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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 - M15-536; BRIEF: This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer. ; DRUG USED: Veliparib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. - Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function. - Life expectancy of 12 weeks or greater. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. - Able to swallow and retain oral medication. - Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy. - Non-childbearing potential. Exclusion Criteria: - History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption. - Evidence of refractory ascites. - Has clinically relevant or significant electrocardiogram abnormalities. ; PRIMARY OUTCOME: Maximum observed plasma concentration (Cmax); 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/IIa - Moderate to Severe (EU); BRIEF: The purpose of the study is to assess the safety and tolerability of daily intravenous NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to modulate the CD3 complex on T-cells. ; DRUG USED: Foralumab; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Cluster of Differentiation 3 (CD3); THERAPY: Monotherapy; LEAD SPONSOR: Light Chain Bioscience - Novimmune SA; CRITERIA: Main Inclusion Criteria: 1. Men and women between 18 and 70 years of age. 2. Crohns Disease Activity Index (CDAI) between 220 and 450. 3. Raised plasma CRP level. 4. Endoscopic inflammation. 5. Crohns disease of at least 6 months duration, with colitis, ileitis, or ileocolitis, confirmed by endoscopy and histology within 28 days of study day 1. Main Exclusion criteria 1. Have received or are planned to receive immunization with a live vaccine within 6 weeks prior to receiving study drug and 12 weeks after treatment cessation. 2. Concomitant disease: - Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease (including a history of seizure disorders or ongoing chronic active conditions such as chronic active hepatitis) - Previous diagnosis of, or known, malignancies - Severe infections, such as hepatitis, pneumonia or pyelonephritis, in the past three months. Less serious infections in the past 3 months, such as acute upper respiratory tract infection (colds) or uncompliant urinary tract infection are permitted at the discretion of the investigator - Active infection requiring antibiotic therapy - Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive - History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of acute CMV or EBV, active Pneumocystic Carinii - History of active tuberculosis (TB) or currently undergoing treatment for TB. Patients with a positive TB skin test or chest x-ray are ineligible. Patients with a history of bacille Calmette Guerin (BCG) vaccination and a newly positive TB skin test or a chest X-ray showing fibrotic lesions consistent with previous TB are ineligible. The PPD skin test must be read between 48 and 72 hours - Stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium Difficile toxin within 4 weeks prior to Study Day 1 ; PRIMARY OUTCOME: Safety and tolerability of intravenous NI-0401 .; SECONDARY OUTCOME 1: Immunological response defined as the percent change in the modulation of the CD3 complex on T-cells[/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 - CLIO; BRIEF: This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression. ; DRUG USED: Lynparza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Universitaire Ziekenhuizen KU Leuven; CRITERIA: Inclusion Criteria: - with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum - At least 1 previous line of chemotherapy - Measurable disease - Patients have a normal organ and bone marrow function measured within 28 days of randomization - WHO 0-2 Exclusion Criteria: - Primary platinum-refractory disease - Known hypersensitivity to olaparib - Resting ECG with QTc > 470 msec - Concomitant use of known potent CYP3A4 inhibitors - Symptomatic uncontrolled brain metastases - Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication ; PRIMARY OUTCOME: Overall Objective Response; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - STELLAR; BRIEF: The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B). ; DRUG USED: CRS-207; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Immune System, Mesothelin; THERAPY: Combination; LEAD SPONSOR: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; CRITERIA: Inclusion Criteria: - Age ≥18 years. - Have histologically- or cytologically-proven adenocarcinoma of the pancreas. Patients with mixed histology will be excluded. - Have metastatic disease. - Have failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer. - Patients with the presence of at least one measurable lesion. - Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator). - ECOG performance status 0 or 1. - Life expectancy of greater than 3 months. - Patients must have adequate organ and marrow function defined by study-specified laboratory tests. - Must use acceptable form of birth control while on study. - Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: - known history or evidence of brain metastases. - Had surgery within the last 28 days - Have received any non-oncology vaccine therapy used for prevention of infectious diseases including seasonal vaccinations within 28 days of study treatment. - Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, GVAX or CRS-207 - Systemic steroids within the last 14 days - Use more than 3 g/day of acetaminophen. - Patients on immunosuppressive agents. - Patients receiving growth factors within the last 14 days - Known allergy to both penicillin and sulfa. - Severe hypersensitivity reaction to any monoclonal antibody. - Have artificial joints or implants that cannot be easily removed - Have any evidence of hepatic cirrhosis or clinical or radiographic ascites. - Have significant and/or malignant pleural effusion - Infection with HIV or hepatitis B or C at screening - Significant heart disease - Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patients ability to comply with study visits and procedures - Unable to avoid intimate contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen. - Are pregnant or breastfeeding. - Have rapidly progressing disease ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity[/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 - NSABP - B-46-I - vs TC & TAC (HER2-); BRIEF: The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: NSABP Foundation Inc; CRITERIA: Inclusion Criteria: - Patients must be female. - The patient must be greater than or equal to 18 years of age and less than or equal to 70 years of age. - The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. - The breast cancer must be HER2-negative based on current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. If the result of the in situ hybridization testing (FISH, chromagen in situ hybridization (CISH), or other) is equivocal, the patient is eligible if there is no plan to administer HER2-targeted therapy. - All of the following staging criteria (according to the 6th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3; By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: ER negative and PgR negative; or Pathologic tumor size greater than 2.0 cm; or T1c (pathologic tumor size greater than 1.0 cm but less than or equal to 2.0 cm) and ER positive (PgR status may be positive or negative) and either Oncotype DX® Recurrence Score of greater than or equal to 25 or grade 3 histology. - Patients must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy). - For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures must be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.) - For patients who undergo mastectomy, margins must be histologically free of invasive tumor and DCIS. - Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi, or pN1b; Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or Axillary lymphadenectomy without SN isolation procedure. - The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days. - Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed. (Either a core biopsy or surgical resection specimen can be used for ER/PgR testing.) - The most recent postoperative blood counts must meet the following criteria: Absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; platelet count must be greater than or equal to 100,000/mm3; and hemoglobin must be greater than or equal to 10 g/dL. - The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests: total bilirubin must be less than or equal to upper limits of normal (ULN)for the lab unless the patient has a bilirubin elevation less than ULN to 1.5 x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and AST must be less than or equal to 1.5 x ULN for the lab. Alkaline phosphatase and aspartate transaminase (AST) may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than or equal to 2.5 x ULN, then the AST must be less than or equal to the ULN. If the AST is greater than the ULN but less than or equal to 1.5 x ULN, then the alkaline phosphatase must be less than or equal to ULN. - Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan) does not demonstrate metastatic disease and the requirements for adequate hepatic function are met. - Patients with alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT, or PET scan does not demonstrate metastatic disease. - The most recent postoperative serum creatinine must be less than or equal to ULN for the lab. - A urine sample must be tested for proteinuria by the dipstick method. Eligibility must be based on the most recent postoperative test result(s) performed within 6 weeks prior to randomization. Urine dipstick must indicate 0-1+ protein. If dipstick reading is greater than or equal to 2+, a 24-hour urine specimen must be collected and must demonstrate less than 1 gram of protein. - Left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multigated acquisition (MUGA) scan must be performed within 90 days prior to randomization. The LVEF must be greater than or equal to 50% regardless of the facilitys lower limits of normal (LLN). Exclusion Criteria: - T4 tumors including inflammatory breast cancer. - Definitive clinical or radiologic evidence of metastatic disease. - Synchronous or metachronous contralateral invasive breast cancer. (Patients with synchronous and/or metachronous contralateral DCIS are eligible.) - Any history of ipsilateral invasive breast cancer or ipsilateral DCIS. - History of non-breast malignancies within 5 years prior to randomization, except for the following: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinomas of the skin. - Previous therapy with anthracyclines, taxanes, or bevacizumab for any malignancy. - Chemotherapy administered for the currently diagnosed breast cancer prior to randomization. - Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.) - Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization. - Active hepatitis B or hepatitis C with abnormal liver function tests. - Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to 1) Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis, 2) History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy. - Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria. - History of hypertensive crisis or hypertensive encephalopathy. - History of transient ischemic attack (TIA) or cerebrovascular accident (CVA). - History of any arterial thrombotic event within 12 months prior to randomization. - Symptomatic peripheral vascular disease. - Intrinsic lung disease resulting in dyspnea. - Unstable diabetes mellitus. - Active infection or chronic infection requiring suppressive antibiotics. - History of a major organ allograft or condition requiring chronic immunosuppression, e.g., kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases. (Patients who have received corneal transplants, cadaver skin, or bone transplants are eligible.) - Any significant bleeding within 180 days prior to randomization, exclusive of menorrhagia in premenopausal women. - Non-healing wound, skin ulcers, or incompletely healed bone fracture. - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the planned start of study therapy. - Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab. - Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization. - History of GI perforation, abdominal fistulae, or intra-abdominal abscess. - Known bleeding diathesis or coagulopathy. - Requirement for therapeutic doses of coumadin or equivalent. - Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. - Conditions that would prohibit administration of corticosteroids. - Chronic daily treatment with corticosteroids (dose of greater than or equal to 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids). - History of hypersensitivity reaction to drugs formulated with polysorbate 80. - Pregnancy or lactation at the time of study entry. - Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up. - Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements. - Use of any investigational product within 4 weeks prior to randomization. ; PRIMARY OUTCOME: Invasive disease-free survival(IDFS)relative to the TAC chemotherapy regimen alone; SECONDARY OUTCOME 1: Invasive disease-free survival (IDFS) relative to the TAC chemotherapy regimen[/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 - TG002 (Canada); BRIEF: Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy. This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU). ; DRUG USED: ToleroMune - Grass; DRUG CLASS: Vaccine; INDICATION: Allergic Rhinitis; TARGET: Immune System, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Circassia Limited; CRITERIA: Inclusion criteria - Male or female, aged 18-65 years. - Minimum 2-year documented history of rhinoconjunctivitis on exposure to grass. - Positive skin prick test to grass allergen. - Minimum qualifying rhinoconjunctivitis symptom scores Exclusion criteria - History of asthma. - A history of anaphylaxis to grassallergen. - Subjects with an FEV1 <80% of predicted. - Subjects who cannot tolerate baseline challenge in the EEU. - Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). - A history of severe drug allergy, severe angioedema or anaphylactic reaction to food. - A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment). ; PRIMARY OUTCOME: Total Rhinoconjunctivitis Symptom Score; SECONDARY OUTCOME 1: Symptom scores for nasal and non nasal symptoms[/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 - ENACT; BRIEF: This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain damage. Up to 200 male and female patients undergoing endovascular repair of brain aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures Days 2-4 and end-of study procedures on Day 30. Standard safety criteria will be analysed. Efficacy endpoints include the ability of NA-1 to: 1) reduce the volume of ischemic embolic strokes, 2) reduce the number of ischemic embolic strokes, 3) reduce vascular cognitive impairment, and 4) reduce the frequency of large strokes induced by the endovascular procedure. The plasma concentrations of NA-1 will also be analyzed. ; DRUG USED: NA-1; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ischemic Stroke; TARGET: PSD-95 (postsynaptic density protein 95)/SAP-90 (synapse-associated protein 90); THERAPY: Monotherapy; LEAD SPONSOR: NoNO Inc.; CRITERIA: Inclusion Criteria - A diagnosis of a ruptured or unruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, stent-assisted coiling, pipeline stent, balloon-assisted coiling, covered stent only, neck-bridge device, re-coiling, or re-treatment of a previously coiled/treated aneurysm. There are no restrictions on adjunctive devices. For patients with a ruptured aneurysm, endovascular repair must take place within 72 hours of the ictal haemorrhage. - If the aneurysm has ruptured, patient should be Grade I-III on the World Federation of Neurological Surgeons (WFNS) grading scale for subarachnoid hemorrhage. If the patient is intubated but alert and able to follow commands (at least a 2-step command), and is not kept intubated for neurological status (i.e., WFNS Grade IV or V), the patient is considered WFNS Grade III and is eligible for the trial. - Absence of ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, stroke-in-evolution, or clinical evidence of cerebral vasospasm within 2 weeks prior to randomization. (If a CT scan, cerebral angiogram, or other imaging performed during the 2 weeks prior to randomization shows radiological vasospasm deemed by the treating physician to be potentially clinically significant, the subject is excluded.) - Brain MRI imaging (DWI and FLAIR sequences) within 2 weeks prior to the endovascular aneurysm repair procedure as detailed in Section 8.2. Imaging must not demonstrate any focal ischemic stroke defined as a new region of restricted diffusion and/or a focal area of reduced perfusion on a relative mean transit time (rMTT) or relative time to peak (rTTP) map - Male or female with a minimum age of 18 years on the day of enrolment. - Female subjects of childbearing potential: Negative pregnancy test. After enrolment, blood will be drawn from women of childbearing potential for a confirmatory test of pregnancy as evaluated by a serum B-hCG test. The definition of non-childbearing potential includes the following: - Surgically sterile (e.g., hysterectomy with or without oophorectomy; fallopian tube ligation; endometrial ablation), at least 30 days prior to signature of the Informed Consent form - At least 5 years post-menopause (i.e., 6 years post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing. Non-surgically sterile females or females with undocumented post-menopausal status must be willing to use a medically approved method of birth control for 3 months after completion of dosing. - Non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing. - Body weight less than or equal to 180 kg. - Normal or abnormal but not clinically significant findings in the - non-neurological physical examination - 12-lead ECG - PQ or PR interval less than or equal to 210 msec; - In unruptured aneurysm cases, QTc interval less than 450 msec for males or 470 msec for females. For ruptured aneurysm cases, QTc interval is not restricted. - vital signs - blood pressure between 80-180/50-100 mm Hg, - body temperature less than or equal to 38.5oC - Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed Informed Consent Form. Exclusion Criteria - Dissecting or mycotic brain aneurysm. Fusiform or atherosclerotic intracerebral aneurysms may be eligible for the trial if endovascular treatment is planned with a goal of exclusion of the aneurysm from the circulation. - Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment. - Known history of life-threatening allergic reaction to any medication. - Chronic renal disease defined as a baseline serum creatinine > 150 umol/L. - Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test. - Women who are breastfeeding. - Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol. - Pre-morbid (estimated) modified Rankin scale score of greater than 2. - Previous serious traumatic brain injury that would preclude the patient from completing the protocol or preclude MRI analysis of small strokes. - Patients with known HIV infection. - Patients who are unable to have an MRI scan for any reason. - Participation in a clinical trial with an investigational drug within 30 days preceding this study. Previous participation in the ENACT trial (e.g,, to treat a prior aneurysm), participation in another trial involving NA-1 or prior receipt of NA-1. - Any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 30 days. ; PRIMARY OUTCOME: Volume of New FLAIR Lesions(MRI); SECONDARY OUTCOME 1: Number of New DWI Lesions (MRI)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - (202) Ext.; BRIEF: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite). ; DRUG USED: Qwo; DRUG CLASS: Biologic; INDICATION: Cellulite; TARGET: Collagen; THERAPY: Monotherapy; LEAD SPONSOR: Endo Pharmaceuticals; CRITERIA: Inclusion Criteria for Observation Phase: - Voluntarily sign and date an informed consent agreement - Have participated in and completed the double-blind study EN3835-201 - Be willing to apply sunscreen to any treated quadrant before each exposure to sun Inclusion Criteria for Treatment Phase: - Voluntarily sign and date an informed consent agreement - Have participated in and completed the double-blind study EN3835-201 - Be willing to apply sunscreen to any treated quadrant before each exposure to sun - Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13 - Be judged to be in good health - Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal Exclusion Criteria for Observation Phase: - None Exclusion Criteria for Treatment Phase: - Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks - Is presently nursing a baby or providing breast milk for a baby - Intends to become pregnant during the study - Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication - History of stroke or bleeding ; PRIMARY OUTCOME: Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase; SECONDARY OUTCOME 1: Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - P05495; BRIEF: This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis. ; DRUG USED: Ilumya; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area [BSA] involvement, moderate or greater score on the Physicians Global Assessment [PGA] scale, and PASI score ≥12 at Baseline) - Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. Participants with psoriatic arthritis may be included in the study Exclusion Criteria: - Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis - Participants who will require oral or injectable corticosteroids during the trial - Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to Screening - Participants with evidence of active or untreated latent tuberculosis (TB) according to Screening criteria specified in the protocol. (Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to treatment with study medication) - Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23 (IL-23) - Participants with prior exposure to two or more tumor necrosis factor (TNF) antagonists with discontinuation due to lack of efficacy. ; PRIMARY OUTCOME: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16; SECONDARY OUTCOME 1: Percentage of Participants With a PASI 75 Response at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - CT-AI-11; BRIEF: The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects. ; DRUG USED: AT-301; DRUG CLASS: Vaccine; INDICATION: Pandemic Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Medigen Biotechnology Corporation; CRITERIA: Inclusion Criteria: - Male or female ≥20 and ≤60 years of age - In good health as determined by medical history, physical examination, and clinical judgment of the investigator - Willing and able to comply with all required study visits and follow-up required by this protocol - Must provide written informed consent Exclusion Criteria: - Known or potential exposure to avian influenza virus or any H5N1 HA antigen vaccine - Had any influenza vaccine within 6 months - Administered with any vaccine within 30 days - A history of hypersensitivity to vaccines or inflammatory or degenerative neurological disease - Receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months - Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity - Any medical illness including clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests - Receiving immunoglobulins and/or any blood products within the three months - Acute disease at the time of enrolment - Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance - Breast feeding or pregnant women ; PRIMARY OUTCOME: Signs and symptoms solicited by vaccination; SECONDARY OUTCOME 1: Serum antibody titers to H5N1 virus[/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/IIa - Healthy Volunteers (Australia/Canada); BRIEF: The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated. The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia. AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia. ; DRUG USED: AEM-28; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Lipoproteins; THERAPY: Monotherapy; LEAD SPONSOR: LipimetiX Development, LLC; CRITERIA: Inclusion Criteria: Single Ascending Dose (SAD) Study: - Male or female non-smoker, ≥18 and ≤55 years of age, with BMI >18.5 and < 32.0 kg/m² - Total cholesterol greater or equal to 5.0 mmol/L (≥194 mg/dL) at screening Multiple Ascending Dose (MAD) Study: - Male or female non-smoker, ≥18 and ≤75 years of age, with BMI >18.5 and < 35.0 kg/m² - Diagnosis of refractory hypercholesterolemia with LDL cholesterol levels > 2.5 mmol/L (97 mg/mL) at screening. - On stable lipid lowering therapy for ≥ 8 weeks - On stable diet for ≥ 12 weeks. Exclusion Criteria: SAD Study: - Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening. - History of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance. MAD Study: - Significant health problems within 6 months prior to screening, which in the opinion of the Medical Sub-Investigator would prevent the subject from participating in the study, including but not limited to: unstable coronary heart disease; transient ischemic attack; stroke; revascularization procedure; uncontrolled hyperthyroidism; coagulation disorder; peptic ulcers or GI bleeding; significant disease of the central nervous system; liver or renal disease. - History of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance. ; PRIMARY OUTCOME: Number of Participants Who Incurred at Least One Treatment Emergent Event; SECONDARY OUTCOME 1: Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change[/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 - Poor Risk AML (MDACC) ; BRIEF: This phase II trial studies the best dose and how well liposomal cytarabine-daunorubicin CPX-351 (CPX-351) works in treating patients with newly diagnosed acute myeloid leukemia and who are at risk for not responding well to treatment. Liposomal cytarabine-daunorubicin CPX-351 combines two chemotherapy drugs that are known to help each other work better, and may work to stop the growth of cancer cells by blocking the cells from dividing. ; DRUG USED: Vyxeos; DRUG CLASS: Non-NME; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA polymerase, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: - Ability to understand and voluntarily sign an informed consent form - Pathological diagnosis of AML according to World Health Organization (WHO) criteria (with at least 20% blasts in the peripheral blood or bone marrow): newly diagnosed de novo AML; except for acute promyelocytic leukemia (APL); newly diagnosed secondary AML, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes [MDS], myeloproliferative disease [MPD] or history of cytotoxic treatment for non-hematologic malignancy) or apparent de novo AML with MDS-associated karyotype - Eastern Cooperative Oncology Group (ECOG) performance status 0-3 - Serum creatinine =< 2.0 mg/dL - Serum total bilirubin =< 2.0 mg/dL - Serum alanine aminotransferase < 3 times the upper limit of normal (ULN); Note: If elevated liver enzymes are related to disease alanine aminotransferase (ALT) should be < 5 times ULN - To be considered at high risk for induction mortality patients must have 1 or 2 of the following risk factors (patients >= 60 must have at least 1 risk factor, patients < 60 must have at least 2 risk factors) present; at least one risk factor in every patient must be an AML-related factor: - AML-related factors include: - Antecedent hematologic disorder (AHD) (MDS, chronic myelomonocytic leukemia [CMML], or MPD) or history of exposure to cytotoxic chemotherapy [therapy-related (t)-AML]), or WHO-defined AML with MDS-related changes or apparent de novo AML with MDS-associated karyotype - Unfavorable cytogenetics as defined by the European Leukemia Net - Patient-related factors: - Age >= 70 - ECOG performance status (PS) >= 2 - Co-morbidities: - Serum creatinine > 1.3 g/dL - Cardiac ejection fraction >= 50% by echocardiography or multi gated acquisition (MUGA) (when left ventricular ejection fraction [LVEF] expressed as a range, at least the upper limit should include 50%) - Able to adhere to the study visit schedule and other protocol requirements - All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile Exclusion Criteria: - Patients with history of second malignancy are eligible if they have documentation of disease stability, off therapy, based on computed tomography (CT) scan or other measures for the 6 months prior to entry in core - Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent - Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks prior to study entry; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 24 hours before study entry in core - Evidence of active central nervous system (CNS) leukemia - Pregnant or lactating women - Uncontrolled infection; to be eligible, patients receiving treatment for an infection (antibiotic, antifungal or antiviral treatment) must be afebrile (< 38.3 degrees Celsius [C]) and without hemodynamic instability or dyspnea from pneumonia for > 48 hours (hrs) prior to the start of induction therapy - Hypersensitivity to cytarabine, daunorubicin or liposomal products - History of Wilsons disease or other copper-metabolism disorder ; PRIMARY OUTCOME: Number of Participants With a Response; SECONDARY OUTCOME 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers; BRIEF: The purpose of the study is to determine the safety and tolerability of escalating doses of ARC-AAT and to evaluate the pharmacokinetics of ARC-AAT and the effect of ARC-AAT on circulating levels of alpha-1 antitrypsin (AAT). The study will consist of two parts, Part A (conducted in healthy volunteers) and Part B (conducted in AATD patients) at up to 9 escalating dose levels with 6 participants per dose level. ; DRUG USED: ARC-AAT; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alpha-1 Antitrypsin Deficiency (A1AD or AATD); TARGET: Alpha-1-antitrypsin (A1AT); THERAPY: Monotherapy; LEAD SPONSOR: Arrowhead Pharmaceuticals; CRITERIA: Inclusion Criteria: (Part A - Healthy Volunteers) - Male or female healthy volunteers 18-50 years of age - Written informed consent - Body mass index between 18.0 and 28.0 kg/m2 - 12-lead electrocardiogram (ECG) at Screening and pre-dose assessment with no clinically significant abnormalities - Non-pregnant/non-nursing females - Non-smoker for at least one year with current non-smoking status confirmed by urine cotinine - Normal lung function (or not clinically significant per investigator assessment) based on spirometry and diffusion capacity of lung for carbon monoxide (DLCO) according to American Thoracic Society (ATS) - European Respiratory Society (ERS) criteria - Highly effective, double barrier contraception (both male and female partners) during the study and for 3 months following the dose of ARC-AAT - Willing and able to comply with all study assessments and adhere to protocol schedule - Suitable venous access for blood sampling - No abnormal finding of clinical relevance at screening - Normal AAT level (Part B-Patients) - As for Part A with the following exceptions: - Male or female patients 18-70 years of age - Confirmed diagnosis of homozygous alpha 1-protease inhibitor deficiency (PiZZ genotype) not receiving alpha-1 antitrypsin augmentation therapy for more than 4 weeks - BMI between 18.0 and 35.0 kg/m2 - Non-smoker for at least three years with current non-smoking status confirmed by urine cotinine Exclusion Criteria: (Part A-Healthy Volunteers) - Current regular smoker of cigarettes or cigars or was a regular smoker over the past 1 year - Recent (within last 6 weeks) transfusion of fresh frozen plasma, platelets, or packed red blood cells, or anticipated need for transfusion during study - Acute signs of hepatitis/other infection within 4 weeks of screening and/or baseline - Concurrent anticoagulants - Use of dietary and/or herbal supplements that can interfere with liver metabolism within 7 days of screening - Use of any drugs known to induce or inhibit hepatic drug metabolism within 14 days prior to study treatment - Depot injection/implant of any drug other than birth control within 3 months prior to study treatment - Diagnosis of diabetes mellitus or history of glucose intolerance - History of poorly controlled autoimmune disease or any history of autoimmune hepatitis - Human immunodeficiency virus (HIV) infection - Seropositive for hepatitis B virus (HBV) or hepatitis C virus (HCV), and/or history of delta virus hepatitis - Uncontrolled hypertension (blood pressure > 150/100 mmHg) - History of cardiac rhythm disturbances - Family history of congenital long QT syndrome or unexplained sudden cardiac death - Symptomatic heart failure (per New York Heart Association [NYHA] guidelines) - Unstable angina, myocardial infarction, severe cardiovascular disease, transient ischemic attack (TIA) or cerebrovascular accident (CVA) within past 6 months - History of malignancy within last 5 years except adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer. - History of major surgery within 3 months of screening - Regular use of alcohol within 1 month prior to screening (i.e., more than fourteen units of alcohol per week) - Evidence of acute inflammation, sepsis or hemolysis or clinical evidence of lower respiratory tract infection - Diagnosis of significant psychiatric disorder - Use of illicit drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to screening or positive urine drug screen - History of allergy or hypersensitivity reaction to bee venom - Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study - Clinically significant history/presence of any gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease - Other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs - Any clinically significant history/presence of poorly controlled neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, metabolic or other uncontrolled systemic disease - Blood donation (500 mL) within 7 days prior to study treatment - History of fever within 2 weeks of screening - Concomitant medical/psychiatric condition or social situation that would affect compliance or result in additional safety risk - Excessive exercise/physical activity within 3 days of screening or enrollment or planned during the study - History of thromboembolic disease, stroke within 6 months of baseline, and/or concurrent anticoagulant medication(s) (Part B-Patients) - As for Part A with the following exceptions: - History of major surgery within 2 months of Screening - Forced expiratory volume at one second (FEV1) at baseline < 60% - AATD patients with liver elastography score > 11 at Screening ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Discontinuations Due to TEAEs; SECONDARY OUTCOME 1: Number of Participants With AAT Reduction > 30% From Baseline (First Occurrence)[/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 - Continuous Pump Trial (Stanford); BRIEF: The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal. ; DRUG USED: Linjeta; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Stanford University; CRITERIA: Inclusion Criteria:1)Type 1 diabetes for at least 1 year 1. The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide level and antibody determinations are not needed. 2) Age : 18 years old ¨C 49.99 years old 3) Continuous subcutaneous insulin infusion (CSII) therapy for at least 3 months 4) Participant consent demonstrated by signing IRB approved documents 6) HgA1c ¡Ü 9% 7) If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative. Exclusion Criteria:1) Chronic oral steroid use 2) The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of sensors or the completion of any aspect of the protocol. 3) Known clinical history of celiac disease or inflammatory bowel disease. 4) Participants will have a negative anti-endomysial antibody or anti-tissue transglutaminase antibody within one year of enrollment. 5) Cystic Fibrosis 6) Inpatient psychiatric treatment in the past 6 months. 7) Currently pregnant or lactating, or anticipate getting pregnant in the next one year. 8) Clinical diagnosis of gastroparesis. 9) Insulin binding capacity greater than 10 microunits per litter ; PRIMARY OUTCOME: The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Apatinib /Pemetrexed /Carboplatin ; BRIEF: This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous Non-small Cell Lung Cancer ; DRUG USED: Camrelizumab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Jiangsu HengRui Medicine Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Subjects with histopathological diagnosis of adenocarcinoma non-small cell lung cancer (NSCLC) and clinical stage IV 2. has not received prior systemic treatment for metastatic NSCLC. 3. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status 4. confirmes by the central laboratory as KRAS gene mutation 5. Has archived Tumor tissue samples 6. Subject must have a measurable target lesion based on RECIST v1.1 . 7. Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug. 8. Subjects should be voluntarily participate in clinical studies and informed consent should be signed. Exclusion Criteria: 1. active brain metastases and meningeal metastasis 2. uncontrollable tumor-related pain 3. massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage; 4. radiotherapy to lung that is >30 Gy within 24 weeks before the first dose, 5. imaging (CT or MRI) showed that the tumor invading the large vessels 6. Known EGFR/ALK mutation. 7. subjects with any known or suspected autoimmune diseases 8. subjects with known or suspected interstitial pneumonia; 9. Subjects with severe cardiovascular and cerebrovascular diseases 10. arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months; 11. female subjects who are pregnant or lactation or who plan to be pregnant during the study period; 12. positive HIV test; 13. active hepatitis B 14. evidence of active TB infection within 1 year before first dose; 15. severe infection occurred within 4 weeks before the first dose 16. patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month 17. subjects who is on systemic immunogenic agents; 18. a history of severe allergic reactions to other monoclonal antibodies/fusion proteins; 19. History of severe allergic reactions to carboplatin or pemetrexed or their preventive drugs; ; PRIMARY OUTCOME: Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1; SECONDARY OUTCOME 1: Duration of Progression-Free Survival (PFS) as Assessed by the Investigator 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 - 144HPS13013; BRIEF: The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Candesartan between free combination of Candesartan and Amlodipine and Candesartan monotherapy. ; DRUG USED: CKD-330; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: Chong Kun Dang Pharmaceutical; CRITERIA: Inclusion Criteria: 1. Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening). 2. Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m² 3. When volunteer in screening, Must include under the items. 1. 100 mmHg ≤ sitting SBP <140 mmHg 2. 60 mmHg ≤ sitting DBP < 90 mmHg 3. 45 bpm ≤ Pulse < 95 bpm 4. Those who decided to join the clinical trials by themselves and to comply with the precautions written consent. Exclusion Criteria: 1. A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease. 2. Have a gastrointestinal disease history that can affect drug absorption(Crohns disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery). 3. The history of clinically significant hypersensitivity reaction about Investigational drugs and foods. 4. The history of drug abuse or drug abuse showed a positive for urine drug test. 5. Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing. 6. Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing. 7. Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing. 8. A heavy alcohol consumer(alcohol>3cup/day or 3times/week within last 1month) 9. A heavy smoker(cigarette>10cigarettes/day) 10. The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis). 11. Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL. 12. Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable). 13. The result of 12-lead ECG in screening test is QTc>450msec. 14. An impossible one who participants in clinical trial by investigators decision including laboratory test result or another reason. ; PRIMARY OUTCOME: AUCτ,ss of Candesartan; SECONDARY OUTCOME 1: Tmax,ss of Candesartan[/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 - ADAPT (WGSG); BRIEF: Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone receptors(ER and/or PR) breast cancer (HEr2+/HR+). A new high potential trastuzumab conjugate T-DM1(trastuzumab was linked with the cytotoxic agent mertansine DM1)was tested with endocrine therapy and without against a standard arm with trastuzumab and endocrine therapy. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: West German Study Group; CRITERIA: Inclusion Criteria: - Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly) - Histologically confirmed unilateral primary invasive carcinoma of the breast - Clinical T1 - T4 (except inflammatory breast cancer) - All clinical N (cN) - No clinical evidence for distant metastasis (M0) - Known HR status and HER2 status (local pathology) Tumor block available for central pathology review - Performance Status ECOG ≤ 1 or KI ≥ 80% - Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients - Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements - The patient must be accessible for treatment and follow-up Additional Inclusion criteria for participation in the HER2+/HR+ sub-protocol: - Confirmed ER and/or PR positive and HER2+ by central pathology - Clinical cT1c - T4a-c (participation of patients with tumors >cT2 is strongly recommended) - All clinical N (participation of patients with cN0, if cT1c is strongly recommended) - Patients must qualify for neoadjuvant treatment - LVEF > 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment) Exclusion Criteria: - Known hypersensitivity reaction to the compounds or incorporated substances - Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri - Non-operable breast cancer including inflammatory breast cancer - Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor - Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry - Male breast cancer - Concurrent pregnancy; patients of childbearing potential must implement - a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment - Breast feeding woman - Sequential breast cancer - Reasons indicating risk of poor compliance Patient not able to consent Additional Exclusion Criteria for participation in the HER2+/HR+ sub-protocol: - Known polyneuropathy ≥ grade 2 - Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study - Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.) - Uncompensated cardiac function (current unstable ventricular arrhythmia - requiring treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial infarction or unstable angina pectoris within 6 months of enrollment, history of severe hypertension, CAD - coronary artery disease) - Severe dyspnea - Pneumonitis Abnormal blood values: - Thrombocytopenia > CTCAE grade 1 - Increases in ALT/AST > CTCAE grade 1 - Hypokalaemia > CTCAE grade 1 - Neutropenia > CTCAE grade 1 - Anaemia > CTCAE grade 1 ; PRIMARY OUTCOME: Comparison of the pCR rates in patients with HER2+/HR+ breast cancer treated by preoperative T-DM1 with or without standard endocrine therapy or trastuzumab with endocrine therapy.; SECONDARY OUTCOME 1: Evaluation of dynamic test regarding prediction of 5-year event-free survival (EFS)[/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 - CAIN457; BRIEF: The purpose of this extension study is to evaluate maintenance of HiSCR response at Week 104 in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials AIN457M2301 (NCT03713619) and AIN457M2302 (NCT03713619). ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Hidradenitis Suppurativa; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - written informed consent must be obtained before any assessment is performed - subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302)and have been receiving secukinumab treatment during Treatment Period 2 Exclusion Criteria: - protocol deviation in the core study which will prevent the meaningful analysis of the extension study - ongoing or planned use of prohibited HS or non-HS treatment - participation in the extension could expose the subject to an undue safety risk - current sever progressive or uncontrolled disease which renders the subject unsuitable for the study. ; PRIMARY OUTCOME: time to loss of response (LOR) in HiSCR reponders; SECONDARY OUTCOME 1: Cumulative rate of subjects who experience a flare in core HiScr responders[/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 - Inguinal Herniorrhaphy; BRIEF: A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy ; DRUG USED: Zynrelef; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Heron Therapeutics; CRITERIA: Inclusion Criteria: 1. Be male or female 18 years of age or older. 2. Female subjects are eligible only if all of the following apply: Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery) - Not lactating - Not planning to become pregnant during the study - Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study Male: o Must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication. 3. Plan to undergo a unilateral inguinal herniorrhaphy 4. Have the ability and be willing to comply with the study procedures 5. Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form. Exclusion Criteria: 1. Unwilling to sign informed consent or not willing or able to complete all study procedures 2. Have a contraindication or be allergic to any medication to be used during the trial period 3. Have clinically significant cardiac abnormalities, that in the opinion of the investigator would pose a health risk to the subject should they participate in the trial 4. Have American Society of Anesthesiologists (ASA) Physical Status classification system category 4 or greater (Appendix E) 5. Have clinically significant renal or hepatic abnormalities (defined as an AST or ALT > 3x ULN, creatinine > 2x ULN) 6. Have another painful condition that may confound pain assessments 7. Have another surgery planned within 30 days of procedure, or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with large scrotal component that would be difficult to reduce surgically 8. Have a known or suspected history of alcohol or drug abuse, or a positive drug screen 9. Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of surgery 10. Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP) 11. Female subjects who are pregnant (positive pregnancy test at screening or on the day of surgery) 12. Subjects who are receiving oxygen therapy at the time of screening 13. Have participated in a clinical trial within 30 days of planned surgery 14. Have a body mass index (BMI) > 39 kg/m2 ; PRIMARY OUTCOME: Mean Summed Pain Intensity (SPI) Score.; 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 - Second Line; BRIEF: The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC) ; DRUG USED: Inlyta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: University Health Network, Toronto; CRITERIA: Inclusion Criteria: - Unresectable and/or metastatic Hepatocellular Carcinoma - Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs - Life expectancy of ≥12 weeks - At least one tumor lesion - At least 2 weeks since the end of prior systemic treatment - No evidence of pre-existing uncontrolled hypertension - ECOG 0 or 1 - Adequate organ function - Not appropriate for curative therapy - Child A or B7 cirrhosis - CLIP score ≤ 4 Exclusion Criteria: - Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment - Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment - Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma - Severe acute or chronic medical or psychiatric condition - Need for treatment with prohibited drugs - Has received local therapy to all measurable lesions - Stage B8 or higher liver cirrhosis - Ascites refractory to diuretic therapy - Clinically significant ECG abnormality ; PRIMARY OUTCOME: Response rate; SECONDARY OUTCOME 1: Feasibility[/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 - PALO-10-14; BRIEF: The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients. ; DRUG USED: Aloxi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Emesis; TARGET: Serotonin 5-HT3 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Helsinn Healthcare SA; CRITERIA: Inclusion Criteria: - Male or female patient aged from full term neonate to less than 17 years. - In-patient or out-patient scheduled to undergo one of the following procedures: - ear, nose and throat surgery (e.g., tonsillectomy, adenoidectomy, myringotomy), - eye surgery (e.g. strabismus, vitreoretinal, cataract surgery), - urological surgery (e.g. orchidopexy, varicocoele), - plastic reconstructive surgery (e.g. cleft lip/cleft palate, burn procedures involving the scalp), - hernia repair, - orthopedic surgery (e.g. foot and ankle deformities, arthroscopic surgeries, ACL surgery),. - cardiac surgery, - neurosurgery. - Patient is scheduled to undergo surgery requiring general intravenous anesthesia - Patient is scheduled to receive nitrous oxide during the maintenance phase of anesthesia - Patient weighs at least 3.2 kg - ASA physical status I, II or III - Fertile patients (male or female) must use reliable contraceptive measures - Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2) - For patients with known hepatic impairment: in the Investigators opinion, the impairment does not jeopardize the patients safety during the study - For patients with known renal impairment: in the Investigators opinion, the impairment does not jeopardize the patients safety during the study Exclusion Criteria: - Lactating females - Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion. - Patient having participated in any previous trial with palonosetron. - History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists - Patient to undergo emergency surgery - Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia - Patient scheduled to receive laryngeal mask anesthesia - Patient scheduled to receive propofol during the maintenance phase of anesthesia - Patient suffering from any concomitant disease uncontrolled by therapy, which, in the judgment of the Investigator, could compromise the outcome of surgery - Patient with history of gastro-esophageal reflux (except for patients up to 12 months) - Patient with ongoing vomiting from any organic cause - Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug ; PRIMARY OUTCOME: Proportion of Patients With Complete Response; SECONDARY OUTCOME 1: Proportion of Patients With no Vomiting[/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/ Carboplatin + Etoposide; BRIEF: The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with carboplatin and etoposide followed by BMS-833923 alone in subjects with extensive-stage Small Cell Lung Cancer (SCLC). ; DRUG USED: BMS-833923; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Hedgehog Signaling Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed small cell lung cancer, without prior chemotherapy treatment - Men and Women at least 18 years old - Eastern Cooperative Oncology Group (ECOG) status 0-2 Exclusion Criteria: - Significant cardiovascular disease - Prior treatment of small cell lung cancer is not permitted, except for palliative radiation to a limited field excluding the chest (e.g. for painful metastasis). - Symptomatic brain metastases - Women pregnant or breastfeeding - Women of childbearing potential (WOCBP) unwilling/unable to use acceptable method to avoid pregnancy - Uncontrolled medical disorder or active infection - Concurrent therapy with any other investigational product ; PRIMARY OUTCOME: Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide; SECONDARY OUTCOME 1: Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma 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 III - STRETTO (Adult mild-moderate); BRIEF: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks. ; DRUG USED: Lebrikizumab; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Age 18-75 years old at study start - Asthma diagnosis for >/= 12 months prior to study start - Bronchodilator response at screening - Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3 - No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan - Stable and symptomatic asthma during the screening period - Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose Exclusion Criteria: - Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start - Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event - Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start - Documented prior treatment failure with Montelukast - Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study - Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start - Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patients ability to participate in the study, or impact the study assessments - History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma - History of alcohol or drug abuse that would impair or risk the patients full participation in the study, in the opinion of the investigator - Current or history of smoking (> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study - Past and/or current use of any anti-IL-13 or anti- IL4/IL-13 therapy, including lebrikizumab - Use of a licensed or investigational monoclonal antibody other than anti IL-13 or anti-IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening - Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start or during screening - Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening - Initiation of or change in allergen immunotherapy within 3 months prior to study start or during screening - Receipt of a live attenuated vaccine within 4 weeks prior to study start of during screening - Pregnancy or breast feeding - Body mass index > 38 kg/m2 - Body weight < 40 kg - History of bronchial thermoplasty ; PRIMARY OUTCOME: Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1); SECONDARY OUTCOME 1: Relative change in morning pre-bronchodilator peak expiratory flow (PEF)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Safety; BRIEF: This is an open-label, dose escalation study to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-A51 capsules in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study will be done in two phases. Phase 1a of this study is designed to determine the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of orally administered BTX-A51 in up to 35 participants who are evaluable for toxicity. Once the MTD is determined, it is planned that an additional 15 participants will be enrolled in Phase 1b of this study for additional experience with safety and efficacy, and to determine the recommended Phase 2 dose (RP2D) which may or may not be different from the MTD. Continued treatment will be available under this study protocol for up to eight 28-day cycles (Continued Treatment Phase) if the Investigator judges the benefit outweighs the risk. Once BTX-A51 treatment has completed, participants will be contacted by telephone every 3 months for up to 2 years after their last treatment for survival status and anticancer therapy (Overall Survival Follow-up). ; DRUG USED: BTX-A51; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: CK1A (Casein Kinase 1 alpha), Cyclin Dependent Kinase (CDK); THERAPY: Monotherapy; LEAD SPONSOR: BioTheryX, Inc.; CRITERIA: Inclusion Criteria: - Demonstration of understanding and voluntarily signing of an informed consent form - Age ≥ 18 years - Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) according to the World Health Organization classification and, with respect to MDS, that is high risk; participants must have refractory or relapsed disease and be ineligible for or have exhausted standard therapeutic options that would otherwise be likely to provide clinical benefit - Eastern Cooperative Oncology Group performance status ≤ 2 and life expectancy of ≥ 6 weeks - Adequate organ function (Grade 1 serum creatinine; Grade 1 total bilirubin; aspartate aminotransferase and/or alanine transaminase ≤ 2 × ULN) - Females of childbearing age must not be pregnant at time of Screening/beginning of treatment and agree to either abstain from sexual intercourse or use highly effective methods of contraception (for up to 3 months after last dose of study drug) - Males sexually active with a woman of childbearing age must agree to use barrier method of birth control during and after the study (up to 3 months after last dose of study drug) Exclusion Criteria: - Diagnosis of acute promyelocytic leukemia - White blood cell count > 20 x 10^9/L - Receipt of cancer chemotherapy (other than hydroxyurea) within 2 weeks prior to the start of study drug - In participants who have undergone autologous or allogeneic stem cell transplantation: transplantation within the 3 months prior to Screening; active graft-versus-host disease requiring anything other than topical corticosteroids and budesonide; treatment with systemic immunosuppressive medications including high-dose steroids (≥ 20 mg prednisolone or equivalent per day), or calcineurin inhibitors (e.g., cyclosporine, tacrolimus) for at least 1 week prior to Screening, and sirolimus, mycophenylate mofetil, azathioprine, or ruxolitinib for at least 2 weeks prior to Screening - Immediate life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation - Persistent toxicities from prior treatment of Grade 2 or higher - Active uncontrolled systemic fungal, bacterial, mycobacterial, or viral infection - Clinically significant cardiac disease - Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally - Any other concurrent medical condition or disease that is likely to interfere with study procedures or results, or that, in the opinion of the Investigator, would constitute a hazard for participating in this study - If female, pregnant or breastfeeding ; PRIMARY OUTCOME: Incidence of dose-limiting toxicities (DLTs); SECONDARY OUTCOME 1: Complete remission (CR) for participants with acute myeloid leukemia (AML)[/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 - Long Term (910); BRIEF: The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study. ; DRUG USED: DiaPep277; DRUG CLASS: Biologic; INDICATION: Diabetes Mellitus, Type I; TARGET: Toll-Like Receptor 2 (TLR2); THERAPY: Monotherapy; LEAD SPONSOR: Andromeda Biotech Ltd.; CRITERIA: Inclusion Criteria: - A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol. - Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L. Exclusion Criteria: - The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study. - The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency. ; PRIMARY OUTCOME: Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion.; SECONDARY OUTCOME 1: improved metabolic control and the insulin dose required to maintain it.[/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 - 003032-77 (Pediatric; Moderate to Severe); BRIEF: The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC). ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy. - Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both. Exclusion Criteria: - Subject with Crohns disease (CD) or indeterminate colitis (IC). - Current diagnosis of fulminant colitis and/or toxic megacolon. - Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. - Chronic recurring infections or active tuberculosis (TB). ; PRIMARY OUTCOME: Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period; SECONDARY OUTCOME 1: Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance 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 - w/Tiragolumab (China); BRIEF: This study will evaluate the efficacy and safety of atezolizumab plus tiragolumab or atezolizumab alone following neoadjuvant chemoradiotherapy (nCRT) in participants with locally advanced rectal cancer (LARC). The study consists of a safety run-in phase and a randomization phase. Participants enrolled in the safety run-in phase will receive atezolizumab + tiragolumab following nCRT. Upon determination of the safety of the treatment regimen, the study will be proceed to the randomization phase. Participants will be randomized in a 1:1 ratio to the atezolizumab + tiragolumab arm or atezolizumab arm. ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of adenocarcinoma of the rectum - Resectable locally advanced rectal cancer, with clinical stage as cT3N+M0 or cT4NanyM0 per American Joint Committee on Cancer (AJCC)/ International Union Against Cancer (UICC) 8th edition - The inferior margin of the tumor ≤10cm from the anal verge - No prior anti-cancer treatment for rectal cancer - Availability of a representative tumor specimen that is suitable for pathological evaluation and biomarker expression analysis - Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1 - At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RESIST) v1.1 - Adequate hematologic and end-organ function - For patients receiving therapeutic anticoagulation: stable anticoagulant regimen - Negative HIV test at screening - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs for at least 5 months after the final dose of atezolizumab and for 90 days after the final dose of tiragolumab, for 6 months after the final dose of capecitabine, for 6 months after the final dose of 5-FU - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and agreement to refrain from donating sperm for at least 90 days after the final dose of tiragolumab, 3 months after final dose of capecitabine, for 6 months after the final dose of 5-FU. Exclusion Criteria: - Evidence of metastatic disease - Histology consistent with small cell carcinoma, squamous carcinoma, or mixed carcinoma - Presence of synchronous colorectal cancer - Presence of obstruction or imminent obstruction - Clinical symptoms or radiological suspicion of bowel perforation - Not eligible for long-course radiotherapy - History of malignancies other than rectal cancer within 3 years prior to screening with the exception of those with a negligible risk of metastasis or death - Active or history of autoimmune disease or immune deficiency - Significant cardiovascular disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - Severe chronic or active infection within 4 weeks prior to initiation of study treatment - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled or symptomatic hypercalcemia - Uncontrolled diabetes or Grade ≥ 2 abnormalities in potassium, sodium, despite standard medical management within 14 days prior to initiation of study treatment - Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies - Treatment with systemic immunostimulatory agents - Treatment with systemic immunosuppressive medication - Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment - Major surgical procedure or significant traumatic injury within 28 days prior to initiation of study treatment, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study treatment - Any other disease, medical condition or abnormality, metabolic dysfunction, alcohol or drug abuse or dependence, physical examination finding, clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications - Treatment with any other investigational agent with therapeutic intent within 28 days prior to study treatment initiation - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins - History of allergic reactions to chemotherapy drugs (5-FU and capecitabine) - Known dihydropyrimidine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to fluoropyrimidine therapy in participants selected to receive capecitabine - Pregnant or breastfeeding ; PRIMARY OUTCOME: Percentage of Participants With Pathological Complete Response (pCR); SECONDARY OUTCOME 1: Percentage of Participants With R0 Resection[/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 - SET (Study 3201, N24HSWD); BRIEF: The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder ; DRUG USED: Hetlioz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-24 Hour Sleep Wake Disorder (Non-24); TARGET: Melatonin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vanda Pharmaceuticals; CRITERIA: Inclusion Criteria: - Ability and acceptance to provide informed consent; - No perception of light by the subjects own report; - Diagnosis of N24HSWD as determined by: 1. History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and 2. Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time. - Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study; - Fluent in English; Exclusion Criteria: - Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment; - Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable; - History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures; - History of intolerance and/or hypersensitivity to melatonin or melatonin agonists; - Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study; - Unable to perform calls to the study IVR system to report questionnaire results; - Exposure to any investigational drug, including placebo, within 30 days or 5 half lives (whichever was longer) of screening; - Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle - Use of melatonin or melatonin agonist ; PRIMARY OUTCOME: Proportion of Patients Entrained as Assessed by Urinary aMT6; SECONDARY OUTCOME 1: Proportion of Patients Entrained as Assessed by Urinary Cortisol[/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 - OMC-SXB-26; BRIEF: The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia. ; DRUG USED: Rekinla; DRUG CLASS: Non-NME; INDICATION: Fibromyalgia; TARGET: GABA-B Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria - Sign & date informed consent - Willing & able to complete trial as described in protocol - > 18 years of age - Meet American College of Rheumatology criteria for Fibromyalgia [Widespread pain for at least 3 months, including all of the following: (1) Pain on right & left sides of body; (2) Pain above & below waist; (3) Pain in axial skeleton; 4) Pain on digital palpation with approximately 4kg force in at least 11 of 18 tender point sites] - (Study continuation) Have an average VAS pain score > 4 on a scale of 0 to 10 as recorded in patient diary the last week before Visit 4. - Discontinue all prescription medication taken for fibromyalgia, including opiates, benzodiazepines, anticonvulsants taken for pain, antidepressants, cyclobenzaprine (Flexeril), and/or tramadol (Ultram) until study completion - Continue all pre-existing nutritional and/or exercise regimens and/or behavioral, massage, acupuncture, physical or cognitive therapies on an unchanged, consistent & regular schedule throughout study - Use only acetaminophen or over-the-counter non-steroidal anti-inflammatory drugs as rescue pain medications & to limit dose to the labeled over-the-counter maximum. Aspirin may only be used as a cardiac protectant; formulations with caffeine are excluded. - Forego ingestion of alcohol for duration of study. - Fertile females must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) for duration of trial. Exclusion Criteria 1. Have any of the following medical conditions: - Other rheumatic disease, such as rheumatoid arthritis, osteoarthritis, or systemic lupus erythematosis - Uncontrolled hypo- or hyper-thyroidism of any type - Unstable cardiovascular, endocrine, neoplastic (excluding localized basal cell carcinoma), gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place patient at risk during trial or compromise objectives outlined in protocol - Myocardial infarction within last six months - On their screening PSG (polysomnogram) have an Apnea Index greater than 10 per hour or an Apnea Hypopnea Index greater than 15 per hour. Note: patients with sleep apnea are not excluded if their indices are below these thresholds while sleeping with CPAP (Continuous Positive Airway Pressure) and they are compliant with CPAP therapy. - Problems that, in the investigators opinion, would preclude the patients participation and completion of this trial or compromise reliable representation of subjective symptoms. - If a patient will have to discontinue antidepressant medication taken for depression, the investigator must make an evaluation as to any risks from cessation of anti-depressant therapy. If, in the opinion of the investigator, a reasonable risk of resultant patient harm exists, patient is excluded from study participation - Current or recent history of substance abuse including alcohol abuse - History of seizure disorder, history of head trauma, migraine headaches or intracranial surgery, & are taking anticonvulsants - Succinic semialdehyde dehydrogenase deficiency 2. Have taken any of these therapies: - gamma-hydroxybutyrate (sodium oxybate) in 30 days prior to signing informed consent - any investigational therapy in 30 days prior to signing informed consent - ever taken anticonvulsants to treat epilepsy or any other convulsions 3. Unwilling to stop these therapies during course of trial: - anticonvulsants prescribed solely for pain - all antidepressants - medication for sleep 4. Have any of the following clinical laboratory results: - Serum creatinine > 2.0 mg/dL - TSH (Thyroid Stimulating Hormone) < 0.3 μU/mL OR TSH > 6 μU/mL - abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal) - elevated serum bilirubin (more than 1.5 times the upper limit of normal) - pre-trial ECG with arrhythmia, greater than a first degree AV block - positive pregnancy test at any time during trial 5. Have any of the following socio-economic factors: - Pending workers compensation litigation or related other monetary settlements - Have an occupation that requires variable shift work or routine night shifts ; PRIMARY OUTCOME: The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - GO40554 (Consolidation Therapy); BRIEF: This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of stable disease or partial response, or in elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in combination with polatuzumab vedotin IV in elderly/unfit participants with previously untreated DLBCL. ; DRUG USED: Mosunetuzumab; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Cluster of Differentiation 20 (CD20), Cluster of Differentiation 3 (CD3); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria for All Cohorts - At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest diameter - Adequate hematologic function - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2; with the exception of South Korea, where participants 80 years or older with ECOG >/= 2 will not be eligible Inclusion Criteria Specific to Cohort A Participants in Cohort A must also meet the following criteria for study entry: - Histologically confirmed DLBCL according to World Health Organization (WHO) 2016 expected to express the cluster of differentiation-20 (CD20) antigen - One prior therapy with any systemic anthracycline-based chemoimmunotherapy containing regimen for previously untreated DLBCL - Best response of SD or PR to prior systemic chemoimmunotherapy at the end of induction treatment in accordance with the Lugano 2014 criteria Inclusion Criteria Specific to Cohorts B and C Participants in Cohorts B and C must also meet the following criteria for study entry: - Previously untreated, histologically confirmed, DLBCL according to WHO 2016 classification - Age >/= 80 years, or - Age 65-79 years and considered ineligible for chemoimmuotherapy (R-CHOP) with at least one of the following: Impairment in at least two activity of daily living (ADL) components as defined in the protocol; impairment in at least two instrumental ADL components as defined in the protocol; cumulative illness rating scale - geriactic (CIRS-G) score of at least one cormorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in >/= 8 comorbidities; impairment in cardiac function, renal function, liver function, or other comorbidities such that the participant is unfit for full-dose immunochemotherapy, such as rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) - Participants with an initial ECOG performance status of 3 may be considered during screening if the performance status is DLBCL-related and if pre-phase treatment during the screening phase (not more than 100 mg/day up to 7 days prior to Cycle 1 Day 1) results in an improvement of ECOG performance status to </= 2 prior to enrollment Exclusion Criteria for All Cohorts Participants who meet any of the following criteria will be excluded from study entry: - Transformed lymphoma - CNS lymphoma - Prior treatment with mosunetuzumab - Prior stem cell transplant (autologous and allogeneic) - History of confirmed progressive multifocal leukoencephalopathy (PML) - Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV) - Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) - Positive SARS-CoV-2 antigen or PCR test within 30 days prior to Cycle 1 Day 1 - Prior solid organ transplantation - Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease - Clinically significant history of liver disease - Prior treatment with radiotherapy within 2 weeks prior to Cycle 1, Day 1 (C1D1) - Significant cardiovascular disease Exclusion Criteria Specific to Cohort A Participants in Cohort A who meet the following criteria will be excluded from study entry: - Prior anti-lymphoma treatment with chemotherapy, immunotherapy, or biologic therapy 4 weeks prior to C1D1 Exclusion Criterion Specific to Cohorts B and C Participants in Cohorts B and C who meet the following criterion will be excluded from study entry: - Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy Exclusion Criteria Specific to Cohort C Participants in Cohort C who meet the following criteria will be excluded from study entry: - Current Grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease ; PRIMARY OUTCOME: Percentage of Participants with Adverse Events; SECONDARY OUTCOME 1: Maximum Serum Concentration (Cmax) of Mosunetuzumab IV[/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 - ISA-P53-CTX; BRIEF: The purpose of this study is to determine whether the addition of cyclophosphamide to the treatment with the p53-SLP vaccine improves clinical efficacy and immunogenicity of the p53-SLP vaccine in ovarian cancer patients. ; DRUG USED: ISA102; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Immune System, p53; THERAPY: Monotherapy; LEAD SPONSOR: University Medical Center Groningen; CRITERIA: Inclusion Criteria: - Written informed consent. - Histological proven epithelial ovarian carcinoma. - At least 4 weeks after termination of the last course of chemotherapy. - Rising CA-125 serum levels after first line treatment and no measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria, or Rising CA-125 serum levels after first line treatment with measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria, but not willing or otherwise not fit to receive second line chemotherapy. - Age 18 years or older, and an life expectancy of at least 3 months. - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. - Performance status 0 to 2 (WHO scale). - Adequate hepatic, renal, and bone marrow function as defined: ASAT < 100 U/l; ALAT < 113 U/l; PT 9-12 seconds; APTT 23-33 seconds; creatinine < 135 μmol/l; WBC > 3.0 x 109/L; platelets > 100 x 109/L; hemoglobin > 6.0 mmol/l. - Adequate venous access for blood collection and i.v. administration of cyclophosphamide. Exclusion Criteria: - Pregnancy and / or breast feeding. - (A)symptomatic cystitis. - Other malignancies (previous or current), except basal or squamous cell carcinoma of the skin. - Immunosuppressive agents, except for topical and inhalation corticosteroids. - Prior therapy with a biological response modifier. - Any other major disease that may interfere with the conduct of the study (e.g. uncontrolled hypertension, severe and/or unstable heart disease, neurological and psychiatric disorders). - Signs or symptoms of CNS metastases. - Known substance abuse (drug or alcohol). ; PRIMARY OUTCOME: Clinical responses to the p53 synthetic long peptide vaccine preceded by cyclophosphamide will be assessed by measurement of serum CA-125 levels and CT-scan.; SECONDARY OUTCOME 1: Safety of the vaccine preceded by cyclophosphamide will be assessed by monitoring the incidence and severity of adverse events using Common Terminology Criteria for Adverse Events v3.0.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 13370; BRIEF: This study is a multicenter, non-randomized, open-label, Phase 2 study of intravenous LY2090314 in participants with acute leukemia. ; DRUG USED: LY2090314; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Glycogen synthase kinase 3 (GSK-3); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have confirmed diagnosis of one of the following: - Acute myelogenous leukemia (AML) that is refractory or relapsed disease. If participants have acute promyelocytic leukemia (APL), they must have received prior all-trans retinoic acid and arsenic trioxide unless ineligible or intolerant to them - Untreated AML (de novo or arising from a myelodysplastic syndrome). In the opinion of the investigator, the participant should not be a candidate for standard therapy and a clinical trial is a preferred treatment option - Have given written informed consent prior to any study-specific procedures - Have adequate organ function including: - Hepatic: Bilirubin less than or equal to 1.5 times the upper limit of normal (ULN). Alkaline phosphatase (ALP) and transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] less than or equal to 5 times ULN - Renal: Serum creatinine less than or equal to the ULN. No known active renal disease. In rare cases, participants may enter treatment with a serum creatinine greater than the ULN as elevations of serum creatinine may be secondary to dehydration - Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale - Have discontinued all previous approved therapies for acute leukemia, including chemotherapy for at least 14 days, and recovered from the acute effects of therapy. Hydroxyurea used to control peripheral blast count is permitted within the first 2 cycles of treatment on study, but it must be stopped at least 24 hours before study drug administration in Cycle 3 - Are reliable and willing to be available for the duration of the study and are willing to follow study procedures - Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug - Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug - Have an estimated life expectancy of greater than or equal to 6 weeks Exclusion Criteria: - Have received treatment within 14 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication - Participants with chronic myelogenous leukemia (CML) including blast crisis phase - Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging - Have serious pre-existing medical conditions (left to the discretion of the investigator) - Have one of the following abnormalities: QTc (Fridericia corrected) interval >450 milliseconds (msec) on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long QT syndrome, previous history of ventricular tachycardia or unexplained syncope, left bundle branch block, or chronic atrial fibrillation - Have family history of long QT syndrome or sudden death due to ventricular arrhythmia - Concomitant medication that may cause QTc prolongation or induce Torsades de Pointes at the time of study entry - Have systolic blood pressure greater than or equal to 160 millimeter of mercury (mm Hg) and diastolic blood pressure greater than or equal to 100 mm Hg - Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class II or higher or participants with a history of arrhythmia that is symptomatic or requires treatment - Have uncorrected electrolyte disorders including potassium - Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry - Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug - Have uncontrolled systemic infection - Females who are pregnant or lactating - Presence of clinical evidence of viral disease caused by human immunodeficiency virus, hepatitis B, or hepatitis C ; PRIMARY OUTCOME: Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs); SECONDARY OUTCOME 1: Number of Participants With Best Response of Complete Response or Partial 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 I - RG012-06 ; BRIEF: This is a Phase 1, open-label, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome. ; DRUG USED: RG-012; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alport Syndrome; TARGET: microRNA (miRNA), miR-21; THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion Criteria: 1. Males or females, ages 18 to 65 years 2. Confirmed diagnosis of Alport syndrome 3. eGFR between 40 and 90 mL/min/1.73m2 4. Proteinuria of at least 300 mg protein/g creatinine 5. For subjects taking an ACE inhibitor or an ARB, the dosing regimen should be stable for at least 30 days prior to screening 6. Willing to comply with contraception requirements Exclusion Criteria: 1. Causes of chronic kidney disease aside from Alport syndrome (such as diabetic nephropathy, hypertensive nephropathy, lupus nephritis, or IgA nephropathy) 2. End stage renal disease (ESRD) as evidenced by ongoing dialysis therapy or history of renal transportation 3. Any other condition that may pose a risk to the subjects safety and well-being 4. Female subjects who are pregnant or lactating ; PRIMARY OUTCOME: Safety - Adverse Events; SECONDARY OUTCOME 1: Pharmacokinetic (PK) parameter - 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 IIa - w/ and w/o Cataplexy; BRIEF: This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo. ; DRUG USED: SUVN-G3031; DRUG CLASS: New Molecular Entity (NME); INDICATION: Narcolepsy; TARGET: Histamine H3 Receptor (HRH3); THERAPY: Monotherapy; LEAD SPONSOR: Suven Life Sciences Limited; CRITERIA: Inclusion Criteria: - Ages of 18 to 65 years (adult), inclusive. - Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International Classification of Sleep Disorders (3rd edition) criteria (new or previously diagnosed). - Have undergone a multiple sleep latency test (MSLT) study showing an MSLT of ≤ 8 minutes. - An ESS score of ≥ 12; and mean MWT time of < 12 min. - Body mass index ranging from 18 to < 45 kg/m2 - Negative urine drug screen. - A woman must be either not of childbearing potential or of childbearing potential practicing highly effective methods of birth control. - Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form (ICF). Exclusion Criteria: - Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of < 6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries. - Use of any investigational therapy within the 30-day period prior to enrollment. - Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline assessments and during the course of the trial. - Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens at night to smoke). - Use of concurrent medications prescribed to treat narcolepsy as specified including stimulants, antidepressants and sodium oxybate. - Current diagnosis of or past treatment for syndromes known to cause sleep disruption or any other cause of daytime sleepiness. - Clinically significant ECG abnormalities. - An occupation requiring variable shift work, night shifts, or frequent overnight travel which disrupts sleep patterns. ; PRIMARY OUTCOME: Epworth Sleepiness Scale (ESS); SECONDARY OUTCOME 1: Clinical Global Impression of Severity (CGI-S)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric; BRIEF: The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age. ; DRUG USED: Durezol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - 0 to 3 years of age. - Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens. - Informed consent signed by a parent or legal guardian. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Presence of any active or suspected viral, bacterial, or fungal disease in the study eye. - Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery. - Patients with posttraumatic cataract. - Active uveitis in the study eye. - Ocular neoplasm in the study eye. - Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS). - Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patients only good eye. - Patients on systemic steroids or nonsteroidal anti-inflammatory drugs. - History of steroid-induced intraocular pressure (IOP) rise. - Currently on medication for ocular hypertension or glaucoma in the study eye. - Diabetes. - Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days; SECONDARY OUTCOME 1: Global Assessment Score of Postoperative Inflammation by Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - REJOICE; BRIEF: This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women. ; DRUG USED: Imvexxy; DRUG CLASS: Non-NME; INDICATION: Vaginal Atrophy; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: TherapeuticsMD; CRITERIA: Inclusion Criteria: 1. Postmenopausal female subjects between the ages of 40 and 75 years (at the time of randomization) with at least: - 12 months of spontaneous amenorrhea (women <55 years of age with a history of hysterectomy without bilateral oophorectomy prior to natural menopause must have follicle stimulating hormone (FSH) levels > 40 mIU/mL), OR - 6 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) levels > 40mlU/mL OR - At least 6 weeks postsurgical bilateral oophorectomy. 2. ≤5% superficial cells on vaginal cytological smear 3. Vaginal pH > 5.0 4. Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom by the subject at screening visit 1A. 5. Moderate to severe symptom of vaginal pain associated with sexual activity at screening visit 1B. 6. Onset of moderate to severe dyspareunia in the postmenopausal years. 7. Subjects should be sexually active (i.e. have sexual activity with vaginal penetration within approximately 1 month of screening visit 1A). 8. Subjects should anticipate having sexual activity (with vaginal penetration) during the conduct of the trial. 9. For subjects with an intact uterus: Subjects must have an acceptable result from an evaluable screening endometrial biopsy. 10. Subjects who have a Body Mass Index (BMI) less than or equal to 38 kg/m2. BMI values should be rounded to the nearest integer (ex. 32.4 rounds down to 32, while 26.5 rounds up to 27). 11. In the opinion of the investigator, the subject will comply with the protocol and has a high probability of completing the study. Exclusion Criteria: 1. Use of the following: 1. Oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening visit 1A (can enter washout); 2. Use of transdermal hormone products within 4 weeks before screening visit 1A (can enter washout); 3. Use of vaginal hormone products (rings, creams, gels) within 4 weeks before screening visit1A (can enter washout); 4. Use of intrauterine progestins within 8 weeks before screening visit 1A (can enter washout); 5. Use of progestin implants/injectables or estrogen pellets/injectables within 6 months before screening visit 1A (cannot enter washout); 6. Use of vaginal lubricants or moisturizers within 7 days before the screening visit 1B vaginal pH assessment. 2. A history or active presence of clinically important medical disease that might confound the study or be detrimental to the subject, examples include: 1. Hypersensitivity to estrogens; 2. Endometrial hyperplasia; 3. Undiagnosed vaginal bleeding; 4. Have a history of a chronic liver or kidney dysfunction/disorder (e.g., Hepatitis C or chronic renal failure); 5. Thrombophlebitis, thrombosis or thromboembolic disorders; 6. Cerebrovascular accident, stroke, or transient ischemic attack; 7. Myocardial infarction or ischemic heart disease; 8. Malignancy or treatment for malignancy, within the previous 5 years, with the exception of basal cell carcinoma of the skin or squamous cell carcinoma of the skin. A history of estrogen dependent neoplasia, breast cancer, melanoma or any gynecologic cancer, at any time, excludes the subject; 9. Endocrine disease (except for controlled hypothyroidism or controlled non-insulin dependent diabetes mellitus). 3. Recent history of known alcohol or drug abuse. 4. History of sexual abuse or spousal abuse that, in the opinion of the PI, may interfere with the subjects assessment of vaginal pain with sexual activity. 5. Current history of Heavy smoking (more than 15 cigarettes per day) or use of e-cigarettes. 6. Use of an intrauterine device within 12 weeks before screening visit 1A. 7. Use of an investigational drug within 60 days before screening visit 1A. 8. Any clinically important abnormalities on screening physical exam, assessments, ECG, or laboratory tests, such as: 1. Unresolved cervical cytologic smear report of atypical glandular cells of undetermined significance (AGUS) or atypical squamous cells of undetermined significance (ASCUS). Cervical cytologic smear report of low-grade squamous intraepithelial lesion (SIL) or greater, CIN1 or greater, or any reported dysplasia; Subjects with ASCUS are eligible only if high risk human papilloma virus (HPV) result is negative. 2. Unresolved findings suspicious for malignancy on the breast exam; incomplete mammogram result (BI-RADS 0) or unresolved findings suggestive of malignant changes or findings requiring short interval follow-up on the prestudy mammogram (subjects must have mammography result of BI-RADS 1 or 2 to enroll.) Mammogram may be performed within 9 months prior to Visit 2 (randomization) with documentation available. (The site must obtain a copy of the official report for the subjects study file, and it must be verified that the mammogram itself is available if needed for additional assessment); 3. In subjects with intact uterus: have a screening endometrial biopsy sample that is found by both primary pathologists to have endometrial tissue insufficient for diagnosis, no endometrium identified, or no tissue identified. (With the approval of the Medical Monitor, the screening endometrial biopsy may be repeated once); 4. In subjects with intact uterus: an endometrial biopsy report by one central pathologist at screening with one of the following: - Endometrial hyperplasia endometrial cancer, proliferative endometrium, weakly proliferative endometrium, disordered proliferative pattern; OR - Endometrial polyps with hyperplasia, glandular atypia of any degree (e.g., atypical nuclei) or cancer; 5. Vulvar or vaginal inflammatory condition such as a contact or allergic dermatitis, lichen sclerosis or other pathological findings; 6. Presence of suspicious vulvar or vaginal lesions for dysplasia, malignancy or other pathology other than atrophy; 7. Painful genital warts or localized areas of ulceration; 8. A history of active, chronic pelvic pain; 9. Interstitial cystitis; 10. Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal for the laboratory used; 11. Fasting total cholesterol greater than 300 mg/dL (7.77 mmol/L) or triglycerides greater than 300 mg/dL (3.39 mmol/L); 12. Fasting blood glucose greater than 125 mg/dL (6.94 mmol/L) with a hemoglobin A1C of greater than or equal to 6.5%; 13. Uncontrolled hypertension; subjects with elevated sitting blood pressure, greater than 140 mm Hg systolic or greater than 90 mm Hg diastolic and may not be using more than 2 antihypertensive medications for the treatment of hypertension; 14. Clinically significant abnormal 12-lead ECG (such as myocardial infarction or other findings suggestive of ischemia) 9. Be known to be pregnant or have a positive urine pregnancy test. (Note: A pregnancy test is not required for subjects who have had bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or are 55 years old or greater and have experienced cessation of menses for at least 1 year. 10. Current use of marijuana. ; PRIMARY OUTCOME: Co-Primary Efficacy Endpoint - Vaginal Superficial Cells; SECONDARY OUTCOME 1: Secondary Efficacy Endpoints - Vaginal Superficial Cells[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD/MAD (Japan); BRIEF: This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days. ; DRUG USED: AZD5069; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Chemokine (C-X-C motif) Receptor 2 (CXCR2) / IL-8 receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Japanese subjects with suitable veins for cannulation or repeated venepuncture. - Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg - Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product Exclusion Criteria: - History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subjects ability to participate in the study. - History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product. - Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator ; PRIMARY OUTCOME: Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry; SECONDARY OUTCOME 1: Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ARTEMIS1; BRIEF: The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters. ; DRUG USED: Nayzilam; DRUG CLASS: Non-NME; INDICATION: Seizure Disorders (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma S.P.R.L.; CRITERIA: Inclusion Criteria: - Has a competent, adult caregiver who can recognize and observe the subjects seizure cluster episodes - Has an established diagnosis of partial or generalized epilepsy that includes the following: - A documented history of seizure clusters lasting a minimum of 10 minutes - Seizure cluster pattern is observable, stereotyped, and recognizably different from the subjects other non-cluster seizure activity (if any) - A second seizure in the seizure cluster typically occurring within 6 hours from the time of cluster recognition - A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures - A seizure cluster pattern established > 3 months before Visit 1 - A frequency of ≥ 3 seizure clusters during the year before Visit 1 - At least 1 seizure cluster occurring ≤ 4 months before Visit 1 - Seizure cluster pattern is confirmed by a central reviewer - Currently on a stable regimen of anti-epileptic drugs (AEDs) with no changes in type of AEDs since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose - Weight is 40 kg to 125 kg, inclusive Exclusion Criteria: - Has a neurological disorder that is likely to progress in the next year - Has severe chronic cardio-respiratory disease - Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1 - Has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before Visit 1 - Has a history of acute narrow-angle glaucoma. - Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years - Currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before Visit 1 ; PRIMARY OUTCOME: Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP); SECONDARY OUTCOME 1: Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - FTIM; BRIEF: This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male volunteers ; DRUG USED: GSK-356278; DRUG CLASS: New Molecular Entity (NME); INDICATION: Huntingtons Disease; TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - AST, ALT, alkaline phosphate and bilirubin less than or equal to 1.5 times upper limit of normal. - Healthy as determined by a responsible and experienced physician based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - Males aged between 18 and 65 years inclusive at the time of signing the informed consent. - Males must agree to appropriate forms of contraception from administration of first dose through to 3 months after taking the final dose. - Body weight greater than or equal to 50 kg and BMI within the range of 18-29.9 m2 (inclusive) - Capable of giving written informed consent. - QTcB or QTcF less than 450 msec Exclusion Criteria: - A positive pre-study Hep B or positive Hep C result within 3 months of screening. - Current or chronic history of liver disease or known hepatic or biliary abnormalities - A positive pre-study alcohol and drug screen - A positive test for HIV antibody. - History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or average daily intake of greater than 3 units - The subject has participated in a clinical trial and has received investigational product within the time period of 30 days prior to first dosing day (or 5 half-lives or twice the duration of the biological effect of the drug, whichever is longer) - Exposure to more than 4 new chemical entities in the last 12 months prior to the first dosing day - Use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose unless in the opinion of the investigator and medical monitor the medication will not interfere with the study procedures or compromise subject safety. - History of sensitivity to any of the study medication or history of drug or other allergy that in the opinion of the investigator or medical monitor contraindicates their participation. - Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period. - Unwillingness or inability to follow the procedures in the protocol. - Subject is mentally or legally incapacitated. - Subjects who have asthma or a history of asthma. - Urinary cotinine levels indicative of smoking or history of regular use of tobacco or nicotine containing products within 6 months prior to screening. - Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose. - History of any significant psychiatric illness. - Any history of suicidal behaviour or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale in the last 6 months. - History of presence of clinically significant cardiac arrhythmias or other clinically significant cardiac disease. ; PRIMARY OUTCOME: To assess safety and tolerability of single escalating oral doses of GSK356278 in healthy male volunteers; SECONDARY OUTCOME 1: To investigate the pharmacokinetics of single escalating doses of GSK356278 in healthy male volunteers[/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 - GlycoNEXT; BRIEF: The study was designed to investigate the efficacy and safety of different doses CHF5259 a long acting muscarinic antagonist in patients with moderate to severe COPD. ; DRUG USED: CHF 5259; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Chiesi Farmaceutici S.p.A.; CRITERIA: Inclusion Criteria: 1. Male or female patients aged ≥ 40 years 2. Patients with a diagnosis of stable COPD at least 12 months before screening visit. 3. Current smoker or ex-smoker with a smoking history of at least 10 pack-years 4. - A post-bronchodilator FEV1 ≥ 40% and ≤70% of the predicted normal value and, - a post-bronchodilator FEV1/FVC < 0.7 and, - a change in FEV1 from the pre-bronchodilator value (reversibility) of at least 5% at screening 5. Patients under bronchodilators with long-acting muscarinic antagonist or long-acting 2 agonist (monotherapy or dual therapy), or patients under ICS + LABA (long-acting beta2-agonist) or ICS (Inhaled Corticosteroids) + LAMA (Long Acting Muscarinic Agonist) for at least 4 weeks prior to screening. (Patients with a FEV1<50% of the predicted value and a history of 1 exacerbation within the last 12 months must have been treated with ICS+LABA or ICS+LAMA before screening) 6. Ability and cooperative attitude to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres) and ability to understand the risks involved. Ability to be trained to use the dry powder inhalers. Exclusion Criteria: 1. Diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigators opinion. 2. Patients had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids, or hospitalisation. 3. Patients with a history of ≥ 2 exacerbations within the last 12 months prior to screening. 4. Patients treated with oral/parenteral β2-agonists or nebulised bronchodilators or phosphodiesterase inhibitors or who received LABA/LAMA/ICS treatment therapy in the 4 weeks prior to screening and during the run-in period. 5. Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period (patients on stable dose of ICS for at least 4 weeks prior to screening are allowed). 6. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia. 7. Patients with known respiratory disorders other than COPD including but not limited to alpha1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease. 8. Patients with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic. 9. Patients who have unstable concurrent disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study; 10. Patients who have a concomitant disease of poor prognosis (e.g., cancer...). 11. Patients who have clinically significant cardiovascular condition diagnosed in the last 6 months 12. Patients with known atrial fibrillation (AF): 1. Paroxysmal Atrial Fibrillation 2. Persistent 3. Long standing persistent. 4. Permanent 13. Patients with a clinically significant abnormal 12-lead ECG that might, in the judgment of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study. 14. Patients whose electrocardiogram 12-lead ECG shows a QTcF>450 ms for males or QTcF > 470 ms for females. 15. Patients with clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study. 16. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control methods 17. Patients known to have intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study. 18. Patients who have evidence of alcohol or drug abuse, not compliant with the study protocol or not compliant with the study treatments according to investigators judgment. 19. Patients with major surgery in the previous 3 months or planned during the trial which may affect patients compliance in study procedures. 20. Patients who have participated in another clinical trial with an investigational drug in the 2 months preceding the screening. ; PRIMARY OUTCOME: FEV1 AUC0-12h normalised by time (L); SECONDARY OUTCOME 1: Change from baseline in morning pre-dose FEV1 (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 - w/Sorafenib; BRIEF: The purpose of this study is to determine if VT-122 provides a clinical benefit when added to Sorafenib in patients with advanced hepatocellular carcinoma (HCC). ; DRUG USED: VT-122; DRUG CLASS: Non-NME; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Beta Adrenergic Receptors, Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Combination; LEAD SPONSOR: Vicus Therapeutics; CRITERIA: Inclusion Criteria: Participants will be required to meet all of the following criteria to be considered eligible for the study: - Have a confirmed diagnosis of HCC. Biopsy is preferred but is not required. - Male and female participants who are ≥18 years of age. - In the opinion of the investigator, the participants have a life expectancy of at least 12 weeks. - Able to take food or nutritional support orally. - On sorafenib for at least 4 weeks prior to randomization. Dose adjustments are allowed prior to randomization. - Have a Karnofsky Performance Score (KPS) equal to or greater than 50. - Have a cirrhotic status of Child-Pugh Class A or B7. - Have the following laboratory parameters: - a. Platelet count ≥50 x 10E9/L. - b. Total bilirubin ≤1.5 mg/dL (≤1.0 mg/dL for primary biliary cirrhosis). If total bilirubin >1.5 mg/dL but <3.0 mg/dL, a patient could be enrolled after consultation with the Medical Monitor. If total bilirubin is >3.0 mg/dL, but the value has been constant for a period of greater than 3 months, a patient could be enrolled after consultation with the Medical Monitor. - c. Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance >60 mL/min calculated using Cockcroft-Gault. - d. Serum albumin ≤3.5 g/dL and/or C-reactive protein (CRP) ≥3 mg/L - Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice. Exclusion Criteria: Participants must not have any of the following criteria to be considered eligible for inclusion in the study: - The patient has a history of another primary cancer, with the exception of: a) curatively resected non-melanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor with no known active disease present that in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis. - Contraindication to sorafenib, propranolol, etodolac, or placebo. - Patient currently on beta-blockers for the treatment of portal hypertension or arrhythmia. [Patients on beta blockers for the treatment of hypertension are allowed if they change to a different drug class, e.g. some classes of angiotensin-converting enzyme (ACE) inhibitors, for controlling hypertension at least one week before randomization]. - Body mass index (BMI) <17.5 kg/m2. - History or evidence of cardiac disease: congestive heart failure; New York Heart Association class 2 or greater; active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrioventricular block of second or third degree, or uncontrolled hypertension. Patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization. - Hypotension at the time of screening (i.e., systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg). - Resting heart rate <60 bpm at time of screening. - Participants with a recent diagnosis of bleeding varices that has not been resolved for a minimum period of 4 weeks. - Any uncontrolled intercurrent illness that, in the opinion of the Investigator, may interfere with study evaluation. - On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine, dopamine, dobutamine, epinephrine, isoproterenol). - Active clinically serious infections [>Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0]. - Known history of human immunodeficiency virus (HIV) infection. - Known central nervous system tumors including metastatic brain disease. - Clinically significant gastrointestinal (GI) bleeding within 30 days prior to Screening. - Substance abuse, medical, psychological or social conditions that may, in the in the opinion of the investigator, interfere with the patients participation in the study or evaluation of the study results. - Known or suspected allergy to the investigational agents or any agent given in association with this trial (hypersensitivity reaction, hives, rash, difficulty breathing swelling of face, lips, tongue, or throat). - Inability to swallow oral medications. - Any condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the study. - Pregnant or breastfeeding participants. Women of childbearing potential (non-childbearing potential is defined as menopausal for at least 2 years, post-bilateral tubal ligation for at least 1 year, post-bilateral oophorectomy or post-hysterectomy) must have a negative urine pregnancy test performed within 10 days prior to the start of study drug. Both men and women enrolled in this trial must use adequate double-barrier birth control measures [2 types of an acceptable form of FDA-approved contraception (e.g., barrier method, Depo-Provera™, Norplant™, Ortho Evra® [birth control patch], oral contraceptives)] during the course of the trial. - Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study. ; PRIMARY OUTCOME: failure free survival; SECONDARY OUTCOME 1: clinical benefit 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 - A2405 - ENESTcmr; BRIEF: The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over. ; DRUG USED: Tasigna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Myelogenous Leukemia (CML); TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months Persistent disease demonstrated by two PCR positive tests 3 months apart both during the past 6 months. Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No other current or planned anti-leukemia therapies Exclusion Criteria: Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months) Patient has received another investigational agent within last 6 months or tyrosine kinase inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation Impaired cardiac function including any one of the following: Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known family history of long QT syndrome. Clinically significant resting brachycardia (<50 beats per minute) QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension) History of or presence of clinically significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry ; PRIMARY OUTCOME: Rate of Confirmed Best Cumulative Complete Molecular Response (CMR); SECONDARY OUTCOME 1: Rate of Confirmed Best Cumulative CMR[/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 - Cytos; BRIEF: The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine. The antibodies will bind nicotine and prevent its passage into the brain. The successfully vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle of nicotine addiction. ; DRUG USED: NIC-002; DRUG CLASS: Vaccine; INDICATION: Smoking Cessation; TARGET: Immune System, Nicotinic Acetylcholine Receptors (nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Cytos Biotechnology AG; CRITERIA: Inclusion Criteria: - Written informed consent - Age 18 to 70 years - Smokers: > 10 and ≤ 40 cigarettes per day and smoking history of more than 3 years - Fageström Test for Nicotine Dependence (FTND) score ≥ 5 - Female participant must meet one of the following criteria: a) no reproductive potential due to menopause, hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 additional months after the last immunization Exclusion Criteria: - Pregnant or nursing - History of severe allergy or immunological disorders - Blood donation within previous 30 days - Surgery within previous 30 days - Use of investigational drugs within previous 60 days - Significant cardiovascular disease: - angina pectoris - congestive heart failure - clinically significant murmurs - previous angioplasty or coronary artery bypass surgery - Active infectious disease: - WBC > 12 000 cells/µL - Seropositivity for Hepatitis B and C - History of risk behavior to acquire HIV - Significant hepatic disease - Significant renal disease - Significant hematological disorder - Significant pulmonary disease - History of malignancy - Autoimmune disease - Organic neurological disorder or significant psychiatric disorder - Use of psychoactive drug within one month before enrolment - Abuse of drugs or alcohol - Subjects using any concomitant medications due to chronic illness which bears a high risk of fluctuation in disease activity or exacerbations during a 12-months period such as coronary heart disease, asthma, severe COPD, chronic rheumatoid disease, diabetes, etc. should be excluded. - Obesity: BMI > 35 kg/m2 - Use of concomitant nicotine replacement treatment (NRT) at screening or visit 1 - Any planned surgical intervention during the study period ; PRIMARY OUTCOME: Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm; SECONDARY OUTCOME 1: Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - NH001-2; BRIEF: The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State. ; DRUG USED: NH001; DRUG CLASS: Non-NME; INDICATION: Chronic Vegetative State; TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Dopamine 4 (D4) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: NeuroHealing Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Patient is between 18 and 50 years of age, inclusive. 2. Male or non-pregnant female (females of child-bearing potential will be required to have undergone a pregnancy test with negative results prior to entry to the study). 3. Patients will have sustained a severe closed head injury within one to four months. 4. Patients will have remained in a vegetative or minimally conscious state between one and four months after injury. 5. Patients will have reached a stabilized clinical state prior to admission to the study (e.g. afebrile, haemodynamic and electrolyte stability). 6. Patients will have a mean DRS score between 17 and 29, when measured twice a day over two consecutive days. 7. Informed consent from a legal representative will have been obtained, according to the procedures outlined in Section 8.1.2. 8. Patients who, according to the investigators opinion, are likely to be available for the required 180-day follow up evaluation. Exclusion Criteria: 1. Patients who are not clinically stable at the time of entry into the study (infections, cardiovascular decompensation, etc.) 2. Patients who require mechanical respiratory assistance. 3. Patients who show signs of progressive neurological deterioration post-TBI. 4. Patients with a known history of medically relevant substance abuse. 5. Patients with history of cardiac disease. 6. Patients who suffered an anoxic event. 7. Patients who have received an investigational drug within 30 days of the study. 8. Patients who have previously used NH001, other dopaminergic agent (e.g. levodopa, amantadine, domperidone) or any known neuro-stimulant (e.g. methylphenidate, amphetamines, atomoxetine, modafinil) within the last 7 days days. 9. Patients who are receiving dopamine blockers (e.g. risperidone, haloperidol, chlorpromazine, flupenthixol, clozapine, olanzapine, quetiapine) 10. Patients who are receiving drugs of the 5HT3 antagonist class, including, for example, ondansetron, granisetron, dolasetron, palonosetron and alosetron. 11. Patients who are receiving tricyclic antidepressants drugs 12. Patients who are receiving type I antiarrhythmics (i.e. quinidine). 13. Patients who have a known history of cardiac arrhythmias or congenital QTc prolongation. 14. Patients who have a known history of previous neurological functional impairment (e.g. stroke, spinal cord injury, dementia, epilepsy, psychiatric diseases). 15. Patients who experienced seizures within the first week post injury or have ongoing seizures. 16. Patients receiving prophylactic anti-convulsive medications. 17. Patients with known allergies to apomorphine, morphine, sulfites or trimethobenzamide. 18. Patients who are receiving nitrates or other vasodilators. 19. Patients receiving CNS acting agents such as barbiturates, morphine, belladonna, opiates. 20. For male patients, patients who are receiving trazodone or any other drug that is known to produce priapism. 21. Patients without a relative or legal guardian to consent to the study. 22. Patients who, according to the investigators opinion, are unlikely to be available for the required 180-day follow up evaluation. ; PRIMARY OUTCOME: Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised; SECONDARY OUTCOME 1: Coma/Near Coma Scale (CNC) Disability Rating Scale (DRS), Glasgow Outcome Scale Extended (GOS-E), ability to participate in 3 hours a day of active rehabilitation, and a clinical impression of change.[/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 - RGH-MD-24 (Dose-Reduction Paradigm); BRIEF: 1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia 2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d ; DRUG USED: Vraylar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening). - Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits. - Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5). - Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1). - Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2. Exclusion Criteria: - Currently meeting DSM-5 criteria for any of the following: - Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders - Bipolar I and II disorder - Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder - History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1. - Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study. - Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating. ; PRIMARY OUTCOME: Time to First Relapse During Double-blind Treatment Period; 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 - PARAGON-HF (HFpEF); BRIEF: The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction. ; DRUG USED: Entresto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Preserved Ejection Fraction (Chronic HFpEF); TARGET: Angiotensin II Receptor Type 1 (AT1), Neutral Endopeptidase/Neprilysin (NEP); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry. - Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry. - Current symptom(s) of HF (NYHA class II-IV) - Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram. - Elevated NT-proBNP Exclusion Criteria: - Any prior measurement of LVEF < 40%. - Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry. - Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF ≥45%. - Current acute decompensated HF requiring therapy. - Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor. - Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2. - Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry. Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.; SECONDARY OUTCOME 1: Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)[/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 - COMPASS; BRIEF: The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Coronary Artery Disease; TARGET: Coagulation Factor X; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Meet criteria for CAD and/or PAD Subjects with CAD must also meet at least one of the following criteria: - Age ≥65, or - Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors Exclusion Criteria: - Stroke within 1 month or any history of hemorrhagic or lacunar stroke - Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms - Estimated glomerular filtration rate (eGFR)<15 mL/min - Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy ; PRIMARY OUTCOME: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death; SECONDARY OUTCOME 1: The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death[/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 - LYT-100-2020-01 ; BRIEF: Part 1 is a multiple ascending dose trial in healthy volunteers (HV) of LYT-100 to determine safety, tolerability, and pharmacokinetic (PK) profile under fed conditions. Part 2 is a single dose safety, tolerability, and PK trial in HV of LYT-100 under fed and fasted conditions. Part 3 is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema ; DRUG USED: LYT-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Edema; TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: PureTech; CRITERIA: Main Inclusion Criteria: Part 1 and 2: Healthy Volunteers 1. Male or female between 18 and 75 years old (inclusive) at the time of screening. 2. In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator. Part 3: Patients with BRCL 1. Female or male between 18 and 80 years old (inclusive) at the time of informed consent. 2. At least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy [FNA]), at the time of study screening. No intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study. 3. At least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening. 4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study. 5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline. 6. Documented evidence of Stage 1 or 2 lymphedema. 7. Receiving standard of care compression or agreeable to using care compression, or no compression at all ≥ 4 weeks prior to screening and throughout the study. Main Exclusion Criteria: Part 1 and 2: Healthy Volunteers 1. History or presence of malignancy at screening or baseline, with the exception of adequately treated localised skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix. 2. Clinically significant infection within 28 days of the start of dosing, or infections requiring parenteral antibiotics within the 6 months prior to screening. 3. Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the Investigator). 4. History or presence at screening or baseline of a condition associated with significant immunosuppression Part 3: Patients with BRCL 1. Bilateral lymphoedema or history of bilateral axillary lymph node removal (i.e., sentinel lymph node or axillary lymph node dissection), or primary lymphoedema or lymphatic or vascular malformation, determined at screening. 2. Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the PI. 3. Recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis, dermatitis, necrotizing fasciitis, or current open wounds or sores in the affected extremity. 4. Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema greater than 4 years, determined at screening. 5. Initiated use of compression or manual lymphatic drainage or other lymphoedema therapies at the start of the study within 4 weeks of the screening visit. Rescreening is allowed following a course of stable compression regimen of > 4 weeks. ; PRIMARY OUTCOME: Safety and tolerability: treatment-emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Efficacy signals of LYT-100[/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 101; BRIEF: Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders affecting both children and adults. KH176 is a novel chemical entity currently under development for the treatment of inherited mitochondrial diseases, including MELAS (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leighs Disease and Lebers Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox modulating agent targeting the reactive oxygen species which are important in the pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a favourable safety profile in the pre-clinical testing, the safety, tolerability and pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in healthy male subjects in this trial ; DRUG USED: Sonlicromanol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mitochondrial Respiratory-Chain Diseases; TARGET: Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: Khondrion BV; CRITERIA: Inclusion Criteria: - Healthy as assessed by medical history, physical examination, Vital Signs, Clinical Laboratory, ECG Exclusion Criteria: - Allergies, - Concomitant medication, - concomitant disease, - relevant surgery, - recent blood donation ; PRIMARY OUTCOME: SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericias Formula (QTcF); 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/MLN0128; BRIEF: The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone. ; DRUG USED: TAK-117; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine (Endometrial) Cancer; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma). 2. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments. 3. At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, chemotherapy/radiation therapy, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitized therapy will be considered a systemic chemotherapy regimen. 4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded). Each lesion must be greater than or equal to (>=) 10 millimeter (mm) in long axis when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam. Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI. 5. Tumor accessible and participant consents to undergo fresh tumor biopsies. 6. Female participants 18 years or older. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 8. Female participants who: - Are postmenopausal for at least 1 year before the screening visit, OR - Are surgically sterile, OR - If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [example, United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), etc.]) after the last dose of study drug, OR - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) 9. Clinical laboratory values as specified below within 4 weeks before the first dose of study drug: - Bone marrow reserve consistent with absolute neutrophil count (ANC) >= 1500 per micro liter (/mcL); platelet count >= 100,000/mcL; hemoglobin A1c (HbA1c) less than (<) 6.5 percent (%). - Total bilirubin must be less than or equal to (<=) 1.5 * the upper limit of normal (ULN). - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be <= 2.5 * the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease in liver. - Creatinine clearance >= 50 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection. - Fasting serum glucose < 130 milligram per deciliter (mg/dL) and fasting triglycerides <= 300 mg/dL. 10. Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling. 11. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. Exclusion Criteria: 1. Positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug. Women who are lactating and breastfeeding are not eligible. 2. Previous treatment with any weekly taxane regimen. 3. History of severe hypersensitivity reactions to paclitaxel or any of its excipients. 4. Previous treatment with phosphoinositide 3-kinase (PI3K), serine/threonine-specific protein kinase (AKT), dual PI3K/ mammalian (or mechanistic) target of rapamycin (mTOR) inhibitors, target of rapamycin complex 1/2 (TORC1/2) inhibitors or TORC1 inhibitors. 5. Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug (participants already receiving erythropoietin on a chronic basis for >=4 weeks are eligible). 6. Participants who are taking proton pump inhibitors (PPIs) within 7 days of the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug. 7. A prothrombin time (PT) or activated partial thromboplastin time (aPTT) above the ULN or a history of a coagulopathy or bleeding disorder. 8. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. 9. Sensory or motor neuropathy >= Grade 2. 10. Central nervous system (CNS) metastasis, endometrial leiomyosarcoma, or endometrial stromal sarcoma. 11. Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or for some other reason that may alter the absorption of sapanisertib or MLN1117. In addition, participants with enteric stomata are also excluded. 12. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection, or any other condition that could compromise participation of the participant in the study. 13. Known human immunodeficiency virus infection. 14. History of any of the following within the last 6 months before administration of the first dose of study drug: - Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures. - Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures. - Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia). - Placement of a pacemaker for control of rhythm. - New York Heart Association Class III or IV heart failure. - Pulmonary embolism. 15. Significant active cardiovascular or pulmonary disease before administration of the first dose of study drug, including: - Uncontrolled hypertension (that is, either systolic blood pressure > 180 millimeter of mercury [mm Hg] or diastolic blood pressure > 95 mm Hg). - Pulmonary hypertension. - Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or pulse oximetry on room air. - Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement. - Medically significant (symptomatic) bradycardia. - History of arrhythmia requiring an implantable cardiac defibrillator. - Baseline prolongation of the rate-corrected QT interval (QTc; example, repeated demonstration of QTc interval > 480 millisecond [ms], or history of congenital long QT syndrome, or torsades de pointes). 16. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 17. Participants with endometrioid histology and histologically confirmed expression of estrogen receptors (ER) and/or progesterone receptors (PgR) who have not received prior endocrine therapy and for whom endocrine therapy is currently indicated. ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)[/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 - IMvigor011; BRIEF: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy. ; DRUG USED: Tecentriq; 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: Hoffmann-La Roche; CRITERIA: Inclusion Criteria for the Surveillance Phase: - Histologically confirmed MIUC (also termed TCC) of the bladder - TNM classification (based on AJCC Cancer Staging Manual, 8th Edition; Amin et al. 2016) at pathological examination of surgical resection specimen as follows: For patients treated with prior NAC: tumor stage of ypT2-4a or ypN+ and M0. For patients who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0 - Surgical resection of MIUC of the bladder - Patients who have received prior platinum-based NAC. - Patients who have not received prior platinum-based NAC, have refused, or are ineligible (unfit) for cisplatin-based adjuvant chemotherapy. - ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood. - Tumor PD-L1 expression per IHC that is evaluable by central testing of a representative tumor tissue specimen. - Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 4 weeks prior to enrollment. - Full recovery from cystectomy and enrollment within 24 weeks following cystectomy. Minimum of 6 weeks must have elapsed from surgery. Additional Inclusion Criteria for the Treatment Phase: - Blood for plasma ctDNA sample evaluated to be ctDNA positive, defined as the presence of two or more mutations out of the 16 mutations identified based on patients WES evaluable (ctDNA assay designability) report - Absence of residual disease and absence of metastasis, as confirmed by a negative baseline CT or MRI scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization, as assessed by the investigator - ECOG Performance Status of <= 2 - Life expectancy >=12 weeks - Adequate hematologic and end-organ function, investigator decision - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs General Medical Exclusion Criteria for the Surveillance Phase: - Known PD-L1 IHC result for adjuvant therapy. The decision for the adjuvant therapy should not be based on the PD-L1 IHC result. If a cap is in effect limiting enrollment of PD-L1 negative patients, this exclusion criterion will not apply. - Pregnancy or breastfeeding - Positive test for HIV, with the following exception: Patients with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a CD4 count >= 200/µL, and have an undetectable viral load - Patients with active hepatitis B virus or hepatitis C. Patients with past HBV infection or resolved HBV infection are eligible. A negative HBV DNA test must be obtained in these patients prior to enrollment. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. - Active tuberculosis confirmed by a test performed within 3 months prior to treatment initiation. - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation - History of autoimmune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study. - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina Cancer-Specific Exclusion Criteria for the Surveillance Phase: - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to study enrollment - Adjuvant chemotherapy or radiation therapy for UC following cystectomy - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to enrollment - Malignancies other than UC within 5 years prior to study enrollment Additional Exclusion Criteria for the Treatment Phase: - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to randomization to the treatment phase Hormone-replacement therapy or oral contraceptives are allowed. - Adjuvant chemotherapy or radiation therapy for UC following cystectomy - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization to the treatment phase - Positive test for HIV, with the following exception: Patients with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a CD4 count >= 200/μL, and have an undetectable viral load. - Patients with active hepatitis B virus or hepatitis C - Active tuberculosis confirmed by a test performed within 3 months prior to treatment initiation ; PRIMARY OUTCOME: Investigator-assessed DFS in Participants Who Are ctDNA Positive Within 24 Weeks of Cystectomy; SECONDARY OUTCOME 1: Overall survival (OS) in Participants Who Are ctDNA Positive Within 24 weeks After Cystectomy[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ROF-DERM_203; BRIEF: The purpose of this study is to evaluate the effect of topical roflumilast on the reduction of atopic dermatitis lesions in adults with atopic dermatitis. ; DRUG USED: Daliresp; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Is male or female between 18 to 65 years of age, inclusive, with atopic dermatitis (AD) meeting Hanifin and Rajkas criteria. 2. Has lesional skin areas of moderate severity characterized by modified local SCORing Atopic Dermatitis (SCORAD) of at least 4, with an erythema score ≥2, and confirmed by a qualified investigator. 3. Has an index/target lesion of moderate severity approximately 20 cm^2, suitable for topical treatment. 4. Is willing to wash out from AD current active therapy prior to entry in the study. 5. Is willing and able to apply the study medication as directed, comply with study instructions and commit to all follow-up visits for the duration of the study. 6. If a male who is nonsterilized and sexually active with a female partner of childbearing potential, agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose. 7. If a female of childbearing potential who is sexually active with a nonsterilized male partner, agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose. 8. Is capable of understanding and complying with protocol requirements in the opinion of the investigator. 9. Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: 1. Has received any investigational compound within 30 days, or within 5 half-lives of the compound (whichever is longer) prior to the Screening visit. 2. Has a history of AD unresponsive or poorly responsive to topical treatments. 3. Has a history of hypersensitivity to phosphodiesterase (PDE)-4 inhibitors or to drugs of similar chemical classes or any inactive ingredients of the trial medication. 4. Has clinically significant abnormal hematological parameters of hemoglobin, hematocrit or erythrocytes at Screening, in the judgment of the investigator. 5. Has a history or current clinically relevant allergy or idiosyncrasy to drugs or food. 6. Had extensive exposure to ultraviolet (UV) light in the 4 weeks prior to first application of study medication, including tanning and sun beds or is intending to have such exposure during the study treatment that may interfere with the study assessments as judged by the investigator. 7. Has evidence of oozing of target lesion. 8. Has a current skin complication such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated. 9. Had systemic treatment with corticosteroids or retinoids for studied condition within 3 months prior to the first application of study medication. 10. Had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 4 weeks prior to first application of study medication. 11. Had treatment with systemic/locally acting medications/procedures that might counter or influence the study aim within 4 weeks prior to first application of study medication and during the study (e.g., anti-histamines). 12. Has used emollients/moisturizers on areas to be treated within 24 hours prior to the first application of study medication. 13. Has used biologics at any time for treatment of AD. 14. Is currently enrolled in an investigational drug or device study. 15. Has any clinically significant illness that may influence the outcome of the trial from 4 weeks before Day 1 through trial completion. 16. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values greater than 2.0 × upper limit of normal (ULN), or other clinically significant abnormal laboratory test that, in the opinion of the Investigator, would compromise the participants ability to safely complete the trial. 17. Has a significant medical condition and/or conditions that, in the opinion of the Investigator, would interfere with the treatment, safety or compliance with the protocol. 18. Has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. 19. Has a history of alcoholism or illicit drug abuse within 5 years prior to the Screening Visit or is currently consuming >14 alcoholic drinks per week. 20. If female, is pregnant, nursing or planning a pregnancy during the study period. 21. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study medication. This criterion does not apply to those participants with successfully resected basal cell or stage I squamous cell carcinoma of the skin. 22. Has a chronic or clinically relevant acute infection. 23. Has a history of depression associated with suicidal ideation and behavior. 24. Has hemodynamically significant cardiac arrhythmias or heart valve deformations. 25. Is an immediate family member, a study site employee, in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or at risk for consenting under duress. 26. Was institutionalized because of a legal or regulatory order. ; PRIMARY OUTCOME: Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD); SECONDARY OUTCOME 1: Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values[/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 - 2012; BRIEF: This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks. Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks. ; DRUG USED: Amdoxovir; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Reverse Transcriptase; THERAPY: Combination; LEAD SPONSOR: RFS Pharma, LLC; CRITERIA: Inclusion Criteria: - Must have completed Study RFSP-AMDX-2010 and received treatment with amdoxovir (500 mg bid or 300 mg bid) for 12 weeks before entry into study RFSP-AMDX-2012. - Must have maintained ≥ 1.0 log10 copies/mL from baseline at Week 12 in Study RFSP-AMDX-2010. - Must not have had any serious adverse experience since enrollment in Study RFSP-AMDX-2010, whether or not considered to be study drug-related. Exclusion Criteria: - Subjects who require ongoing therapy of nephrotoxic drugs or competitors of renal excretion. - Subjects who require therapy with hematologic, bone marrow suppressive or cytotoxic agents. - Subjects who require medications that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with life-threatening adverse events. - Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations. - Women who are pregnant or breastfeeding. ; PRIMARY OUTCOME: HIV-1 viral load; SECONDARY OUTCOME 1: Incidence of adverse 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 I/II - w/Rituximab and Vincristine; BRIEF: This is a single-arm, open-label, multicenter, dose escalation, phase 1-2 study of alisertib (MLN8237) administered in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)/transformed follicular lymphoma (TFL) treated with rituximab and vincristine. The study has three parts as follows: Phase 1, Part 1: Safety lead-in cohort to evaluate alisertib (MLN8237) and rituximab. Phase 1, Part 2: Dose escalation cohort to evaluate alisertib (MLN8237) + Rituximab + Vincristine and determine Phase 2 dose. Patients with other types of B-cell lymphoma (including mantle cell or Burkitts lymphoma may enroll in Parts 1 and 2. Phase 2: Alisertib (MLN8237) + Rituximab + Vincristine in patients with relapsed or refractory DLBCL or TFL at recommended Phase 2 dose. Note that in 2013 Sponsor decision was taken to not initiate the phase 2 portion of the trial, which would have investigated the triplet at the recommended phase 2 dose identified in part 2. This decision was based on reprioritization within the company and not on any clinical or safety outcomes observed. ; DRUG USED: Alisertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Aurora Kinase; THERAPY: Combination; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL)/transformed follicular lymphoma (TFL). Note: Patients with Mantle Cell or Burkitts lymphoma may be eligible for enrollment to the safety lead-in and dose escalation cohorts, parts 1 & 2 only - Relapsed or refractory after at least 1 prior systemic treatment for aggressive lymphoma (including anthracycline unless contra-indicated). Relapse following an autologous stem cell transplant is allowed. - Relapsed after autologous stem cell transplantation or not be eligible for autologous stem cell transplantation or refuse autologous stem cell transplantation. Patients enrolled to the phase 2 part must have received prior rituximab. - Measurable disease as specified in study protocol - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 - Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of alisertib (MLN8237) or agree to abstain from heterosexual intercourse. Patients should also use effective contraception for 12 months following the last dose of rituximab and 1 month following the last dose of alisertib (MLN8237. - Male patients who agree to practice effective barrier contraception through 4 months after the last dose of MLN8237 or agree to abstain from heterosexual intercourse - Voluntary written consent Exclusion Criteria - Received more than 4 prior systemic treatment regimens for lymphoma - Known human immunodeficiency virus (HIV) positive or acquired immunodeficiency syndrome (AIDS)-related illness; hepatitis B virus, or hepatitis C virus; known history of Charcot-Marie-Tooth disease or polio - Autologous stem cell transplant less than 3 months prior to enrollment - Patients who have undergone allogeneic stem cell or organ transplantation any time - Systemic antineoplastic therapy, including glucocorticoids or treatment with an investigational agent within 14 days preceding the first dose of study drug treatment. Steroids are permitted for administration with rituximab to prevent or treat infusion reaction - Treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment within 42 days (21 days if clear evidence of progressive disease) prior to the first day of study drug treatment - Treatment with radioimmunoconjugates or toxin immunoconjugates, such as ibritumomab-tiuxetan, or tositumomab, within 12 weeks prior to the first day of study drug treatment - Radiotherapy within 21 days prior to the first dose of study drug treatment - Treatment with enzyme-inducing antiepileptic drugs, such as phenytoin, carbamazepine, or phenobarbital, or with rifampin, rifabutin, rifapentine, or St. Johns wort, within 14 days prior to the first dose of alisertib (MLN8237) also not permitted during study - Cardiac status as described in protocol - Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment - History of hemorrhagic or thrombotic cerebrovascular event in the past 12 months - Clinically uncontrolled central nervous system involvement - Inability to receive IV rituximab or vincristine, or to swallow tablets or inability or unwillingness to avoid taking anything by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose of alisertib (MLN8237) - History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness - Female patients who are lactating or pregnant - Serious medical or psychiatric illness or laboratory abnormality that could, in the investigators opinion, potentially interfere with the completion of treatment according to the protocol - Clinically apparent ≥ Grade 2 neuropathy due to any cause in the 3 months prior to enrollment, or history of ≥ Grade 3 neuropathy related to vincristine at any time - Prior treatment with Aurora A-targeted agents, including alisertib (MLN8237) - Patients who have received myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment - Patients with known hypersensitivity to rituximab, vincristine (or vinca alkaloids), or their diluents ; PRIMARY OUTCOME: Number of Participants With Clinically Significant Vital Signs Findings (Treatment Related and Unrelated) [Phase 1]; SECONDARY OUTCOME 1: Overall Response Rate as Assessed by the Investigator [Phase 1][/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - DARWIN3 (Moderate to Severe); BRIEF: The primary objective of the study is to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis. Participants will be enrolled in this open-label long-term follow-up study after they have completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204 (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants will also be examined for long-term effects of filgotinib administration on disease activity (efficacy), subjects disability, fatigue, and quality of life. ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Key Inclusion Criteria: - Male or female who are 18 years of age or older on the day of signing informed consent - Participants who completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the Investigators judgment - Females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib Key Exclusion Criteria: - Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason - Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), according to the Investigators judgment - Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary Sjogrens syndrome - Any condition or circumstances which, in the opinion of the Investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Safety and Tolerability of Long-Term Dosing of Filgotinib as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Adverse Events; SECONDARY OUTCOME 1: Percentage of Participants Achieving American College of Rheumatology (ACR)20 Response at Every Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Dose Finding (Healthy Subjects); BRIEF: The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm. This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose. ; DRUG USED: LY3375880; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-33 (Interleukin-33)IL-33 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Are overtly healthy males or females, as determined by medical history and physical examination - Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Exclusion Criteria: - Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy - Are women who are of childbearing potential or who are lactating ; PRIMARY OUTCOME: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration; SECONDARY OUTCOME 1: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880[/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 - ARVI; BRIEF: A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment. The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI. ; DRUG USED: XC-8; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Histamine Receptors (unspecified) ; THERAPY: Monotherapy; LEAD SPONSOR: PHARMENTERPRISES LLC; CRITERIA: Inclusion Criteria: 1. Men and women aged 18 to 45 years (inclusively). 2. Clinically diagnosed influenza or other acute or moderate ARVI based on the patients body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs. 3. Uncomplicated course of ARVI or influenza. 4. The onset of symptoms no more than 36h prior to the inclusion into the study. 5. Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period. 6. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol. 7. Signed Informant Consent Form. Exclusion Criteria: The patient will be deemed ineligible for the study meeting any of the following criteria: 1. Complicated course of influenza or ARVI (including the presence / development of bacterial infection). 2. Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action. 3. Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis). 4. Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs). 5. Infectious diseases during the last week before including into the study. 6. History of bronchial asthma. 7. History of increased convulsive activity. 8. Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patients prognosis, and make him/her ineligible for the clinical study). 9. History of oncological diseases, HIV, tuberculosis. 10. Hypersensitivity to excipients of the XC8. 11. Diabetes mellitus, lactose intolerance, lactase deficiency. 12. Drug or alcohol abuse. 13. Participation in any other clinical trial in the last 90 days. 14. Pregnancy or lactation. 15. Military or prison populations. 16. Impossibility or inability to comply with the study procedures. 17. A member of the investigators family or other person interested in the results of the study 18. Abnormal laboratory results, which, according to the study doctor, interfere with the patients inclusion in the study. 19. History of renal insufficiency. 20. Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01. - ; PRIMARY OUTCOME: Time to sustained improvement in clinical symptoms; SECONDARY OUTCOME 1: Body temperature below 37°C without further elevation[/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 Ib/II - CP-MGD007-02 (w/MGA012); BRIEF: The primary goal of this study is to characterize the safety, tolerability, and maximum tolerated dose (MTD) of MGD007 when combined with MGA012. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of the combination of MGD007 and MGA012 will also be assessed. ; DRUG USED: MGD007; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Cluster of Differentiation 3 (CD3), gpA33, Immune System; THERAPY: Combination; LEAD SPONSOR: MacroGenics; CRITERIA: Inclusion Criteria: - Histologically proven, relapsed/refractory metastatic colorectal cancer - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Measurable disease per RECIST 1.1 criteria - Participants in the Dose Escalation Phase must have had recurrence, progression or intolerance to standard therapy consisting of at least 2 prior standard regimens (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease. Participants in the Cohort Expansion portion will be allowed to participate after 1 prior standard regimen. Those who are inappropriate candidates for or have refused treatment with these regimens are also eligible. No more than 5 prior therapies are permitted. Patients previously treated with MGD007 on Study Protocol CP-MGD007-01 and who did not develop antibodies to MGD007 while on the CP-MGD007-01 study, may be enrolled. Patients that were previously treated on CP-MGD007-01 will only be treated on this study once MTD/MAD has been defined. - Availability of sufficient tumor specimens to enable retrospective determination of gpA33, CD3, PD-1, and PD-L1 expression - 30 participants in the Cohort Expansion portion must have lesions that are accessible for paired biopsies with acceptable clinical risk in the judgment of the investigator. Exclusion Criteria: - Symptomatic central nervous system (CNS) metastases. No concurrent treatment for the CNS disease; no progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases; no concurrent leptomeningeal disease or cord compression - History of known or suspected autoimmune disease with certain exceptions - History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation. - Major surgery, systemic anti-neoplastic therapy, or investigational therapy within 4 weeks - Radiation therapy within 2 weeks - Systemic corticosteroids (≥ 10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days - History of Grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors including anti-LAG-3, anti-PD-1, anti PD-L1, or anti-CTLA-4 antibodies - Clinically significant cardiovascular disease; gastrointestinal disorders; pulmonary compromise; viral, bacterial, or systemic fungal infections - History of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome - History of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction. ; PRIMARY OUTCOME: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Peak Plasma Concentration[/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 - Pemetrexed Maintenance; BRIEF: - Open label - Enrollment in the order of confirmation of eligibility and HPV+ tumor status - Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR) mutation status, performance status and first-line induction chemotherapy outcome; - Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus ADXS11-001 vs. 42 patients receiving pemetrexed alone) - Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy - Control Arm: Pemetrexed only - Positive control: pemetrexed chemotherapy ; DRUG USED: Axalimogene Filolisbac; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Combination; LEAD SPONSOR: Advaxis, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female patients, ≥ 20 years of age 2. Patients with NSCLC 3. Patients whose disease has either responded or not progressed following 4-6 cycles of first-line induction chemotherapy. 4. Patients with documented/confirmed intra-tumor positivity for HPV 5. Patients with no major existing co-morbidities or medical conditions that will preclude administration of therapy, in the opinion of the Investigator 6. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 7. Patients will use contraception during the study 8. Patients with the ability to understand and give written informed consent for participation in this trial Exclusion Criteria: 1. Women who are pregnant or breast feeding 2. Patients with histologically- or cytologically-confirmed squamous cell-classified NSCLC 3. Patients with disease progression following first-line induction chemotherapy 4. Patients with known active and uncontrolled central nervous system (CNS) or leptomeningeal metastases 5. Patients with an active second primary malignancy or history of another malignancy 6. Patients with inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy, including ≥ Grade 2 neuropathy 7. Patients with inadequate recovery from any previous surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to the start of study treatment 8. Patients with evidence of inadequate organ function as defined in protocol 9. Patients with a known allergy to both of the following antibiotics: ampicillin, trimethoprim-sulfamethoxazole 10. Patients with a known allergy to anti-emetic medications and/or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, celecoxib) 11. Patients with a history of severe hypersensitivity reaction to pemetrexed disodium (Alimta® or equivalent), or any of the excipients used in its formulation 12. Patients with a history of an autoimmune disorder requiring systemic treatment within the past 3 months, or a documented history of a clinically severe autoimmune disease or a syndrome that requires systemic steroid or immunosuppressive agents 13. Patients with a known immunodeficiency including patients: with HIV infection, who have undergone previous organ transplantation and require immunosuppressive therapy or long-term immunosuppressive therapy for any other reason 14. Patients with interstitial lung disease or active, non-infectious pneumonitis, active or prior documented inflammatory bowel diseases (e.g., Crohns disease, ulcerative colitis) 15. Patients with an active infection requiring systemic therapy, prior to dosing with study drug 16. Patients with any other life-threatening illness, uncontrolled medical condition (e.g., elevated troponin or creatinine; uncontrolled diabetes), significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator would either compromise the patients safety or interfere with evaluation of the study treatment 17. Patients with a psychiatric disorder, substance abuse disorder, or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary study-related evaluations 18. Patients with a history of or current evidence of any condition, therapy, or laboratory abnormality that might: confound the results of the trial, interfere with the patients participation in the trial, or suggest that participation in the trial is not in the best interest of the patient, in the opinion of the treating investigator ; PRIMARY OUTCOME: Number of study participants with objective tumor response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST); SECONDARY OUTCOME 1: Distribution of overall response rate (ORR) as assessed by RECIST v1.1 and irRECIST[/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 - ORION-10 (US); BRIEF: This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States. ; DRUG USED: Leqvio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: The Medicines Company; CRITERIA: Inclusion Criteria: 1. Male or female participants ≥18 years of age. 2. History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]). 3. Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL). 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening. 5. Participants on statins should be receiving a maximally tolerated dose. 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins. 7. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation. Exclusion Criteria: 1. New York Heart Association (NYHA) class IV heart failure. 2. Uncontrolled cardiac arrhythmia 3. Uncontrolled severe hypertension 4. Active liver disease 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age. 2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization. 3. Women who are surgically sterilized at least 3 months prior to enrollment. 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide). 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer. 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9 The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percentage Change in LDL-C From Baseline to Day 510; SECONDARY OUTCOME 1: Absolute Change in LDL-C From Baseline to Day 510[/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 - KIDS A-LONG (Pediatric); BRIEF: The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes. ; DRUG USED: Eloctate; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bioverativ Therapeutics Inc.; CRITERIA: Key Inclusion Criteria: - Severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII - Male <12 years of age and weight ≥13 kg - History of at least 50 documented prior exposure days to FVIII - No current, or history of, inhibitor development to FVIII Key Exclusion Criteria: - Other coagulation disorders in addition to Hemophilia A - History of anaphylaxis associated with any FVIII or IV immunoglobulin administration NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Occurrence of FVIII Inhibitor Development; SECONDARY OUTCOME 1: Annualized Bleeding 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 IIa - TELE-ABC; BRIEF: A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem]) ; DRUG USED: Xermelo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Biliary Tract Cancer; TARGET: Tryptophan hydroxylase; THERAPY: Combination; LEAD SPONSOR: TerSera Therapeutics LLC; CRITERIA: Inclusion Criteria: - Male or female adults, ≥18 years of age. Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of XERMELO - Histopathologically or cytologically-confirmed, unresectable, locally advanced, recurrent, or metastatic biliary tract cancer (BTC) - Naïve to tumor-directed therapy in locally advanced, unresectable, or metastatic setting - Measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Plans to initiate treatment with 1L therapy (cisplatin plus gemcitabine) - Ability to provide written informed consent prior to participation in any study-related procedure Exclusion Criteria: - Prior exposure to XERMELO, telotristat ethyl, telotristat etiprate, LX1032, or LX1606 - Primary tumor site in the ampulla of Vater - Treatment with photodynamic therapy for localized disease or to relieve biliary obstruction in the presence of metastatic disease within the past 30 days - Hematology laboratory values of: a. Absolute neutrophil count (ANC) ≤1,500 cells/mm^3; or b. Platelets ≤100,000 cells/mm^3; or c. Hemoglobin (Hgb) ≤9 g/dL; or d. White blood count (WBC) ≤3,000 cells/mm^3 - Hepatic laboratory values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT): a. >5 x upper limit of normal (ULN) if patient has documented history of hepatic metastases; or b. >2.5 x ULN if no liver metastases are present - Serum albumin <2.8 g/dL - Total bilirubin >1.5 x ULN or >1.5 mg/dL - Prothrombin time (PT) or international normalized ratio (INR) >1.5 x ULN - Serum creatinine or serum urea >1.5 x ULN - Estimated glomerular filtration rate (eGFR) <50 mL/min - Positive pregnancy test, pregnant, or breastfeeding - Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study - Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study - Myocardial infarction within the past 6 months - Active bleeding diathesis - Life expectancy ≤3 months - Current complaints of persistent constipation or history of chronic constipation, bowel obstruction or fecaloma within the past 6 months - Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other immunosuppressive agent(s) - History and/or uncontrolled hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV)-1 or HIV-2 - History of substance or alcohol abuse within the past 2 years - History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption - History of malignancy or active treatment for malignancy within 5 years - Receipt of live, attenuated vaccine or close contact with someone who has received a live, attenuated vaccine within the past 1 month - Receipt of any investigational agent or study treatment (ie, any treatment or therapy not approved by the FDA for the treatment of BTC) within the past 30 days - Receipt of any protein or antibody-based therapeutic agents within the past 3 months - Treatment with any tumor-directed therapy within the past 6 months with curative intent - Existence of any surgical or medical condition that, in the judgment of the Investigator, might compromise patient safety or the outcome of the study - Presence of any clinically significant findings (relative to the patient population) during review of medical history or upon physical exam that, in the Investigators or Medical Monitors opinion, would compromise patient safety or the outcome of the study - Evidence of brain metastases - Unable or unwilling to communicate or cooperate with the Investigator for any reason - Employee of Sponsor or clinical site, or relative of any member of a clinical sites staff ; PRIMARY OUTCOME: Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologists Assessment; SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Bortezomib/Dexamethasone (Japan); BRIEF: The purpose of this study is to assess the safety and the tolerability of siltuximab up to 11.0 mg/kg in combination with bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma. ; DRUG USED: Sylvant; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: IL-6 (Interleukin-6); THERAPY: Combination; LEAD SPONSOR: Janssen Pharmaceutical K.K.; CRITERIA: Inclusion Criteria: - Patients proven to have symptomatic or nonsecretory multiple myeloma - Patients with a measurable lesion - Patients who have previously received 1-3 regimens for multiple myeloma - Patients must have progressed on or be refractory to the most recent line of treatment - Patients with Eastern Cooperative Oncology Group performance status of 0-2 - Patients having the following laboratory values within 14 days before the scheduled day of initial administration of the study drug: hemoglobin 8 g/dL or more, absolute neutrophil count 1,000/mm3 or more, platelet count 50,000/mm3 or more, aspartate aminotransferase, and alanine aminotransferase 2.5 times or more of upper limit of normal range, total bilirubin 1.5 times or more of upper limit of normal range, calculated creatinine clearance 20 mL/min or more, corrected serum calcium less than 12.5 mg/dL Exclusion Criteria: - Patients with primary amyloidosis, plasma cell leukemia or other conditions in which M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions - Patients with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy - Patients who have undergone allogeneic bone marrow transplantation within 28 days before the start of treatment with the study drug - Patients who have been exposed to agents targeting interleukin-6 (IL-6) or the IL-6 receptor - Patients refractory to bortezomib - Patients having treatment discontinued because of the toxicity of bortezomib - Patients requiring dose reduction because of the toxicity of bortezomib - Patients who have received chemotherapy, plasmapheresis or radiation therapy within 21 days before the start of treatment (within 42 days for nitrosoureas) - Patients who have undergone major surgery including open biopsy (excluding bone marrow) within 21 days before study treatment or planning to have surgery (except for minor surgical procedures) during the study - Human immunodeficiency virus antibody-positive, hepatitis C virus antibody-positive or hepatitis B surface antigen-positive patients - Patients with known hypersensitivity to boron or mannitol - Patients with a history of unmanageable severe infusion reactions to monoclonal antibodies or to murine, chimeric or human proteins or their excipients - Patients with concurrent medical condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in the study - Patients with significant cardiac disease characterized by significant ischemic coronary disease, significant arrhythmias, or congestive heart failure (New York Heart Association Class III or IV) or myocardial infarction within 6 months before the first dose of study drug - Patients who are clinically diagnosed with pneumonitis (interstitial pneumonia) or pulmonary fibrosis or have abnormal interstitial shadows bilaterally on chest CT, with or without symptoms ; PRIMARY OUTCOME: Number of patients with adverse events as a measure of safety and tolerability; SECONDARY OUTCOME 1: Serum siltuximab concentration[/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 - F01; BRIEF: This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months. ; DRUG USED: Pegunigalsidase alfa; DRUG CLASS: Biologic; INDICATION: Fabrys Disease; TARGET: Globotriaosylceramide glycolipid; THERAPY: Monotherapy; LEAD SPONSOR: Protalix; CRITERIA: Inclusion Criteria: - Symptomatic adult Fabry patients (≥18 yrs) - Males: plasma and/or leucocyte alpha galactosidase activity (by activity assay) less than lower limit of normal (LLN in plasma=3.2 nmol/hr/ml, LLN in leucocytes=32 nmol/hr/mg/protein) - Females: historical genetic test results consistent with Fabry mutations - Globotriaosylceramide (Gb3) concentration in urine > 1.5 times upper normal limit - Patients who have never received enzyme replacement therapy (ERT) in the past, or patients who have not received ERT in the past 6 months and have a negative anti alpha galactosidase antibody test - eGFR ≥ 60 mL/min/1.73m2 - The patient signs informed consent - Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method Exclusion Criteria: - Participation in any trial of an investigational drug within 30 days prior to study screening - Chronic kidney disease stages 3-5 (CKD 3-5) (Appendix 7) - History of dialysis or renal transplantation - Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy initiated or dose changed in the 4 weeks prior to screening - Severe myocardial fibrosis by MRI (≥2 late-enhancement [LE] positive left ventricular segments) (Weidemann et al. 2009) - History of clinical stroke - Pregnant or nursing - Presence of HIV and/or HBsAg and/or Hepatitis C infections - Known allergies to ERT - Known allergy to Gadolinium based contrast agents - Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patients compliance with the requirements of the study ; PRIMARY OUTCOME: Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - OLFUS-VIPES (Ext.); BRIEF: The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: - To assess the efficacy of Viaskin Peanut after up to 36 months of treatment. - To evaluate the safety of long-term treatment with Viaskin Peanut. - To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut. ; DRUG USED: Viaskin Peanut; DRUG CLASS: Biologic; INDICATION: Food Allergies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: DBV Technologies; CRITERIA: Inclusion Criteria: - Adult and pediatric subjects (≥7 years) who completed the VIPES study, with a mandatory and documented DBPCFC at Month 12 in the VIPES study. - Signed informed consent from adult subjects or parent(s)/guardian(s) of children <18 years and childrens assent for children >7 years or as per country-specific regulations or laws. This consent should be signed no later than Visit 11 in the VIPES study. - Negative pregnancy test for women of childbearing potential at Visit 10 in the VIPES study. - Female subject of childbearing potential must use effective methods of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Documented sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age. - Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study. Exclusion Criteria: - Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for more than two doses of epinephrine. - Pregnancy or lactation. - Females of childbearing potential planning a pregnancy in the coming 2 to 3 years. - Subjects who became allergic to chocolate or who do not want to consume the chocolate study challenge vehicle anymore. - Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the food challenge formula used during the VIPES study. - Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to skin prick testing or food challenges. - Subjects with asthma that has evolved and now fulfills any of the criteria defined as follows: - uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled β2-agonists. - at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months. - prior intubation for asthma in the past year. - Subjects receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy. - Subjects receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy. - Subjects receiving or planning to receive any type of immunotherapy to any food (e.g. oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) during their participation in the study. - Subjects receiving or planning to receive any aeroallergen immunotherapy during their participation in the study. - Allergy or known history of reaction to Tegaderm® with no possibilities to use an alternative dressing approved by the sponsor. - Subjects suffering from generalized dermatologic disease (e.g. severe atopic dermatitis, uncontrolled generalized eczema, ichthyosis vulgaris) with no intact zones to apply the patches. - Any new disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias. - A history of non compliance in the VIPES study. Non compliance is defined as subjects not applying the patch at all for 60 days or more (this can be either consecutive or intermittent non-application of the patches) during the whole VIPES study duration - Participation in another clinical intervention study in the past year, other than the VIPES study. - Subjects on any experimental drugs in the past year, other than those used in the VIPES study. Other inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Treatment Responders at Months 12 and 24; SECONDARY OUTCOME 1: Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 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 Ia/Ib - w/BGB-A317; BRIEF: This trial studied the safety, pharmacokinetics, and antitumor activity of the anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb) BGB-A317 (tislelizumab) in combination with the poly(adenosine diphosphate ribose) polymerase (PARP) inhibitor BGB-290 (pamiparib) in participants with advanced solid tumors. ; DRUG USED: Pamiparib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. Participants voluntarily agreed to participate by giving written informed consent. 2. Must have received standard of care in the primary treatment of their disease. 3. Participants who had the below specified histologically confirmed malignancies that had progressed to the advanced or metastatic stage: 1. In Part A, the participants must have had an advanced malignancy, including but not limited to high-grade serous cancer of the ovary, fallopian tube, or peritoneum, triple negative breast cancer, small cell lung cancer (SCLC), primary peritoneal cancer, and any tumor likely to harbor DNA damage repair deficiencies susceptible to treatment with a PARP inhibitor or likely to be responsive to a PD-1 blocker. 2. In Part B, the participants recruited to 1 of the 8 expansion arms must have had advanced solid tumors of the following types: Arm 1: Participants with relapsed, platinum-sensitive high-grade epithelial, non-mucinous, ovarian cancer, fallopian tube, or primary peritoneal cancer (EOC) must have met the following criteria: i. Must have had at least 2 prior platinum-containing treatments in any treatment setting. ii. Must have had platinum-sensitive recurrent disease and must not have progressed (by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 criteria) within 6 months of the completion of the last platinum-containing line of treatment. • Note: Participants may have received additional non-platinum-based chemotherapy for recurrence after prior last platinum-containing regimen if the criteria for platinum sensitivity were met. iii. Arm 1a: Participants with relapsed, platinum-sensitive high-grade EOC with either known deleterious or suspected deleterious germline or somatic breast cancer susceptibility gene 1/2 (BRCA1/2) mutations or with homologous recombination deficiency (HRD). • If HRD or BRCA1/2 mutation status from archival tissue was unknown or had not been previously evaluated, then the archival tissue must have undergone tissue screening using a validated diagnostic test to determine eligibility. If the diagnostic test result was BRCA1/2 or HRD positive, the participant was eligible for enrollment in Arm 1a. iv. Arm 1b: Participants with relapsed, platinum-sensitive high grade EOC who otherwise met the above criteria and were without known germline or somatic BRCA1/2 mutations and without HRD mutation. Arm 2: Participants with triple negative breast cancer must have met the following criteria: i. 0-1 prior platinum-containing treatment in any treatment setting. • Note: participants could have received additional therapy after the last platinum-containing line of treatment if the other eligibility criteria were met. ii. Participants who received at least 1 prior treatment but not more than 3 prior lines of treatment in the advanced or metastatic setting. iii. Known deleterious or suspected deleterious germline or somatic BRCA1/2 mutations or with documented HRD. • If HRD or BRCA1/2 mutation status from archival tissue was unknown or had not been previously evaluated, then the archival tissue must have undergone tissue screening using a validated diagnostic test to determine eligibility. If the diagnostic test result was HRD positive, then the participant was eligible for enrollment in Arm 2. • If archival tissue was not available and the participant submitted a fresh tumor biopsy, then the diagnostic test needed to demonstrate somatic BRCA1/2 mutation or HRD positivity. Arm 3: Participants with metastatic castration-resistant prostate cancer, including but not limited to mutations in homologous recombination (HR) pathways and/or defined by HRD algorithms, and must have met the following criteria: i. May be either chemotherapy-naïve, but must have received prior abiraterone acetate and/or enzalutamide treatment, or have previously had no more than 2 taxane-based chemotherapy lines of treatment, including docetaxel and carbazitaxel. If docetaxel was used more than once, this was considered as 1 line of treatment. ii. At least 2 weeks since the completion of prior flutamide, bicalutamide, and nilutimide, or enzalutamide and abiraterone treatment. iii. Documented prostate cancer with one of the following: - Surgically or medically castrated. The testosterone levels did not need to be checked if the participant had undergone surgical castration for > 4 months. Participants receiving chemical castration should have had testosterone levels checked at baseline and confirmed to be in the castrate levels (< 0.5 ng/mL or 1.735 nM). In all cases, the luteinizing hormone-releasing hormone antagonist/agonist was to be continued in these participants. - Participants with only non-measurable bone lesions must have had disease progression based on Prostate Cancer Clinical Trials Working Group with 2 or more new lesions or have had prostate-specific antigen progression before enrolment. iv. Known deleterious or suspected deleterious germline or somatic BRCA1/2 mutations or with documented HRD. - If HRD or BRCA1/2 mutation status from archival tissue was unknown or had not been previously evaluated, then the archival tissue must have undergone tissue screening using a validated diagnostic test to determine eligibility. If the diagnostic test result was HRD positive, then the participant was be eligible for enrollment in Arm 3. - If archival tissue was not available and the participant summitted a fresh tumor biopsy, then the diagnostic test needed to demonstrate somatic BRCA1/2 mutation or HRD positivity. Arm 4: Participants with extensive-stage disease SCLC must have met the following criteria: i. Received at least 1 and not more than 2 prior lines of treatment; ii. At least 1 prior line of treatment must have contained a platinum agent Arm 5: Participants with human epidermal growth factor receptor-2 (HER2)-negative gastric or gastroesophageal junction cancer must have met the following criteria: i. May have received at least 1 and not more than 2 prior lines of treatment Arm 6: Participants with locally advanced or metastatic urothelial (muscle-invasive bladder, ureter, urethra, or renal pelvis) cancer must have met the following criteria: i. Received at least 1 and not more than 2 prior lines of treatment in the advanced or metastatic disease setting; ii. At least 1 prior line of treatment must have contained a platinum agent Arm 7: Participants with advanced or metastatic pancreatic adenocarcinoma must have met the following criteria: i. Received at least 1 but not more than 2 lines of treatment in either an advanced or metastatic setting; ii. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent; iii. Participants with known deleterious germline or somatic BRCA1/2 mutation could be considered for the study even if platinum naïve. Arm 8: (Note: Closed to enrollment) Participants with advanced or metastatic recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix and participants with tumors known to be mismatch repair deficient or HRD positive) must have met the following criteria: i. Participants with a complete response, partial response, or stable disease from at least 1 prior platinum-containing treatment in any treatment setting; ii. The Sponsor medical monitor would approve tumor types for Arm 8 prior to screening. • Note: Excluded tumor types included participants with bone or soft tissue sarcoma; central nervous system (CNS) malignancies; colorectal cancer (except microsatellite instability-high colorectal cancer is permitted); cutaneous or ocular melanoma; hematologic malignancies; HER2-negative breast cancer without BRCA mutation; mesothelioma, papillary, follicular, medullary or Hürthle cell thyroid cancer; unknown primary malignancy. 4. Participants who were treated with chemotherapy or any investigational therapies, if eligible, must have completed at least 4 weeks or at least 5 half-lives (whichever is longer, but no less than 3 weeks) before the study drug administration, and all adverse events (AEs) had either returned to baseline or stabilized. 5. At least 2 weeks from palliative radiotherapy. 6. Participants must have had archival tumor tissue or agree to a tumor biopsy for mutation and biomarkers analysis unless previously discussed with Sponsors medical monitor or its designee (fresh tumor biopsies were recommended at baseline in participants with readily accessible tumor lesions and who consented to the biopsies). Participants with ovarian, fallopian tube, primary peritoneal, or breast cancer in Part A and all participants enrolled in Part B must also have agreed to provide fresh blood sample at the baseline for the evaluation of BRCA mutations and/or confirmation of prior BRCA results or other HR deficiency mutations, even if it was previously tested. 7. Participants must have had measurable disease as defined in RECIST v1.1. Participants with metastatic castration-resistant prostate cancer and epithelial, non-mucinous, ovarian cancer, fallopian tube, or primary peritoneal cancer may have used separate disease-specific criteria. 8. Male or female ≥ 18 years of age on the day of signing informed consent. 9. Must have had an Eastern Cooperative Oncology Group Performance Status ≤ 1. 10. Must have had a life expectancy ≥ 12 weeks. 11. Must have had adequate organ function. 12. Females of childbearing potential must have been willing to use a highly effective method of birth control for the duration of the study, and for at least 6 months after the last dose of investigational drug, and have had a negative serum pregnancy test within 7 days of the first dose of study drug(s). 13. Non-sterile males and their female partners must have been willing to use a highly effective method of birth control for the duration of the study and for at least 6 months after the last dose of investigational drug. Nonsterile males must have avoided sperm donation for the duration of the study and for at least 6 months after last study drug. 14. Females must have agreed not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration. Key Exclusion Criteria: 1. Participants with ovarian cancer who have platinum-resistant/refractory disease, defined as progressive disease at the first tumor assessment while receiving platinum-containing chemotherapy. 2. Participant had history of severe hypersensitivity reactions to other mAbs. 3. Any major surgery within 28 days before first dose of study drugs. 4. Prior allogeneic stem cell transplantation or organ transplantation. 5. Participants with toxicities (as a result of prior anticancer therapy) that had not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (for example, alopecia, neuropathy and specific laboratory abnormalities). 6. Concurrent participation in another clinical trial. 7. Prior malignancy within the previous 2 years except for locally curable non-melanoma dermatologic cancers that had been apparently cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the skin, cervix, breast, bladder, or prostate. 8. Symptomatic CNS metastasis or leptomeningeal disease. Note: Baseline magnetic resonance imaging of the brain and spinal cord was required for SCLC participants enrolled in Arm 4 if they had a history of CNS disease. Note: Participants with previously treated CNS metastatic disease were eligible for any arm if CNS metastatic disease was asymptomatic, clinically stable, and did not require corticosteroids or anticonvulsants within a minimum of 4 weeks of enrollment. 9. Prior therapies targeting PD-1, programmed death-ligand 1 (PD-L1), or PARP. 10. Active autoimmune diseases or history of autoimmune diseases that may have relapsed. Note: Participants with the following diseases were not excluded and may have proceeded to further screening: 1. Controlled Type I diabetes; 2. Hypothyroidism managed with no treatment other than with hormone replacement therapy; 3. Controlled celiac disease; 4. Skin diseases not requiring systemic treatment (for example, vitiligo, psoriasis, alopecia); 5. Any other disease that was not expected to recur in the absence of external triggering factors. 11. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 2 weeks of the study drug administration. Note: Participants who were currently or had previously been on any of the following steroid regimens were not excluded: 1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent); 2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption; 3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (for example, for contrast dye allergy) or for the treatment of a non-autoimmune condition (for example, delayed-type hypersensitivity reaction caused by contact allergen). 12. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, et cetera. 13. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, et cetera. 14. History of non-viral hepatitis or cirrhosis. 15. Positive human immunodeficiency virus status. 16. A known history of hepatitis B virus or hepatitis C virus infection. 17. History of alcohol abuse. 18. Underlying medical conditions or alcohol or drug abuse or dependence that, in the investigators opinion, would be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs; or insufficient compliance during the study according to investigators judgement. 19. Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening, or otherwise altering the product formulation. Participants should not have had gastrointestinal illnesses that would have precluded the absorption of pamiparib, which was an oral agent. 20. Had been administered a live vaccine within 4 weeks (28 days) of initiation of study therapy. 21. Any of the following cardiovascular criteria: 1. Current evidence of cardiac ischemia; 2. Current symptomatic pulmonary embolism; 3. Acute myocardial infarction ≤ 6 months prior to Day 1; 4. Heart failure of New York Heart Association Classification III or IV ≤ 6 months prior to Day 1; 5. Grade ≥ 2 ventricular arrhythmia ≤ 6 months prior to Day 1; 6. History of cerebrovascular accident within 6 months before first dose of study drugs. 22. Use or had anticipated need for food or drugs known to be strong or moderate cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers ≤ 10 days (or ≤ 5 half-lives, whichever is shorter) prior to Day 1. Note: Other protocol-defined Inclusion/Exclusion criteria may have applied. ; PRIMARY OUTCOME: Part A: Number Of Participants Experiencing Adverse Events (AEs); SECONDARY OUTCOME 1: Part A: Minimum Observed Plasma Concentration (Ctrough) Of Tislelizumab[/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/MEK162 (Triple Negative BC Included); BRIEF: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162. Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days. ; DRUG USED: Buparlisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Array Biopharma, now a wholly owned subsidiary of Pfizer; CRITERIA: Inclusion Criteria: - Histologically/ cytologically confirmed, advanced non resectable solid tumors - Measurable or non-measurable, but evaluable disease as determined by RECIST Exclusion Criteria: - Patients with primary CNS tumor or CNS tumor involvement. - Diabetes mellitus - Unacceptable ocular/retinal conditions ; PRIMARY OUTCOME: Incidence of Dose Limiting Toxicities; SECONDARY OUTCOME 1: Number of participants with adverse events and 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 - Duke University ; BRIEF: The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention. ; DRUG USED: Empatic; DRUG CLASS: Non-NME; INDICATION: Obesity; TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Sodium and Calcium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Duke University; CRITERIA: Inclusion Criteria: Age 18-65 years; BMI 30-50 Exclusion Criteria: Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks) - ; PRIMARY OUTCOME: Change in Body Weight; SECONDARY OUTCOME 1: Proportions of Patients With 5% Weight Loss[/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 - 1-BETTER; BRIEF: This trial will include 2 portions (phase 1 and phase 2). The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced pancreatic cancer and to determine the recommended dose for the subsequent Phase 2 study. The phase 2 portion will be implemented with the maximum established tolerated dose (MTD) of XB2001. The target enrollment in the phase 2 portion is 60 patients which will be randomized on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU (Arm 2). ; DRUG USED: Natrunix; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: IL-1 (Interleukin-1); THERAPY: Combination; LEAD SPONSOR: XBiotech, Inc.; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent - At least one measurable lesion according to Response Evaluation Criteria in Solid Tumor V1.1 - Documented disease progression after one prior gemcitabine-based therapy OR one FOLFIRINOX and gemcitabine combination therapy - Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 or Karnofsky performance status (KPS) ≥ 70 - Adequate hepatic, renal and bone marrow function Exclusion Criteria: - Clinically significant decrease in performance status (medical records) within 2 weeks of intended first dose administration - Clinically significant GI disorders - Severe arterial thromboembolic events less than 6 months before inclusion - Prior Whole Brain Radiation Therapy (WBRT) - Evidence of brain metastases - NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure (defined as ≥ 160/100 mm Hg) - Use of strong CYP3A4 inducers or inhibitors and/or UGT1A1 inhibitors within 14 days prior to Visit 1/Baseline visit. ; PRIMARY OUTCOME: To establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced pancreatic cancer.; SECONDARY OUTCOME 1: Progression Free Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - REPLACE; BRIEF: Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements. ; DRUG USED: Natpara; DRUG CLASS: Biologic; INDICATION: Hypoparathyroidism; TARGET: Parathyroid Hormone Receptor (PTHR); THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria Patients who meet all of the following inclusion criteria can be enrolled and potentially randomized into this study: - Adult males or females 18 to 85 years of age (prior to screening) - History of hypoparathyroidism for ≥ 18 months - Requirement for vitamin D metabolite/analog therapy with calcitriol ≥0.25 μg per day or alphacalcidol ≥0.50 μg per day prior to randomization. Requirement for supplemental oral calcium treatment ≥ 1000 mg per day over and above normal dietary calcium intake - Serum thyroid function tests within normal laboratory limits at screening - Serum magnesium levels within laboratory normal limits - Serum 25-hydroxyvitamin D [25(OH)D] level ≤ 1.5-fold the laboratory upper limit of normal - Creatinine clearance > 30 mL/min on two separate measurements OR creatinine clearance > 60 mL/min AND serum creatinine < 1.5 mg/dL - With regard to female patients: women who are postmenopausal and women who are surgically sterilized can be enrolled. Women of childbearing potential must have a negative pregnancy test at Randomization and be willing to use two medically acceptable methods of contraception for the duration of the study. Exclusion Criteria Patients who have any of the following during the screening visit are not eligible for enrollment in this study: - Known history of hypoparathyroidism resulting from an activating mutation in the CaSR gene or impaired responsiveness to PTH (pseudohypoparathyroidism) - Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism, Pagets disease, insulin dependent diabetes mellitus (IDDM) or poorly controlled Type II diabetes mellitus (HbA1C > 8%), severe and chronic cardiac, liver or renal disease, Cushings syndrome, neuromuscular disease such as rheumatoid arthritis, myeloma, pancreatitis, malnutrition, rickets, recent prolonged immobility, active malignancy, primary or secondary hyperparathyroidism, a history of parathyroid carcinoma, hypopituitarism, acromegaly, or multiple endocrine neoplasia types I and II - Patients with a history of thyroid cancer must be documented to be disease-free for a period of at least 5 years - Patients dependent on regular parenteral calcium infusions (eg calcium gluconate) to maintain calcium homeostasis - Patients that have undergone gastric resection or have active peptic ulcer disease requiring medical therapy - Use of prohibited medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, estrogens and progestins for hormone replacement therapy,methotrexate, or systemic corticosteroids within respective prohibited periods - Previous treatment with PTH-like drugs, including PTH(1-84), PTH(1-34) or other N-terminal fragments or analogs of PTH or PTH-related protein within 6 months prior to screening - Other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets, or cinacalcet hydrochloride within the prohibited period - Use of oral bisphosphonates within the previous 6 months or IV bisphosphonate preparations within the previous 12 months prior to screening - Seizure disorder/epilepsy with a history of a seizure within the previous 6 months prior to screening - Presence of open epiphyses - Irradiation (radiotherapy) to the skeleton within 5 years - Serum 25-hydroxyvitamin D levels greater than 1.5-fold the laboratory upper limit of normal - Participation in any other investigational trial in which receipt of investigational drug or device occurred within 6 months prior to screening for this study - Pregnant or lactating women - History of diagnosed drug or alcohol dependence within the previous 3 years - Clinical history of renal calculi within the past 12 months - History of gout - Disease processes that may adversely affect gastrointestinal absorption, including but not limited to short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohns disease - Chronic/severe cardiac disease including but not limited to cardiac insufficiency, arrhythmias, bradycardia (resting heart rate < 60 beats/minute), or hypotension (systolic and diastolic blood pressures < 100 and 60 mmHg, respectively) - History of cerebrovascular accident (CVA). ; PRIMARY OUTCOME: The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.; SECONDARY OUTCOME 1: Percentage Changes From Baseline in Daily Calcium Dose 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 I - HV-2093; BRIEF: The primary objectives are: - To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo - To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are: - To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo - To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration - To assess the immunogenicity of REGN10933 and REGN10987 ; DRUG USED: Ronapreve; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Immune System, SARS-CoV-2; THERAPY: Combination; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study 2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening 3. Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission Key Exclusion Criteria: 1. Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization 2. Subject-reported clinical history of COVID-19 as determined by investigator 3. Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection 4. Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19 5. Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening 6. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations) in the past 6 months prior to screening 7. Received investigational or approved SARS-CoV-2 vaccine 8. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol 9. Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply ; PRIMARY OUTCOME: Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration; SECONDARY OUTCOME 1: Proportion of participants with treatment-emergent adverse events (TEAEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 0116 (w/Rituximab); BRIEF: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117. ; DRUG USED: Zydelig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: p110 delta/PIK3CD, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion: - Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy - Require therapy for CLL - Have experienced CLL progression < 24 months since the completion of the last prior therapy - Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities. ; PRIMARY OUTCOME: Progression-Free Survival; 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 III - ODYSSEY-NIPPON (Includes Monthly Dosing, Japan); BRIEF: Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia. Secondary Objective: - To evaluate the effect of two treatment regimens of alirocumab on other lipid parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non HDL-C), total cholesterol (TC), lipoprotein (a) (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1). - To evaluate the safety and tolerability of alirocumab administration. - To evaluate the development of anti-alirocumab antibodies. - To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration. - To evaluate the long-term safety in participants receiving open-label alirocumab administration. ; DRUG USED: Praluent; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : Participants with hypercholesterolemia (heFH or non-FH) receiving non statin LMTs or the lowest strength of statin. Exclusion criteria: - LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in participants with heFH or in participants with non-FH who have a history of documented coronary heart disease. - LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit (Week -3) in participants with non-FH participants who had a history of documented diseases or other risk factors classified as primary prevention category III as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. - Not on a stable dose of LMT (including diet therapy alone) in the run-in period or the screening period. - Fasting serum TGs >400 mg/dL (>4.52 mmol/L) at the screening period. - Systolic blood pressure (BP) >160 mmHg or diastolic BP >100 mmHg at the run-in visit (Week -7) or the screening visit (Week -3) or the randomization visit (Week 0). The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percent Change From Baseline in Calculated LDL-C at Week 12- Intent to Treat (ITT) Analysis; SECONDARY OUTCOME 1: Percent Change From Baseline in Calculated LDL-C at Week 12- On-Treatment Analysis[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - POC (Europe); BRIEF: - Approximately 45 patients suffering from mild to moderate ulcerative colitis will be examined for any side effects (safety and tolerability) that may occur when taking GLPG0974 or matching placebo (2:1 ratio) for 28 days. - During the course of the study, patients will also be evaluated for improvement of disease activity by different efficacy measures, the amount of GLPG0974 present in the blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the blood, colon biopsies and faeces will be explored. ; DRUG USED: GLPG0974; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: GPR43/FFA2 (Free Fatty Acid Receptor 2); THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Key Inclusion Criteria: - Men or women between 18 to 75 years of age inclusive, on the day of signing the informed consent with a documented history of UC. - Presence of mild-to-moderately active ulcerative colitis as evidenced by clinical signs and endoscopy. - Medication: 5-ASA. - Absence of infectious colitis. Key Exclusion Criteria: - History of sensitivity to any component of the study drug - Any concurrent illness, condition, disability or clinically significant abnormality (including lab tests) that represents a safety risk , may affect the interpretation of data, or may prevent the subject to safely complete the assessments - Positive serology for HIV 1 or 2 or hepatitis B or C, or any history of HIV or hepatitis. - History of active infections requiring intravenous antibiotics within the past four weeks prior to randomization. - History of bowel surgery, or presence or history of intestinal malignancy. - Suspicion of Crohns disease, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis. - History of lower GI bleeding disorder, other than UC. - A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (other than UC), pulmonary or metabolic disease. - History of tuberculosis (TB) infection. - Treatment with systemic corticosteroids within 1 week prior to randomization. - Treatment with TNF-α inhibitors or other biologics within 2 months prior to randomization. - Treatment with immunosuppressants, initiated or changed within 3 months prior to randomization . - Current use of probiotic or prebiotic preparations - Regular daily use of NSAIDs, within 7 days prior to randomization. - Administration of any experimental therapy within 90 days or 5x the half-life. - History of drug or alcohol abuse. - Pregnant or lactating women. - Medical, psychiatric, cognitive, or other conditions that compromise the subjects ability to complete the study. ; PRIMARY OUTCOME: Number of adverse events; SECONDARY OUTCOME 1: Changes in (partial) Mayo clinical disease activity score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I -11-041; BRIEF: NOTE: This study is now recruiting only patients with Myeloproliferative Neoplasms (MPN). Dose escalation has been completed. The purpose of this study is to test a new drug, called PU-H71 for the first time in humans, to find out what effects, good or bad, this new drug has on the patient and the cancer at different dose levels. PU-H71 blocks a protein called Heat Shock Protein-90 (Hsp90). Hsp90 is found in both normal and cancer cells, but may be more important in cancer cells. Attacking Hsp90 can stop the function of certain proteins that are needed for cancer cells to survive. The diseases that are part of this study may be especially sensitive to attacking Hsp90, and the investigators have seen signs of disease control in patients with MPN. This study is currently enrolling a cohort expansion for patients with myeloproliferative neoplasms (MPN). ; DRUG USED: PU-H71; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Heat Shock Protein 90 (HSP90); THERAPY: Monotherapy; LEAD SPONSOR: Memorial Sloan Kettering Cancer Center; CRITERIA: Inclusion Criteria: - The safety-expansion phase will be open to accrual only for patients with MPN. - ≥ 18 years of age - For patients with solid malignancies and lymphoma, radiographically detectable (Either FDG-PET, CT scan/ MRI or Bone Scan) or measurable disease will be required. Measurable disease is defined as at least one measurable lesion ≥ 10 mm on CT scan (15 mm for nodal lesions). - Prior therapy for advanced malignancy with no current curative option - Neutrophil count ≥ 1,000/μL, platelet count ≥ 50,000/μL, and hemoglobin ≥ 8 g/dL (Platelet count must be assessed at least 7 days after a prior transfusion, if any) - Serum bilirubin ≤ 1.5 mg/dL; - AST and ALT≤ 1.5 × ULN - Serum creatinine ≤ 1.5 mg/dL or creatinine clearance of ≥ 50 mL/min based on a 24-hour urine collection - Patients receiving hydroxyurea may continue receiving it for up to 14 days after the start of protocol treatment if WBC >30 x10^9/L. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Patients with HIV/AIDS are allowed on study if they have an undetectable viral load, CD4 > 300 and on stable Highly Active Antiretroviral Therapy (HAART) regimen for 1 month. - Patients who have been treated for at least two weeks with stable doses of corticosteroids to address conditions unrelated to their malignancy will be allowed to continue this treatment during enrollment on the current trial. - Patients currently being treated with a gonadotropin-releasing hormone agonist (GnRH agonist), bicalutamide or with bisphosphonates may continue treatment while on clinical trial PU-H71 as long as the treatment has been initiated before the study start. GnRH agonist must have been well tolerated for at least three months. - Optional participation in the microdose imaging trial, IRB#10-139. - Signed written informed consent and HIPAA consent. - PATIENTS WITH MPN must be: - On ruxolitinib for at least three months and on a stable dose for at least 1 month prior to enrollment and taking at least 5 mg twice daily of ruxolitinib - Tolerating ruxolitinib but with persistent manifestations of disease (i.e. persistent splenomegaly, abnormal blood counts, persistent constitutional symptoms residual fibrosis in bone marrow (2+ or greater), or measurable allele burden as evidenced of clonal JAK2 or MPL mutation). - Ruxilitinib treatment requirements will be waived for patients who have failed this treatment in the past or for whom this treatment is otherwise contraindicated EXCLUSION CRITERIA - Ejection fraction < 50%, as determined by echocardiogram or MUGA scan - Symptomatic brain or CNS metastases. Previously treated and stable CNS disease is allowed. - Any of the following for the treatment of cancer within 2 weeks of first study treatment: chemotherapy, immunotherapy, experimental therapy or biologic therapy. - Any major surgical procedure or radiation within 4 weeks of first study treatment - Active liver disease, including viral or other hepatitis, or cirrhosis - Pregnancy or lactation - Active hepatitis or other active infections - Any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months. - Patients with a permanent pacemaker - Patients with a QTcF or QTcB > 480 ms in the baseline EKG - Systemic corticosteroids (e.g. prednisone ≥ 12.5 mg/day or dexamethasone ≥ 2 mg/day) for the purpose of palliating tumor-related symptoms will not be allowed within 1 week of starting treatment on trial. ; PRIMARY OUTCOME: To assess the safety of PU-H71 in patients with advanced malignancies.; SECONDARY OUTCOME 1: To assess anti-tumor activity as defined by response rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Saxa or Dapa; BRIEF: The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy. ; DRUG USED: Qtern; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4), SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Patients aged ≥18 years old at time of informed consent; 2. Patients with Type 2 diabetes mellitus (T2DM) defined as HbA1C≥7.5% to ≤10.0% at screening visit; 3. Stable metformin therapy for at least 8 weeks prior to enrolment at a dose of ≥1500mg per day; 4. BMI ≤45.0kg/m2 at Enrolment visit; 5. Fasting Plasma Glucose (FPG) ≤ 270mg/dl(15.0mmol/L) at the enrolment visit; 6. For Females Only: Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study medication in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: 1. History of diabetes insipidus, Type 1 diabetes or Latent Autoimmune Diabetes of Adults, diabetic ketoacidosis or hyperosmolar nonketotic coma and Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to Enrolment (Visit 1), or other signs and symptoms. 2. History of pancreatitis. 3. Administration of any antihyperglycaemic therapy, other than metformin, for more than 14 days (consecutive or not) during the 8 weeks prior to enrolment 4. Any use of DPP-4 inhibitor or SGLT-2 inhibitor within 8 weeks prior to enrolment. 5. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency and/or significant abnormal liver function, including patients with Alanine transaminase (ALT) and/or Aspartate transaminase (AST) ≥3x ULN (Upper Limit of Normal)and/or Total Bilirubin ≥2.0x ULN. History of severe hepatobiliary disease or hepatotoxicity with any medication. Positive serologic evidence of current infectious liver disease, including patients who are known to be positive for Hepatitis viral antibody ImmunoglobulinM (IgM), Hepatitis B surface antigen, and Hepatitis C virus antibody. 6. Moderate or severe impairment of renal function [defined as Estimated Glomerular Filtration Rate (eGFR) <60milliLitre/min/1.73 m2 (estimated by Modification in Diet and Renal Disease (MDRD)) or serum creatinine ≥1.5mg/dL in males or ≥1.4mg/dL in females]. Conditions of congenital renal glucosuria, history of unstable or rapidly progressing renal disease. 7. History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the patient at risk because of participation in the study, may influence the results, or may limit the patients ability to participate in or complete the study. ; PRIMARY OUTCOME: Change From Baseline in HbA1c at Week 24; SECONDARY OUTCOME 1: Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks[/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 - MIMOSA; BRIEF: The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy. ; DRUG USED: ACA-125; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: CA-125 / MUC-16, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Menarini Group; CRITERIA: Inclusion Criteria: At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the following inclusion criteria: - Age >/= 18 years; - Properly executed written informed consent; - History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; - History of debulking surgery and 6-8 cycles of standard platinum/taxane based non-investigational IV-IP chemotherapy; - Complete clinical response defined as: - Normal physical examination; - No symptoms suggestive of persistent cancer; - No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks; - Negative chest x-ray (or chest CT scan) within the previous 4 weeks; - Serum CA125 within the normal laboratory range. - Adequate hematologic, renal and hepatic function: - Absolute Neutrophil Count (ANC) >/=1.5 * 109/l; - Platelets >/= 75 * 109/l; - Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl); - Serum creatinine </= 1.5 * ULN (Upper Limit of Normal); - Bilirubin </= 1.5 * ULN; AST, ALT, AP </= 2.5 * ULN. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) </= 2. Exclusion Criteria: Patients are ineligible to participate in the study, if any of the following criteria are present: - any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy; - known active autoimmune disease requiring chronic treatment with immunosuppressive agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.); - known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.); - known infection with hepatitis B, or hepatitis C; - history of recent myocardial infarction (</= 6 months) or decompensated heart failure (New York Heart Association - NYHA class >/= III); - previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front line chemotherapy. - concomitant use of any other investigational agent; - any prior investigational anti-cancer vaccine or monoclonal antibody; - known allergy to murine proteins; - any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures; - clinically significant active infection; - concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.); - major surgery within the previous 2 weeks; - radiotherapy within the previous 4 weeks; - any significant toxicity from prior chemotherapy; - unreliability or inability to follow protocol requirements; - potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period; - pregnancy. ; PRIMARY OUTCOME: Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC); SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - A2220 - Chronic Plaque; BRIEF: The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patients body area is affected by the disease (compared to placebo). ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization At randomization, moderate to severe psoriasis as defined by: - PASI score of 12 or greater and, - IGA score of 3 or greater and, - Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment. Exclusion Criteria: - Forms of psoriasis other than chronic plaque-type - Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization - Previous exposure to AIN457 - Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to - Known immunosuppression (e.g., AIDS) at screening and / or randomization - History or evidence of active tuberculosis at screening - Active systemic infections (other than common cold) - History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years. - Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study - Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study - Inability or unwillingness to undergo repeated venipuntures - History or evidence of drug or alcohol abuse - Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13; SECONDARY OUTCOME 1: Percentage of Participants With Investigators Global Assessment (IGA) Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - CRPC; BRIEF: The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509. ; DRUG USED: Erleada; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Aragon Pharmaceuticals, Inc.; CRITERIA: NON-METASTATIC CRPC Inclusion Criteria 1. Histologically or cytologically proven prostate cancer with high risk for development of metastases, defined as either a PSA value >=8 ng/mL within the last 3 months or PSA Doubling Time <=10 months 2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration) 3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. A life expectancy of at least 3 months Exclusion Criteria 1. Distant metastases, including CNS and vertebral or meningeal involvement 2. Prior treatment with MDV3100 3. Prior treatment with abiraterone 4. Prior treatment with ketoconazole 5. Concurrent treatment with medications known to have seizure potential 6. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible. 7. QTc > 450 msec 8. History of seizure or condition that may predispose to seizure 9. Evidence of severe or uncontrolled systemic disease or HIV infection METASTATIC CRPC, TREATMENT-NAIVE Inclusion Criteria 1. Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression 2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration) 3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. A life expectancy of at least 3 months Exclusion Criteria 1. History of, or current metastases in the brain or untreated spinal cord compression 2. Prior treatment with MDV3100 3. Prior treatment with abiraterone 4. Prior treatment with ketoconazole 5. Concurrent treatment with medications known to have seizure potential 6. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible. 7. QTc > 450 msec 8. History of seizure or condition that may predispose to seizure 9. Evidence of severe or uncontrolled systemic disease or HIV infection METASTATIC CRPC, CHEMOTHERAPY-NAIVE, POST-ABIRATERONE Inclusion Criteria 1. Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression 2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration) 3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. A life expectancy of at least 3 months 6. Patients must have received a minimum of 6 months of abiraterone treatment prior to disease progression Exclusion Criteria 1. History of, or current metastases in the brain or untreated spinal cord compression 2. Prior treatment with MDV3100 3. Prior treatment with ketoconazole 4. Concurrent treatment with medications known to have seizure potential 5. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible. 6. QTc > 450 msec 7. History of seizure or condition that may predispose to seizure 8. Evidence of severe or uncontrolled systemic disease or HIV infection ; PRIMARY OUTCOME: Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12; SECONDARY OUTCOME 1: Phase 1 and 2: Median Time to PSA Progression[/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 - JUNIPER (Safety); BRIEF: This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohns disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events. ; DRUG USED: Etrolizumab; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: Part 1 Open-Label Extension: - Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol Part 2 Safety Monitoring: - Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1 - Patients who transfer from Part 1 - Completion of the 12-week safety follow-up period prior to entering Exclusion Criteria: Part 1 Open-Label Extension: - Any new, significant, uncontrolled condition Part 2 Safety Monitoring: - No exclusion criteria ; PRIMARY OUTCOME: Part 1: Number of Participants with Crohns Disease Activity Index (CDAI) Remission Over Time; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Emtricitabine/TAF vs. Dolutegravir/Emtricitabine/TAF; BRIEF: This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF. ; DRUG USED: Biktarvy; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent) - Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening - Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC) - Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula - CD4+ cell count ≥ 200 cells/µL at screening Key Exclusion Criteria: - A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol - Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP) - Chronic hepatitis B virus (HBV) infection - Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible) - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline - Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.; SECONDARY OUTCOME 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - MODULAATE; BRIEF: This study is a Phase 2/3 prospective, double-blind, randomized, multi-center, placebo-controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an allogeneic hematopoietic cell transplant (HCT). ; DRUG USED: CSL964; DRUG CLASS: Biologic; INDICATION: Graft vs. Host Disease (GVHD) - Treatment; TARGET: Alpha-1-antitrypsin (A1AT); THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Male or female subjects, ≥12 years of age (≥ 18 years of age for subjects at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome and myeloproliferative neoplasms - Planned myeloablative conditioning regimen Exclusion Criteria: - Prior autologous or allogeneic HCT - T-cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti-thymocyte globulin [ATG], alemtuzumab) for GVHD prophylaxis - Planned umbilical cord blood (UCB) transplant ; PRIMARY OUTCOME: The time to Grade II-IV acute graft versus host disease (aGVHD) or death; SECONDARY OUTCOME 1: Proportion of subjects with lower GI aGVHD or Grade III-IV aGVHD in any organ[/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 - MYSTICOL (301); BRIEF: This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea. ; DRUG USED: Myobloc; DRUG CLASS: Biologic; INDICATION: Neurology - Other; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause - Investigator sites will review entire list of inclusion criteria with potential subjects Exclusion Criteria: - Any known prior exposure to botulinum toxin type B, or known adverse reaction or sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC solution components. - Prior botulinum toxin treatment to the salivary glands at any time - Investigator sites will review entire list of exclusion criteria with potential subjects ; PRIMARY OUTCOME: Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - TRIDENT-1; BRIEF: Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. ; DRUG USED: Repotrectinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Anaplastic lymphoma kinase (ALK), ROS kinase, Src Kinase Family, Trk (Tropomyosin Receptor Kinase) Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Turning Point Therapeutics, Inc.; CRITERIA: PHASE 1 Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests. 2. ECOG PS 0-1. 3. Age ≥18 (or age ≥ 20 of age as required by local regulation). 4. Capability to swallow capsules intact (without chewing, crushing, or opening). 5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed. 6. Prior cytotoxic chemotherapy is allowed. 7. Prior immunotherapy is allowed. 8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. 9. Patients with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria. 10. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation 11. Life expectancy ≥ 3 months. PHASE 2 Key Inclusion Criteria 1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion. 2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either: 1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility. • Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor. OR 2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation of fusion status by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment will be accepted to determine molecular eligibility. - Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 4. Age ≥12 (or age ≥ 20 as required by local regulation). 5. Willing and able to provide written institutional review board (IRB)/institutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17. 6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible. 7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3 rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all inclusion and exclusion criteria are met. i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors 8. Subjects with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria. 9. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation 10. Life expectancy ≥ 3 months. Key Exclusion Criteria PHASE 1 and PHASE 2 1. Concurrent participation in another therapeutic clinical trial. 2. Symptomatic brain metastases or leptomeningeal involvement. 3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years. 4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry 5. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2 6. Any of the following cardiac criteria: Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) > 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval. 7. Known active infections (bacterial, fungal, viral including HIV positivity). 8. Gastrointestinal disease (e.g., Crohns disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption. 9. Peripheral neuropathy of CTCAE ≥grade 2. 10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded. ; PRIMARY OUTCOME: Dose limiting toxicities (DLTs) (Phase 1); SECONDARY OUTCOME 1: Maximum plasma concentration (CMAX) of repotrectinib (TPX-0005) (Phase 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 - COMBI-AD - w/Dabrafenib; BRIEF: This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months. ; DRUG USED: Mekinist; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible. - Surgically rendered free of disease no more than 12 weeks before randomization. - Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains). - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. - Adequate hematologic, hepatic, renal and cardiac function. Key Exclusion Criteria: - Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases. - Evidence of distant metastatic disease. - Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed. - History of another malignancy or concurrent malignancy including prior malignant melanoma. Exceptions to this include: Patients who have been disease-free for 5 years or patients with a history completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, or other malignancies for which the patient has been disease free for > 5 years. - History or current evidence of cardiovascular risk. - History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR) ; PRIMARY OUTCOME: Relapse-free Survival (RFS); 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 - ODYSSEY ESCAPE; BRIEF: The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekly LDL apheresis therapy. ; DRUG USED: Praluent; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Men and women ≥18 years of age at the time of the screening visit 2. Diagnosis of HeFH (Heterozygous familial hypercholesterolemia) 3. Currently undergoing LDL (low-density lipoprotein) apheresis therapy QW (weekly) or Q2W (every 2 weeks) or at least 8 weeks prior to the screening visit Exclusion Criteria: 1. Homozygous FH (familial hypercholesterolemia) 2. Background medical LMT (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit 3. LDL apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit 4. An LDL apheresis schedule other than QW to Q2W 5. Initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2) 6. Initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2) 7. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 8 weeks prior to the screening visit (week -2), or between the screening and randomization visit 8. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins 9. Known history of a positive test for human immunodeficiency virus 10. Use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer 11. Patients who have been treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in any other clinical studies 12. Pregnant or breastfeeding women ; PRIMARY OUTCOME: Change in Standardized Rate of Apheresis Treatments From Week 7 to Week 18; SECONDARY OUTCOME 1: Percent Change From Baseline in Calculated LDL-C (Pre-apheresis) at Week 6[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Males; BRIEF: AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and potentially also asthma (in combination with an inhaled corticosteroid [ICS]). The therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism bronchodilators, with an equivalent or superior safety and tolerability profile. The primary purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A multiple ascending dose (MAD) design has been selected for this study following the first time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in an ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent doses will be decided based on safety, tolerability and pharmacokinetic (PK) data generated in the previous dose. The aim of this study is to also enable further investigations in healthy subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable side-effect profile compared to other inhaled bronchodilators on the market as a treatment for COPD and asthma. ; DRUG USED: AZD8871; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of written informed consent prior to conducting any study-related procedures, including withdrawal of medications. 2. Male subjects aged 18 to 55 years, inclusive at Screening. 3. Body mass index (BMI) calculated as weight in kg/height in m2 from ≥18 to ≤30 kg/m2 and weight ≥50 kg at Screening. 4. Healthy, free from any clinically significant disease/ conditions (including all cardiovascular conditions), as determined by medical history, physical examination, clinical laboratory testing, 12-lead ECG findings at Screening and admission to the unit. 5. Spirometry readings (FEV1 and Forced Vital Capacity [FVC]) to be ≥80% of predicted value calculated using Quanjer 2012 reference equations (Quanjer et al 2012) at Screening. 6. Normal blood pressure (BP) (defined as systolic BP [SBP] ≥90 and ≤140 mmHg, and diastolic BP [DBP] ≥50 and ≤90 mmHg) at Screening and admission to the unit, measured after resting in supine position for at least 10 minutes. 7. Normal heart rate (HR) (defined as HR ≥45 and ≤90) measured after resting in supine position for at least 10 minutes at Screening and admission to the unit. 8. Negative for hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody (IgM), hepatitis C antibody and human immunodeficiency virus (HIV) I and II antibodies at Screening. 9. Negative for drugs of abuse and alcohol tests at Screening and admission to the unit. 10. Normal serum potassium at Screening and at admission to the unit. 11. Willing and able to comply with study specific procedures and restrictions Exclusion Criteria: 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 2. Surgical history clinically relevant for the purpose of the study or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of Screening. 3. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin. 4. Current smokers, or a smoking history during the last 6 months or total smoking history of more than 10 pack-years. Use of electronic cigarettes or other forms of nicotine, current use or use within the last 6 months. 5. Prolonged QTcF interval, >450 ms at Screening, or family history of long QT syndrome. 6. Any clinically significant arrhythmia noted on telemetry recording, prior to randomisation. 7. History of excessive use or abuse of alcohol within the past 2 years. 8. History of drug abuse within the past 2 years. 9. Donation or loss >400 ml of blood and plasma within the previous 3 months prior to Visit 1, Screening. 10. History of presence of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the Investigator or history of hypersensitivity to drugs pharmacologically related to study drug. 11. PR (PQ) interval shortening <120 ms (PR >110 ms but <120 ms is acceptable if there is no evidence of ventricular pre-excitation) at Screening. 12. PR (PQ) interval prolongation (> 240 ms), intermittent second (Wenckebach block while asleep is not exclusive), or third degree atrioventricular block, or atrioventricular dissociation at Screening. 13. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS >110 ms. 14. Subject who does not agree to follow instructions to avoid partner pregnancy. 15. Subject who is not able to adhere to the restrictions on prior and concomitant medications. 16. Used any investigational drug within 3 months prior to Screening or within the equivalent time of 5 half-lives of receiving the last administration, whichever is longer, or on an extended follow-up after receiving an IMP. 17. Subjects unable to communicate reliably with the Investigator. 18. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order. ; PRIMARY OUTCOME: Number of Participants With ≥1 Treatment Emergent Adverse Event in Any Category.; SECONDARY OUTCOME 1: Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Single Dose).[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TEMPO; BRIEF: The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D). ; DRUG USED: Eleclazine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ventricular Tachycardia or Fibrillation; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) [shock or ATP] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within 60 days prior to screening - Use of highly effective contraception methods if female of childbearing potential or sexually active male - Must be hemodynamically stable Key Exclusion Criteria: - New York Heart Association (NYHA) Class IV heart failure - Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within 4 weeks prior to screening or during the screening period before randomization - Hemodynamically significant primary obstructive valvular disease - History of congenital heart disease - Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type 3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered. - Individuals who are being considered for cardiac transplantation and are on a cardiac transplant list - History of seizures or epilepsy - Cardiac ablation within 3 months prior to screening or planned cardiac ablation during the study - Severe renal impairment - Abnormal liver function tests - Currently taking Class I and Class III antiarrhythmic drugs; such medications should be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to randomization - Currently taking drugs or products that are strong inhibitors or inducers of CYP3A; such medications should be discontinued 5 half-lives prior to randomization - Currently taking ranolazine; ranolazine should be discontinued at least 7 days prior to randomization - Females who are pregnant or are breastfeeding - Individuals with a subcutaneous ICD - Body mass index (BMI) ≥ 36 kg/m^2 Note: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24; SECONDARY OUTCOME 1: Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Nail Psoriasis; BRIEF: Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis ; DRUG USED: Ilumya; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Sun Pharmaceutical Industries Limited; CRITERIA: Inclusion Criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: 1. Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator). 2. Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by: - mNAPSI score of ≥20. - ViSENPsO ≥3 3. Subjects must have moderate to severe plaque psoriasis at Screening and Baseline, defined by: - s-PGA score of at least 3. - Body Surface Area (BSA) involvement of ≥10%. - PASI ≥12 4. Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy. Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: 1. Subjects who have predominantly non-plaque forms of psoriasis, specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis. 2. Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment. 3. Subjects with fungal nail infection should be excluded from the study. Subjects in whom the Investigator suspects a fungal nail infection in addition to nail psoriasis should have scrapings sent for direct microscopy and fungal culture. If fungal culture or direct microscopy of nail scrapings turns out to be positive for fungal infection, the subject should be excluded from the study. At the discretion of the investigator, Periodic Acid-Schiff (PAS) staining for nail clippings could also be considered to rule of fungal infection of the nails. Direct microscopy or fungal culture are not required if fungal infection is diagnosed in PAS staining. 4. Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis. 5. Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations. ; PRIMARY OUTCOME: The proportion of subjects who achieve at least a 75% improvement from baseline in totalmNAPSI at Week 28.; SECONDARY OUTCOME 1: The proportion of subjects with a score of 0 - normal or 1 - minimal nail psoriasis and at least a 2-point decrease from baseline at Week 28 as measured by the ViSENPsO.[/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 - PK/PD; BRIEF: The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2. ; DRUG USED: JNJ-64264681; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participants must have Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 - Participants must have cardiac parameters within the following range: corrected QT interval (QTcF) less than or equal to <= 480 milliseconds based on the average of triplicate assessments performed as close as possible in succession (the full set of triplicates should be completed in less than 10 minutes) - Women of childbearing potential must have a negative highly sensitive serum pregnancy test (example: beta human chorionic gonadotropin [beta-hCG]) at screening, and a negative serum or urine pregnancy test prior to the first dose of study drug - Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug administration - Participants must be willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: - Participant has known active central nervous system (CNS) involvement - Participant has received prior solid organ transplantation - Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or its excipients - Participant has been treated with an investigational drug (including investigational vaccines) within five half-lives or 2 weeks before the planned first dose of study drug - Participant is experiencing toxicities from previous anticancer therapies that have not resolved to baseline levels, or to Grade 1 or less (except for alopecia and peripheral neuropathy) ; PRIMARY OUTCOME: Part 1: Number of Participants With Dose Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Plasma Concentration of JNJ-64264681[/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 - ALT-601-201; BRIEF: The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19. ; DRUG USED: NasoVAX; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Altimmune, Inc.; CRITERIA: Inclusion Criteria: 1. Able and willing to provide informed consent (Patients themselves must provide written informed consent before the performance of any study-related procedures, and surrogate consent by family members, designated legal representatives or caregivers will not be permitted). 2. Men and women 18 years of age and older 3. Early COVID-19, defined as one or more symptom(s) of fever (oral temperature ≥ 100.4 degrees F), cough, or shortness of breath, onset of these symptoms within 72 hours of screening, and confirmation of SARS-CoV-2 infection by a polymerase chain reaction (PCR)-based or rapid antigen diagnostic. 4. Resting SpO2 ≥ 96.0% on room air on two successive measurements 5. For women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]) - Negative urine pregnancy test at Screening - Willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the last dose of study drug 6. For men with sexual partners of childbearing potential, willingness to practice a highly effective method of contraception, as defined above, for 45 days after the last dose of study drug 7. Ability and willingness to comply with all aspects of the study, including reliable internet access, through the entire study period Exclusion Criteria: 1. Pregnant or lactating women or planning to conceive a child during the next 3 months 2. Resting respiratory rate >20 breaths/min on room air or resting pulse rate ≥ 125 beats per minute 3. A rapidly worsening course that in the opinion of the Investigator or treating medical practitioner would lead to hospitalization within the next 24-48 hours 4. Any chronic pulmonary disease, including chronic obstructive pulmonary disease and asthma, or other respiratory diseases that could exacerbate independent of COVID-19 5. The following risk factors for severe COVID-19 (Cohorts 1 and 2 only) (Centers for Disease Control 2020), which based on ongoing review of efficacy and safety data, the DMC may remove part or all of these risk factors if preliminary data show no signal for adverse or paradoxical effects: 1. Severe obesity, defined as body mass index ≥ 40 kg/m2 2. History of: - Severe cardiovascular disease, including but not limited to congestive heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, or pulmonary hypertension - Diabetes mellitus - Chronic or current vaping or cigarette smoking - Chronic kidney disease requiring dialysis - Chronic liver disease, including but not limited to chronic viral hepatitis, non-alcoholic steatohepatitis, or cirrhosis of any cause - Hemoglobin disorder, including sickle cell disease and thalassemia 6. History of Bells Palsy 7. Nasal conditions that might affect the suitability of intranasal medication, such as a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or nasal surgery other than cosmetic rhinoplasty. 8. Use of hydroxychloroquine within the past 4 months, chloroquine with the past 9 months, or other investigational agents for COVID-19 within the past 30 days 9. History of conditions associated with immunocompromise, including but not limited to poorly controlled HIV, or treatments known to affect the immune system, including but not limited to oral or intravenous corticosteroids, alkylating drugs, antimetabolites, cytotoxic drugs, radiation, immune-modulating biologics (including interleukin [IL]-6, IL-12, Janus kinase inhibitors or antagonists), and cancer treatments, within 30 days of Screening, or anticipated use within 6 months following participation in this study 10. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a patients ability to give informed consent ; PRIMARY OUTCOME: Percentage of Patients With Clinical Worsening; SECONDARY OUTCOME 1: Maximal Severity of COVID-19 After Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - GSP 301- PoC; BRIEF: A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray, DYMISTA® and PATANASE®. ; DRUG USED: Ryaltris; DRUG CLASS: Non-NME; INDICATION: Allergic Rhinitis; TARGET: Glucocorticoid Receptor (GR), Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Glenmark Pharmaceuticals Ltd. India; CRITERIA: Inclusion Criteria: - Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test Exclusion Criteria: - Pregnant or lactating women - Patients with known hypersensitivity to any of the components of the formulation - Patients with a history of seasonal asthma during ragweed season. - Patient requiring chronic use of inhaled or systemic corticosteroids - Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening - Patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or Rhinitis Medicamentosa as determined by the Investigator. - Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, uncontrolled Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving MAO inhibitor therapy. ; PRIMARY OUTCOME: Change in mean post-treatment instantaneous Total Nasal Symptoms Score (iTNSS) for Molo 1 and Molo 2 compared with placebo from baseline to end of treatment; SECONDARY OUTCOME 1: Change in mean post-treatment iTNSS for Molo 1 and Molo 2 compared with reference products Dymista and Patanase[/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 - 136 (Japan); BRIEF: This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks. ; DRUG USED: Janumet; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK), Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Type 2 Diabetes Mellitus (T2DM) - Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c ≥ 6.0% and ≤ 9.0%; or - Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and < 10.0% Exclusion Criteria: - Type 1 diabetes mellitus, - Secondary diabetes mellitus, or - Gestational diabetes mellitus ; PRIMARY OUTCOME: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - NCI; BRIEF: Background: Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers caused by HPV have a HPV protein called E7 inside of their cells. In this new therapy, researchers take a person s blood, remove certain white blood cells, and insert genes that make them to target cancer cells that have the E7 protein. The genetically changed cells, called E7 TCR cells, are then given back to the person to fight the cancer. Researchers want to see if this can help people. Objective: To determine a safe dose and efficacy of E7 TCR cells and whether these cells can help patients. Eligibility: Adults ages 18 and older with an HPV-16-associated cancer, including cervical, vulvar, vaginal, penile, anal, or oropharyngeal. Design: Participants will list all their medicines. Participants will have many screening tests, including imaging procedures, heart and lung tests, and lab tests. They will have a large catheter inserted into a vein. Participants will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. The cells will be changed in the lab. Participants will stay in the hospital. Over several days, they will get: Chemotherapy drugs E7 TCR cells Shots or injections to stimulate the cells Participants will be monitored in the hospital up to 12 days. They will get support medicine and have blood and lab tests. Participants will have a clinic visit about 40 days after cell infusion. They will have a physical exam, blood work, scans, and maybe x-rays. Participants will have many follow-up visits with the same procedures. At some visits, they may undergo leukapheresis. Participants will be followed for 15 years. ; DRUG USED: KITE-439; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Human Papillomavirus (HPV), Stem Cells/Other Cell Therapies, T lymphocytes, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: - INCLUSION CRITERIA: 1. Measurable metastatic or refractory/recurrent HPV-16+ cancer (determined by in situ hybridization (ISH) or a polymerase chain reaction (PCR)-based test). 2. Patients must be HLA-A*02 by low resolution typing, and HLA-A*02:01 by one of the high resolution type results. 3. All patients must have received prior first line standard therapy or declined standard therapy. 4. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible. 5. Greater than or equal to 18 years of age. 6. Able to understand and sign the Informed Consent Document. 7. Clinical performance status of ECOG 0 or 1. 8. Patients of both genders must be willing to practice birth control from the time of enrollment on this study up to four months after treatment. Patients must be willing to undergo testing for HPV-16 prior to becoming pregnant after this period. 9. Women of childbearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus. Women of childbearing potential are defined as all women except women who are postmenopausal or who have had a hysterectomy. Postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least one year. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR transduced PBL, breastfeeding should be discontinued if the mother is treated with E7 TCR transduced PBL. These potential risks may also apply to other agents used in this study. 10. Serology: - Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.) - Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. a. Hematology: - Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim. - WBC greater than or equal to 3000/mm^3 - Platelet count greater than or equal to 100,000/mm^3 - Hemoglobin > 8.0 g/dL b. Chemistry: - Serum ALT/AST less than or equal to 2.5 times the upper limit of normal - Calculated creatinine clearance (CCr) greater than or equal to 50 mL/min/1.73^2 using the Cockcroft-Gault equation - Total bilirubin less than or equal to 1.5 mg/dL, except in patients with Gilberts Syndrome who must have a total bilirubin less than 3.0 mg/dL c. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Note: Patients may have undergone minor surgical procedures within the past three weeks, as long as all toxicities have recovered to Grade 1 or less. EXCLUSION CRITERIA: 1. Active systemic infections (for e.g.: requiring anti-infective treatment), coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, severe obstructive or restrictive pulmonary disease. Patients with abnormal pulmonary function tests but stable obstructive or restrictive pulmonary disease may be eligible. 2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 3. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). 4. Patients with autoimmune diseases such as Crohn s disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis or pancreatitis, and systemic lupus erythematosus. Hypothyroidism, vitiligo and other minor autoimmune disorders are not exclusionary. 5. Patients on immunosuppressive drugs including corticosteroids. With the exception of: intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) -Systemic corticosteroids at physiologic doses 10 mg/day of prednisone or equivalent; or, -Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 6. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine or aldesleukin. 7. Patients with a history of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test. 8. Documented LVEF of less than or equal to 45% tested. The following patients will undergo cardiac evaluations 1. Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or 2. Age greater than or equal to 50 years old 9. Any other condition, which would, in the opinion of the Principal Investigator, indicate that the subject is a poor candidate for the clinical trial or would jeopardize the subject or the integrity of the data obtained. 10. Subjects with baseline screening pulse oxygen level of < 95% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated ; PRIMARY OUTCOME: Phase II: Determine safety and effficacy of E7 TCR cells plus aldesleukin; SECONDARY OUTCOME 1: To assess progression-free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SELECT-BEYOND; BRIEF: The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1. ; DRUG USED: Rinvoq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Diagnosis of rheumatoid arthritis (RA) for≥ 3 months. - Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug. - Participant has been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide. - Meets both of the following criteria: - ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits. - hsCRP ≥ 3mg/L at Screening Visit. Exclusion Criteria: - Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). - History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]). Current diagnosis of secondary Sjogrens Syndrome is permitted. ; PRIMARY OUTCOME: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12; SECONDARY OUTCOME 1: Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CL-1031 (Japan); BRIEF: The objective of this study is to verify the efficacy and investigate the safety of the study drug when ASP0456 is administered orally for 4 weeks and 52 weeks. ; DRUG USED: Linzess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Patients with SBM frequency for < 3 times/week, since ≥ 6 months prior to preliminary enrollment - Patients with one or more related symptoms for ≥ 6 months prior to preliminary enrollment - Patients at whom loose (mushy) or watery stools are rarely present without the use of laxatives for ≥ 6 months prior to preliminary enrollment - Patients who underwent pancolonoscopy or contrast enema after development of the CC symptoms and within 5 years prior to preliminary enrollment, and in whom no organic change was observed which dose not influence on CC symptoms - Female patients must be either: If of non-childbearing potential: - Post-menopausal at the preliminary enrollment, or documented surgically sterile Or, if of childbearing potential, - Agree not to try to become pregnant during the study and for 28 days after the final study drug administration - And have a negative urine pregnancy test at screening - And, if heterosexually active, agree to consistently use two forms of highly effective birth control throughout the study period and for 28 days after the final study drug administration - Female patients must agree not to breastfeed throughout the study period and for 28 days after the final study drug administration - Female patients must not donate ova starting throughout the study period and for 28 days after the final study drug administration - Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control starting at Screening and continue throughout the study period, and for 28 days after the final study drug administration - Male subject must not donate sperm starting at Screening and throughout the study period and, for 28 days after the final study drug administration Exclusion Criteria: - Patients who have met the Rome III diagnostic criteria for IBS; with recurrent abdominal pain or discomfort for ≥ 3 days/month in the last 3 months prior to preliminary enrollment, associated with ≥ 2 of the 3 characteristics described below and with the symptoms (IBS symptoms) described above for ≥ 6 months prior to preliminary enrollment 1. Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool - Patients with a history of surgical resection of the stomach, gallbladder, small intestine, or large intestine - Patients with a history or current evidence of inflammatory bowel disease or ischemic colitis - Patients with concurrent infectious enteritis, hyperthyroidism or hypothyroidism, constipation due to anorectal dysfunction, drug-induced constipation, constipation due to other organic diseases or active peptic ulcer - Patients with apparent mechanical obstruction - Patients with megacolon or megarectum - For female patients, patients with concurrent endometriosis or adenomyosis - Patients who are considered to have severe depression or a severe anxiety disorder that can affect the efficacy evaluation of the study drug - Patients with a history of abuse of drugs or alcohol, or current abuse of drugs or alcohol - Patients who used/underwent or are scheduled to use/undergo prohibited concomitant drugs or therapies, or in whom prohibited examinations were conducted or are scheduled to be conducted 3 days prior to the start of the bowel habit observation period - Patients with a history or current evidence of malignant tumors - Patients with concurrent serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal disorders, blood diseases, or neurological/psychiatric diseases - Patients with a history of drug allergies - Patients who have participated in the clinical trial of ASP0456 or have been administered ASP0456 - Patients who have participated or are participating in another clinical trial or post-marketing clinical study of other ethical drugs or medical devices within 12 weeks prior to obtaining informed consent ; PRIMARY OUTCOME: Change from baseline in weekly mean SBM frequency during one week of administration (Part I); SECONDARY OUTCOME 1: Change from baseline in weekly mean SBM frequency[/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 - RECAPTURE-2; BRIEF: The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis ; DRUG USED: Avycaz; DRUG CLASS: Non-NME; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - 18 to 90 years of age inclusive - Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after - Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem) - Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis Exclusion Criteria: - Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem - Patients urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI - Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant - Patient is immunocompromised - Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality ; PRIMARY OUTCOME: Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test; SECONDARY OUTCOME 1: Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)[/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 - Radboud University; BRIEF: This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers. ; DRUG USED: Adrecizumab; DRUG CLASS: Biologic; INDICATION: Sepsis and Septic Shock; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Radboud University Medical Center; CRITERIA: Inclusion Criteria: 1. Written informed consent to participate in this trial prior to any study-mandated procedure. 2. Male subjects aged 18 to 35 years inclusive. 3. Subjects have to agree to use a reliable way of contraception with their partners from study entry until 3 months after study drug administration. 4. BMI between 18 and 30 kg/m², with a lower limit of body weight of 50 kg and a upper limit of 100 kg. 5. Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters. Exclusion Criteria: 1. Unwillingness to abstain from any medication, recreational drugs, anti-oxidant or vitamin supplements during the course of the study and within 7 days prior to the treatment day. 2. Unwillingness to abstain from smoking or alcohol 1 day prior to the treatment day and during the first 24 hours of the study. 3. Surgery or trauma with significant blood loss or blood donation within 3 months prior to the treatment day. 4. History, signs or symptoms of cardiovascular disease, in particular: - History of frequent vasovagal collapse or of orthostatic hypotension - Resting pulse rate ≤45 or ≥100 beats / min - Hypertension (RR systolic >160 or RR diastolic >90) - Hypotension (RR systolic <100 or RR diastolic <50) - Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block - Any chronic cardiac arrhythmias, except PACs, PVCs 5. Renal impairment: plasma creatinine >120 µmol/L 6. Liver function tests (alkaline phosphatase, AST, ALT and/or γ-GT) above 2x the upper limit of normal. 7. History of asthma 8. Atopic constitution 9. CRP above 2x the upper limit of normal or clinically significant acute illness, including infections, within 2 weeks before administration of the study drug. 10. Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to study drug administration. 11. Known or suspected of not being able to comply with the trial protocol. 12. Known hypersensitivity to any excipients of the drug formulations used. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study. ; PRIMARY OUTCOME: Safety and tolerability expressed in total number of treatment related (serious) adverse events; SECONDARY OUTCOME 1: Area under the curve (AUC) of free Adrecizumab (pharmacokinetics)[/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/Azacitidine (China); BRIEF: This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of HMPL-523 in combination with Azacitidine in previously untreated elderly patients with AML who are not eligible for standard induction therapy. ; DRUG USED: HMPL-523; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Combination; LEAD SPONSOR: Hutchison Medipharma Limited; CRITERIA: Inclusion Criteria: 1. Subject must have confirmation of AML by WHO criteria, except for APL (M3) 2. Subject must be ≥ 65 years of old and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors 3. Subject must have received no prior treatment for AML with the exception of hydroxyurea 4. ECOG performance status of 0-1. For dose-expansion stage, ECOG PS of 2 will also be eligible Exclusion Criteria: 1. Subject has received treatment of hypomethylating agent and/or chemo therapeutic agent for MDS or MPN 2. Subject has known active CNS involvement or extramedullary sarcoma from AML 3. Subject has favorable risk cytogenetics as categorized by the NCCN Guidelines Version 1, 2018 for Acute Myeloid Leukemia, such as inv(16) or t(16;16) or t(8;21) or t(15;17) 4. Subject has a white blood cell count > 25 × 109/L (Hydroxyurea is permitted to meet this criterion) 5. Subject with serum amylase or lipase > the ULN 6. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. 7. Subject who dont have enough liver or renal function 8. Subject with New York Heart Association (NYHA) Class III or greater congestive heart failure 9. Subject received herbal therapy ≤ 1 week prior to initiation of study treatment 10. Subject received prior treatment with any SYK inhibitors (Fostamatinib) or FLT3 inhibitor (Quizartinib) or multi-target inhibitor with SYK or FLT3 inhibition activity (Midostaurin) ; PRIMARY OUTCOME: Adverse Event (AE) monitoring of HMPL-523 in combination with azacitidine; SECONDARY OUTCOME 1: Maximum plasma concentration (Cmax) of HMPL-523[/INST]No</s>