Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78[/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 - OPN305-102; BRIEF: When a patient receives a kidney transplant particularly if the kidney is from an older donor or one who has had the kidney removed after their heart has stopped, there is a risk that the newly transplanted kidney may not function immediately. If the delay in function means that dialysis is needed in the first 7 days after the transplantation then this is known as delayed graft function or dDGF. Also delayed graft function that does not require dialysis but is present because the serum creatinine does not fall sufficiently is known as functional delayed graft function or fDGF. This problem is often due to an excessive inflammatory reaction to not having had a blood supply between the time of donation and transplant. OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be partly responsible for increasing the risk of this inflammation. It is hoped that the effects of the inflammation will be reduced and therefore prevent dDGF and fDGF from occurring. The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF as well as improving other measures of kidney function and the overall safety of the antibody. In the first part of the study, each patient received an Infusion of one of three possible doses of OPN-305 or a placebo and in the second part the most suitable dose of OPN-305 and a placebo would be used. The purpose of this second part of the study is to find out if a dose of OPN-305 which has already been tested in an earlier part of this study can prevent kidney graft dysfunction. For the purposes of this study, kidney function will be assessed using the composite of delayed graft function (dDGF) because dialysis is necessary in the first 7 days and functional delayed graft function that does not require dialysis but is present because the serum creatinine, a key measure of renal function, does not fall sufficiently (fDGF) in the first 7 days post-transplant. Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft function of patients who have completed the 6-month post-transplant period under Part A or Part B of OPN305-102. ; DRUG USED: OPN-305; DRUG CLASS: Biologic; INDICATION: Delayed Graft Function (DGF); TARGET: Toll-Like Receptor 2 (TLR2); THERAPY: Monotherapy; LEAD SPONSOR: Opsona Therapeutics Ltd.; CRITERIA: Inclusion criteria INCLUSION CRITERIA FOR TRANSPLANT RECIPIENTS - First or second renal transplant recipient - for second renal transplantations; - The second transplant should NOT be due to rejection - Panel Reactive Antibody (PRA) should be <10% - Minimum 3 months since the loss of the first transplanted kidney - Dialysis-dependent at the time of transplantation as documented by: - Requirement for at least 2 dialysis sessions/week in the 56 days before transplantation INCLUSION CRITERIA FOR DONOR KIDNEY: - The donor kidney must be considered compatible according to local transplant guidelines - An ECD donor defined as: o Extended Criteria Donor defined as: - Donor ≥60 years of age - Donor 50-59 years of age with two of three of the following criteria present: - Death due to cerebrovascular accident - Pre-existing history of systemic hypertension - Terminal creatinine > 1.5mg/dL (132.6 µmol/L) - Kidney allograft maintained in cold storage with or without machine perfusion Exclusion Criteria EXCLUSION CRITERIA FOR TRANSPLANT RECIPIENTS: - Use of an investigational drug in the 30 days before Study Day 1 - Participation in any other research - Known hypersensitivity to human monoclonal antibodies or any of the study-drug excipients - Previous hypersensitivity to basiliximab or anti-thymocyte globulin (ATG) - History or known HIV, HBV, or HCV-positive - History of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin or cervical intraepithelial neoplasia - Scheduled to undergo multi-organ transplantation - Planned dual kidney transplantation - Presence of clinically significant infections requiring continued therapy - Active tuberculosis - Existence of any surgical or medical condition, other than the current transplantation which, in the opinion of the investigator, might significantly alter the distribution, metabolism or excretion of study medication - Presence of uncontrolled diabetes mellitus. - Current drug and/or alcohol abuse - History or presence of a medical condition or disease that in the investigators assessment would place the patient at an unacceptable risk for study participation - Lactating or pregnant woman - Patient institutionalized by administrative or court order EXCLUSION CRITERIA FOR ALL DONOR KIDNEYS - DCD or SCD donor kidney - Terminal creatinine >3mg/dL - Donor who is known to have received an investigational drug for I-R injury or graft rejection (immunosuppressant) in the 48h before organ recovery - Participation in any other research (drug or non-drug) - Kidney donor <5 years of age or <20kg body weight - Living donor allograft - HLA or ABO incompatible kidney as defined by a negative cytotoxic crossmatch - Donor institutionalized by administrative or court order ; PRIMARY OUTCOME: Measure of Early Graft Function EGF; SECONDARY OUTCOME 1: Creatinine at 7 and 14 days and at 1, 3 and 6 months[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 1643 (Persistent Hypercholesterolemia); BRIEF: The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD. ; DRUG USED: Evkeeza; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Angiopoietin-like 3 (ANGPTL3); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: The inclusion/ exclusion criteria below, include, but are not limited to, the following: Key Inclusion Criteria: 1. Men and women, ages 18 through 80 at the screening visit 2. Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD 3. A history of clinical ASCVD, for those patients who are non-HeFH. 4. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening 5. For those patients with HeFH who are not receiving a statin at screening, documentation of inability to tolerate at least 2 statins. 6. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit 7. For those patients with a history of clinical ASCVD, serum LDL-C ≥ 70 mg/dL at screening (1 repeat lab is allowed) 8. For those patients without a history of clinical ASCVD, serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed) 9. Provide signed informed consent Key Exclusion Criteria: 1. Known history of homozygous FH (clinically, or by previous genotyping) 2. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins 3. Newly diagnosed diabetes (within 3 months prior to screening) 4. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening) 5. Laboratory findings during screening period (not including randomization labs): 1. Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus 2. Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction) 3. Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential 4. Estimated glomerular filtration rate < 30 mL/min/1.73 m^2 5. TSH > 1.5 x ULN 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN 6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization 7. History of heart failure (New York Heart Association [NYHA] Class III-IV) within 12 months before screening 8. History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening 9. History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer) 10. Having received LDL apheresis within 2 months before screening 11. Pregnant or breast-feeding women 12. Women of childbearing potential who are unwilling to practice a highly effective birth control method 13. Men who are sexually active with women of childbearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period regardless of vasectomy status. ; PRIMARY OUTCOME: Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand); SECONDARY OUTCOME 1: Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)[/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 - LTS ACN-05; BRIEF: The purpose of this study is to determine the safety of photodynamic therapy (PDT) with lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne. ; DRUG USED: Lemuteporfin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acne; TARGET: Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: Dermira, Inc.; CRITERIA: Inclusion Criteria: - Stage 1 only: healthy subjects - Stage 1-4: male or female subjects age 18 years or older - Stage 2: subjects with sebum excretion rate of 4 or higher on forehead - Stage 2-4: subjects with at least 2 inflammatory acne lesions on the forehead - Stage 3-4: subjects with sebum excretion rate of 5 or higher on forehead Exclusion Criteria: - Poor skin condition on back (Stage 1) or face (Stage 2 & 3) - Severe facial acne, acne fluminans/conglobata, or nodulocystic acne - Stage 2-4: previous use of Diane-35 within 6 months of Day 0, systemic acne treatment or systemic antibiotic treatment within 28 days of Day 0, topical acne treatment to the face within 14days of Day 0 or PDT to the face within 3 months of Day 0 - Stage 2-4: previous treatment of isotretinoin or other oral retinoids ; PRIMARY OUTCOME: Change in sebum excretion rate; SECONDARY OUTCOME 1: Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)[/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 - 002 (Japan); BRIEF: The primary objective of this study is to investigate the effect of 5 mg KHK2375 on progression free survival (PFS) when administered orally at weekly intervals in combination with exemestane in a placebo-controlled, double-blind comparative study in subjects with advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are to investigate the effect of on overall survival (OS) and the antitumor effect and to evaluate the pharmacokinetics and safety. ; DRUG USED: Entinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Histone Deacetylase (HDAC); THERAPY: Combination; LEAD SPONSOR: Kyowa Kirin Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Personally submitted voluntary written informed consent to participate in the study 2. Age ≥ 20 years at the time of consent 3. Histologically or cytologically confirmed breast cancer positive for estrogen receptor (ER) and/or progesterone receptor (PgR) 4. Human epidermal growth factor 2 (HER2)-negative 5. Stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is impossible 6. Pre/Peri- and postmenopausal women - Postmenopausal status is defined either by: 1. Age ≥ 55 years and ≥ 1 year of amenorrhea 2. Age < 55 years and ≥ 1 year of amenorrhea, with blood estradiol (E2) < 20 pg/mL 3. Age < 55 years with hysterectomy, with ovaries and E2 < 20 pg/mL - Surgical menopause with bilateral oophorectomy Pre/perimenopausal women may be enrolled only if they agree to receive an luteinizing hormone-releasing hormone (LH-RH) agonist 7. Eastern Cooperative Oncology Group(ECOG) performance status (PS) of 0 or 1 at enrollment 8. Measurable or nonmeasurable lesions per RECIST version 1.1 criteria 9. Subjects meeting either of the following criteria: - History of treatment with a nonsteroidal aromatase inhibitor (AI) for advanced or recurrent breast cancer, and development of progressive disease (PD) after the most recent prior treatment - No history of treatment with endocrine therapy for advanced or recurrent breast cancer that has recurred during or within 12 months after postoperative adjuvant therapy with an nonsteroidal AI 10. An adverse event for which a causal relationship to prior treatment cannot be denied (except alopecia) is Grade ≤ 1 in severity or has returned to the baseline level, i.e., the level before the start of the prior treatment 11. The latest laboratory values obtained prior to enrollment must meet all of the following requirements: - Hemoglobin concentration: ≥ 9.0 g/dL - Platelet count: ≥ 100000/μL - Neutrophil count: ≥ 1500/μL - Serum creatinine: ≤ 2.0 mg/dL - Total bilirubin in serum: < 1.5 × institutional upper limit of normal (≤ 3 mg/dL for subjects with Gilberts syndrome) - Aspartate transaminase(AST) and Alanine transaminase(ALT): ≤ 3.0 × institutional upper limit of normal Exclusion Criteria: 1. Endocrine therapy (except for LH-RH agonist), treatment with everolimus, treatment with a cyclin-dependent kinase inhibitor, or radiation therapy within 14 days before enrollment Subjects with prior treatment with exemestane may be enrolled if they meet either of the following criteria: - Start of treatment with exemestane for advanced or recurrent breast cancer within 28 days before enrollment - Recurrence-free period >12 months after completion of treatment with exemestane as postoperative adjuvant therapy. For painful bone lesions or impending fractures, radiation therapy may be used concomitantly if there is a measurable or nonmeasurable lesion that is suitable for efficacy evaluation in a region other than the radiation field 2. Two or more prior chemotherapy regimens for advanced or recurrent breast cancer 3. Chemotherapy within 21 days before enrollment 4. Treatment with bisphosphonates or anti-RANKL antibody that is scheduled to be started within 7 days before the first dose of investigational product 5. History of or current central nervous system metastasis, or current leptomeningeal or periosteal disease 6. History of cancer other than breast cancer within 5 years, or concurrent cancer other than breast cancer (except for basal cell carcinoma of skin, squamous cell carcinoma of skin, and intraepithelial carcinoma of uterine cervix).Subjects continuing to receive treatment for cancer other than breast cancer are ineligible for enrollment 7. Ongoing treatment with any other anticancer therapy or investigational product (Except for treatment with exemestane or radiotherapy as described in exclusion criterion 1) 8. Prior treatment with histone deacetylase inhibitor (e.g. valproate, vorinostat) 9. Known allergy to imidazoles, exemestane, or entinostat 10. Any medical or psychiatric condition that could affect compliance with the protocol, ability to give consent, or assessment of anticipated toxicities 11. Uncontrolled complications (e.g., active infections) 12. Positive for either hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody 13. Any other conditions unsuitable for the study in the opinion of the investigator or subinvestigator ; PRIMARY OUTCOME: Progression Free Survival(PFS) defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1); SECONDARY OUTCOME 1: Overall survival (OS)[/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 - SAkuraStar (Monotherapy); BRIEF: The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD. ; DRUG USED: Enspryng; DRUG CLASS: Biologic; INDICATION: Neuromyelitis Optica (Devics Syndrome, NMO); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: 1. Participants must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following: 1. NMO as defined by Wingerchuk et al. 2006 criteria (requires all of the following 3 criteria: I. Optic neuritis, II. Acute myelitis, III. At least two of three supportive criteria: Contiguous spinal cord lesion identified on a magnetic resonance imaging [MRI] scan extending over 3 vertebral segments; Brain MRI not meeting diagnostic criteria for multiple sclerosis [MS]; NMO-IgG seropositive status) 2. NMOSD as defined by either of following criteria with anti-aquaporin-4 (AQP4) antibody seropositive status at screening: i. Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion); ii. Optic neuritis, single, recurrent or simultaneous bilateral 2. Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening 3. Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening 4. Age 18 to 74 years, inclusive at the time of informed consent 5. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol Exclusion Criteria: 1. Clinical relapse onset (including first attack) within 30 days prior to baseline Exclusion Criteria Related to Previous or Concomitant Therapy: 2. Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time 3. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline 4. Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline 5. Treatment with any investigational agent within 3 months prior to baseline Exclusions for General Safety: 6. Pregnancy or lactation. 7. For participants of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [participants or partner] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug 8. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline 9. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML) 10. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency 11. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline 12. Evidence of chronic active hepatitis B or C 13. History of drug or alcohol abuse within 1 year prior to baseline 14. History of diverticulitis that, in the Investigators opinion, may lead to increased risk of complications such as lower gastrointestinal perforation 15. Evidence of active tuberculosis (excluding participants receiving chemoprophylaxis for latent tuberculosis infection) 16. Evidence of active interstitial lung disease 17. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline 18. History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured) 19. History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions) 20. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening 21. History of Stevens-Johnson syndrome 22. Following laboratory abnormalities at screening*. 1. White blood cells <3.0 x10^3/microliter (μL) 2. Absolute neutrophil count <2.0 x 10^3 /μL 3. Absolute lymphocyte count <0.5 x 10^3 /μL 4. Platelet count <10 x 10^4 /μL 5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal. - If retest is conducted, the last value of retest before randomization must meet study criteria. ; PRIMARY OUTCOME: Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period; SECONDARY OUTCOME 1: Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB 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 I/II - ALT-002-SRE-01; BRIEF: The purpose of this trial is to define an effective and safe dose of AP-002 in advanced or recurrent solid tumors for which there are no standard therapies to use in subsequent studies in advanced or recurrent breast, non-small cell lung cancer (NSCLC) or prostate cancers. ; DRUG USED: AP-002; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bone Complications (Including Bone Metastases); TARGET: Osteoblast, Osteoclast; THERAPY: Monotherapy; LEAD SPONSOR: Altum Pharmaceuticals INC; CRITERIA: Inclusion Criteria: 1. Phase 1: Patients with advanced or recurrent solid tumors with target (± non-target) or with only non-target disease, for which there is no standard therapy available Phase 2: Patients with advanced or recurrent breast cancer, NSCLC, or prostate cancer with target (± non-target) or with only non-target disease for which there is no standard therapy available 2. Patients with bone metastases but without target disease are eligible 3. Patients with bone metastases must have at least one bone lesion that has not received radiation therapy within 6 weeks prior to Cycle 1 Day 1 4. Patients must discontinue bisphosphonate and/or denosumab treatment. 5. Age ≥ 18 years 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 7. O2 saturation ≥ 92% on room air per pulse oximetry 8. Exhaled nitrous oxide ≤ 50 parts per billion (ppb) 9. Adequate hematologic, hepatic and renal function defined as: 1. Hemoglobin ≥ 9 g/dL 2. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L 3. Platelet count ≥ 75 × 109/L 4. Total bilirubin ≤ 2 × upper limit of normal (ULN). Patients with an established diagnosis of Gilberts syndrome with an unconjugated bilirubin ≤ 2 mg/dL and conjugated bilirubin within normal limits (WNL) are eligible. 5. Serum electrolytes WNL 6. Transaminases ≤ 3 × ULN 7. Prothrombin time (PT)/international normalized ratio (INR), thromboplastin time (PTT), or activated PTT (aPTT) ≤ 1.5 × ULN. For patients on therapeutic coumadin, PT (INR) ≤ 2.5 × ULN is acceptable; for patients on therapeutic heparin, PTT (or aPTT) ≤ 2.5 × ULN 8. Corrected creatinine clearance ≥ 40 mL/minute, based on the Cockcroft-Gault equation 10. Patient must have discontinued prior antineoplastic therapy at least 21 days prior to Cycle 1 Day 1 and have recovered or stabilized from any prior AEs related to the prior therapy 11. Provision of signed and dated informed consent form 12. Serum 25-hydroxyvitamin D ≥ 30 ng/mL by investigative site laboratory at screening Exclusion Criteria: 1. Evidence of benign primary hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, mild alkali syndrome, sarcoidosis or other granulomatous disease 2. Treatment with calcitonin, mithramycin or cinacalcet within 7 days prior to the date of the screening 3. Receiving dialysis for renal failure 4. Patients with a known history of clinically significant active infection, including human immunodeficiency virus (HIV), hepatitis B, or hepatitis C 5. Patients with active central nervous system (CNS) metastases are not eligible, but patients with treated, stable CNS metastases are allowed 6. Patients with QT interval of ≥ 480 msec on ECG 7. Patients with Pagets disease of bone 8. Patients of childbearing potential unwilling to abstain from sexual intercourse, or employ effective barrier methods of contraception during participation in this trial 9. Pregnancy or lactation. A negative pregnancy test will be required for women of childbearing potential prior to study enrollment and will be repeated throughout the study. Women of childbearing potential will be defined as women who have not had natural or pharmacologic menopause, nor surgical sterilization. 10. Patients unwilling or unable to take oral medication, requiring a nasogastric or gastrostomy tube, or unwilling to adhere to the treatment regimen and fasting requirements 11. Patients unwilling to comply with all study procedures or who are unavailable for the duration of the study 12. Known allergies to any components of the AP-002 Drug Product ; PRIMARY OUTCOME: Safety Assessment; SECONDARY OUTCOME 1: Efficacy Assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - COMPOSE I; BRIEF: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure. ; DRUG USED: Cinaciguat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy - Subjects must have the clinical diagnosis of CHF made at least three months prior to enrollment - Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: - dyspnea and - clinical evidence of volume overload Exclusion Criteria: - Acute de-novo heart failure - Acute myocardial infarction and/or myocardial infarction within 30 days - Valvular heart disease requiring surgical intervention during the course of the study - Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease - Primary hypertrophic cardiomyopathy - Acute inflammatory heart disease, eg, acute myocarditis - Unstable angina requiring angiography ; PRIMARY OUTCOME: Pulmonary Capillary Wedge Pressure; SECONDARY OUTCOME 1: Cardiac index (CI)[/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 - 1001; BRIEF: Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients . ; DRUG USED: Lorbrena; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Anaplastic lymphoma kinase (ALK), ROS kinase; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria - Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA) approved FISH assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by FISH or RT PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT). All patients (ALK positive and ROS1 positive) must have archival tissue sample available and collected prior to enrollment. - Disease Status Requirements: Phase 1: ALK-positive NSCLC and ROS1-positive patients must either be treatment naïve in the advanced setting or have had disease progression after at least 1 previous ALK/ROS1 inhibitor therapy(ies). Phase 2: ALK-positive NSCLC patients must either be or have had: - Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ALK inhibitor therapy allowed). - Disease progression after crizotinib only. No prior chemotherapy is allowed in the metastatic disease setting. - Disease progression after crizotinib and 1 or 2 prior regimens of chemotherapy in the metastatic disease setting. - Disease progression after 1 prior ALK inhibitor therapy other than crizotinib. Patients may have had any number of prior chemotherapy regimens in any disease setting. - Disease progression after 2 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting. - Disease progression after 3 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting. ROS1-positive NSCLC patients may be: - Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ROS inhibitor therapy). - Any number of prior therapies (ie, chemotherapy and/or ROS inhibitor therapies). - Tumor Requirements: All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. Patients who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) are eligible. - Adequate Bone Marrow, Pancreatic Function, Renal Function and Liver Function. - Negative Serum pregnancy test for females of childbearing potential Exclusion Criteria - Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry. - Systemic anti cancer therapy completed within a minimum of 5 half lives of study entry. - Prior therapy with an antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including, but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (anti-CTLA-4) antibody. - Active and clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness. - Clinically significant cardiovascular disease (that is, active or <3 months prior to enrollment): cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), second-degree or third-degree AV block (unless paced) or any AV block with PR >220 msec. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or congenital long QT syndrome. - History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis. - Current use or anticipated need for food or drugs that are known strong or moderate CYP3A4 inhibitors, inducers and substrates; drugs that are CYP2C9 substrates; drugs that are sensitive CYP2B6 substrates; drugs that are strong CYP2C19 inhibitors; drugs that are strong CYP2C8 inhibitors; and drugs that are P-gp substrates. ; PRIMARY OUTCOME: Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1; SECONDARY OUTCOME 1: Percentage of Participants With Overall and Intracranial Objective Response (Phase 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 I/II - 2201; BRIEF: This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies. ; DRUG USED: MGTA-456; DRUG CLASS: Biologic; INDICATION: Bone Marrow Transplant and Stem Cell Transplant; TARGET: Aryl hydrocarbon receptor (AhR), Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with a diagnosis that qualifies them for a DUCBT - Absence of recent active mold infection - Adequate organ function - Availability of eligible donor material Exclusion Criteria: - Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used - Human immunodeficiency virus (HIV) infection - Active infection - Extensive prior chemotherapy - Prior myeloablative allotransplantation or autologous transplant. ; PRIMARY OUTCOME: Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.; SECONDARY OUTCOME 1: Incidence of Neutrophil Recovery Within 42 Days[/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 - SAD; BRIEF: The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses. The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing ; DRUG USED: BI 456906; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria - Healthy male according to the assessment of the Investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests - Age of 18 to 45 years (incl.) - Body Mass Index (BMI) of 20.0 to 29.9 kg/m2 (incl.) - Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation Exclusion criteria - Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator - Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders - Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders - Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation) - Further exclusion criteria apply ; PRIMARY OUTCOME: [N (%)] of subjects with drug-related adverse events.; SECONDARY OUTCOME 1: AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)[/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 - w/Insulin Pump (CSII); BRIEF: The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus. There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part. ; DRUG USED: Lyumjev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year - Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%) Exclusion Criteria: - Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening - More than one episode of severe hypoglycaemia in the last 6 months - Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency - Have obvious clinical signs or symptoms of liver disease - Have a history of renal impairment ; PRIMARY OUTCOME: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part; SECONDARY OUTCOME 1: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part[/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 - AAAS2936 (Newly Diagnosed Diffuse Midline Gliomas); BRIEF: The blood brain barrier (BBB) prevents some drugs from successfully reaching the target source. Convection-Enhanced Delivery (CED) is a method of direct infusion of drugs under controlled pressure to the tumor that may reduce systemic side effects of drugs in the patient. The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor over 9-11 days. ; DRUG USED: MTX110; DRUG CLASS: Non-NME; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Histone Deacetylase (HDAC); THERAPY: Combination; LEAD SPONSOR: Luca Szalontay; CRITERIA: Inclusion Criteria: - Aged more than 3 years up to the 18th birthday - Radiological diagnosis of DIPG with tumor confined to the region of the pons or - thalami without cystic changes or hematoma obstructing the planned catheter trajectories - Radiological diagnosis of thalamic gliomas confined to bilateral thalami without cystic changes or hematoma obstructing the planned catheter trajectories - Radiological features of DIPG: intrinsic, pontine based infiltrative lesion; hypointense in T1 weighted images (T1WIs) and hyperintense in T2 sequences, with mass effect on the adjacent structures and occupying at least 50% of the pons - No prior therapy is allowed other than involved field radiotherapy (54Gy) and cerebrospinal fluid (CSF) diversion for hydrocephalus, including endoscopic third ventriculostomy (ETV) or a ventriculo-peritoneal shunt. No concomitant medicine or therapies for treatment are permitted while the patient is enrolled in this study. - Karnofsky performance status or Lansky play score of ≥70 assessed at diagnosis - Total bilirubin: within normal institutional limits - Aspartate Aminotransferase (AST)(SGOT)/Alanine Aminotransferase (ALT)(SGPT): ≤ 2.5 × institutional upper limit of normal (ULN) - Creatinine: within normal institutional limits - Creatinine clearance: ≥ 60 mL/min/1.73m2 for patients with creatinine levels above institutional normal - Absolute neutrophil count: ≥ 1,500/μL - Platelet count: ≥ 100,000/μL - no transfusion within 7 days - Hemoglobin level: ≥ 10g/dL - no transfusion within 7 days - Partial Thromboplastin Time (PT) and activated partial thromboplastin time (APTT): within normal institutional limits - No documented current bleeding disorder - No medical condition that would preclude general anesthesia - No severe acute infection or unexplained febrile illness - Not pregnant or nursing - negative serum pregnancy test if appropriate within 7 days of study entry (adequate contraceptive methods for females and males required) - No documented allergy to compounds of similar chemical or biologic composition to MTX110 or gadolinium compounds - Subjects with a history of seizures/epilepsy should be on anticonvulsant medication prior to the first operative procedure on study, with serum levels within a therapeutic range - Subjects must be able to undergo MR-imaging with gadolinium-based contrast administration (e.g. no ferrous-containing implants, no pacemakers, etc.) - All subjects or their legal guardians must sign a document of informed consent indicating their understanding of the investigational nature and the potential risks associated with this study. When appropriate, pediatric subjects will be included in all discussions in order to obtain verbal and written assent Exclusion Criteria: - Radiological evidence of distant disease outside the pons or thalami - Radiological evidence of metastatic disease within the central nervous system (CNS) at diagnosis - Subjects with an uncorrectable bleeding disorder - Subjects with multifocal or leptomeningeal disease beyond the pons or the thalami - Subjects with signs of impending herniation or an acute intratumoral hemorrhage - Subjects that have received or are on concurrent chemotherapy or biologic therapy for the treatment of their tumor - Subjects who are pregnant or breastfeeding - Previous experimental or trial-based therapy - Patients who are known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MTX110. - Patients with systemic diseases which may be associated with unacceptable anesthetic/operative risk ; PRIMARY OUTCOME: Incidence of Adverse Events; SECONDARY OUTCOME 1: Steady state volume of drug distribution[/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 - STAT; BRIEF: Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV. Hence, ART is recommended for all persons with HIV viremia regardless of cluster of differentiation 4 (CD4) count. This is an open-label single arm which will evaluate the feasibility, efficacy and safety using a fixed dose combination (FDC) of Dolutegravir (DTG) plus Lamivudine (3TC) as a first line regimen of a rapid Test and Treat model of care over 48 weeks. Participants with new and confirmed diagnosed HIV-1 who are willing to start study treatment immediately following diagnosis will receive 50 milligram (mg) DTG + 300 (mg) 3TC FDC as first line therapy without waiting for screening laboratory results, at the Screening/Day 1 Visit. The total duration for the study will be 52 weeks and 4 weeks of follow up period if required. This study will be conducted in United States (US) with approximately 120 participants. ; DRUG USED: Dovato; DRUG CLASS: Non-NME; INDICATION: HIV / AIDS; TARGET: HIV Gag protein, HIV-1 protease (HIV PR); THERAPY: Combination; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Eligible participants must be able to understand and comply with protocol requirements, instructions, and restrictions. - Eligible participants must be likely to complete the study as planned. - Eligible participants must be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g. no active problematic substance abuse, acute major organ disease, or potential long-term work assignments out of the country). - Participant must be more than or equal to 18 at the time of signing the informed consent. - Participants must have a new and confirmed diagnosis of HIV-1 infection and are willing to initiate ART immediately (or, for those participants referred from another site, within 14 days of initial diagnosis at the external clinic/testing center). - Participant must have an initial positive rapid HIV test and participant has a second positive confirmatory rapid HIV test, using a test kit from a different manufacturer than the first test or participant has been identified as HIV-1 infected using an FDA-approved 4th generation assay antigen/antibody combination immunoassay or 3rd generation immunoassay that detects and differentiates HIV-1 and HIV-2 antibodies; participant has a confirmatory HIV western blot or an HIV-1 RNA or participant has a positive FDA-approved 4th generation assay and a positive 3rd generation immunoassay that detects and differentiates HIV-1 and HIV-2 antibodies. - Antiretroviral-naïve. Participants who received HIV post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) in the past are allowed as long as the last PEP/PrEP dose was more than 6 months from HIV diagnosis or there is documented HIV seronegativity at least 2 months after the last prophylactic dose and prior to the date of HIV diagnosis. - Male and/or female participants. - Participants who are female at birth are eligible to participate if at least one of the following conditions applies: Not pregnant [as confirmed by a negative urine human chorionic gonadotropin (hCG) test at Screening/Day 1. - Pregnant and post the first trimester (the physician and patient should decide whether enrolling in this study is in the participants best interest during the consent process) - Not a participant of childbearing potential (POCBP) or a POCBP agrees to follow the contraceptive guidance, is currently taking hormonal contraceptives and continues for at least 2 weeks after the last dose of study medication. Participants who are female at birth and who are in the following categories are not considered POCBP, premenarchal, premenopausal female with one of the following: documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy or postmenopausal, a postmenopausal state is defined as no menses for 12 months without an alternative medical cause; a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in participants who are female at birth and not using hormonal contraception or hormonal replacement therapy (HRT); participants who are female at birth on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. - Participants who are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: - Participants who are breastfeeding, plan to become pregnant or breastfeed during the study. - Participants who are in their first trimester of pregnancy. - HIV-1 drug resistance genotype test results are known prior to Screening/Day 1. - Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease except for esophageal candidiasis and cutaneous Kaposis sarcoma not requiring systemic therapy. - Participants with known or suspected Hepatitis B infection. - Participants with known or suspected severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - Participants with known moderate to severe renal impairment (creatinine clearance less than 30ml/minute per 1.73 square meter); - Participant with ongoing malignancy other than basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study Medical Monitor for inclusion of the participant. - Participants who in the investigators judgment, poses a significant suicidality risk. - Participants with any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participants ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. - Participants with substance abuse disorders or social restraints that the Investigator considers to be possible deterrents to successful initiation of ART. - Participants with history or presence of allergy or intolerance to the study drugs or their components. - Participants with treatment with any of the following agents within 28 days of the first dose of study treatment, radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant. - Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. - Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study treatment. ; PRIMARY OUTCOME: Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) Regardless of Antiretroviral Therapy (ART) Regimen at Week 24 by ITT-E Missing = Failure Analysis; SECONDARY OUTCOME 1: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Regardless of ART Regimen at Week 48 by ITT-E Missing = Failure Analysis[/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 - Spasticity w/MS; BRIEF: A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes: 1. To determine whether AV650 is safe for patients with multiple sclerosis; 2. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and, 3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only). ; DRUG USED: Tolperisone; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuromuscular Spasm and Spasticity; TARGET: Calcium Channel, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Avigen; CRITERIA: Inclusion Criteria: - Male or female subjects between 18 and 70 years of age (inclusive) - Signed and dated informed consent - Definite MS as per Poser or MacDonald Criteria (either relapsing remitting or secondary progressive course) - Expanded Disability Status Score (EDSS) from 3.0 to 6.5 (inclusive) at Screening - Stable MS for at least 30 days before screening - Female of child bearing potential and male subjects whose partner is of child bearing potential who are willing to ensure that they or their partner use effective double-barrier contraception during the study and for 90 days thereafter - If female, be neither pregnant nor nursing (Confirmation that the subject is not pregnant must be established by a negative serum hCG pregnancy test at baseline.) - Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group - If a subject is on anti-spastic treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening - If a subject is on MS treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening Exclusion Criteria: - Subjects who have participated in another research study within 90 days of Screening - Significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of Screening - Known hypersensitivity to tolperisone HCl, its components, or other lidocaine/lidocaine-like products - Use of tolperisone HCl within 30 days of screening - Significant changes in MS treatments (dosage, frequency, or route of administration) within 30 days of Screening - Spasticity due to neurological disorders other than MS - Any psychiatric disorder or cognitive impairment that precludes fully informed consent or safe participation in the study - Subjects who have suffered an acute relapse of MS or who continue to suffer from an acute relapse of MS within 90 days of Baseline - History of alcohol or substance abuse within one year of Screening - Concurrent clinically significant immunologic, pulmonary, renal, hepatic, or endocrine disease and/or other unstable or major disease other than MS - Clinically significant cardiovascular disorders, such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or acute myocardial infarction - QT prolongation greater than 480 msec or greater than 450 msec if accompanied by a partial bundle branch block, or other ECG abnormality in the judgment of the Investigator - Diastolic blood pressure <50mmHg or >105mmHg; heart rate <50 beats per minute (bpm) or >110bpm, after 3 minutes in a sitting position; heart rate by ECG <50bpm or >110bpm - History of epilepsy (except childhood febrile seizures) - Current malignancy or history of malignancy that has not been in remission for more than five years, except basal cell skin carcinoma and cervical cancer (with treatment) - Female subject who is pregnant, nursing, or planning pregnancy during the course of the study - Scheduled elective surgery or other procedures requiring general anesthesia during the study - Subject who is terminally ill in the judgment of the Investigator - Subject who is inappropriate for placebo medication in the judgment of the Investigator - Systemic corticosteroid therapy within 28 days of randomization, with the exception of inhaled medications for asthma - Exacerbation of MS within 30 days of Baseline - Regular levo-dopa therapy within 7 days of randomization - Subjects taking antiarrhythmic medications - Donation of blood during the study ; PRIMARY OUTCOME: To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS; SECONDARY OUTCOME 1: To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS; and to determine the pharmacokinetic (PK) profile of AV650 at two dose levels[/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 - Exon 15 Mutations; BRIEF: This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V600E. ; DRUG USED: Zelboraf; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 - Histologically-confirmed metastatic melanoma (unresectable Stage IIIc or IV) with an activating BRAF mutation other than V600E, as detected by DNA sequencing of exon 15 performed at a centralized laboratory - Measurable disease (as defined by RECIST, v1.1) - Adequate recovery from most recent systemic or local treatment for cancer - Adequate organ function within 28 days prior to initiation of treatment - For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of vemurafenib - For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of vemurafenib - Negative serum pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study - Agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of vemurafenib; for male participants, agreement not to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib - Signed informed consent form (prior to study entry and before performing any study-related procedures) Exclusion Criteria: - Invasive malignancy other than melanoma at the time of enrollment and within 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years - Pregnant or breast-feeding - Inability to swallow pills - Concurrent anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, including participation in an experimental drug study) - Radiation therapy </= 1 week prior to first administration of vemurafenib and stereotactic radiotherapy </= 1 day prior to first administration of vemurafenib - Prior treatment with a BRAF or MEK inhibitor - Either a concurrent condition (including medical illness, such as active infection requiring treatment with IV antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study - History of congenital long QT syndrome or a corrected QT (QTc) interval > 450 ms at baseline - Ongoing cardiac dysrhythmia >/= Grade 2 - Unwillingness to practice effective birth control - Inability to comply with other requirements of the protocol ; PRIMARY OUTCOME: Best Objective Response Rate (BORR); SECONDARY OUTCOME 1: Time to BORR[/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 - SAD/MAD (Healthy Subjects); BRIEF: The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects. ; DRUG USED: MT-7117; DRUG CLASS: New Molecular Entity (NME); INDICATION: Porphyria; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Healthy and free from clinically significant illness or disease - Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65 - A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2 Exclusion Criteria: - Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks - Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, renal, cardiovascular or skin disease, or history of any significant psychiatric/psychotic illness disorder - Clinically relevant abnormal medical history, physical findings or laboratory values ; PRIMARY OUTCOME: Safety and Tolerability as measured by number of participants with adverse events; SECONDARY OUTCOME 1: Maximum plasma concentration (Cmax)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Geriatric/Younger Adults; BRIEF: This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body)properties of FIAsp (faster-acting insulin aspart) in geriatric and younger adult subjects with type 1 diabetes. ; DRUG USED: FIAsp; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female aged 18-35 years (both inclusive) (younger adult group) or below or equal to 65 years (geriatric group) at the time of signing informed consent - Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months - Body mass index (BMI) 18.5-28.0 kg/m^2 (both inclusive) Exclusion Criteria: - Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening - Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) - Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period ; PRIMARY OUTCOME: Area under the glucose infusion rate curve; SECONDARY OUTCOME 1: Area under the serum insulin aspart concentration-time curve[/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 - ECHO-305 w/Pembrolizumab; BRIEF: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1). ; DRUG USED: Epacadostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation. - Measurable disease based on RECIST 1.1. - Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥ 50% of tumor cells (tumor proportion score [TPS] ≥ 50%) as assessed by immunohistochemistry at a central laboratory. - Life expectancy of at least 3 months. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function per protocol-defined criteria. Exclusion Criteria: - Known untreated central nervous system metastases and/or carcinomatous meningitis. - History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. - Symptomatic ascites or pleural effusion. - Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. - Active autoimmune disease that has required systemic treatment in past 2 years. - Has had an allogeneic tissue/solid organ transplant. - Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority. - Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility. - History or presence of an abnormal electrocardiogram (ECG) that, in the Investigators opinion, is clinically meaningful. - Use of protocol-defined prior/concomitant therapy. ; PRIMARY OUTCOME: Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo; SECONDARY OUTCOME 1: Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo[/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 - PLX123-01; BRIEF: The purpose of this research study is to evaluate safety, pharmacokinetics and preliminary efficacy of the investigational drug PLX73086 in subjects with solid tumors including subjects with locally advanced or refractory tenosynovial giant cell tumor (TGCT). ; DRUG USED: PLX73086; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pigmented Villonodular Synovitis (PVNS); TARGET: Macrophage Colony Stimulating Factor 1 (M-CSF1)/M-CSF Receptor/FMS/CD115/CSF-1/CSF1R; THERAPY: Monotherapy; LEAD SPONSOR: Plexxikon; CRITERIA: Inclusion Criteria: - Age ≥ 18 years old. - Part 1: Subjects with solid tumors that are refractory to, relapsed after or intolerant to standard therapy, or for whom no standard therapy exists or who are considered by the investigator to be inappropriate for standard therapy. - Part 2: Subjects with histologically confirmed, locally advanced or refractory TGCT (including metastatic disease) that has been deemed unresectable by an orthopedic surgeon or similar qualified personnel. - Measurable disease by RECIST 1.1 criteria. - Women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of dosing and must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 3 months after the last dose of study drug, Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 3 months after the last dose of study drug. - All associated toxicity from previous or concurrent cancer therapy must be resolved (to ≤ Grade 1 or Baseline) prior to study treatment administration. - Willingness and ability to provide written informed consent prior to any study-related procedures and comply with all study requirements. - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. - Life expectancy ≥ 3 months. - Adequate hematologic, hepatic, and renal function. Exclusion Criteria: - Symptomatic brain metastases. - Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of PLX73086. - Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study. - Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Subjects with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible. - Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption. - Baseline mean QTcF ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening. - Clinically significant cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded - Congenital long QT syndrome or subjects taking concomitant medications known to prolong the QT interval (e.g., tricyclics, azithromycin, methadone). - History of clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months. - Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication). - Strong CYP3A4 inhibitors or inducers as well as inhibitors of breast cancer resistance protein (BCRP) within 14 days or 5 drug half-lives, whichever is longer, before start of study drug. - Subjects with > Grade 1 (high or low) serum potassium, magnesium, or calcium levels. - Women who are breast-feeding or pregnant. - Non-healing wound, ulcer, or bone fracture. - Known HIV-positive individuals on combination antiretroviral therapy. - Subjects with known active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy. - Uncontrolled intercurrent illness (i.e., active infection ≥ Grade 2) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the subjects ability to participate. - The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the subject inappropriate for inclusion in this study. ; PRIMARY OUTCOME: Safety of PLX73086, as measured by adverse events and serious adverse events [Part 1 and Part 2 of research study]; SECONDARY OUTCOME 1: Efficacy of PLX73086 measured by overall response rate (ORR) [Part 1 of research study][/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 102 (Australia); BRIEF: This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with advanced malignancies including solid tumors, lymphomas, leukemias and multiple myeloma. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells. ; DRUG USED: Marizomib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Proteasome; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Karnofsky Performance Status (KPS) > 70%. - Histologically-confirmed advanced malignancy for which a standard, approved therapy is not available. - Adequate renal, liver, pancreatic and hematologic function - Signed informed consent (sample IC form is provided in Appendix A). Exclusion Criteria - Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days - Patients that require G-CSF and/or platelet support during screening and are likely to require G-CSF and/or platelet support for the duration of the clinical trial. - Patients with ongoing coagulopathies and/or taking anticoagulants - Patients receiving intrathecal therapy. - Known brain metastases. - Pre-existing adrenal insufficiency; concomitant therapy with replacement corticosteroids. Pre-existing acute or chronic pancreatitis. - Significant cardiac disease. - Pregnant or breast-feeding women. - Concurrent, active secondary malignancy for which the patient is receiving therapy. (Lymphoma patients with a diagnosis of a potentially hormone-sensitive tumor who are without evidence of disease for this second malignancy may continue to receive hormonal therapy). - Patients with proteinuria Grade 2 or greater - Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics. - Patients who are known to be HIV positive or have active Hepatitis A, B, or C infection. ; PRIMARY OUTCOME: Determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NPI-0052; SECONDARY OUTCOME 1: To evaluate the pharmacokinetics activity of NPI-0052[/INST]No</s>