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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - innovaTV 205; BRIEF: This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part. ; DRUG USED: Tivdak; DRUG CLASS: Biologic; INDICATION: Cervical Cancer; TARGET: Antibody-drug Conjugate (ADC), Tissue Factor; THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after standard of care treatments or are ineligible or intolerant to standard of care for recurrent or stage IVB cervical cancer (Arms A, B and C only). - Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H only). - Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than two prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and G only). - Must have baseline measurable disease per RECIST v1.1. - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms). - Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration - Participants of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration. - Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms). Exclusion Criteria: - Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms) - Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms) - Has clinically significant bleeding issues or risks - Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arm A and bevacizumab-eligible participants in Arm H) - Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arms A and H only) - Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arms A and H only) - Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms). - Clinically significant cardiac disease - Requires anti-coagulation therapy (Arms A and H only) ; PRIMARY OUTCOME: Dose escalation: Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Number of adverse events (AEs)[/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 - 203 - KIRMONO (Smoldering MM); BRIEF: The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma. ; DRUG USED: IPH 2101; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Immune System, KIR (Killer Immunoglobulin-like Receptors); THERAPY: Monotherapy; LEAD SPONSOR: Innate Pharma; CRITERIA: Inclusion Criteria: 1. SMM of any risk level according to a definition derived of the International Myeloma Working Group definition ( Br J Haematol 2003; 121: 749) : Serum M protein ≥ 3 g/dl , AND/OR Bone Marrow plasma cells ≥ 10 % with no evidence of end-organ damage (CRAB) - (C)Absence of hypercalcemia : Ca < 10.5 mg/dl - (R)Absence of renal failure : creatinine < 2mg/dl (177 μmol/l) or calculated creatinine clearance(according to MDRD) > 50 ml/min - (A)Absence of anemia : Hb > 11 g/dl - (B)Absence of lytic bone lesion on standard skeletal survey (MRI could be used if clinically indicated) 2. Measurable disease defined as a disease with a serum M protein ≥ 1 g/dl 3. No evidence of fatigue, recurrent infections or any clinical suspicion of MM 4. Diagnosis of SMM confirmed on two consecutive assessments (ie fluctuation under 25% of serum protein level) performed with at least a 4 week interval. 5. Age > 18 years or < 75 years 6. ECOG performance status of 0 or 1 7. Male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study when relevant 8. Informed consent signed by the patient Exclusion Criteria: 1. Previous treatment having a proven or potential impact on myelomatous cells proliferation or survival (including IMiDs or proteasome inhibitors, conventional chemotherapies within the last 5 years, steroids within the last month prior to enrolment). Previous bisphosphonates started less than 3 months prior to enrolment. 2. Use of any investigational agent within the last 3 months 3. Clinical laboratory values at screening - Platelet < 75 x 10^9 /l - ANC < 1.5 x 10^9 /l - Bilirubin levels >1.5 ULN ; ALT and AST > 3 ULN (grade 1 NCI) 4. Primary or associated amyloidosis 5. Abnormal cardiac status with any of the following 1. NYHA stage III or IV congestive heart failure 2. myocardial infarction within the previous 6 months 3. symptomatic cardiac arrhythmia requiring treatment or persisting despite appropriate treatment 6. Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen 7. History of or current auto-immune disease 8. History of other active malignancy within the past five years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma). 9. Serious concurrent uncontrolled medical disorder 10. History of allograft or solid organ transplantation 11. Pregnant or lactating women 12. Any condition potentially hampering compliance with the study protocol and follow-up schedule ; PRIMARY OUTCOME: Rate of Patients Achieving an Objective Response; SECONDARY OUTCOME 1: Safety Assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SELECT (CVOT); BRIEF: The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo (dummy medicine). Which treatment the participants get is decided by chance. The participants chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age greater than or equal to 45 years at the time of signing informed consent - Body mass index (BMI) greater than or equal to 27 kg/m^2 - Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease Exclusion Criteria: Cardiovascular-related: - Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Presently classified as being in New York Heart Association (NYHA) Class IV heart failure Glycaemia-related: - HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening - History of type 1 or type 2 diabetes (history of gestational diabetes is allowed) - Treatment with glucose-lowering agents within 90 days before screening - Treatment with any glucagon-like-peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening General safety: - History or presence of chronic pancreatitis - Presence of acute pancreatitis within the past 180 days prior to the day of screening - Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma - End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed - Severe psychiatric disorder which in the investigators opinion could compromise compliance with the protocol - Known or suspected hypersensitivity to trial products or related products - Previous participation in this trial. Participation is defined as randomisation - Receipt of any investigational medicinal product within 30 days before screening - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method - Any disorder, unwillingness or inability, which in the investigators opinion, might jeopardise the participants safety or compliance with the protocol ; PRIMARY OUTCOME: Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke; SECONDARY OUTCOME 1: Time to CV 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 III - OPTIC - vs. Moxifloxacin; BRIEF: The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia. ; DRUG USED: Nuzyra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Paratek Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: - Patients, ages 18 years or older who have signed the informed consent - Has qualifying bacterial pneumonia - Female patients must not be pregnant at the time of enrollment - Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug Exclusion Criteria: - Known or suspected hospital-acquired pneumonia - Evidence of significant immunological disease - Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic - Has received an investigational drug within past 30 days - Women who are pregnant or nursing ; PRIMARY OUTCOME: Number of Participants With Early Clinical Response; SECONDARY OUTCOME 1: Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) 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 II - w/ Rituximab (Cornell University); BRIEF: This is a phase II, multicenter study to determine the efficacy and safety of first-line lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received no prior systemic therapy. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Weill Medical College of Cornell University; CRITERIA: Inclusion Criteria: - Understand and voluntarily sign an informed consent form. - Age > = 18 years at the time of signing the informed consent form. - Able to adhere to the study visit schedule and other protocol requirements. - Histologically confirmed diagnosis of mantle cell Non-Hodgkins Lymphoma with cyclin D1 overexpression by immunohistochemistry, and a characteristic immunophenotypic profile with CD5(+), CD23(-), CD20(+), and CD10(-). In tumor tissues with negative cyclin D1, evidence of cyclin D2 or D3 overexpression by immunohistochemistry will be acceptable. - No prior systemic therapy for lymphoma including chemotherapy or immunotherapy. Patients may have received involved-field radiation therapy which has been discontinued at least 4 weeks prior to treatment in this study. - Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension. - Low and intermediate-risk disease as defined by MIPI score. - Subject who the investigator considers that chemotherapy is not indicated. - ECOG performance status of < = 2 at study entry. - Laboratory test results within these ranges: - Absolute neutrophil count > = 1000 /mm³ - Platelet count > = 75,000 /mm³ - Calculated creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula • Total bilirubin < = 2 x ULN - AST (SGOT) and ALT (SGPT) < = 3 x ULN. - Disease free of prior malignancies for > = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer. - All subjects must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. - Subjects of reproductive potential agree to use birth control throughout their participation in this study, and for three months following study termination. - Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days). FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. - Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). - Asymptomatic carriers of hepatitis B virus can be considered for study if they agree to and comply with close monitoring and suppressive therapy with lamivudine during treatment and for additional six months after coming off study. Exclusion Criteria: - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. - Pregnant or breast feeding females. - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. - Use of any other experimental drug or therapy within 28 days of baseline. - Patient on corticosteroids within two weeks prior to study entry, except for prednisone < = 10 mg/day or equivalent for purposes other than treating MCL. - Known hypersensitivity to thalidomide. - Any prior use of lenalidomide. - Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. - Known central nervous system (CNS) involvement by lymphoma. - Patient at high risk for deep vein thrombosis not willing to take DVT prophylaxis. - Patient has had major surgery within the last 3 weeks ; PRIMARY OUTCOME: Overall Response Rate; SECONDARY OUTCOME 1: Progression-free Survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Infections From MBL Producing Gram(-) Bacteria; BRIEF: Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI), nosocomial pneumonia (NP) including hospital acquired pneumonia (HAP) and ventilator associated pneumonia (VAP), complicated urinary tract infections (cUTI), or bloodstream infections (BSI) due to metallo-β-lactamase (MBL)- producing Gram-negative bacteria. ; DRUG USED: ATM AVI; DRUG CLASS: New Molecular Entity (NME); INDICATION: Intra-Abdominal Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria All Subjects 1. Subject must be ≥18 years of age. 2. Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study. 3. Subjects must have a confirmed diagnosis of serious bacterial infection, specifically cIAI, HAP/VAP, cUTI, or BSI requiring administration of IV antibacterial therapy. 4. Subjects must have an MBL- positive Gram- negative bacteria (an Enterobacteriaceae and/or Stenotrophomonas maltophilia for which the imipenem or meropenem MIC is ≥ 4 µg/mL), that was isolated from an appropriate specimen obtained within 7 days prior to screening. 5. Female subject of childbearing potential must have a negative serum or urine pregnancy test, with sensitivity of at least 25 mIU/mL. 6. Subjects who have received more than 48 hours of an appropriate prior systemic antibiotic[s] for a carbapenem non -susceptible pathogen may be enrolled if they demonstrate worsening or lack of improvement of objective symptoms or signs of infection (Note: antibiotic[s] is considered appropriate if microbiological susceptibility test results show that all carbapenem non -susceptible pathogens are susceptible to the systemic antibiotic[s] received). Additional Inclusion Criteria- cIAI Subjects 1. Subject must have a specimen obtained from an abdominal source during a surgical intervention within 7 days prior to screening from which a study qualifying pathogen was isolated upon culture. Surgical intervention includes open laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery. 2. The subject has at least 1 of the following diagnosed during the surgical intervention: • Cholecystitis with gangrenous rupture or perforation or progression of the infection beyond the gallbladder wall; • Diverticular disease with perforation or abscess; - Appendiceal perforation or peri-appendiceal abscess; - Acute gastric or duodenal perforations, only if operated on >24 hours after diagnosis; - Traumatic perforation of the intestines, only if operated on >12 hours after diagnosis; - Other secondary peritonitis (not primary/ spontaneous bacterial peritonitis associated with cirrhosis or chronic ascites); - Intra abdominal abscess (including of the liver and spleen provided that there is extension beyond the organ with evidence of intra peritoneal involvement). 3. Subject has at least 1 of the following signs / symptoms from each of the following 2 groups: • Group A: Evidence of systemic inflammatory response: • Documented fever (defined as body temperature ≥38°C) or hypothermia (with a rectal core body temperature ≤35°C); • Elevated white blood cells (WBC) (>12000 cells/µL); • Systolic blood pressure (SBP) <90 mmHg or mean arterial pressure (MAP) <70 mmHg, or a SBP decrease of >40 mmHg; • Increased heart rate ( >90 beats per minute [bpm]) and respiratory rate (>20 breaths/min); • Hypoxemia (defined as oxygen [O2] saturation <95% by pulse oximetry); • Altered mental status. • Group B: Physical findings consistent with intra abdominal infection, such as: • Abdominal pain and/or tenderness, with or without rebound; • Localized or diffuse abdominal wall rigidity; • Abdominal mass. Additional Inclusion Criteria - HAP/VAP Subjects 1. Onset of symptoms >48 hours after admission or <7 days after discharge from an inpatient care facility (for which the duration of admission was >3 days). 2. New or worsening infiltrate on chest X- ray (or computerized tomography [CT]- scan) obtained within 48 hours prior to randomization. 3. At least 1 of the following: - Documented fever (temperature ≥38°C) or hypothermia (rectal/core temperature ≤35°C); - WBC ≥10,000 cells/mm3, leukopenia with total WBC ≤4500 cells/mm3, or >15% immature neutrophils (bands) noted on peripheral blood smear. 4. At least 2 of the following: • A new cough (or worsening of cough at Baseline); • Production of purulent sputum or purulent endotracheal secretions; • Auscultatory finding consistent with pneumonia/pulmonary consolidation (eg, rales, rhonchi, bronchial breath sounds, dullness on percussion, egophony); • Dyspnea, tachypnea, or hypoxemia (O2 saturation <90% or partial pressure of O2 [pO2]<60 mmHg while breathing room air); • Need for acute changes in the ventilator support status/system to enhance oxygenation, as determined by worsening oxygenation (arterial blood gas [ABG] or pO2 in arterial blood [PaO2]/fraction of inspired O2 [FiO2]) or needed changes in the amount of positive end expiratory pressure. 5. Subjects must have a respiratory specimen obtained within 7 days prior to screening for Gram stain and culture from which a study qualifying pathogen was isolated upon culture. This includes culture of either an expectorated sputum or a specimen of respiratory secretions obtained by endotracheal aspiration in intubated subjects, or by bronchoscopy with bronchoalveolar lavage (BAL), mini BAL or protected specimen brush (PSB) sampling. Additional Inclusion Criteria - cUTI Subjects 1. Subject had urine within 7 days prior to screening that cultured positive; containing ≥10^5 colony forming unit (CFU)/mL of at least 1 carbapenem non susceptible, MBL positive Gram-negative bacteria, ie, the isolate from the study qualifying culture. 2. Subject had pyuria in the 7 days prior to screening as determined by a midstream clean catch or catheterized urine specimen with ≥10 white blood cells (WBCs) per HighPower Field (HPF) on standard examination of urine sediment or ≥10 WBCs/mm3 in unspun urine. 3. Subject demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis as defined by the following criteria: a. Acute pyelonephritis indicated by flank pain (which must have onset or worsened within 7 days of enrollment) or costovertebral angle tenderness on examination and at least 1 of the following: i) Fever, defined as body temperature ≥38°C (with or without patient symptoms of rigor, chills, or warmth); ii) Nausea and/or vomiting. OR b. Complicated lower UTI, as indicated by qualifying symptoms plus at least 1 complicating factor as follows: i) Qualifying symptoms: subject must have at least 2 of the following symptoms with at least 1 symptom from Group A: • Group A symptoms include dysuria, urgency, frequency, and or suprapubic pain; • Group B symptoms include fever (defined as body temperature ≥38°C with or without patient symptoms of rigor, chills, warmth), nausea, and/or vomiting. ii) Complicating factors: subject must have at least 1 of the following complicating factors: • Documented history of urinary retention (male subjects); • Obstructive uropathy that is scheduled to be medically or surgically relieved during study therapy and before the EOT; • Functional or anatomical abnormality of the urogenital tract, including anatomic malformations or neurogenic bladder, or with a postvoid residual urine volume of at least 100 mL; • Use of intermittent bladder catheterization or presence of an indwelling bladder catheter for at least 48 hours; • Urogenital procedure (such as cystoscopy or urogenital surgery) within the 7 days prior to obtainment of the specimen used for the study qualifying culture. Additional Inclusion Criteria - BSI Subjects 1. Subject has a confirmed diagnosis of primary BSI or catheter related BSI (CR- BSI). 2. Signs and symptoms of systemic infection characterized by at least one of the following: 1. Chills, rigors, or fever (temperature of ≥38.0°C or ≥100.4°F); 2. Elevated white blood cell count (≥10,000/mm3) or left shift (>15% immature polymorphonuclear leukocytes (PMNs)). Exclusion Criteria All Subjects 1. History of serious allergic reaction (anaphylaxis, angioedema, bronchospasm, hypersensitivity) to any systemic antibacterial allowed per protocol. 2. Subject has a concurrent infection that may interfere with the evaluation of response to the study antibiotics. 3. Subject has a need for effective concomitant systemic antibacterials in addition to those allowed per protocol for the diagnoses under study. 4. Estimated CrCL ≤15 mL/min or anticipated requirement for dialysis during the study. Additional Exclusion Criteria - cIAI Subjects 1. Subject has infections limited to the hollow viscous, such as simple cholecystitis, gangrenous cholecystitis without rupture, and simple appendicitis, or has acute suppurative cholangitis, infected necrotizing pancreatitis, or pancreatic abscess. 2. Subject has abdominal wall abscess or small bowel obstruction without perforation or ischemic bowel without perforation. 3. Subject has a cIAI managed by staged abdominal repair (STAR), or open abdomen technique, or marsupialization. This criterion is intended to exclude subjects in whom the abdomen is left open, particularly those for whom re operation is planned. Additional exclusion criteria - cUTI Subjects 1. Subjects with suspected or confirmed complete obstruction of any portion of the urinary tract, perinephric or intrarenal abscess, or prostatitis, or history of any illness that, in the opinion of the investigator, may confound the results of the study or pose additional risk in administering the study therapy to the subject. 2. Any recent history of trauma to the pelvis or urinary tract. Additional exclusion criteria - BSI Subjects 1. Subject has a prosthetic cardiac valve or synthetic endovascular graft. 2. Subject has a suspected or documented medical condition with well-defined requirement for prolonged antibiotic treatment (eg, infectious endocarditis, osteomyelitis/septic arthritis, undrainable/undrained abscess, unremoveable/unremoved prosthetic associated infection). ; PRIMARY OUTCOME: Proportion of subjects with clinical cure in the microbiological Intent-To-Treat (micro-ITT) analysis set; SECONDARY OUTCOME 1: Proportion of subjects with clinical cure in the Microbiologically Evaluable (ME) analysis set[/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 - LY03004 MD; BRIEF: This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat injections ; DRUG USED: Rykindo; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Luye Pharma Group Ltd.; CRITERIA: Inclusion Criteria: 1. Male or female patients aged 18 to 65 years old 2. Patients must have a DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder based on the Mini-International Neuropsychiatric Interview (MINI) 3. Patients must be clinically stable on antipsychotic medications other than risperidone or paliperidone or clozapine for at least 4 weeks prior to screening, based on clinical assessments AND a Positive and Negative Syndrome Scale (PANSS) total score less than or equal 70 at Screening Visit 4. Patients with a Body Mass Index in range of 18.0 to 35.0 5. Patients with an Informed Consent Form signed by the patient or legally authorized representative Exclusion Criteria: 1. Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV-TR 2. Patients who received oral risperidone or paliperidone or clozapine within 14 days prior to screening, or Risperdal® Consta® within 100 days prior to screening or paliperidone palmitate within 10 months prior to screening 3. Patients with neuroleptic malignant syndrome or physical fatigue associated with dehydration or malnutrition 4. Patients who pose a significant risk of a suicide attempt based on history, investigators judgment or have answered yes to the questions 4 or 5 for current or past 30 days on the screening form of the Columbia Suicide Severity Rating Scale (C-SSRS) 5. Patients with a history of sensitivity to akathisia and other EPS, especially with previous use of risperidone or paliperidone 6. Patients with uncontrolled diabetes mellitus as indicated by a HbA1c level greater than or equal to 7% 7. Patients with a history of or currently having epilepsy or convulsion disorders 8. Patients who have had electroconvulsive therapy within the past 2 months prior to screening 9. Patients who used medication known to be an inducer or inhibitor for CYP 2D6 within 2 weeks prior to screening 10. Patients with a history of allergic reaction to risperidone or to the excipients of LY03004 11. Patients who have met DSM-IV-TR criteria for substance abuse or dependence with the exception of caffeine or nicotine in the past 6 months prior to screening 12. Patients with a history of clinically relevant cardiac arrhythmias, cardiovascular disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis 13. Patients who are currently taking medications with primarily CNS activities such as antidepressants, mood stabilizers or anticonvulsants 14. Patients who have participated in a clinical trial of another investigational drug within 30 days prior to screening 15. Female patients who are pregnant or are breastfeeding or are of childbearing potential without adequate use of contraception 16. Patients who have any clinically relevant hepatic, renal and cardiac dysfunction, or other medical condition or laboratory abnormality, which in the judgment of the investigator would interfere with the subjects ability to participate in the study ; PRIMARY OUTCOME: Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®; SECONDARY OUTCOME 1: Number of Participants with Adverse Events as a Measure of Safety and Tolerability[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Repeat Doses (Severe); BRIEF: GSK3772847, an anti-interleukin (IL)33 receptor monoclonal antibody, is a novel treatment for asthma. This is a phase 2a study which aims to evaluate efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in subjects with moderately severe asthma. The study will be conducted in 4 phases including screening, run-in phase, treatment phase and follow-up. In treatment phase, eligible subjects will be randomized to receive either GSK3772847 or placebo administered via intravenous (IV) route every 4 weeks in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. During the treatment phase, the background therapy will be switched to FP 500 mcg for 2 weeks and the dose of FP will be reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. The total duration of study will be approximately 33 weeks and approximately 165 subjects with moderately severe asthma who are maintained on high-dose of inhaled corticosteroids/ Long-Acting Beta-2-Agonists (ICS/LABA) will be randomized. ; DRUG USED: GSK3772847; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-33 (Interleukin-33)IL-33 Receptor; THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Age: At least 18 years of age at the time of signing the informed consent. - Males and females: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow highly effective contraceptive methods from 4 weeks prior to the first dose of study medication and until at least 16 weeks after the last dose of study medication and completion of the follow-up visit. - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. - A subject with a documented diagnosis of moderate severe asthma based on Global Initiative for Asthma (GINA) 2016 Guidelines, whose asthma has been managed with regular treatment of high dose ICS defined as FP 500 mcg twice daily (i.e. 1000 mcg total daily dose) or equivalent, and LABA for at least 4 months. Additional therapy with a leukotriene receptor antagonist (LTRA) is permissible. - Airway reversibility of at least 12 percent and 200 milliliter (mL) in FEV1 at Screening (Visit 1), or documented reversibility prior to Screening (Visit 1), or documented history of bronchial hyper reactivity (e.g. fall in FEV1 from baseline of more than or equal to 20percent with standard doses of methacholine or histamine, or more than or equal to 15 percent with standardized hyperventilation, hypertonic saline or mannitol challenge) from a bronchoprovocation study [e.g. methacholine challenge prior to Screening (Visit 1)]. - ACQ-5 score more than or equal to 1.0 and less than 4.0 at Screening (Visit 1). - Had at least one asthma exacerbation within 12 months prior to screening that required treatment with systemic corticosteroid and/or hospitalization. - All subjects must be able to replace their current Short-Acting Beta2-Agonists (SABA) treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, per product label, for the duration of the study. Randomization inclusion criteria: - ACQ-5 score more than or equal to 1.0 and less than 4.0 at Visit 2. - Compliance with completion of the Daily eDiary reporting defined as completion of all questions/assessments on more than or equal to 4 of the last 7 days during the run-in period. Exclusion Criteria: - Current smokers or former smokers with a smoking history more than or equal to 10 pack years. - Presence of a known pre-existing, clinically important respiratory conditions (e.g. pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma. - A pre-bronchodilator FEV1 less than 50 percent predicted of normal value at Screening (Visit 1). - Subjects with a diagnosis of malignancy or in the process of investigation for a malignancy. Subjects with carcinoma that have not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment. - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at Screening (Visit 1) or within 3 months prior to first dose of study treatment. - Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of subject eligibility. - Weight: less than 50 kilograms (kg) and more than 150 kg. - Regular use of systemic corticosteroids for conditions including asthma within 3 months prior to Screening (Visit 1). - Subjects with high parasympathetic tone (e.g. trained athletes with baseline bradycardia) or chronic conditions associated with parasympathetic surges (e.g. migraines). - Other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes. Subjects with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1). - Clinically significant organic heart disease [e.g. Coronary artery disease (CAD), New York Heart Association (NYHA) Class III/IV heart failure]. - Ongoing infections (i.e. not resolved within 7 days prior to Screening [Visit 1]) or recurrent infections (i.e. requiring treatment for an identical diagnosis within 3 months) requiring systemic antibiotics Known, pre-existing parasitic infestations within 6 months prior to Screening. - A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. - A known immunodeficiency such as human immunodeficiency virus infection. - Subjects with allergy or intolerance to a monoclonal antibody or biologic or to any components of the formulation used in this study. - Subjects with a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Screening (Visit 1). - Subjects who are unable to follow study instructions such as visit schedule, dosing directions, study eDiary completion, or use of a standard metered dose inhaler. Subjects who have known evidence of lack of adherence to controller medication and/or ability to follow physicians recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits. - Subjects who have previously participated in a study of GSK3772847. - Use of the prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study. Potential subjects should not be washed out of their medication solely for the purpose on enrolling in the trial. - A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub investigator, study coordinator, or employee of the participating investigator. - In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a diary card/questionnaire. - Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. Randomization exclusion criteria: - Evidence of clinically significant abnormal laboratory tests during screening which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality. - Evidence of clinically significant abnormal ECG findings at Visit 2. - An abnormal and significant finding from 24-hour Holter monitoring at Screening (Visit 1). Investigators will be provided with Holter reviews conducted by an independent cardiologist to assist in evaluation of subject eligibility. - Liver function at screening (Visit 1): ALT more than 2 x upper limit of normal (ULN) and bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35 percent); Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - Subjects with ongoing asthma exacerbation at the time of Visit 2. - A pre-bronchodilator FEV1 less than 50 percent predicted of normal value at Visit 2. - Positive pregnancy test at Visit 0, Screening (Visit 1) or Visit 2. - Ongoing or recurrent infections requiring systemic antibiotics. ; PRIMARY OUTCOME: Percentage of Participants With Loss of Asthma Control Over Weeks 0-16; SECONDARY OUTCOME 1: Percentage of Participants With >=0.5 Point Asthma Control Questionnaire (ACQ-5) Score Increase From Baseline[/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 - ATTRACTION-2 (Japan); BRIEF: The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Ono Pharmaceutical Co. Ltd; CRITERIA: Inclusion Criteria: - Men & women ≥20 years of age - Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) - Histologically confirmed adenocarcinoma - Refractory to or intolerant of standard therapy - ECOG Performance Status score 0 or 1 - A life expectancy of at least 3 months Exclusion Criteria: - Current or past history of severe hypersensitivity to any other antibody products - Patients with multiple primary cancers - Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment - Patients with active, known or suspected autoimmune disease ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Progression-free survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 4137 (Healthy & Type 1 Diabetes Subjects); BRIEF: This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a range of single doses of subcutaneous insulin 338. ; DRUG USED: NN1438; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Trial Part 1 (Healthy subjects): - Male subject - Age 18-55 (both inclusive) at the time of signing inform consent - Body mass index 19.0-29.9 kg/m^2 (both inclusive) - Trial Part 2 (Subjects with type 1 diabetes mellitus): - Male subject or female subject of non-child bearing potential. Non-child bearing potential: being surgically sterilized (i.e. tubal ligation, bilateral oopherectomies or hysterectomised) for more than 3 months or being postmenopausal (as defined by amenorrhoea for at least 2 years prior to screening and documented by follicle-stimulating hormone (FSH) 40 U/L) - Age 18-64 years (both inclusive) at the time of signing inform consent - Body mass index 19.0-29.9 kg/m^2 (both inclusive) - Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer - Treated with multiple daily insulin injections or insulin pump treatment for 12 months or longer - Glycated hemoglobin (HbA1c) 9.0% or less - Fasting C-peptide less than 0.3 nmol/L Exclusion Criteria: - Trial Part 1 (healthy subjects): - History of, or presence of, cancer, diabetes mellitus or any clinically significant cardiovascular, respiratory, metabolic (including dyslipidemia), renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator - Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator - Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco products) or smoking 1 cigarette or less per day and not considering being able to refrain from smoking or refrain from use of other types of nicotine products (e.g. such as chewing tobacco, nicotine gums) during the in-house periods - Trial Part 2 (subjects with type 1 diabetes mellitus): - History of, or presence of, cancer or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, venereal, neurological, psychiatric, other major disorders or personal and/or family history of thromboembolism, as judged by the investigator - Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the past 6 months before start of this trial (screening) - Cardiac problems defined as: 1) decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time, or 2) acute myocardial infarction at any time, or 3) angina pectoris within the last 12 months before start of this trial (screening) - Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco products) or smoking 1 cigarette or less per day and not considering being able to refrain from smoking or refrain from use of other types of nicotine products (e.g. such as chewing tobacco, nicotine gums) during the in-house periods. ; PRIMARY OUTCOME: Incidence of adverse events; SECONDARY OUTCOME 1: Incidence of hypoglycaemic episodes[/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 - Lung PK; BRIEF: The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers. ; DRUG USED: Sivextro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Inclusion Criteria: - Healthy males and females, between 18 and 55 years of age, inclusive - Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control - Males must be surgically sterile, abstinent, or practicing an effective method of birth control - BMI between 20 and 34.9 kg/m2, inclusive Exclusion Criteria: - Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes - Physician-diagnosed migraine headaches within 3 years - Previous enrollment in a TR-701 or TR-701 FA trial ; PRIMARY OUTCOME: Pharmacokinetic parameters from plasma.; 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 - EGFR/KRAS; BRIEF: This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult patients with advanced Non-small-cell Lung Cancer (NSCLC), who have received at least two prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified based on their molecular tumor etiology. The following strata was assigned: Patients with Epidermal growth factor receptor (EGFR) activating mutations, Patients with Kirstin Raus sarcoma virus (KRAS) activating mutations, Patients with EML4-ALK (anaplastic lymphoma kinase) translocations and patients that were both EGFR and Kras wild type. ; DRUG USED: AUY922; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Heat Shock Protein 90 (HSP90); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with histologically or cytologically confirmed advanced (stage IIIB or stage IV) NSCLC who have received at least two prior lines of treatment. Patients who, in the investigators opinion, are deemed unsuitable for the standard 2nd line chemotherapy will be eligible for protocol participation. One of the prior lines must have included a platinum agent. Prior treatment with a platinum agent is not a requirement for EGFR mutant patients and patients with EML4-ALK translocations - Patients enrolled to the fifth stratum, modified EGFR mutant, must have documented prior response to EGFR TKI as defined by CR, PR or SD for 6 months or greater unless patient has de novo resistance to EGFR TKI (e.g. exon 20 insertions.) - All patients must have at least one measurable lesion as defined by RECIST criteria. Previously irradiated lesions are not measurable unless the lesion is new or has demonstrated clear progression after radiation - World Health Organization (WHO) performance status ≤ 2. For patients enrolled to the fifth stratum, modified EGFR mutant, World Health Organization (WHO) performance status ≤ 1 - Patients enrolled to the fifth stratum, modified EGFR mutant, must be willing and suitable to undergo fresh baseline biopsy prior to study treatment (unless patient had recent biopsy after EGFR TKI progression that concluded resistance to EGFR TKI.) - Hematologic: - Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L. - Hemoglobin (Hgb) ≥ 9 g/dl. - Platelets (plt) ≥ 100 x 109/L. Biochemistry: - Total calcium (corrected for serum albumin) within normal limits or correctable with supplements. - Magnesium within lower normal limits or correctable with supplements. Adequate liver function defined as: - AST/SGOT and ALT/SGPT ≤ 3.0 x Upper limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastasis are present. - Serum bilirubin ≤ 1.5 x ULN. - Serum albumin > 2.5 g/dL. - Serum creatinine ≤ 1.5 x ULN or 24 hour clearance ≥ 50 mL/min. Exclusion Criteria: - Patients who have received more than four lines of prior treatment. Exception: Patients enrolled to the fifth stratum, modified EGFR mutant, must not have received more than two prior lines of therapy. Chemotherapy administered as adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study. - Patients with a history of CNS metastasis. Note: Patients without clinical signs and symptoms of CNS involvement are not required to have MRI of the brain. Exception: Patients with treated brain metastases who are asymptomatic, who has discontinued corticosteroids, and who have been clinically stable for one month will be eligible for protocol participation. This exception is not valid for patients enrolled to the fifth stratum, modified EGFR mutant. These patients must not have CNS involvement. - Prior anti-neoplastic treatment with any HSP90 or HDAC inhibitor compound. - Patients must not have received: - any systemic anti-cancer treatment or radiotherapy within 4 weeks prior to first dose of study treatment and should have recovered to baseline or less than Grade 1 from toxicities of such therapy prior to the first dose of study treatment - 2 weeks for palliative radiotherapy to bones, 6 weeks for nitrosoureas and mitomycin - 4 weeks for monoclonal antibodies - and ≤5 half-life of the agent or active metabolites [if any] for continuous systemic anti-cancer treatment or investigational - Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Response Assessment by Study Stratum - Per Investigator Assessment; SECONDARY OUTCOME 1: Overall Survival Rate Using Kaplan Meier Estimates - Per Investigator Radiological Review[/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 - US; BRIEF: To determine the maximum tolerated dose (MTD) of ularitide in the treatment of subjects hospitalized with symptomatic acute decompensated heart failure (ADHF). ; DRUG USED: Ularitide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Preserved Ejection Fraction (Acute HFpEF); TARGET: Natriuretic Peptide Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Facet Biotech; CRITERIA: Inclusion Criteria: To be considered eligible for inclusion, subjects must meet all of the following criteria: - Males and females who are 18 years or older. - Unplanned hospitalization for ADHF. - Randomization should occur as soon as possible from presentation to emergency department or hospital for ADHF up to 24 hours from admission. - Dyspnea at rest as assessed by the subject not more than 1 hour prior to randomization. Subjects must have the ability to interpret and report self-assessed dyspnea. - At least 1 of the following 2 criteria: 1. Prior medical history of CHF (eg, prior hospitalization for CHF or left ventricular ejection fraction <40%, as determined by transthoracic echocardiography at the time of screening or previously determined and documented in the patients chart as follows): - Within the previous 6 months in subjects with unstable symptoms, or - Within the previous 12 months in subjects with stable symptoms. 2. Clinical evidence (at screening) of heart failure, including abnormal jugular venous pressure (JVP) (eg, >8 cm above the clavicle, assessed at 45°angle), rales or crackles more than a third above bases, or 2+ lower extremity edema. - On optimal background therapy for ADHF (as determined by the investigator); subjects are required to have received, at a minimum, at least 1 hour of oxygen supplementation and at least one dose of IV furosemide at a minimum dose of 40 mg with the last bolus being delivered >2 hours before study drug administration is initiated (or another diuretic at a comparable dose; eg, 2 mg bumetanide or 20 mg torsemide, with the last bolus being delivered >4 hours before study drug administration is initiated. - If subject received IV opiate, the last dose must have been >3 hours before administration of study drug. - Women of childbearing potential must have a negative pregnancy test prior to being randomized in the study. Women and men of reproductive potential will agree to utilize effective contraception during the entire treatment period and for 1 month after receiving the last dose of ularitide or placebo. - Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations). Exclusion Criteria: Any subject will be ineligible for this study if any one of the following criteria is met: - Breathing rate <18 breaths per minute (measured during 60 seconds). - A systolic blood pressure (SBP) <110 mmHg or >180 mmHg within an hour before randomization, or SBP <120 mmHg for subjects receiving IV inotropics or vasodilators. A SBP <90 mmHg in two successive measurements within 30 minutes before randomization. (Subjects on baseline IV inotropes or vasodilators must be on a stable dose for ³3 hours prior to randomization.) - BNP <400 pg/mL or NT?pro-BNP <1200 pg/mL anytime from initial presentation to hospital to time of randomization. - Use of IV contrast material within 48 hours before infusion of study drug. - History of central or peripheral neurological ischemic disorder (stroke, etc.). - Active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy, constrictive pericarditis, severe aortic stenosis, uncorrected primary valvular disease, or significant obstructive valve disease. - Acute decompensated heart failure associated with endocrine (eg, thyroid storm), metabolic, or drug-related toxicity. - Elevation of serum creatinine?kinase myocardial band (CK?MB) or cardiac troponin (Troponin I) >2 times the upper limit of normal within 6 hours prior to randomization. - Active, ongoing myocardial ischemia, hospitalization for acute myocardial infarction, or administration of thrombolytic therapy in the last 30 days prior to randomization, or, any ECG abnormalities in the opinion of the investigator, suggestive of active ischemic changes. - Percutaneous coronary intervention, coronary artery bypass graft surgery, other cardiac surgery, or major noncardiac surgery within 90 days prior to randomization. - Any cardiogenic shock (SBP <90 mmHg with signs or symptoms of organ hypoperfusion) from initial presentation to randomization. - Any significant volume depletion or severe electrolyte imbalance. - Renal disorder with a creatinine clearance <30 mL/min, as calculated by the Cockcroft-Gault equation at screening. - Use of a phosphodiesterase type 5 (PDE 5) inhibitor such as sildenafil within 72 hours prior to randomization. - Planned coronary revascularization procedure (percutaneous coronary intervention or coronary artery bypass grafting) during current hospital admission. - Use or anticipated need for invasive or noninvasive mechanical circulatory or ventilatory support. - Anemia (hemoglobin <10 mg/dL or a hematocrit <30%). - Vasculitis, active infective endocarditis, or suspected infections including pneumonia or sepsis. - Body temperature ≥ 38º C. - Significant acute or chronic respiratory disorder (eg, severe chronic obstructive pulmonary disease) or primary pulmonary hypertension with baseline dyspnea that may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements. - Terminal illness other than CHF with expected survival <180 days. - Previous exposure to ularitide. - Nesiritide treatment in the last 30 days prior to randomization. - Allergy to natriuretic peptides. - Participation in a clinical drug trial or investigational device trial within 30 days prior to randomization. - Current drug abuse or chronic alcoholism (at the Investigators determination). - Women who are pregnant or breast-feeding. Women of childbearing age will have a urine pregnancy test to determine pregnancy status within 24 hours prior to randomization. - Any condition that, in the investigators opinion, makes the subject unsuitable for study participation, including a history of repeated admission related to non-adherence to prescribed medication. - For subjects with concomitant invasive hemodynamic monitoring (ie, pulmonary artery catheter monitoring): Baseline PCWP ≤ 20 mmHg. ; PRIMARY OUTCOME: The MTD of ularitide infused over 48 hours.; SECONDARY OUTCOME 1: Frequency, severity, and relationship of AEs and serious adverse events (SAEs) to study drug through Day 32 (ie, 30 days following the end of study drug infusion).[/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 - OL006; BRIEF: The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body. ; DRUG USED: Aptocine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Combination; LEAD SPONSOR: Light Sciences Oncology; CRITERIA: Inclusion Criteria: - Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI - Biopsy proven evidence of colorectal cancer - At least one liver lesion that can be measured in one dimension at >10 mm with spiral CT scan (CT preferred but MRI allowed) - ECOG Performance Status 0-2 - Life expectancy of at least 16 weeks - At least 30 days must have elapsed since the completion of any prior antineoplastic therapy and the patient must have recovered from acute side effects before day 0 - Understanding and ability to sign written informed consent - 18 years of age or more - Adequate hematologic, liver and renal functions as evidenced by the following: WBC > 2.5 × 10^9/L ; Platelet Count > 100 × 10^9/L ; Hemoglobin > 90 g/L ; Neutrophils >1.5 × 10^9/L ; PT and PTT < 1.5 Control ; SGOT, SGPT < 5 × ULN ; GGT < 5 × ULN ; Alkaline phosphatase < 5 × ULN ; Bilirubin < 3 × ULN ; Creatinine < 1.5 × ULN Exclusion Criteria: - Patients who are candidates for complete surgical resection - Patients who received bevacizumab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizumab or cetuximab is prohibited while participating in this study - Patients who would require more than a total number of 12 light source applications over three Litx™ experimental treatments (no more than 4 light sources per treatment). - Patients who have a single measurable tumor greater than 7.5 cm in any organ - Target lesions irradiated within 3 months of randomization - Patients with tumor involvement in greater than 50% of parenchyma of the liver - Evidence of major vessel invasion of any organ - Patients with any non-colorectal cancers except for adequately treated basal or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient has been disease-free for ≥ 3 years, or other cancer from which the patient has been disease-free for ≥ 5 years - Known sensitivity to porphyrin-type drugs or known history of porphyria - Pregnancy or breast-feeding patients. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study - Concurrent participation in another clinical trial involving experimental treatment - Any concurrent disease or condition that in the opinion of the investigator impairs the patients ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigators opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trials data. ; PRIMARY OUTCOME: Overall Survival; 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 - ATHOS-I; BRIEF: The investigators propose a dose finding study to determine the feasibility of Angiotensin II (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to increase mean arterial pressure, this could lead to future pharmacologic development based on the AII hormonal pathway. The investigators propose a 20 patient, randomized, placebo-controlled, blinded study in the treatment of high-output shock. Patients with high-output shock and a cardiovascular SOFA (sequential organ failure score) score of > 4 will be eligible. In addition, patients must already be receiving cardiac output monitoring and have a cardiac index > 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous AII or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety and dose finding feasibility study. The investigators are starting with a small cohort consistent with similar types of studies. The investigators estimate that ten patients in each arm will generate a basis for determining if there is sufficient signal for AII to improve blood pressure at the doses outlined. The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a MAP of 65 mmHg. Secondary endpoints will be the effect of AII on urine output, serum lactate, and creatinine clearance. 30 day post dose mortality will also be assessed. Subjects discharged prior to day 30 will be contacted by telephone for this assessment. ; DRUG USED: Giapreza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypotension/Shock; TARGET: Angiotensin II Receptor Type 1 (AT1), Angiotensin II Receptor Type 2 (AT2); THERAPY: Monotherapy; LEAD SPONSOR: George Washington University; CRITERIA: Inclusion Criteria: 1. High-output shock 2. Cardiovascular SOFA score of > 4 3. Cardiac Index > 2.4 liters/min/BSA 1.73m2 4. Indwelling arterial line already present as part of standard care 5. Age > 21 years of age 6. Signed consent form 7. Use of indwelling urinary catheter as standard care expected at least for 12 hours during the study interventions Exclusion Criteria: 1. Patients with acute coronary syndrome 2. Patients with a known history of vasospasm 3. Patients with a history of asthma 4. Patients currently experiencing bronchospasm 5. Patients with active bleeding with an anticipated need for > 4 units of PRBC or Hemoglobin < 7g/dL or any other condition that would contraindicate drawing serial blood samples ; PRIMARY OUTCOME: Efficacy; SECONDARY OUTCOME 1: Biomarkers[/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 - SPRINT; BRIEF: The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy. Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in all colorectal cancers and since the adaptive immune system plays a role in the prognosis of rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might boost the tumor-specific immune response and increase the number of tumor-infiltrating lymphocytes (TILs). ; DRUG USED: Tecemotide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Immune System, Mucin 1 (MUC-1); THERAPY: Combination; LEAD SPONSOR: Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: 1. Male and female subjects with histologically documented resectable rectal adenocarcinoma in Stage 2-4 2. Availability of tumor biopsy sufficient for immunological analysis 3. Indication to receive neoadjuvant concomitant chemoradiotherapy consisting of a radiation dose of 45-52 Gy and capecitabine 825 mg/m^2 orally twice daily. The use of an equivalent schedule based on 5-FU is acceptable 4. Magnetic resonance imaging small pelvis / computed tomography thorax/abdomen (or X-ray thorax) to document absence of metastatic disease. Imaging must not be older than 6 weeks prior to randomization 5. Eastern Cooperative Oncology Group performance status of 0 or 1 6. Written informed consent 7. Greater than or equal to (>=) 18 years of age Exclusion Criteria: 1. Previous chemotherapy and/or previous radiotherapy of the pelvic region 2. Relapsing disease 3. Previous vaccination with any MUC1 vaccine and other therapeutic cancer vaccines 4. Previous organ transplantation (bone marrow or solid organs) 5. Subjects with metastatic disease (except for solitary, resectable liver or lung metastases) 6. Inadequate hematological function (that is, platelet count less than 140*10^9 per liter [/L], or white blood cell less than 2.5*10^9/L, or hemoglobin less than 90 gram per liter). Clinically significant hepatic dysfunction (that is alanine aminotransferase greater than 2.5*upper limit of normal [ULN], or aspartate aminotransferase greater than 2.5*ULN, or bilirubin greater than 1.5*ULN). Inadequate renal function (that is serum creatinine greater than 1.5*ULN) 7. Autoimmune diseases 8. Recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies 9. Clinically significant cardiac disease, for example, New York Heart Association Classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by medical history and an electrocardiogram 10. Other protocol defined exclusion criteria could apply ; PRIMARY OUTCOME: Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery); SECONDARY OUTCOME 1: Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)[/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 - Acute VOC; BRIEF: A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects with Sickle-Cell Disease (SCD). ; DRUG USED: Sevuparin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Coagulation Factor X, Selectins, Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Modus Therapeutics AB; CRITERIA: Inclusion Criteria: - Sign a written informed consent (adults, parents) and assent (adolescents) - Male or female, age 12-50 years. - Diagnosis of Sickle cell disease - Subjects admitted for an acute, painful VOC to be treated/or treated with parenteral opioid analgesia. - Expectancy of need for hospitalization during at least 48 hours. - Be at least 1 year postmenopausal, surgically sterile, or if Women of Child Bearing Potential (WOCBP), e.g. following menarche practicing an effective method of birth control Exclusion Criteria: - Severe hepatic failure/disease, abnormal liver enzyme tests or history of hepatitis B virus (HBV), hepatitis C virus (HCV) - Abnormal conjugated (direct) bilirubin 3 fold above ULN - History of clinically significant bleeding in vital organs - Current clinically significant bleeding, as judged by the investigator - Current use of acetylsalicylic acid (ASA), anti-platelet therapy, anticoagulant therapy - Abnormal coagulation laboratory values - A platelet count <75,000/µL. - BMI >35 - Subjects with more than 5 hospitalizations for VOC during the last 6 months - Evidence of acute SCD complications other than VOC at screening - The use of strong opioids for > 3 consecutive days during the last 15 days before presenting to the hospital - History of chronic drug abuse. - Renal dysfunction - Known infection (positivity) with human immunodeficiency virus (HIV), HBV or HCV. - Significant ECG abnormality - History of a clinically significant drug allergy to heparin, LMWHs, sevuparin, or morphine. - Use of any investigational agent during the 30 days prior to the first dose. - For females: pregnancy, lactating or intention of becoming pregnant - Evidence of clinically significant disorders that might interfere with the study aim or safety of the subject - Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study. ; PRIMARY OUTCOME: Time to resolution of VOC; SECONDARY OUTCOME 1: Frequency and pattern of treatment-emergent adverse event (TEAEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - KEYNOTE-669/ECHO-304 (w/Pembrolizumab); BRIEF: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). ; DRUG USED: Epacadostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Measurable disease based on RECIST v1.1. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function per protocol-defined criteria. - Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer. - Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen. Exclusion Criteria: - Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors. - Disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. - Use of protocol-defined prior/concomitant therapy. - Known additional malignancy that is progressing or has required active treatment within the past 3 years. - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Active autoimmune disease that has required systemic treatment in past 2 years. - Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority. - Known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is detected). ; PRIMARY OUTCOME: Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen; SECONDARY OUTCOME 1: Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - boosted (Atazanavir or Darunavir); BRIEF: The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to < 18 years) with HIV. ; DRUG USED: Tybost; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Cytochrome p450; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - HIV-1 infected, virologically suppressed males and females Age ≥ 4 weeks to < 18 years (according to requirements of enrolling Cohort). - Body weight at screening ≥ 25 to < 40 kg (Cohort 2); ≥ 14 to < 25 kg (Cohort 3); ≥ 3 to < 25 kg (Cohort 4); ≥ 3 to < 14 kg (Cohort 5) - Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening visit. - Participants enrolled prior to implementation of Amendment 7: 2 NRTIs and ATV/r once daily or DRV/r once daily or twice daily. - Participants enrolled after the implementation of Amendment 9: - Cohorts 2, 3 and 4 (Group 1): 2 NRTIs plus a third agent per local prescribing guidelines. Participants will switch from their current third agent to ATV or DRV at Day 1. Participants taking DRV must be on once-daily dosing or must switch to once daily at or prior to Day 1. Cohort 4 (Group 1), participants may also switch their current third agent to LPV/r at Day 1. Participants will switch their NRTI backbone to F/TAF. - Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): 2 NRTIs plus a third agent per local prescribing guidelines or treatment naive. Participants on treatment will switch from their current third agent to ATV or LPV/r (Cohort 4 [Groups 2 to 4]), or to a third unboosted agent (Cohort 5 [Groups 1 to 3]). Participants will switch their NRTI backbone to F/TAF. - Participants undergoing dose modifications to their ARV regimen for growth or switching medication formulations are considered to be on a stable ARV regimen. - Documented plasma HIV-1 RNA for ≥ 3 months preceding the screening visit: - Participants enrolled after the implementation of Amendment 9: - For Cohorts 2, 3, and 4 (Group 1), virologically suppressed ≥ 3 months preceding the screening visit: HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) - For Cohorts 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3), on an ARV regimen irrespective of plasma HIV-1 RNA copies or treatment naive; a participant is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment - For virologically suppressed participants, unconfirmed virologic elevations of HIV-1 RNA ≥ 50 copies/mL (transient detectable viremia, or blip) prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on 2 consecutive HIV-1 RNA tests. - Adequate renal function: Estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73m2 using the Schwartz formula. If ≥ 1 year old, eGFR greater than or equal to the minimum normal value for age using the Schwartz Formula. If < 1 year old as follows: - Age Minimum Value for eGFR (mL/min/1.73 m2) > 28 days to ≤ 95 days 30, ≥ 96 days to ≤ 6 months 39, > 6 to < 12 months 49 - Participants must not have documented or suspected resistance to applicable study drugs including FTC, TFV, ATV, DRV, or LPV. Participants < 14 kg (Cohorts 4 [Groups 2 to 4] and 5 [Groups 1 to 3]) with M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed. - Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age). - Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): Last dose of nevirapine or efavirenz, if applicable, ≥ 14 days prior to enrollment. Note: Other protocol defined Inclusion/Exclusion criteria do apply. ; PRIMARY OUTCOME: Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV; SECONDARY OUTCOME 1: PK Parameter: Ctau of ATV, DRV, TAF, and TFV[/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 - 003 (Multiple Dose); BRIEF: The study was conducted as a placebo-controlled, randomized, 22-week double-blind study which included a dose titration period. An additional transition period occurred for those patients who elected to enroll into the open-label extension study, APD811-007. A total of 61 patients with PAH were enrolled. ; DRUG USED: Ralinepag; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: United Therapeutics; CRITERIA: Inclusion Criteria: - Males or females aged 18-75 years, inclusive - Symptomatic WHO Group 1 PAH classified by one of the following subgroups: - Idiopathic pulmonary arterial hypertension (IPAH); - Heritable pulmonary arterial hypertension (HPAH); - Drugs and toxins induced; - Associated pulmonary arterial hypertension (APAH); specifically connective tissue diseases, HIV infection and congenital heart disease. - Has had the diagnosis of PAH confirmed by cardiac catheterization - Has WHO/NYHA functional class II- IV symptomatology - Previously diagnosed with PAH and on stable oral disease-specific PAH therapy with either an ERA and/or an agent acting on the nitric oxide pathway, i.e. a PDE5 inhibitor or a soluble guanylate cyclase stimulator. Stable is defined as no change in dose within 3 months of the start of Screening and for the duration of the study - Has 6MWT distances of 100-500 m, and within 15% of each other on 2 consecutive tests done on different days at Screening - Has pulmonary function tests (PFTs) within 6 months prior to the start of Screening with no evidence of significant parenchymal lung disease - Has a ventilation-perfusion (V/Q) lung scan or pulmonary angiogram within 5 years prior to Screening and concomitant with or following diagnosis of PAH that shows no evidence of thromboembolic disease - If on vasodilators (including calcium channel blockers), digoxin, spironolactone, or L-Arginine supplementation; the patient must be on a stable dose for at least 1 month prior to the start of Screening Exclusion Criteria: - Newly diagnosed with PAH and on no disease-specific PAH therapy - Previous participation in any clinical study with an investigational drug, biologic, or device within 2 months prior to the Screening visit - Acutely decompensated heart failure within 1 month prior to start of Screening - Systolic blood pressure <90 mm Hg at Screening - Evidence or history of left-sided heart disease and/or clinically significant cardiac disease - Use or chronic administration (defined as >30 days) of a prostacyclin or prostacyclin analogue within 3 months of Screening - Any previous use of a prostacyclin or prostacyclin analogue that was stopped for safety or tolerability issues associated with pharmacology/mechanism of action - Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study ; PRIMARY OUTCOME: Change From Baseline in Pulmonary Vascular Resistance (PVR); 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 - NF1-202; BRIEF: This is a randomized, double-blind, vehicle-controlled, parallel group dose response study evaluating the safety and effectiveness of 2 concentrations of NFX-179 Gel in subjects with cutaneous neurofibromas. At Visit 1, the investigator will identify 10 Target cNFs that fulfil the enrollment criteria. The Target cNFs must be located on the subjects face, anterior trunk, or upper extremities. Two Target cNFs must be on the face and 8 must be on the anterior trunk or upper extremities. The study medication will be applied topically QD to the Target cNFs for 182days (26 weeks). During the duration of the study subjects will be evaluated for safety and efficacy. ; DRUG USED: NFX-179; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neurofibromatosis (NF); TARGET: MAPK/ERK (mitogen-activated protein kinases/extracellular signal-regulated kinases; Ras-Raf-MEK-ERK pathway); THERAPY: Monotherapy; LEAD SPONSOR: NFlection Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Subject is at least 18 years of age 2. Subject must provide written informed consent prior to any study procedures 3. Subject must have a clinical diagnosis of NF1 4. Subject has 10 clinically diagnosed Target cNFs with preferably 2 Target cNFs located on the face and 8 Target cNFs located on the anterior trunk or upper extremities. Alternatively, at least 1 Target cNF is located on the face, in which case 9 Target cNFs must be located on the anterior trunk or upper extremities. Each Target cNF must meet the following criteria: - Has, in the investigators opinion, a clinically typical appearance - Is not within 1 cm of the orbital rim - Is not covered with hair that might, in the investigators opinion, interfere with obtaining photographs or impair evaluation of the cNF - Has a Physicians Tumor Assessment grade ≥2 - Is dome shaped - Is not pedunculated - Is a discrete cNF surrounded by sufficient non-affected skin that, in the investigators opinion: - The dimensions can be measured - The perimeter can be outlined in the study photographs - Is not irritated (e.g., bleeding, inflamed) - Is not in an area subject to repeated trauma (e.g., area that is shaved, on the beltline, under a bra strap, etc.) - Does not have an active cutaneous infection - Target cNFs on the face must have the following tumor dimensions: - Has a length that is ≥5mm and ≤14mm - Has a width that is ≥5mm and ≤14mm - Has a height that is ≥2mm. - Target cNFs on the anterior trunk or upper extremities must have the following tumor dimensions: - Has a length that is ≥7mm and ≤14mm - Has a width that is ≥5mm and ≤14mm - Has a height that is ≥2mm. 5. Subject agrees to avoid exposure of Target cNFs to excessive sunlight and to use her/his routine sunscreen if excessive exposure cannot be avoided 6. Subject agrees NOT to use tanning beds 7. Subject is willing to forego treatment of each Target cNF, except protocol specified therapy, during the study 8. Female subjects who are women of childbearing potential must have a negative urine pregnancy test result and be willing to use a protocol approved, contraceptive method for the duration of the study 9. Subject is willing and able to follow all study instructions and to attend all study visits. Exclusion Criteria: 1. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on or in proximity to any Target cNF that, in the investigators opinion, impairs evaluation of any the cNFs or which exposes the subject to an unacceptable risk by study participation: - Corticosteroids; 30 days - Prescription retinoids (e.g., tazarotene, tretinoin, adapalene); 30 days - > 5% of an alpha-hydroxy acid (e.g., glycolic acid, lactic acid); 30 days - Fluorouracil; 30 days - Imiquimod; 30 days - LASER, light (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]) or other energy-based therapy; 180 days - MEK inhibitor or BRAF inhibitor; ever. 2. The subject has used any of the following systemic medications therapies within the specified period prior to Visit 1: - Retinoids (e.g., etretinate, isotretinoin); 90 days - MEK inhibitors; 180 days - BRAF inhibitors; 180 days 3. Subject has a history of hypersensitivity to any of the ingredients in the study medications 4. Subject has any known intercurrent illness or physical condition that would, in the investigators opinion, impair evaluation of a Target cNF or which exposes the subject to an unacceptable risk by study participation 5. Subject has, in the investigators opinion, clinically relevant history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis 6. Subject has a history of metastatic disease, or active cancer (excluding nonmelanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or Stage 0 chronic lymphocytic lymphoma) within the previous 5 years 7. Subject has any condition (e.g., other skin conditions or diseases, metabolic dysfunction, physical examination findings, clinical laboratory findings) or situation (e.g., vacation, scheduled surgery) that would, in the investigators opinion, impair evaluation of a Target cNF or which exposes the subject to an unacceptable risk by study participation 8. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within the previous 30 days ; PRIMARY OUTCOME: Safety and effectiveness of once daily NFX-179 gel treatment for 182 days measured by local tolerability assessments, safety laboratory tests, and target cNF volume reduction; SECONDARY OUTCOME 1: Percent of subjects with at least 50% Target cNF volume reduction after 182 days[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PIDD; BRIEF: This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD). ; DRUG USED: Asceniv; DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: ADMA Biologics, Inc.; CRITERIA: Inclusion Criteria: To be eligible to participate in this study, the subjects must meet the following criteria: 1. Signed a written informed consent or a specific assent form for minors. 2. Have a diagnosis of primary immunodeficiency disease. 3. Be ≥ 2 years and ≤ 75 years. 4. Have body weight ≥ 12 kg at screening. 5. Have been receiving IGIV at a dose that has not been changed by >50% of the mean dose on a mg/kg basis for at least 3 months prior to study entry and have maintained a trough serum Immunoglobulin G (IgG) level ≥ 500 mg/dL on the previous 2 assessments prior to receiving RI 002. The trough level must be at least 300 mg/dL above the pre-treatment serum IgG level. 6. For female subjects, be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant by adherence to a reliable contraceptive method for the duration of the study. Exclusion Criteria: Subjects must be excluded if they meet any of the following criteria: 1. Have a known hypersensitivity to immunoglobulin or any excipient in RI-002. 2. Have a history of a severe anaphylactic or anaphylactoid reaction to blood or any blood-derived product. 3. Have a specific Immunoglobulin A (IgA) deficiency, history of allergic reaction to products containing IgA or has demonstrable antibodies to IgA. 4. Have uncompensated hemodynamically significant congenital or other heart disease. 5. Have a medical condition that is known to cause secondary immune deficiency. 6. Have a significant T-cell deficiency or deficiency of granulocyte number or function. 7. Have significant renal impairment or have a history of acute renal failure. 8. Have abnormal liver function. 9. Be receiving chronic anti-coagulation therapy. 10. Have a history of deep vein thrombosis (DVT), thrombotic or thrombo-embolic event, or are at increased risk for thrombotic events. 11. Current daily use of the following medications: - corticosteroids (> 7.5 mg (or equivalent dose on a mg/kg basis) of prednisone equivalent per day for > 30 days) - immunomodulatory drugs - immunosuppressive drugs (excluding topical pimecrolimus (Elidel) and tacrolimus (Protopic)) 12. Administration of a hyperimmune or specialty high titer immunoglobulin product. 13. Have uncontrollable arterial hypertension. 14. Have a history of hemolysis or positive Coombs test while undergoing treatment with IGIV therapy. 15. Be morbidly obese as indicated by a Body Mass Index (BMI) ≥ 40 16. Have received any blood product (other than Immunoglobulin G) within 3 months prior to screening. 17. Have received any Respiratory Syncytial Virus (RSV) specific products, including palivizumab (Synagis®) within 3 months prior to screening. 18. Have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months. 19. Have any condition or abnormal laboratory assessment judged by the investigator to preclude participation in the study. 20. Are currently pregnant or nursing. 21. Have hepatitis A, B, or C. ; PRIMARY OUTCOME: Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008)); SECONDARY OUTCOME 1: Incidence of All Infections (Serious and Non-serious)[/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 - Safety/Tolerability; BRIEF: Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well. ; DRUG USED: Cycloset; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Dopamine 2 (D2) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: VeroScience; CRITERIA: Inclusion Criteria: - Type 2 diabetes - age 30-80 years - body mass index < 43 kg/m2 - HbA1c ≤ 10% for at least 12 weeks prior to screening - stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents (no more than 2), or insulin (with or without no more than 1 oral hypoglycemic agent) for 4 weeks prior to randomization Exclusion Criteria: - Subject who had taken prescription sympathomimetic drugs within seven (7) days prior to the first screening visit. Prescription sympathomimetic drugs were not allowed for any period greater than ten (10) consecutive days during the course of the study. Other ergot alkaloid derivatives or anti-migraine medications such as zolmitriptan (Zomig) and sumatriptan (Imitrex) were not permitted during the study. - Subject who had a history of alcoholism or drug abuse in the three (3) years prior to the first screening visit. - Subject who had a known hypersensitivity to any of the formulation components of the study drug. - Subject who had received any experimental drug or used an experimental device in the 30 days prior to the first screening visit or would do so during the study. - Subject who was pregnant or lactating women or women planning to become pregnant during the study. Women of childbearing potential had to have a negative pregnancy test at screening. Women who became pregnant were discontinued from the study. - Subject who had given donations of blood during the 30 days prior to the screening visit. Donation of blood also was prohibited during the study and for 30 days after completion of the study. - Subjects with clinically significant major organ system disease, such as - seizure disorder - significant gastroparesis or orthostatic hypotension (autonomic neuropathy) - cerebrovascular accident in the previous 6 months - uncontrolled hypertension (systolic BP >160 or diastolic BP > 100 at screening) - coronary artery bypass graft or coronary angioplasty in the previous 3 months, myocardial infarction in the previous 6 months, or unstable angina pectoris (chest pain at rest, worsening chest pain, or admission to the ER or hospital for chest pain) within the previous 3 months - congestive heart failure defined by NYHA as Class III or IV - clinical nephrotic syndrome, or renal impairment with a serum creatinine > 1.4 mg/dl if female receiving treatment with metformin, > 1.5 mg/dl if male receiving treatment with metformin, and > 1.6 mg/dl in not on metformin - impaired liver function, including having AST or ALT greater than three times the upper limit of normal - active infection (e.g., HIV, hepatitis), or a history of severe infection during the 30 days prior to screening - major surgical operation during the 30 days prior to screening - cancer, other than non-melanoma skin or non metastatic prostate cancer within the past 5 years - Any concurrent illness, other than diabetes mellitus, not controlled by a stable therapeutic regimen - Working rotating, varying or night shifts - Patients taking unapproved herbal supplements that may be associated with a risk of cardiovascular events (such as ephedra, yohimbe etc) - Patients who had started therapy with an erectile dysfunction drug within 2 weeks prior to screening; patients could not begin treatment with an erectile dysfunction drug during the study period; patients previously taking erectile dysfunction drugs could do so only under medical supervision. - Subjects with circumstances or abnormalities (e.g., blindness or a history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study. - Clinically significant abnormalities (values outside the normal range) on screening central laboratory evaluation unless discussed with and approved by the study principal investigator or Sponsor medical monitor. ; PRIMARY OUTCOME: Subjects Experiencing Serious Adverse Events; SECONDARY OUTCOME 1: Number of Subjects Experiencing Serious Cardiovascular 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 - Study 002 (Japan); BRIEF: This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed. ; DRUG USED: Siliq; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 Receptor (IL-17R); THERAPY: Monotherapy; LEAD SPONSOR: Kyowa Kirin Co., Ltd.; CRITERIA: Inclusion Criteria: - Subject has had stable moderate to severe plaque psoriasis for at least 6 months. - Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator. - Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline. Exclusion Criteria: - Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis. - Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis. - Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection - Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol. - Subject has used the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus , topical vitamin A, activated form D3 or activated form D3 analogue preparations, weak through strong topical steroids (excluding application on the scalp, axillae, and groin) - Subject has used the following therapies within 28 days of the first dose: any other systemic psoriasis therapy (eg, vitamin A, calcineurin inhibitors, methotrexates, steroids), UVA therapy (with or without psoralen), very strong or strongest topical steroid, tar therapy - Subject has used the following therapies within 3 months of the first dose: adalimumab, etanercept, infliximab, or live vaccines - Subject has used ustekinumab within 6 months of the first dose - Subject has previously used an anti-interleukin-17 biologic therapy ; PRIMARY OUTCOME: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12; SECONDARY OUTCOME 1: PASI 75 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 - ENDOMAX (Endocvascular Interventions); BRIEF: The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes. ; DRUG USED: Angiomax; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral Arterial Disease (PAD); TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: The Medicines Company; CRITERIA: Inclusion Criteria: - Participants ≥ 18 years of age - Must be undergoing one of the following PEI procedures: - Carotid artery stenting - Lower Extremity Interventions (LEI) for Critical Limb Ischemia - LEI for claudication - Provide written informed consent prior to any study-specific procedure being performed Exclusion Criteria: - Any known contra-indication to the use of bivalirudin or UFH - Acute limb ischemia - Planned amputation regardless of the outcome of the PEI - Dialysis dependent - Weight less than 38 kg or more than 202 kg - History of any bleeding diathesis or severe hematological disease - History of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage - Gastrointestinal or genitourinary bleeding within the 30 days prior to randomization - Any surgery (excluding punch or shave skin biopsy) within the 30 days prior to randomization - Concomitant percutaneous coronary intervention - Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization - International normalized ratio >1.7 within 24 h prior to the index procedure - Administration of therapeutic doses of UFH within 30 min prior to the index procedure (a low dose [≤2000 U] of heparin is permitted during the diagnostic angiogram prior to the intervention) - Administration of enoxaparin within 8 h; other low molecular weight heparins or fondaparinux within 24 h; any oral anti-Xa or antithrombin agent within 48 h; or thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index procedure - Severe contrast allergy that cannot be pre-medicated - Procedures performed by radial access when they are intended as the primary access site for the index procedure - Known or suspected pregnant women or nursing mothers - Previous enrollment in this study (MDCO-BIV-12-03) - Participation in other investigational drug or device trials within 30 days prior to randomization - Participants who, for any reason, are deemed by the investigator to be inappropriate for this study ; PRIMARY OUTCOME: Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC); SECONDARY OUTCOME 1: Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration[/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/Metronidazole vs. Meropenem (Ped.); BRIEF: This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) plus metronidazole, compared with that of meropenem in pediatric participants with cIAI. ; DRUG USED: Zerbaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Intra-Abdominal Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has a legally acceptable representative who provides documented informed consent/assent for the trial. - Aged from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18 years of age. - Require IV antibacterial therapy for the treatment of presumed or documented cIAI. - Has an operative procedure for the current diagnosis and management of cIAI planned or completed within 24 hours of the first dose of an antibacterial drug. Note: Participants with a diagnosis of necrotizing enterocolitis are exempt and not required to have surgery planned or completed in order to be eligible. - Has in compliance baseline intra-abdominal specimen collection. - Is not of reproductive potential; but if of reproductive potential agrees to avoid becoming pregnant or impregnating a partner during screening, while receiving study treatment and for at least 30 days after the last dose of study treatment. - Female of reproductive potential is not pregnant, and not planning to become pregnant within 30 days of the last day of treatment administration; and is nonlactating. Exclusion Criteria: - Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days prior to the first dose of study treatment in this current trial. - Has previously participated in any trial of ceftolozane or ceftolozane/tazobactam or has enrolled previously in the current trial and been discontinued. - Has a history of any moderate or severe hypersensitivity (e.g, anaphylaxis), allergic reaction, or other contraindication to any of the following: β-lactam antibiotics (e.g, penicillins, cephalosporins, and carbapenems), β-lactamase inhibitors (e.g, tazobactam, sulbactam, clavulanic acid, avibactam), or metronidazole. - Has an IAI within the past 1 year prior to randomization known to be caused by a pathogen resistant to either IV study treatment. - Has a concomitant infection at the time of randomization that requires non-study systemic antibacterial therapy in addition to IV study treatment or oral step-down therapy. - Has received potentially therapeutic antibacterial therapy for a duration more than 24 hours during the 48 hours preceding the first dose of study treatment, unless is considered to be failing antibiotic therapy for cIAI. - Has any of the following: a) intractable cIAI that the investigator anticipates would require more than 14 days of study treatment; b) abdominal wall abscess; c) small bowel obstruction; d) ischemic bowel disease without perforation; e) traumatic bowel perforation with surgery within 12 hours of perforation; f) perforation of gastroduodenal ulcers requiring surgery within 24 hours of perforation; g) suspected uncomplicated intra-abdominal infection (e.g, cholecystitis without rupture or extension beyond the gallbladder wall); h) acute suppurative cholangitis; i) infected necrotizing pancreatitis; j) pancreatic abscess. - Has moderate or severe impairment of renal function. - Has a seizure disorder or is anticipated to be treated with divalproex sodium or valproic acid during the course of study treatment. - Is receiving, or is expected to receive, any prohibited medications. - Has any rapidly progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure, or septic shock. - Has an immunocompromising condition. - Has a history of malignancy ≤5 years prior to signing informed consent. - Is planning to receive suppressive/prophylactic antibiotics with gram-negative activity after completion of study treatment. ; PRIMARY OUTCOME: Number of Participants Experiencing ≥1 Adverse Events (AEs); SECONDARY OUTCOME 1: Percentage of Participants With a Clinical Response of Cure at the End of Treatment (EOT) 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 II - Ewings Sarcoma; BRIEF: This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis® (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the antitumor activity of Zalypsis. ; DRUG USED: Zalypsis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bone Cancer; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: PharmaMar; CRITERIA: Inclusion Criteria: 1. Voluntary written informed consent, obtained from the patient or his/her representative before the beginning of any specific study procedures. 2. Age ≥ 16 years. 3. Histologically or cytologically confirmed EFT (Ewing Family of Tumors), with recurrent disease. 4. Documented failure to at least one prior chemotherapy regimen for their disease. 5. Radiographic documentation of disease progression at study entry. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≤ 2. 7. Life expectancy ≥ 3 months. 8. Complete recovery from the effects of drug-related adverse events (AEs) derived from previous treatments, excluding alopecia and grade 1 peripheral neuropathy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.0. 9. At least one measurable lesion (target lesion according to the RECIST v.1.1), located in a non-irradiated area and adequately measured less than four weeks before study entry. Tumors within a previously irradiated field will be designated as non-target lesions unless progression is clearly documented or biopsy proven. 10. Absolute neutrophil count (ANC) ≥ 1.5 x 109/l; platelet count ≥ 100 x 109/l, and hemoglobin ≥ 9 g/dl. 11. Adequate renal function: calculated creatinine clearance (using Cockcroft and Gaults formula) ≥ 30 ml/min. 12. Adequate hepatic function: - Total bilirubin ≤ 1.5 x upper limit or normality (ULN), unless due to Gilberts syndrome. - Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN in case of hepatic metastases), and alkaline phosphatase (AP) ≤ 2.5 x ULN (≤ 5 x ULN in case of extensive bone involvement). - Albumin ≥ 25 g/l. 13. Left ventricular ejection fraction (LVEF) within normal limits (LVEF of at least 50%). 14. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment. Acceptable methods of contraception include complete abstinence, intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository). Exclusion Criteria: 1. Prior therapy with Zalypsis®. 2. Pregnant or lactating women or women of childbearing potential not using an appropriate contraceptive method. 3. Less than three weeks from prior radiation therapy, biological therapy or chemotherapy. 4. Less than six weeks from prior nitrosourea, mitomycin C, high-dose chemotherapy or radiotherapy involving the whole pelvis or over 50% of the spine, provided that acute effects of radiation treatment have resolved. Hormonal therapy and palliative radiation therapy (i.e., for control of pain from bone metastases) must be discontinued before study entry. 5. Patients with a prior invasive malignancy (except non-melanoma skin cancer and in situ cervix carcinoma) who have had any evidence of disease within the last five years or whose prior malignancy treatment contraindicates the current protocol therapy. 6. Evidence of progressive or symptomatic central nervous system (CNS) metastases or leptomeningeal metastases. 7. Other diseases or serious conditions: - Increased cardiac risk, as defined by: - Unstable angina or myocardial infarction within 12 months before inclusion in the study. - New York Heart Association (NYHA) grade II or greater congestive heart failure. - Symptomatic arrhythmia or any arrhythmia requiring ongoing treatment. - Abnormal electrocardiogram (ECG), i.e., patients with the following are excluded: QT prolongation - QTc > 480 msec; signs of cardiac enlargement or hypertrophy; bundle branch block; partial blocks; signs of ischemia or necrosis, and Wolff Parkinson White patterns. - History or presence of valvular heart disease. - Uncontrolled arterial hypertension despite optimal medical therapy. - Previous mediastinal radiotherapy. - Previous treatment with doxorubicin at cumulative doses exceeding 400 mg/m2. - History of significant neurological or psychiatric disorders. - Active infection requiring systemic treatment. - Significant non-neoplastic liver disease (e.g., cirrhosis). - Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Immunocompromised patients, including those known to be infected with the human immunodeficiency virus (HIV). - Uncontrolled (i.e., requiring relevant changes in medication within the last month or hospital admission within the last three months) endocrine diseases (e.g., diabetes mellitus, hypo- or hyperthyroidism, adrenal disorder). 8. Any other major illness that, in the Investigators judgment, will substantially increase the risk associated with the patients participation in the study. The Investigator should feel free to consult the Study Coordinator or the Sponsor(s) in case of uncertainty in this regard. 9. Limitation of the patients ability to comply with the treatment or to follow-up at a participating center. Patients enrolled into this trial must be treated and followed at a participating center. 10. Treatment with any investigational product within 30 days prior to inclusion in the study. 11. Known hypersensitivity to any component of Zalypsis®. ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Best Tumor 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 - PEGASUS; BRIEF: Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria ; DRUG USED: Empaveli; DRUG CLASS: New Molecular Entity (NME); INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Apellis Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - At least 18 years of age - Primary diagnosis of PNH confirmed by high-sensitivity flow cytometry - On treatment with eculizumab. Dose of eculizumab must have been stable for at least 3 months prior to the Screening Visit - Hb <10.5 g/dL at the Screening Visit - Absolute reticulocyte count > 1.0x ULN at the Screening Visit - Platelet count of >50,000/mm3 at the Screening Visit - Absolute neutrophil count >500/mm3 at the Screening Visit - Vaccination against Neisseria meningitides types A, C, W, Y and B, Streptococcus pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day 1 dosing, or within 14 days after starting treatment with APL-2. Unless documented evidence exists that subjects are non-responders to vaccination as evidenced by titers or display titer levels within acceptable local limits - Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening and Day -28 Visit (Run-in Period) and must agree to use protocol defined methods of contraception for the duration of the study and 90 days after their last dose of study drug - Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and 90 days after their last dose of study drug - Willing and able to give informed consent - Willing and able to self-administer APL-2 (administration by caregiver will be allowed) - Have a body mass index (BMI) ≤35.0 kg/m2 Exclusion Criteria: - Active bacterial infection that has not resolved within 14 week of Day -28 (first dose of APL-2) - Receiving iron, folic acid, vitamin B12 and EPO, unless the dose is stable, in the 4 weeks prior to Screening - Hereditary complement deficiency - History of bone marrow transplantation - History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the investigational product or SC administration - Participation in any other investigational drug trial or exposure to other investigational agent within 30 days or 5 half-lives (whichever is longer) - Currently breast-feeding women - Inability to cooperate or any condition that, in the opinion of the investigator, could increase the subjects risk of participating in the study or confound the outcome of the study This study includes cardiac safety evaluations. The following cardiac eligibility criteria are necessary to avoid confounding the cardiac safety outcomes: - History or family history of Long QT Syndrome or torsade de pointes, unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden death - Myocardial infarction, CABG, coronary or cerebral artery stenting and /or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months or greater than Class 2 Angina Pectoris or NYHA Heart Failure Class >2 - QTcF > 470 ms, PR > 280 ms - Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block unless the patient has an implanted pacemaker or implantable cardiac defibrillator (ICD) with backup pacing capabilities - Receiving Class 1 or Class 3 antiarrhythmic agents, or arsenic, methadone, ondansetron or pentamidine at screening - Receiving any other QTc-prolonging drugs (see Appendix 4 in Section 19.4), at a stable dose for less than 3 weeks prior to dosing - Receiving prophylactic ciprofloxacin, erythromycin or azithromycin for less than one week prior to the first dose of study medication (must have a repeat screening ECG after one week of prophylactic antibiotics with QTcF < 470 ms) ; PRIMARY OUTCOME: Least Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCP; SECONDARY OUTCOME 1: Percentage of Subjects Who Did Not Require a Transfusion (Transfusion Avoidance) During the RCP[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PACIFIC-4; BRIEF: This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation. ; DRUG USED: Imfinzi; 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: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Main Cohort Key Inclusion Criteria: 1. Age ≥18 years 2. Planned SoC SBRT as definitive treatment 3. WHO/ECOG PS of 0, 1 or 2 4. Life expectancy of at least 12 weeks 5. Body weight >30 kg 6. Submission of tumor tissue sample if available 7. Adequate organ and marrow function required 8. Patients with central or peripheral lesions are eligible 9. Staging studies must be done during screening (PET-CT within 10 weeks) 10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions Main Cohort Key Exclusion Criteria: 1. Mixed small cell and non-small cell cancer 2. History of allogeneic organ transplantation 3. History of another primary malignancy with exceptions 4. History of active primary immunodeficiency 5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort 6. Prior exposure to immune-mediated therapy with exceptions Osimertinib Cohort Key Inclusion Criteria 1. Age ≥18 years 2. Planned SoC SBRT as definitive treatment 3. World Health Organization (WHO)/ECOG PS of 0, 1, or 2 4. Patients with central or peripheral lesions are eligible 5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions 6. Staging studies must be done during screening (PET-CT within 10 weeks) 7. Submission of available tumor tissue sample 8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R) 9. Adequate bone marrow reserve or organ function required 10. Female patients should be using highly effective contraceptive measures 11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation Osimertinib Cohort Key Exclusion Criteria 1. Mixed small cell and non-small cell cancer 2. Patients currently receiving potent inducers of CYP3A4 3. Patients with known or increased risk factor for QTc prolongation 4. Treatment with any of the following: - Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation - Prior treatment with neoadjuvant or adjuvant EGFR TKI - Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 - Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib 5. Any of the following cardiac criteria - Mean resting corrected QT interval >470 msec, obtained from 3 ECGs - Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval - Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD ; PRIMARY OUTCOME: Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC; SECONDARY OUTCOME 1: Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Male Subjects; BRIEF: This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects ; DRUG USED: DA-5206; DRUG CLASS: Non-NME; INDICATION: Allergy; TARGET: Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Dong-A ST Co., Ltd.; CRITERIA: Inclusion Criteria: - Healthy male volunteer 19 years to 45 years - Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg - The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate Exclusion Criteria: - Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease - Subject with acute disease within 28 days before the first dose of Investigational product - Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug - Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study ; PRIMARY OUTCOME: Area under the plasma concentration versus time curve (AUC); 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 - BC-CO-2; BRIEF: Current therapies for metastatic or unresectable Colon Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of metastatic or unresectable Colon Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with metastatic or unresectable Colon Cancer ; DRUG USED: Antineoplastons; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Burzynski Research Institute; CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists - Metastatic or unresectable disease - Measurable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal - No hepatic failure Renal: - Creatinine no greater than 2.5 mg/dL - No renal failure - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No chronic heart failure - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease, such as chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No active infection - No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulatory agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier) Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agent allowed - No prior antineoplaston therapy ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RELEVANCE (Follicular, GELARC-0683C, Companion Study); BRIEF: The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: The Lymphoma Academic Research Organisation; CRITERIA: Inclusion Criteria: - Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a - Have no prior systemic treatment for lymphoma. - Must be in need of treatment - Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not previously irradiated. - Stage II, III or IV disease. - Must be ≥ 18 years and sign an informed consent. - Performance status ≤ 2 on the ECOG scale. - Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) - Willing to follow pregnancy precautions Exclusion Criteria: - Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b follicular lymphoma. - Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 10 mg/day prednisone (over these 4 weeks). - Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent. - Known Seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV)or human immunodeficiency virus (HIV). - Life expectancy < 6 months. - Known sensitivity or allergy to murine products. - Prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 10 years. - Prior use of lenalidomide. - Neuropathy > Grade 1. - Presence or history of CNS involvement by lymphoma. - Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis. - serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) > 3x upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma - total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma - creatinine clearance of < 30 mL/min - Pregnant or lactating females. - Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study. ; PRIMARY OUTCOME: COMPLETE RESPONSE RATE; SECONDARY OUTCOME 1: Number of participants with 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 IIIb - ALLY 3 (w/Sofosbuvir, GT-3); BRIEF: To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Key Inclusion Criteria: - Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications - Subjects chronically infected with hepatitis C virus (HCV) genotype 3 - Subjects who are HCV treatment-naive - Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited) - HCV RNA ≥10,000 IU/mL at screening Key Exclusion Criteria: - HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted - Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair - Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening - Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed) - Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy ; PRIMARY OUTCOME: Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND); SECONDARY OUTCOME 1: Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)[/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 - 201 (US); BRIEF: To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD) ; DRUG USED: SPR720; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tuberculosis; TARGET: Topoisomerase II (DNA gyrase) and IV; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Spero Therapeutics; CRITERIA: Inclusion Criteria: - Has a diagnosis of NTM-PD due to MAC - Had at least 1 prior positive culture (sputum or bronchoalveolar lavage) positive for MAC in the previous 6 months - Has an induced sputum culture at screening positive for MAC by at least one of the following methods performed by the microbiology laboratory: quantitative culture on solid agar or growth on liquid media (MGIT) - Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC, has culture evidence of persistent, recurrent, or relapsed disease and has been off therapy for at least 6 months - In the opinion of the Investigator, is ready to initiate treatment (treatment naïve) or reinitiate treatment (previously treated) within the next 3 months, and for whom a delay, in order to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable - Had clinical signs and symptoms within the 6 weeks before the date of consent that are consistent with NTM-PD with at least two of the following: 1. chronic cough 2. fatigue 3. frequent throat clearing 4. shortness of breath (dyspnea) 5. coughing up of blood (hemoptysis) 6. excessive mucus (sputum) production 7. fever 8. night sweats 9. loss of appetite 10. unintended weight loss 11. wheezing 12. chest pain - Has a measured forced expiratory volume in 1 second (% predicted FEV1) ≥30% on pulmonary function test within 3 months prior to consent - Has a chest radiograph (CXR) or computed tomography (CT) scan within 6 months prior to consent with findings consistent with NTM-PD. If no CXR or CT scan is available, a CXR or CT scan should be performed at screening to confirm eligibility. - Other inclusion criteria per protocol Exclusion Criteria: - Has disseminated or extrapulmonary NTM - Has end-stage NTM-PD or treatment-refractory NTM-PD and is unlikely to respond to protocol-specified SOC treatment - Had isolation on sputum cultures of any species of Mycobacterium other than a species included in MAC within the past 6 months - Had prior isolation of MAC with macrolide resistance - Has received any systemic (oral or IV) or inhaled antibiotic with activity against MAC between consent and randomization - Has a potentially confounding underlying pulmonary disease, including but not limited to cystic fibrosis, active pulmonary malignancy (primary or metastatic), NTM-hypersensitivity disease pneumoconiosis, or another advanced lung disease with a % predicted FEV1<30% - Other exclusion criteria per protocol ; PRIMARY OUTCOME: Maximum Plasma Concentration (Cmax) of SPR719; SECONDARY OUTCOME 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ATX-101-10-17 (EU); BRIEF: To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin). ; DRUG USED: Kybella; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fat Removal; TARGET: Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Kythera Biopharmaceuticals; CRITERIA: Inclusion Criteria: 1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2. 2. Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS). 3. Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD). 4. History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study. 5. Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures. 6. Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality. 7. Signed informed consent obtained before any study-specific procedure is performed. Exclusion Criteria: 1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment. 2. Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS). 3. Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome. 4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat. 5. Body mass index (BMI) greater than 30. 6. Currently on or considering starting a weight reduction regimen. 7. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subjects ability to undergo study procedures or provide informed consent. 8. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization. 9. History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine). 10. Previous randomization into this study or previous treatment with ATX-101. 11. Treatment with an investigational device or agent within 30 days of randomization. ; PRIMARY OUTCOME: Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response; SECONDARY OUTCOME 1: Percentage of Participants With a CR-SMFRS 2-grade 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 Ib/II - 1st-Line w/RT+Temozolomide; BRIEF: The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM). ; DRUG USED: Turalio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Macrophage Colony Stimulating Factor 1 (M-CSF1)/M-CSF Receptor/FMS/CD115/CSF-1/CSF1R; THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo, Inc.; CRITERIA: Inclusion Criteria: - Male or female patients ≥18 years old. - Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides. - The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration. - A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1. - Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality. - Patients must receive RT at the participating institution. - Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose. - Karnofsky performance status of ≥70. - Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5x 109/L, Hgb >10 g/dL, platelet count ≥100 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN). - Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements. Exclusion Criteria: - Evidence of recurrent GBM or metastases detected outside of the cranial vault. - Investigational drug use within 28 days of the first dose of PLX3397 or concurrently. - Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment. - Prior radiation or chemotherapy for glioblastoma or glioma. - Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields. - Prior allergic reaction to temozolomide. - History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage. - Active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix. - Chronic active hepatitis B or C. - Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of study drug. - Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigators opinion would be likely to interfere with a patients participation in the study, or with the interpretation of the results. - Women of child-bearing potential who are pregnant or breast feeding. - At Screening QTcF ≥450 msec for males and ≥470 msec for females. ; PRIMARY OUTCOME: Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group; SECONDARY OUTCOME 1: Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Advanced Breast Cancer; BRIEF: This is a 2-part, Phase 1 FIH study with Phase 1a designed to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) in subjects with metastatic cancers with a human epidermal growth factor receptor 2 (HER2) test result that is in situ hybridization (ISH) positive (+) or immunohistochemistry (IHC) 3+ or 2+, and Phase 1b designed to assess anticancer activity and safety in three expansion cohorts: two different advanced breast cancer expansion cohorts (namely, for tumors that test as HER2 ISH positive or IHC3+ and for tumors that test as HER2 ISH negative with IHC 2+), and one advanced gastric cancer expansion cohort (for tumors that test as HER2 ISH positive or IHC3+). ; DRUG USED: ARX788; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Zhejiang Medicine Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Life expectancy >12 weeks. 2. BMI is between 18 to 32 kg/m2 3. Subjects whose advanced cancer has failed treatment or whose cancer has progressed following available standard therapy or for whom such therapy is not acceptable to the subject. Subjects whose tumor tissue local laboratory results are HER2 ISH positive or IHC3+ must have been previously treated with a HER2 targeting therapy (e.g. trastuzumab, in the country or region where such therapies are available and part of standard of care), or have failed SOC therapy. Subjects who have been previously treated with a HER2 targeting therapy such as trastuzumab or ado-trastuzumab emtansine are eligible. 4. Disease measurability: Phase 1a: measureable or non-measureable disease; Phase 1b: disease must be measureable (per RECIST v1.1) (subjects with non-measureable disease are not eligible for Phase 1b). 5. Histopathologic evidence of breast cancer based upon pathologists report. 6. Tumor tissue local laboratory HER2 testing results (clinical pathology report) based on FDA or other regulatory agency approved, validated or commercially available IHC or ISH HER2 assay. Pre-screening for HER2 is allowed only for subjects with breast and gastric cancer, where applicable. Subjects with other types of cancer must have previously tested for HER2 status by HER2 IHC or ISH assay. 1) Phase 1a: ISH positive or IHC 2+ or 3+. 2) Phase 1b: Cohort 1: advanced breast cancer, ISH positive or IHC 3+; Cohort 2: advanced breast cancer, ISH negative with IHC 2+; and Cohort 3: advanced gastric cancer, ISH positive or IHC 3+. 7. Local pathology laboratory determination of HER2 status will be accepted, provided that the local laboratory is an accredited site for HER2 testing. In Phase 1b, if the local laboratory was not accredited at the time of testing, an adequate tumor tissue sample is required for central pathology laboratory HER2 testing. The tissue sample may be provided as 10 pre-cut unstained slides or a tumor block. 8. Eastern Cooperative Oncology Group Performance Status of 0 to 1. 9. Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the NCI-CTCAE v 4.03. 10. The last dose of prior anticancer therapy must have been administered at least 28 days prior to the first dose of the IMP. 11. Adequate bone marrow function defined by absolute neutrophil count of ≥1.5×109/L, platelet count of ≥100.0×109/L, and hemoglobin of ≥9.0 g/dL. 12. Adequate hepatic function defined by serum total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransferase ≤2.5 × ULN (or ≤5 × ULN in subjects with liver metastases). 13. Adequate renal function assessed by serum creatinine within reference lab normal limits and creatinine clearance (by Chronic Kidney Disease Epidemiology [CKD-EPI] Collaboration equation) ≥60 mL/min. 14. Adequate cardiac function as assessed by cardiac troponin I within normal range; left ventricular ejection fraction ≥ 50% or institutional lower limit of normal; cumulative anthracycline dose <360 mg/m2 doxorubicin or equivalent. 15. Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol. 16. Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or who commits to use an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 3 months following the last dose of study treatment. 17. Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study. Exclusion Criteria: Any subject who meets any of the following criteria should be excluded from the study: 1. History of allergic reactions to any component of the ARX788. 2. 2. History of seizure disorder. 3. History of unstable central nervous system (CNS) metastases or seizure disorder related to the malignancy; however, those subjects who were treated for prior CNS metastases and who are asymptomatic may participate in the study as long as they are not receiving treatment with steroids. 4. History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia. 5. Grade 2 to 4 peripheral neuropathy (NCI CTCAE v 4.03). 6. Non-manageable electrolyte imbalances including hypokalemia, hypocalcemia, or hypomagnesemia (Grade 2 or greater based on NCI CTCAE v 4.03). 7. Any uncontrollable intercurrent illness, infection, or other conditions that could limit study compliance or interfere with assessments. 8. Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 28 days before the first dose of the IMP. 9. Significant surgical intervention within 21 days of the first dose of the IMP or with ongoing post-operative complications if more than 21 days. 10. Radiotherapy administrated less than 21 days prior to the first dose of the IMP, or localized palliative radiotherapy administered less than 7 days prior to the first dose of the IMP, or radiotherapy induced toxicity of Grade 2 or greater based on NCI CTCAE v 4.03. 11. Pregnancy or breast feeding. 12. Refusal to use effective methods of contraception (see inclusion criteria for details). 13. Legal incapacity/limited legal capacity for providing informed consent. ; PRIMARY OUTCOME: Maximum tolerated dose of ARX788; SECONDARY OUTCOME 1: Number of subjects with 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 - Dose Escalation; BRIEF: An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors ; DRUG USED: BAY1179470; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Fibroblast Growth Factor Receptor-2; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months - Adequate bone marrow, liver, and renal function. For subjects in the additional cohort: - Subjects with advanced, histologically or cytologically confirmed gastric cancer. - At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed Exclusion Criteria: - History of severe allergic reactions to monoclonal antibody therapy - Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management - Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study ; PRIMARY OUTCOME: Number of participants with Adverse Events as a Measure of Safety and Tolerability; SECONDARY OUTCOME 1: Tumor 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 II - QD vs BID (CP543.2002); BRIEF: This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata. ; DRUG USED: CTP-543; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alopecia Areata; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Concert Pharmaceuticals; CRITERIA: Inclusion Criteria: - Definitive diagnosis of alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted. - At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline. - Clinical lab results within the normal range Exclusion Criteria: - Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp. - Treatment with systemic immunosuppressive medications or biologics. - Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study ; PRIMARY OUTCOME: Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24; SECONDARY OUTCOME 1: Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline[/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/b - Dose Escalation; BRIEF: This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkins Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available. ; DRUG USED: CG-806; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), FMS-like tyrosine kinase 3 (FLT-3) ; THERAPY: Monotherapy; LEAD SPONSOR: Aptose Biosciences Inc.; CRITERIA: Inclusion Criteria: - Age ≥ 18 years - Life expectancy of at least 2 months - ECOG Performance Status ≤ 2 - Patients must be able to swallow capsules - Adequate hematologic parameters, unless cytopenias are disease caused - Adequate renal, liver and cardiac function parameters Exclusion Criteria: - Patients with GVHD requiring systemic immunosuppressive therapy - Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder - Clinically significant intravascular coagulation - Treatment with other investigational drugs within 14 days prior to first study treatment administration ; PRIMARY OUTCOME: Incidence of treatment-emergent adverse events of CG-806; SECONDARY OUTCOME 1: Pharmacokinetic variables including maximum 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 II - CVAY736A2201; BRIEF: This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters ; DRUG USED: VAY736; DRUG CLASS: Biologic; INDICATION: Sjogrens Syndrome; TARGET: B-cell activating factor (BAFF); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Fulfilled revised American European Consensus Group criteria for pSS - Seropositive at screening for anti-Ro/SSA antibodies - Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic. Exclusion Criteria: - Secondary Sjogrens syndrome - Use of other investigational drugs - Active viral, bacterial or other infections - Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening ; PRIMARY OUTCOME: Change in multi-dimensional disease activity; SECONDARY OUTCOME 1: Change in patient-reported disease activity measures[/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 - sIBM; BRIEF: This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis ; DRUG USED: BYM338; DRUG CLASS: Biologic; INDICATION: Sporadic Inclusion Body Myositis (sIBM); TARGET: Activin A; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis Exclusion Criteria: - Unable to walk at least 3 meters without assistance from another person - Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months - patients with a history or presence of renal impairment and/or liver disease Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Effect of BYM338 on Thigh Muscle Volume by MRI; SECONDARY OUTCOME 1: Effect of BYM338 on muscle function by Timed Get Up and Go test[/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 - LUX-Head & Neck 3 (1200.161); BRIEF: This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate. ; DRUG USED: Gilotrif; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3, ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy. - Documented progressive disease based on investigator assessment according to RECIST, following receipt of a cisplatin and/or carboplatin and/or Nedaplatin based regimen administered for recurrent and/or metastatic disease independent of whether patient progressed during or after platinum based therapy. - Measurable disease according to RECIST (version 1.1). - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at Visit 2. - Male and female patients age is 18 years or older - Signed and dated written informed consent that is in compliance with ICH-GCP and local law. Exclusion criteria: - Progressive disease within three months after completion of curatively intended treatment for locoregionally advanced or for metastatic head and neck squamous cell cancer (HNSCC). - Primary tumour site nasopharynx (of any histology), sinuses, and/or salivary glands. - Any other than one previous platinum based systemic regimen given for recurrent and/or metastatic disease, with the exception of immunotherapy used either before or after platinum based treatment. Re-challenge with the platinum based regimen after a temporary break is considered an additional line regimen only in case of progression within the break. - Prior treatment with EGFR-targeted small molecules. - Treatment with any investigational drug less than four weeks or anti-cancer therapy less than three weeks prior to randomization (except palliative radiotherapy to bones to alleviate pain). - Unresolved chronic toxicity, other than hearing loss, tinnitus or dry mouth, CTCAE grade >2 from previous anti-cancer therapy or unresolved skin toxicities CTCAE grade >1 and/or diarrhoea CTCAE grade >1 caused by prior treatment with EGFR targeted antibodies. - Previous tumour bleeding CTCAE grade =3. - Requirement for treatment with any of the prohibited concomitant medications. - Major surgical or planned procedure less than four weeks prior to randomization (isolated biopsies are not considered as major surgical procedures). - Any other malignancy unless free of disease for at least five years except for: - Other HNSCC of a location as described in inclusion criterion number 1 - Appropriately treated superficial basal cell skin cancer - Surgically cured cervical cancer in situ - For Korea: endoscopically cured superficial esophageal and/or gastric cancer is allowed - Known lesion or signs of brain metastasis. - Known pre-existing interstitial lung disease (ILD). - Clinically relevant cardiovascular abnormalities, as judged by the investigator, such as, but not limited to, uncontrolled hypertension, congestive heart failure NYHA classification =III, unstable angina, myocardial infarction within six months prior to randomization, or poorly controlled arrhythmia. - Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom in the opinion of the investigator, e.g. Crohns disease, malabsorption or CTCAE grade >1 diarrhoea of any aetiology at randomization. - Known HIV, active hepatitis B, active hepatitis C, and/or other known severe infections, including but not limited to tuberculosis, as judged by the investigator. - Other significant disease that in the investigators opinion would exclude the subject from the trial. - Screening laboratory values: - Absolute neutrophil count (ANC) <1.5x10^9/l - Platelet count <75x10^9/l - Total bilirubin >1.5 times the upper limit of normal (ULN) - Aspartate amino transferase (AST) or alanine amino transferase (ALT) >3 times the ULN (if related to liver metastases >5 times the ULN) - Calculated creatinine clearance <50 ml/min (as evidenced by using the Cockcroft-Gault formula). - Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or to use adequate contraception during the trial and for at least six months after end of treatment. Adequate methods of contraception and definition of child-bearing potential. - Pregnancy or breast feeding. - Known or suspected hypersensitivity to any of the study medications or their excipients. - Patients unable to comply with the protocol, in the opinion of the investigator. ; PRIMARY OUTCOME: progression free survival (PFS), defined as the time from the date of randomization to the date of progression evaluated according to RECIST 1.1 or to the date of death, whichever occurs first; SECONDARY OUTCOME 1: Overall survival (OS), defined as the time from the date of randomization to the date of death (regardless of the cause of death)[/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 - OHSU; BRIEF: The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes. ; DRUG USED: Gvoke RTU Micro; DRUG CLASS: Non-NME; INDICATION: Hyperinsulinemia/Hypoglycemia; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Xeris Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male and female subjects on insulin infusion pump therapy for treatment of type 1 diabetes 2. Between the ages of 18 and 50 years of age, inclusive, at Screening. 3. Females of childbearing potential with a negative serum pregnancy test prior at screening and negative urine pregnancy tests prior to the Treatment visits, using an approved forms of contraception for the duration of participation in the study (i.e. until after last dose). 4. Male subjects are required to use a condom and another of the methods of contraception in #3 above starting at Randomization and for the duration of the study. 5. Hemoglobin A1c (HbA1c) < 9.0 %. 6. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 7. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures. Exclusion Criteria: 1. Clinical evidence of microvascular complication(s) other than mild microalbuminuria or history of mild non-proliferative retinopathy 2. Any chronic diseases or illness that interferes with glucose metabolism, except for T1DM, or medications other than hypothyroidism on appropriate thyroid hormone replacement. 3. Blood pressure (BP) readings at Screening where Systemic BP <90 or >140 mm Hg, and Diastolic BP <50 or >90 mm Hg. 4. Cardiovascular event within 6 months prior to screening such as unstable angina, acute coronary syndrome, myocardial infarction, therapeutic coronary procedure (e.g., stent placement, Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery By-pass Grafting (CABG)), stroke or transient ischemic attack. 5. Study participants who are pregnant at Screening. 6. Breast feeding must be discontinued if a subject wishes to participate in this study. 7. Positive test for hepatitis B, hepatitis C, or HIV found at Screening. 8. Positive urine drug test for illicit drugs at Screening. 9. History of allergies to glucagon, glucagon-like products or to any of the excipients in the investigational formulation. 10. Known presence of hereditary problems of glycogen storage disease, galactose and /or lactose intolerance 11. Administration of glucagon more than once within the three (3) months prior to Screening 12. Subjects with any of the following abnormalities in clinical laboratory tests at Screening, confirmed by a single repeat, if necessary: - Hemoglobin (Hb) below the lower limits of normal for the laboratory - Total bilirubin above the upper limits of normal for the laboratory - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above the upper limits of normal for the laboratory - Creatinine above the upper limits of normal for the laboratory 13. History of regular alcohol consumption as defined by alcohol intake in a quantity exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor. 14. Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study and during participation in the current study 15. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed red blood cells, platelets or quantities less than 500 mL are allowed at investigator discretion. 16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. ; PRIMARY OUTCOME: Serious Adverse Events; SECONDARY OUTCOME 1: Glucagon Cmax (Fasting)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - SGN33A-004 (w/Azacitidine); BRIEF: This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS). ; DRUG USED: Vadastuximab Talirine; DRUG CLASS: Biologic; INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 33 (CD33/SIGLEC-3), DNA; THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification. - Previously untreated for Myelodysplastic Syndrome (MDS) - Age ≥18 years of age. - Eligible for therapy with azacitidine. - Life expectancy of at least 12 weeks. - Eastern Cooperative Oncology Group (ECOG) performance status ≤2. - Adequate baseline laboratory parameters. Exclusion Criteria: - Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs). - History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis. - Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer). - Candidates for allogeneic stem cell transplant at the time of screening. ; PRIMARY OUTCOME: Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study; SECONDARY OUTCOME 1: Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CAPS - 201 Study; BRIEF: This is a Phase 2 study to investigate the safety and efficacy of ATI-450 for the Maintenance of Remission in Patients with Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed with Anti-IL-1 Therapy. ; DRUG USED: ATI-450; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cryopyrin (CIAS1)-Associated Periodic Syndromes (CAPS); TARGET: Mitogen-Activated Protein Kinase-Activated Protein Kinase 2 (MK2), p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: Aclaris Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease. Prior agreement between the Investigator and Aclaris for study eligibility is required for patients who do not have a molecular diagnosis of NALP3 mutations available (either testing not performed, or testing performed, but negative) upon study entry. For those patients who have not been molecularly tested for NALP3 mutations, molecular testing should be performed during the study. - Patients with a PGA score of minimal or less and hsCRP and SAA values within the normal range (≤10mg/L), and who are considered to have achieved that response as a result of successful anti-IL-1 therapy. - Continuous Treatment with anti-IL1 therapy for at least 6 months. - Able to understand and comply with study procedures and able to provide informed consent. - Male or non-pregnant, non-nursing female patients at least 18 years of age, inclusive. - Female patients who are of childbearing potential must use 2 methods of highly effective contraception* - one of which must be a physical barrier- for the duration of the study and for 30 days after the last dose. - Male patients of childbearing potential with a female partner of childbearing potential must agree to use a condom plus another highly effective form of birth control for the duration of the study and for 90 days after the last dose. - Female patients must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing on Day 1. - Willing and capable of taking appropriate Covid-19 risk mitigation precautions (e.g. wearing a mask in public, adhering to social distancing, etc.) as required by local, state, or federal guidelines during participation in the study. Exclusion Criteria: - Participation in any clinical study with an investigative agent within 12 weeks prior to entry or within 5 half-lives of the investigational agent. - Being treated with another immuno-suppressive agent (i.e., in addition to an anti-IL-1 product) for CAPS syndrome (anti- IL-1 therapy will have been used for at least 6 months and will be stopped at study entry). - Use of any of the following treatments within the indicated washout period prior to the baseline visit: - Systemic immunosuppressant or immunomodulatory therapy (e.g., etanercept, alefacept, infliximab, methotrexate) within 16 weeks prior to Visit 2 (excluding anti- IL-1 therapy for CAPS). - Janus Kinase (JAK) inhibitors (systemic or topical) within 4 weeks prior to Visit 2. - Systemic corticosteroids within 4 weeks prior to Visit 2 (Intranasal, inhaled, and topical ocular corticosteroids are allowed). - History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result. [Previous treatment with anti-IL1 therapy is not an exclusion] - A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result. - Live vaccinations within 3 months prior to the start of the trial, or during the trial. - History of recurrent and/or evidence of active bacterial, fungal, or viral infections. - History or evidence of active or latent tuberculosis (TB). - Tests performed at a central laboratory at screening that meet any of the criteria below (out of range labs may be rechecked one time, after consultation with sponsor or designee, before patient is considered a screen failure): - White blood cell (WBC) count <3.0×103 cells/mm3 - Absolute neutrophil count (ANC) <1.5×103 cells/mm3 - Lymphocyte count <0.5×103 cells/mm3 - Platelet count <100×103 cells/mm3 - Hemoglobin <10 g/dL - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2×upper limit of normal (ULN) - Total bilirubin level >2×ULN, unless patient has been diagnosed with Gilberts disease and this is clearly documented - Estimated glomerular filtration rate Estimated glomerular filtration rate (eGFR), <40 mL/min/1.73m2 based on Modification of Diet and Renal Disease formula - Any clinically significant laboratory abnormality that would affect interpretation of study data or safety of the patients participation in the study, per the judgment of the investigator. - Patient has clinically significant abnormal findings other than CAPS from physical examination that may affect the interpretation of study data or the safety of the patients participation in the study, per the judgment of the investigator. - Patient has a clinically important history of a medical disorder that would compromise patient safety or data quality, per the judgement of the investigator. - Blood pressure (BP) levels (in supine position after at least 5 minutes rest): <90 mmHg or >140 mmHg for systolic BP or <40 mmHg or >90 mmHg for diastolic blood pressure. - Patients with history of stroke. - Significant cardiac disease that would affect interpretation of study data or the safety of the patients participation in the study, per the judgment of the investigator, including recent myocardial infarction or unstable angina, or heart failure with New York Heart Association Class III or IV symptoms. - Patients with the following screening or pre-dose ECG findings, specifically: - Evidence of atrial fibrillation, atrial flutter, complete right or left bundle branch block, Wolff-Parkinson-White Syndrome, or other significant rhythm disturbance - Evidence of acute ischemia - Screening or pre-dose baseline mean QTcF >450 msec for males or >470 msec for females (use of the ECG algorithm is acceptable for this purpose) - Personal or family history of congenital long QT syndrome or sudden death - Any other finding that is considered clinically significant - A confirmed diagnosis of Covid-19 at baseline or at any time during the study. ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - w/Pemetrexed/Carboplatin; BRIEF: This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC). ; DRUG USED: Bavituximab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Phosphatidylserine; THERAPY: Combination; LEAD SPONSOR: UNC Lineberger Comprehensive Cancer Center; CRITERIA: Inclusion Criteria: - Greater than or equal to 18 - Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy - Evaluable disease by clinical or radiographic parameters - No history or concomitant malignancy - Adequate organ and marrow function - Female subjects with negative urine or serum pregnancy - ECOG must be 0 or 1 Exclusion Criteria: - Squamous cell, small cell, or mixed histology - Known history of bleeding diathesis or coagulopathy - Cavitary tumors or tumors invading or abutting large blood vessels - Any history of thromboembolic events - Ongoing therapy with oral or parenteral anticoagulants - Major surgery within 4 weeks of Day 1 of treatment - Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease) - any history of significant vascular disease - Congestive heart failure - History of any condition requiring anti-platelet therapy - Serious non healing wound - Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis - Unable or unwilling to discontinue use of prohibited medications - D-dimers >2 x ULN as measured on 2 separate occasions at least 1 day apart ; PRIMARY OUTCOME: Measure number of severe side effects seen during first cycle of therapy; SECONDARY OUTCOME 1: Progression free survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb; BRIEF: The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy. ; DRUG USED: Nabiximols; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cancer Pain; TARGET: Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - The patient has advanced active cancer for which there is no known curative therapy. - The patient is able (in the investigators opinion) and willing to comply with all study requirements. - The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment. - The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the World Health Organization (WHO) analgesic ladder. - The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study. Exclusion Criteria: - The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain. - Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. - Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug. - The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure). - The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction. ; PRIMARY OUTCOME: Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline; SECONDARY OUTCOME 1: Change in Cumulative Average Pain Response Curves[/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 - 20090072 Extension (Safety); BRIEF: The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohns disease. ; DRUG USED: Siliq; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: IL-17 Receptor (IL-17R); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subject was randomized into study 20090072 (NCT01150890) and completed the week 12 evaluation. - Subject completed the week 12 evaluation in study 20090072 no more than 1 year prior to the planned first visit of AMG 827 in 20100008. - Subject or subjects legally acceptable representative has provided informed consent. - Subject meets regional recommendations for immunizations, eg, United States Centers for Disease Control and Prevention recommendations for subjects enrolled in the United States. - For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: If testing is clinically indicated in the opinion of the investigator (eg, because of known recent exposure), then subject has negative test for hepatitis B, hepatitis C, and/or human immunodeficiency virus (HIV). - For female subjects with ≤ 4 weeks between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: Subject has a negative urine pregnancy test at baseline prior to the first dose of AMG 827 in the open-label extension (except those at least 2 years post menopausal or surgically sterile). - For female subjects with > 4 weeks between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: Subject has a negative serum pregnancy test within 28 days before initiating AMG 827 and a negative urine pregnancy test at baseline prior to the first dose of AMG 827 in the open-label extension (except those at least 2 years post menopausal or surgically sterile). - For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008, if clinically indicated in the opinion of the investigator (eg, because of known recent exposure) please assess the following: - If the subject entered 20090072 with a negative purified protein derivative (PPD) test: Subject must have a negative PPD test within 30 days prior to the planned first dose of AMG 827. Tuberculin skin tests should be considered positive when they have greater than or equal to 5 mm of induration at 48-72 hours after test is placed. - If the subject entered 20090072 with a positive PPD: Subject must have a negative Quantiferon test within 30 days prior to the planned first dose of AMG 827. Exclusion Criteria: - Subject had any serious adverse event reported during study 20090072 and considered to be related to investigational product. - Subject experienced an adverse event or laboratory abnormality in study 20090072 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject, prevent the subject from completing the study, or interfere with the interpretation of the study results. - Subject has known sensitivity to any of the products to be administered during dosing. Other medical conditions - Subject is currently experiencing an infection of Common Terminology Criteria for Adverse Events grade 2 (if requiring oral medication) or higher. Subject is ineligible until the infection resolves. - Subject has a serious infection, defined as requiring hospitalization or intravenous antibiotics, within 8 weeks before the first dose of AMG 827 in 20100008. - For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: Subject has recurrent or chronic infections, defined as ≥ 3 infections requiring anti-microbials over the past 12 months prior to screening. - Subject has a significant concurrent medical condition, including - Type 1 diabetes - Uncontrolled type 2 diabetes - Moderate to severe heart failure (New York Heart Association class III or IV) - Myocardial infarction within the last year - Current or history of unstable angina pectoris within the last year - Uncontrolled hypertension as defined by resting blood pressure ≥ 150/90 mmHg prior to first investigational product dose (confirmed by a repeat assessment) - Severe chronic pulmonary disease (eg, requiring oxygen therapy) - Major chronic inflammatory disease or connective tissue disease other than Crohns disease (eg, systemic lupus erythematosus, rheumatoid arthritis, psoriasis) - Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma - History of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin). - Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject - Laboratory abnormalities - For subjects with > 4 weeks between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008, subject has laboratory abnormalities at screening, including - Elevated aspartate aminotransferase or alanine aminotransferase (> 2x upper limit of normal) - Serum direct bilirubin ≥ 1.5x upper limit of normal - Hemoglobin < 10 g/dL - Hemoglobin A1c > 8.0 (for subjects with type 2 diabetes) - Platelet count < 125,000 /mm^3 - White blood cell count < 3,000 cells/mm^3 - Absolute neutrophil count < 2,000/mm^3 - Creatinine clearance < 50 mL/min (Cockroft-Gault formula, central lab will calculate value and provide to sites) - Any other laboratory abnormality, which, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject, prevent the subject from completing the study, or interfere with the interpretation of the study results - Washouts and non-permitted drugs - Subject has used Tysabri (natalizumab) subsequent to study 20090072. - Subject received an anti-tumor necrosis factor agent within 8 weeks prior to the first dose of AMG 827 in 20100008. - Subject received other commercially available biologic agent (eg, ustekinumab) within 12 weeks prior to the first dose of AMG 827 in 20100008. - Subject received an investigational agent (other than AMG 827), investigational procedure, or participated in an investigational device study subsequent to study 20090072. - Subject received live vaccines within 12 weeks prior to the first dose of AMG 827 in 20100008. - Subject received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus within 4 weeks prior to the first dose of AMG 827 in 20100008. - General or other - Female subject is not willing to use highly effective contraception during treatment with AMG 827 (except if at least 2 years postmenopausal or surgically sterile). - Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study. - Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. - Subject will not be available for protocol required study visits, to the best of the subject and investigators knowledge. ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: CDAI Score Over Time[/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 - PLUTO (w/Sofosbuvir; GT4); BRIEF: The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study. ; DRUG USED: Olysio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Monotherapy; LEAD SPONSOR: Janssen R&D Ireland; CRITERIA: Inclusion Criteria: - Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (>) 10000 international unit per milliliter (IU/mL) - Subjects who are treatment naive or treatment-experienced. - Subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening - Subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, CT scan or magnetic resonance imaging [MRI]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (HCC) - Women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential Exclusion Criteria: - Evidence of clinical hepatic decompensation - Any liver disease of non-HCV etiology - Subjects with a past history of treatment with an approved or investigational DAA - Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening) - Infection/co-infection with HCV non-genotype 4 ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)[/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 - Mild to Moderate AD; BRIEF: The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimers disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people. Fifty patients with mild to moderate Alzheimers disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a placebo surgery where no medication will be injected. All study participants will be followed for at least two years after surgery. ; DRUG USED: CERE-110; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Nerve growth factor (NGF)/receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sangamo Therapeutics; CRITERIA: Inclusion Criteria: - Diagnosis of mild to moderate Alzheimers disease - Approved medications for Alzheimers disease may be taken if the dose has been stable for 3 months - A study partner who can attend all study visits - Good general health - Medically able to undergo neurosurgery Exclusion Criteria: - Significant neurological disease other than Alzheimers disease - Significant depression or other psychiatric disorder - Unstable medical conditions ; PRIMARY OUTCOME: Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-Cog); SECONDARY OUTCOME 1: Neuropsychological Test Battery[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - SRN-705-006; BRIEF: This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with Basal Cell Carcinoma (BCC). Goals: - To determine the safe and effective recommended dose of STP705 for the treatment of basal cell carcinoma. - Analysis of biomarkers common to BCC formation pathway including TGF-β1 and COX-2. ; DRUG USED: STP705; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin Cancer - Basal Cell Carcinoma (BCC); TARGET: Cyclooxygenase 2 (COX2) / Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Transforming Growth Factor-beta (TGF-beta) and Superfamily; THERAPY: Monotherapy; LEAD SPONSOR: Sirnaomics; CRITERIA: Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study: 1. Male or female adult ≥ 18 years of age. 2. Primary, histologically confirmed trunk or extremity (non-peri-orbital/-anogenital/-facial/-scalp) basal cell carcinoma lesion suitable for excision with a minimum diameter of 0.5 cm and with a maximum diameter of 2.0 cm. 3. Histological diagnosis made no more than 6 months prior to the screening visit. 4. Histological biopsy removed ≤25% of the original volume of the target lesion. 5. No other dermatological disease in the BCC target site or surrounding area, which in the opinion of the investigator, could interfere with the study. 6. Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period. 7. Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study. 8. Laboratory values for the tests (listed in the Study Schedule) within the reference ranges as defined by the central laboratory, or out of range test results that is clinically acceptable to the investigator. Ability to follow study instructions and likely to complete all study requirements. 9. Written informed consent obtained, including consent for tissue to be examined and stored by the Central Histology Lab. 10. Written consent to allow photographs of the target BCC lesion to be used as part of the study data and documentation. 11. For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral / implant/ injectable/ transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy). Exclusion Criteria: 1. Pregnant or lactating. 2. Presence of known or suspected systemic cancer. 3. Histological evidence of SCC, or any other non-BCC tumor in the biopsy specimen. 4. Histological evidence of infiltrative or other aggressive histological subtype growth patterns in the biopsy specimen. 5. History of recurrence of the target BCC lesion. 6. Evidence of dermatological disease or confounding skin condition with in 2 cm margin of the target BCC lesion, e.g., SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa. 7. Concurrent disease or treatment that suppresses the immune system; 8. Patients with baseline QTC > 480 msec using Fredericas formula. 9. Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk. 10. Known sensitivity to any of the ingredients in the study medication. 11. Use of a tanning beds or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the study. 12. Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit. 13. Use of systemic retinoids within the 6 months prior to the screening period. 14. Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period. 15. Use of topical immunomodulators within 2 cm of the target BCC lesion within the 4 weeks prior to the screening period. 16. Treatment with the following topical agents within 2 cm of the target BCC lesion within the 4 weeks prior to the screening visit: amino-levulinic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, ingenol mebutate, or imiquimod. 17. Treatment with liquid nitrogen, surgical excision (excluding diagnostic incisional biopsy) or curettage within 2 cm of the target BCC lesion during the 4 weeks prior to the screening visit. 18. Evidence of current chronic alcohol or drug abuse. 19. Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit. 20. In the investigators opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study. 21. Taking any other investigational product within 1 month of first dose of STP705. ; PRIMARY OUTCOME: Proportion of participants with histological clearance of treated basal cell carcinoma lesion at the End of Treatment (EOT); SECONDARY OUTCOME 1: Change in clinical diameter of the treated basal cell carcinoma lesion over the 6 week treatment period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - YKP3089C039 (Pediatric); BRIEF: The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing. ; DRUG USED: Xcopri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: GABA, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: SK Life Science, Inc.; CRITERIA: Inclusion Criteria: 1. Diagnosis of epilepsy with partial-onset seizures (POS) with or without secondarily generalized seizures according to the International League Against Epilepsys (ILAE) Classification of Epileptic Seizures). A diagnosis should have been established at least 6 months prior to Visit 1 by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allows provided that the participant meets the other diagnosis criterion (i.e., clinical history, including a history of treatment failure with at least 2 AEDs) 2. Male or female subjects, from age 2 to less than 18 years at the time of informed consent 3. Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds [lb]) 4. Written informed consent signed by the subject, legal guardian, or legally authorized representative (LAR) prior to entering the study in accordance with the ICH GCP guidelines. Age appropriate assent will be obtained for children and adolescents. If the written informed consent is provided by the legal guardian or LAR because the subject is unable to do so, a written or verbal assent from the subject must also be obtained 5. Are currently being treated with stable doses of 1 to a maximum of 2 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a participant, the dose must be stable for at least 8 weeks prior to Visit 1. A vagal nerve stimulator (VNS) will not be counted as one of the 2 allowable AEDs 6. In the Investigators opinion, parents or caregivers must be able to report accurate seizure assessments during the screening and study periods and subjects must be able to ingest study drug 7. Subjects with an implanted vagal nerve stimulator will be allowed if the vagal nerve stimulator was implanted at least 5 months prior to Visit 1 (Screening) and the stimulator parameters have not been changed for 30 days prior to Visit 1 and for the duration of the study 8. Subjects following a ketogenic diet will be allowed as long as the diet has been stable for at least 30 days prior to Visit 1 (Screening) and will remain stable for the duration of the study Exclusion Criteria: 1. Progressive neurological disease, including degenerative CNS diseases and progressive tumors 2. Evidence of clinically significant disease or any medical condition that would compromise the subjects ability to safely complete the study including, but not limited to, hepatic or renal failure, ischemic disease, human immunodeficiency virus (HIV) infection, active sexually transmitted disease (STD), active viral hepatitis, or malignancy 3. Positive urine screen of drugs of abuse (if not due to concomitant medication, e.g., benzodiazepines as hypnotics) for Cohort 1 subjects. 4. History of anoxic episodes require resuscitation within 6 months before Visit 1, drug or alcohol dependency or abuse within approximately the last 2 years or use of illegal recreational drugs. 5. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product 6. Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 72 hours before Day 1 and 72 hours before the day of multiple dose PK sampling (Day 59 for Cohort I) 7. Consumption of grapefruit or grapefruit-containing products within 72 hours before Day 1 and 72 hours before the day of multiple dose PK sampling (Day 59 for Cohort I) 8. Significant clinical laboratory abnormalities, including elevation of serum AST or ALT more than 2 times the upper limit or normal (ULN) for each age group. 9. Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before Day 1 10. Scheduled for surgery during the study 11. Ketogenic diet or vagal nerve stimulation that has undergone alteration within 30 days of Visit 1 12. Treatment with an investigational drug or device (other than VNS) ≤ 30 days before Visit 1 13. Females who are breastfeeding or pregnant at Screening or Baseline or who are of reproductive age and do not agree to be abstinent or to use highly effective methods of contraception 14. Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1 15. Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1 16. Have an unstable psychiatric diagnosis that may confound participants ability to participate in the study or that may prevent completion of the protocol-specified tests (e.g., in the judgement of the investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months before Visit 1, current psychotic disorder, acute mania) 17. Any suicidal ideation with intent or without a plan within 6 months before Visit 2 in participants aged 6 and above. 18. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator could affect the participants safety or interfere with study assessments 19. Evidence of significant hematological disease; white blood cell (WBC) count equal or less than 2500/μL (2.50 1E+09/L) or an absolute neutrophil count equal or less than 1000/μL (1.00 1E+09/L) 20. Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than 450 msec or shortened corrected QT interval (QTc) defined as less than 350 msec 21. Subject has a history or any serious drug-induced hypersensitivity reaction (including, but not limited to, Stevens Johnson syndrome, toxic epidermal necrolysis, or DRESS) or any drug-related rash requiring hospitalization. 22. History or AED-associated rash that involved conjunctiva or mucosae 23. History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication 24. Concomitant use of phenytoin and clobazam as these drugs may influence cenobamate plasma exposure. Subjects who took phenytoin or clobazam in the past must be off these drugs for at least 30 days prior to Visit 1. 25. Concomitant use of vigabatrin. Participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 and with documentation showing no evidence of vigabatrin-associated clinically significant abnormality in a visual perimetry test 26. A history of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1- time rescue) more than twice within the 30 days prior to Visit 1 (Screening) 27. A VNS implanted less than 5 months before Visit 1 or changes in parameter less than 30 days before Visit 1 (or thereafter during the study) 28. Presence of Familial short QT syndrome or relevant replicated QTc interval (QTcF less than 340 msec or greater than 450 msec in males and greater than 470 msec in females) on electrocardiogram (ECG) ; PRIMARY OUTCOME: The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri; SECONDARY OUTCOME 1: Safety - adverse events (AEs) reporting after a single and multiple doses of Xcopri[/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 - BAYOU (w/Olaparib, First-Line); BRIEF: A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria: 1. Provision of signed and dated, written ICF 2. Histologically or cytologically documented TCC/UC of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) also meeting the following: Unresectable, Stage IV disease; No prior systemic therapy for unresectable, Stage IV disease. 3. Ineligible for platinum-based chemotherapy defined as (i) in the opinion of the Investigator, unfit for carboplatin-based chemotherapy and (ii) meeting one of the following criteria: CrCl <60 mL/min calculated by Cockcroft-Gault equation; Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss (25 dB in 2 consecutive wave ranges); CTCAE Grade ≥2 peripheral neuropathy; New York Heart Association Class III heart failure; ECOG 2. 4. Known tumor HRR mutation status prior to randomization. 5. World Health Organization (WHO)/ECOG performance status of 0, 1, or 2. 6. Patients with at least 1 RECIST 1.1 target lesion at baseline. 7. Ability to swallow oral medications. 8. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Exclusion criteria 1. Active or prior documented autoimmune or inflammatory disorders. 2. Other invasive malignancy within 5 years before the first dose of the IP. 3. Major surgical procedure within 28 days prior to the first dose 4. Brain metastases or spinal cord compression unless the patients condition is stable and off steroid for at least 14 days 5. History of active primary immunodeficiency. 6. Active infection including tuberculosis (TB) 7. History of allogenic organ transplantation. 8. Uncontrolled intercurrent illness 9. Prior exposure to a PARP inhibitor or immune-mediated therapy. 10. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. 11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the IP. 12. No radiation therapy is allowed, unless it is (1) definitive radiation that had been administered at least 12 months prior; (2) palliative radiation to the brain, with associated criteria for stability or lack of symptoms; or (3) palliative radiation to painful bony lesions (this must comprise less than 30% of the bone marrow) or symptomatic pelvic soft tissue mass(es). 13. Receipt of live attenuated vaccine within 30 days prior to the first dose of the IP. 14. Patients with a known hypersensitivity to durvalumab, olaparib, or any of the excipients of the products. 15. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab and 6 months for participants taking also Olaparib in case of female participants, 90 days after receipt of the last dose of the IP in case of male participants. ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - HGT-SAN-055; BRIEF: Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease (LSD) caused by loss in activity of 1 of 4 enzymes necessary for degradation of the glycosaminoglycan (GAG) heparan sulfate (HS) in lysosomes. MPS IIIA results from deficiency of the enzyme heparan N-sulfatase (sulfamidase). MPS IIIA symptoms arise on average at 7 months of age, with the average age of diagnosis at 4.5 years for the majority of patients. The central nervous system (CNS) is the most severely affected organ system in patients with MPS IIIA, evidenced by deficits in language development, motor skills, and intellectual development. In addition, there are abnormal behaviors including but not limited to aggression and excess motor activity/hyperactivity that contribute to disturbances in sleep.Overall, individuals with MPS IIIA have a marked developmental delay and significantly reduced lifespan of 15 years of age on average. The purpose of this study is to determine the safety and tolerability of rhHNS via ascending doses administered via an a surgically implanted intrathecal drug delivery device (IDDD) intrathecal (IT) route once monthly (or every two weeks) for 6 months in patients with MPS IIIA. ; DRUG USED: SHP610; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis IIIA (MPS IIIA; Sanfilippo A Syndrome); TARGET: N-sulfo-D-glucosamine; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria Each patient had to meet the following criteria to be eligible for the study: 1. a.) Patients had a documented deficiency in sulfamidase enzyme activity of ≤10% of the lower limit of the normal range as measured in fibroblasts or leukocytes. AND either b or c b.) Patients had a normal enzyme activity level of at least 1 other sulfatase (to rule out multiple sulfatase deficiency) as measured in fibroblasts or leukocytes. c.) Patients had 2 documented mutations. 2. The patient was ≥3 years of age and had a developmental age ≥1 year. 3. Patients must have been medically stable, in the opinion of the Investigator, to accommodate the protocol requirements, including travel, assessments, and IDDD surgery, without placing an undue burden on the patient/patients family. 4. The patients parent(s) or legal guardian must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient, the patients parent(s), or legal guardian. The patients, patients parents or legal guardians consent and patients assent as appropriate, must have been obtained. Exclusion Criteria Patients who met any of the following criteria were excluded from the study: 1. The patient had significant non-MPS IIIA related CNS impairment or behavioral disturbances that would confound the scientific integrity or interpretation of study assessments, as determined by the investigator. 2. The patient had MPS IIIA behavioral-related issues, as determined by the investigator, that would have precluded performance of study neurocognitive and developmental testing procedures 3. The patient was pregnant, breast feeding, or was a female patient of childbearing potential who would not or could not comply with the use of an acceptable method of birth control such as condoms, barrier method, oral contraception, etc. 4. The patient was blind and/or deaf. 5. The patient had any known or suspected hypersensitivity to anesthesia or was thought to have an unacceptably high risk for anesthesia due to airway compromise or other conditions. 6. The patient or the patients family had a history of neuroleptic malignant syndrome, malignant hyperthermia, or other anesthesia-related concerns. 7. The investigator may have chosen to exclude patients who have had complications resulting from prior lumbar punctures. 8. The patient had a CNS shunt. 9. The patient had skeletomuscular/spinal abnormalities or other contraindications for the surgical implantation of the IDDD. 10. The patient had a history of poorly controlled seizure disorder. 11. The patient was currently receiving psychotropic or other medications, which in the investigators opinion, would have been likely to substantially confound test results and the dose and regimen of which cannot be kept constant throughout the study. 12. The patient could not sustain absence from aspirin, non-steroidal medications, or medications that affected blood clotting within 1 week prior to a relevant study related procedure (eg, device implantation if applicable), or had ingested such medications within 1 week before any procedures in which any change in clotting activity would have been deleterious. 13. The patient had received treatment with any investigational drug or a device intended as a treatment for MPS IIIA within the 30 days prior to, or during the study, or was enrolled in another study that involved an investigational drug or device (screening through safety follow-up contact). 14. The patient received a hematopoietic stem cell or bone marrow transplant. 15. The patients parent(s), or patients legal guardian(s) was/were unable to provide consent or the patient could not provide assent, as appropriate, due to, but not limited to, the inability to understand the nature, scope, and possible consequences of the study, or did not agree to comply with the protocol defined schedule of assessments. ; PRIMARY OUTCOME: Number of Treatment Emergent Serious Adverse Events (SAE); SECONDARY OUTCOME 1: Change From Baseline in Developmental Quotient (DQ) Using Bayley Scales of Infant Development Third Edition (BSID III) and Kaufman Assessment Battery for Children Second Edition (KABC II) at Week 22[/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 - 1st Line; BRIEF: This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Non-surgically castrated participants must continue the use of luteinizing hormone-releasing hormone (LHRH) agonists during protocol treatment. ; DRUG USED: Cixutumumab; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria - The participant is male and at least 18 years of age - The participant has histologically-confirmed adenocarcinoma of the prostate - The participant has radiographic evidence of metastatic prostate cancer (stage M1 [D2]) - The participant has prostate cancer unresponsive or refractory to hormone therapy - The participant must have evidence of progressive disease defined as at least one of the following: - a. Progressive measurable disease: using conventional solid tumor criteria. - b. Bone scan progression: at least one new lesion on bone scan. - c. Increasing prostate specific antigen (PSA): at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2 - The participant has a PSA ≥ 2 nanograms/milliliter (ng/mL) - The participant has not received prior chemotherapy for metastatic prostate cancer - The participant had prior surgical or medical castration with a serum testosterone level of < 50 ng/mL. If the method of castration is LHRH agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment - All clinically significant toxic effects (excluding alopecia) of prior surgery, radiotherapy, or hormonal therapy have resolved to grade ≤ 1 based on National Cancer Institute - Common Terminology Criteria for Adverse Events, (NCI-CTCAE)Version 3.0 - The participant has not received antiandrogen therapy for at least 6 weeks (4 weeks for flutamide) prior to study entry and is without evidence of an antiandrogen withdrawal response. For participants whose progression is documented solely by PSA increase, the most recent PSA value enabling study entry must be drawn after the required antiandrogen washout period - The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 - The participant has adequate organ function including: absolute neutrophil count ≥ 1500/microliter (μL); platelets ≥ 100,000/μL; hemoglobin ≥ 9.0 grams per deciliter (g/dL); bilirubin ≤ 1.5 times the institutional upper limit of normal (ULN); aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 3 times ULN (< 5x ULN if liver metastases are present); creatinine ≤ 1.5 x ULN (or calculated creatinine clearance > 60 milliliter/minute (mL/min); and urine protein ≤ 1+ (if urine protein is ≥ 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study) - The participant has fasting serum glucose < 120 milligrams per deciliter (mg/dL) or below the ULN - The participant has adequate coagulation function as defined by an international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 ULN (unless on oral anticoagulant therapy). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3) - The participant is asymptomatic from prostate cancer. Participants with minimal, infrequent cancer-related symptoms are eligible. Criteria regarding pain and analgesic use are detailed below - The participant has a life expectancy > 6 months - The participant, if sexually active, agrees to use contraceptives while on study - The participant has provided signed informed consent Exclusion Criteria - The participant has any active malignancy (other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms), or has an adequately-treated prior cancer but has been disease free for < 3 years - The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia (well-controlled atrial fibrillation is permitted), psychiatric illness/social situations, active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels, tumor invading to rectal lumen, or known varices), or any other serious uncontrolled medical disorder in the opinion of the investigator - The participant has a known hypersensitivity to therapeutic protein products - The participant has known or suspected brain or leptomeningeal metastases - The participant has received radiotherapy ≤ 21 days prior to first dose of IMC-A12 - The participant has received prior radiation therapy to > 30% of the bone marrow or prior strontium-89, rhenium-186, rhenium-188, or samarium-153 (participants who have received standard dose radiation to the pelvis for prostate cancer and no additional radiotherapy are eligible) - The participant has a known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness - The participant has received more than one course of radiotherapy to a single site of metastatic bony disease - The participant has a bone scan that indicates superscan (that is (ie), extensive metastasis to bone in numerous areas, too numerous to count or define) - The participant is receiving corticosteroids (dexamethasone, prednisone, or others) for anorexia, weight loss, analgesia or other cancer-related symptoms(Corticosteroids may not be instituted once a participant has begun therapy on-study - The participant requires ongoing, regularly scheduled opiate analgesic therapy for cancer related pain. Intermittent, infrequent low-potency opiate-use (example, oxycodone, codeine) is permitted - The participant has a history of prior treatment with other agents that specifically target the insulin-like growth factor (IGF) receptor ; PRIMARY OUTCOME: Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab; SECONDARY OUTCOME 1: Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs)[/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 - Sub-Saharan Africa; BRIEF: This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth. ; DRUG USED: Pomalyst; DRUG CLASS: New Molecular Entity (NME); INDICATION: Kaposis Sarcoma; TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: AIDS Malignancy Consortium; CRITERIA: Inclusion Criteria: - Participants must have measurable cutaneous KS that has been pathologically confirmed by an acquired immunodeficiency syndrome (AIDS) Malignancy Consortium (AMC)-approved pathologist; diagnostic tissue must be available to satisfy the tissue submission requirements for central pathology review - Participants may not show evidence for ongoing improvement in KS lesions in the 4 weeks prior to enrollment - HIV positive. Documentation of HIV-1 infection by means of any one of the following: - HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL confirmed by a licensed screening antibody and/or HIV antibody antigen combination assay; - Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. NOTE: The term licensed refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally. WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load. - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky performance status [KPS] >= 50) - Life expectancy >= 12 weeks - Hemoglobin >= 8 g/dL - Absolute neutrophil count (ANC): >= 1,000 cells/mm^3 (1.0 x 10^9/L) - Platelets: >= 75,000 cells/mm^3 (75.0 x 10^9/L) - Total bilirubin: =< 1.5 times the upper limit of normal (ULN), unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be =< 2 times the ULN - Serum aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) / alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN - Estimated or measured creatinine clearance > 60 mL/minute (1.00 mL/s) (serum creatinine =< 2.0 mg/dL / 176.8 umol/L) - Currently receiving local standard of care antiretroviral therapy (ART) for >= 12 weeks, with HIV viral load =< 400 copies/mL; participants are required to be on antiretroviral regimens that are in accordance with the current International AIDS Society guidelines concurrently with chemotherapy; the specific agents are at the discretion of the investigator and the use of investigational agents currently available on an expanded access basis is allowed - A female of childbearing potential (FCBP) is a female who has achieved menarche at some point and who meets one of the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), or 3) does not have a serum or plasma follicle stimulating hormone (FSH) > 40 mIU/mL and a history of amenorrhea x >= 1 year - FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, including one of the following highly effective, long-acting methods, DepoProvera, an intrauterine device (IUD), an implant*, or bilateral tubal ligation, if it can be verified that the procedure was performed, and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing - NOTE: Implants containing levonorgestrel and etonogestrel are prohibited in women receiving efavirenz, as drug interactions will render the implants ineffective - Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy - All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; serum or urine pregnancy testing will be repeated in FCBP, and must be negative, within 24 hours of starting each new cycle of pomalidomide - Able to take aspirin (>= 81 mg) daily as prophylactic anticoagulation - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Participants who are receiving any other investigational agents - Any prior use of thalidomide, lenalidomide, or pomalidomide - History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide - Visceral disease requiring cytotoxic chemotherapy (i.e., pulmonary KS, symptomatic gastrointestinal KS). KS-related lymphedema is permitted. - Use of agents containing zidovudine (including Combivir and Trizivir) are prohibited; in order to be eligible, participants taking zidovudine must change to a different regimen at least 7 days prior to therapy initiation; changes to antiretroviral therapy (ART) therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.) - Use of medications or substances that are strong inhibitors of CYP1A2, which include amiodarone, cimetidine, fluoroquinolones (e.g., ciprofloxacin, enoxacin), fluvoxamine, and ticlopidine is prohibited - Use of erythropoietin is prohibited - Co-administration of corticosteroids greater than doses required for treatment of adrenal insufficiency is prohibited - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection for which the participant has not completed at least 14 days of therapy prior to study enrollment and/or is not clinically stable; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements - Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with pomalidomide - Specific KS therapy, including cytotoxic chemotherapy but not including ART, within the past 4 weeks - Use of other anticancer treatments or agents within the past 4 weeks - History of malignant tumors other than KS, unless: - In complete remission for >= 1 year, or - Completely resected basal cell carcinoma, or - In situ squamous cell carcinoma of the cervix or anus - Grade >= 1 peripheral neuropathy - History of myocardial infarction (MI), cerebrovascular accident, or venous or arterial thromboembolism, unless line-related thrombosis without embolus occurring within 1 year prior to study entry - Known procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome - Any condition, including the presence of current laboratory abnormalities or other factor that, in the opinion of the investigator, places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study ; PRIMARY OUTCOME: Overall response rate; SECONDARY OUTCOME 1: Changes in CD4 T cell count[/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 - PSC12 (<u>></u>50 Years of Age); BRIEF: The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population. ; DRUG USED: FluBlok; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Protein Sciences Corporation; CRITERIA: Inclusion Criteria: 1. Ambulatory adults aged 50 and older. 2. Medically stable, as determined by medical history and targeted physical examination. Medically stable is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to study. 3. Absence of underlying conditions that make participation in the study contrary to the subjects best interest. 4. Able to understand and comply with planned study procedures. 5. Provides written informed consent prior to initiation of any study procedure. Exclusion Criteria: 1. Known contraindication to either study vaccine (see product package inserts) 2. Receipt of any other influenza vaccine within 180 days prior to enrollment in this study. 3. Underlying disease or ongoing therapy that might cause immunocompromise, e.g. cytotoxic agents or supraphysiologic doses of corticosteroids, such that response to vaccination might be sub-optimal. ; PRIMARY OUTCOME: Number of Participants With rtPCR-confirmed Influenza-Like Illness; SECONDARY OUTCOME 1: Number of Participants With Culture-confirmed Influenza-Like Illness[/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 RRMS; BRIEF: This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study. ; DRUG USED: Plegridy; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Interferon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: Part 1: - Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS. - Must have an EDSS score between 0.0 and 5.5. - Must have experienced >= 1 relapse in the 12 months prior to randomization (Day 1) or >= 2 relapses in the 24 months prior to randomization (Day 1) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1). Part 2: • Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol. Key Exclusion Criteria: Part 1: - Primary progressive, secondary progressive, or progressive relapsing. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing participants by the lack of clinically stable periods or clinical improvement. - History of severe allergic or anaphylactic reactions or known drug hypersensitivity. - Known allergy to any component of Avonex or BIIB017 formulation. - Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (Day 1). - Any previous treatment with PEGylated human IFN β-1a. Part 2: - Any significant changes in medical history occurring after enrollment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the participants participation in Part 1. The Investigator must re-assess the participants medical fitness for participation and consider any factors that would preclude treatment. - The participant could not tolerate BIIB017 in Part 1. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Part 1: Annualized Relapse Rate (ARR) at Week 96; SECONDARY OUTCOME 1: Part 1: ARR at Week 48[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Continuation; BRIEF: The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101. ; DRUG USED: Rixubis; DRUG CLASS: Biologic; INDICATION: Hemophilia B; TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: Main Inclusion Criteria: - Subject and/or legal representative has/have voluntarily provided signed informed consent - Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical study 251101 (pediatric study) - Subject was 12 to 65 years old at the time of screening for Study 250901 or < 12 years old at the time of screening for Study 251101 - Subject has severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory - Subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study 250901 or Pediatric Study 251101 Main Exclusion Criteria: - Subject received factor IX product(s) other than BAX 326 upon completion of Baxter Pivotal Study 250901 or Pediatric Study 251101 - Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B - For subjects transferring from Pivotal Study 250901: Subjects weight is < 35 kg or > 120 kg - Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the Continuation Study ; PRIMARY OUTCOME: Adverse Events Possibly or Probably Related to the Investigational Product; SECONDARY OUTCOME 1: Treatment of Bleeding Episodes: Number of Infusions Per Bleeding Episode Required Until Bleed Resolution[/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 - INTERLINK-1 (w/Cetuximab); BRIEF: This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer. ; DRUG USED: Monalizumab; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Immune System, Natural Killer Cells (NK Cells), Natural Killer Group 2A (NKG2A); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Are aged 18 years and over - Recurrent or metastatic squamous cell carcinoma of the SCCHN, oral cavity, oropharynx, hypopharynx, or larynx which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy - Received prior treatment using a programmed cell death ligand-1 (PD-L1) inhibitor - Prior platinum failure - Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN - Has measurable disease per RECIST 1.1 - A fresh or recently acquired tumor tissue for the purpose of biomarker testing - World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: - Head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies - Had prior cetuximab therapy (unless it was administered in curative locally advanced setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose) - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohns disease], diverticulitis - Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) ; PRIMARY OUTCOME: Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set; SECONDARY OUTCOME 1: Overall Survival in Full Analysis Set (FAS)[/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 - CIMPASI-I; BRIEF: The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis. ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma S.P.R.L.; CRITERIA: Inclusion Criteria: - Provided informed consent - Adult men or women >= 18 years - Chronic plaque psoriasis for at least 6 months - Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and Physicians Global Assessments score >= 3 - Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy - Other protocol-defined inclusion criteria may apply Exclusion Criteria: - Erythrodermic, guttate, generalized pustular form of psoriasis - History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol - Congestive heart failure - History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease - Concurrent malignancy or a history of malignancy as described in the protocol - History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis) - Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose - Any other condition which, in the Investigators judgment, would make the subject unsuitable for participation in the study - Other protocol-defined exclusion criteria may apply ; PRIMARY OUTCOME: Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16; SECONDARY OUTCOME 1: Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Dose Finding; BRIEF: In this study researchers want to gather more information about safety and effectiveness of BAY 2599023 (DTX201), a drug therapy that delivers the human factor VIII gene into the human body by use of a viral vector to treat the disease. By replacing the defective gene with a healthy copy the human body may produce clotting factor on its own. Hemophilia A is a bleeding disorder in which the human body does not have enough clotting factor VIII, a protein that controls bleeding. Researcher want to find the optimal dose of BAY 2599023 (DTX201) so that the body may produce enough clotting factor on its own. ; DRUG USED: DTX201; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Males age 18 years or older. - Confirmed diagnosis of hemophilia A as evidenced by their medical history with plasma FVIII activity levels < 1% of normal or at screening. - Have >150 exposure days (EDs) to FVIII concentrates (recombinant or plasma-derived). If on prophylaxis, are required to be willing to stop prophylactic treatment at specified time points throughout the study or If on-demand: should have had > 4 bleeding events in the last 52 weeks - Agree to use reliable barrier contraception. Exclusion Criteria: - History of allergic reaction to any FVIII product. - Clinically relevant findings in the physical examination considered critical by the treating physician, including obesity with BMI > 35 kg/m*2 - Current evidence of measurable inhibitor against factor VIII, prior history of inhibitors to FVIII protein or clinical history suggestive of inhibitor. - Evidence of active hepatitis B or C. - Currently on antiviral therapy for hepatitis B or C. - Significant underlying liver disease. - Serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm*3; HIV+ and stable participants with CD4 count >200/mm*3 and undetectable viral load are eligible to enroll. - Detectable antibodies reactive with AAVhu37capsid. - Participant with another bleeding disorder that is different from hemophilia A (e.g., von Willebrand disease, hemophilia B). - Participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational product within the last 12 weeks. - Known or suspected hypersensitivity or allergic reaction to trial product(s) or related FVIII products or any component of BAY2599023 (DTX201), or a contraindication to prednisolone ; PRIMARY OUTCOME: Number of patients with adverse events (AEs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and AEs/SAEs of special interest; SECONDARY OUTCOME 1: Expression pattern of FVIII activity.[/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 - 01-05-TL-491-008; BRIEF: The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan in participants with essential hypertension. ; DRUG USED: Edarbi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria 1. Has essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg, inclusive at Day minus 1) and 24-hour mean systolic blood pressure greater than or equal to 130 mm Hg and less than or equal to 170 mm Hg at Day 1). 2. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. 3. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator. 4. The subject is willing to discontinue current antihypertensive medications at the Screening Day minus 21 visit. If the subject is on amlodipine prior to screening, the subject is willing to discontinue this medication at Screening Day minus 28. Exclusion Criteria 1. Sitting trough clinic diastolic blood pressure greater than 114 mm Hg at Day minus 1. 2. Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality. 3. History of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack. 4. Clinically significant cardiac conduction defects (eg, third degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or atrial flutter). 5. Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. 6. Secondary hypertension of any etiology. 7. Is noncompliant (less than 70% or greater than 130%) with study medication during Placebo Run-In Period. 8. Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m2) at Screening. 9. Known or suspected unilateral or bilateral renal artery stenosis. 10. History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within the past 2 years. 11. History of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those subjects with basal cell or stage I squamous cell carcinoma of the skin). 12. Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening. 13. Alanine aminotransferase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening. 14. Hyperkalemia (defined as serum potassium greater than the upper limit of normal per the central laboratory) at Screening. 15. Upper arm circumference less than 24 cm or greater than 42 cm. 16. Works night (3rd) shift (defined as 11 PM to 7 AM). 17. Currently participating in another investigational study or has participated in an investigational study within 30 days prior to Screening. 18. Any other serious disease or condition at Screening (or Randomization) that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol. 19. Randomized in a previous azilsartan medoxomil study. ; PRIMARY OUTCOME: Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.; SECONDARY OUTCOME 1: Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure[/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 - STELLA; BRIEF: This study uses special blood cells called multiple tumor-associated antigen (TAA)-specific T cells to treat patients with acute lymphoblastic leukemia (ALL) which has come back, or may come back, or has not gone away after standard treatment, including an allogeneic hematopoietic stem cell transplant (HSCT). The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin lymphomas that are infected with Epstein-Barr virus (EBV). EBV is found in cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the bodys immune system and escape being killed. The investigators previously tested whether special white blood cells (called T cells) that were trained to kill EBV-infected cells could affect these tumors, and in many patients the investigators found that giving these trained T cells caused a complete or partial response. Other cancers express specific proteins that can be targeted in the same way. The investigators have been able to infuse such tumor-targeted cells into up to 10 patients with lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment appears to be safe. Therefore, the investigators now want to test whether the investigators can direct these special T cells against other types of cancers that carry similar proteins called tumor-associated antigens (TAAs). These proteins are specific to the leukemia cell, so they either do not show up, or show up in low quantities, on normal human cells. The investigators will grow T cells from patients stem cell donors in the laboratory in a way that will train them to recognize the tumor proteins WT1, PRAME and Survivin, which are expressed on most ALL cancer cells. The cells will be infused at least 30 days post-allogeneic HSCT. In this study, the investigators want to see whether these cells will be able to recognize and kill leukemia cells that express these antigens. These donor-derived multiTAA-specific T cells are an investigational product not yet approved by the U.S. Food and Drug Administration. The purpose of this study is to find the largest safe dose of donor-derived multiTAA-specific T cells for patients with ALL. ; DRUG USED: MT-401; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Melanoma antigen-encoding gene (MAGE), NY-ESO-1 (Cancer-testis antigen), PRAME/MAPE/OIP4, Stem Cells/Other Cell Therapies, Survivin, Synovial Sarcoma X (SSX) Breakpoint Family, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Baylor College of Medicine; CRITERIA: Inclusion Criteria: Only patients who receive infusions in the integrated Cell and Gene Therapy (CAGT) Transplant program at Texas Childrens Hospital (TCH) or Houston Methodist Hospital (HMH) are eligible for this study. 1. Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as: (i) Adjuvant therapy for ALL (Group A), or (ii) Treatment for relapsed/residual ALL disease (Group B) Residual disease at the time of transplant or post-transplant relapse is defined as PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry, or increased blasts on bone marrow biopsy or in the peripheral blood. Minimal residual disease (MRD )will be defined as detection in blood or marrow of any of the following: (i) Any leukemia-specific marker (such as t(12;21); t(9;22) or t(4;11)) documented in the patients leukemia cells pre-transplant on a post-transplant evaluation. (ii) A leukemia-specific phenotype (e.g. expression of markers including CD10 and/or CD19 or CD3 and/or CD4 or CD8) post-transplant at a level greater than or equal to 0.01%. (iii) Mixed donor chimerism (greater than 20%). 2. Life expectancy greater than or equal to 6 weeks. 3. Karnofsky/Lansky score of greater than or equal to 50. 4. Patient or parent/guardian capable of providing informed consent. 5. Bilirubin less than or equal to 2X upper limit of normal. 6. AST less than or equal to 3X upper limit of normal. 7. Serum creatinine less than or equal to 2X upper limit of normal. 8. Hgb greater than or equal to 7.0 g/dL (can be transfused). 9. Pulse oximetry of greater than 90% on room air. 10. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ATL infusion. Male partner should use a condom. 11. Available donor-derived multiTAA-specific T cell line. 12. No other investigational anti-neoplastic therapy for one month prior to entry in this study. 13. Undergoing Stem Cell Transplant at CAGT Exclusion Criteria: 1. Patients receiving ATG or Campath within 28 days of infusion. 2. Patients receiving a Donor Lymphocyte Infusion (DLI) within 4 weeks of planned T cell infusion. 3. Less than 30 days post-allogeneic stem cell transplant. 4. Severe intercurrent infection. 5. Evidence of GVHD greater than Grade II. 6. Pregnant or lactating. 7. Currently taking corticosteroids (greater than 0.5 mg/kg/day prednisone or equivalent). Donor Eligibility: Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have fulfilled eligibility for and consented to stem cell donation as per the stem cell transplant programs standard operating procedures. Subjects must be at least 12 kg or 24 pounds to be eligible for stem cell donation. The stem cell donor will have already been selected by the primary Bone Marrow Transplant attending according to CAGT SOPs for Donor Evaluation, Donor Selection, and Donor Deferral. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for T cell generation, provided that there are no new reasons for ineligibility since the stem cell collection. In this study, the subjects hematopoietic stem cell donor will also be the donor for the T cells. ; PRIMARY OUTCOME: Number of patients with dose-limiting toxicities (DLTs).; SECONDARY OUTCOME 1: Number of patients with a decrease in the marker of disease.[/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 - CL02-204; BRIEF: A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain. ; DRUG USED: CL-H1T; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Charleston Laboratories, Inc; CRITERIA: Inclusion Criteria: 1. Able to understand and willing to give written informed consent and authorize the Health Insurance Portability and Accountability Act (HIPAA) prior to entering the study. 2. Men and women with episodic migraine who meet the criteria of the International Headache Societys Headache Classification Committee for migraine with or without aura. 3. Between the ages of 18 and 75 years of age, inclusive. 4. A history of episodic migraine for at least 1 year. 5. Maximal frequency of 8 migraine attacks per month; minimum frequency of 2 migraine attacks per month; at least 48 hours of headache-free time between migraine attacks. 6. Maximum total headache days of 14 per month. 7. History of migraine headache with nausea ≥ 50% of the time. 8. Able and willing to complete an electronic diary (eDiary) to record the details of a migraine attack treated with investigational treatment. 9. Able to swallow a capsule whole. 10. Report headache on the Headache Pain Scale at Baseline before treatment. 11. Report the presence of nausea on the Nausea Scale at Baseline before treatment. 12. Women of childbearing potential (WOCBP) must practice an acceptable method of birth control (acceptable methods of birth control in this study include: surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partners vasectomy, or a double-barrier method [condom or diaphragm with spermicide]). Use of intrauterine devices and hormonal contraceptives must begin at least 8 weeks prior to Screening. 13. Willing and able to comply with the protocol requirements for the duration of the study. Exclusion Criteria: 1. A clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation. Such conditions may include cardiac, respiratory, hepatic, renal or metabolic diseases, peripheral vascular disease, any systemic disease, acute infection, or neurological disease (including Parkinsons Disease or other condition associated with a movement disorder), current malignancy or recent history (within 5 years) of malignancy (other than squamous cell or basal cell carcinoma) or any medical condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study. 2. A positive saliva screen for alcohol or a positive urine drug screen for cocaine, narcotics, benzodiazepines, opioids, tetrahydrocannabinol (THC), barbiturates, amphetamines, or any prescription drugs unless such a positive result can be explained by stated concomitant medications. 3. Regularly smoke cigarettes or use opiate analgesic drugs, benzodiazepines, ergot containing drugs, alcohol, THC, or other drugs of abuse that, at the discretion of the Investigator, may interfere with the evaluation of the endpoints in the trial. 4. Unstable use of prophylactic migraine medication (eg, change of dose or type of medication) during the 30 days prior to Screening Visit. 5. Subjects using monoamine oxidase-A (MAO-A) inhibitors and who cannot be washed out. 6. Subjects using selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, THC, or systemic corticosteroids over the past month prior to the Screening Visit. 7. Daily use of antipsychotics at least 15 days prior to randomization. 8. Medication overuse: 1. Opioids for headache ≥ 10 days during the 90 days prior to Screening Visit; 2. Combination medications that contain an opioid and/or barbiturate (eg, Fiorinal®) ≥ 10 days during the 90 days prior to Screening Visit. 3. Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications ˃ 14 days a month during the 90 days prior to Screening Visit. 4. Triptans or ergots ≥ 10 days a month during the 90 days prior to Screening Visit. 9. Use of mini prophylaxis for menstrual migraine. 10. History of allergic reaction or drug sensitivity to any triptans. 11. History of allergic reaction or drug sensitivity to promethazine. 12. History of allergic reaction or drug sensitivity to acetaminophen. 13. History of extrapyramidal reaction (eg, akathisia or dystonia) to neuroleptic treatments. 14. Subjects who are pregnant (positive urine hCG: Human chorionic gonadotropin test at Screening Visit) or breastfeeding. 15. Use of experimental or investigational treatments and/or participation in drug clinical studies within the 6 months before the Screening Visit. 16. Subjects who are employees of the Sponsor. 17. Relatives of, or staff directly reporting to, the Investigator. ; PRIMARY OUTCOME: Percentage of subjects who are pain-free 2 hours after taking investigational treatment; SECONDARY OUTCOME 1: Percentage of subjects with no vomiting 2 hours after taking the investigational treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - NIH; BRIEF: A two stage, phase I/II, double-blinded, randomized, placebo-controlled study of hepatitis C virus (HCV)uninfected male and female injection drug users (IDU) aged 18 to 45. AdCh3NSmut1 and MVA-NSMut HCV vaccine will be administered to 68 (+/-4) volunteers in stage 1. A planned interim analysis of safety and immunogenicity will be conducted. If no safety signal is detected and there is evidence of a measurable immune response to HCV then 472 (+/-4) volunteers will be enrolled in stage 2. Primary objectives are to 1) assess the safety of AdCh3NSmut1 and MVA-NSmut compared to placebo when administered to HCV-uninfected IDUs and 2) determine if AdCh3NSmut1 and MVA-NSmut HCV vaccines will reduce incidence of chronic HCV infection compared to placebo among HCV-uninfected IDUs. Planned study duration is approx 63 months (accrual time, 2 months vaccination, 18 months follow-up, and 9 months extended observation for subjects becoming viremic in the last month of follow-up). ; DRUG USED: ProCvax; DRUG CLASS: Vaccine; INDICATION: Hepatitis C Prevention (Vaccines, Antiviral); TARGET: T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Allergy and Infectious Diseases (NIAID); CRITERIA: Inclusion Criteria: - Comprehension of informed consent. - 18-45 year old men or women with acknowledged active IDU in the past 90 days and have no travel plans that would interfere with ability to meet the study visit schedule. - In good general health as determined by a participating study physician and results within acceptable ranges for clinical laboratory evaluations as detailed in Appendix A. - Negative for antibodies to hepatitis C virus (anti-HCV). - Negative for HCV RNA. - Negative antibodies to HIV. - Negative for HBsAg. - Able and willing (in the Investigators opinion) to comply with all study requirements. - Willing to allow the investigators access to their medical records. - Willingness to practice continuous effective contraception from the screening visit through 90 days after the last vaccination (males and females). - Among females, a negative pregnancy test within 24 hours prior to vaccination. - Agreement to refrain from blood donation during the course of the study or after the study. - Provide written informed consent prior to initiation of any study procedures. - Willing to provide contact information for study follow-up activities, including the address, name and contact information of three people who can be contacted to facilitate follow-up compliance. Exclusion Criteria: - The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic device, blood product, or medication) or has received an experimental agent within 30 days prior to enrollment in this study, or expects to receive another experimental agent during participation in this study. - Prior receipt of a recombinant simian or human adenoviral vaccine or MVA vaccine. - Administration of immunoglobulins and/or any blood products within the 90 days preceding the planned administration of the vaccine candidate. - Any confirmed or suspected immunosuppressive or immunodeficient state, including: HIV infection; asplenia; recurrent, severe infections. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (i.e., known hypersensitivity to aminoglycosideantibiotics or to egg proteins). - History of clinically significant contact dermatitis or other significant dermatological conditions such as psoriasis. - Any history of anaphylaxis in reaction to vaccination. - Pregnancy, lactation or willingness/intention to become pregnant during the study. - History of cancer (except for successfully treated basal cell carcinoma of the skin and cervical carcinoma in situ). - History of severe psychiatric illness, including severe depression, history of suicidal ideation, suicidal attempts, or psychosis requiring medication. The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis that is uncontrolled and would interfere with the ability to adhere to the protocol. - Any other serious chronic illness requiring hospital specialist supervision. - Suspected or known current alcohol abuse as defined by a score of 10 or more on the Alcohol Use Disorders Identification Test (AUDIT) C test (a standardized screening tool used to identify hazardous drinkers or those with active alcohol use disorders, including abuse or dependence). - At high risk of HIV infection by the following criteria (adapted from HIV Network for Prevention Trials (HIVNET) behavioral criteria for high risk of HIV): (1) sexually active male who has sex with men (MSM), defined as (i) male who has had anal sex with male sexual partner or partners in the past year or (ii) a male who exchanged sex with male partner(s) for money or drugs in the past year; and (2) female and in a current relationship with a high risk male (active MSM, HIV positive male). - Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the result of the study, or may influence the subjects ability to participate in the study. - History of or current diagnosis of Diabetes mellitus. - History of or current diagnosis of autoimmune disease. - History of or current cardiac disease including history of myocardial infarction or arrhythmia. - Current diagnosis of active liver disease. - History of seizure disorder or currently taking anti-convulsant therapy that would interfere with safety evaluation. - Uncontrolled hypertension (defined as systolic blood pressure being greater than 140mm Hg or diastolic blood pressure being greater than 90mm Hg). - History of splenectomy. - Long term immunosuppressive use (defined as taken for 14 days or more in total at any time during the past 180 days) of high dose oral or parenteral glucocorticoids (high dose defined as prednisone >/=20 mg total daily dose, or equivalent dose of other glucocorticoids); or high-dose inhaled steroids (high dose defined as >800 mcg/day of beclomethasone dipropionate or equ ivalent); or any use of hepatotoxic or non-FDA approved medication. - Have an acute illness, including an oral temperature greater than or equal to 100.4 degrees Fahrenheit, within 7 days prior to the first vaccination. - Immunization against another pathogen within 14 days of planned injection. Second vaccination exclusion criteria: The following events associated with vaccine immunization constitute absolute contraindications to further administration of vaccine. The subject will not receive additional vaccination, but will continue with scheduled follow-up procedures except vaccination. 1. Anaphylactic reaction following administration of vaccine. 2. Pregnancy. If a woman reports having a positive home urine pregnancy test or a positive in clinic urine pregnancy test prior to a scheduled second vaccination, she is not eligible to receive the study vaccine. If she later returns to clinic and reports having a negative home urine pregnancy test and this is confirmed by a negative in clinic urine pregnancy test and a negative blood pregnancy test she may be eligible for the second vaccination if she is still within the vaccination window and no other exclusion criteria are met. The following adverse events constitute contraindications to administration of vaccine at that point in time. If any one of these adverse events occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date (within 28 days of scheduled administration) or withdrawn at the discretion of the investigator. The subject will not receive additional vaccination, but will continue with all scheduled follow-up procedures except vaccination. 3. Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). The vaccine dose can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., temperature of <38°C (100.4°F). 4. Temperature of >38°C (100.4°F) at the time of vaccination. 5. Immunization against another pathogen within 14 days of vaccination ; PRIMARY OUTCOME: Number of Participants With Chronic Hepatitis C Virus (HCV) Infection at 6 Months; SECONDARY OUTCOME 1: Number of Participants With Positive Cell Mediated Immune 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 - Japan; BRIEF: The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors. ; DRUG USED: LY3039478; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cancer; TARGET: Gamma-secretase, Notch Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. - In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate. - Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale. - Adequate organ function, including hematologic, hepatic, and renal. - Estimated life expectancy of ≥12 weeks. Exclusion Criteria: - Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively. - Have serious preexisting medical conditions. - Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea. - Have an active bacterial, fungal, and/or known viral infection. - Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results. ; PRIMARY OUTCOME: Number of Participants with LY3039478 Dose-Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478[/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/IIb - Mild to Moderate; BRIEF: This study determines the Maximum Tolerable Dose (MTD) by maximum BSA percentage treated and evaluates efficacy of various concentrations of AMTX-100 CF versus placebo (vehicle). The study has two parts: Phase I (Part 1): Approximately Twenty five (25) subjects with various treatable Body Surface Area (BSA) involvement of Mild to Moderate Atopic Dermatitis will be enrolled in the study and treated with 1.1% w/w AMTX-100 CF. Phase II (Part 2): Approximately sixty (60) subjects with Mild to Moderate Atopic Dermatitis with various treatable BSA involvement of Mild to Moderate Atopic Dermatitis will be randomized to be treated with 1.1% w/w AMTX-100 CF3 concentration or Vehicle (Placebo) in the study. ; DRUG USED: AMTX-100; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Amytrx Therapeutics, Inc.; CRITERIA: Part 1 Inclusion Criteria: Subjects are required to meet ALL of the following criteria for enrollment into the Phase I (Part 1) of the study: 1. Male or female subjects who are 18 years or older 2. If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) double-barrier contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL 3. All fertile female subjects as described above need to have a negative urine pregnancy test at the screening and baseline visits 4. Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements 5. Subject is able to apply topical products on all treatable assigned areas by self and/or caregiver (if applicable), per the Investigator 6. Subject is in general good physical/mental health per the Investigator 7. Subjects Total Body Surface Area (BSA) is between 1.5 and 2.1 m2 per the Mosteller formula 8. The subject has physician confirmed mild to moderate Atopic Dermatitis (AD) defined by the Eichenfield revised criteria of Hannifin and Rajka, for at least 6 months prior to study enrollment 9. Validated Investigators Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 2 or 3 (mild to moderate) at the screening and baseline visits 10. Subject has Atopic Dermatitis (AD) involvement with eligible treatable percent of the BSA appropriate for topical treatment per the assigned cohort at the screening and baseline visits per below: 1. Cohort 1: 3% BSA ≤ AD Affected Area ≤ 6% BSA 2. Cohort 2: 6% BSA < AD Affected Area ≤ 12% BSA 3. Cohort 3: 12% BSA < AD Affected Area ≤ 24% BSA 4. Cohort 4: 24% BSA < AD Affected Area ≤ 48% BSA 5. Cohort 5: 48% BSA < AD Affected Area ≤ 70% BSA Note: Calculation of Treatable BSA percentage (% of the total BSA that is AD-involved, excluding the scalp, face, eyes, eyelids, neck, hands, palms, feet, groin, genitals or axillae) will be completed by one of the 2 methods below: - Handprint Method: the area represented by the palm with all five digits adducted together is approximately 1% of the subjects BSA - Rule of Nines: Where values of 9% or 18% of BSA are assigned to specific regions in the adult subject (head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) Part 1 Exclusion Criteria: Subjects are required to meet NONE of the following criteria for enrollment into the Phase I (Part 1) of the study: 1. Pregnant or lactating females or women who are planning for pregnancy in the next 6 months 2. Women at postpartum for 3 months or less prior to screening 3. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator may interfere with the conduct of the study 4. Subjects with abnormal vital signs, physical and dermatological exams or clinical laboratory evaluations considered clinically significant by the Principal Investigator, which in the opinion of the PI would significantly interfere with the study conduct 5. Subjects with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator 6. The subject has a planned major surgical intervention for a pre-existing condition within the duration of the study 7. The subject has a history of drug or alcohol abuse that would impair or risk the subjects full participation in the study, in the opinion of the investigator. 8. Participation in a clinical trial within 3 months, or more than two clinical trials within 12 months prior to screening 9. Concurrent or recent use of topical steroids, topical immunosuppressive/immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) or salicylic acid within 14 days of the baseline visit 10. The subject has severe AD as determined by vIGA-AD™ score higher than 3 11. The subject cannot avoid systemic treatments (including systemic corticosteroids, immunotherapy, biologics or phototherapy) for AD during the study per the Investigator 12. The subject has previously received any systemic treatments, immunotherapy, biologics or phototherapy for AD within 12 months prior to study enrollment 13. Current or expected use of prohibited medications as described in Section 7, unless approved by the study Medical Monitor 14. The subject has concurrent contact dermatitis or history of anaphylactic reaction Part 2 Inclusion Criteria: Subjects are required to meet ALL of the following criteria for randomization into the Phase II (Part 2) of the study: 1. Male or female subjects who are 18 years or older. 2. If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) double-barrier contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL. 3. All fertile female subjects as described above need to have a negative urine pregnancy test at the screening and baseline visits. 4. Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements. 5. Subject is able to apply topical products on all the treatable areas by self and/or caregiver (if applicable), per the Investigator. 6. Subject is willing and able to comply with all clinic visits and study-related procedures. 7. Subject is able to understand and complete study-related questionnaires. 8. The subject has physician confirmed mild to moderate Atopic Dermatitis (AD) defined by the Eichenfield revised criteria of Hannifin and Rajka, for at least 6 months prior to study enrollment. 9. Validated Investigators Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 2 or 3 (mild to moderate) at the screening and baseline visits. 10. Eczema Area and Severity Index (EASI) score lower than 23 at the screening and baseline visits 11. Subject has Atopic Dermatitis (AD) involvement of between 5% and 70% of the treatable BSA (excluding the scalp, face, eyes, eyelids, neck, hands, palms, feet, groin, genitals or the axillae) appropriate for topical treatment at the screening and baseline visits. Note: Calculation of Treatable BSA percentage (% of the total BSA that is AD-involved, excluding the scalp, face, eyes, eyelids, neck, hands, palms, feet, groin, genitals or the axillae) will be completed by the Rule of Nines method: o Where values of 9% or 18% of BSA are assigned to specific regions in the adult subject (head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) 12. Subjects must be applying stable doses of an additive-free, basic bland emollient twice-daily for at least 1 week immediately before the baseline visit (Visit 2, Day 0), and to be continued throughout the study. Note: The additive-free, basic bland emollients should be applied no earlier than 1 hour before or after the administration of the study treatment. Part 2 Exclusion Criteria: Subjects are required to meet NONE of the following criteria for randomization into the Phase II (Part 2) of the study: 1. Pregnant or lactating females or women who are planning for pregnancy in the next 6 months 2. Women at postpartum for 3 months or less prior to screening 3. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator may interfere with the conduct of the study 4. Subjects with abnormal vital signs, physical and dermatological exams or clinical laboratory evaluations considered clinically significant by the Principal Investigator, which in the opinion of the PI would significantly interfere with the study conduct 5. Subjects with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator 6. The subject has a planned major surgical intervention for a pre-existing condition within the duration of the study 7. The subject has a history of drug or alcohol abuse that would impair or risk the subjects full participation in the study, in the opinion of the investigator. 8. Participation in a clinical trial within 3 months, or more than two clinical trials within 12 months prior to screening 9. Concurrent or recent use of prescription moisturizers, topical steroids, topical immunosuppressive/immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) or salicylic acid within 14 days of the baseline visit 10. The subject has severe AD as determined by vIGA-AD™ score higher than 3 11. The subject cannot avoid systemic treatments (including systemic corticosteroids, immunotherapy, biologics or phototherapy) for AD during the study per the Investigator 12. The subject has previously received any systemic treatments, immunotherapy, biologics or phototherapy for AD within 12 months prior to study enrollment 13. Current or expected use of prohibited medications and procedures during study treatment, as described in Section 7, unless approved by the study Medical Monitor 14. Subject has unstable AD or any consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms 15. Subject has a significant active systemic or localized infection, including known actively infected AD 16. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit 17. The subject has previously received AMTX-100 CF 18. Subject has any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion of the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patients participation unreliable, or may interfere with study assessments 19. The subject has concurrent contact dermatitis; or history of anaphylactic reaction ; PRIMARY OUTCOME: Part 1 (Phase I) Primary: Maximum Tolerable Dose; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Azacitidine or Cytarabine; BRIEF: This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states. ; DRUG USED: FT-2102; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Isocitrate Dehydrogenase (IDH); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Forma Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia [APL] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy. - Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site - Good performance status - Good kidney and liver function Exclusion Criteria: - Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy - Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias - Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy ; PRIMARY OUTCOME: Maximum Tolerated Doses (MTDs) or Maximum Evaluated Doses (MEDs) [Phase 1]; SECONDARY OUTCOME 1: Area under the plasma concentration versus time curve (AUC) [Phase 1 and Phase 2][/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 1502 (Study 1 - EU/Australia); BRIEF: ; DRUG USED: Fintepla; DRUG CLASS: Non-NME; INDICATION: Dravet Syndrome (Epilepsy); TARGET: Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: ; CRITERIA: ; PRIMARY OUTCOME: ; 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 - APDS; BRIEF: This is an open-label study conducted to investigate safety, pharmacokinetics and pharmacodynamics of repeat doses of inhaled nemiralisib (NEMI) in participants with activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110 delta-activating mutation causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI) ; DRUG USED: GSK2269557; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Immunodeficiencies; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Male and female subjects aged 18 or older at the time of signing the informed consent. - Patients with a clinical phenotype consistent with APDS, including a history of recurrent (frequency greater than would be expected in an immunocompetent individual) ear, sinus or pulmonary infections, and who have a known type 1 APDS-associated genetic PI3K delta mutation (i.e. E1021K, N334K, E525K and C416R). - Body weight >=45 kilograms (kg) and body mass index (BMI) >=18 kg/square meter (m^2) (inclusive) - Male subject. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until completion of the follow-up telephone call at 1-2 weeks from last dose. Vasectomy with documentation of azoospermia. Male condom plus partner use of one of the following contraceptive options: 1. Contraceptive subdermal implant 2. Intrauterine device or intrauterine system 3. Combined estrogen and progestogen oral contraceptive, 4. Injectable progestogen 5. Contraceptive vaginal ring 6. Percutaneous contraceptive patches. This is an all inclusive list of those methods that meet the GSK definition of highly effective: having a failure rate of less than 1% per year when used consistently and, correctly and, when applicable, in accordance with the product label. For non-product methods (e.g. male sterility), the investigator determines what is consistent and correct use. The GlaxoSmithKline (GSK) definition is based on the definition provided by International Conference on Harmonisation (ICH). - Female subject. A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: 1. Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until completion of the follow-up telephone call at 1-2 weeks from last dose. - Capable of giving signed informed consent as described in protocol which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. Exclusion Criteria: - Alanine aminotransferase (ALT) >2xupper limit normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Current or chronic history of liver disease except where hepatomegaly is identified by their clinician to be secondary to APDS, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - Corrected QT interval (QTc) > 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block - A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - Regular or chronic treatment with strong inhibitors of Cytochrome P450 (CYP) 3A4 and/or CYP2D6 (this includes some anti-epileptic treatments, macrolide antibiotics, oral antifungal treatments and anti-tuberculosis therapy are prohibited from the screening visit until the end of treatment visit. Where clinically appropriate, an alternative drug in the same class (or unrelated class) that is not a strong CYP3A4 and/or CYP2D6 inhibitor can, after signing informed consent, be substituted for the original strong inhibitor of these enzymes - Use of unstable dosing regimen with intravenous (i.v.) immunoglobulin (Ig) /subcutaneous (s.c.) Ig in the last 6 months before screening. Stable maintenance immunoglobulin regimen, as per local practice, such as regular injections with a consistent dosing interval (e.g. monthly) is acceptable. - Previous use of an mechanistic target of rapamycin (mTOR) antagonist (e.g. rapamycin, everolimus) or PI3K delta inhibitor (selective or non-selective PI3K inhibitors). - History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (~240 milliliters [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. - History of sensitivity to any of the study medications, or components thereof (including lactose) or a history of drug or other allergy (including a milk protein allergy) that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. - History of previous intolerance of the induced sputum procedure. - Bronchoalveolar Lavage (BAL) sub study only: History of bronchospasm in response to the brochoscopy/BAL procedure - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dose of study medication in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - A positive test for human immunodeficiency virus (HIV) antibody. - Exposure to more than 4 investigational medicinal products within 12 months prior to the first dose of study medication. ; PRIMARY OUTCOME: Number of Participants With Any Serious Adverse Events (SAEs) and Any Non-serious Adverse Events (Non-SAEs); SECONDARY OUTCOME 1: Plasma Concentration Following Administration of NEMI[/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 - AQUARIUS; BRIEF: The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range. ; DRUG USED: Tekturna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiovascular Disease; TARGET: Renin; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg. - Patients with or without current treatment for hypertension - Angiographic evidence of coronary artery disease - At least 2 qualifying Cardiovascular risk factors at Visit 1 Exclusion Criteria: - Baseline IVUS determined unacceptable - Patients requiring treatment with disallowed study medications - Patients with clinically significant heart disease - Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25% - Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2: - Angiotensin converting enzyme inhibitors - Angiotensin receptor blockers - aldosterone receptor blockers or a direct renin inhibitor. - Other conditions may apply ; PRIMARY OUTCOME: Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment; SECONDARY OUTCOME 1: Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS[/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 - MCI186-17 (Ext); BRIEF: This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients. ; DRUG USED: Radicava; DRUG CLASS: New Molecular Entity (NME); INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681. Exclusion Criteria: - Patients with such complications as Parkinsons disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone. - Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681. - Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception. - Patients who are participating in other clinical trials except the study NCT00330681. - In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician. ; PRIMARY OUTCOME: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks; SECONDARY OUTCOME 1: Number of Participants With Death or a Specified State of Disease Progression[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - Chronic Progressive MS; BRIEF: The purpose of the study is to determine the safety and tolerability, dose-limiting toxicities, maximum tolerated dose, and recommended therapeutic dose of intravenously administered MIS416 weekly in patients with chronic progressive multiple sclerosis. ; DRUG USED: MIS416; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Innate Immunotherapeutics; CRITERIA: Inclusion Criteria: - At least 18 years of age. - Diagnosis of MS, by the McDonald criteria. - Chronic progressive MS (CPMS), defined as either primary progressive MS (PPMS) or secondary progressive MS (SPMS), per the criteria of the National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. [NOTE: In the dose-confirmation phase, only subjects with SPMS may be enrolled]. - MS is clinically active with worsening clinical status within the past 2 years, defined as an increase in EDSS by 1 point or more, sustained for at least 6 months. - Expanded Disability Status Scale (EDSS) of 2.5 to 7.0 at Screening. - The following laboratory values must be documented within 3 days prior to initiation of study drug: - Absolute neutrophil count (ANC) >= 1 x 109/L - Platelet count >= 100 x 109/L - Serum creatinine =< 1.5 mg/dL - AST (SGOT) and ALT (SGPT) =< 2 × upper limit of normal. - Provide written informed consent to participate. Exclusion Criteria: - Relapsing-remitting MS or progressive-relapsing MS - Any immunomodulatory drug therapy or immunosuppressive therapy within the previous six months, or vaccine or systemic corticosteroids within the previous 60 days, prior to initiation of study drug. - Exposure to other experimental treatments currently under investigation in MS clinical trials, including alemtuzamab, rituximab, fingolimod, and clabribine. - A diagnosis or history of collagen vascular disease (including Sjögrens syndrome and systemic lupus erythematosus), anticardiolipin antibody syndrome, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL), sarcoidosis, vasculitis, Bechets syndrome and/or Lyme disease. - History of alcohol or drug abuse (with the exception of cannabinoids) within 2 years prior to initiation of study drug. - Previous exposure to MIS416. ; PRIMARY OUTCOME: Safety profile, including maximum tolerated dose; SECONDARY OUTCOME 1: Pharmacodynamic assessments[/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. Finasteride; BRIEF: The purpose of this six month study is to show that dutasteride is safe and more effective than placebo, and at least as safe and effective as finasteride in treating hair loss in men with androgenetic alopecia. Three doses of dutasteride will be investigated. ; DRUG USED: Avodart; DRUG CLASS: New Molecular Entity (NME); INDICATION: Androgenetic Alopecia; TARGET: steroid 5a-reductase; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Norwood-Hamilton Type III vertex, IV, or V Exclusion Criteria: - History or evidence of hair loss other than androgenetic alopecia - Scarring of the scalp - Use of dutasteride in previous 18 months - Use of finasteride within previous 12 months - Hair transplantation or hair weaving within 6 months - Use of Minoxidil within previous 6 months - Use of drugs with anti-androgenetic/androgenetic properties within previous 6 months - Use of Drugs that cause hypertrichosis or hypotrichosis within previous 6 months - Light or laser treatment of scalp within previous 3 months - Cosmetic products aimed at improving or correcting signs of hair loss within previous 2 weeks ; PRIMARY OUTCOME: Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT); SECONDARY OUTCOME 1: Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT[/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 - VERSATILE-002; BRIEF: VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). ; DRUG USED: PDS0101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Combination; LEAD SPONSOR: PDS Biotechnology Corp.; CRITERIA: Inclusion Criteria: - The participant (or legally acceptable representative if applicable) provides written informed consent for the study. - Be ≥18 years of age on the day of signing the informed consent. - Checkpoint-naïve subjects: Have a history of histologically- confirmed diagnosis of squamous cell cancer of the head and neck (HNSCC) that is recurrent, metastatic, or persistent with: - Confirmed HPV16 infection - Confirmed tumor PDL1 expression defined as a combined positive score (CPS) ≥1 using the FDA-approved Dako PD-L1 immunohistochemistry (IHC) 22C3 PharmDx Assay. - No prior receipt of any immunological therapy for metastatic disease. - Checkpoint experienced subjects have a history of histologically-confirmed diagnosis of HNSCC that is recurrent, metastatic, or persistent with: - Confirmed HPV16 infection - Characterization of tumor PDL1 expression using the FDA-approved PD-L1 IHC 22C3 PharmDx Assay. - Receipt of prior treatment with checkpoint inhibitors as a single agent or in combination, and have received at least 2 doses of the agent or a minimum of 6 weeks on treatment - Have documented clinical progression or recurrence that has been radiologically confirmed - Have recurrent and/or metastatic measurable disease based on RECIST 1.1 as assessed by the local PI/radiology. There must be confirmation that the subjects imaging shows at least 1 lesion that is appropriate for selection as a target lesion per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. - Have adequate organ function as defined in Hematological: ANC ≥1500/μL, Platelets ≥100 000/μL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L; Renal: Creatinine ≤1.5 × ULN measured or calculated creatinine clearance >30mL/min with creatinine levels or >1.5 × institutional ULN; Hepatic: Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5 × ULN, AST and ALT ≤2.5 ULN (5 × ULN for subjects with liver metastases); Coagulation: INR, PTT ≤1.5 × ULN. Specimens must be collected within 10 days prior to the start of study combination treatment. - If subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention. - For female subjects defined as women of childbearing potential (WOCBP), a negative urine pregnancy test must be obtained during screening. Women who are surgically sterile or at least 2 years postmenopausal do not require pregnancy testing. Note: Female subjects of childbearing potential must be willing to use an effective method of contraception for the course of the study through 120 days after the last dose of study medication. - Male subjects of childbearing potential must agree to use a condom as an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - Pregnancy Exclusion: A female subject defined as a WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. - Has received prior therapy with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX40, CD137) and was discontinued from that treatment due to a Grade 3 or higher AE. - Has received prior systemic anti-cancer therapy including investigational agents within 30 days prior to treatment. Note: Subjects must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Subjects with ≤Grade 2 neuropathy and ≤Grade 2 alopecia are an exception to this criterion and may qualify for therapy. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting treatment. - Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all-radiation-related toxicities, not require corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<2 weeks of radiotherapy) to non- CNS disease. - Coordination and timing of coronavirus disease 2019 (COVID-19) vaccination should be based on local investigator clinical assessment and judgment. Note: Whenever possible, it is recommended to avoid COVID vaccination on the day of PDS0101 and/or pembrolizumab dosing because it may be difficult to attribute certain AEs (eg, fever, infusion reaction) to the study drug(s) or the COVID vaccine if they are both administered on the same day. - Has received a live vaccine within 30 days prior to the first dose of treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed. - Received immunotherapy/immunomodulatory or immunosuppressive agents (e.g. IFNs, tumor necrosis factor, interleukins, immunoglobulins or other biological response modifiers [GM-CSF, granulocyte colony-stimulating factor, macrophage colony- stimulating factor]) within 6 weeks prior to administration of the first study combination treatment. - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 30 days prior to the first dose of study treatment. Note: Subjects who entered the follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent. - Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects eligible as long as there are no symptoms of graft- versus-host disease (GVHD). - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Current or recent use of physiologic doses of intra-articular, topical, or inhaled corticosteroids is acceptable. - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) or other malignant tumors that have undergone potentially curative therapy are not excluded. - Has known active central nervous system (CNS) metastases and/or carcinomatosis meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that repeat imaging should be performed during study screening clinical stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment). - Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. - Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not consider a form of systemic treatment and is allowed. - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Has an active infection requiring systemic therapy. - Subjects with known HIV and/or history of Hepatitis B or C infections or known to be positive for Hepatitis B antigen (HBsAg)/Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay. - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participants participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator. - Has a known psychiatric or substance abuse disorder that would interfere with the subjects ability to cooperate with the requirements of the study. - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of any study treatment. - Has had an allogenic tissue/solid organ transplant. - Has received administration of colony-stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 30 days prior to Day 1. - Has a history of interstitial lung disease. - Female subjects defined as WOCBP unwilling or unable to use highly effective contraception method(s) for the duration of the study: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation. - Progestogen-only hormonal contraception - Intrauterine device - Intrauterine hormone-releasing system - Bilateral tubal occlusion - Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success. - Any prior Grade ≥3 immune-related adverse event(irAE) while receiving any previous checkpoint inhibitor or immunotherapy agent, or any unresolved irAE >Grade 1 except for endocrine AEs managed with replacement therapy. - Developed immune-related toxicity while on prior checkpoint inhibitor therapy that has not yet returned to Grade 1 or better. - History of any drug allergies or significant adverse reactions to any of the components of PDS0101 ; PRIMARY OUTCOME: Best Overall Response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) of the combination of pembrolizumab and PDS0101.; SECONDARY OUTCOME 1: Progression-Free Survival (PFS) in all patients[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AfFIRM (Low/High-AAG); BRIEF: The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study. Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide. ; DRUG USED: ARRY-520; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Kinesin spindle protein (KSP); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Key Inclusion Criteria: - Patients with confirmed multiple myeloma whose treatment history must include all of the following: 1. Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy). 2. Received at least 2 cycles of a bortezomib-containing regimen and 2 cycles of a lenalidomide-containing regimen, unless intolerant to these agents (defined as requiring discontinuation due to toxicity). 3. Disease refractory to a carfilzomib-containing regimen and/or a pomalidomide containing regimen. Refractory is defined as either failure to achieve a minimal response (MR) or better while on therapy, or development of progressive disease (PD) while on therapy or within 60 days from last dose of therapy. - Measurable multiple myeloma disease, defined as meeting at least one of the following criteria within 14 days prior to first dose of study drug: 1. A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL. 2. Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours. 3. Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study drug. - Adequate hematology, hepatic and renal function laboratory values within 14 days prior to first dose of study drug. - Additional criteria exist. Key Exclusion Criteria: - Prior treatment with filanesib (ARRY-520) or any other KSP inhibitor. - Past or current plasma cell leukemia. - Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed). - POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes). - Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug. - Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study drug. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis. - Use of an investigational agent that is not expected to be cleared by the time of first dose of study drug or that has been demonstrated to have prolonged side effects. Patients must have recovered from all side effects to a Grade 0 or 1 (except alopecia and neuropathy). - Any severe concurrent disease or condition (including severe graft-versus-host disease, requirement for dialysis, symptomatic congestive heart failure [New York Heart Association Class III or IV], unstable angina pectoris, cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation. - Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C. - Acute active infection requiring treatment. - Additional criteria exist. ; PRIMARY OUTCOME: In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate.; SECONDARY OUTCOME 1: In patients with high Baseline AAG, assess the efficacy of the study drug in terms of objective response rate.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 202; BRIEF: The primary objectives of this study are to assess whether participants with traumatic brain injury (TBI) administered glyburide begun within 10 hours of injury will show a decrease in magnetic resonance imaging (MRI)-defined edema and/or hemorrhage, compared to placebo and to assess the safety and tolerability of glyburide compared to placebo in participants with TBI. The secondary objectives include analyzing brain cell loss, computerized tomography (CT) scan /MRI abnormalities, reduction of mortality and or improvement of function or physiology, incidence of decompression craniectomy, incidence of neuroworsening, and to assess the steady state concentrations of glyburide in TBI participants. ; DRUG USED: Cirara; DRUG CLASS: Non-NME; INDICATION: Traumatic Brain Injury (TBI); TARGET: Sulfonylurea receptor (ATP-sensitive potassium channel, ABCC8); THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: 1. Documented closed head TBI 2. Clearly defined time of injury no more than 10 hours before administration of study drug/placebo 3. GCS 4-14. The GCS will be obtained free of the effects of sedating and/or paralytic drug. Complicated mild must have GCS 13-14 and one or more of the following: Intraparenchymal clots or contusions in aggregate > 10cc; Midline shift > 5mm; IVH, SDH, EDH seen on more than one CT scan slice. 4. Age 18-75 years 5. Patients in whom a dedicated peripheral IV line can be placed for study drug administration 6. Written consent obtained from legally authorized representative (LAR) Exclusion Criteria: 1. No documented TBI or time of impact not certain 2. Penetrating brain injury 3. Spinal column instability and/or spinal cord injury with neurodeficit 4. Concomitant severe non survivable injury 5. Pregnant, or a positive pregnancy test 6. Women who intend to breastfeed during Study Days 1-4. 7. Blood glucose <50mg/dL 8. Severe renal disorder from the patients history (e.g. dialysis) or serum creatinine of > 2.5 mg/dL 9. Severe liver disease or total bilirubin >1.5 times upper limit of normal 10. INR>1.4 11. Systolic BP<90 mm Hg not responsive to fluid resuscitation 12. Blood alcohol > 250mg/dL 13. Inability to have MRI (pacemaker, non-MR compatible pressure monitor, etc.) 14. Hospitalization for brain injury, psychiatric or neurological disease within previous 3 years 15. Emergent or urgent surgical operation anticipated (in OR, bedside procedures excluded) that would prevent dosing with study drug within 8 hours of injury. 16. Known use of Coumadin (warfarin), Plavix (clopidogrel), Effient (prasugrel) or Pletal (cilostazol), heparin, low molecular weight heparin, heparinoids, or abciximab or similar antiplatelet agents in the previous 72 hours (Note that patients later found to have taken these medications will not be automatically excluded from the study.) 17. Use of sulfonylurea drugs within the prior 30 days 18. Treatment with another investigational drug within the prior 30 days 19. Allergy to sulfonylurea drugs 20. Known diagnosis of G6PD enzyme deficiency 21. PaO2 < 60 mm Hg on admission (for patients in whom blood gases are drawn per standard of care) 22. Non-English speaking legally authorized representative and subjects (University of Maryland only) 23. Prisoners or others who may be unable to make a truly voluntary and uncoerced decision whether or not to participate in the study 24. Any other clinical condition which in the opinion of the investigator makes the patient unsuitable for inclusion into the study ; PRIMARY OUTCOME: Change from Baseline in Edema; SECONDARY OUTCOME 1: Change from Baseline in Brain Volume[/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 - US; BRIEF: The purpose of this study is to evaluate the safety and tolerability of multiple doses of ND-L02-s0201 in subjects with moderate to extensive hepatic fibrosis. ; DRUG USED: ND-L02-s0201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: Heat Shock Protein 47 (HSP47); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: 1. Male or female between 18 and 75 years 2. Diagnosis of METAVIR F3-4 hepatic fibrosis determined by liver biopsy done within 12 months before screening (Cohort 1) or at the pre-dose biopsy within 6 weeks before treatment (Cohorts 2 and 3) 3. Adequate and stable synthetic hepatic function (albumin ≥ 3 g/dL, international normalized ratio [INR] ≤ 1.4 x upper limit of normal [ULN] and stable by prior medical history). 4. Adequate and stable hepatic function as measured by alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamate transferase (GGTP), and total bilirubin (ALT/AST ≤ 5 x ULN, ALP ≤ 4 x ULN, GGTP ≤ 4 x ULN, bilirubin ≤ 2x ULN and stable by prior medical history). 5. Platelet count ≥ 75,000/mm3, hemoglobin ≥ 10 g/dL, and white blood cell count (WBC) > 3000/µL. 6. No signs of decompensated liver disease (ascites, hepatic encephalopathy, or variceal bleeding). 7. No clinically significant abnormalities on 12-lead electrocardiogram (ECG). 8. No other intercurrent medical conditions or infections considered clinically significant by the Investigator. 9. Clinical laboratory assessments are within the laboratory limits of normal values or not considered clinically significant by the Investigator. 10. Vitamin A levels at screening must be less than or equal to the upper limit of normal (ULN 95 µg/dL or 3.32 µmol/L). 11. Any male subject, if sexually active, agrees to use barrier contraceptive techniques as defined in the protocol. If female, the subject must be of non-childbearing potential as defined in the protocol. 12. Subjects who are active substances abusers may be enrolled at the discretion of the Principal Investigator. 13. Willing and able to provide written informed consent and comply with the study procedures and visit schedule, including follow up visits. Exclusion Criteria: 1. Any disease or condition which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND L02 s0201, or would place the subject at increased risk. 2. On ongoing therapy for HCV/HBV, or received therapy for HCV/HBV within 12 weeks prior to administration of study drug. 3. On interferon therapy for any disease or received interferon therapy for any disease within 12 weeks prior to administration of study drug. 4. History of bone disease, including osteoporosis and osteomalacia, Pagets disease of bone, or a history of unexplained fractures or fractures after minimal trauma. 5. Alpha-fetoprotein (AFP) ≥ 50 ng/mL or signs of abnormality or hepatocellular carcinoma on ultrasound survey of the liver. 6. Carcinoembryonic antigen (CEA) levels above the ULN. 7. Laboratory test results include abnormal values considered to be clinically significant by the Investigator. 8. Participated in a concurrent interventional study with the last intervention occurring within 12 weeks prior to administration of study drug. 9. Taken vitamin A or vitamin D supplements or multi-vitamins that contain vitamin A or vitamin D between the screening visit and administration of study drug. 10. History, within the last 2 years, of alcohol abuse, significant mental illness, or physical dependence on any opioid. 11. Veins unsuitable for repeated venipuncture or IV infusion (eg, veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture). 12. Received recent treatment with alternative therapies, which, in the opinion of the Investigator, could potentially confound clinical or laboratory assessments. 13. Lost more than 500 mL of blood within 56 days prior to administration of study drug. 14. Body mass index (BMI) > 38 kg/m2. 15. History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness (AIDS). 16. History of malignancy within the last 5 years with the exception of basal cell carcinoma. 17. Woman of childbearing potential. 18. History of hypersensitivity to H2-receptor antagonists. 19. Any other reason that, in the opinion of the Investigator or the Sponsors Medical Monitor, makes the subject unsuitable for enrollment. ; PRIMARY OUTCOME: Number of participants with serious and non-serious adverse events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CLO-311; BRIEF: Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive active study drug in an open-label manner. ; DRUG USED: Topical Clonidine Gel; DRUG CLASS: Non-NME; INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy; LEAD SPONSOR: BioDelivery Sciences International; CRITERIA: Inclusion Criteria: - The subject has provided written informed consent. - The subject has Type 1 or Type 2 diabetes mellitus with glycemic control that has been optimized on diet therapy, oral anti-hyperglycemic agents and/or insulin. - The subject must be a male or non-pregnant, non-lactating female. Females must be practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥12 months). Non-pregnancy will be confirmed (as applicable) by a pregnancy test conducted at the Entry Visit. Double-barrier methods, hormonal contraceptives, and abstinence are acceptable birth control methods for this study. - The subject has completed their 12-week participation according to the protocol in the previously conducted double-blind study, CLO-290. - The subject is medically stable at the end-of-study visit (Day 85) of Study CLO-290, and in the opinion of the Investigator, is in otherwise good general health based on physical examination, ECG, and laboratory evaluation. - Subject has the capabilities of applying topical gel to both feet TID. A caregiver, trained by the study staff to apply study medication, would be a suitable alternative to self-application of the treatment. Exclusion Criteria: - The subject is using an implanted medical device (e.g., spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain. - The subject is clinically hypotensive with a resting diastolic blood pressure <60 mmHg or a systolic blood pressure <90 mmHg. - The subject has recent history (within the past 3 months) or current symptoms of orthostatic hypotension with a sudden fall in blood pressure on standing accompanied by dizziness and lightheadedness. - The subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study. - The subject has a history of substance abuse disorder as defined by DSM-IV-TR within the past 6 months, has current evidence for substance abuse disorder, or is receiving medicinal treatment for drug abuse. - The subject has symptomatic or severe coronary insufficiency, clinically significant cardiac conduction disturbances, myocardial infarction (within last 6 months), cerebrovascular disease, or chronic obstructive pulmonary disease (COPD) requiring oxygen therapy. - The subject is likely to be noncompliant or unreliable in providing ratings as judged by the Investigator. - The subject has evidence of clinically significant peripheral vascular disease as evidenced by a history of intermittent claudication or evidence of vascular ulcers, including venous stasis ulcers. - The subject is currently taking or has taken clonidine in any form other than Clonidine Gel study drug (i.e., oral, transdermal patch) over the past 4 months. - The subject has developed hypersensitivity or intolerance to clonidine. - The subject is currently receiving any non-oral treatment that could affect neuropathic pain. - Subject has a history of malignancy within the past 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix. - The subject has clinical evidence of pedal edema or venous stasis disease associated with significant skin changes on physical examination. ; PRIMARY OUTCOME: Summary of Neuropathic Pain Symptom Inventory (NPSI); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CLEAR Wisdom (1002-047); BRIEF: The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol not adequately controlled by their current therapy. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Esperion Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Fasting LDL-C ≥100 mg/dL - High cardiovascular risk (diagnosis of HeFH and/or ASCVD) - Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated statin either alone or in combination with other LMTs Exclusion Criteria: - Total fasting triglyceride ≥500 mg/dL - Renal dysfunction or nephrotic syndrome or history of nephritis - Body Mass Index (BMI) ≥50kg/m2 - Significant cardiovascular disease or cardiovascular event in the past 3 months ; PRIMARY OUTCOME: Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C); SECONDARY OUTCOME 1: Percent Change From Baseline to Week 24 in LDL-C[/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/Mylotarg; BRIEF: The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied. ; DRUG USED: Dacogen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA Methyltransferase (DNMT); THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age >/= to 16 years at the time of signing the informed consent form. 3. Diagnosis of Acute myeloid leukemia (AML) [other than acute promyelocytic leukemia (APL)] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk Intermediate-2 or high by International Prognostic Scoring System (IPSS) or >/= to 10% blasts) MDS will also be eligible. All non-hematological toxicity of previous cancer therapy should have resolved to </= grade 1 (except alopecia or other toxicities not involving major organs). 4. Eastern Cooperative Oncology Group (ECOG) performance status of </= to 3 at study entry. 5. Laboratory test results within these ranges (unless due to leukemia): Serum creatinine </= 2 mg/dL Total bilirubin </= 2 mg/dL aspartate aminotransferase (AST) (SGOT) and/or alanine aminotransferase (ALT) (SGPT) </= 2.5 x ULN or </= 5 times Upper limit of normal (ULN) if related to disease 6. Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partners vasectomy, hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Exclusion Criteria: 1. Pregnant or breastfeeding females. 2. Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk. 3. Use of any other experimental drug or therapy for leukemia within 7 days unless there is clear evidence of rapid disease progression. 4. Use of hydrea to control proliferative disease will be allowed prior to starting therapy on study and for up to 7 days each during cycle 1-3 (Maximum daily dose of 7gm). ; PRIMARY OUTCOME: Number of Participants With Complete Response (CR); 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 - ARCHER; BRIEF: This study is being conducted in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) to determine if intravitreal (IVT) injections of ANX007 reduce GA lesion growth rate. The results will be used to guide further development of ANX007 in participants with geographic atrophy. The total duration of participation is expected to be approximately 19 months. ; DRUG USED: ANX-007; DRUG CLASS: Biologic; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Complement Component 1q (C1q), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Annexon, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of geographic atrophy of the macula secondary to age-related macular degeneration as determined by the Investigator and confirmed by the Central Reading Center. - GA lesion must have the following characteristics as determined by the independent Central Reading Center based on assessment of FAF imaging at screening: 1. Well-demarcated GA with a total area (baseline lesion size) ≥2.5 millimeter squared (mm^2) and ≤17.5 mm^2. 2. If GA is multifocal, at least 1 focal lesion must measure ≥1.25 mm^2 with the overall aggregate area of GA as specified above. 3. Presence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (that is, pattern = none) is exclusionary. 4. The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any peripapillary atrophy. - Normal luminance BCVA of 24 to 83 letters, inclusive, using ETDRS charts (20/25 to 20/320 Snellen equivalent, inclusive). - A female participant is eligible if she is not pregnant or breastfeeding and is a woman of non-childbearing potential or is using a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period and for at least 30 days after the last dose of study intervention. Exclusion Criteria: - Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye. - Any evidence of choroidal neovascularization (CNV) in the study eye: 1. Any history of CNV of any cause based on medical history. 2. Evidence of prior or active CNV or related findings (for example, retinal pigment epithelial rips or tears) based on FAF, Spectral Domain Optical Coherence Tomography (SD-OCT) imaging, intravenous fluorescein angiography (IVFA) and color fundus photo as assessed by the Central Reading Center. - Spherical equivalent of -8.00 diopters (D) myopia or higher in the study eye. - Uncontrolled glaucoma in the study eye (Intraocular pressure [IOP] >25 mmHg despite treatment with anti- glaucoma medication) or history of neovascular glaucoma. - History of glaucoma filtration surgery, minimally-invasive glaucoma surgery involving an implant, or vitrectomy surgery, or other procedure in the study eye that could affect drug distribution and/or clearance. - Any current or prior ocular disease, other than geographic atrophy, that in the opinion of the Investigator could interfere with the conduct of the study including, but not limited to, insufficient pupil dilation, retinal or optic nerve disease, media opacity, or aphakia in the study eye. - History of any prior IVT treatment for any indication in the study eye. - Any prior treatment for AMD in the study eye (for example, surgical, radiation, thermotherapeutic, or laser intervention), except oral supplements or minerals. ; PRIMARY OUTCOME: GA lesion growth rate; SECONDARY OUTCOME 1: Safety: Participants with treatment-emergent adverse events (TEAEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - A3051036 - vs. Zyban (12 Weeks); BRIEF: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation. ; DRUG USED: Chantix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Smoking Cessation; TARGET: Nicotinic Acetylcholine Receptor - a4ß2 subtype &lt;br&gt;(a4ß2 nAChR), Nicotinic Acetylcholine Receptor - a7 subtype &lt;br&gt;(a7 nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: - Subjects who have used bupropion (Zyban or Wellbutrin) previously. ; PRIMARY OUTCOME: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.; SECONDARY OUTCOME 1: Continuous abstinence Weeks 9-52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/Ib - ARC-4 (w/Carboplatin/Pemetrexed); BRIEF: This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and clinical activity of etrumadenant (AB928) in combination with carboplatin and pemetrexed, with or without an anti-PD-1 antibody (pembrolizumab or zimberelimab), in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC). ; DRUG USED: AB928; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Adenosine A2a Receptor, Adenosine A2b Receptor, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Arcus Biosciences, Inc.; CRITERIA: Inclusion Criteria: - Male or female participants; age ≥ 18 years - Pathologically confirmed nonsquamous NSCLC that is metastatic, locally advanced, or recurrent with progression - Arm A participants must fulfill one of the following: - Participant has a genetic alteration (mutation or rearrangement) and has received all available targeted therapy. Previous treatment with chemotherapy or PD-1/-L1 therapy is not allowed. - Participant has not received any therapy for the disease under study and standard therapy is refused. - Participant has progressed on PD-1/-L1 therapy (monotherapy or combination regimen). Previous treatment with chemotherapy is not allowed. - Participant has progressed on PD-1/-L1 therapy (monotherapy or combination regimen) and has received less than 4 cycles of carboplatin/pemetrexed and further chemotherapy is appropriate. - Participant has received any number of prior treatments and is without alternative or curative therapy. - Arm B participants must fulfill one of the following: - Participant has a genetic alteration (mutation or rearrangement) and has received all available targeted therapy. Previous treatment with chemotherapy or PD-1/-L1 therapy is not allowed. - Participant has not received any therapy for the disease under study and standard therapy is refused. - Participant has received any number of prior treatments and is without alternative or curative therapy. - Arm 1 and Arm 2 participants must have a sensitizing epidermal growth factor receptor (EGFR) mutation with disease progression or treatment intolerance after one or more approved TKIs. Previous treatment with chemotherapy or PD-1/L-1 therapy is not allowed. - No TKI therapy within 5 days of Cycle 1 Day 1 - The last dose of previous investigational therapy is at least 4 weeks or 5 half-lives prior to Cycle 1 Day 1. - Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. - Confirm that an archival tissue sample is available and ≤ 24 months old; if not, a new biopsy of a tumor lesion should be obtained at screening - Adequate organ and marrow function Exclusion Criteria: - Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of etrumadenant, 90 days after the last dose of zimberelimab or pembrolizumab, or 6 months after the last dose of pemetrexed, whichever is longer - Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy - Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer - Prior use of an adenosine pathway targeting agent - Due to potential for drug-drug interactions with etrumadenant, participants must not have had: - Treatment with breast cancer resistance protein substrates or P-glycoprotein with a narrow therapeutic window, administered orally within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment. - Treatment with known strong cytochrome P450 3A4 (CYP3A4) inducers and strong CYP3A4 inhibitors within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment ; PRIMARY OUTCOME: Percentage of participants with Adverse Events; SECONDARY OUTCOME 1: Percentage of participants with anti-drug antibodies to zimberelimab[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - 03 - Triglycerides; BRIEF: This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Esperion Therapeutics, Inc.; CRITERIA: Major Inclusion Criteria: - Provision of written informed consent prior to any study-specific procedure - Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements - Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications and supplements - BMI between 18 and 35 mg/kg2 Major Exclusion Criteria: - Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension - Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal) ; PRIMARY OUTCOME: Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C); SECONDARY OUTCOME 1: Percent Change From Baseline to Week 12 in TG[/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 - PIONEER-PEDS1; BRIEF: The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits. ; DRUG USED: Reyvow; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1F receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria: - History of migraine attacks for more than 6 months - Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit - Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours - Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator - Participant must be able to swallow a tablet - For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening - Participants must weigh at least 15 kilograms (kg) Exclusion Criteria: - Participants must not be pregnant or nursing - Participants must not have any acute, serious, or unstable medical condition - Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator ; PRIMARY OUTCOME: Percentage of Participants with Pain Freedom (High Dose); SECONDARY OUTCOME 1: Percentage of Participants with Pain Freedom (Mid 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 III - LUNA3; BRIEF: This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily. For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up. For adult participants, the maximum duration of the long-term extension (LTE) period will be 12 months from the date of the last adult participant to enter the LTE. For pediatric participants, the maximum duration of the LTE period will be 12 months from the date of the last pediatric participant to enter the LTE. ; DRUG USED: PRN1008; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Principia Biopharma, a Sanofi Company; CRITERIA: Inclusion Criteria: 1. Patients will be male and female with primary ITP with duration of >6 months in pediatric participants aged 12 to <18 years (pediatric participants aged 10 to <12 years will be enrolled in the EU [EEA countries] only) and duration of >3 months in ages 18 years and above 2. Patients who had a response (achievement of platelet count ≥50,000/µL) to IVIg/anti-D or CSs that was not sustained and who have documented intolerance, insufficient response or any contra-indication to any appropriate courses of standard of care ITP therapy 3. An average of 2 platelet counts at least 5 days apart of <30,000/µL during the Screening period and no single platelet count >35,000/µL, within 14 days prior to the first dose of study drug. - Pediatric patients must additionally be determined to need treatment for ITP as per clinical assessment by the Investigator. 4. Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5 X 10^9/L, AST/ALT ≤1.5 x upper limit of normal [ULN], albumin ≥3 g/dL, total bilirubin ≤1.5 x ULN [unless the patient has documented Gilbert syndrome], glomerular filtration rate >50 [Cockcroft and Gault method]) 5. Hemoglobin >9 g/dL within 1 week prior to Study Day 1 6. All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 7. Patients must be able to provide written informed consent or informed assent with corresponding informed consent obtained from the patients guardian and agree to the schedule of assessments Exclusion Criteria: 1. Patients with secondary ITP 2. Pregnant or lactating women 3. History (within 5 years of Study Day 1) or current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non melanoma skin cancer 4. Transfusion with blood, blood products, plasmapheresis, or use of any other rescue medications with intent to increase platelet count within 14 days before Study Day 1 5. Change in CS and/or TPO-RA dose within 14 days prior to Study Day 1 (more than 10% variation from current doses) 6. Immunosuppressant drugs other than CSs within 5 times the elimination half-life of the drug or 14 days of Study Day 1, whichever is longer 7. Treatment with rituximab or splenectomy within the 3 months prior to Study Day 1 - Patients treated with rituximab will have normal B-cell counts prior to enrollment 8. Has received any investigational drug within the 30 days before receiving the first dose of study medication, or at least 5 times elimination half-life of the drug (whichever is longer); patient should not be using an investigational device at the time of dosing - Patients who previously received treatment with Brutons Tyrosine Kinase (BTK) inhibitors (except rilzabrutinib) within 30 days before the first dose of study drug are not eligible - Patients who previously received rilzabrutinib at any time are not eligible 9. History of solid organ transplant 10. Myelodysplastic syndrome 11. Live vaccine within 28 days prior to Study Day 1 or plan to receive one during the study 12. Planned surgery in the time frame of the dosing period ; PRIMARY OUTCOME: Durable platelet response during the last 6 weeks of the 24-week blinded treatment period (not for EU and UK); SECONDARY OUTCOME 1: Number of weeks with platelet count ≥50,000/μL OR between ≥30,000/μL and <50,000/μL and at least doubled from baseline over the 24-week blinded treatment period in the absence of rescue therapy[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RESPOND (NVS, Canada-cost-effectiv.); BRIEF: To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Stable Type 1 or Type 2 diabetes mellitus - Visual impairment due to focal or diffuse DME in at least one eye Exclusion Criteria: - Active conditions in the study eye that could prevent the improvement of visual acuity on study treatment - Active eye infection or inflammation - History of stroke, renal failure or uncontrolled hypertension Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12; SECONDARY OUTCOME 1: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9[/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 - Moderate/Severe (005); BRIEF: This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis. ; DRUG USED: Prurisol; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: Folate Receptor (FOLR1); THERAPY: Monotherapy; LEAD SPONSOR: Innovation Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Evidence of a personally signed and dated written informed consent to participate in the clinical study 2. Male or non-pregnant female adults at least 18 years of age at time of informed consent 3. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to baseline (at time of first study dose) 4. Moderate to severe plaque psoriasis as defined at baseline by: 1. PASI score of 12 or greater, and 2. Static PGA score of moderate (3) or severe (4), and 3. Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater 5. Candidate for systemic therapy or phototherapy 6. Willing to limit ultraviolet light exposure from sunbathing, use of tanning booths, prolonged outdoor exposure, or from other UV light sources during the study. 7. Willing and able to comply with scheduled visits, study assessments and l laboratory tests, and other study procedures Exclusion Criteria: 1. Positive blood test for HLA-B*5701 allele 2. Currently have forms of psoriasis other than chronic plaque-type, (e.g., guttate, erythrodermic, exfoliative, palmoplantar, pustular), with the exception of nail psoriasis 3. Evidence of drug-induced psoriasis, e.g., a new onset or current exacerbation of psoriasis from beta-blockers, calcium channel inhibitors, antimalarial drugs or lithium 4. Psoriasis flare or rebound within 4 weeks prior to Screening 5. Active inflammatory diseases other than psoriasis that might confound the evaluation of study treatment on signs and symptoms of psoriasis. 6. . Any of the following prohibited treatments that do not meet the specified minimum washout period: 1. Biologic immunomodulating treatments of brodalumab or ustekinumab within 24 weeks prior to start of study treatment 2. Biologic immunomodulating treatments such as adalimumab, etanercept, infliximab, ixekizumab, secukinumab or certolizumab pegol within 12 weeks prior to start of study treatment 3. Systemic immunomodulating treatments other than biologics within 4 weeks prior to start of study treatment, e.g., oral corticosteroids, injectable corticosteroids (intraarticular, intramuscular, cutaneous/subcutaneous or intravenous), methotrexate, cyclosporine, cyclophosphamide, apremilast - Inhaled or intranasal corticosteroids with predominantly local effect (e.g., to treat asthma) are allowable - Use of corticosteroids in the eye or the ear are allowable 4. Other systemic treatments for psoriasis within 4 weeks prior to start of study treatment, e.g., retinoids, fumarates - Any such treatment used to treat a symptom of psoriasis but not the condition itself (e.g., anti-histamines for pruritus) is not restricted 5. Photochemotherapy, e.g., Psoralens + UVA phototherapy (PUVA), within 4 weeks prior to start of study treatment 6. Phototherapy, e.g., UVA, UVB, within 2 weeks prior to start of study treatment 7. Topical treatments that could affect signs and symptoms of psoriasis within 2 weeks prior to start of study treatment, e.g., corticosteroids, vitamin D analogs, retinoids, pimecrolimus, tacrolimus, tars, keratolytics - Allowable exceptions are: low or least potent (Class 6 or 7) topical corticosteroids for use on face, palms, soles, and intertriginous areas only; tar and salicylic acid preparations/shampoos for use on scalp only; bland emollient for use on any body region 7. Past vaccination with live vaccine within 6 weeks prior to start of study treatment, or plans for administration during the study 8. Any investigational or experimental therapy or procedure or participation in any interventional trial within 4 weeks or 5 half-lives (whichever is longer) prior to start of study treatment 9. Women of child-bearing potential who are not using reliable means of contraception, e.g., abstinence, surgical sterilization (hysterectomy and/or bilateral oophorectomy or partner vasectomy) or tubal ligation, double barrier method, oral/ injected/ implanted/ transdermal hormonal contraception, intrauterine device or intrauterine system, throughout study participation, and for 4 weeks after the end of treatment 10. Women of child-bearing potential who are pregnant or nursing (lactating), or planning a pregnancy while participating in the study 11. History of any ongoing, chronic or recurrent infectious disease (with the exception of episodic herpes labialis and herpes genitalis, and vaginal yeast infections) 12. Evidence of tuberculosis infection as defined by a positive QuantiFERON®-TB Gold In-Tube test (QFT-G) at Screening, or subjects with an indeterminate QFT-G test result with any retest result as indeterminate or positive 13. History of either untreated or incompletely treated latent or active tuberculosis infection 14. Ongoing or recent history of any non-psoriatic uncontrolled (in the Investigators medical opinion) systemic disease, including, but not limited to renal, hepatic, hematologic, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, neurologic, or psychiatric disease. (e.g., A past or current history of hypertension that is controlled with diet and/or medications is not exclusionary.) 15. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years with the exception of: basal cell or squamous cell carcinoma or actinic keratoses that have been treated or excised with no evidence of recurrence in the past 12 weeks; cervical carcinoma in situ or non-invasive malignant colon polyps that have been removed 16. Active systemic infections during the past two weeks (exception: common cold) prior to start of study treatment or any infection that reoccurs on a regular basis 17. Past medical history of infection with HIV, hepatitis B or hepatitis C 18. History of any allergic reaction to any formulation of abacavir 19. Previous treatment with any abacavir-containing product, e.g., Ziagen®, Epzicom®, or Trizivir® 20. Previous participation in a clinical study of Prurisol 21. Presence of any medical or psychiatric condition that, in the Investgators opinion, makes it unlikely that the requirements of the protocol will be completed 22. History of alcohol or substance abuse, unless in full remission for more than 6 months prior to start of study treatment 23. Electrocardiogram (ECG) obtained at Screening visit which shows medically relevant abnormalities which may affect subject safety or interpretation of study results 24. Observed clinical laboratory values/abnormalities during Screening that show any one or more of the following: 1. Screening total white blood cell (WBC) count <2.5 x 10^9/L, or platelets <100 x 10^9/L or neutrophils <1.2 x 10^9/L or hemoglobin <8.5 g/dL 2. Screening serum creatinine level exceeding 2.0 mg/dL (176.8 µmol/L) 3. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2 x ULN 25. Any other severe acute or chronic medical or psychiatric condition or test abnormality(ies) that, in the Investigators opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subjects participation in the study ; PRIMARY OUTCOME: Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12; SECONDARY OUTCOME 1: Proportion of subjects achieving a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Study 004; BRIEF: The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female volunteers. ; DRUG USED: Trofinetide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Traumatic Brain Injury (TBI); TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Monotherapy; LEAD SPONSOR: Neuren Pharmaceuticals Limited; CRITERIA: Inclusion Criteria: - Aged between 18 years and 50 years (inclusive). - Females only. - Weight 50 to 105 kg - BMI of 18 to 30 kg/m2. - General Health: Healthy, determined by a medical history with particular attention to: - a drug history identifying any known drug allergies and the presence of drug abuse; - any chronic use of medication; and - a thorough review of body systems. This will also be determined by having no clinically significant abnormal findings on physical examination, which includes an electrocardiogram (ECG), which in the opinion of the Investigator would jeopardize the safety of the subject or impact on the validity of the study results. - Venous Access: Volunteers with adequate venous access in their left and right arm to allow collection of blood samples and drug administration. - Language: Fluent in the English language. - Informed Consent: Have voluntarily given written informed consent to participate in this study. Exclusion Criteria: - Pregnant and lactating females are excluded from participating in the study. - History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations. - History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or hematological disorders. - Any history of asthma during the last 10 years. - A creatinine clearance of less than 75 mL/min. - Any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of the investigational product. - History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation. - History of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies. - Pregnancy. - Any evidence of organ dysfunction, or any clinically significant clinical laboratory value, including a liver function test (LFT) > 1.5 x upper limit of normal (ULN). - Difficulty abstaining from alcohol during the 48 hours prior to dose administration and until completion of blood sampling at exit assessment. - History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug screen for drugs of abuse. - Difficulty in abstaining from any prescription medications for 14 days prior to dose administration and for the duration of the study. - Difficulty in abstaining from over-the-counter (OTC) medications or herbal supplements for 14 days prior to dose administration and for the duration of the study, (with the exception of occasional analgesia, vitamin and other nutrient supplement use, at the discretion of the Investigator). - Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines, (e.g., coffee, tea, cola and chocolate) during the 24 hours prior to dose administration and whilst confined at the clinical study facility. - History of any psychiatric illness which may impair the ability to provide written informed consent. - Poor protocol compliers or those unlikely to attend. - Receipt of any drug as part of a research study within 30 days of initial dose administration in this study. - Standard blood donation (usually 550 mL) within the 12-week period before dose administration. - Unusual dietary habits and excessive or unusual vitamin intakes. - Vaccination or immunizations within 30 days of initial dose administration. - QT/QTc Exclusions i.e., a marked baseline prolongation of corrected QT interval > 450 ms in two ECGs, or a history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). ; PRIMARY OUTCOME: Incidence of AEs and SAEs; 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/Phosphate Binder (Japan); BRIEF: To evaluate the effect and safety of KHK7791 in combination with phosphate binders to treat Hyperphosphatemia in ptatients on HD. ; DRUG USED: Ibsrela; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Sodium-hydrogen exchanger 3 (NHE3) ; THERAPY: Combination; LEAD SPONSOR: Kyowa Kirin Co., Ltd.; CRITERIA: Inclusion Criteria: - Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination. - Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination. - Taking phosphate binders three times per day. The prescribed drug and dosage regimen should have been unchanged during the last 2 weeks before screening examination. - Serum phosphorus levels should be in the range of ≥6.1 and ≤10.0 mg/dL at screening examination. - If on any vitamin D or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination. Exclusion Criteria: - iPTH >600 pg/mL (should be based on the most recent value from the patients medical records, etc. before pre-enrollment) - Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome - History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination. - Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis). - Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as myocardial infarction and unstable angina) requiring hospitalization within 6 months before screening examination. - Uncontrollable hypertension or diabetes. - Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center (relocate to another hospital/clinic) during the study period. - Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix). ; PRIMARY OUTCOME: Comparing changes in serum phosphorus levels between hemodialysis patients taking KHK7791 in combination with phosphate binders and those taking placebo in combination with phosphate binders.; SECONDARY OUTCOME 1: Changes in serum Ca × P levels from baseline.[/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/Sunitinib; BRIEF: This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma. ; DRUG USED: Trebananib; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Angiopoietins; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subjects must have a histologically confirmed metastatic renal cell cancer (RCC) with a clear cell component - Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification - Measurable disease with at least one unidimensionally measurable lesion per Response Evaluation Criteria in Solid Tumor (RECIST) guidelines with modifications - Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening - Eastern Cooperative Oncology Group (ECOG) of 0 or 1 Exclusion Criteria: Disease related - Known history of central nervous system metastases. - Previous treatment (excluding surgery, prior cytokine-based immunotherapy and palliative radiotherapy) for advanced or metastatic renal cell carcinoma - Focal radiation therapy for palliation of pain from bony metastases within 14 days of enrollment. Medications - Currently or previously treated with sunitinib or other small molecule inhibitors of vascular endothelial growth factor (VEGF) - Currently or previously treated with agents that neutralizing VEGF - Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor - Currently or previously treated with agents inhibiting the mammalian target of rapamycin (mTOR) - Current or within 30 days prior to enrollment treatment with immune modulators - Concomitant or previous use within 30 days prior to enrollment of any strong inducer of CYP3A4 - Concomitant or previous use of amiodarone within 6 months prior to enrollment General medical - Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent - Major surgery within 28 days prior to enrollment or still recovering from prior surgery - Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. The use of anti-hypertensive medications to control hypertension is permitted. Other - Other investigational procedures are excluded - Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) Other inclusion/exclusion criteria may apply, per protocol. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations (DCs) Due to Adverse Events (AEs); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PK Study (Japan); BRIEF: - To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart failure (HF) with reduced ejection fraction - To evaluate the safety and tolerability of oral omecamtiv mecarbil ; DRUG USED: Omecamtiv Mecarbil (Oral); DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Myosin ATPase; THERAPY: Monotherapy; LEAD SPONSOR: Cytokinetics; CRITERIA: Inclusion Criteria: - Japanese male or female ≥ 20 years and ≤ 85 years of age - History of chronic stable heart failure (HF) with reduced ejection fraction, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening - Treated for HF with optimal pharmacological therapy - Left ventricular ejection fraction ≤ 40% at screening Exclusion Criteria: - Severe uncorrected valvular heart disease - Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease - Acute myocardial infarction, unstable angina, or persistent angina at rest within 30 days prior to randomization - Systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg, or heart rate (HR) > 110 beats per minute (bpm) or HR < 50 bpm - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 - Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply. ; PRIMARY OUTCOME: Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time; SECONDARY OUTCOME 1: Change From Baseline at Week 16 in Systolic Ejection Time (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 - w/Capecitabine; BRIEF: This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle. ; DRUG USED: Tesetaxel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Genta Incorporated; CRITERIA: Inclusion Criteria: - At least 18 years of age - Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma - Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing chemotherapy (Enrollment of patients with a history of prior taxane therapy in the adjuvant setting is allowed provided at least 6 months have passed since the conclusion of that therapy.) - ECOG performance status of 0 or 1 - Adequate bone marrow, hepatic, and renal function - At least 3 weeks and recovery from effects of prior surgery and anticancer therapy, with resolution of any toxicity to not more than Grade 1 Exclusion Criteria: - Brain metastasis or leptomeningeal disease - Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for 5 or more years) - Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C infection - Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour period within the 30 days prior to enrollment in this study - Significant medical disease other than cancer - Neuropathy at least Grade 2 - Difficulty swallowing - Malabsorptive disorder - Need for other anticancer treatment while receiving study medication - Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity. A washout period of at least 2 weeks is required prior to the first dose of study medication. - Pregnancy or lactation - History of hypersensitivity to tesetaxel, capecitabine, 5-fluorouracil, or any of their components ; PRIMARY OUTCOME: Incidence of adverse events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CP-Q13VLP-008; BRIEF: This is a multiple sites phase II trial, randomized, observer-blind, dose ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine administered in elderly subjects (50 years old and more). A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75 subjects to receive one injection of either a non-adjuvanted low, medium or high dose level of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined with Alhydrogel® as adjuvant or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80) ; DRUG USED: MT-2271; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Medicago; CRITERIA: Inclusion Criteria: 1. Male and female subjects, 50 years of age or older. 2. BMI of ≥18 and ≤32. 3. Give his/her consent to participate in this study (by signing the informed consent form). In the opinion of the Investigator, competence and willingness to provide written, informed consent for participation after reading the informed consent form. The subject must have adequate opportunity to discuss the study with an Investigator or qualified designee. 4. Healthy as judged by the Investigator or designee and determined by general physical examination, vital signs, clinical laboratory tests, and medical history conducted no more than 90 days prior to study vaccine administration. Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigators judgment, the condition is unlikely confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is defined as no new onset of exacerbation of pre-existing chronic disease 6 months prior to immunization. Based on Investigators judgment, a subject with more recent stabilisation of a disease may still be eligible. 5. Comprehension of the study requirements, expressed availability for the required study period, ability to attend scheduled visits, accessible by phone on a consistent basis. 6. If female, have a negative serum pregnancy test result at screening and negative urine pregnancy test on Day 0 prior to immunization. 7. Female of childbearing potential must use an effective method of contraception for 1 month prior to immunization and agrees to continue employing adequate birth control measures for at least 60 days post-immunization. Moreover, she must have no plan to become pregnant for at least 2 months post-immunization. Abstinent subjects should be asked what method(s) they would use, should their circumstances change, and subjects without a well-defined plan should be excluded. The following relationship or methods of contraception are considered to be effective: - Hormonal contraceptives (e.g., injectable, topical [patch], estrogenic vaginal ring, etc.); - Intra-uterine device (IUD) with or without hormonal release; - Male partner using a condom plus spermicide or sterilized partner (at least 1 year prior to immunization); - History of credible abstinence (self-reported); - Heterosexual abstinence at least 60 days post-immunization; - Female partner. 8. Non-childbearing females defines as: - Surgically-sterile (defined as bilateral tubal ligation or hysterectomy performed more than 1 month prior to immunization); - Post-menopausal (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation). Exclusion Criteria: 1. According to Investigators opinion, presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Uncontrolled is defined as: 1. Requiring a new medical or surgical treatment within one month prior to study vaccine administration which would interfere with vaccine evaluation or study completion (subject requiring medical or surgical treatment that would not interfere with evaluation [e.g., minor knee surgery, cataracts, etc.] would be eligible); 2. Requiring a change in medication dosage in one month prior to study vaccine administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable). 2. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigators opinion, would render the subject unable to provide informed consent or unable to provide valid safety observations and reporting. 3. Any autoimmune disease or any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection, Hepatitis B or C, or the presence of lymphoproliferative disease. 4. Administration of any vaccine (including any other influenza vaccine) within 30 days prior to study enrolment or planned administration within the period from the vaccination up to blood sampling at Day 21 or within 30 days prior to blood sampling at Day 201. Immunization on an emergency basis will be evaluated in a case-by-case by the Investigator. 5. Administration of any adjuvanted or investigational influenza vaccine within 1 year prior to study enrolment or planned administration prior to the end of this trial (Day 201). Administration of any standard, not adjuvanted influenza vaccine (e.g., live attenuated Trivalent Inactivated Influenza Vaccine (TIV) or Quadrivalent Inactivated Vaccine (QIV) vaccine IN or split TIV or QIV vaccine by either intra-dermal or intramuscular route) prior to the 30-day exclusion period mentioned above would be acceptable. 6. Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while participating in this study (approximately 7-12 months [depending when subjects undergo screening session and Day 201 visit]). 7. Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone per day, or equivalent for more than 7 consecutive days or for 10 or more days in total, within one month of study vaccine administration, any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within 3 months of vaccination. Routine use of standard doses of nasal or inhaled glucocorticoids is allowed. 8. Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin (no more than 325 mg/day), and without a clinically apparent bleeding tendency are eligible. Subjects treated with new generation drugs that will not increase risk of intramuscular bleeding (such as clopidogrel) are also eligible. 9. History of allergy to any of the constituents of the VLP quadrivalent study vaccine, Alhydrogel® (aluminum hydroxide) or to the phosphate buffered saline (PBS; used as placebo), or tobacco allergy. 10. History of anaphylaxis reaction to any food, medication or bee sting. 11. Any history of severe asthma (e.g., status asthmatic, hospitalization for asthma control) or recurrent asthma episodes requiring medical attention in the last 3 years (≥ 1 episode/year). 12. Continuous use of anti-histamines in the last 4 weeks prior to immunization or use of anti-histamines 48 hours prior to study immunization. 13. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at injection site which may interfere with injection site reaction rating. 14. Have received a blood transfusion within 90 days prior to study vaccination. 15. If female, have a positive or doubtful pregnancy test prior to immunization or lactating females. 16. Vital sign abnormalities (systolic blood pressure and/or diastolic blood pressure, heart rate). Although a vital signs measurement is out of the acceptable ranges, a subject may be included in the study based on Investigators judgment. Presence of any febrile illness (including oral temperature (OT) ≥38.0˚C within 24 hours prior to immunization). Such subjects may be re-evaluated for enrolment after resolution of illness. 17. Cancer or treatment for cancer within 3 years of study vaccine administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible. Person with non-treated, non-disseminated local prostate cancer are eligible. 18. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. ; PRIMARY OUTCOME: Immunogenicity; SECONDARY OUTCOME 1: Immunogenicity (against vaccine strains and heterologous strains)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIa - vs. Vilanterol Inhalation Powder; BRIEF: This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline. ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Type of subject: Outpatient - Informed consent: Subjects must give their signed and dated written informed consent to participate - Gender: Male subjects or female subjects. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception. - Age: >=40 years of age at Screening (Visit 1) - COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it is also associated with significant systemic consequences. - Severity of disease: Subjects with a measured post-albuterol (salbutamol) FEV1/ Forced Vital Capacity (FVC) ratio of <=0.70 and FEV1 >=30 to <=70 percent of predicted normal values using Global Lung Function Initiative 2012 reference equations at Screening (Visit 1). - Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. - History of COPD exacerbation: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Screening (Visit 1) that required either systemic/oral corticosteroids, antibiotics and/or hospitalization. - Current symptoms of COPD: A Subject Diary combined symptom score (combination of breathlessness, cough, sputum, and night time awakenings requiring treatment with albuterol [salbutamol]) of >=4 on at least 5 of the 7 days immediately preceding Visit 2 (Randomization) - QTc Criteria: QTc <450 msec or QTc <480 msec for patients with bundle branch block. Exclusion Criteria: - Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. - Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD). - Other respiratory disorders: Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), primary pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases. - Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1). - Chest X-ray (or computed tomography [CT] scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 1 year prior to Screening (Visit 1). - Hospitalization: Subjects who are hospitalized due to poorly controlled COPD that has not resolved at least 4 weeks prior to Screening (Visit 1) and at least 6 weeks following the last dose of systemic corticosteroids. - Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Screening (Visit 1): Acute worsening of COPD that is managed by subject with systemic corticosteroids or antibiotics or that requires treatment prescribed by a physician. - Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Screening (Visit 1). - COPD exacerbation/lower respiratory tract infection during the Run-In Period: Subjects who experience a moderate/severe COPD exacerbation (As per definition of COPD Exacerbations and Pneumonia in protocol) and/or a lower respiratory tract infection (including pneumonia) during the Run-In Period. - Abnormal, clinically significant laboratory finding: Subjects who have an abnormal clinical significant finding in any liver chemistry test at Screening (Visit 1) or upon repeat prior to randomization. - Abnormal, clinically significant 12-lead ECG at Screening (Visit 1): Subjects who have an abnormal, clinically significant 12-Lead electrocardiogram (ECG) finding at Screening (Visit 1) or upon repeat prior to randomization. - Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., patients requiring implantable cardioverter-defibrillators (ICD), pacemaker requiring a rate set >60 beats per minute (bpm), uncontrolled hypertension, New Your Heart Association Class IV, known left ventricular ejection fraction <30 percent) neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or hematological abnormalities. - Liver disease: Subjects who have unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). Note: Subjects with chronic stable hepatitis B and C are eligible if the subject otherwise meets entry criteria (e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of screening). However, subjects with chronic stable hepatitis B are excluded if significant immunosuppressive or cytotoxic agents are administered, due to risk of hepatitis B reactivation, unless the hepatitis B antivirals are administered as outlined in the Chronic Hepatitis B American Association for the Study of Liver Diseases (AASLD) Practice Guidelines. - Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis. - Contraindications: Subjects with a history of allergy or hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroids) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subjects participation will also be excluded. - Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years - Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol (salbutamol) or their ipratropium bromide for the 4-hour period required prior to spirometry testing at each study visit. - Additional medication: Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications) - Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen as needed (prn) use (i.e., <=12 hours per day) is not exclusionary. - Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV). - Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded. - Non-Compliance during Run-In Period: Failure to demonstrate adequate compliance defined as completion of Diary Card (completed all diary entries on at least 5 of the last 7 consecutive days), the ability to withhold anti-COPD medications and to keep clinic visit appointments. In addition, subjects must have recorded the Run-In study medication use on at least 5 of the last 7, consecutive days of the Run-In period to continue in the study. - Potential of non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits. - Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. - Prior use of study medication/other investigational drugs: Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer. Note: Subjects who participated in a previously completed study and/or were excluded/ withdrawn from an ongoing study that included/includes FF/VI and/or VI are eligible to participate in the current study, if they have not received investigational study medication within 30 days of Screening (Visit 1). - Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. ; PRIMARY OUTCOME: Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84; SECONDARY OUTCOME 1: Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - JGDG (w/Doxorubicin); BRIEF: The main purpose of this study is to gather information about the use of an investigational drug called olaratumab with a drug for soft tissue sarcoma called doxorubicin. ; DRUG USED: Lartruvo; DRUG CLASS: Biologic; INDICATION: Sarcoma; TARGET: Platelet-derived growth factor receptor (PDGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - The participant has histologically- or cytologically-confirmed malignant soft tissue sarcoma - The participant has advanced soft tissue sarcoma (STS), not amenable to treatment with surgery or radiotherapy - The participants Eastern Cooperative Oncology Group (ECOG) performance status is 0-2 - The participant has available tumor tissue from either the primary or metastatic tumor for determination of PDGFRα expression - The participant has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500 μL, hemoglobin ≥ 9.0 g/dL, and a platelet count of 100,000/μL obtained within 2 weeks prior to study entry - The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN) - The participant has adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the participants creatinine clearance is ≥ 45 mL/min - Because the teratogenicity of Olaratumab is not known, women of childbearing potential (WOCBP) and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation Exclusion Criteria: - The participant has histologically- or cytologically-confirmed Kaposis sarcoma - The participant has untreated central nervous system metastases - The participant received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (ie, mitoxantrone) - The participant received prior radiation therapy to the mediastinal/pericardial area - The participant has a history of another primary cancer, with the exception of a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry - The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent - The participant has an elective or a planned major surgery to be performed during the course of the study - The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry - The participant has known immunodeficiency virus (HIV) infection - The participant, if female, is pregnant or lactating - The participant has a known allergy to any of the treatment components ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Number of Participants With AEs and SAEs for Phase 2 Portion[/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: This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis. ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Subject must have body surface area (BSA) ≥ 10% and a target fingernail Modified Nail Psoriasis Severity Index (mNAPSI) ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail mNAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Week 0. - Subject must have a Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain Numeric Rating Scale (NRS) score of >3. - Subjects must have a Physicians Global Assessment (PGA) of Fingernail Psoriasis and a PGA of Skin Psoriasis of at least moderate. - Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Week 0, ustekinumab must have been discontinued at least 12 weeks prior to Week 0. - Target fingernail must have mNAPSI score of ≥ 8. - Adult subjects with clinical diagnosis of chronic plaque psoriasis (with disease duration of at least 6 months). Exclusion Criteria: - Prior adalimumab therapy. - Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis. - Recent infection requiring treatment. - Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse. - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. - History of cancer, except successfully treated skin cancer. ; PRIMARY OUTCOME: Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26; SECONDARY OUTCOME 1: Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26[/INST]Yes</s>