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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 I/II - Single Agent or w/Anti-Cancer Agents; BRIEF: APG-1387 is a potent, bivalent small-molecule Inhibitor of Apoptosis Protein (IAP) antagonist. APG-1387 has shown strong dose- and schedule-dependent antitumor activities in multiple human cancer xenograft models, APG-1387 also demonstrates its synergistic effect in combination with immune checkpoint inhibitor anti-PD-1 antibody, and such a combinatory effect was further enhanced by chemotherapeutic agent. A total of 35 patients with advanced solid tumors or lymphomas have been treated with APG-1387 in two Phase I dose-escalation studies in Australia and in China. Ten dose levels have been tested ranging from 0.3 mg to 45 mg in these two studies. Based on the preliminary results, APG-1387 is well-tolerated at the dose levels evaluated to date. APG-1387 is intended for the treatment of patients with advanced solid tumors and hematologic malignancies. After establishing the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several Ib /II studies will be implemented accordingly to further access the antitumor effects of APG-1387 in combination with either pembrolizumab or the chemotherapeutic agents. ; DRUG USED: APG-1387; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: IAPs (Inhibitor of apoptosis proteins); THERAPY: Monotherapy; LEAD SPONSOR: Ascentage Pharma Group Inc.; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically confirmed solid tumor or hematological malignancies 2. Life expectancy ≥ 3 months 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 4. Corrected QT interval (QTc) ≤ 450 ms in males, and ≤ 470 ms in females 5. Adequate hematologic function 6. International normalized ratio (INR), prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x upper limit of normal (ULN) 7. Adequate renal and liver function 8. Willingness to use contraception 9. Ability to understand and willingness to sign a written informed consent form 10. Willingness and ability to comply with study procedures and follow-up examination 11. Have provided tissue for biomarker analysis from a newly or recently-obtained biopsy of a tumor lesion not previously irradiated Exclusion Criteria: 1. Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to entering the study 2. Received hormonal, biologic (< 2 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days of study entry 3. Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days of study entry 4. Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Patients who have received prior radiotherapy for previous brain metastasis must have discontinued steroids for 14 days prior to study entry and be clinically stable 5. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia 6. Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid 7. Use of therapeutic anticoagulants 8. International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≥ 1.5 x ULN 9. Concurrent treatment with an investigational agent or device within 28 days prior to the first dose of therapy 10. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry 11. Neurologic instability per clinical evaluation due to tumor involvement of the central nervous system (CNS) 12. History of Bells palsy 13. Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation 14. Active infection requiring systemic antibiotic/ antifungal medication 15. Known or suspected Wilsons Disease 16. Prior treatment with IAP inhibitors 17. History of hypersensitivity to paclitaxel, or any therapeutic antibody 18. Has an active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents 19. Is on chronic systemic steroid therapy 20. Has received a live vaccine within 30 days prior to first dose 21. Has had an allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Anti-tumor effects of APG-1387 as a single agent[/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 - Weill Medical College (Cornell); BRIEF: Previous experience with antibody therapy in both NHL and CLL warrants further exploration of new antibody treatments for these diseases. Immunomedics has developed hLL1 (previously designated EPB-1), which is a CDR-grafted, fully humanized monoclonal antibody specifically targeting CD74.38 The human IgG1 backbone for hLL1 is the same as hLL2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated in clinical trials of patients with B-cell malignancies and autoimmune disorders. This is a Phase I, open-label, study conducted in patients with recurrent non-Hodgkins lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who have progressed after at least one prior standard treatment. All patients will receive hLL1 administered intravenously once daily Monday through Friday of each of 2 consecutive weeks (10 total doses.) Patients will be assigned to a cohort for hLL1 treatment dose assignment (escalating doses of hLL1 per statistical plan) in order to determine the maximum tolerated dose (MTD) for this administration schedule. ; DRUG USED: Milatuzumab; DRUG CLASS: Biologic; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Cluster of Differentiation 74 (CD74); THERAPY: Monotherapy; LEAD SPONSOR: Weill Medical College of Cornell University; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of recurrent B cell non-Hodgkins lymphoma or diagnosis of recurrent chronic lymphocytic leukemia - Patient has received at least one prior treatment with standard chemotherapy and at least one prior treatment with rituximab (negative HAHA test required if received prior humanized antibody treatment) - Patient has not received anti-cancer therapy within 28 days of treatment unless disease progression has been demonstrated and toxicities from prior therapy have resolved - Available tumor tissue (lymph node/mass, blood or bone marrow) for correlative analyses (paraffin or frozen, recent or archived) - Measurable disease as defined by a tumor mass > 1.5 cm in one dimension or WBC > 5,000 (CLL patients) - Age > 18 years - Patient has KPS > 50% - Absolute granulocyte count > 1000 cells/mm3 - Platelet count > 50,000 cells/mm3 - Creatinine < 2.0 x ULN - Total bilirubin < 2.0 x ULN - Patient agrees to use birth control if of reproductive potential - Patient has signed IRB-approved informed consent Exclusion Criteria: - Known central nervous system (CNS) involvement by lymphoma - Known HIV disease - Patient is pregnant or nursing - Patient is receiving other investigational drugs - Known serum human anti-human antibodies (HAHA) - Estimated life expectancy of < 3 months ; PRIMARY OUTCOME: To determine the toxicity profile and maximum tolerated dose (MTD) of hLL1 when administered to patients with recurrent non-Hodgkins lymphoma and chronic lymphocytic leukemia; 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 - Rituxan Refractory Indolent NHL (China); BRIEF: The primary objective of the study is to determine the overall response rate (ORR), which includes complete response (CR) and partial response (PR), to bendamustine treatment in participants with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a rituximab-containing therapy. ; DRUG USED: Treanda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: DNA, p53; THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - The participant has documented relapse from indolent B-cell NHL. Participants with the following subtypes of indolent NHL are eligible for this study: i) small lymphocytic lymphoma (peripheral B cell count <5000 cells/cubic millimeters [mm^3]) ii) lymphoplasmacytic lymphoma iii) splenic marginal zone B-cell lymphoma (±villous lymphocytes) iv) extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type v) nodal marginal zone lymphoma (±monocytoid B-cells) vi) follicle center lymphoma vii) follicular (grade 1, 2, or 3a) lymphoma - The participant has disease documented to have progressed despite rituximab treatment. The participants disease is considered to be rituximab refractory if any of the following criteria are met at any time during the participants treatment history (progression must be documented by computed tomography [CT] scan or magnetic resonance imaging [MRI] or biopsy) or if a participant has palpable lymph nodes that were well documented in size and, after rituximab treatment, palpable disease remains or comes back [CT, MRI, or biopsy is preferred and performed whenever possible to document progressive disease (PD)]: i) rituximab-only regimen: Participants who receive a full course of single-agent rituximab (at least 2 doses of 375 mg/m^2 [or a therapeutically-active dose] weekly) and have no response (do not obtain a PR or better) to treatment or progress after a full regimen of rituximab was given. ii) rituximab maintenance therapy or extended schedule: Participants who have a history of a full course of rituximab (at least 2 doses of 375 mg/m^2 [or a therapeutically-active dose] as a single agent [weekly] or in combination with chemotherapy [day 1 of each of 4 cycles]) and are on a maintenance regimen, and progress before the next scheduled rituximab dose or after completing a maintenance rituximab regimen. iii) rituximab-chemotherapy combination regimen: Participants who receive a full course of rituximab (at least 2 doses of 375 mg/m^2 or a therapeutically-active dose [on day 1 of each of 2 cycles]) in combination with chemotherapy and have no response (do not obtain a PR or better) to treatment or progress after the last dose of rituximab in a regimen. iv) full rituximab exposure treatment: Participants who have a history of a full course of rituximab treatment (at least 2 doses of 375 mg/m^2 [or a therapeutically-active dose] as a single agent or in combination with chemotherapy) and, in a subsequent rituximab/chemotherapy combination regimen, have no response (do not obtain a PR or better) to treatment or progress after the last dose of rituximab in a given regimen, even if the subsequent regimen included less than 2 doses of rituximab. Participants could receive additional systemic treatment after the qualifying rituximab regimen. - The participant has received treatment with at least 1, but no more than 3, previous chemotherapy regimens. A regimen is defined as a new treatment combination or agent. Retreatment with the identical regimen or agent does not count as a new regimen; however, change from cyclophosphamide, vincristine, and prednisolone (CVP) to cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) is counted as a new regimen. Rituximab, radioimmunotherapy, or other biologic treatments not combined with chemotherapy are not counted as a regimen. - The participant has a bidimensionally measurable disease with at least 1 lesion measuring 2.0 centimeters (cm) or more in a single dimension. Participants who have previous involved-field irradiation can be included, provided the irradiated area is not the only source of measurable disease. - The participant has a World Health Organization (WHO) performance status of 0, 1, or 2. - The participant has absolute neutrophil count (ANC) 1000 cells/mm^3 or more and platelet count 85000 cells/mm^3 or more. - The participant has a creatinine clearance of more than 30 mL/min as determined by the Cockcroft-Gault calculation. - The participant has adequate hepatic function (no more than 2.5 times the upper limit of normal (ULN) for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and no more than 1.5 times the upper limit of the normal range (ULN) for total bilirubin). Participants with nonclinically significant elevations of bilirubin due to Gilberts disease are eligible. - The participant has had a bone marrow biopsy within 6 weeks before the 1st dose of bendamustine. - Women of childbearing potential (not surgically sterile or 1 year postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method starting 2 weeks before the start of study drug treatment, during study drug treatment, and for 3 months after the end of study drug treatment. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. - Women of childbearing potential must have a negative serum or urine pregnancy test. - Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method starting 2 weeks before the start of study drug treatment, during study drug treatment, and for 3 months after the end of study drug treatment. - The participant has an estimated life expectancy of at least 3 months. - The participant (or participants legal representative) provides written informed consent. Exclusion Criteria: - The participant has received previous radiotherapy, radioimmunotherapy, chemotherapy, or immunotherapy within 4 weeks before day 1 of cycle 1 or has failed to recover (to Common Terminology Criteria for Adverse Events [CTCAE] toxicity grade 1 or 2) from clinically significant nonhematologic adverse events due to any agents administered previously. - The participant has received treatment with an investigational agent within 4 weeks of day 1 of cycle 1. - The participant has received hematopoietic growth factors within 4 weeks of day 1 of cycle 1. However, participants receiving chronic erythropoietin treatment are eligible for inclusion in this study. - The participant has a history of previous high-dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible). - The participant is receiving or has received treatment with therapeutic doses of systemic steroids within 4 weeks of day 1 of cycle 1. (Low doses of chronic steroids [prednisone or equivalent] up to 20 mg/day for non-neoplastic disorders or for indications other than lymphoma or lymphoma-related complications are permitted.) - The participant has transformed disease. - The participant has any history of central nervous system (CNS) or leptomeningeal lymphoma. - The participant has, or has had within the past 5 years, an active malignancy other than the target cancer. The exceptions are prostate cancer (Gleason grade <6 with prostate specific antigen [PSA] levels within the normal range), in situ cervical or breast carcinoma, and nonmelanoma skin cancer that have received definitive treatment. - The participant is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study immediately.) - The participant has a serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives. - The participant is known to be positive for human immunodeficiency virus (HIV), have active hepatitis B, or active hepatitis C (anti-hepatitis C virus [HCV] positive). Hepatitis B surface antigen must be tested. The determination of active disease is left up to the Investigator. - The participant has a known hypersensitivity to mannitol. - The participant has used bendamustine previously. ; PRIMARY OUTCOME: Overall Response Rate (ORR) (Assessed by Independent Review Committee [IRC]); SECONDARY OUTCOME 1: Duration of Response (DOR) (Assessed by IRC)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Ipilimumab or IFN-Alpha-2b; BRIEF: This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG-interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Atezolizumab will be administered as intravenous (IV) infusion every 3 weeks (q3w). ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically or cytologically documented locally advanced or metastatic solid tumors meeting the following study drug-specific criteria: - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 - Life expectancy greater than or equal to (>/=) 12 weeks - Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end organ function as confirmed by laboratory results within 14 days prior to the first study treatment Inclusion criteria specific to Arm A: Atezolizumab+ Ipilimumab - Escalation stage: NSCLC participants - Mandatory biopsy cohort: NSCLC or melanoma atezolizumab - Prior atezolizumab-treated cohort: participants with NSCLC or melanoma previously treated with atezolizumab Inclusion criteria specific to Arm B: Atezolizumab+ Interferon alfa-2b - Escalation stage: RCC or melanoma participants - Expansion stage: RCC or melanoma participants - Mandatory biopsy cohort: RCC or melanoma participants - Prior immunotherapy-treated cohort: participants with RCC, NSCLC, or melanoma previously treated with programmed death-ligand 1 (PD-L1)/ Programmed death 1 (PD-1) Inclusion Criteria Specific to Arm C (Atezolizumab plus PEG-Interferon Alafa-2a): - Cohort 1: participants with RCC Inclusion Criteria Specific to Arm D (Atezolizumab plus PEG-Interferon Alfa-2a +Bevacizumab) - Cohort 1: participants with metastatic RCC with no prior line of systemic therapy for metastatic disease - Cohorts 2-3: disease progression during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic non-squamous solid tumors; participants with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements must have failed or are intolerant to prior treatment with EGFR or ALK inhibitors; participants with melanoma with actionable BRAF mutations (e.g., V600) must have failed or are intolerant to prior treatment with BRAF inhibitors Inclusion Criteria Specific to Arm E (Atezolizumab +Obinutuzumab) - R/M HNSCC participants with at least one prior line of systemic therapy Inclusion Criteria Specific to prior Anti-PD-L1/PD-1 Treated Cohorts: - No permanent discontinuation of atezolizumab or other immunotherapies due to a treatment-related adverse event - Recovery from all immunotherapy-related adverse events to Grade less than or equal to (≤) 1 or baseline at the time of consent Exclusion Criteria: General Medical Exclusions: - Pregnant and lactating women - Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the following exception: (1) hormone-replacement therapy or oral contraceptives; (2) tyrosine kinase inhibitors (TKIs) that have been discontinued greater than (>) 7 days prior to Cycle 1, Day 1, baseline scans must be obtained after discontinuation of prior TKIs - Investigational therapy within 28 days prior to initiation of study treatment - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of the atezolizumab formulation - History of or active autoimmune disease - History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, risk of pulmonary toxicity, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - Prior allogeneic bone marrow transplantation or prior solid organ transplantation - History of human immunodeficiency virus (HIV) - Participants with active hepatitis B - Participants with active hepatitis C - Participants with active tuberculosis - Participants with a history of confirmed progressive multifocal leukoencephalopathy - Any serious medical condition, physical examination finding, or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the participants safe participation in and completion of the study Cancer-Specific Exclusions: - Active or untreated central nervous system (CNS) metastases, as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments - Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >/= 2 weeks prior to screening - Leptomeningeal disease - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); participants with indwelling catheters are allowed. - Uncontrolled tumor-related pain - Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab - History of other malignancy within 2 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated surgically with curative intent, or other cancers with a similar outcome Exclusion Criteria Related to Medications: - Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies (Note: Participants enrolled in the prior anti-PD-L1/PD-1 treated cohorts with melanoma may have received prior anti-cytotoxic T-lymphocyte-associated protein 4 treatment or other immunotherapies) - Treatment with systemic immunostimulatory agents within four weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1 - Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1 (the use of inhaled corticosteroids and mineralocorticoids is allowed) Exclusion Criteria Specific to Interferon Alpha Therapy (Arms B-D): - History of depression, suicidal ideation or behavior, bipolar disorder, or psychosis - Hypersensitivity to interferon alpha or any component of the product Exclusion Criteria Specific to Bevacizumab (Arm D) - Inadequately controlled hypertension - Prior history of hypertensive crisis or hypertensive encephalopathy - Significant vascular disease within 6 months prior to Day 1 - History of hemoptysis - Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) - History of tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 - Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding - Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure - Proteinuria, as demonstrated by urine dipstick or > 1.0 gram of protein in a 24-hour urine collection - Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume Exclusion Criteria Specific Obinutuzumab (Arm E) - Hypersensitivity to obinutuzumab - Prior treatment with obinutuzumab ; PRIMARY OUTCOME: Recommended Phase II Dose (RP2D) of Atezolizumab When Given in Combination With Ipilimumab and Interferon Alfa-2b; SECONDARY OUTCOME 1: Percentage of Participants with Best Overall Response, as Assessed Using Conventional Response Evaluation Criteria in Solid Tumors (RECIST) v1.1[/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 - C-002 ; BRIEF: The purpose of this study is to evaluate the safety and tolerability of two dose levels of OP0201 and placebo, when administered intranasally in healthy adults subjects. ; DRUG USED: OP0201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ear Infections (Antibacterial); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Novus Therapeutics, Inc; CRITERIA: Inclusion Criteria includes but is not limited to: 1. Body mass index of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at Screening. 2. Able and willing to follow study instructions (including compliance with daily study treatment administration) and likely to complete all required study visits as assessed by the Investigators judgement. 3. Female subjects must agree to use an acceptable method of contraception (for pregnancy considerations and contraceptive requirements). 4. Female subjects who are of childbearing potential must have a negative urine pregnancy test result at Screening and Day -1 prior to randomization. 5. Male subjects must agree to use contraception 6. Subjects must agree to refrain from immersing their head fully under water (eg, swimming, diving) from the time of signed informed consent until after the study exit visit. 7. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee. Exclusion Criteria includes but is not limited to: 1. History or presence of significant medical condition or a clinically significant abnormal finding, as determined by the Investigator. 2. Presence of a clinically significant abnormal olfactory test finding at Screening defined as a total UPSIT score <35 (for females) and <34 (for males). 3. Clinically significant ear disorder/disease currently or within 6 weeks prior to Screening. 4. History of tympanostomy tubes in one or both ears within 1 year prior to Screening. 5. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to Screening. 6. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to Screening. 7. Clinically relevant blockage of one or both nasal passages, in the Investigators opinion. 8. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening. ; PRIMARY OUTCOME: Number of Participants With of Adverse Events; SECONDARY OUTCOME 1: Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint[/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 - J204 (Japan); BRIEF: The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin. ; DRUG USED: DS-8500; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GPR119/Glucose-Dependent Insulinotropic Receptor (GDIR); THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo Co., Ltd.; CRITERIA: Inclusion Criteria: - Japanese patients with type 2 diabetes - Patients aged ≥ 20 years at the time of informed consent - Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus - Patients who have HbA1c ≥ 7.0% and < 9.0% Exclusion Criteria: - Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis - Patients receiving or requiring treatment with insulin - Patients with a body mass index (BMI) of < 18.5 kg/m2 or ≥ 35.0 kg/m2 - Patients with clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of < 45 mL/min per 1.73 m2) or clinically significant renal disease - Patients with fasting plasma glucose ≥ 240 mg/dL ; PRIMARY OUTCOME: change in 24 hour weighted mean glucose; SECONDARY OUTCOME 1: change in fasting plasma glucose[/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 - Study 301; BRIEF: This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD. ; DRUG USED: Dasotraline; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: - Subject is male or female, 18 to 55 years old, inclusive, at the time of informed consent. - Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined subtype) established by a comprehensive psychiatric evaluation that reviews psychiatric criteria. Diagnosis is confirmed by Adult ADHD Clinical Diagnostic Scale (ACDS). Note: The diagnosis of ADHD and appropriateness of inclusion in the trial will be independently confirmed by external expert review. Experts will review diagnostic and other screening instruments for each subject and approval is required before a subject can be randomized. The Mini International Neuropsychiatric Interview (MINI) will be administered to confirm the absence of any other comorbid psychiatric disorders. - Subject has an ADHD RS IV with adult prompts total score of ≥ 26 at screening and at Baseline. - Subject has a CGI S score of ≥ 4 at screening and at Baseline. - Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug at screening. - If the subject has a positive drug screen for ADHD medications (eg, amphetamine) at screening, the subject must have a negative repeat UDS at least 7 days before baseline. - Subject is male or a non pregnant, non lactating female. - Female subjects must have a negative serum pregnancy test at screening; females who are post menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test. - Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use an effective and medically acceptable form of birth control, as defined in Section 10.4, throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion. - Subject must have a stable living arrangement that allows for consistent participation for the full duration of the study. - Subject must be able to comply with study medication administration and adhere to protocol requirements. - Subject can read well enough to understand the informed consent form and other subject materials. - Subjects must complete a practice trial for the TASS assessment at one timepoint during Screening. Exclusion Criteria: - Subject has a ≥ 25% improvement on the ADHD RS IV total score between screening and baseline. - Subject has a psychiatric disorder other than ADHD that has been the primary focus of treatment at any time during the 12 months before screening. - Subject has a past history of, or current presentation consistent with, bipolar disorder (including bipolar I and bipolar II), schizophrenia, schizoaffective disorder, or any other psychotic disorder; a personality disorder per DSM 5 criteria. - Subject has a history of drug dependence or Substance Related Disorder (excluding nicotine and caffeine) within the 12 months before screening, as defined by DSM 5 criteria. -- Subject has Hamilton Anxiety Rating Scale (HAM A) total score ≥ 21 at screening and baseline. - Subject has PSQI total score ≥ 8 at screening or baseline or moderate to severe insomnia as determined by the Investigator. - Subject has a history of non-response (per clinician judgment) to two adequate treatment regimens of stimulant or non-stimulant treatment for ADHD. - Subject has a history of epilepsy, seizures (except childhood febrile seizures), unexplained syncope or other unexplained blackouts (except single incident), or head trauma with loss of consciousness lasting more than 5 minutes, or a history of clinically significant multiple head traumas without loss of consciousness. - Subject has an acute or chronic medical condition (other than ADHD) that in the opinion of the investigator could confound clinical assessments or interfere with the ability of the subject to participate in the study. - Subject is currently taking or has taken within 6 weeks prior to screening an antidepressent medication; antipsychotic medication; or lithium (any lithium preparation or formulation). - Subject is currently taking or has taken within the previous 6 months an anticonvulsant medication (eg, phenytoin, carbamazepine, lamotrigine, valproic acid); antipsychotic medication; or lithium (any lithium preparation or formulation). - Subject is currently taking an alpha 2 adrenergic receptor agonist (including clonidine and guanfacine). - Subject has a life-time history of a pattern of abuse or diversion of stimulants. - Subject has a body mass index (BMI) less than 18 or greater than 35 kg/m2 at screening or baseline. - Subject answers yes to suicidal ideation item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at screening (in the past month). Subjects who answer yes to this question must be referred to the Investigator for follow up evaluation. - Subject has attempted suicide within 2 years before the screening period. - Subject has history of positive test for Hepatitis B surface antigen or Hepatitis C antibody and has liver function test results at screening above the upper limit of normal (ULN) for the reference laboratory. - Subject is known to have tested positive for human immunodeficiency virus (HIV). - Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study. - The subjects screening ECG shows a corrected QT interval using Fridericias formula (QTcF) of ≥ 450 msec for male subjects or ≥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report. - The subjects screening hematology results show an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value ≥ 2 times the ULN, or a blood urea nitrogen (BUN) value ≥ 1.5 times the ULN for the reference range. - Subject has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study medication formulation. - Subject is currently participating or has participated in a clinical trial within the last 90 days or has participated in more than 2 clinical trials within the past year. This includes studies using marketed compounds or devices. Note: Subjects will be checked for multiple study enrollments by site staff. - Subject has been incarcerated in a prison within 12 months prior to Screening. - Subject has previously been randomized in a clinical trial of dasotraline. - Subject is an investigational site staff member or the relative of an investigational site staff member. ; PRIMARY OUTCOME: Change from baseline at Week 8 in ADHD symptoms measured by the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score.; SECONDARY OUTCOME 1: Change from baseline in ADHD symptoms measured with the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score at Weeks 1, 2, 4, and 6.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - B2601003 (Extension to B2601001); BRIEF: This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimers Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patients participation will last approximately 52 weeks. ; DRUG USED: PF-05236812; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Successful completion of study B2601001 - MMSE 12 or greater Exclusion Criteria: - Study B2601001 Week 32 MRI with clinically important exclusionary findings. - Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001 ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs); 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 - Study 046; BRIEF: The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied. ; DRUG USED: Ixempra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: R-Pharm; CRITERIA: - Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy. - Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel). - Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline. - Patients must be resistant to taxane therapy. - Patients may not have any history of brain and/or leptomeningeal metastases. - Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory). - Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda) ; PRIMARY OUTCOME: Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC); SECONDARY OUTCOME 1: Overall Response Rate (ORR) Per IRRC[/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 - ARIES 2 (Europe, S. America, Israel); BRIEF: A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension. ; DRUG USED: Letairis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Endothelin Receptor Type A (EDNRA); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - 18 years of age and older - Current diagnosis of either PPH or PAH secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or HIV infection at the Screening Visit - Right heart catheterization, completed prior to Screening Visit must meet pre-specified hemodynamic criteria - Female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit - Male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the Informed Consent Form Exclusion Criteria: - PAH due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea - Portopulmonary hypertension - Bosentan within four weeks prior to Screening - Phosphodiesterase type V inhibitor or chronic prostanoid therapy within four weeks prior to Screening - IV inotrope use within two weeks prior to Screening - ALT or AST lab value that is greater than 1.5 times the upper limit of normal - Pulmonary function tests not meeting pre-specified criteria - Contraindication to treatment with an ERA - History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years - Females who are pregnant or breastfeeding ; PRIMARY OUTCOME: Change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo.; SECONDARY OUTCOME 1: Change from baseline measured after 12 weeks of treatment compared to placebo in the Borg Dyspnea Index immediately following exercise, WHO functional class and SF-36 Health Survey.[/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 - HGT-HIT-045; BRIEF: Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously. A new formulation of idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration. This Phase I/II study is designed to obtain necessary safety and exposure data, as well as secondary and exploratory outcome measures, to be interpreted and used in the design of subsequent clinical trials. ; DRUG USED: TAK-609; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis II (MPS II; Hunter Syndrome); TARGET: Sulfated alpha-L-iduronic acid; THERAPY: Combination; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: 1a. A deficiency in iduronate-2-sulfatase enzyme activity of ≤10 % of the lower limit of the normal range as measured in plasma, fibroblasts, or leukocytes (based on normal range of measuring laboratory) AND 1b. A documented mutation in the iduronate-2-sulfatase gene OR A normal enzyme activity level of one other sulfatase as measured in plasma, fibroblasts, or leukocytes (based on normal range of measuring laboratory). 2. The patient is male and is ≥3 and <18 years of age . 3. The patient has evidence at Screening of early stage (duration and severity metrics per protocol) Hunter syndrome-related Central Nervous System (CNS) involvement, defined as: - The patient has an Intelligence quotient (IQ) ≤77 OR - There is evidence of a change of ≥1 but ≤2 standard deviations decline from a previous protocol-defined neurodevelopmental assessment. The duration of protocol-defined neurologic involvement is at least 3 months but less than 36 months as documented in the patients medical history. 4. The patient has received and tolerated a minimum of 6 months of treatment with weekly intravenous idursulfase, and has received 80% of the total planned infusions within that time frame, including having received 100% of the planned infusions within 4 weeks immediately preceding the surgical insertion of the IDDD. 5. The patient must have sufficient auditory capacity, with or without aids, to complete the required protocol testing, and be compliant with wearing the aid on scheduled testing days. 6. The patient, patients parent(s), or legally authorized guardian(s) must have voluntarily signed an Institutional Review Board / Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. The guardians consent must be obtained. Exclusion Criteria: 1. The patient has clinically significant non-Hunter syndrome-related CNS involvement which is judged by the Investigator to be likely to interfere with the accurate administration and interpretation of protocol assessments. 2. The patient has an IQ ≥78 3. The patient has a CNS shunt. 4. The patient has experienced an infusion-related anaphylactoid event or has evidence of consistent severe adverse events related to treatment with Elaprase which, in the Investigators opinion, may pose an unnecessary risk to the patient. 5. The patient has any known or suspected hypersensitivity to anesthesia or is thought to be at an unacceptably high risk for anesthesia due to compromised airways or other conditions 6. The patient has a history of complications from previous lumbar punctures or technical challenges in conducting lumbar punctures such that the potential risks would exceed possible benefits for the patient. 7. The patient or patients family has a history of neuroleptic malignant syndrome, malignant hyperthermia, or other anesthesia-related concerns. 8. The patient has a history of poorly controlled seizure disorder. 9. The patient has a significant medical or psychiatric comorbidity(ies) that might affect study data or confound the integrity of study results. 10. The patient is currently receiving chronic psychotropic therapy (e.g., neuroleptics, benzodiazepines, antidepressants, anticonvulsants, stimulants, etc.) which in the Investigators opinion would likely affect the neurocognitive assessments. Intermittent use of selected short half-life agents (benzodiazepine, sedatives, etc.) may be permitted as long as there are 5 half-lives between last drug administered and study-related procedures including neurocognitive assessments. 11. The patient has received treatment with any investigational drug or device within the 30 days prior to study entry. 12. The patient has received a cord blood or bone marrow transplant at any time, or has received blood product transfusions within 90 days prior to Screening. 13. The patient is unable to comply with the protocol, (e.g., has significant hearing or vision impairment, a clinically relevant medical condition making implementation of the protocol difficult, unstable social situation, known clinically significant psychiatric/behavioral instability, is unable to return for safety evaluations, or is otherwise unlikely to complete the study), as determined by the Investigator. 14. The patient has skeletomuscular/spinal abnormalities or other contraindications for the surgical implantation of the IDDD. 15. The patient has an opening CSF pressure upon lumbar puncture that exceeds 30 cm H2O(water) . ; PRIMARY OUTCOME: Number of Serious Adverse Event (SAE); SECONDARY OUTCOME 1: Change From Baseline in CSF Glycosaminoglycans [GAGs] at Week 27[/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 - LIBRETTO-121; BRIEF: This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor. ; DRUG USED: Retevmo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: RET; THERAPY: Monotherapy; LEAD SPONSOR: Loxo Oncology, Inc.; CRITERIA: Inclusion Criteria: - Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies - Evidence of an activating RET gene alteration in the tumor and/or blood - Measurable or non-measurable disease - Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50 - Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days - Adequate hematologic, hepatic and renal function. - Ability to receive study drug therapy orally or via gastric access - Willingness of men and women of reproductive potential to observe conventional and effective birth control Exclusion Criteria: - Major surgery within two weeks prior to planned start of LOXO-292 - Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 - Active uncontrolled systemic bacterial, viral, fungal or parasitic infection - Clinically significant active malabsorption syndrome - Pregnancy or lactation - Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292) - Uncontrolled symptomatic hypercalcemia or hypocalcemia - Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension - Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]) ; PRIMARY OUTCOME: To Determine the Safety of Oral LOXO-292 in Pediatric Participants with Advanced Solid Tumors: Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Plasma Concentrations of LOXO-292[/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/Regorafenib; BRIEF: The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: JAK/STAT ; THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic. - Previous treatment with fluoropyrimidine-, oxaliplatin- and irinotecan- based chemotherapy, an anti-VEGF therapy (if no contraindication) and if KRAS wild type and no contraindication, an anti-EGFR therapy. - Radiographically measurable or evaluable disease (per RECIST v1.1) - Life expectancy of ≥ 12 weeks. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 - Three or more weeks have elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities. - Prior radiotherapy to disease sites is allowed with certain protocol-defined restrictions. Exclusion Criteria: - Prior treatment with regorafenib. - Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs. - Active peptic ulcer disease, inflammatory bowel disease (eg, ulcerative colitis, Crohns disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding. - Recent history (≤ 3 months) or ongoing partial or complete bowel obstruction unless due to disease under study and corrected with surgery. - Blood pressure ≥ 140/90 mmHg. - Active bleeding diathesis or history of any major bleeding (eg, requiring transfusion of red blood cells (RBCs), central nervous system (CNS) bleeding, or significant hemoptysis within 6 months of enrollment. Subjects with bleeding secondary to underlying disease (including gastrointestinal (GI) perforation or fistula) that has been corrected by surgery or alternative procedure may be included. - Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class II, III, or IV congestive heart failure, and arrhythmia requiring therapy. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MO22201; BRIEF: This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. ; DRUG USED: Tarceva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - adult patients, >=18 years of age; - advanced (stage IIIB/IV)non-small cell lung cancer; - measurable disease; - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. Exclusion Criteria: - prior exposure to agents directed at the HER axis; - prior chemotherapy or systemic anti-tumor therapy after advanced disease; - unstable systemic disease; - any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix; - brain metastasis or spinal cord compression. ; PRIMARY OUTCOME: Median Progression Free Survival (PFS) Time; SECONDARY OUTCOME 1: Percentage of Participants Alive and Free From Disease Progression[/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 - w/Exemestane (ER/PR+); BRIEF: The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer. ; DRUG USED: Xtandi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Androgen receptors; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Willing and able to provide informed consent; - Postmenopausal; - Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal; - Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed; - Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report; - Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible; - Eastern Cooperative Oncology Group (ECOG) status of 0 or 1; Exclusion Criteria: - Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator; - Any condition or reason that interferes with the patients ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator; - Current or previously treated brain metastasis or leptomeningeal disease; - Prior therapy (> 28 days) with exemestane in the metastatic setting (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible); - Requires treatment for tuberculosis or HIV infection; - Radiation therapy within 7 days before randomization; - History of another invasive cancer within 5 years before randomization; - History of seizure or any condition that may predispose to seizure; - Clinically significant cardiovascular disease; - Active gastrointestinal disorder; - Major surgery within 28 days prior to randomization; - Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization; - Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor; - Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides; - Hypersensitivity reaction to exemestane. ; PRIMARY OUTCOME: Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS); SECONDARY OUTCOME 1: Clinical Benefit Rate-24 (CBR-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 III - IMAGINE 7 (Crossover); BRIEF: The primary purpose of participation in this study is to compare the safety and efficacy of different dosing schedules of LY2605541 and how different dosing schedules of LY2605541 affect Hemoglobin A1c (HbA1c). Participants will be treated for up to 36 weeks with LY2605541 (one 12-week Lead-in period and two 12-week Randomization periods) and will participate in a total of 42 weeks of total study enrollment, including a 2-week Screening period and a 4-week Follow-up period. ; DRUG USED: LY2605541; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Type 1 diabetes mellitus for at least 1 year - Have an HbA1c value <9.0% - Have a body mass index (BMI) ≤35.0 kilogram per square meter (kg/m^2) - Currently using basal/ bolus insulin - Women of childbearing potential are not breastfeeding and must use methods to prevent pregnancy Exclusion Criteria: - Have excessive insulin resistance - Are taking medications other than insulin for diabetes - High triglycerides - Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia as determined by the investigator) within 6 months prior to entry into the study - Have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or diabetic ketoacidosis) in the past 6 months - Have cardiac disease with functional status that is New York Heart Association (NYHA) Class III or IV (per NYHA Cardiac Disease Classification) - Have impaired renal function - Have impaired liver function - Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c measurement - Have cancer, recent cancer, or risk of cancer - Have a known hypersensitivity or allergy to any of the study insulins or their excipients - Have chronic systemic glucocorticoid users - Have clinically significant diabetic autonomic neuropathy - Have irregular sleep/wake cycle - Have been treated with a drug within the last 30 days that has not received regulatory approval at the time of study entry - Prior study participation - Are using or have used niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening ; PRIMARY OUTCOME: Hemoglobin A1c (HbA1c) at 12 Weeks; SECONDARY OUTCOME 1: 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events[/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 - PomdeSAR (w/PomDex); BRIEF: Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: - To evaluate the infusion duration (Part B). - To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). - To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). - To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of pomalidomide when administered in combination (Part A). - To describe the efficacy of the combination of SAR650984 with Pd in terms of overall response rate and clinical benefit rate based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (Part A and B). - To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density at baseline (Part A). ; DRUG USED: Sarclisa; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Cluster of Differentiation 38 (CD38); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Patient has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria. - Patient had received at least two previous therapies including lenalidomide and proteasome inhibitor and have demonstrated disease progression on therapy or after completion of the last therapy. - Patients with measurable disease defined as at least one of the following: - Serum M protein ≥0.5 g/dL (≥5 g/L); - Urine M protein ≥200 mg/24 hours; - Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65). Exclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status >2. - Poor bone marrow reserve. - Poor organ function. - Known intolerance/hypersensitivity to IMiDs, dexamethasone, boron or mannitol, sucrose, histidine or polysorbate 80. - Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the Investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results. - Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Dose Limiting Toxicities (DLTs); 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/II - PLATFORM (w/durvalumab); BRIEF: This is a global, open-label, multi-arm, parallel multi-cohort, multi-center, Phase 1/2 study to determine the safety, tolerability, PK, efficacy and patient-reported quality of life of JCAR017 in combination with various agents. This protocol is intended to evaluate various drug combinations with JCAR017, as separate arms, over the life of the protocol, using the same objectives. Each combination will be evaluated separately (ie, the intention is not to compare between combinations) for the purposes of the objectives, trial design, and statistical analysis. The following combinations will be tested: Arm A: JCAR017 in combination with durvalumab Arm B: JCAR017 in combination with CC-122 (avadomide) Arm C: JCAR017 in combination with CC-220 (iberdomide) Arm D: JCAR017 in combination with ibrutinib Arm E: JCAR017 in combination with relatlimab and/or nivolumab Arm F: JCAR017 in combination with CC-99282 Additional arms will be added by way of amendment once combination agents have been selected. The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms. ; DRUG USED: Breyanzi; DRUG CLASS: Biologic; INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, T lymphocytes; THERAPY: Combination; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (). 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 4. Subject must have aggressive B-cell NHL according to the 2016 revision of the WHO classification of lymphoid neoplasms, histologically confirmed at last relapse by the treating institution, defined as: 1. Diffuse large B-cell lymphoma (DLBCL) Not otherwise specified (NOS) including transformed indolent Non-Hodgkin lymphoma (NHL) 2. Follicular lymphoma Grade 3B 3. T cell/histiocyte-rich large B-cell lymphoma 4. Epstein-Barr virus (EBV) positive DLBCL, NOS 5. Primary mediastinal (thymic) large B-cell lymphoma 6. High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma) 5. Subjects disease must have relapsed or be refractory to at least 2 prior lines of therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline. 6. Subject must have 1. Positron emission tomography (PET)-positive (Deauville score 4 or 5) and computed tomography (CT) measurable disease as per Lugano Classification 2. Sum of product of perpendicular diameters (SPD) of up to 6 index lesions ≥ 25 cm2 by CT scan (not applicable to Arm A or B or subjects with Richters transformation) 7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at screening 8. Adequate organ function 9. Subjects must agree to not donate blood, organs, sperm or semen, and egg cells for usage in other individuals 10. Participants must agree to use effective contraception Exclusion Criteria: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study based on investigator´s judgment. 2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study based on investigator´s judgment. 3. Subject has any condition that confounds the ability to interpret data from the study based on investigator´s judgment. 4. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following non-invasive malignancies: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin 3. Carcinoma in situ of the cervix 4. Carcinoma in situ of the breast 5. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative. 6. Other completely resected stage 1 solid tumor with low risk for recurrence 5. Prior treatment with any prior gene therap y product 6. Prior treatment with any adoptive T cell therapy; prior hematopoietic stem cell transplant (HSCT) is allowed 7. Allogeneic HSCT within 90 days of leukapheresis 8. Prior treatment with the combination agent from the assigned arm: 1. Anti PD-1 or PD-L1 (Arm A and E) 2. CC-122 (Arm B) 3. CC-220 (Arm C) 4. Prior treatment with ibrutinib is not exclusionary for subjects on any study arm 5. Anti LAG-3 targeted agent (Arm E) 6. CC-99282 (Arm F) 9. Presence of acute or chronic graft-versus-host disease (GVHD) 10. Presence of the following: 1. Active hepatitis B or active hepatitis C infection 2. History of or active human immunodeficiency virus (HIV) infection 11. Uncontrolled bacterial, viral or fungal infection at the time of leukapheresis, lymphodepleting chemotherapy or JCAR017 infusion 12. Any history of myocarditis (Arm E); history of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease (all arms) 13. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, or psychosis 14. Subjects with active CNS or cerebrospinal fluid (CSF) involvement by malignancy 15. Pregnant or nursing (lactating) women. 16. Subjects with active auto immune disorders/processes or active neurological or inflammatory disorders 17. For subjects to receive oral combination therapy (Arms B, C, D or F): History of a gastrointestinal (GI) condition or procedure that in the opinion of the investigator may affect oral drug absorption. 18. Progressive tumor invasion of venous or arterial vessels. 19. Deep venous thrombosis (DVT)/pulmonary embolism (PE) not managed on a stable regimen of anticoagulation. ; PRIMARY OUTCOME: Dose-limiting toxicity (DLT) rates; SECONDARY OUTCOME 1: Adverse Events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Immune/BRT/UC-01; BRIEF: This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult patients with active moderate to severe UC . Eligible patients will be randomly assigned in a 2:1 ratio to one of two treatment groups, bertilimumab 10 mg/kg or matching placebo, respectively ; DRUG USED: Bertilimumab; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: Eotaxin-1 / Chemokine (C-C motif) ligand 11 ; THERAPY: Monotherapy; LEAD SPONSOR: Immune Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Males or females, 18 to 70 years of age inclusive. 2. Diagnosed with active moderate to severe UC per standard diagnostic criteria for a minimum of 3 months: - Mayo score of 6-12 (inclusive) at the Screening Visit - Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 (assessed centrally) - Rectal Bleeding Sub-score of ≥1 - Physicians Global Assessment (PGA) Sub-score of ≥2. 3. Levels of eotaxin-1 in biopsied colon tissue of ≥100 pg/mg protein. 4. Adequate cardiac, renal and hepatic function as determined by the Investigator and demonstrated by screening laboratory evaluations and physical examination results; these findings must all be within normal limits or judged not clinically significant by the Investigator. Exclusion Criteria: 1. History of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy. 2. Currently receiving total parenteral nutrition (TPN). 3. Positive Clostridium difficile toxin stool assay. 4. Tested positive for active/latent mycobacterium tuberculosis (TB) infection. 5. Pregnant or breast-feeding, or plan to become pregnant during the study. 6. Males who are young and childless or planning to have more children in the future. 7. Known hypersensitivity to bertilimumab or any of the drug excipients. 8. History of infection requiring administration of any IV antibiotic, antiviral or antifungal medication within 30 days of Screening or any oral anti-infective agent within 14 days of Screening. 9. Severe UC evidenced by the following signs of toxicity: heart rate >100 beats/min at rest, temperature >37.8°C, hemoglobin <10.0 g/dL. 10. Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge. 11. Received a vaccine or other immunostimulator within 4 weeks prior to screening. 12. Use of >4.8 g mesalazine or equivalent within 2 weeks prior to the screening visit. Mesalazine ≤4.8 g is allowed if the dose during the 2 weeks prior to the screening visit was stable. 13. Use of systemic corticosteroids exceeding the equivalent of 20 mg/day of prednisone within four weeks prior to the screening visit (see Section 6.9.1). 14. Change in dose of immunosuppressive drugs (e.g., corticosteroids, 6-mercaptopurine [6-MP], azathioprine) within four weeks prior to the screening visit. 15. Use of TNF-blockers (e.g., infliximab or adalimumab) within 60 days of the screening visit. 16. Use of chronic non-steroidal anti-inflammatory (NSAID) therapy. Occasional use of NSAIDs or acetaminophen for headache, arthritis, myalgias, menstrual cramps, etc., or daily use of low dose (81-162 mg) aspirin for cardiovascular prophylaxis is allowed. 17. Patients diagnosed with: - Crohns disease - Diverticulitis or diverticulosis - Indeterminate colitis (inability to distinguish between UC and Crohns disease [as assessed by the Investigator]) - Microscopic colitis (collagenous or lymphocytic colitis) - Ischemic or infectious colitis - Clostridium difficile colitis within 90 days of the screening visit - Parasitic disease within 90 days of the screening visit - Systemic fungal infection within 90 days of the screening visit. 18. History of positive serology of hepatitis B or C, or human immunodeficiency virus (HIV) infection. 19. Congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, organ transplantation). 20. Clinically significant abnormal laboratory test results, unless regarded by the Investigator as related to UC, including but not limited to: - Hemoglobin level <10.0 g/dL - White blood cell count < 3 x 103/µL - Lymphocyte count < 0.5 x 103/µL - Platelet count <100 x 103/µL or >1200 x 103/µL - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 the upper limit of normal (ULN) - Alkaline phosphatase >3 ULN - Serum creatinine >2 ULN. 21. Active abuse of alcohol or drugs. 22. Known malignancy or history of malignancy that could reduce life expectancy. 23. Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol. 24. Participation in a clinical trial of an investigational (unapproved) product ; PRIMARY OUTCOME: Clinical response; SECONDARY OUTCOME 1: Change in UCEIS score from screening to Day 56[/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 Ext. (US); BRIEF: - This is a single centre, phase I, randomized, double-blind, placebo-controlled, crossover, dose escalating study of P7435 using single and multiple doses, to be conducted in healthy male and female (Non child bearing) subjects having BMI between 19 to 40 kg/m2. - The study will be conducted in 2 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study and Part B will consist of the Multiple Ascending Dose (MAD) study. ; DRUG USED: P7435; DRUG CLASS: New Molecular Entity (NME); INDICATION: Metabolic - General; TARGET: Diglycerol Acyltransferase (DGAT); THERAPY: Monotherapy; LEAD SPONSOR: Piramal Enterprises Limited; CRITERIA: Inclusion Criteria: 1. Subjects who are willing and are able to provide a written informed consent to participate in the study 2. Adult male and female subjects aged between 18 and 60 (both inclusive) years old 3. Subjects with a BMI between 19 to 40 kg/m2 4. Subjects, who are healthy, as having no clinically significant abnormalities in medical history, physical examination, clinical laboratory test results (hematology, biochemistry and urinalysis), vital signs and 12-lead electrocardiogram (ECG). The clinical significance of any abnormal finding in these parameters is left to the judgment of the Investigator, in conjunction with the Sponsors clinical leader prior to enrolment 5. Subjects who smoke less than 10 cigarettes per day and are able to refrain from smoking during confinement 6. Subjects with the ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, power drinks) and grapefruit juice starting from 72 hrs prior to the first admission (confinement) and continuing throughout the study 7. Subjects who have a high probability for compliance with the study procedures including ability and willingness to swallow capsules during the study and allow withdrawing blood samples 8. Male subjects who are agreeable to use methods of contraception as specified in the protocol during the study and up to 30 days after the administration of the last dose of the study drug 9. Female subjects who are of non-child bearing potential defined as females who are either post menopausal [i.e. 1 year of natural (spontaneous) amenorrhea or break-through bleeding together with follicle stimulating hormone (FSH) confirmation of post-menopausal state at screening)] or surgically sterilized [hysterectomy, tubal occlusion, bilateral oophorectomy or bilateral salpingectomy]. FSH is required to document post-menopausal status in women <55 years of age or in women >55 with < 2 years since last menstrual period. FSH is not required for women >55 with >2 years since last menstrual period. Exclusion Criteria: 1. Employees of the Sponsor, Clinical Research Organization (CRO) or clinical sites 2. Subjects in an acute disease state within 7 days before Day -1 of the study 3. Subjects with past or current diseases of any organ or system (such as, but not limited to, gastrointestinal, cardiac, renal, hepatic that is considered to be clinically significant by the Investigator, in conjunction with the Sponsors clinical leader or subjects suffering from any condition that can affect the absorption, distribution, metabolism and excretion of orally administered medicines. Subjects with conditions such as non malignant skin diseases and childhood asthma can be included based on the Investigators discretion and discussed with the Sponsor a priori) 4. Subjects with known congenital QTc prolongation or having QTcF value of >450 msec 5. Subjects with a history of sleep apnea, irregular sleep/wake cycle or working in night shifts 6. Subjects with a history of hypo/hyperthyroidism, (except those with thyroxin replacement and on stable dose since last 2 months) or repeated abnormal TSH values at screening or obesity of endocrine origin 7. Subjects with a history of anaphylaxis or angioedema, or other clinically important food or drug allergy 8. Subjects with known lactose intolerance and / or intolerance / allergy to any component of the diet, including milk, soy and the high fat breakfast proposed to be given during the study 9. Subjects with a history of mental handicap, psychiatric disorders including (but not limited to) eating disorders, seizures or significant head trauma 10. Subjects with a history of drug abuse, addiction or use of recreational drug 11. Subjects with a history of alcoholism for more than 2 years or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study (one drink is equal to one unit of alcohol - one glass wine, half pint beer, one measure or ounce of spirit) 12. Subjects with a history of fainting from blood collections or vasovagal syncope 13. Subjects with prior exposure to P7435 or participation in any of the previous cohorts 14. Subjects with a positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies 15. Subjects with positive findings in urine drug screen 16. Subjects with a positive finding in urine alcohol screen 17. Subjects who have participated in another clinical trial within 30 days prior to the first drug administration 18. Subjects who are consuming any prescription drugs (including, but not limited to, sedatives and steroids); herbal supplements (including, but not limited to, St. Johns Extract); or any other drugs likely to cause pharmacokinetic interaction within 30 days or 5 half lives, before first drug administration whichever is longer. Subjects using any other over-the-counter drugs (with the exception of paracetamol/NSAIDs and multivitamins that may be allowed up to 3 and 7 days before admission to the clinic, respectively) within 14 days or 5 half lives, prior to the first drug administration. Subjects who have undergone any weight loss surgery or are taking weight loss medications (including alternate medicine products) within 90 days prior to first drug administration 19. Subjects following an unusual diet e.g. low caloric, low sodium, within 30 days prior to first drug administration 20. Subjects who have donated blood (i.e. 350 mL) within 90 days prior to first drug administration. ; PRIMARY OUTCOME: Number of participants with adverse events (single and multiple dose studies); SECONDARY OUTCOME 1: Food Effect[/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 - Study 134; BRIEF: This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in surgically menopausal women who are taking estrogen therapy. ; DRUG USED: Intrinsa HSDD; DRUG CLASS: Non-NME; INDICATION: Female Sexual Arousal Disorder; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Warner Chilcott; CRITERIA: Inclusion Criteria: Eligible women must: 1. Be 20-70 years old and in generally good health 2. Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening 3. Be receiving a stable dose of estrogen replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen. 4. Be, in her own judgment, in a stable monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry. 5. Meet the criteria for having hypoactive sexual desire disorder. Exclusion Criteria: Eligible women must not: 1. Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product) 2. Be experiencing any chronic or acute life stress relating to any major life change 3. Be experiencing depression and/or receiving medication for such illness or disorder 4. Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages) 5. Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months 6. Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years 7. Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years 8. Have abnormal laboratory test results upon initial screening for this study 9. Have previously participated in P&GP study 1999068 or 1999092 10. Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days. ; PRIMARY OUTCOME: To assess the efficacy of testosterone transdermal system (TS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL).; SECONDARY OUTCOME 1: To assess the efficacy measured by the change from baseline in sexual desire; personal distress as measured by the Personal Distress Scale score; the other 6 domains of the profile of Female Sexual Function; and the other 8 SAL endpoints.[/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 - ZEST (Elderly DLBCL); BRIEF: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy. ; DRUG USED: Zevalin; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 20 (CD20), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Participant was 60-years of age or older at time of randomization 2. Histologically confirmed Ann Arbor stage II, III, or IV diffuse large B-cell lymphoma (DLBCL); or follicular lymphoma (FCL) Grade 3B according to the Revised European American lymphoma (REAL)/ World health organization (WHO) classification (from initial diagnosis made prior to starting R-CHOP therapy. Results from a pre R-CHOP marrow shall be available for review. 3. Local pathology review confirming the DLBCL diagnosis and cluster of differentiation 20 (CD20) positivity, and no evidence of DLBCL in bone marrow upon confirmation of complete remission (CR). 4. A paraffin block or original slides available for confirmatory pathology review. Participants may be randomized based on the local pathology result. 5. Age-adjusted international prognostic index (IPI) of 1, 2, or 3. The age-adjusted IPI was defined by one point for Lactate dehydrogenase (LDH) > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ eastern cooperative operations group (ECOG) performance status >1. 6. First-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14 or dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) chemotherapy. Participants who received pre-phase therapy for the purpose of improving performance status prior to initiating R-CHOP are eligible. 7. Complete remission (CR) according to the International Workshop Response Criteria for non-Hodgkins lymphoma (NHL) described by Cheson et al after first-line treatment. Computerized tomography (CT) scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of chemotherapy. Applicability of the neck CT means that the participant had involvement of the neck region by palpation / physical examination at first diagnosis. 8. A negative Fluorine-18-deoxyglucose positron emission tomography (FDG-PET) scan confirming complete response, with negative defined as a score of 1-3 on the Deauville 5-point scale used to quantify radionucleotide density in PET scans as determined locally (Morschhauser 200735). 9. Bone marrow cellularity greater than 15%, no evidence of myelodysplasia morphologically and no evidence of involvement with lymphoma either at the pre R-CHOP marrow or on repeat assessment pre-Zevalin. After completing R-chemotherapy, a repeat marrow is required for participant randomized to the Zevalin arm only. 10. A world health organization/eastern cooperative oncology group (WHO/ECOG) performance status of 0, 1 or 2. 11. Adequate hematopoietic functions: Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/ liter (L), Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 10^9/L. 12. Life expectancy of 6 months or longer. 13. Written informed consent obtained according to local guidelines. Exclusion Criteria: 1. Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, participants treated for Stage I or II cancers are eligible provided they have a life expectancy of > 5 years. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer. 2. Prior radioimmunotherapy, including radiation therapy for Non-Hodgkins lymphoma) NHL, or any other NHL therapy. 3. Presence of primary gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis. 4. Histological transformation of low-grade NHL. 5. Active hepatitis B or C. 6. Known history of human immunodeficiency virus (HIV) infection. 7. Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease. 8. Abnormal renal function: serum creatinine > 2.0 × ULN. 9. Non-recovery from the toxic effects of chemotherapy to < grade 2, or interfering with Zevalin treatment. 10. Known hypersensitivity to murine or chimeric antibodies or proteins. 11. Granulocyte-colony stimulating factor (G-CSF) or Granulocyte macrophage-colony stimulating factor (GM-CSF) therapy within 4 weeks prior to Zevalin or observation. 12. Concurrent severe and/or medically uncontrolled disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study. 13. Treatment with investigational drugs less than 4 weeks prior to Zevalin or observation. 14. Major surgery less than 4 weeks prior to Zevalin or start of observation. 15. Concurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment. Participants on a chronic dose of prednisone for a medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20 milligram (mg) daily, stable for 4 weeks, are permissible. 16. Unwillingness or inability to comply with the protocol. ; PRIMARY OUTCOME: Overall Survival (OS) for Living Participants; SECONDARY OUTCOME 1: Progression-Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - AML/MDS; BRIEF: This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally administered emavusertib (CA-4948) monotherapy in adult patients with Acute Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS). Patients enrolling in the Phase 1 portion of the study must meet one of the following criteria prior to consenting to the study: - R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor - R/R AML with spliceosome mutations of SF3B1 or U2AF1 - R/R hrMDS with spliceosome mutations of SF3B1 or U2AF1 - Number of pretreatments: 1 or 2 The Phase 2a Dose Expansion will be in 3 Cohorts of patients: 1. R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor; 2. R/R AML with spliceosome mutations of SF3B1 or U2AF1; and 3. R/R hrMDS (IPSS-R score > 3.5) with spliceosome mutations of SF3B1 or U2AF1. All patients above have had ≤ 2 lines of prior systemic anticancer treatment. In previous versions of this protocol there was a Phase 1b portion of the study, in which patients with AML or hrMDS received CA-4948 in combination with venetoclax. This part of the study is no longer open for enrollment. ; DRUG USED: CA-4948; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Immune System, Interleukin-1 receptor-associated kinase 4 (IRAK4), Myeloid differentiation primary response 88 (MYD88); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Curis, Inc.; CRITERIA: Inclusion Criteria: 1. Males and females ≥18 years of age 2. Life expectancy of at least 3 months 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤1 4. Cytomorphology based confirmed diagnosis of MDS or AML (as per WHO 2016 classification) with the following characteristics. Phase 1 Dose Escalation (Monotherapy) • AML (primary or secondary, including treatment-related) after failing at least 1 standard treatment (may include chemotherapy, re induction therapy or stem cell transplantation). OR • Higher-risk R/R MDS that are considered resistant/refractory following at least 2 to 3 cycles of hypermethylating agent (HMA) or evidence of early progression Phase 2a Dose Expansion (Monotherapy) Patients with: - R/R AMLwith FLT3 mutations who have been previously treated with a FLT3 inhibitor - R/R AML with spliceosome mutations of SF3B1 or U2AF1 - R/R hrMDS (IPSS-R score > 3.5) with spliceosome mutations of SF3B1 or U2AF1 - Number of pretreatments: 1 or 2 5. Acceptable organ function at screening 6. Ability to swallow and retain oral medications 7. Negative serum pregnancy test in women of childbearing potential 8. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use highly effective contraceptive methods for the duration of the study and for 90 days after the last dose of emavusertib 9. Willing and able to provide written informed consent and comply with the requirements of the trial 10. Able to undergo serial bone marrow sampling and peripheral blood sampling Exclusion Criteria: 1. Diagnosed with acute promyelocytic leukemia (APL, M3) 2. Has known active central nervous system (CNS) leukemia 3. Allogeneic hematopoietic stem cell transplant (Allo-HSCT) within 60 days of the first dose of emavusertib, or clinically significant graft-versus-host disease (GVHD) requiring ongoing up titration of immunosuppressive medications prior to start of emavusertib 4. Chronic myeloid leukemia (CML) 5. Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 3 weeks (or 5 half-lives) prior to start of emavusertib. Localized radiation or surgical resection of skin cancers allowed. 6. Use of any investigational agent within 3 weeks or 5 half-lives, whichever is shorter, prior to start of emavusertib 7. Presence of an acute or chronic toxicity resulting from prior anti-cancer therapy, with the exception of alopecia that has not resolved to Grade ≤ 1within 7 days prior to start of emavusertib; presence of any acute or chronic non-hematological toxicity ≥ Grade 3 at Screening, or prior to start of emavusertib must resolve to ≤ Grade 2. 8. Known allergy or hypersensitivity to any component of the formulation of emavusertib 9. Major surgery, other than diagnostic surgery, <28 days from the start of emavusertib; minor surgery <14 days from the start of emavusertib 10. Patients with active advanced malignant solid tumors 11. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness 12. Hepatitis B virus (HBV) DNA positive or Hepatitis C virus (HCV) infection <6 months prior to start of emavusertib unless viral load is undetectable, or HCV with cirrhosis 13. Uncontrolled or severe cardiovascular diseaseincluding myocardial infarction or unstable angina within 6 months prior to CA-4948, New York Heart Association Class II or greater congestive heart failure, or left ventricular ejection fraction < 40% by echocardiogram or multi-gated acquisition scan, serious arrhythmias uncontrolled on treatment, clinically significant pericardial disease, cardiac amyloidosis, congenital long QT syndrome, or QTc with Fridericias correction (QTcF) that is unmeasurable or > 450 msec on Screening electrocardiogram (ECG) 14. Gastrointestinal disease or disorder that could interfere with the swallowing, oral absorption, or tolerance of emavusertib 15. Pregnant or lactating 16. Systemic fungal, bacterial, viral, or other infection that is not controlled 17. Any other severe, acute, or chronic medical, psychiatric or social condition, or laboratory abnormality that may increase the risk of trial participation or emavusertib administration ; PRIMARY OUTCOME: Determine Maximum Tolerated Dose (MTD) of emavusertib (CA-4948) monotherapy (Phase 1); SECONDARY OUTCOME 1: To characterize the pharmacokinetic (PK) parameters of emavusertib measured by Cmax (Phase 1 and 1b)[/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; BRIEF: This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be administered orally at a dose of 10 mg daily. ; DRUG USED: Afinitor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Ahmad Tarhini; CRITERIA: Inclusion Criteria: 1. Cytologically or histologically confirmed small cell carcinoma of the lung that has progressed post first-line therapy. Mixed small and non-small cell tumors are excluded. 2. Prior chemotherapy for small cell carcinoma. Up to 2 prior chemotherapy regimens for small cell lung carcinoma are allowed. No prior therapy with an m-TOR inhibitor (e.g. CCI-779). 3. Unidimensionally measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area. 4. ECOG performance status 0-2. 5. A minimum of 4 weeks should elapse from prior chemotherapy. Patients must have fully recovered from the effects of any prior surgery or radiation therapy or other anticancer therapies, including immunotherapy and investigational agents. 6. No progressive brain metastases. Brain metastases should have been previously treated with surgery and/or radiation. 7. Patients with a prior malignancy should have at least 3 years of disease-free survival. Prior curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer or other in situ malignancies are allowed. 8. No other coexisting medical condition that would preclude full compliance with the study. 9. Required laboratory values (obtained < 1 week prior to enrollment): - ANC >/= 1500/mm³ - Platelets >/= 100,000/mm³ - AST and ALT ≤ 3 x ULN (upper limits of normal). In patients with liver metastases AST and ALT should be < 5 x ULN. - Total bilirubin up to 1.5 x ULN (upper limits of normal). 10. Age >/= 18 years and capacity to give informed consent. 11. Patients should be advised to discontinue drugs that interact with CYP3A4 (see list of examples in Table 3.1 of the full protocol), if medically safe. 12. All patients must have given signed, informed consent prior to registration on study. Exclusion Criteria: 1. Prior treatment with any investigational agent within the preceding 4 weeks. 2. Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration). 3. A known history of HIV seropositivity. 4. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). 5. Patients with an active, bleeding diathesis or on anticoagulation (except low dose warfarin). 6. Pregnant and lactating women are excluded from the study because the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk. 7. Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study. 8. Patients should not be on chronic systemic glucocorticoids or other immunosuppressant. ; PRIMARY OUTCOME: Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.; 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 I/II - PHEarless ; BRIEF: This is a Phase 1/2, open-label, dose escalation study to evaluate the safety, efficacy and tolerability of BMN 307 in adult PKU subjects with PAH deficiency. Participants will receive a single administration of BMN 307 and will be followed for safety and efficacy. ; DRUG USED: BMN 307; DRUG CLASS: Biologic; INDICATION: Phenylketonuria (PKU); TARGET: Phenylalanine; THERAPY: Monotherapy; LEAD SPONSOR: BioMarin Pharmaceutical; CRITERIA: Inclusion Criteria: - Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency - Ability and willingness to maintain dietary protein intake consistent with baseline intake - Willingness to abstain from hepatotoxic substances post-BMN 307 administration - Willingness and capable per investigator opinion to comply with study procedures and requirements - Willingness to use effective methods of contraception - Plasma Phe levels > 600 µmol/L Exclusion Criteria: - Subjects with primary BH4 deficiency or other forms of BH4 metabolism deficiency - Clinically significant liver dysfunction or disease - Prior treatment with gene therapy - Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study - History of malignancy ; PRIMARY OUTCOME: Change from baseline in mean Plasma Phe levels; SECONDARY OUTCOME 1: Change from baseline in mean Plasma Phe 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 IIa - EMBRACE (w/DMARDs); BRIEF: Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs). ; DRUG USED: BIIB057; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Combination; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: - Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months - Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater - No prior treatment with biologics - Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening Exclusion Criteria: - History of inflammatory joint disease other than RA - Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection - History of malignancy, carcinoma in situ, or high-grade dysplasia - History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease. - Clinically significant cardiac disease - Treatment with prednisone >10 mg orally daily - Intra-articular steroid injection within 28 days before screening - Clinically significant abnormality in hematology or blood chemistry values at screening ; PRIMARY OUTCOME: Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline); SECONDARY OUTCOME 1: Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the 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 - 101; BRIEF: This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101. ; DRUG USED: CUDC-101 (Oral); DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: EGFR (Epidermal Growth Factor Receptor), HER2/neu or ErbB-2, Histone Deacetylase (HDAC); THERAPY: Monotherapy; LEAD SPONSOR: Curis, Inc.; CRITERIA: Inclusion Criteria: - Subjects with advanced, refractory solid tumors and a histopathologically confirmed diagnosis - Subjects must have no further standard of care options or have refused standard therapy - Measurable or evaluable disease - Age ≥ 18 years - ECOG performance < 2 - Life expectancy ≥ 3 months - If female, neither pregnant or lactating - If of child bearing potential, must use adequate birth control - Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; - Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2 - Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN - Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation - Serum magnesium and potassium within normal limits (may be supplement to achieve normal values) - Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids - Able to render informed consent and to follow protocol requirements. Exclusion Criteria: - Anticancer therapy within 4 weeks of study entry. Prostate cancer subjects on LHRH hormonal therapy may be enrolled and continue on this therapy. - Use of investigational agent(s) within 30 days of study entry - History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment. - Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. - The following are permitted but should be used with caution and other suitable agents used if possible: - Subjects receiving concomitant medications metabolized by CYP 3A4 and CYP 2D6 - CYP3A4 inducers - CYP3A4 inhibitors - Warfarin ; PRIMARY OUTCOME: The highest dose level of CUDC-101 at which <33% of at least 6 or more subjects experiences a dose limiting toxicity.; SECONDARY OUTCOME 1: Number of patients that show a response (complete response or partial response) based on RECIST criteria.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EMPA-REG OUTCOME (1245.25 - CV Safety); BRIEF: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk. ; DRUG USED: Jardiance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization. 3. Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients 4. Age >= 18 years 5. Body Mass index <= 45 at Visit 1 6. Signed and dated informed consent 7. High cardiovascular risk Exclusion criteria: 1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day) 2. Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in. 3. Planned cardiac surgery or angioplasty within 3 months 4. Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in. 5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia) 7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 8. Contraindications to background therapy according to the local label 9. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight 10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus 11. Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who: - are nursing or pregnant or - are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner 12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake 13. Participation in another trial with an investigational drug within 30 days prior to informed consent 14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial 15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent ; PRIMARY OUTCOME: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.; SECONDARY OUTCOME 1: Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris[/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 - DETERMINE (2nd/3rd-Line); BRIEF: This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period. ; DRUG USED: Tremelimumab; DRUG CLASS: Biologic; INDICATION: Mesothelioma; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: 1. Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma; 2. Disease not amenable to curative surgery; 3. Age 18 and over at the time of consent; 4. ECOG Performance status 0-1; 5. Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent. 6. Recovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or 1, except for toxicities not considered a safety risk, 7. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as: 9. Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. 10. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations; 11. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. 12. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product. Exclusion Criteria: 1. Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma; 2. Received any prior mAb against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1); 3. History of chronic inflammatory or autoimmune disease with symptomatic disease within the last 3 years prior to randomization. 4. Active, untreated central nervous system (CNS) metastasis 5. Any serious uncontrolled medical disorder or active infection that would impair the subjects ability to receive investigational product; 6. History of other malignancy unless the subject has been disease-free for at least 3 years; 7. Pregnant or breast feeding at time of consent; 8. Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol; 9. Active or history of diverticulitis; 10. Active or history of inflammatory bowel disease, irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea. Active or history of systemic lupus erythematosus or granulomatosis with polyangiitis; 11. History of sarcoidosis syndrome; 12. Currently receiving systemic corticosteroids or other immunosuppressive medications or has a medical condition that requires the chronic use of corticosteroids. 13. Subjects should not be vaccinated with live attenuated vaccines within one month prior to starting tremelimumab treatment; 14. The last dose of prior chemotherapy or radiation therapy was received less than 2 weeks prior to randomization; 15. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of vitiligo and alopecia; 16. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results; 17. Concurrent enrollment in another clinical study or receipt of an investigational product within the last 4 weeks 18. Employees of the study site directly involved with the conduct of the study, or immediate family members of any such individuals; 19. Subjects with a history of hypersensitivity to compounds of similar biologic composition to tremelimumab or any constituent of the product. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: OS Rate at 18 Months by Treatment Arm[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Cytoreductive Surgery; BRIEF: This study looks to enroll subjects with ovarian cancer who will be having standard of care surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the tumor will also be studied. This study will also help us compare the amount of EC1456 seen in tumors and how the tumors are imaged by the 99mTc-etarfolatide single-photon emission tomography (SPECT) or single-photon emission tomography with in-line x-ray computed tomography (SPECT/CT). All subjects will undergo a 99mTc-etarfolatide SPECT or SPECT/CT scan within 2 weeks prior to EC1456 administration. Individual subjects will then receive 1 of the following 2 doses of EC1456 pre-operatively: - 4 mg/m2 - 8 mg/m2 EC1456 will be administered at 1 of the following 2 time points: - <8 hours before planned surgery - 48±4 hours before planned surgery Blood will be collected for pharmacokinetic (PK) studies right after EC1456 dosing and again right before surgery. At the time of surgery, tumor samples will be removed and sent to Endocyte for analysis. ; DRUG USED: EC1456; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Endocyte; CRITERIA: Inclusion Criteria: 1. Subject must have the ability to understand, and have signed an approved informed consent form (ICF). 2. Subjects must have cytologically or pathologically confirmed advanced ovarian cancer and be scheduled for primary, interval, or secondary, cytoreductive surgery as a part of standard of care for treatment of ovarian cancer, and have at least 1 lesion that can be removed at surgery. 3. Subject must be ≥18 years of age. 4. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Subjects with central nervous system (CNS) metastases must be neurologically stable and off of steroids for at least 14 days before pre-registration. Subjects with asymptomatic CNS metastatic disease without associated edema, shift, and a requirement for steroids or anti-seizure medications may be eligible after discussion with the sponsors medical monitor. 6. Subjects must have recovered (to baseline/ stabilization) from prior chemo- or radiotherapy and associated acute toxicities must have resolved to a NCI CTCAE v4 Grade 1 or less, with the exception of alopecia. 7. Subject must have adequate organ function: - Bone marrow reserve: - Absolute neutrophil count ≥1.5 × 109/L. - Platelets ≥100 × 109/L. - Hemoglobin ≥9 g/dL. - Cardiac: - Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal. LVEF must be evaluated within 28 days prior to the dose of EC1456. - Cardiac Troponin I within normal limits. - Electrocardiogram QT segment corrected by the method of Fridericia QTcFridericia (QTcF) < 450 msec on at least 2 of 3 screening ECGs. On site determination of QTcF may be used for screening purposes. - Hepatic: - Total bilirubin ≤1.5 × the upper limit of normal (ULN). - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST - 3.0 × ULN, or ≤5.0 × ULN for subjects with liver metastases. - Renal: Serum creatinine ≤1.5 × ULN, or for subjects with serum creatinine >1.5 × ULN, creatinine clearance ≥50 mL/min. 8. Subjects of childbearing potential: - All women of childbearing potential MUST have a negative urine or serum pregnancy test within 1 week prior to the 99mTc-etarfolatide imaging procedure and within 1 week prior to the dose of EC1456. - Women of childbearing potential must practice an effective method of birth control (e.g., oral, transdermal or injectable contraceptives, intrauterine device [IUD], or double-barrier contraception, such as diaphragm and spermicidal jelly) for the duration of their participation in Exclusion Criteria: 1. In the opinion of the investigator, a subjects physical condition might create a hardship for tolerating the radionuclide imaging procedures or a single administration of EC1456 (e.g., due to pain or dyspnea in prolonged supine positions). 2. Use of the following medications within 6 months prior to EC1456 administration: amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine, or sotalol. 3. Subject has a co-morbid medical condition that, in the opinion of the investigator, is known to have a major impact on the pharmacokinetics (PK), distribution, metabolism, or elimination of either small molecule drug conjugate (SMDC). 4. Subject has known active hepatitis B or hepatitis C. 5. Subject has active uncontrolled infection(s). ; PRIMARY OUTCOME: To assess tumor penetration of EC1456 in frozen tissue; SECONDARY OUTCOME 1: To assess tumor penetration EC1456 in formalin fixed tissue samples (intratumoral levels of EC1456 in tissue blocks using anti-tubulysin IHC testing)[/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 - HAVEN 6 (w/o FVIII Inhibitors, China); BRIEF: This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII). ; DRUG USED: Hemlibra; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor IX, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Diagnosis of mild (FVIII level between >5% and <40%) or moderate (FVIII level between ≥1% and ≤5%) congenital Hemophilia A without FVIII inhibitors - Weight ≥3 kilograms (kg) - Need for prophylaxis based on investigator assessment - A negative test for inhibitor (i.e., <0.6 Bethesda Units per milliliter [BU/mL]) within 8 weeks prior to enrollment - No documented inhibitor (i.e., <0.6 BU/mL), FVIII half-life <6 hours, or FVIII recovery <66% in the last 5 years - Documentation of the details of prophylactic or episodic FVIII treatment and of number of bleeding episodes for at least the last 24 weeks prior to enrollment - Adequate hematologic, hepatic, and renal function - For women of childbearing potential: agreement to remain abstinent or use contraception (as defined in the protocol) during the treatment period and for at least 24 weeks after the final dose of study drug Exclusion Criteria: - Inherited or acquired bleeding disorder other than mild or moderate congenital hemophilia A - History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the investigators judgment - Previous (within the last 12 months) or current treatment for thromboembolic disease or signs of thromboembolic disease - Other conditions that may currently increase the risk of bleeding or thrombosis - History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection - Planned surgery during the emicizumab loading dose phase (surgeries in participants on emicizumab from Week 5 onwards are allowed) - Known HIV infection with CD4 counts <200 cells per microlitre (/μL) - Concomitant disease, condition, significant abnormality on screening evaluation or laboratory tests, or treatment that could interfere with the conduct of the study, or that would in the opinion of the investigator, pose an additional unacceptable risk in administering study drug to the participant - Receipt of any of the following: An investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration with the exception of prior emicizumab prophylaxis; A non-hemophilia-related investigational drug within last 30 days or 5 half-lives, whichever is shorter; or Any other investigational drug currently being administered or planned to be administered - Inability to comply with the study protocol in the opinion of the investigator - Pregnant or breastfeeding, or intending to become pregnant during the study (women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug) ; PRIMARY OUTCOME: Model-Based Annualized Bleed Rate for Treated Bleeds; SECONDARY OUTCOME 1: Model-Based Annualized Bleed Rate for All Bleeds[/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 - Extension; BRIEF: This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy ; DRUG USED: Iptacopan; DRUG CLASS: New Molecular Entity (NME); INDICATION: C3 Glomerulopathy (C3G), including Dense Deposit Disease (DDD) and C3 Glomerulonephritis (C3GN); TARGET: Factor D (alternate complement pathway); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients must have completed the treatment period of the CLNP023X2202 or CLNP023B12301 trial on study drug Exclusion Criteria: - Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study - Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening. - History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects - History of HIV or any other immunodeficiency disease ; PRIMARY OUTCOME: CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint; SECONDARY OUTCOME 1: CLNP023X2202: Number of participants who achieve the 2-component composite renal endpoint[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - POX-MVA-027 (Freeze-Dried); BRIEF: A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects ; DRUG USED: Jynneos; DRUG CLASS: Vaccine; INDICATION: Smallpox; TARGET: Immune System, Smallpox virus; THERAPY: Monotherapy; LEAD SPONSOR: Bavarian Nordic; CRITERIA: Inclusion criteria 1. Male and female subjects, 18-55 years of age 2. The subject has read, signed and dated informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedures and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form 3. Body Mass Index (BMI) ≥ 18.5 and < 35 4. Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or with a history of hysterectomy. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products) 5. WOCBP must have a negative serum pregnancy test at screening (SCR) and a negative urine pregnancy test within 24 hours prior to each vaccination 6. White blood cells ≥ 2500/mm3 and < ULN 7. Absolute neutrophil count (ANC) within normal limits 8. Hemoglobin within normal limits 9. Platelets within normal limits 10. Adequate renal function defined as a calculated Creatinine Clearance (CrCl) > 60 ml/min as estimated by the Cockcroft-Gault equation: - For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl x 72) = CrCl (ml/min) - For women: multiply the result by 0.85 = CrCl (ml/min) 11. Adequate hepatic function defined as: - Total bilirubin ≤ 1.5 x upper limit of normal (ULN) in the absence of other evidence of significant liver disease - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 1.5 x ULN 12. Troponin I < 2 x ULN 13. Electrocardiogram (ECG) without clinically significant findings, e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia Exclusion criteria 1. Typical vaccinia scar 2. Known or suspected history of smallpox vaccination 3. History of vaccination with any poxvirus-based vaccine 4. US Military service before 1991 or after January 2003 5. Pregnant or breast-feeding women 6. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy 7. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subjects ability to complete the trial in the opinion of the investigator 8. History of or active autoimmune disease, persons with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded 9. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment 10. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site 11. History or clinical manifestation of clinically significant and severe hematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders 12. Clinically significant mental disorder not adequately controlled by medical treatment 13. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor 14. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years 15. Twenty percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Programs Risk Assessment Tool: http://hin.nhlbi.nih.gov/atpiii/calculator.asp NOTE: This criterion applies only to subjects 20 years of age and older 16. Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months) 17. Known allergy to IMVAMUNE® vaccine and its constituents, e.g. tris(hydroxymethyl)-amino methane, including known allergy to egg or aminoglycoside (gentamycin) 18. History of anaphylaxis or severe allergic reaction to any vaccine 19. Acute disease (illness with or without a fever) at the time of enrollment 20. Body Temperature ≥ 100.4°F (38.0°C) at the time of enrollment 21. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after trial vaccination 22. Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after trial vaccination 23. Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (Visit 5) 24. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy 25. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (Visit 5) 26. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the trial vaccine or planned administration of such a drug during the trial period (with the day of the FU call being considered the last day of the trial period). 27. Trial personnel ; PRIMARY OUTCOME: ELISA GMT; SECONDARY OUTCOME 1: Number of Participants With Serious Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - R.A.C.E.; BRIEF: The purpose of this study is to evaluate the pharmacokinetics, safety and preliminary efficacy of 3 doses of Cand5. Cand5 is a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF. The target population are patients with diabetic macular edema. ; DRUG USED: Bevasiranib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: OPKO Health, Inc.; CRITERIA: Inclusion Criteria: 1. Patients must be male or female age 21 or older. 2. Patient must sign (and be given) a copy of the written informed consent form. 3. Patients must have the diagnosis of diabetes mellitus (type 1 or type 2). Patients with the following will be considered to be sufficient evidence that diabetes is present: - Current regular use of insulin for the treatment of diabetes mellitus OR - Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes OR - Documented diabetes by WHO criteria 4. Patients must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye. 5. Patients must have a mean retinal thickness on OCT ≥ 250 microns in the central subfield. Exclusion Criteria: 1. Patients with a history of chronic renal failure requiring dialysis or kidney transplant. 2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control), including: - Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled. - Patients with HbA1C > 10%OR - Patients with systolic blood pressure greater than 170 mmHg and/or diastolic blood pressure greater than 100 mmHg (Note: If blood pressure is brought below 170/100 mmHg by anti-hypertensive treatment, patient can become eligible). 3. Past panretinal photocoagulation (PRP) for diabetes within 12 weeks of screening or PRP expected to be needed in the next three months in the study eye. 4. Focal laser therapy to the retina of the study eye within 12 weeks of screening. 5. Any intraocular surgery or ocular laser procedures in the study eye within 12 weeks of screening. 6. Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry. ; PRIMARY OUTCOME: Change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.; SECONDARY OUTCOME 1: Mean BCVA line/letters change from baseline at the 12-week evaluation.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Ha03-001; BRIEF: The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home. ; DRUG USED: Xeglyze; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: Metal ions (e.g., Ca2+, Cu2+, Zn2+, and Fe2/3+), MMP (metalloproteinase); THERAPY: Monotherapy; LEAD SPONSOR: Dr. Reddys Laboratories Limited; CRITERIA: Inclusion Criteria: 1. Male or female, aged six months of age or older. 2. Is in good general health based on medical history. 3. Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members. 4. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home. 5. Belongs to a household with an eligible index subject with active head lice infestation. 6. Agrees to an examination for head lice and to all visits and procedures throughout the study. 7. Has signed an informed consent and/or assent form. Exclusion Criteria: 1. Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0. 2. Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol. 3. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol. 4. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit. 5. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment. 6. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data. 7. Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations. 8. Has eczema or atopic dermatitis of skin/scalp. 9. Has had a prior reaction to Nix® or products containing permethrin. 10. Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments. 11. Has received an investigational agent within 30 days prior to Day 0. 12. Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location). ; PRIMARY OUTCOME: Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.; 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 - 07P4; BRIEF: This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. ; DRUG USED: Asparlas; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Asparagine; THERAPY: Monotherapy; LEAD SPONSOR: Childrens Oncology Group; CRITERIA: Inclusion Criteria: - Patients must be eligible for and enrolled on AALL08B1 or the successor classification study - Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health Organization [WHO] 2008 classification) (also termed B-precursor acute lymphoblastic leukemia) - White blood cell (WBC) >= 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids - Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal therapy - Patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented - Pregnancy tests with a negative result must be obtained in all post-menarchal females - Lactating females must agree that they will not breastfeed a child while on this study Exclusion Criteria: - Patients with Down syndrome are excluded from this study - Patients with testicular leukemia at diagnosis are excluded from this study - Pregnant female patients are excluded from this study ; PRIMARY OUTCOME: Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy); SECONDARY OUTCOME 1: Pharmacodynamics (PD)[/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 - SPARTAN; BRIEF: The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer. ; DRUG USED: Erleada; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Aragon Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equal to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy) - Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises, at least 1 week apart, with the last PSA greater than (>) 2 nanogram per milliliter (ng/mL) - Maintain castrate levels of testosterone within 4 weeks prior to randomization and throughout the study - Patients currently receiving bone loss prevention treatment with bone-sparing agents must be on stable doses for at least 4 weeks prior to randomization - Patients who received a first generation anti-androgen (for example, bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND must show continuing disease (PSA) progression (an increase in PSA) after washout - At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors, estrogens, and any other anti-cancer therapy prior to randomization - At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization - Eastern Cooperative Oncology Group Performance Status 0 or 1 - Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade <= 1 or baseline prior to randomization - Adequate organ function according to protocol-defined criteria - Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility Exclusion Criteria: - Presence of confirmed distant metastases, including central nervous system and vertebral or meningeal involvement - Symptomatic local or regional disease requiring medical intervention - Prior treatment with second generation anti-androgens - Prior treatment with CYP17 inhibitors - Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer - Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting - History of seizure or condition that may pre-dispose to seizure - Concurrent therapy with protocol-defined excluded medications - History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months prior to randomization; uncontrolled hypertension; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patients ability to comply with study procedures ; PRIMARY OUTCOME: Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR); SECONDARY OUTCOME 1: Time to Metastasis (TTM)[/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 - Entourage (Germany); BRIEF: This study evaluates the efficacy and safety of THX-110 in the management of tics and other symptoms (e.g. rage attacks, anxiety, depression, sleep difficulties) in patients with Tourette syndrome. In the first part of the study, half of the patients will receive THX-110, while the other half will receive a placebo. After completion of the first study part, patients will have the opportunity to continue into the second part of the study. In this part, all participants will receive THX-110. ; DRUG USED: SCI-110; DRUG CLASS: Non-NME; INDICATION: Tourettes Syndrome; TARGET: Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor, PPAR alpha; THERAPY: Monotherapy; LEAD SPONSOR: SciSparc; CRITERIA: Inclusion Criteria: 1. Tourette syndrome according to DSM-5 2. Male and female subjects with an age between ≥18 and <65 years 3. Total tic score (TTS) of the YGTSS >18 4. CGI-S ≥4 5. Medication (and stimulation parameters for deep brain stimulation) for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study and subject must consent to maintain the stable dose during the study 6. Signed written informed consent and willingness to comply with treatment and follow-up procedures 7. Subjects capable of understanding the investigational nature, potential risks and benefits of the clinical study 8. Women of child-bearing potential must have a negative pregnancy test (i.e., negative for urine human chorionic gonadotropin [hCG]) before first treatment with study medication. They must practice a highly effective, reliable and medically approved contraceptive regimen during the study (e.g., theoretical failure rate less than 1% per year a when used consistently and correctly), which include oral or parenteral or implanted hormonal contraception, vaginal ring releasing hormonal contraception (e.g., Nuvaring), intrauterine device or intrauterine system. Post-menopausal women may enter this study. Post-menopausal women are defined as those without menses in the past 12 months without an alternative medical cause, and with a serum follicle stimulating hormone (FSH) in the post-menopausal range. Women who are surgically sterile may enter this study with historical documentation of surgical procedure (bilateral tubal ligation or bilateral oophorectomy at least 6 weeks prior screening or hysterectomy or uterine agenesis) and a negative pregnancy test. 9. Male subjects must be willing to use a condom with sexual partners during this study and for a period of three months following the last administration of study medication until the follow-up visit. Male subjects must be willing to abstain from sperm donation for 3 months after the completion of this study. Exclusion Criteria: 1. Comorbid OCD, ADHD, depression, or anxiety disorder when unstable and/or in need of an initial adjustment for a therapy 2. Presence of a comorbid psychiatric condition as developmental disability, psychotic illness or bipolar disorder 3. Ongoing behavioural treatment for tics 4. History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder 5. Current clinical diagnosis of substance abuse or dependence 6. History of cannabis dependence 7. Secondary and other chronic tic disorders or other significant neurological disorders 8. History of severe cardiac diseases, severe cardiovascular diseases, severe renal disorders, or severe hepatic diseases and/or positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B 9. Concomitant medications have to be on stable dose since at least 6 weeks before entering the study and must be well tolerated at baseline without causing dizziness, confusion, sedation, or somnolence such as central nervous system depressants (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants) 10. Use of cannabis or CBM in the 30-day period prior to study entry and/or positive delta-9-THC urine test at baseline 11. Positive pregnancy test, i.e., positive for urine beta-hCG 12. Pregnant or breast-feeding women 13. Subjects who received any investigational medication or used any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug or device study, or is scheduled to receive an investigational drug or to use an investigational device during the course of the study 14. Subjects with a known allergy, hypersensitivity, or intolerance to the active substances and/or excipients of study medication (e.g., cannabis, cannabinoids, sesame oil) 15. Any condition, which in the opinion of the investigator, would interfere with the evaluation of the study product or poses a health risk to the subject 16. Subjects who are employees of the sponsor or employees or close relatives of the investigator ; PRIMARY OUTCOME: Change in YGTSS-TTS; SECONDARY OUTCOME 1: Response to treatment according to YGTSS-TTS[/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 - vs. Tranexamic Acid; BRIEF: The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the study is to define minimally effective dose of MDCO-2010. ; DRUG USED: MDCO-2010; DRUG CLASS: New Molecular Entity (NME); INDICATION: Coronary Artery Bypass Graft (CABG); TARGET: Coagulation Factor X, Coagulation Factor XI, Kinin-Kallikrein System , Plasmin; THERAPY: Monotherapy; LEAD SPONSOR: The Medicines Company; CRITERIA: Inclusion Criteria: - For Stage 1: Planned primary isolated CABG surgery - For Stage 2: Planned primary isolated CABG surgery, OR Planned primary combined CABG and aortic valve replacement surgery - Men, aged 18 to 85 years, or Women, aged 18 to 85 years, either of postmenopausal status, defined as ≥1 year since last menstrual period AND if less than 65 years old with a negative pre-operative pregnancy test within 24 hours of surgery OR with medical history of hysterectomy or bilateral oophorectomy - Written informed consent Exclusion Criteria: - Off-pump surgery or hybrid procedures - Patients undergoing repeat sternotomy - Planned deep hypothermic circulatory arrest (<28°C) - Known allergy, sensitivity, or contraindications to tranexamic acid - Epileptiform disorders, history of seizure activity, or anticonvulsive medication - Administration of clopidogrel, ticagrelor or ticlopidine within 5 days prior to surgery or prasugrel within 7 days prior to surgery. - Administration of low molecular weight heparin, glycoprotein IIb/IIIa inhibitors, or fondaparinux within 12 hours prior to surgery - Known history of coronary stent thrombosis within the last three months - History of stroke or transient ischemic attack within 3 months prior to surgery - History of deep venous thrombosis or pulmonary embolism - LVEF ≤35% or Grade III or IV - Body mass index <20 or >35 - Known active gastrointestinal (GI) or other non-catheterization bleeding within 7 days prior to surgery - Preoperative coagulation abnormalities defined as: - Platelet count <100,000/L or >350,000/L, or - International normalized ration (INR) >1.5, or - Hematocrit <36%, or - aPTT >1.5 x ULN - Major surgical procedures within 30 days prior to surgery - Patient inability or refusal to receive donor blood products if necessary - Creatinine >2 mg/dL or estimated glomerular filtration rate (eGFR) (calculated using Modification of Diet in Renal Disease [MDRD] equation <30 mL/min) - Known heparin-induced thrombocytopenia type II - Known history of thrombophilia, such as AT-III, Protein C or Protein S deficiency, Factor V Leiden, anti-phospholipid syndrome - Active liver disease defined as any known current infectious, neoplastic or metabolic pathology of the liver OR ALT or AST elevation >2x ULN or total bilirubin elevation >1.5x ULN at Screening - Any condition requiring ongoing chronic immunosuppressive medication - Malignancy within 5 years prior to surgery - Receipt of an investigational drug or device within 60 days prior to surgery Any other condition which, in the opinion of the Principal Investigator, would put the subject at increased risk from participating in the study or otherwise prevent a patients participation in the study ; PRIMARY OUTCOME: Chest Tube Drainage at 12 Hours After Surgery; 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 - (Advanced Cancer); BRIEF: The objective of this study is to determine a recommended Phase 2 dose range of LY2875358 that may be safely administered to participants with advanced cancer. In Part A and Part A2 of this study, escalating doses of LY2875358 as monotherapy and in combination with erlotinib will be evaluated for safety and tolerability, respectively. Part B is a dose-confirmation segment for LY2875358 therapy in 5 different types of cancer: nonsquamous non-small cell lung cancer (NSCLC), castrate resistant prostate cancer (CRPC) with bone metastases, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), or uveal melanoma with liver metastases, and for LY2875358 in combination with trametinib in participants with uveal melanoma with liver metastases. ; DRUG USED: Emibetuzumab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Part A: Have histological or cytological evidence of cancer (solid tumor, lymphoma, or multiple myeloma) that is advanced and/or metastatic and an appropriate candidate for experimental therapy - Part A2: Histologic or cytologic diagnosis of advanced Non Small Cell Lung Cancer (NSCLC), Stage IIIB with malignant pleural effusion or Stage IV, completed at least 1 prior systemic regimen, and eligible for erlotinib therapy. - Part B: Candidate for experimental therapy after standard therapies used or non-eligible for standard therapies. Histological or cytological evidence of 1 of the 5 tumor types: - Castrate-resistant prostate cancer (CRPC) with bone metastasis: --Progressive Disease in the setting of castrate level of testosterone - Renal Cell Carcinoma (RCC): --Histologic diagnosis of either clear-cell or papillary RCC (metastatic and unresectable, or bilateral, multifocal, unresectable RCC localized to kidneys). - NSCLC: --Histologic or cytologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV - Hepatocellular Carcinoma (HCC) --Histologic or cytologic diagnosis of hepatocellular carcinoma - Uveal Melanoma with liver metastasis - Part A: Have the presence of measurable or nonmeasurable disease as defined by the RECIST v1.1 (Eisenhauer et al. 2009) or Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) or have measureable disease for multiple myeloma. - Part A2 & B (RCC, NSCLC, HCC, and uveal melanoma): Have measurable disease as defined by RECIST v1.1. - Give written informed consent prior to any study-specific procedures. - Adequate organ function. - Performance status of less than or equal to 2 on ECOG scale. - Discontinued all previous cancer therapies, and any agents that have not received regulatory approval, for at least 21 days and recovered from the acute effects of therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days. - Reliable and available for the duration of the study and willing to follow study procedures. - Males and females (reproductive potential): Use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug. - Females (childbearing potential): Have had a negative serum pregnancy test before the first dose of study drug and not be breast-feeding. - Estimated life expectancy that will permit the participants to complete 8 weeks of treatment. Exclusion Criteria: - Serious preexisting medical conditions - Symptomatic central nervous system malignancy or metastasis (screening not required). - Acute or chronic leukemia. - Active infection including HIV, hepatitis A, B or C - Have second primary malignancy that may affect the interpretation of results. - Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C. - Patients with active alcohol abuse, as determined by the treating investigator. - Part A2: Unable to swallow tablets. Intolerant of therapy with erlotinib. Concomitant treatment with the cytochrome P450 3A (CYP3A) modulators. Must not have received treatment with any of these modulators within 14 days of study treatment. - Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction 6 months prior to study drug - QTc greater than 470 msec. - Received previous treatment with any c-MET experimental therapeutic. - Part B Expansion Cohort 1 (CRPC): 1. Increasing use of daily doses of opioid analgesics within 28 days prior to enrollment in the study. 2. Neuroendocrine prostate cancer. 3. Patients who have a solitary bone metastasis that has been irradiated are not eligible. - Part B Expansion Cohort 6 (LY2875358 plus trametinib in participants with uveal melanoma with liver metastasis): Contra-indications for trametinib ; PRIMARY OUTCOME: Recommended Phase 2 dose range of LY2875358 monotherapy and in combination with erlotinib; SECONDARY OUTCOME 1: Pharmacokinetics: 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 II - Melanoma w/Brain Metastases; BRIEF: This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma [except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal. ; 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 participants, >/= 18 years of age - Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test) - Measurable brain metastases, defined as lesions that were accurately measured in at least one dimension (longest diameter to be recorded) as ≥0.5 cm in the brain MRI with contrast, treated or untreated - Participants may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed - Participants may or may not have symptoms related to their brain metastases - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Participants must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma Exclusion Criteria: - Increasing corticosteroid dose during the 7 days prior to first dose of study drug - Leptomeningeal involvement in participants with no prior treatment for brain metastases - Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled 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 - Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy ≤1 week prior to first administration of vemurafenib; and stereotactic radiotherapy ≤1 day prior to prior to first administration of vemurafenib - Prior treatment with BRAF or MEK inhibitors - Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug ; PRIMARY OUTCOME: Best Overall Response Rate (BORR) Within Brain of Previously Untreated Participants (Assessed by Independent Review Committee [IRC] Using Modified Response Evaluation Criteria in Solid Tumors [RECIST]); SECONDARY OUTCOME 1: Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated or Untreated Brain Metastases as Assessed by the IRC Using RECIST v1.1[/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/IIa - w/Paclitaxel (S. Korea); BRIEF: This is an open-label, single-center, single-arm, dose escalation and dose expansion Phase I/IIa study designed to determine the recommended Phase 2 dose (RP2D) and the safety and tolerability profile along with preliminary signs of efficacy of rivoceranib in combination with paclitaxel as a second-line therapy in advanced, recurrent and/or metastatic gastric or gastroesophageal junction cancer. This study will also characterize the pharmacokinetic (PK) parameters of rivoceranib and paclitaxel when given in combination. ; DRUG USED: Rivoceranib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Elevar Therapeutics; CRITERIA: Inclusion Criteria 1. Participants with documented locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer refractory to or relapsing after first line platinum and fluoropyrimidine containing chemotherapy (with or without trastuzumab) with an indication for therapy with paclitaxel and an antiangiogenic agent. If disease progression occurs during or within 6 months after completion of any adjuvant chemotherapy, this therapy is considered a first-line chemotherapy for participant eligibility. 2. Participants who have provided tumor tissue prior to initiation of first-line therapy and have provided or can provide tumor tissue prior to screening in this study. This will be optional for Phase I participants. Tumor tissue must not have been irradiated. 3. Participants who have at least 1 measurable lesion as defined by RECIST v1.1. This will be optional for Phase I participants. 4. Adequate bone marrow, renal, and liver function evidenced by: 1. Hematologic: Absolute neutrophil count of ≥1,500/cubic millimeter (mm^3), platelet count of ≥ 1,00,000/mm ^3, and hemoglobin of ≥9.0 grams (g)/deciliter (dL). Transfusion of platelets or red blood cells to meet the inclusion criteria within 2 weeks of screening is not allowed. 2. Adequate renal function, defined as meeting any 1 of the following criteria: i. Serum creatinine <1.5 × upper limit of normal (ULN). ii. Creatinine clearance based on the Cockcroft-Gault estimate ≥50 milliliters per minute (mL/min) or creatinine clearance based on urine collection (12 or 24 hours) ≥50 mL/min. iii. In addition, urinary protein should be <2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24 hour urine or urine protein/creatinine ratio must be collected and must demonstrate <2 g of protein in 24 hours. c) Hepatic: Serum bilirubin <1.5 × ULN, aspartate and alanine aminotransferase ≤3.0 × ULN (≤5.0 × UNL, if with liver metastases). If liver and/or bone metastases alkaline phosphatase ≤5 × ULN. 5. Blood coagulation tests: Prothrombin time and international normalized ratio ≤1.5 × ULN. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Estimated life expectancy of at least 12 weeks. 8. Ability to swallow the study drug without chewing, breaking, crushing, opening or otherwise altering the product formulation. If vomiting occurs, the dose will not be replaced. Antiemetics must be used at efficacious doses. 9. No major gastrointestinal disease (e.g., chronic diarrheal disease) or intestinal surgery that can jeopardize drug absorption. Exclusion Criteria 1. Prior use of taxane (paclitaxel or docetaxel) or any contraindication for therapy with paclitaxel. 2. Previous treatment with rivoceranib or any other systemic therapy with a vascular endothelial growth factor (VEGF) pathway inhibitor. 3. Known hypersensitivity to rivoceranib or any component of its formulation or history of severe adverse events, including uncontrolled hypertension or other common anti-angiogenesis drug class effects during prior exposure to vascular inhibitors. 4. Any unresolved toxicity Grade >1 (except alopecia) from previous anticancer therapy (including radiotherapy). 5. Has history of another malignancy within 2 years prior to screening. Participants with the following are eligible for this study if, in the opinion of the investigator, they do not pose a significant risk to life expectancy: 1. Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (Tis). 2. Curatively treated cervical carcinoma in situ. 3. Thyroid papillary cancer with prior treatment. 4. Carcinoma of the skin without melanomatous features. 5. Prostate cancer which has been surgically or medically treated and not likely to recur within 2 years. 6. Known brain metastasis or other central nervous system metastasis that is either symptomatic or untreated. Metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by computed tomographic scan at least 4 weeks before screening without evidence of cerebral edema. Participants on stable dose of corticosteroids or anticonvulsants are permitted. 7. Has received prior anticancer therapy within 3 weeks before Cycle 1 Day 1. Traditional herbal remedies with anti-infective, immune stimulating, or anticancer properties are not allowed from screening throughout the entire period of study participation. 8. Current or recent (within 10 days of Cycle 1 Day 1) use of full dose oral or parenteral anticoagulants or other thrombolytic agents for therapeutic (as opposed to prophylactic) purposes, clinically serious non-healing wounds, or incompletely healed bone fracture. A maximum dose of 325 milligrams (mg)/day of aspirin is allowed. 9. Participants who had therapeutic paracentesis of ascites (>1 liter [L]) within the 2 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (>1L) within 2 months of Cycle 1 Day 1. 10. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19. 11. Active bacterial infections (including tuberculosis and syphilis) requiring systemic antibiotic therapy. 12. Known history of human immunodeficiency virus infection. 13. Active hepatitis B or C infection or chronic hepatitis B or C infection requiring treatment with antiviral therapy or prophylactic antiviral therapy; unless evidence of viral suppression has been documented and the participant will remain on appropriate antiviral therapy throughout the study. 14. Child-Pugh Stage B and C liver function impairment. 15. Pregnant or breastfeeding women. Participants unwilling to comply with birth control requirements will not be eligible. 16. History of uncontrolled hypertension (blood pressure ≥140/90 mmHg and change in antihypertensive medication within 7 days prior to screening) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy. History of hypertensive crisis, and hypertensive encephalopathy. 17. Participants who have a known history of symptomatic congestive heart failure (New York Heart Association III to IV), symptomatic or poorly controlled cardiac arrhythmia, complete left bundle branch block, bifascicular block, or any clinically significant ST segment and/or T wave abnormalities, corrected QT interval by Fredericia (QTcF) > 450 msec for males or QTcF > 470 milliseconds (msec) for females prior to screening. 18. History of bleeding diathesis or clinically significant bleeding within 14 days prior to Cycle 1 Day 1. This includes a history of gastrointestinal bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3 months prior to Cycle 1 Day 1 that, in the investigators opinion, may place the participant at risk of side effects from anti-angiogenesis products. 19. History of clinically significant thrombosis (bleeding or clotting disorder) within the past 3 months prior to Cycle 1 Day 1 that, in the investigators opinion, may place the participant at risk of side effects from anti-angiogenesis products. 20. History of other significant cardiovascular diseases or vascular diseases within the last 6 months prior to screening (e.g., myocardial infarction or unstable angina pectoris, stroke or transient ischemic attack, or significant peripheral vascular diseases) that, in the investigators opinion, may pose a risk to the participant on vascular endothelial growth factor receptors (VEGFR) inhibitor therapy. 21. History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies. 22. Psychological, familial, sociological, or geographical conditions including drug or alcohol abuse that do not permit compliance with the study participation or evaluation of the study results. ; PRIMARY OUTCOME: Phase I: Incidence of Dose-Limiting Toxicities (DLT) During Cycle 1; SECONDARY OUTCOME 1: Phase I: Maximum Observed Concentration (Cmax)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Mature B-cell Malignancies (China); BRIEF: The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types. ; DRUG USED: BGB-11417; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Monotherapy; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. Confirmed diagnosis of only one of the following: Cohort A a. Marginal Zone Lymphoma i. R/R extranodal, splenic or nodal disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for MZL is available per investigators assessment. ii. Active disease requiring treatment. b. Follicular Lymphoma i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that has relapsed after, or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for FL is available per investigators assessment. ii. Active disease requiring treatment. c. Diffuse Large B-cell Lymphoma i. R/R DLBCL defined as disease that relapsed after, or been refractory to, at least one line of anti-CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for DLBCL is available per investigators assessment. ii. Active disease requiring treatment. d. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Cohort A that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richters transformation) are not eligible for Cohort A. ii. Active disease requiring treatment. Cohorts B and C a. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria: i. R/R disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of standard therapy for ≥ 2 consecutive cycles, and no effective standard therapy is available per investigators assessment. ii. Requiring treatment based on IWCLL criteria. 2. Measurable disease by computed tomography/magnetic resonance imaging, defined as: 1. CLL: At least 1 lymph node > 1.5 centimeters (cm) in longest diameter and measurable in 2 perpendicular dimensions. For Cohort B, participants should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C. 2. DLBCL, FL, MZL, SLL: At least 1 lymph node > 1.5 cm in longest diameter OR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions. For MZL isolated splenomegaly is considered to indicate measurable disease for this study. For SLL, participants in Cohort B should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C. Key Exclusion Criteria: 1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer. 2. Underlying medical conditions that, in the investigators opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results. 3. Known central nervous system involvement by lymphoma/leukemia. 4. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richters syndrome. 5. Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric cell therapy unless ≥ 6 months after cell infusion. 6. Prior allogeneic stem cell transplant. ; PRIMARY OUTCOME: MTD Of BGB-11417 As Recommended By The Bayesian Logistic Regression Model Or The MAD; SECONDARY OUTCOME 1: Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of BGB-11417[/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 - PEP; BRIEF: The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed. ; DRUG USED: AV7909; DRUG CLASS: Vaccine; INDICATION: Anthrax Infection (Antibacterial); TARGET: Anthrax protective antigen , Bacillus anthracis (Anthrax), Immune System, Toll-like receptor 9 (TLR9); THERAPY: Monotherapy; LEAD SPONSOR: Emergent BioSolutions; CRITERIA: Inclusion Criteria: - Be 18-50 years old - Be in good health - Have access to a computer and the internet so you can complete a diary - Agree to abstain from sex the first 84 days of the study or practice birth control if you are a woman who is able to get pregnant - Have not donated blood for the previous 8 weeks Exclusion Criteria: - A known anaphylactic response, severe systemic response, or serious hypersensitivity reaction to a prior immunization. - A history of latex allergy. - Have received a shot (vaccine), including flu shots, in the past 6 weeks or plan to get a shot for 4 weeks after the last study shot is given. - Have previously served in the military any time after 1990 or plan to enlist in the military from Screening through Day 84. - Prior immunization with anthrax vaccine, recombinant protective antigen (rPA) vaccine, or known exposure to anthrax organisms. - Have participated in anthrax therapeutic or vaccine studies (monoclonal anti-PA or anthrax immune globulins or anthrax vaccines). - Participation in any investigational study involving use of a pharmacological intervention within 30 days before the Screening visit or planning to participate in a study requiring dosing through the 12-month safety follow-up telephone call. - Have a known diagnosis of any immunodeficiency disease including but not limited to: acquired immune deficiency syndrome (AIDS), common variable immunodeficiency disease, immunoglobulin A (IgA) deficiency, or hypogammaglobulinemia. - Past history of significant autoimmune disease such as rheumatoid arthritis, lupus erythematous, psoriasis in the area of vaccinations, or requires immunotherapy, glomerulonephritis, or autoimmune thyroiditis. - Have received immunosuppressive therapy with cytotoxic drugs or Rituximab within the past 2 years. - A history of cytotoxic chemotherapy or radiation therapy. - Chronic (>10 days) daily oral or parenteral corticosteroid therapy in the past 12 months. - Any lung disease, including reactive airway disease, which requires the daily use of medications. - A female currently breastfeeding or with a positive pregnancy test. - A history of drug or alcohol abuse within 12 months prior to Screening, or a positive result on a urine drug screen for cocaine, marijuana, opiates, methamphetamines, benzodiazepines, or oxycodone. - Any tattoo or other skin condition in the deltoid region on either arm that may obscure the assessment of the injection sites. - A medical condition that, in the opinion of the PI or designee, could adversely impact the subjects participation or safety or the conduct of the study. - Any planned elective in-patient surgery during the study period. ; PRIMARY OUTCOME: Toxin Neutralizing Antibody (TNA) Level at Day 63; SECONDARY OUTCOME 1: TNA Level at Day 42[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KEYNOTE-866; BRIEF: A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients. ; DRUG USED: Keytruda; 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: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology. - Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis. - Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND). - Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Have adequate organ function. - Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. Exclusion Criteria: - Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions. - Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). - Has ≥N2 disease or metastatic disease (M1) as identified by imaging. - Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol. - Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder. - Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC. - Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention. - Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection. - Has a known psychiatric or substance abuse disorder. - Has had an allogenic tissue/solid organ transplant. ; PRIMARY OUTCOME: Event-Free Survival (EFS); SECONDARY OUTCOME 1: Pathologic Complete Response (pCR) Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 2202; BRIEF: This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration. ; DRUG USED: Tesidolumab; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye. - An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye. - History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye. Exclusion Criteria: - History of recurrent non-response to anti-VEGF therapy in the study eye. - In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary). - Choroidal neovascularization due to a cause other than AMD. - In the study eye, media opacity that, in the investigators opinion, could interfere with conduct of the study. - History of infectious uveitis or endophthalmitis in either eye. - Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor. - Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye ; PRIMARY OUTCOME: Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time; SECONDARY OUTCOME 1: The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.[/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 - Impaired Hepatic Function; BRIEF: This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function. ; DRUG USED: Ibrance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Body Mass Index (BMI) of 18 to 40 kg/m2; and a total body weight >50 kg (110 lbs) - Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study - Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: - Any condition possibly affecting drug absorption (eg, gastrectomy) - A positive urine drug screen - Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for 90 days after the last dose of investigational product - History of sensitivity to heparin or heparin-induced thrombocytopenia - Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing - Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol - Use of tobacco or nicotine products in excess of 5 cigarettes per day (or equivalent) - History of sensitivity to palbociclib ; PRIMARY OUTCOME: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf); SECONDARY OUTCOME 1: Unbound AUCinf (AUCinf,u)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - LIBERTY ASTHMA TRAVERSE (OLE); BRIEF: Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: - Systemic exposure - Anti-drug antibodies - Biomarkers ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544. Exclusion criteria: - Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant. The above information was not intended to contain all considerations relevant to a Participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE 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 II - 1650-CL-0201; BRIEF: The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650 (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed objective response rate (ORR) (phase 2) in participants with incurable platinum refractory germ cell tumors. This study also evaluated the following efficacy measures for confirmed objective response rate (ORR); clinical benefit rate (CBR); duration of response (DOR); and progression-free survival (PFS); as well as safety and tolerability; the effect of ASP1650 on changes in serum beta human chorionic gonadotropin (βhCG) and alpha-fetoprotein (AFP); and the pharmacokinetics of ASP1650. ; DRUG USED: iMAB027; DRUG CLASS: Biologic; INDICATION: Testicular Cancer; TARGET: CLDN6; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Global Development, Inc.; CRITERIA: Inclusion Criteria: - A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration. - Subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration. - A male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study treatment administration. - Subject agrees not to participate in another interventional study while receiving study drug in present study. Disease Specific Criteria: - Subject has histological evidence of germ cell tumor. - Subject must have a germ cell tumor that is not amenable to cure with either surgery or chemotherapy. - Subjects with seminoma and non-seminoma are eligible. - Subject must have received initial cisplatin based combination chemotherapy AND demonstrated progression following at least 1 salvage regimen for advanced germ cell neoplasm (including relapsed primary mediastinal nonseminomatous germ cell tumor). 1. Initial cisplatin based combination therapy includes bleomycin-etoposide-cisplatin, cisplatin-etoposide, etoposide-ifosfamide-cisplatin or similar regimens. 2. Salvage regimens include high dose chemotherapy, paclitaxel-ifosfamide-cisplatin, vinblastine-ifosfamide cisplatin or similar regimens 3. Failure of prior therapy is defined as: A > 25% increase in the products of perpendicular diameters of measurable tumor masses during prior therapy, which are not amenable to surgical resection; OR the presence of new tumor that are not amenable to surgical resection; OR an increase in alpha-fetoprotein (AFP) or beta human chorionic gonadotropin (βhCG) (≥ 50% increase in 2 separate samples collected at least 1 week apart are required if rising tumor markers are the only evidence of failure). NOTE: Subjects with clinically growing teratoma (enlarging mature teratoma arising during or after chemotherapy for a non seminomatous germ-cell tumor and with normal serum levels of AFP and βhCG) should undergo surgical resection if feasible. - Subjects with late relapse (> 2 years) not amenable to resection are eligible. - Subjects must have evidence of recurrent or metastatic carcinoma by 1 or more of the following: 1. Subject has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy. 2. Subject has a baseline rising tumor marker (AFP or βhCG). NOTE: If a rising tumor marker is the only evidence of progressive disease, at least 2 consecutive rising values at least 1 week apart are needed. Subjects with only evidence of disease as rising tumor marker AFP and βhCG will be assessed for alternate causes of increased serum levels of these markers, such as cross reaction with luteinizing hormone (LH) (can be tested if needed by testosterone suppression of LH), hepatitis, use of marijuana or second primary tumor. Physical or Laboratory Findings: - Subject must have an available tumor specimen in a tissue block or unstained serial slides, or subject is an appropriate candidate for tumor biopsy and is amenable to undergoing a tumor biopsy during the screening period. - Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. - Subject must meet all of the following criteria based on the centrally analyzed laboratory tests within 14 days prior to the first dose of study treatment. If repeat screening labs are required, local laboratory results can be used to confirm eligibility. In case of multiple central laboratory data within this period, the most recent data should be used to determine eligibility. 1. Hemoglobin ≥ 8 g/dL 2. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L 3. Platelets ≥ 75 x 109/L 4. Albumin ≥ 2.5 g/dL 5. Total bilirubin ≤ 2 x upper limit of normal (ULN) or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 2 x ULN 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present) 7. Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 8. Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 2 x ULN (except for subjects receiving anticoagulation therapy) Exclusion Criteria: Prohibited Treatment or Therapies: - Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to first dose of study treatment. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) is eligible. Subject who received systemic steroids for asymptomatic central nervous system (CNS) metastases within 14 days prior to first dose of study treatment is eligible. - Subject has received other investigational agents or devices within 28 days prior to first dose of study treatment. - Subject has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse event (AE) due to monoclonal antibody (mAb) agents administered more than 4 weeks earlier. - Subject has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 2 or at baseline) from AEs due to a previously administered agent. Medical History or Concurrent Disease: - Subject has prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies requiring permanent discontinuation. - Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment. - Subject has an active human immunodeficiency virus (HIV) infection or known active hepatitis B (HBsAg) or C infection. Subjects with well-controlled HIV infections (i.e., without detectable viral load) are eligible. For subjects who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, an HBsAg deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. Subjects with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA) test results are eligible. - Subject has active infection requiring systemic therapy that has not completely resolved within 14 days prior to first dose of study treatment. - Subject has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Subject with asymptomatic CNS metastases is eligible. - Subject has had a major surgical procedure and has not completely recovered within 28 days prior to the first dose of study treatment. - Subject has psychiatric illness or social situations that would preclude study compliance. - Subject has another malignancy for which treatment is required. Subject with negligible risk of metastasis or death is eligible (e.g., basal or squamous cell skin cancer, localized prostate cancer treated with curative intent or incidental prostate cancer T1-T2a, Gleeson ≤ 3 + 4, PSA ≤ 0.5 and who are undergoing active surveillance). - Subject has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data. ; PRIMARY OUTCOME: Recommended Phase 2 Dose (RP2D) of ASP1650; SECONDARY OUTCOME 1: Percentage of Participants With Confirmed Objective Response by RECIST v1.1[/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/III - TCB-101-001; BRIEF: To determine the safety, tolerability, maximum tolerated dose (MTD) and efficacy of ImmuniCell® in patients with melanoma, renal cell cancer (RCC) or non-small cell lung cancer (NSCLC). The study is an adaptive design that has 3 stages: Stage 1 - dose escalation, Stage 2 - efficacy, and Stage 3 - confirm efficacy in one of the tumor types. ; DRUG USED: ImmuniCELL; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: TC Biopharm; CRITERIA: Inclusion Criteria: 1. Male or female patients aged ≥18 years 2. Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1 3. Subjects with histological or cytological confirmation of advanced malignant melanoma, renal cell carcinoma or NSCLC which are refractory to current standard treatments or who have indolent disease for which immunotherapy may be beneficial 4. Measurable disease according to the irRC criteria 5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted <2 weeks prior to Cycle 1: - Creatinine ≤ 1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 ml/min - Total bilirubin ≤ 1.5 x ULN - Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN with liver metastases - Absolute lymphocyte count ≥1.0 x 10E9/L - Absolute Neutrophil Count (ANC) ≥1.5 x 10E9/L - Platelets ≥100 x 10E9/L - Haemoglobin ≥ 10 g/dL 6. Life expectancy of at least 3 months 7. Suitable increase in starting γδ T cell number to final γδ T cell number in the proliferation assay between 10 days in culture 8. Able to give informed, written consent 9. For female patients and female partners of male patients: must be surgically sterile, postmenopausal, or compliant with two forms of contraception (one of which must be a barrier method) during and for 6 months after the treatment period; female patients must have a negative urine pregnancy test at screening and must not be breast-feeding. Exclusion Criteria: 1. Other primary cancers apart from non-melanoma skin cancers, carcinoma - in situ of the cervix, or a prior cancer treated with curative intent more than 2 years ago without any evidence or recurrent disease 2. Uncontrolled systemic infection 3. Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency) 4. Treatment with bisphosphonates, for instance zoledronate, in the previous 3 months and throughout the trial 5. New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months 6. Clinically-significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy. 7. Ulcerative Colitis / Inflammatory bowel disease, Addisons disease 8. Pregnancy or lactation before or during the trial. A urine pregnancy test will be carried out at screening 9. Taking any other investigational medicinal product (IMP) or participation in another interventional clinical trial in the previous 30 days 10. Less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and less than 6 weeks since mitomycin C and nitrosureas 11. Substance abuse, medical, psychological or social conditions that may interfere with the subjects participation in the trial or evaluation of the trial results 12. Any other condition considered by a trial physician to be inappropriate for inclusion to the study such as contraindications to leukapheresis (contraindications to heparin which are: recent cerebral haemorrhage; peptic ulcer; recent surgery to eye or nervous system; hypersensitivity to heparin; past history of Type II heparin induced thrombocytopenia; past history of significant spontaneous haemorrhage; known haemophilia or other bleeding disorder). 13. Serological evidence of active infection ; PRIMARY OUTCOME: Proportion of patients with drug-related > grade 3 toxicity (except for nausea, vomiting or grade 3 diarrhoea without maximal supportive therapy; anaemia, alopecia, or asymptomatic grade 3 laboratory findings that last for < 7 days); SECONDARY OUTCOME 1: Changes in markers of immune response (such as IFN-γ, IL-2 and TNF-α) before the first and subsequent ImmuniCell® infusions[/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 - DIGEST; BRIEF: The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy. ; DRUG USED: S-1; DRUG CLASS: Non-NME; INDICATION: Gastric Cancer; TARGET: Dihydropyrimidine dehydrogenase (DPD) , Thymidylate Synthase; THERAPY: Combination; LEAD SPONSOR: Taiho Oncology, Inc.; CRITERIA: Inclusion Criteria: - Has given written Informed Consent. - Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction. - No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago. - Life expectancy of at least 3 months. - Able to take medications orally. - Eastern Cooperative Oncology Group performance status 0 to 1. - Adequate organ function (bone marrow, kidney and liver). Exclusion Criteria: - Certain type(s) of non-measurable lesion(s), if the only one(s). - Certain serious illness or medical condition(s). - Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the Informed Consent Form. - Treatment with drugs interacting with S-1, 5-FU, or cisplatin. - Pregnant or lactating female. - Known hypersensitivity to fluoropyrimidines or cisplatin. Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Study X2101; BRIEF: This study has two phases, a dose escalation phase and a dose expansion phase. For dose escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoint for this objective will be occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to characterize the safety and tolerability of the maximum tolerated dose or recommended phase 2 dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), assessment of clinical laboratory values, and vital sign measurements. ; DRUG USED: AEB071; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Diffuse large B-cell lymphoma (DLBCL) with activating mutations in CD79 (A or B subunits). DLBCL that arose from transformed indolent lymphoma is allowed. - Prior treatment and relapse following anthracycline-based chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH alone. There is no limit to prior therapy allowed. - Patients may be treated with localized radiation to as many as two sites of disease, so long as measurable or evaluable disease remains at untreated sites. - Patients may be treated with corticosteriods immediately prior to enrollment and during the course of the study treatment as long as steriod treatment is tapered to a toal daily dosage of 10mg or less of prednisone (or its equivalent) prior to AEB071 administration - WHO performance status of ≤2 Exclusion Criteria: - Patients at screening who are treated with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that can not be discontinued. - Impaired cardiac function or clinically significant cardiac diseases, including any of the following: - History or presence of ventricular tachyarrhythmia - Presence of unstable atrial fibrillation (ventricular response > 100 bpm); Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria. - Angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study drug - Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen) - Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma. - Patients with impairment of GI function or GI disease that could interfere with the absorption of AEB071. - Patients with a known history of Human Immunodeficiency Virus (HIV) - HIV testing is not required as part of this study - Patients with a known history of active hepatitis B or C infection unless they are on antiviral therapy - The determination of active hepatitis status should be as per standard of care at each site - Hepatitis B and C testing is not required as part of this study Time since the last prior therapy for treatment of underlying malignancy**: - Cytotoxic chemotherapy: ≤ than the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all) - Biologic therapy (e.g., antibodies): ≤ 4 weeks - ≤ 5 x t1/2 of a small molecule therapeutic, not otherwise defined above **Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia - Patients with any history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies. - Patients having undergone major surgery less than 4 weeks prior to enrollment or that have not fully recovered from prior surgery. - Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Frequency of Dose Limiting Toxicity (DLT) during cycle 1 (Dose Escalation phase); SECONDARY OUTCOME 1: Overall Response Rate, using NHLIWG criteria[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ZA001 (Newly Diagnosed, Treatment-naïve); BRIEF: This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203). ; DRUG USED: Telacebec; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tuberculosis; TARGET: Mitochondrial Electron Transport Chain, Tuberculosis; THERAPY: Monotherapy; LEAD SPONSOR: Qurient Co., Ltd.; CRITERIA: Inclusion Criteria: 1. A new episode of pulmonary TB determined by testing at the study appointed laboratory: Mycobacterium tuberculosis positive and rifampicin and isoniazid sensitive on a rapid molecular test 2. A chest X-ray taken no more than 14 days before Screening which in the opinion of the Investigator is consistent with TB 3. Sputum smear positive on direct microscopy for acid-fast bacilli on at least 1 pre-treatment sputum sample 4. Ability to produce an adequate volume of sputum as determined by an approximately 16-hour overnight sample collection 5. Be of non-childbearing potential or using effective methods of birth control, as defined in the protocol Exclusion Criteria: 1. The patient is mentally or legally incapacitated at Screening 2. Any condition or circumstance, in the opinion of the Investigator, which may make the patient unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the patients safety 3. Clinically significant evidence of extra-thoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator 4. The patient has been infected with hepatitis B or C virus as confirmed by tests for hepatitis B core antibodies, hepatitis B surface antigens, and the hepatitis C virus antibodies 5. The patient with history of allergic reaction to isoniazid, rifampicin, pyrazinamide, ethambutol or related substances (eg, tosylate), as confirmed by the clinical judgement of the Investigator ; PRIMARY OUTCOME: The EBA (early bactericidal activity) of telacebec (Q203); 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 - 1220.5 - Treatment-Naive/Experienced; BRIEF: The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients. ; DRUG USED: Faldaprevir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL >=100,000 IU/mL Liver biopsy within 2 years prior to study enrolment showing necroinflammatory activity or presence of fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65 years Females and males with adequate contraception Exclusion criteria: Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening Previous treatment with protease inhibitor Evidence of liver disease due to causes other than chronic HCV infection HIV-1 or HIV-2 positive HBV positive Decompensated liver disease, or history of decompensated liver disease Active or suspected malignancy or history of malignancy within the last 5 years History of alcohol or drug abuse within the past 12 months. Usage of any investigational drug within 30 days prior to enrolment, or 5 half-lives, whichever is longer Known hypersensitivity to any ingredient of the study drugs Condition that is defined as one which in the opinion of the investigator may put the patient at risk because of participation in the study or may influence the results of the study or the patients ability to participate in the study Alpha-fetoprotein value > 100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in two congruent imaging studies Total bilirubin > 1.5x ULN wiht ratio of direct/indirect >1. ALT or AST levels > 5x ULN INR prolonged to >1.5x ULN Exclusion criteria related to PegIFN and/or RBV restrictions. ; PRIMARY OUTCOME: Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo; SECONDARY OUTCOME 1: Virological Response at Week 2[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Males; BRIEF: The primary objective of this trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK), including dose proportionality of BI 1358894 after single dosing. ; DRUG USED: BI 1358894; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psychiatric Disorder or Disease; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion Criteria: - Healthy male according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests - Age of 18 to 45 years (incl.) - BMI of 18.5 to 29.9 kg/m2 (incl.) - Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation - Willingness to comply with contraception requirements. Subjects who are sexually active, must use, with their female partner, adequate contraception throughout the study and until one month after the last administration of trial medication. Adequate methods are: - Sexual abstinence or - A vasectomy performed at least 1 year prior to screening in combination with a barrier method (condom) or - Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subjects female partner or - The use of condoms, if the female partner uses in addition an adequate contraception method, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide) - Unprotected sexual intercourse with a pregnant female partner is not allowed throughout the study and until one month after the last administration of trial medication Exclusion Criteria: - Any finding in the medical examination (including BP, PR or ECG) is deviating from normal - 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 - C-Reactive Protein > ULN, erythrocyte sedimentation rate (ESR) ≥ 15 millimeters/hour, liver and kidney parameter above ULN, other laboratory values outside the reference range the investigator considers to be of clinical relevance - Any evidence of a concomitant disease judged as clinically relevant by the investigator - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders - Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair) - Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders - History of relevant orthostatic hypotension, fainting spells, or blackouts - Chronic or relevant acute infections - History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) - 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) - Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug - Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day) - Inability to refrain from smoking on specified trial days - Alcohol abuse (consumption of more 30 g per day for males) - Drug abuse as per investigator judgment or positive drug screening - Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial - Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial - Inability to comply with dietary regimen of trial site - A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant ECG finding at screening - A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome) - Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study - Any lifetime history of suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) - Any suicidal ideation of type 2 to 5 on the C-SSRS in the past 12 months (i.e. active suicidal thought, active suicidal thought with method, active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent) ; PRIMARY OUTCOME: Number [N (%)] of subjects with drug- related adverse event; SECONDARY OUTCOME 1: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data time point tz)[/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 - Alone or w/PDR001; BRIEF: The purpose of this study is to assess the safety, tolerability, and identify the recommended doses of single agent CJM112, and of CJM112 or LCL161 in combination with PDR001, in patients with relapsed and/or refractory multiple myeloma. ; DRUG USED: CJM112; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Must be able to provide written informed consent before any screening procedures. - Male or female patients ≥18 years of age. - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. - Patients with a confirmed diagnosis of multiple myeloma who have received two or more lines of therapy including an IMiD and PI, and are relapsed and/or refractory to their most recent line of therapy. Patients who have received a prior autologous bone marrow transplant and otherwise meet the inclusion criteria are eligible for this study. - Must have measurable disease defined by at least 1 of the following 3 measurements: - Serum M-protein ≥ 0.5 g/dL OR - Urine M-protein ≥ 200 mg/24 hours OR - Serum free light chain (FLC) > 100 mg/L of involved FLC - All patients must be willing to undergo a mandatory serial bone marrow aspirate and/or biopsy at screening and subsequently following treatment for the assessment of biomarker/pharmacodynamics and disease status. Exceptions may be considered after documented discussion with Novartis. Other inclusion criteria included in the protocol might apply. Exclusion Criteria: - Use of systemic chronic steroid therapy (≥10mg /day of prednisone or equivalent), or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal, or ophthalmic steroids are allowed. - Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type. - Active, known or suspected autoimmune disease other than patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur. - Patients with prior known toxicity attributed to PD-1 or PDL-1 directed therapy, which led to discontinuation of these agents, will be excluded from the PDR001 containing arms of the study. - Patients with prior known toxicity from IL-17A directed therapy, which led to discontinuation of the study treatment, will be excluded from CJM112 containing arms of the study. - Any of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of study treatment): - Absolute neutrophil count (ANC) < 1,000/mm3 without growth factor support within 7 days prior to testing - Platelet count < 75,000 mm3 without transfusion support within 7 days prior to testing - Bilirubin > 1.5 times the upper limit of the normal range (ULN) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN - Calculated creatinine clearance < 30 ml/min according to Cockcroft-Gault equation Other exclusion criteria included in the protocol might apply. ; PRIMARY OUTCOME: Number of patients reporting dose limiting toxicities; SECONDARY OUTCOME 1: Immunogenicity of PDR001 and CJM112[/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 - COG-ADVL1014 w/ cyclophosphamide (Pediatric) ; BRIEF: This phase I trial studies the side effects and the best dose of viral therapy in treating young patients with solid tumors that have come back or that have not responded to standard therapy. Some tumors have cells with a genetic weakness that makes them unable to fight off a virus called wild-type reovirus. The virus causes cells with this weakness to die, and may therefore be able to kill tumor cells without damaging normal cells. Cyclophosphamide is a drug used in chemotherapy that stops tumor cells from dividing and causes them to die. Giving wild-type reovirus together with cyclophosphamide may kill more tumor cells. ; DRUG USED: Pelareorep; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Oncolytic Virus Therapy, Ras; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients with relapsed or refractory solid tumors, with the exception of central nervous system (CNS) tumors and lymphomas, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse - Patients must have either measurable or evaluable disease - Patients current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life - Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score - Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and immunizations - Must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea) - At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair - At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair - At least 6 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines - At least 3 half-lives of the antibody after the last dose of a monoclonal antibody - >= 2 weeks for local palliative radiation therapy (XRT) (small port); >= 24 weeks must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation - No evidence of active graft vs host disease and >= 12 weeks must have elapsed since stem cell transplant or infusion - Patients must not have received any previous viral-based anti-neoplastic therapies - Viral immunizations, including influenza, may not have been administered within 7 days prior to enrollment; Note: patients may not receive any viral immunizations after enrolling on study until 28 days post their last planned REOLYSIN infusion - Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 - Platelet count >= 100,000/mm^3 (transfusion independent (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) - Patients with known bone marrow metastatic disease will be eligible for study but not evaluable for hematologic toxicity (maximum of one per cohort); such patients must meet the blood counts above (may receive transfusions provided they are not be known to be refractory to red cell or platelet transfusion); if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR serum creatinine based on age and/or gender as follows: - 0.8 mg/dL (3 to < 6 years of age) - 1.0 mg/dL (6 to < 10 years of age) - 1.2 mg/dL (10 to < 13 years of age) - 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age) - 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age) - Bilirubin (sum of conjugated plus unconjugated) =< 1.5 x upper limit of normal (ULN) for age - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L - Serum albumin >= 2 g/dL - Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by gated radionuclide study - Normal pulmonary function tests (PFTs) (including diffusion capacity of carbon monoxide [DLCO]) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen); for patients who do not have respiratory symptoms, full PFTs are NOT required - Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled - Nervous system disorders National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v. 4) resulting from prior therapy must be =< grade 2 - All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines Exclusion Criteria: - Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method - Patients who have an uncontrolled infection are not eligible - Patients with chronic diarrhea, urinary incontinence during the day or at night, or patients who are not completely toilet trained will not be eligible - Patients will be excluded if they have household contacts who are pregnant, immunosuppressed or infants less than 3 months of age; household contacts are defined as anyone living with the patient during the isolation period of the treatment cycles - Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible - Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are excluded due to risk of viral infectivity of REOLYSIN; therefore, patients with a pre-existent infection are not eligible - Patients who are currently receiving other anti-cancer agents are not eligible - Patients who are currently receiving another investigational drug are not eligible - Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post transplant are not eligible for this trial - Patients must not have received corticosteroids, immune modulators or antiviral therapy for 7 days prior to enrollment and must not have an anticipated need for any of these therapies, intravenous immune globulin (IVIG) must not have been administered within 2 weeks prior to enrollment - Patients should avoid taking acetaminophen with REOLYSIN; whenever suitable, physicians should utilize alternative medications - Patients with known germline mutations affecting Ras activation (e.g. NF-1, Cardio-facial-cutaneous syndrome, Noonan syndrome, Costello syndrome) will be excluded from enrollment - Patients with known metastatic CNS disease involvement are excluded - Patients with primary CNS tumors are excluded ; PRIMARY OUTCOME: Maximum-tolerated dose (MTD), defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT), graded using the NCI CTCAE v. 4.0; SECONDARY OUTCOME 1: Time course of viral clearance of wild-type reovirus[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/Atezolizumab ; BRIEF: This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2). ; DRUG USED: Ciforadenant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Adenosine A2a Receptor; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: General Inclusion Criteria - Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1 - Life expectancy greater than or equal to 3 months - Histologically or cytologically confirmed metastatic, non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC) - Measurable disease (at least one target lesion) - Adequate hematologic and end-organ function - Tumor accessible for biopsy - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm Inclusion Criteria for Cohort 1 - No prior systemic therapy for metastatic NSCLC - High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs >= 50% or TC3 Inclusion Criteria for Cohort 2 - Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC Exclusion Criteria - Prior allogeneic stem cell or solid organ transplantation - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - History of leptomeningeal disease - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan - History of malignancy other than NSCLC within 2 years prior to screening - Active tuberculosis - Severe infection within 4 weeks prior to initiation of study treatment ; PRIMARY OUTCOME: Percentage of Participants with Objective Response; SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Taiwan; BRIEF: The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis. The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies. ; DRUG USED: PHN031; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoporosis / Osteopenia; TARGET: Osteoblast; THERAPY: Monotherapy; LEAD SPONSOR: PhytoHealth Corporation; CRITERIA: Inclusion Criteria: 1. Women 40-60 years of age. 2. Must be postmenopausal (0.5~5 years post cessation of menses) or ovariectomized or hysterectomy women who have documented elevated Follicle Stimulating Hormone FSH (>30mIU/ml) with low serum estradiol (<20 pg/ml). 3. The lumbar vertebral BMD T-score is between -1and -2.5 SD. 4. The body mass index (BMI) is between 19 and 29 kg/m2. 5. Completed informed consent and signed informed consent form. Exclusion Criteria: 1. Have diseases which may affect bone metabolism, e. g., hyper-or hypocalcemia, hyperthyroidism, osteogenesis imperfecta, malignancy, chronic gastrointestinal disease, extensive Pagets disease, alcoholism, and renal or hepatic impairment. 2. Has taken drug therapy for osteoporosis within the previous six months (excluding calcium supplements) prior to this study. 3. Chronic or continued use of hormone replacement drugs or medications that may affect bone calcium metabolism, for example, phosphate-binding antacids, many diuretics, adrenal or anabolic steroids, heparin, anticonvulsants, fluoride in excess of 1 mg/day and supplements of vitamin D or A in excess of RDAs. 4. Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL ~ 66.1 pg/mL). 5. Patients with fracture history. 6. Patients who can not promise to keep from taking stimulant drinks (for example, coffee, tea, alcoholic drink, and Coke) that may cause loss of bone calcium, during the study period. ; PRIMARY OUTCOME: Biochemical Markers; SECONDARY OUTCOME 1: Bone Densitometry[/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 - IGNITE 2 (Part 1, Lead-In); BRIEF: This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI). ; DRUG USED: Xerava; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Tetraphase Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Male and female participants with either: a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR b. cUTI with at least 1 of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately 100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not congestive heart failure or volume related) such that the serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN: creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as, bladder diverticula, redundant urine collection system) EXCEPT surgery within the last month Exclusion Criteria: 1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in participants with cUTI, including: 1. Participants with a history of a levofloxacin-resistant urinary tract infection 2. Likely to receive ongoing antibacterial drug prophylaxis prior to the late Post-Treatment visit (such as, participants with vesiculo-ureteral reflux) ; PRIMARY OUTCOME: Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit; SECONDARY OUTCOME 1: Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BRISK-TA (Study 037); BRIEF: The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy. ; DRUG USED: Brivanib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Fibroblast Growth Factor Receptor (FGFR) , VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Patients with diagnosis of hepatocellular carcinoma - Cirrhotic status of Child-Pugh Class A or B with a score of 7 - ECOG performance status of 0 or 1 - Adequate hematologic, hepatic, and renal function Exclusion criteria: - Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC - History of cardiac disease - Active and untreated hepatitis B - Inability to swallow tablets or untreated malabsorption syndrome - History of human immunodeficiency virus (HIV) infection ; PRIMARY OUTCOME: To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy; SECONDARY OUTCOME 1: To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy[/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 - JAVELIN Merkel 200; BRIEF: This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC). ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Merkel Cell Carcinoma; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Signed written informed consent - Age 18 years and above - Histologically proven MCC - Participants must have received at least 1 line of chemotherapy for metastatic MCC and must have progressed after the most recent line of chemotherapy - For Part B - Participants must not have received any prior systemic treatment for metastatic MCC. Prior chemotherapy treatment in the adjuvant setting (no clinically detectable disease; no metastatic disease) is allowable if the end of treatment occurred at least 6 months prior to study start) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST Version 1.1 (including skin lesions) - Adequate hematological, hepatic and renal function (renal function considered adequate as per protocol definition) - Highly effective contraception for both male and female participants, if the risk of conception exists - Fresh Biopsy or Archival Tumor Tissue - Estimated life expectancy of more than 12 weeks Exclusion Criteria: - Participation in another interventional clinical trial within the past 30 days (participation in observational studies is permitted) - Concurrent treatment with a non permitted drug - Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints) such as antiprogrammed death 1 (PD-1), anti-PD-L1, or anticytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody; for Part B, the Investigator must consult with the Medical Monitor and consider other co-regulatory targets such as 4-1BB - Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy [with the exception of palliative bone-directed radiotherapy, or radiotherapy administered on non-target superficial lesions], immune therapy, or cytokine therapy except for erythropoietin). Radiotherapy administered to superficial lesions is not allowed if such lesions are considered target lesions in the efficacy evaluation or may influence the efficacy evaluation of the investigational agent - Major surgery for any reason, except diagnostic biopsy, within 4 weeks and/or if the participant has not fully recovered from the surgery within 4 weeks - Concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of trial treatment. Short-term administration of systemic steroids (that is, for allergic reactions or the management of immune-related adverse events [irAE]) while on study is allowed. Also, participants requiring hormone replacement with corticosteroids for adrenal insufficiency are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses <= 10 mg or equivalent prednisone per day. Note: Participants receiving bisphosphonate or denosumab are eligible. - Participants with active central nervous system (CNS) metastases are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 2 months, and do not require continued steroid therapy - Previous malignant disease (other than MCC) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin and for Part A cervical carcinoma in situ or for Part B carcinoma in situ (skin, bladder, cervical, colorectal, breast or low grade prostatic intraepithelial neoplasia or Grade 1 prostate cancer) - Prior organ transplantation, including allogeneic stem-cell transplantation - Part A: Known history of testing positive for HIV or known acquired immunodeficiency syndrome (AIDS) or any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. For Part B, known history of testing positive for HIV or known AIDS in consultation with the Medical Monitor or HBV or HCV infection at screening (positive HBV surface antigen or HCV RNA if anti- HCV antibody screening test positive). - Active or history of any autoimmune disease (except for participants with vitiligo) or immunodeficiencies that required treatment with systemic immunosuppressive drugs - Known severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to (>=) 3 NCI CTCAE v 4.0), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) - Persisting toxicity related to prior therapy Grade > 1 NCI-CTCAE v 4.0; however, sensory neuropathy Grade <= 2 is acceptable 14. Pregnancy or lactation - Known alcohol or drug abuse - Clinically significant (that is, 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 - All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the Investigator, might impair the participants tolerance of trial treatment - Any psychiatric condition that would prohibit the understanding or rendering of informed consent - Legal incapacity or limited legal capacity - Non oncology vaccine therapies for prevention of infectious disease (for example, seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of trial drug administration. Vaccination while on trial is also prohibited except for administration of inactivated vaccines (for example, inactivated seasonal influenza vaccine) ; PRIMARY OUTCOME: Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1; SECONDARY OUTCOME 1: Part A: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1[/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 - 790; BRIEF: The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. ; DRUG USED: Mapracorat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor – Transrepression Selective Agonist (SEGRA); THERAPY: Monotherapy; LEAD SPONSOR: Bausch & Lomb Incorporated; CRITERIA: Inclusion Criteria: - Subjects who are candidates for routine, uncomplicated cataract surgery. - Subjects who, in the Investigators opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye. - Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1). Exclusion Criteria: - Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study. - Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit. - Presence of active external ocular disease: infection or inflammation of the study eye. - Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components. - Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol. ; PRIMARY OUTCOME: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells; SECONDARY OUTCOME 1: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.[/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/Itraconazole (Healthy Subjects); BRIEF: This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug interaction study in healthy subjects. The primary purpose of this study is to evaluate the effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720). ; DRUG USED: Ipatasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Within body mass index (BMI) range 18.5 to 32.0 kg/m2, inclusive - In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs - Clinical laboratory evaluations (including chemistry panel [fasted at least 8 hours], hematology, and urinalysis [UA] with complete microscopic analysis within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator) - Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -2) - Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens Exclusion Criteria: - Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the Investigator) - History of diabetes requiring insulin or fasting glucose ≥160 mg/dL - History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator - history of stomach or intestinal surgery or resection, or other GI disorder that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed - history or presence of an abnormal ECG, which, in the Investigators opinion, is clinically significant ; PRIMARY OUTCOME: Maximum Observed Plasma Concentration (Cmax) of ipatasertib and its Metabolite (G-037720); SECONDARY OUTCOME 1: Number of Participants Who Experienced at Least 1 Adverse Event[/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 - TRANSFORM-1; BRIEF: Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts bodys normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires. ; DRUG USED: Navitoclax; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) . - Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days immediately preceding the date of randomization. -- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as measured by the MFSAF v4.0. - Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+). - Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan. - Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria per National Comprehensive Cancer Network guidelines. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Exclusion Criteria: - Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor. - Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant. - Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH). ; PRIMARY OUTCOME: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24); SECONDARY OUTCOME 1: Change in Total Symptom Score (TSS)[/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/IIa - 102-M; BRIEF: The purpose of this study is to determine whether a one-time injection of allogeneic mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the face. ; DRUG USED: Stemedyne-MSC; DRUG CLASS: Biologic; INDICATION: Skin Photodamage; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Stemedica Cell Technologies, Inc.; CRITERIA: Key Inclusion Criteria: - Males and Females 40-70 years of age - Good general health - Fitzpatrick skin type I-III - Fitzpatrick Wrinkle Scale class III. Fine to deep wrinkles, numerous lines with or without redundant skin folds - Ability to understand and provide signed informed consent - Reasonable expectation that subject will attend all scheduled safety follow-up visits - Reasonable expectation that subject will maintain skin care regimen for the duration of the trial - Adequate organ function Key Exclusion Criteria: - History of malignant neoplasm within the past 5 years, or Stage 3 or 4 of any cancer at any time - History of melanoma, leukemia, or lymphoma (any stage) - Persistent pre-cancerous lesions (e.g., actinic keratosis) - Active cutaneous infection of the head and/or neck - Active cutaneous neoplasm in the treatment area - Topical use of any anti-aging creams on the head and/or neck; if used, subject must agree to discontinue for the one year of follow-up on study - Cosmetic or surgical treatment on face/neck in 6 months before study (includes laser, chemical peels, fillers, botulinum toxin) - Prior treatment with stem cells - Positive for hepatitis B, C or HIV - Abnormal and clinically significant findings on screening ECG - Abnormal and clinically significant findings on screening CT scan of the chest (without contrast) - Clinically significant medical condition for which participation in the study would pose a safety risk to the subject - Major surgery within 4 weeks of Study Day 1 - Participation in another study with an investigational drug or device within 3 months prior to stem cell administration - Participation in another study concurrent with the one-year duration of the trial - History within the past year of drug or alcohol abuse - Females known to be pregnant, lactating or having a positive pregnancy test (will be tested during screening) or planning to become pregnant during the study - Sexually active males and females of child-bearing potential must use an effective method of birth control for duration of the study (approximately 13 months from the screening visit) - Allergies to bovine and porcine products ; PRIMARY OUTCOME: MSC Safety and Tolerability; SECONDARY OUTCOME 1: MSC Efficacy[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LUNA3; BRIEF: This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily. For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up. For adult participants, the maximum duration of the long-term extension (LTE) period will be 12 months from the date of the last adult participant to enter the LTE. For pediatric participants, the maximum duration of the LTE period will be 12 months from the date of the last pediatric participant to enter the LTE. ; DRUG USED: PRN1008; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Principia Biopharma, a Sanofi Company; CRITERIA: Inclusion Criteria: 1. Patients will be male and female with primary ITP with duration of >6 months in pediatric participants aged 12 to <18 years (pediatric participants aged 10 to <12 years will be enrolled in the EU [EEA countries] only) and duration of >3 months in ages 18 years and above 2. Patients who had a response (achievement of platelet count ≥50,000/µL) to IVIg/anti-D or CSs that was not sustained and who have documented intolerance, insufficient response or any contra-indication to any appropriate courses of standard of care ITP therapy 3. An average of 2 platelet counts at least 5 days apart of <30,000/µL during the Screening period and no single platelet count >35,000/µL, within 14 days prior to the first dose of study drug. - Pediatric patients must additionally be determined to need treatment for ITP as per clinical assessment by the Investigator. 4. Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5 X 10^9/L, AST/ALT ≤1.5 x upper limit of normal [ULN], albumin ≥3 g/dL, total bilirubin ≤1.5 x ULN [unless the patient has documented Gilbert syndrome], glomerular filtration rate >50 [Cockcroft and Gault method]) 5. Hemoglobin >9 g/dL within 1 week prior to Study Day 1 6. All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 7. Patients must be able to provide written informed consent or informed assent with corresponding informed consent obtained from the patients guardian and agree to the schedule of assessments Exclusion Criteria: 1. Patients with secondary ITP 2. Pregnant or lactating women 3. History (within 5 years of Study Day 1) or current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non melanoma skin cancer 4. Transfusion with blood, blood products, plasmapheresis, or use of any other rescue medications with intent to increase platelet count within 14 days before Study Day 1 5. Change in CS and/or TPO-RA dose within 14 days prior to Study Day 1 (more than 10% variation from current doses) 6. Immunosuppressant drugs other than CSs within 5 times the elimination half-life of the drug or 14 days of Study Day 1, whichever is longer 7. Treatment with rituximab or splenectomy within the 3 months prior to Study Day 1 - Patients treated with rituximab will have normal B-cell counts prior to enrollment 8. Has received any investigational drug within the 30 days before receiving the first dose of study medication, or at least 5 times elimination half-life of the drug (whichever is longer); patient should not be using an investigational device at the time of dosing - Patients who previously received treatment with Brutons Tyrosine Kinase (BTK) inhibitors (except rilzabrutinib) within 30 days before the first dose of study drug are not eligible - Patients who previously received rilzabrutinib at any time are not eligible 9. History of solid organ transplant 10. Myelodysplastic syndrome 11. Live vaccine within 28 days prior to Study Day 1 or plan to receive one during the study 12. Planned surgery in the time frame of the dosing period ; PRIMARY OUTCOME: Durable platelet response during the last 6 weeks of the 24-week blinded treatment period (not for EU and UK); SECONDARY OUTCOME 1: Number of weeks with platelet count ≥50,000/μL OR between ≥30,000/μL and <50,000/μL and at least doubled from baseline over the 24-week blinded treatment period in the absence of rescue therapy[/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 Agent or w/PDR001; BRIEF: The purpose of this first-in-human study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult patients with advanced solid tumors. By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors, Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells. This study has been designed as a Phase I, open-label, multi-center study with a dose escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose expansion part of FAZ053 as single agent. FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as every 6 weeks may be evaluated in parallel. A patient may continue treatment with FAZ053 single agent or in combination with PDR001 until the patient experiences unacceptable toxicity, confirmed disease progression per immune related Response Criteria and/or treatment is discontinued at the discretion of the investigator or the patient. ; DRUG USED: LAE005; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Written informed consent prior to any procedure. - Dose escalation cohorts of FAZ053 single agent and FAZ053 in combination with PDR001: Patients with advanced/metastatic solid tumors with measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor, who have progressed despite standard therapy, or for whom no standard therapy is available. - Dose expansion groups of FAZ053 single agent: Patients with advanced/metastatic solid tumors with at least one measurable lesion as determined by RECIST version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor (for FAZ053 single agent no treatment with an anti-PD-L1 inhibitor is permitted), who have progressed despite standard therapy, or for whom no standard therapy is available and fit into one of the following groups: - FAZ053 single agent: TNBC/ Chordoma/ ASPS - Performance Status (PS) ≤ 2: - Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institutions guidelines. Patient must be willing to undergo a new tumor biopsy at screening/ baseline and during therapy on this study. Exclusion Criteria: - Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy (e.g. radiotherapy or surgery) or increasing doses of corticosteroids within the prior 2 weeks. Patients with treated brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to study enrollment) and off of steroids for at least 2 weeks before administration of any study treatment. - History of severe hypersensitivity to study treatment excipients and additives or other monoclonal antibodies (mAbs) and/or their excipients. - Active, known or suspected autoimmune disease. Patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded. - Treatment with cytotoxic or targeted antineoplastics within 3 weeks of initiation of study treatment. For cytotoxic agents that have major delayed toxicity a washout period of one cycle is indicated (examples are nitrosoureas and mitomycin C which typically require a 6 week washout). Prior antibodies or immunotherapies require a 6 week washout. - Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (≥ 10mg/day prednisone or equivalent). Topical, inhaled, nasal and ophthalmic steroids are allowed. - Active infection requiring systemic antibiotic therapy. Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Number of participants with Adverse Events (AEs) as a measure of safety and tolerability; SECONDARY OUTCOME 1: Serum concentration-time profiles of FAZ053 as single agent and FAZ053 in combination with PDR001.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric (US/EU/Australia); BRIEF: The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic ; DRUG USED: Ixiaro; DRUG CLASS: Vaccine; INDICATION: Japanese Encephalitis; TARGET: Immune System, Japanese Encephalitis Virus ; THERAPY: Monotherapy; LEAD SPONSOR: Valneva Austria GmbH; CRITERIA: Inclusion Criteria: - Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination - Written informed consent by the subjects legal representative(s), according to local requirements, and written informed assent of the subject, if applicable - Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception. - The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7. Exclusion Criteria: - Clinical manifestation or history of any Flavivirus disease - Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study - History of immunodeficiency or immunosuppressive therapy - Known HIV, HBV or HCV infection - History of hypersensitivity reactions to other vaccines - Acute febrile infection at each visit during which the subject receives a vaccination - Active or passive immunization within 1 week before and 1 week after each IC51 vaccination. ; PRIMARY OUTCOME: Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination; SECONDARY OUTCOME 1: Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - KEYNOTE-046; BRIEF: A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 with Pembrolizumab (MK-3475) in patients with metastatic castration-resistant prostate cancer. Part A will be dose-determining of ADXS31-142 monotherapy. Part B will be dose-determining of ADXS31-142 and Pembrolizumad (MK-3475) in combination. Part B expansion will treat additional patients with the recommended dose from Part B. ; DRUG USED: ADXS-PSA; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Immune System, Prostate-Specific Antigen (PSA); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Advaxis, Inc.; CRITERIA: Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. 2. Be 18 years of age or older on day of signing informed consent. 3. Have progressive metastatic castration resistant prostate cancer, on androgen deprivation therapy, based on as least one of the following criteria: 1. PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval with a minimum PSA of 2 ng/ml. 2. Progression of bi-dimensionally measurable soft tissue (nodal metastasis) assessed within 1 month prior to registration by a CT scan or MRI of the abdomen and pelvis. 3. Progression of bone disease (evaluable disease) (new bone lesion(s)) by bone scan. 4. Has discontinued antiandrogens (bicalutamide, nilutamide) >6 weeks and enzalutamide >4 weeks prior to Day 1 of trial treatment 5. Have a performance status of 0 or 1 on the ECOG Performance Scale. Exclusion Criteria: 1. Received more than 3 prior systemic treatment regimens with chemotherapy , hormonal, or immunotherapy in the metastatic setting or received more than 1 prior chemotherapeutic regimen in the metastatic setting 2. Has a diagnosis of immunodeficiency or is receiving any systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Day 1 of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. 3. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered agent. 5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in a Merck MK-3475 clinical trial. 6. Has a contraindication to administration of ampicillin or trimethoprim/ sulfamethoxazole. 7. Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant. ; PRIMARY OUTCOME: Number of subjects with adverse events in each dose level; SECONDARY OUTCOME 1: Progression Free Survival as measured by RECIST 1.1 or ir RECIST[/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 - PETIT (Pediatric); BRIEF: Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized, placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17 years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label fashion, and a review of safety, pharmacokinetic and platelet count data will be performed regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized treatment, all patients will receive eltrombopag in an open label fashion. The total duration of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week review of the first 5 patients no safety issues are identified, dosing will begin in the next lower age cohort with an initial group of 5 patients. The same procedure will be followed in terms of safety review and subsequent enrolment and randomisation of the additional patients. Initiation of the younger age cohort will take place once data from the previous has been evaluated. Doses will be adjusted according to platelet counts and tolerability. The study will include a review of the safety data by a Data Safety Monitoring Board. ; DRUG USED: Promacta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects between 1 year and <18 years of age at Day 1. - Written informed consent from subjects guardian and accompanying informed assent from subject (for children over 6 years old). - Confirmed diagnosis of chronic ITP, according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia. - Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments. - Day 1 (or within 48 hours prior) platelet count <30 Gi/L. - Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective. - Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1. - Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective. - Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range. - Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder. - The following clinical chemistries for the subjects MUST NOT exceed the upper limit of normal (ULN) reference range by more than 20%: creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%. - For subjects of child-bearing potential (after menarche): subject must not be sexually active or is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must use one of the following highly effective methods of contraception (i.e., Pearl Index <1.0%) from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: - Complete abstinence from intercourse; - Intrauterine device (IUD); - Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); - Systemic contraceptives (combined or progesterone only). Exclusion Criteria: - Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease). - Concurrent or past malignant disease, including myeloproliferative disorder. - Subjects who are not suitable for continuation of their current therapy for at least 7 additional additional weeks. - Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1. - History of platelet agglutination abnormality that prevents reliable measurement of platelet counts. - Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening. - Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis). - Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders) - Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1. - Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist. - For female subjects who have reached menarche status, an inability or unwillingness to provide a blood or urine specimen for pregnancy testing. - Female subjects who are pregnant or lactating. ; PRIMARY OUTCOME: Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2); SECONDARY OUTCOME 1: Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - AMT/P2GI/001 Part III; BRIEF: The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma. The primary endpoint is progression free survival rate at 18 weeks after registration ; DRUG USED: AMT2003; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Auron Healthcare GmbH; CRITERIA: Inclusion Criteria: - Cancer confirmed by histology or cytology - At least one measurable lesion - Advanced disease refractory to standard therapy or for which no standard therapy exists - Life expectancy of at least 3 months Exclusion Criteria: - Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma - Body weight below 45 kg - Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control - Confirmed diagnosis of HIV - Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II - Chemotherapy or radiotherapy less than 4 weeks prior to entry - Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery) - Participation in a clinical trial less than 30 days prior to entry in the study ; PRIMARY OUTCOME: Progression free survival;at 18 weeks after registration; SECONDARY OUTCOME 1: Best overall response rate (ORR, CR and PR) within 18 weeks after registration[/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 - BALANCE-EXTEND; BRIEF: The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib. ; DRUG USED: Rinvoq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Subjects who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) with upadacitinib (ABT-494) and did not develop any discontinuation criteria. 2. If the subject has evidence of new latent tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive study drug. 3. If female, subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. 4. Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures. Substudy: 1. Must currently be enrolled in the main study. 2. Must have been receiving a stable dose of upadacitinib (either 15 mg QD or 30 mg QD) for a minimum of 4 weeks prior to the Vaccination visit. 3. Must have been on a stable dose of background methotrexate (no change in dose or frequency) for a minimum of 4 weeks prior to the Vaccination visit. 4. If subject is on corticosteroids, must remain on a stable dose of ≤ 10 mg/day of prednisone or equivalent corticosteroid therapy for at least 4 weeks after the vaccination visit. 5. Must meet the prescribing specifications as per local label requirements to receive Prevnar 13® vaccine. 6. Willing to receive Prevnar13® vaccine. Exclusion Criteria: 1. Pregnant or breastfeeding female. 2. Ongoing infections at Week 0 that have not been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled but not dosed until the infection has been successfully treated. 3. Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug. 4. Laboratory values from the visit immediately prior to Baseline Visit (local requirements may apply) meeting the following criteria: - Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 3.0 × upper limit of normal (ULN) - Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m^2 - Total white blood cell count (WBC) < 2,000/μL - Absolute neutrophil count (ANC) < 1,000/μL - Platelet count < 50,000/μL - Absolute lymphocytes count < 500/μL - Hemoglobin < 8 g/dL 5. Enrollment in another interventional clinical study while participating in this study. 6. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug. Substudy: 1. Receiving any conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than methotrexate 2. Receiving > 10 mg/day of prednisone or equivalent corticosteroid therapy. 3. Receipt of any steroid injection within 4 weeks prior to Vaccination visit. 4. History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®. 5. History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit. 6. Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit. 7. Receipt of any pneumococcal vaccine. 8. Subject is not suitable for the sub-study as per the Investigators judgment. ; PRIMARY OUTCOME: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time; SECONDARY OUTCOME 1: Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Non-Hospitalized Adult Subjects; BRIEF: The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay. ; DRUG USED: JNJ-53718678; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Syncytial Virus (RSV) Treatment; TARGET: RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to 5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the participant becomes aware of the first sign and/or symptom consistent with a viral infection - Participant has been diagnosed with respiratory syncytial virus (RSV) infection using a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test - Before randomization, a woman must be not of childbearing potential defined as: Premenarchal, Postmenopausal or Permanently sterile - A male participant must agree to the use of acceptable contraceptive measures - With the exception of the RSV-related illness the participant must be medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening Exclusion Criteria: - Hospitalized participants or participants expected to be hospitalized within 24 hours of screening - History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments - Participants who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study - Participants who are considered by the investigator to be immunocompromised within the past 12 months - Participant has known or suspected chronic or acute hepatitis B or C infection - Women who are pregnant or breastfeeding - Participants with clinically significant abnormal ECG findings (other than QT-interval corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500 millisecond [ms]) not consistent with the underlying condition in the study population, as judged by the investigator ; PRIMARY OUTCOME: Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3; SECONDARY OUTCOME 1: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KEYNOTE-585; BRIEF: The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: - Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and - Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease. - Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice. - Is willing to provide tissue from a tumor lesion at baseline and at time of surgery. - Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment. - Has adequate organ function. - Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy. - Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. - Has life expectancy of greater than 6 months. Exclusion Criteria: - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Has an active infection requiring systemic therapy. - Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. - Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial. - Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy. - 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 14 days prior the first dose of study treatment. - Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded. - Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients. - Has an active autoimmune disease that has required systemic treatment in past 2 years. - Has a known history of human immunodeficiency virus (HIV) infection. - Has a known history of Hepatitis B or known active Hepatitis C virus infection. - Has a known history of active tuberculosis (TB). - Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. - Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy. - Has had an allogenic tissue/solid organ transplant. - Has received a live vaccine within 30 days prior to the first dose of study treatment. ; PRIMARY OUTCOME: Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms; SECONDARY OUTCOME 1: Percentage of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms Separately and in Combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - ENCORE; BRIEF: A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy. ; DRUG USED: Molgradex; DRUG CLASS: Biologic; INDICATION: Cystic Fibrosis (CF); TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116; THERAPY: Monotherapy; LEAD SPONSOR: Savara Inc.; CRITERIA: Inclusion Criteria: 1. Written informed consent obtained from participant. 2. Confirmed diagnosis of CF according to the Cystic Fibrosis Foundation (CFF) 2017 Consensus Guidelines. 3. History of chronic pulmonary infection with M. avium complex (MAC) or M. abscessus complex (MABSC) (defined as at least three positive NTM cultures (sputum or BAL for the same species (MAC) or subspecies (MABSC) within the 2 years prior to the screening visit, with at least one positive within the past 6 months and a minimum of 50% of NTM cultures positive over the past 2 years) that does not demonstrate response to current treatment course based on decreasing NTM burden or frequency of positive cultures, and in the opinion of the Investigator is unlikely to resolve with current treatment course. 4. Subject fulfills criteria for inclusion in one of the following groups: Group 1: Subject with chronic pulmonary MAC or MABSC infection currently on a multidrug NTM guideline-based antimycobacterial regimen, which has been ongoing for at least 9 months prior to the Baseline visit. Group 2: Subject with chronic pulmonary MAC or MABSC infection who has stopped a multidrug NTM guideline-based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance. Group 3: Subjects with chronic pulmonary MAC or MABSC infection not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen based on failure to meet ATS/IDSA criteria for NTM pulmonary disease (i.e. absence of radiologic findings and clinical symptoms beyond what is expected from underlying CF). 5. Ability to produce sputum or be willing to undergo an induction protocol that produces sputum for clinical evaluation. 6. An additional sputum culture performed by the central laboratory, which is positive for the same species (MAC) or subspecies (MABSC) of NTM as before the trial within 10 weeks of Baseline. 7. CF which in the Investigators opinion is clinically stable and not expected to require lung transplantation within the next year. 8. FEV1 ≥ 30% of predicted at screening that is normalized for age, gender, race, and height, using the Global Lung Function Initiative (GLI) equation. 9. Subjects who are co-infected with a respiratory pathogen, e.g. P. aeruginosa or S. aureus, must either be stable on a regular suppression antibiotic regimen or must be, in the opinion of the Investigator, stable despite the lack of such treatment. 10. Female or male ≥18 years of age. 11. If female, subjects who have been post-menopausal for more than 1 year or females of childbearing potential after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with less than 1% failure rate) during and until 30 days after last dose of trial treatment, having a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at dosing at Baseline (Visit 2) and must not be lactating. For purposes of this study, the Sponsor defines acceptable methods of contraception as: - Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug. - A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion. - Intrauterine devices (IUDs), inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration. - Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion. - Hysterectomy or surgical sterilization. - Vasectomized partner - Abstinence. Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam) is not considered an acceptable form of contraception. NOTE: For subjects prescribed Orkambi: Orkambi may substantially decrease hormonal contraceptive exposure, reducing the effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi. 12. If male, subjects who, if sexually active of reproductive potential and non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6 months and not diagnosed with infertility through demonstration of azoospermia in a semen sample and/or absence of vas deferens through ultrasound) are willing to use a barrier method of contraception, or their female partner must use an acceptable method of contraception, during the study and until 30 days after last dose of medication. 13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified in the protocol as judged by the Investigator. Exclusion criteria: 1. Use of non-maintenance antibiotic for a concurrent pulmonary or extrapulmonary infection within 28 days prior to the Baseline visit. 2. Use of a maintenance antibiotic regimen containing azithromycin for a concurrent non-NTM pulmonary infection within 28 days prior to the Baseline visit. For subjects in Group 1, azithromycin is allowed if part of ongoing multidrug NTM guideline-based antimycobacterial regimen. 3. Prior therapy with inhaled or systemic granulocyte macrophage colony stimulating factor (GM-CSF). 4. Subjects with hemoptysis of ≥60 mL in a 24-hour period within 4 weeks prior to Screening. 5. Life expectancy of less than 6 months according to Investigators judgement. 6. History of, or present, myeloproliferative disease, leukemia or other hematological malignancy. 7. Active pulmonary malignancy (primary or metastatic); or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study period. 8. Active autoimmune disorder or other condition requiring therapy associated with significant immunosuppression, e.g. such as systemic corticosteroids at a dose equivalent of 10 mg/day or more of prednisolone or other significant immunosuppressant medications, within 3 months prior to Screening or anticipated during the study period. Inhaled or topical corticosteroids, or brief courses (<14 days) of systemic corticosteroids for pulmonary exacerbations or other self-limited conditions are permitted. 9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications, or changes in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators, within 28 days prior to the Baseline visit. 10. Pulmonary tuberculosis requiring treatment or treated within 2 years prior to Screening. 11. History of human immunodeficiency virus (HIV) infection or other disease associated with significant immunodeficiency. 12. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation. 13. History of congestive heart failure (CHF) New York Heart Association (NYHA) Class III or greater in severity. 14. History of cardiovascular ischemic event within 6 months of Baseline. 15. Any change in chronic NTM multi-drug antimycobacterial regimen within 28 days prior to Screening. 16. Treatment with any investigational medicinal product within 28 days of Screening. 17. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product. 18. Any other condition that, in the opinion of the Investigator, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. ; PRIMARY OUTCOME: Number of Participants With Sputum NTM Culture Conversion to Negative; SECONDARY OUTCOME 1: Number of Participants With NTM Sputum Culture Microbiological Cure[/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 - AEGIS-1 (Ulcerative Colitis); BRIEF: The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC). ; DRUG USED: Accrufer; DRUG CLASS: Non-NME; INDICATION: Anemia; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Shield Therapeutics; CRITERIA: Inclusion Criteria: - Competency to understand and sign the IEC/IRB approved informed consent form prior to any study mandated procedure, and willing/able to comply with study requirements - Age ≥ 18 years - Current diagnosis of quiescent UC as defined by SCCAI score of < 4 - Current diagnosis of IDA as defined by Hb ≥ 9.5 g/dl and <12.0 g/dl for women and ≥ 9.5 g/dl and <13.0 g/dl for men; ferritin < 30 µg/l - Prior OFP failure as defined per protocol - If receiving protocol-allowed immunosuppressant must be on stable dose - Females of childbearing potential must agree to use a reliable method of contraception Exclusion Criteria: - Anaemia due to any cause other than iron deficiency - Intramuscular or intravenous injection or administration of depot iron preparation, blood infusions, or erythropoietin within 3 months - Oral iron supplementation use within 1 month - Use of immunosuppressant with known effect of anaemia induction within 1 month - Vitamin B12 or Folic Acid injection/infusion within 4 weeks - Untreated Vitamin B-12 or Folic Acid deficiency - Known hypersensitivity or allergy to ST10-021 or components of the study medication, or contraindication for treatment with iron preparations - Other chronic or acute inflammatory or infectious diseases - Creatinine > 2.0 mg/dl - AST or ALT levels ≥ 5 times the upper limit of normal - Cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject - History of malignancy within the past 5 years (except in situ removal of basal cell carcinoma) - Significant neurologic or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results - Participation in another interventional clinical study within 30 days or during the study - Inmates of a psychiatric ward, prison, or other state institution - Investigator or any other team member involved directly or indirectly in the conduct of the clinical study - Scheduled or expected hospitalization and/or surgery during the course of the study - Females who are pregnant or lactating ; PRIMARY OUTCOME: Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS); SECONDARY OUTCOME 1: Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)[/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 - Proof-of-Concept; BRIEF: - Thirty six patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 or matching placebo for 4 weeks. - During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined. ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL; - Have received methotrexate for six months or longer and at a stable dose of 7.5 to 25 mg/week (extremes included) for at least four weeks prior to screening and willing to continue on this regimen for the duration of the study; - If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening; - If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least two weeks prior to screening; - Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses); - Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least four weeks after the last dose of study drug. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and - Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments. Exclusion Criteria: - Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate; - Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents); - Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening; - Receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening; - Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis, requiring hospitalization; - Positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A; - History of any inflammatory rheumatological disorders other than RA; - History of tuberculosis (TB) infection; - Pregnant or lactating women. ; PRIMARY OUTCOME: The number of patients with an ACR20 score at Week 4 as a measure of efficacy; SECONDARY OUTCOME 1: The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy[/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 - PATENT-CHILD (Pediatric); BRIEF: This study was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary arterial hypertension (PAH) group 1. The study design consisted of a main study part followed by an optional long-term extension part. The main treatment period consisted of two phases: titration phase up to 8 weeks and a maintenance phase up to 16 weeks. ; DRUG USED: Adempas; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Children from 6 years to less than 18 years of age with pulmonary arterial hypertension (PAH) - Diagnosed with PAH : - Idiopathic (IPAH) - Hereditable (HPAH) - PAH associated with (APAH) - Connective tissue disease - Congenital heart disease with shunt closure more than 6 months ago (no open shunts, confirmed by RHC no less than 4 months after surgery) Regardless of the type of PAH, the following findings are not exclusionary: --- Patent foramen ovale (PFO) and asymptomatic, isolated, ostium secundum atrial septal defect (OS-ASD) ≤ 1 cm (both confirmed by echocardiogram) and not associated with hemodynamic alterations indicative of significant shunt, e.g. Qp/Qs ratio less <1.5:1 are not exclusionary - PAH diagnosed by right heart catheterization (RHC) at any time prior to enrolment (for patients with closed shunts - RHC no less than 4 months after surgery) - PAH confirmed by a RHC at any time prior to start of study, with mean pulmonary artery pressure (PAPmean) ≥25 mmHg at rest, pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg, and pulmonary vascular resistance (PVR) >240 dyn•sec•cm^-5 (i.e., ≥3.0 wood units•m^2) - Patients must be on standard of care PAH medications, allowing Endothelin Receptor Antagonists (ERA) and/or Prostacyclin Analogues (PCA), for at least 12 weeks prior to baseline visit. Two groups of patients will be included: - Prevalent: Patients currently on PAH medication (allowing ERA and/or PCA) who need additional treatment (discretion of the investigator) - Incident: Treatment naïve patients initiated on PAH medication (allowing ERA and /or PCA) and then riociguat added once patients are stable on standard of care - WHO functional class I-III - Adolescent females of childbearing potential can only be included in the study if a pregnancy test is negative. Adolescent females of childbearing potential must agree to receive sexual counseling and use effective contraception as applicable. Effective contraception is defined as progestogen-only hormonal contraception associated with inhibition of ovulation (implant), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), or any combination of adequate methods of birth control (e.g. condoms with hormonal contraception). Agreement to use contraception is required from the signing of the informed consent form up until 4 weeks after the last study drug administration. - Young men must agree to use adequate contraception when sexually active. - Written inform consent provided and if applicable child assent provided Exclusion Criteria: - Concomitant use of the following medications: phosphodiesterase (PDE) 5 inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific phosphodiesterase (PDE) inhibitors (theophylline, dipyridamole), nitrates or NO donors (such as amyl nitrite) in any form -- Pretreatment with NO donors (e.g. nitrates) within the last 2-weeks before visit 1. The use of any drug including NO acutely for testing during catheterization is not an exclusion criterion. - Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization or any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening - Systolic blood pressure (SBP) more than 5 mmHg lower than the age-, sex- and height-adapted level of the 50th SBP percentile (NHBPEP, 2004) - History of left-sided heart disease, including valvular disease or heart failure - Pulmonary hypertension related to conditions other than specified in the inclusion criteria - WHO functional class IV - Pulmonary veno-occlusive disease - Screening aspartate transaminase (AST) and/ or alanine transaminase (ALT) more than 3 times the upper limit of normal (ULN) - Severe restrictive lung disease - Severe congenital abnormalities of the lung, thorax, and diaphragm - Clinically relevant hepatic dysfunction (especially Child Pugh C) - Renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73m^2 e.g. calculated based on Schwartz formula) - PH associated with idiopathic interstitial pneumonia (PH-IIP) ; PRIMARY OUTCOME: Number of Participants With Any Treatment-emergent Adverse Events; SECONDARY OUTCOME 1: Change in 6-minute Walking Distance From Baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Safety/Tolerability; BRIEF: This is a single arm, open-label, multicenter phase I study to assess the safety, tolerability and preliminary efficacy of autologous T cells transduced with a specific γδTCR, i.e. TEG002, in a dose escalation and expansion study in relapsed/refractory Multiple Myeloma patients. The study will comprise of a Dose Escalation Segment and an Expansion Segment. The study consists of a screening period, leukapheresis of mononuclear cells, and conditioning chemotherapy, followed by TEG002. All subjects continue to be followed regularly for safety and efficacy assessments until 1 year after TEG002 administration. ; DRUG USED: GDT-002; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Immune System, Stem Cells/Other Cell Therapies, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Gadeta B.V.; CRITERIA: Inclusion Criteria: - Signed informed consent - Adult - Relapsed or refractory Multiple Myeloma as defined by the IMWG - Life expectancy ≥3 months - ECOG performance status 0 or 1 - Adequate vital organ function - Adequate bone marrow function - Toxicities from prior/ongoing therapies recovered to ≤ Grade 2 or subjects baseline - WCBP and men who can father children must be willing and able to use adequate contraception Exclusion Criteria: - Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined - Pregnant or lactating women - Amyloidosis - Uncontrolled infection(s) - Active CNS disease - Previous allogeneic-HSCT - History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. - Subjects that received experimental or systemic therapy < 14 days before TEG002 infusion - NYHA Class ≥ II - Patients depending on dialysis - Patients with a history of pulmonary embolism or deep vein thrombosis - T cell mediated active autoimmune disease OR any active autoimmune disease requiring immunosuppressive therapy ; PRIMARY OUTCOME: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs); SECONDARY OUTCOME 1: Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients[/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 - Cataract Surgery (C13-04); BRIEF: The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery. ; DRUG USED: Dexycu; DRUG CLASS: Non-NME; INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: ICON Bioscience Inc; CRITERIA: Inclusion Criteria: 1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB). 2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation. 3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye. 4. The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye. 5. The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology. 6. A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study. 7. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel. Key Exclusion Criteria: 1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0. 2. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening. 3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time. 4. Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study. 5. Patients with an allergy or hypersensitivity to dexamethasone. 6. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye). 7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0. 8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening. 9. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening. 10. Patients with planned intraocular or laser surgery in the study eye for the duration of the study. ; PRIMARY OUTCOME: Number of Participants With Anterior Chamber Cell Clearing; 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 - AUAT-201; BRIEF: This Phase 2, multicenter, randomized study will evaluate the safety, tolerability and efficacy of ATI-501 for the treatment of Alopecia Areata (AA), Alopecia Universalis (AU) or Alopecia Totalis (AT) in adult subjects. ; DRUG USED: ATI-501; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alopecia Areata; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Aclaris Therapeutics, Inc.; CRITERIA: Inclusion Criteria: Subjects must meet the following criteria to be eligible for participation in the study: 1. Able to comprehend and willing to sign an Informed Consent Form (ICF). 2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent. 3. Have a clinical diagnosis of stable Alopecia Areata (AA), Alopecia Universalis (AU), or Alopecia Totalis (AT). 4. If the subject is a woman of childbearing potential (WOCBP), she must have: - Negative urine and serum pregnancy tests at Screening (Visit 1); and - A negative urine pregnancy test at Baseline (Visit 2); and - Agree to not be planning a pregnancy during the study duration and use a highly effective method of contraception for the duration of the study and 30 days after the last dose of study medication. (Refer to Section 8.4.2). 5. Be in good general health and free of any known disease state or physical condition which, in the investigators opinion, might impair evaluation of the subject or which might expose the subject to an unacceptable risk by study participation. 6. Be willing to maintain the same hair style and hair dyeing throughout the study period. 7. Subjects taking hormonal replacement therapies must be on stable doses for 6 months prior to enrollment and remain on a maintenance dose throughout the study. 8. Subjects taking thyroid replacement medication must be on stable doses for 6 months prior to enrollment and remain on a maintenance dose throughout the study. 9. Sexually active male subjects whose partner is a WOCBP must agree to use a barrier method of contraception from the first dose of study medication to at least 30 days after the last dose of study medication. Exclusion Criteria: Subjects are excluded from this study if any 1 or more of the following criteria is met: 1. Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last dose of study medication. 2. Diffuse AA or a history of an atypical pattern of AA. 3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia (AGA) or scarring alopecia. 4. Active skin disease on the scalp or a history of skin disease on the scalp that in the opinion of the investigator would interfere with study assessments of efficacy or safety. 5. Active scalp trauma or other condition affecting the scalp that, in the investigators opinion, may affect the course of AA, AU or AT or interfere with the study conduct or evaluations. 6. The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit. 7. History of, or current, severe, progressive or uncontrolled autoimmune, metabolic, hepatic, endocrine, renal, gastrointestinal, pulmonary, cardiovascular, genitourinary, or hematological disease, neurologic or cerebral disorders, or coagulation disorders that, as determined by the Investigator, would preclude participation in and completion of study assessments. 8. History of, current or suspected systemic or cutaneous malignancy and /or lymphoproliferative disease, other than subjects with a history of adequately treated and well healed and completely cleared non-melanoma skin cancers (e.g. basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease. 9. Evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment, or history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy for latent tuberculosis may participate. 10. History of serious local infection (e.g., cellulitis, abscess) or systemic infection including but not limited to a history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to Baseline. Subjects on an antibiotic for a nonserious, acute local infection must complete the course prior to enrollment into the study. 11. Positive for HIV, Hepatitis B or C. Subjects with serologic evidence of Hepatitis B vaccination (HepB surface Ab without the presence of Hep B surface Ag will be allowed to participate). 12. History of recurrent herpes zoster (more than one episode) or disseminated herpes zoster (a single episode) or disseminated herpes simplex (single episode) or cytomegalovirus (CMV) that resolved less than 2 months before study enrollment. Subjects with a history of frequent outbreaks of Herpes Simplex Virus (defined as 4 or more outbreaks a year). 13. Subjects who have received any of the following treatments for the timeframes specified below: - Disease Modifying Anti-Rheumatic Drugs (DMARDS), Biologics or immunosuppressants, including but not limited to: anakinra, adalimumab, azathioprine, corticosteroids, cyclosporine, etanercept, infliximab, methotrexate, TNF inhibitors, ustekinumab within 1 month or 5 half-lives (whichever is greater) of Baseline (Visit 2). - Plaquenil within 2 months of Baseline (Visit 2). - Janus kinase (JAK) inhibitors (oral or topical) within 6 months of Baseline (Visit 2). - Intralesional steroids or platelet rich plasma injections in the scalp within 1 month of Baseline (Visit 2). - Topical treatments on the scalp with anthralin, bimatoprost, corticosteroids, diphencyprone, diphenylcyclopropenone (DPCP), squaric acid dibutylester (SADBE), minoxidil, pimecrolimus, or tacrolimus within 1 month of Baseline (Visit 2). - Phototherapy (narrow band Ultraviolet B [NB UVB] or broadband therapy) within 4 weeks of Baseline (Visit 2). 14. Participation in an investigational drug or device trial in which administration of an investigational drug or device occurred within 30 days or 5 half-lives (whichever is longer) of Baseline (Visit 2). 15. Any condition possibly affecting oral drug absorption, e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding are not exclusionary. 16. Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp for at least two weeks prior to a study visit, at the discretion of the investigator, based on the ability to assess hair growth. 17. Vaccination with a live or attenuated vaccine within 6 weeks prior to Baseline (Visit 2) or planned vaccination with these vaccines at any time during treatment or within 6 weeks following discontinuation of study medication. ; PRIMARY OUTCOME: Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24; SECONDARY OUTCOME 1: Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TREAT 1 (80 mg); BRIEF: Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy. ; DRUG USED: Acapodene - ADT; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: GTx; CRITERIA: Inclusion Criteria: To be eligible for participation in this study, subjects must meet all of the following criteria (minor deviations may be discussed with the medical monitor for possible inclusions): - Give voluntary, signed informed consent in accordance with institutional policies - Be male, aged ≥ 50 years - Have histologically documented prostate cancer. Subjects with metastatic prostate cancer may still be considered for the study as long as they are not disqualified by other inclusion/exclusion criteria and there is a reasonable expectation that their medical condition will not interfere with the objectives of the study and that adequate follow-up and compliance with the study protocol can be achieved for the full 24-month duration of the study. - Have been on: - ADT treatment (either luteinizing hormone-releasing agonist [LHRHa] or orchiectomy) for at least 6 months; Or - Intermittent LHRHa for at least the preceding 12 months is acceptable, but subjects must be maintained on uninterrupted treatment for the duration of this study once they are randomized into the study. - Be aged ≥ 70 years or have BMD of lumbar spine or femoral neck at or below the specified thresholds for study entry: - Hologic BMD (g/cm2): L1-L4 - 0.926; Femoral neck - 0.717 - Lunar BMD (g/cm2): L1-L4 - 1.050; Femoral neck - 0.840 - Serum prostate-specific antigen (PSA) ≤ 4 ng/mL - Have a Zubrod performance status ≤ 1 - Subject weight < 300 lbs (weight limitation of DEXA equipment) - Agree to complete a daily diary of medication intake and to provide tablet containers for accurate counts - Agree to use an effective method of contraception, if the partner is of childbearing age, while on study - Have adequate bone marrow, liver and renal function: - White blood cell (WBC) count ≥ 3,000/mm3; - Platelet count ≥ 100,000/mm3; - Bilirubin ≤ 1.5 mg/dL; - AST and ALT < 2x upper limit of normal; - Serum creatinine ≤ 2.0 mg%. Exclusion Criteria: Subjects with any of the following will not be eligible for enrollment: - Taking bisphosphonates, selective estrogen receptor modulators (SERMs), parathyroid hormone (PTH), Forteo® (teriparatide), calcitonin, or oral glucocorticoids within 45 days of randomization - Have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic and lumbar spine (at least eight evaluable vertebrae in the range T4 to L4) [for example, severe scoliosis, or sequelae of orthopedic procedures or other surgery] - Have > 4 vertebral fragility fractures - Have any history of other carcinomas within the last 5 years (except nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of recurrence which will not be excluded). NOTE: Patients with cancers other than nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of tumor recurrence for at least 5 years after definitive treatment will not be excluded from this study. - Have Pagets disease of bone - Have active systemic viral, bacterial or fungal infections requiring treatment - Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol for the full 24-month duration of the study - Received treatment with other investigational agents within 30 days prior to randomization - Taking finasteride (e.g., Proscar®), dutasteride (e.g., Avodart®), Danocrine® (danazol) or testosterone-like supplements, such as dehydroepiandrosterone (DHEA) [subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study] - Taking herbal medicine or dietary supplements for prostate health, such as PC SPES and saw palmetto (also known as Serenoa repens) [subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study]. Lycopene and selenium are not prohibited and no washout is required. - Have a history of thromboembolic disease including deep vein thrombosis or pulmonary embolus - Have a history of chronic hepatitis or cirrhosis - Have received prior treatment with toremifene ; PRIMARY OUTCOME: Percentage of subjects at 24 months with at least one new vertebral fracture determined by blinded central review of radiographs of the thoracic and lumbar spine; SECONDARY OUTCOME 1: Percentage of subjects with at least one new or worsening vertebral fracture at 24 months[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - R/R T-/NK-Cell Lymphomas; BRIEF: This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts: - Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) - Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) - Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant). ; DRUG USED: Tislelizumab; DRUG CLASS: Biologic; INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria - Confirmed diagnosis of relapsed or refractory extranodal NK/T-cell lymphoma (nasal or non-nasal type, peripheral T-cell lymphoma - not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, mycosis fungoides, or Sezary syndrome) - Age 18 years or older - Relapsed or refractory to at least 1 prior systemic therapy - Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) for participants in Cohort 1 and 2 - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Life expectancy ≥ 6 months - Adequate respiratory function - Adequate bone marrow function - Adequate renal and hepatic function Key Exclusion Criteria - Known central nervous system (CNS) involvement by lymphoma - Previously received immune checkpoint therapy - Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 or lower prostate cancer - Active autoimmune disease or history of autoimmune diseases that may relapse with some exceptions - Severe or debilitating pulmonary disease - Clinically significant cardiovascular disease - Active fungal, bacterial, and/or viral infection requiring systemic therapy - Known infection with HIV or active viral hepatitis B or C infection - Major surgery within 4 weeks of the first dose of study drug - Pregnant or lactating women - Vaccination with a live vaccine within 35 days prior to the first dose of study drug - Hypersensitivity to tislelizumab - Concurrent participation in another therapeutic clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Duration of Response (DOR)[/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 - Study 113173; BRIEF: The purpose of this clinical study is to examine the safety, immunogenicity and clinical activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic [ASCI]) administered as a first line treatment in patients with unresectable and progressive metastatic cutaneous melanoma. ; DRUG USED: GSK2302032A; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, PRAME/MAPE/OIP4; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: 1. Male or female patient with histologically proven cutaneous melanoma. Phase I segment: All melanoma patients with stage IV M1b and stage IV M1c including completely resected stage IV patients but with the exception of stage IV M1c disease with serum lactate dehydrogenase > 1.5 x Upper Limit of Normal or with involvement of the Central Nervous System. Phase II segment: All melanoma patients with measurable, unresectable stage III melanoma including in-transit metastasis (with (N3) or without (N2c) nodal metastasis) and stage IV M1a melanoma. The patient should have documented progressive disease within 12 weeks of registration into the trial. Patients with resected stage IV and with stage IV M1b or M1c disease cannot be included. 2. Written informed consent for PRAME expression screening and gene profiling on resected tumor tissue and for the complete study has been obtained from the patient prior to shipment of the sample for expression testing and prior to the performance of any other protocol-specific procedure. 3. The patient is >= 18 years old at the time of signing the first informed consent form. 4. The patients tumor shows expression of the PRAME antigen as determined by RT-PCR analysis or any updated technique on fresh tissue sample. 5. Eastern Cooperative Oncology Group performance status of 0 or 1. 6. The patient has adequate bone marrow reserve, renal, adrenal and hepatic function as assessed by standard laboratory criteria. 7. Female patients of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. 8. Female patients of childbearing potential may be enrolled in the study, if the patient: - has practiced adequate contraception for 30 days prior to the study product administration, and - has a negative pregnancy test on the day of administration, and - has agreed to continue adequate contraception during the entire treatment period and for 2 months after the completion of the study product administration series. 9. In the view of the investigator, the patient can and will comply with all the requirements of the protocol. Exclusion Criteria: 1. The patient has at any time received systemic chemotherapy, (bio)-chemotherapy or CTLA-4 monoclonal antibodies for metastatic disease. 2. The patient is scheduled to receive any other anticancer treatment, including but not limited to (bio)-chemotherapeutic or immunomodulating agents and radiotherapy. 3. The patient has received any cancer immunotherapy containing the PRAME antigen or any cancer immunotherapy for his/her metastatic disease. 4. The patient requires concomitant treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents. 5. Use of any investigational or non-registered product (drug or vaccine) other than the study product within the 30 days preceding the first ASCI dose injection or planned use during the study period 6. The patient has (had) previous or concomitant malignancies at other sites (including carcinoma in situ), except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured. 7. The patient has an allergy to any component of the study investigational product or has a history of previous allergic reactions to vaccinations. 8. The patient has a history of confirmed adrenal dysfunction. 9. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. 10. The patient is known to be positive for the human immunodeficiency virus (HIV). 11. The patient has an uncontrolled bleeding disorder. 12. The patient has a family history of congenital or hereditary immunodeficiency. 13. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures. 14. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. 15. For female patients: the patient is pregnant or lactating. ; PRIMARY OUTCOME: Number of Patients With Dose-limiting Toxicity (Phase I); SECONDARY OUTCOME 1: Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - NANOPAC-2020-01; BRIEF: This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer. ; DRUG USED: NanoPac; DRUG CLASS: Non-NME; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: NanOlogy, LLC; CRITERIA: Inclusion Criteria: - Signed informed consent; - Age ≥18 years and able to tolerate the EBUS-TBNI procedure; - Histologically/cytologically confirmed lung cancer. Eligible subjects may include, for example: primary or recurrent non-resectable disease, locally advanced stages II and III with nodal disease, stage IV advanced disease; - At least one lesion documented via imaging (within 4 weeks of Screening) which can be accessed using EBUS-TBNI; - Subject is not a candidate for surgery; - Has received or plans to receive SOC chemotherapy; adequate hematologic recovery must be confirmed according to the institutions SOC; - Performance Status (ECOG) 0-2 at study entry; - Life expectancy of at least 6 months; - Adequate marrow, liver, and renal function at study entry; - ANC ≥ 1.5 x 109/L; - Hemoglobin ≥ 9.0 grams/dL; - Platelets ≥ 75 x 109/L; - Total bilirubin ≤ 1.5x institutional ULN; - AST/ ALT ≤ 2.5x institutional ULN; - Creatinine ≤ 1.5x institutional ULN; - Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.* Exclusion Criteria: - Significant cardiac disease (Class III or IV per New York Heart Association guidelines); - Active bacterial, viral, or fungal infections (including active AIDS, hepatitis B or hepatitis C); - Symptomatic central nervous system (CNS) metastasis which are neurologically unstable, or CNS disease requiring increase in steroid dose (treated metastatic disease and stable steroid use are not excluded) - Known hypersensitivity to study agent; - Pregnant or breastfeeding women. ; PRIMARY OUTCOME: Number of participants with treatment emergent adverse events; SECONDARY OUTCOME 1: Concentration of paclitaxel in the systemic circulation post-injection[/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 - coBRIM (BRAF+, w/Zelboraf); BRIEF: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator. ; DRUG USED: Cotellic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Participants with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist - Participants must be naïve to treatment for locally advanced unresectable or metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed - Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test - Measurable disease per RECIST v1.1 - Eastern Clinical Oncology Group performance status of 0 or 1 - Consent to provide archival for biomarker analyses - Consent to undergo tumor biopsies for biomarker analyses - Life expectancy greater than or equal to (≥) 12 weeks - Adequate hematologic and end organ function Exclusion Criteria: - History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment - Palliative radiotherapy within 14 days prior to the first dose of study treatment - Major surgery or traumatic injury within 14 days prior to first dose of study treatment - Active malignancy other than melanoma that could potentially interfere with the interpretation of efficacy measures. Participants with a previous malignancy within the past 3 years are excluded except for participants with resected basal cell carcinoma or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast - History of or evidence of retinal pathology on ophthalmological examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion, or neovascular macular degeneration - Uncontrolled glaucoma with intraocular pressure - Serum cholesterol ≥ Grade 2 - Hypertriglyceridemia ≥ Grade 2 - Hyperglycemia (fasting) ≥ Grade 2 - History of clinically significant cardiac dysfunction - Participants with active central nervous system (CNS) lesions (including carcinomatous meningitis) are excluded. However, participants are eligible if: 1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND 2. There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 3 weeks after radiotherapy or surgery - Current severe, uncontrolled systemic disease - History of malabsorption or other condition that would interfere with absorption of study drugs - Pregnant, lactating, or breast feeding women ; PRIMARY OUTCOME: Progression-free Survival; SECONDARY OUTCOME 1: Overall Survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ARTemis (Cambridge University); BRIEF: RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving combination chemotherapy together with or without bevacizumab is more effective in treating patients with nonmetastatic breast cancer. PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy works compared with giving combination chemotherapy together with bevacizumab in treating patients with nonmetastatic breast cancer. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Cambridge University Hospitals NHS Foundation Trust; CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed invasive breast cancer - HER2-negative disease - IHC 0/1 OR IHC 2+ and FISH negative - Must meet 1 of the following criteria: - Unifocal tumor meeting 1 of the following criteria: - T2 or T3 tumors (radiological size > 20 mm) - T4 tumor of any size with direct extension to the chest wall or the skin - Inflammatory carcinoma with tumor of any size - Multifocal tumor meeting the following criteria: - The sum of each tumors maximum diameter must be ≥ 20 mm (total radiological tumor size ≥ 20 mm) - Other locally advanced disease meeting 1 of the following criteria: - Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter > 20 mm or clinical N2) and primary breast tumor of any diameter - Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter > 20 mm or clinical N2), without a primary breast tumor identified and the presence of breast cancer in a lymph node must be histopathologically confirmed by lymph node biopsy (tru-cut or whole lymph node) - Embedded paraffin tumor block available from pre-chemotherapy biopsy and surgical specimen - Bilateral disease allowed - No evidence of metastatic disease - No prior breast cancer except for ductal carcinoma in situ of the breast surgically cured > 10 years ago - Any hormone receptor status PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - WBC > 3 x 10^9/L - Hemoglobin > 10 g/dL - Platelet count > 100 x 10^9/L - AST/ALT ≤ 1.5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 2 times ULN - Bilirubin normal - Isolated elevation of bilirubin to ≤ 3 times ULN with a presumptive diagnosis of Gilbert syndrome allowed if AST/ALT and alkaline phosphatase are within normal limits - Creatinine ≤ 1.5 times ULN - PT and PTT/aPTT ≤ 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - Must be fit to receive chemotherapy on this trial, in the opinion of the responsible clinician, as indicated by the following criteria: - No clinically significant cardiac abnormalities - No myocardial infarction within the past 6 months - LVEF normal (at least 50%) by MUGA scan or echocardiogram - No prior ischemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, inflammatory bowel disease, gastroduodenal ulcer, symptomatic diverticulitis, or bleeding diathesis - No uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg) with or without antihypertensive medication - Patients with initial blood pressure elevations are eligible provided initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria - No other previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast treated by surgery only and disease-free for 10 years - No concurrent medical or psychiatric problem that might prevent completion of treatment or follow-up - No presence of active uncontrolled infection - No history of nephritic or nephrotic syndrome - No traumatic injury within the past 28 days - No evidence of other disease that, in the opinion of the investigator, places the patient at high risk of treatment-related complications - No nonhealing wound, peptic ulcer, or bone fracture PRIOR CONCURRENT THERAPY: - No prior neoadjuvant endocrine therapy - No prior chemotherapy or radiotherapy - No major surgical procedure within the past 28 days - No concurrent full therapeutic dose of anticoagulants or aspirin > 325 mg/day, clopidogrel > 75 mg/day, or corticosteroids ; PRIMARY OUTCOME: Complete pathological response rates (tumor and lymph nodes); SECONDARY OUTCOME 1: Disease-free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Advanced Malignancies; BRIEF: This phase I trial studies the side effects and best dose of CB-5339 in treating patients with solid tumors that has spread to other places in the body (advanced) or lymphomas. CB-5339 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ; DRUG USED: CB-5339; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Cdc48p/p97; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients with histologically documented metastatic or locally advanced (not amenable to surgery) solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy or therapy known to prolong survival; or aggressive lymphoma who have refused or have no remaining curative options (e.g., stem cell transplant). Patients with indolent lymphomas must have undergone 3 or more prior regimens of therapy - Any prior therapy must have been completed >= 4 weeks (6 weeks for nitrosoureas and mitomycin C) or, if known, >= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity. Prior definitive radiation should have been completed >= 4 weeks or palliative radiation should have been completed >= 2 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the principal investigator [PI]s discretion). Patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) at the PIs discretion and should have recovered to grade 1 or baseline from any toxicities - Patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment) - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) and life expectancy > 3 months - Absolute neutrophil count >= 1,500/mcL - Platelets >= 100,000/mcL (solid tumor patients) - Platelets >= 75,000/mcL (lymphoma patients) - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN - Creatinine =< 1.5 x institutional ULN OR 60 mL/min/1.73 m^2 for patients with creatinine levels above 1.5 x institutional normal - The effects of CB-5339 on the developing human fetus are unknown. For this reason and because p97 inhibitors agents may be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 4 months afterwards. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CB-5339 administration - Ability to understand and the willingness to sign a written informed consent document - Subjects on the expansion cohort must also be willing to undergo two core biopsy procedures if there is a lesion amenable to biopsy - Left ventricular ejection fraction >= the lower limit of normal by echocardiogram (ECHO) at entry - Mean QT interval corrected for heart rate (QTc) < 470 ms using Fridericias correction Exclusion Criteria: - Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study - Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia - Patients who are receiving any other investigational agents - Patients with clinically significant illnesses which would compromise participation in the study, including but not limited to active or uncontrolled infection, immune deficiencies, hepatitis B, hepatitis C, active tuberculosis, uncontrolled asthma, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, myocardial infarction within the past 6 months, cerebral vascular accident/stroke within the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements. - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for >= 4 weeks after treatment of the brain metastases. Patients on anti-seizure medications may be enrolled at the discretion of the principal investigator providing that these patients are taking non-enzyme- inducing anti-seizure medications or can be converted to these - Pregnant women are excluded from this study because CB-5339 may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with this agent, breastfeeding should be discontinued if the mother is treated with CB-5339 - Current or previous history of sight-threatening retinal disease, including (but not limited to) proliferative diabetic retinopathy, severe retinal vascular disease, and advanced age-related macular degeneration - Patients with a history of QT-prolongation or of Torsades de pointes (TdP), or of taking QT-prolonging drugs, are not eligible ; PRIMARY OUTCOME: Incidence of adverse events (Phase I); SECONDARY OUTCOME 1: Pharmacodynamic analysis (expansion phase)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Neupogen; BRIEF: The overall purpose of this study is to assess the dose response, efficacy, and safety of three different dose levels of AVI 014 (granulocyte colony-stimulating factor [G-CSF]) in breast cancer patients at high (>20%) risk for chemotherapy-induced severe neutropenia. ; DRUG USED: SBC-014; DRUG CLASS: Biologic; INDICATION: Neutropenia / Leukopenia; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: AviGenics; CRITERIA: Inclusion Criteria: - Able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study. - Women, aged 18 years and older - Histologically confirmed breast cancer, undergoing one of a variety of chemotherapy regimens, or with other risk factors that could lead to a >20% risk of developing severe neutropenia. Patients receiving chemotherapy regimens with high-risk for severe neutropenia are eligible; eligibility of patients receiving intermediate-risk chemotherapy regimens must be discussed with the Medical Monitor for the presence of additional patient-specific risk factors. - Must be receiving first-line adjuvant or neoadjuvant therapy for localized breast cancer or first-line chemotherapy for metastatic breast cancer. It is recommended that patients with human epidermal growth factor receptor 2 (HER2/neu)-positive breast cancer should be receiving Herceptin® (trastuzumab), if approved and available for this indication. - Eastern Cooperative Oncology Group (ECOG) Performance Status of grade 0 to 2 - Adequate renal (serum creatinine and blood urea nitrogen [BUN] <3 times the upper limit of normal [ULN]) and hepatic (serum bilirubin, aspartate aminotransferase [AST], and alanine aminotransferase [ALT] <3 times ULN) function. - Able to adhere to the study visit schedule and other protocol requirements. - Women who are not pregnant and do not plan to become pregnant during the study. Women of childbearing potential must have a negative serum pregnancy test result within seven days before the first dose of study drug and must be using adequate non hormonal barrier contraception before entering the study and throughout the study. Non childbearing potential is defined as post-menopausal for at least one year, surgically sterile, or having had a hysterectomy before study start. Exclusion Criteria: - Pregnant or lactating women. - History or clinical evidence of a serious medical illness, including renal, hepatic, respiratory, cardiovascular, endocrine, neurologic, psychiatric, or hematologic disease, which in the opinion of the investigator will interfere with study participation. - Metastatic brain or meningeal tumors. - Ascites or pleural effusions. - Any active infection requiring systemic antimicrobial therapy. - Known to be positive for human immunodeficiency virus (HIV, anti-HIV+), hepatitis B antigen (HBAg[+]), or hepatitis C antibody (HCVAb[+]). - Known or suspected hypersensitivity to the study drug or its components, such as avian products, including influenza vaccine, or to E. coli-derived proteins. - Currently receiving radiation therapy for treatment of a malignant condition, or have completed radiation therapy within 14 days before study entry. Radiation therapy for oncologic emergency is allowed. - Participated in another therapeutic clinical study (i.e., not an epidemiological study or genomic screening study) during the past 30 days, or are likely to simultaneously participate in another therapeutic clinical study. - History of, or known current problems with, substance abuse, or any medical, psychological, and/or social condition that may interfere with the patients participation in the study, or with evaluation of the study results. - Any condition that could jeopardize the patients safety and compliance, as judged by the investigator. ; PRIMARY OUTCOME: The primary efficacy endpoint is duration of grade 4 neutropenia (DSN), defined as ANC <0.5 x 109/L during chemotherapy cycle 1.; SECONDARY OUTCOME 1: • Incidence of grade 4 neutropenia • Duration of neutropenia (defined as the number of days with ANC <0.5 x 109/L and <0.1 x 109/L)[/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 - Monotherapy (205); BRIEF: The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC). ; DRUG USED: Ocaliva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: Farnesoid X receptor (FXR)/NR1H4 ; THERAPY: Monotherapy; LEAD SPONSOR: Intercept Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Definite or probable PBC diagnosis as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors: - History of elevated alkaline phosphatase levels for at least 6 months - A positive anti-microbial antibody (AMA) titer or, if AMA negative or in low titer (<1:80), PBC-specific antibodies - Liver biopsy consistent with PBC 2. Taking UDCA for at least 12 months (stable dose for ≥ 3 months) prior to Day 0 or unable to tolerate UDCA (no UDCA for ≥ 3 months prior to Day 0). 3. Contraception: Female participants must have been postmenopausal, surgically sterile, or if premenopausal, were prepared to use ≥ 1 effective (≤ 1% failure rate) method of contraception during the trial and until at least 30 days after the last dose of Investigational Product. 4. Must have provided written informed consent and agreed to comply with the trial protocol. Key Exclusion Criteria: 1. Participants with decompensated PBC (as determined by the Investigator). 2. Severe pruritus or systemic treatment for pruritus (for example, treatment with bile acid sequestrants or rifampicin) within 2 months of Day 0. 3. History or presence of other significant liver diseases including: - Active or chronic Hepatitis B or C virus infection - Primary sclerosing cholangitis - Alcoholic liver disease - Definite autoimmune liver disease or overlap hepatitis - Nonalcoholic steatohepatitis Note: Participants with Gilberts disease or those with a history of hepatitis B who were currently antigen negative and seroconverted were not considered exclusionary. 4. Uncontrolled diabetes or other uncontrolled or unstable medical condition that may have interfered with trial results. 5. Administration of any of the following medications as specified below: - Prohibited 28 days prior to Day 0: bile acid sequestrants including cholestyramine, colesevelam, colestipol or omega-3 fatty acid containing dietary supplements - Prohibited 3 months prior to Day 0 and throughout trial participation: serum-lipid modifying agents including 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, fenofibrate or other fibrates, nicotinic acid and derivatives, ezetimibe, Vitamin E (other than as standard dietary supplement) - Prohibited 6 months prior to Day 0 and throughout the trial participation: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline; budesonide and other systemic corticosteroids; potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin) - Prohibited 12 months prior to Day 0 and throughout the trial participation: antibodies or immunotherapy directed against interleukins or other cytokines or chemokines 6. Planned change in diet or exercise habits during participation in the trial. 7. Presence or history of clinically significant cardiac arrhythmias that may have prohibited the participant from participating in the trial. 8. If female: known pregnancy, or had a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. 9. Recent (3 months prior to day 0) participation in another trial involving OCA or participation in another investigational trial (30 days prior to Day 0) and during the trial. ; PRIMARY OUTCOME: Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration; SECONDARY OUTCOME 1: Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II/III - Non-hospitalized; BRIEF: Phase 1 - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 3 - Cohort 1 (≥18 Years Old, Not Pregnant at Randomization) • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death - Cohort 2 (<18 Years Old, Not Pregnant at Randomization) - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To further characterize the concentrations of REGN10933 and REGN10987 in serum over time - Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987 ; DRUG USED: Ronapreve; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva) - Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization - Maintains O2 saturation ≥93% on room air - Is able to understand and complete study-related questionnaires (patients aged ≥12 years only) Key Exclusion Criteria: - Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization - Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit - Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational) - Prior use (prior to randomization), current use (at randomization) or planned use (within 90 days of study drug administration or per current CDC recommendations, as applicable) of any authorized or approved vaccine for COVID-19 - Has participated, is participating or plans to participate in a clinical research study evaluation any authorized, approved or investigational vaccine for COVID-19 NOTE: Other Protocol defined Inclusion/Exclusion criteria apply ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3]; SECONDARY OUTCOME 1: Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COAST-W; BRIEF: The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA). ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Are ambulatory. - Have an established diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria. - Participants have a history of back pain ≥3 months with age at onset <45 years. - Have had prior treatment with at least 1 and not more than 2 TNF inhibitors. - Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs. - Have a history of prior therapy for axSpa for at least 12 weeks prior to screening. Exclusion Criteria: - Have total ankylosis of the spine. - Have never taken a TNF inhibitor medication or have taken more than 2. - Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year. - Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis. - Have a compromised immune system. - Have any other serious and/or uncontrolled diseases. - Have either a current diagnosis or a recent history of malignant disease. - Have had major surgery within 8 weeks of baseline, or will require surgery during the study. - Are pregnant or breastfeeding. ; PRIMARY OUTCOME: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response; SECONDARY OUTCOME 1: Percentage of Participants Achieving an ASAS20 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 - PURE - 01; BRIEF: Patients with T2-T4a N0 urothelial bladder carcinoma (UBC) with residual disease after transurethral resection of the bladder (TURB, surgical opinion, cystoscopy or radiological presence) will receive 3 cycles of pembrolizumab (MK-3475) at the dose of 200mg 3 weekly prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 3 weeks of the last dose (accounting for a total of 9 weeks). Computed tomography (CT) scan and fluorodeoxyglucose positron emission tomography (FDG-PET)/CT scan will be done during screening and before surgery. After cystectomy, patients with the evidence of pathologic stage T3-4 (pT3-4) and/or pathologically node-positive disease will be managed according to local guidelines. Further anti programmed-death (PD)-1 or anti PD-ligand 1 (PD-L1) therapy will not be given post-operatively. PD-L1 status will be centralized and assessed on TURB specimen using an anti-PD-L1 antibody (Ab) and a prototype immunohistochemical (IHC) assay. PD-L1 positivity will be defined as any staining in the stroma or in ≥1% of tumor cells. Pathologic complete response (pCR) is the primary endpoint. All patients enrolled who receive at least 1 cycle of study drug will be includes in the intention-to-treat (ITT) analysis. The alternative hypothesis (H1) is pCR ≥20% and null hypothesis (H0) pCR≤10%. A 2-stage design will be used to estimate the number of pts required. Out of 90 pts overall, with the first stage of 49 pts, ≥6 pCR will be required in the first stage, and ≥13 pCR in the whole study population (80% power and a 2-sided test of significance at the 10% level). Correlative research on tissue/blood samples will include immune-cell profiling in tumor and blood during Pembrolizumab, cytokine assessment, and molecular profiling of tumor samples. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; CRITERIA: Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Ability to comply with the protocol. 3. Age ≥ 18 years. 4. Histopathologically confirmed transitional cell carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern. 5. Fit and planned for cystectomy (according to local guidelines). 6. Clinical stage T2-T4a N0 M0 disease by CT (or MRI) + PET/CT (within 4 weeks of randomization by RECIST v1.1). 7. Residual disease after TURB (surgical opinion, cystoscopy or radiological presence). 8. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for testing at the study sponsor site and determined to be evaluable for tumor PD-L1 expression prior to study enrolment; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Merck representatives. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 10. Adequate hematologic and end-organ function tests. Exclusion Criteria: - Patients taking regular oral steroids, above the allowed limit of 10mg/day methylprednisolone or analogues, for any reason. Patients must not have had steroids for 28 days prior to study entry. - Previously intravenous chemotherapy bladder cancer. Patients who have previously had radiotherapy or concurrent chemo-radiation would be eligible. - Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score ≤ 3 + 4 and PSA < 10 ng/mL undergoing active surveillance and treatment naive). - Evidence of measurable nodal or metastatic disease. - Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome). - Pregnant female patients. All female patients of childbearing potential with a positive pregnancy test within 2 weeks prior to the first dose of study treatment will be excluded from the study. - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias, or unstable angina. - Severe infections within 4 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia. - Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis. - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the pembrolizumab formulation - History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegeners granulomatosis, Sjögrens syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. - Patients with a history of autoimmune-related hypothyroidism, unless on a stable dose of thyroid-replacement hormone. - Patients with uncontrolled Type 1 diabetes mellitus - Uncontrolled hypercalcemia - Patients with prior allogeneic stem cell or solid organ transplantation. - History of idiopathic pulmonary fibrosis - Positive test for HIV. - Patients with active hepatitis infection - Patients with active tuberculosis. - Prior treatment with anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents. - Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrolment - History of severe immune-related adverse effects from anti-CTLA-4 (CTCAE Grade 3 and 4). - Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment. ; PRIMARY OUTCOME: Pathologic complete response; SECONDARY OUTCOME 1: Adverse events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pregnant Women (Africa); BRIEF: The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome. ; DRUG USED: Zithromax; DRUG CLASS: New Molecular Entity (NME); INDICATION: Malaria; TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound). - Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age. - Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. - Subjects who are available for follow up at delivery and on 28 days post delivery. Exclusion Criteria: - Age <16 years old or >35 years old. - Multiple gestations as per the ultrasound at screening. - Clinical symptoms of malaria. - Hemoglobin < 8 g/dL (at enrollment). - Any condition requiring hospitalization at enrollment. - History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability. - Inability to tolerate oral treatment in tablet form. - Known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides. - Requirement to use medication during the study that might interfere with the evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation. - Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption. - Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia. - Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death. ; PRIMARY OUTCOME: Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population; SECONDARY OUTCOME 1: Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population[/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 - LP0058-1362 (Japan); BRIEF: This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary objective is the assessment of PK in Japanese subjects. Data obtained from this trial will be used to compare with existing data from the other Phase 1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects will allow the inclusion of Japanese patients into Phase 2b studies. ; DRUG USED: Orismilast; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: 1. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study-related procedures. 2. An understanding, willingness and ability to fully comply with study procedures and restrictions. 3. Japanese men aged >20 to <45 years (from date of signing informed consent which is defined as the beginning of the Screening Period). This inclusion criterion will only be assessed at the Screening Visit. 4. Japanese subjects must have lived outside of Japan for ≤ 5 years in total and be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese. 5. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m². Exclusion Criteria: 1. Current or recurrent disease (i.e. with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator) that could affect the action, absorption, or disposition of LEO 32731, or could affect clinical assessments or clinical laboratory evaluations. 2. Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures. 3. Any history of psychiatric or mental health issue such (including depression) deemed clinically significant as assessed by the Investigator. 4. Any history of/or active cancer or malignancy (other than squamous cell carcinoma more than 5 years prior). 5. History of Wiskott-Aldrich Syndrome 6. History of active tuberculosis, and/or history of partially or incomplete treatment of tuberculosis. 7. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subjects ability to participate in the study. 8. Use of any prescribed systemic or topical medication(s) within 14 days or 10 half-lives (whichever is longer) prior to Day 1 of the dosing period. 9. Use of any systemic or topical non-prescribed or over-the-counter (OTC) medication(s) (including multivitamin, herbal, or homeopathic preparations) within 7 days or 5 half-lives (whichever is longer) prior to Day 1 of the dosing period. The occasional use of paracetamol (acetaminophen) is allowed to treat short term adverse events; subject to review by the investigator. The maximum allowed daily dose is 2000 mg for paracetamol at the discretion of the investigator. 10. Consumption of more than 21 units of alcohol per week. 11. History or clinical evidence of substance and/or alcohol abuse within the 12 months before screening. Alcohol abuse is defined as regular weekly intake of more than 21 units for males. 12. Positive test results for alcohol, drugs of abuse at screening or Day -1. 13. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch) within 90 days prior to Day 1 of the dosing period. 14. Use of an investigational product within 90 days prior to Day 1 of the dosing period or active enrolment in another drug or vaccine clinical study. 15. Known or suspected intolerance, hypersensitivity or allergy (excluding non-active hayfever) to any drug, food or other known substance (including investigational product, its closely related compounds, and/or any of the stated ingredients). ; PRIMARY OUTCOME: Area under the plasma concentration-time curve from zero to 12 hour (AUC0-12) on day 12 of LEO 32731.; 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 - w/Standard of Care (Canada); BRIEF: This study is a Phase 1, open label, non-randomized, two-arm interventional clinical trial to evaluate the safety and efficacy of Virazole® in hospitalized adult patients who have tested positive for COVID-19 and, as a result, have significant respiratory distress (PaO2/FiO2 ratio <300 mmHg). ; DRUG USED: Virazole; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: IMPDH I (Inosine Monophosphate Dehydrogenase 1), RNA synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: 1. Male or non-pregnant female ≥ 18 years of age. 2. Willing and able to provide written informed consent (or provided by a proxy). 3. Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection. 4. PaO2/FiO2 ratio <300 mmHg. 5. Illness of any duration, and at least one of the following: - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR - Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, OR - Requiring mechanical ventilation and/or supplemental oxygen. 6. Once released from the hospital, women of childbearing potential (WOCBP) and all men must agree to use at contraception methods for 9 months. Exclusion Criteria: 1. Pregnant or breast feeding. 2. Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.). 3. Presence of secondary bacterial pneumonia. 4. Presence of significant pulmonary fibrosis. 5. Hypotension (need for hemodynamic pressors to maintain blood pressure). 6. Greater than 7 days on mechanical ventilation. 7. Anemia defined as hemoglobin or RBC <75% of the institutional lower limit of normal for race, age and gender. 8. History of COPD or bronchospasm prior to COVID-19 infection. 9. History of hypersensitivity to ribavirin. 10. Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subjects participation in the study 11. Subject is currently participating in any drug or device clinical investigation. 12. Subject has received an investigational agent or approved drug that, in the Investigators judgement, may have a chemical or pharmacological interaction with Virazole if administered within 5 half-lives or 30 days of the Baseline Visit. ; PRIMARY OUTCOME: Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment; SECONDARY OUTCOME 1: Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.[/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/Romidepsin or Bortezomib (TCLs) (MSKCC); BRIEF: The purpose of this study is to test the safety of a study drug called duvelisib. ; DRUG USED: Copiktra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral T-Cell Lymphoma (PTCL) - NHL; TARGET: p110 delta/PIK3CD, p110 gamma/PIK3CG, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Memorial Sloan Kettering Cancer Center; CRITERIA: Inclusion Criteria: - Pathologically confirmed T-cell lymphomas at the enrolling institution, including stage ≥ Ib CTCL, which has relapsed or progressed after at least one systemic therapy. - Age ≥ 18 - Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment. For the dose expansion phase, in progressing subjects, a 2 week washout may be allowed after discussion with the MSK Principal Investigator. - Previous radiation and/or surgery must have been discontinued or completed at least 2 weeks prior to treatment in this study and adverse effects must have resolved to Grade 1 or baseline. Lymph node or other diagnostic biopsies within 2 weeks are not considered exclusionary. ° Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSK Principal Investigator. - ECOG ≤ 2 - Meet the following laboratory criteria without use of growth factor support or platelet transfusions for 1 week: i) Absolute neutrophil count ≥ 1.0 K/mcl, ii) Platelet count ≥ 80 K/μl (in the expansion cohorts, if thrombocytopenia is due to bone marrow involvement platelet count must be ≥ 50 K/μL), iii) Patients enrolled in the dose escalation phase who are not enrolled on the expansion cohorts must have calculated creatinine clearance ≥ 50ml/min by Cockcroft-Gault formula. Patients enrolled in the Dose Expansion phase must have calculated creatinine clearance ≥ 40ml/min by Cockcroft-Gault formula. iv) Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN if documented hepatic involvement with lymphoma, or ≤ 5 x ULN if history of Gilberts syndrome; AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; ≤ 5 ULN if due to lymphoma involvement - Measurable disease for dose expansion and lead in phase only. Measurable disease defined by: 1. Revised International Working Group (Cheson, 2007) Classification for systemic lymphoma or 2. Atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood 3. or bone marrow mSWAT > 0 or Sezary couny >/= 1000 cells/ul - Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (< 7 days) must have been discontinued at least 6 days prior to study treatment. Stable ongoing corticosteroid use (≥ 30 days) up to an equivalent dose of 20 mg of prednisone is permissible. i) Topical steroids that have been used for > 3 weeks may be continued (CTCL only). All other histologies (not CTCL): Topical steroids use is permissible without restriction - Women of reproductive potential† must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test. All women of reproductive potential, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control (e.g. latex condoms) throughout the study and for 30 days after the last dose of study drug. - A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months). Exclusion Criteria: - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. - Pregnant females. (Lactating females must agree not to breast feed while taking the study medications). - Prior use of duvelisib if discontinued due to toxicity. - For the romidepsin arm of the study, prior therapy with romidepsin if discontinued due to toxicity. - For the bortezomib arm of the study, prior therapy with a proteasome inhibitor if discontinued due to toxicity. - For the bortezomib arm of the study, patients with grade ≥2 peripheral neuropathy. - History of chronic liver disease, veno-occlusive disease, or current alcohol abuse. - Administration of a live vaccine within 6 weeks of first dose of study drug. - Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy) - Known seropositive and requiring anti-viral therapy for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects with chronic hepatitis B or C as defined as test . - Subjects with positive Hep B serology. Subjects with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g., polymerase chain reaction [PCR] test) to be enrolled, and will require prophylactic antiviral treatment (e.g., F) initiated prior to the first dose of study drug, an continued until approximately 6 to 12 months after completion of study drug(s). - Patients with positive hepatitis C virus Ab - Subjects with active EBV unrelated to underlying lymphoma (positive serology for anti-EBV VCA IgM antibody and negative for anti-EBV EBNA IgG antibody, or clinical manifestations and positive EBV PCR consistent with active EBV infection. - Subject with active CMV (positive serology for anti-CMV IgM antibody and negative for anti-CMV IgG antibody and positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy will be excluded from participation in the study. Carriers will be monitored per institutional guidelines. - Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma) - Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator. - Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-call lymphoma) is permissible after discussion with the MSK Principal Investigator. - Known central nervous system or meningeal involvement (in the absence of symptoms, investigation into central nervous system involvement is not required). - Uncontrolled infection requiring systemic antimicrobials - The following known cardiac abnormalities: 1. Congenital long QT syndrome. 2. QTc/QTf interval ≥ 480 milliseconds; unless secondary to pacemaker or bundle branch block. 3. Myocardial infarction within 6 months. (Subjects with a history of myocardial infarction within the last 6 to12 months who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate.) 4. Other significant ECG abnormalities including 2nd degree atrio- ventricular (AV) block (AV) block type II, 3rd degree AV block. 5. Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Appendix B). In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present. II-IV (see Appendix B). In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present. 6. An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present. 7. Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix C) and/or ejection fraction <45% by MUGA, echocardiogram, or cardiac MRI. 8. A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD). 9. Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes. 10. Uncontrolled hypertension, i.e., blood pressure (BP) of ≥170/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month prior to study registration) and meet all other inclusion criteria. 11. Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers) 12. For patients enrolling on the Romidepsin arm; taking drugs associated with significant QTc/QTf prolongation, unless able to be switched to non-QTc/QTf prolonging medication or on a stable dose without significant QT prolongation (>470 msec). Caution should be used when administering study drugs to patients taking medications significantly metabolized by these enzymes refer to (http://medicine.iupui.edu/clinpharm/ddis/clinical-table/) for clinically relevant medications. Particular attention should be paid to patients receiving warfarin. Patient should have coagulation parameters monitored regularly, and warfarin dose adjusted accordingly. If these drugs cannot be discontinued or replaced enrollment may be allowed after discussion with MSK PI. ; PRIMARY OUTCOME: maximum tolerated dose (MTD); SECONDARY OUTCOME 1: overall response rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ECOG E3A06 (Smoldering MM; NCI); BRIEF: This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following: - Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells at any time before initiating study treatment, including a marrow which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization - Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light chain (FLC) assay; FLC assay must be performed within 28 days of randomization - Patients must have measurable levels of monoclonal protein (M-protein): >= 1g/dL on serum protein electrophoresis or >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization - Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL) - Hemoglobin >= 11 g/dL within four weeks prior to randomization - Platelet count >= 100,000/mm^3 within four weeks prior to randomization - Absolute neutrophil count (ANC) >= 1,500/mm^3 within four weeks prior to randomization - Calculated creatinine clearance >= 30 mL/min within four weeks prior to randomization - Bilirubin =< 1.5 mg/dL within four weeks prior to randomization - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGPT) (aspartate aminotransferase [AST]) =< 2.5 times upper limit of normal within four weeks prior to randomization - No prior or concurrent systemic or radiation therapy for the treatment of myeloma - Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted - Prior or concurrent use of erythropoietin is disallowed - Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted - Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day - Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted - Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months - Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 - Patients must not have baseline bone lesions or plasmacytomas - Patients with monoclonal gammopathy of undetermined significance are not eligible - Patients must not have grade 2 or higher peripheral neuropathy - Patients must not have active, uncontrolled infection - Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation - Patients should not have New York Heart Association classification III or IV heart failure - Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years - Patients should not be felt to have an immediate need for chemotherapy - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting cycle 1 of lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure - Human immunodeficiency virus (HIV) infection is not excluded; HIV+ patients must meet the following criteria: - Cluster of differentiation (CD)4 cell count >= 350/mm^3 - No history of acquired immune deficiency syndrome (AIDS)-related illness - Not currently prescribed zidovudine or stavudine ; PRIMARY OUTCOME: Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint); SECONDARY OUTCOME 1: Proportion of Participants With Response (Phase II Secondary Endpoint)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EPIC-E; BRIEF: The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC. ; DRUG USED: Vepoloxamer; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Mast Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Completed participation in study MST-188-01 (EPIC study) - Subject age 4 through 65 years - Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia - Subject requires hospitalization Exclusion Criteria: - Subject has acute chest syndrome - Subjects laboratory results indicate inadequate organ function - Subject is pregnant or nursing an infant - Subject had a painful crisis requiring hospitalization within the preceding 14 days - Subject has been transfused within the past 14 days - Subject has complications related to SCD ; PRIMARY OUTCOME: Safety as measured as the incidence of adverse events; SECONDARY OUTCOME 1: Rate of re-hospitalization for recurrence of VOC[/INST]No</s>