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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 II - Study 206; BRIEF: Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria ; DRUG USED: Reloxaliase; DRUG CLASS: Biologic; INDICATION: Hyperoxaluria; TARGET: Oxalate; THERAPY: Monotherapy; LEAD SPONSOR: Allena Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Signed a informed consent form or an assent 2. Aged 12 or older with body weight ≥ 35kg 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohns disease, short bowel syndrome, or other malabsorption syndrome) 4. Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening 6. In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening 7. Patients on dialysis, must be stable for greater than 3 months Exclusion Criteria: 1. Unable or unwilling to discontinue Vitamin C supplementation ; PRIMARY OUTCOME: Change in plasma oxalate; SECONDARY OUTCOME 1: Change in 24-hr urinary oxalate excretion[/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 - MOVE-PD (Parkinson); BRIEF: The purpose of this study, called MOVE-PD, is to investigate how individuals with Parkinsons disease (PD) and chronic constipation (CC) respond to RM-131 as compared to placebo. The study will look at how well RM-131 affects the frequency of spontaneous bowel movements over a 14-day period. The study will also evaluate the safety and tolerability of the study drug and evaluate whether the study drug relieves the uncomfortable GI symptoms related to chronic constipation in patients who are unsatisfied with other therapies they have tried for constipation. ; DRUG USED: Relamorelin; DRUG CLASS: Biologic; INDICATION: Chronic Idiopathic Constipation; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Motus Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Able to provide written informed consent and be willing and able to comply with study procedures. - Diagnosis of Parkinsons disease - Diagnosis of chronic constipation (CC), including experiencing constipation for ~12 or more weeks in the preceding 12 months. - Regular treatment for chronic constipation during the last 6 months, and dissatisfaction with current treatment for CC, after treatment with at least 2 regimens for constipation (see note at end of this section). - Stable medication history defined as no changes in regimen for at least 2 weeks prior to the baseline period - Body mass index of 18-40 kg/m2 - Mini-mental status exam (at screening) ≥26 - Female patients must have negative serum or urine pregnancy tests and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. A vasectomized partner will be allowed as one in conjunction with another single-barrier method. - Female patients unable to bear children must have this documented in the case report form(i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). Post-menopausal status will be confirmed by follicle stimulating hormone (FSH) in women less than 60 years of age Note the following medications are allowed: - Selective serotonin reuptake inhibitor (SSRI), SNRI, and tricyclic antidepressants are permissible at stable doses. All medications shall be reviewed and dis/approved by the investigator on a case-by-case basis. - Benzodiazepines are permissible at stable doses - Stable doses of antacids, NSAIDS, Cox-2 inhibitors, calcium supplements, thyroid replacement, estrogen replacements, low-dose aspirin for cardioprotection, and birth control (but with adequate back up contraception as drug interactions with birth control have not been conducted) are permissible - Dopamine agonists and amantadine allowed if on a stable dose - Deep brain stimulation is allowed. Exclusion Criteria: - Unable or unwilling to provide informed consent or to comply with study procedures - Diagnosis of secondary constipation beyond that of Parkinsons disease - Structural or metabolic diseases that affect the GI system - Unable to withdraw the following medications 48 hours prior to the baseline period and throughout the study (except as protocol defined rescue medications; see below): - Medications that alter GI transit including laxatives, prokinetics, erythromycin, narcotics, and anti-cholinergics (except as protocol defined rescue medications). - GABAergic agents - Drugs with a low therapeutic index, such as warfarin, digoxin, anti-seizure medications - NOTE: Parkinsons disease therapies are allowed. Exceptions for Parkinsons disease medications include: - Cogentin (benztopine), Artane (trihexyphenidyl), and apomorphone are excluded - History of recent major surgery (within 60 days of screening) - Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc. - History of symptomatic orthostatic hypotension or significant history of dizziness - History of hypersensitivity to mannitol which is an ingredient of both active and placebo study medications - Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator - Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities (including prolonged QTc > 500 msec) or abnormal blood pressure at screening except minor deviations deemed to be of no clinical significance by the Investigator - Acute GI illness within 48 hours of the baseline period - History of major GI surgery, except that patients with uncomplicated appendectomy or cholecystectomy are allowed. - ALT or AST > 1.5 X upper limit of normal (ULN) during screening - Females who are pregnant or breastfeeding - History of excessive alcohol use or substance abuse - Patient or caregiver unable to administer daily SC injections - Participation in an investigational clinical study within the 30 days prior to dosing in the present study - Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study ; PRIMARY OUTCOME: Investigate the effects of treatment with RM-131 for 14 days on the frequency of spontaneous bowel movements (SBMs) when administered to patients with Parkinsons Disease (PD) and Chronic Constipation (CC); SECONDARY OUTCOME 1: Evaluate the safety and tolerability of multiple doses of RM-131 when administered to patients with PD and CC[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II/III - Children (6 Months to 11 Years Old); BRIEF: This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated. ; DRUG USED: Comirnaty; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: BioNTech SE; CRITERIA: Inclusion Criteria 1. Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and <16 years of age. 2. Participants parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. 4. Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation. 5. Negative urine pregnancy test for female participants who are biologically capable of having children. 6. Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 7. The participant or participants parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written). Exclusion Criteria 1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19. 2. Phase 1 only: Known infection with HIV, HCV, or HBV. 3. Receipt of medications intended to prevent COVID-19. 4. Previous or current diagnosis of MIS-C. 5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigators judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results 6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 7. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 8. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted. 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 10. Female who is pregnant or breastfeeding. 11. Previous vaccination with any coronavirus vaccine. 12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study. 14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. 15. Previous participation in other studies involving study intervention containing LNPs. 16. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. ; PRIMARY OUTCOME: Percentage of participants in Phase 1 reporting local reactions; SECONDARY OUTCOME 1: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs[/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 - RP-001 (River Plate); BRIEF: The study is designed to assess the safety and efficacy of Vismed®, a special eye drop containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being compared to another eye drop, identical in composition except that it does not contain the active ingredient, sodium hyaluronate. This eye drop is designed as the vehicle. Some subjects are to receive Vismed® treatment, while others are to receive the vehicle; the assignment of subjects to receive either Vismed or vehicle is to be random. The two-week treatment phase is followed by a one week follow-up period to evaluate safety of Vismed®. ; DRUG USED: AL-2354A; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Eye (Ophthalmology); TARGET: Hyaluronic acid; THERAPY: Monotherapy; LEAD SPONSOR: Lantibio; CRITERIA: Inclusion Criteria: - Male and female adults aged 18 years and over. - Subjects should have at least a 3-month documented history of dry eye in both eyes diagnosed as dry eye syndrome, keratoconjunctivitis sicca (KCS), or due to Sjögren syndrome (immune exocrinopathy). - Subjects must agree to discontinue all artificial tears from Screening through the duration of the treatment period (Screening to Day 14). - Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening. - Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study. - Subjects must provide signed informed consent prior to participation in any study-related procedures. Exclusion Criteria: - Pregnancy or lactation. - Females of childbearing potential who are not using systemic contraception, are not postmenopausal (≥ 1 year), or are not surgically sterilized. - Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening. - Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication. - Any active inflammation of the eye not due to KCS (eg, iritis, scleritis, etc.). - Participation in any other clinical trial within 30 days prior to Screening. - Prior participation in a previous clinical trial of Vismed®. ; PRIMARY OUTCOME: staining of the cornea and conjunctiva; SECONDARY OUTCOME 1: staining of the cornea and conjunctiva[/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 402; BRIEF: The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes. The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine. ; DRUG USED: Bexagliflozin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Theracos; CRITERIA: Inclusion Criteria: - Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes. - Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive). - HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%. - Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications. - Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L). - If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study. - Female subjects must be surgically sterilized or postmenopausal. Exclusion Criteria: - Type 1 diabetes or diabetes treated with insulin injection. - Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these. - Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening. - Positive results on screen for drugs of abuse. - Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer. - Previous treatment with EGT0001474 or EGT0001442. ; PRIMARY OUTCOME: Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study; SECONDARY OUTCOME 1: Change in the Body Weight From Baseline at Week 4[/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 - PHOTON (8mg Dosage); BRIEF: The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: - To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response - To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Diabetic macular edema (DME) with central involvement in the study eye - Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME - Willing and able to comply with clinic visits and study-related procedures - Provide informed consent signed by study participant or legally acceptable representative Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment. Key Exclusion Criteria: - Evidence of macular edema due to any cause other than diabetes mellitus in either eye - Active proliferative diabetic retinopathy in the study eye - IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye - Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time - Treatment with ocriplasmin (JETREA®) in the study eye at any time NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply ; PRIMARY OUTCOME: Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48; SECONDARY OUTCOME 1: Percentage of Participants With a ≥2 Step Improvement From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Score at Week 48[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MATRIX EG; BRIEF: The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach. ; DRUG USED: Matuzumab; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: - Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus - Metastatic disease - Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from archived tissues - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 - At least 1 measurable lesion (modified World Health Organization criteria) Exclusion Criteria: - Previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed greater than (>) 12 months prior to study treatment - Radiotherapy or major surgery within 4 weeks prior to treatment - Brain metastases - Peripheral neuropathy or ototoxicity greater than or equal to (>/=) Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events Version 3 [NCICTC V3]) - Abnormal electrocardiogram (ECG) ; PRIMARY OUTCOME: Percentage of Participants With Objective Response Assessed by Independent Review Committee; SECONDARY OUTCOME 1: Duration of Objective Response Assessed by Independent Review Committee[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/RCHOP or RCHP; BRIEF: This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b. ; DRUG USED: Denintuzumab Mafodotin; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 19 (CD19), Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b; - patients must have high intermediate or high risk disease - Tumor tissue available from most recent biopsy to determine cell of origin - Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter - Eastern Cooperative Oncology Group performance status ≤2 - Age 18 years or older - Adequate study baseline laboratory parameters Exclusion Criteria: - Previous history of treated indolent lymphoma - History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years - History of progressive multifocal leukoencephalopathy - Cerebral/meningeal disease related to the underlying malignancy - Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment ; PRIMARY OUTCOME: Part B Outcome Measure: Complete Response Rate (CR); SECONDARY OUTCOME 1: Event-free Survival (EFS) Between Study Arms in Part B[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/Etoposide & Cisplatin; BRIEF: M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED. ; DRUG USED: MSC2490484A; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: DNA-PK; THERAPY: Combination; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: To be eligible for the study (Phase Ib and Phase II) the participant must fulfill all of the following criteria: - Male or female participants at least 18 years of age - Histological or cytological diagnosis of SCLC - Extensive disease (ie, disease beyond ipsilateral hemithorax, which may include malignant pleural or pericardial effusion or hematogenous metastases [Tany, Nany, M1a/b; T3-T4, Nany, M0, due to multiple lung nodules or extent of disease that precludes a tolerable radiation field, as judged by the Investigator]) - Participants eligible for first line platinum-based chemotherapy - Measurable or evaluable disease according to RECIST v1.1 - Eastern Cooperative Oncology Group performance status (ECOG PS) less than equals to (<=) 2 - Life expectancy of greater than equals to (≥) 3 months - Female participants of childbearing potential and male participants with female partners of childbearing potential must be willing to avoid pregnancy Note: Other protocol defined criteria could apply. Exclusion Criteria: Participants are not eligible for the study if they fulfill any of the following exclusion criteria: - Prior anticancer therapy for extensive disease (ED) SCLC including experimental agents. - Concurrent use of other anticancer therapy including any investigational agent within 28 days prior to the first dose of the investigational drug M3814. - Extensive prior radiotherapy (RT) on more than 30% of bone marrow reserves (by Investigator judgment) - Prior bone marrow/stem cell transplantation within 5 years before study start (Phase II only) - Major surgical intervention within 28 days prior to the first dose of investigational drug administration. Intervention(s) to establish the diagnosis for SCLC is permitted within 28 days as long as participants are cleared by the medical and surgical teams. - Poor vital organ functions defined as: - Bone marrow impairment as evidenced by hemoglobin less than (<) 9.0 gram per deci liter (g/dL) (5.7 micromole per liter (μmol/L)), absolute neutrophil count < 1.5 × 109/L, platelets < 100 × 109/L - Renal impairment as evidenced by calculated creatinine clearance < 60 mL/minutes (min) (according to the Cockcroft-Gault formula) - Liver function abnormality as defined by total bilirubin greater than (>) 1.5 × upper limit of normal (ULN) or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 × ULN (participants with liver involvement: a maximum of AST/ALT 5 × ULN) - Contraindication to the use of etoposide or cisplatin - Participants currently receiving (or unable to stop using prior to receiving the first dose of investigational drug) medications or herbal supplements known to be potent inhibitors of cytochrome P450 (CYP) 3A and CYP2C19 (unless treatment can be discontinued at least 1 week prior to receiving the first dose of investigational drug) or potent inducers of CYP3A and CYP2C19 (unless treatment can be discontinued at least 3 weeks prior to receiving the first dose of investigational drug). Note: Other protocol defined criteria could apply. ; PRIMARY OUTCOME: Phase Ib: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.; SECONDARY OUTCOME 1: Phase Ib: Number of Subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Ipilimumab/Nivolumab (Emory); BRIEF: This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread. ; DRUG USED: Pepinemab; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Semaphorin 4D/CD100; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Emory University; CRITERIA: Inclusion Criteria: - Stage I-IVA cytologically or histologically-proven head and neck squamous cell carcinoma (HNSCC), p16 positive and negative allowed - Oropharyngeal tumors must have p16 testing done - Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection - Archival tissue prior to treatment available from at most 6 months prior to study enrollment. Otherwise new pre-treatment biopsy mandatory - No prior treatment for HNSCC - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Absolute neutrophil count ≥ 1,500 cells/µL - Platelets ≥ 100,000/µL - Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell [prbc] transfusion) - Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN - Albumin ≥ 3.0 g/dL - Serum creatinine ≤ 1.5 x ULN - Calculated creatinine clearance of ≤ 50 mL/min - International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level < 1.1 units/mL (U/mL) are allowed on the trial - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures - Ability to understand and willingness to sign a written informed consent document - Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion - Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion - Female subjects of childbearing age must have a negative serum pregnancy test at study entry Exclusion Criteria: - Poor venous access for study drug administration - Nasopharynx cancer, cancer of unknown primary, sinonasal cancer - Determined not to be a surgical candidate due to medical co-morbidities - Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation) - Prior organ allograft or allogeneic bone marrow transplantation - Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll - Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease - Women who are pregnant or lactating - Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug 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 - Clinical evidence of bleeding diathesis or coagulopathy - Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma fully resected) unless disease free for a minimum of one year - Patients that have had prior treatment for HNSCC are not eligible - Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment - Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration - History of severe hypersensitivity reactions to other monoclonal antibodies - Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab - No archival tissue available pre-study treatment, and repeat biopsy not feasible ; PRIMARY OUTCOME: Change in immune profile in the tumor microenvironment; SECONDARY OUTCOME 1: Incidence of adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EMPOWER-CSCC 1; BRIEF: Groups 1 to 4 To estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced treated with cemiplimab ; DRUG USED: Libtayo; DRUG CLASS: Biologic; INDICATION: Skin Cancer - Squamous Cell Carcinoma (SCC) ; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - At least 1 measurable lesion - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - Adequate bone marrow function - Adequate renal function - Adequate hepatic function - Archived or newly obtained tumor material - Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6) - Surgical or radiological treatment of lesions contraindicated Key Exclusion Criteria: - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events - Prior treatment with an agent that blocks the PD-1/PD-L1pathway - Prior treatment with a BRAF inhibitor - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40. - Untreated brain metastasis(es) that may be considered active - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus - History of non-infectious pneumonitis within the last 5 years - Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments - Known allergy to doxycycline or tetracycline - Patients with a history of solid organ transplant - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Investigator Assessments of ORR[/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 - TARMAC (w/Tisagenlecleucel); BRIEF: This is an open label, multi-center, single-arm, phase II study investigating the efficacy and safety of the combination of ibrutinib and Tisagenlecleucel in twenty patients with relapsed or refractory Mantle Cell Lymphoma (MCL) or who had sub-optimal response to standard therapy in the presence of TP53 mutation. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Combination; LEAD SPONSOR: Peter MacCallum Cancer Centre, Australia; CRITERIA: Inclusion Criteria: - Patients must meet all the following criteria for study entry: 1. Written informed consent prior to screening procedures 2. Be ≥18 years of age on the day of signing informed consent 3. Have a confirmed diagnosis of MCL according to World Health Organization (2016) criteria 4. Have sufficient fresh or archival material available for central review 5. At least one site of radiographically assessable disease not previously irradiated (lymph node with largest diameter ≥1.5cm, or unequivocal evaluable hepatomegaly/splenomegaly or marrow phase disease) 6. Meet at least one of the following disease criteria: - Have relapsed, or progressed following at least 1 prior line of systemic chemoimmunotherapy for MCL (may include ibrutinib or other BTK-inhibitor in combination) - Be refractory to at least one prior line of chemoimmunotherapy (refractory is defined as less than a conventional PR following 2 cycles of anthracycline or cytarabine-containing therapy) - Have achieved <CR on PET imaging following 2 cycles of anthracycline or cytarabine-containing therapy in the presence of aberrations of p53; or <CR post autologous stem cell transplantation - Failure to achieve CR following at least 6 months of an ibrutinib or BTK inhibitor -containing front-line regimen, or failure to achieve PR following 8 weeks of a BTK inhibitor 7. Have a life expectancy of ≥ 3 months, as judged by the investigator 8. Have acceptable haematological function within 7 days prior to registration, defined as: - Absolute neutrophil count ≥1x10^9/L (may be supported by growth) - Absolute lymphocyte count ≥0.3x10^9/L or absolute CD3+ fraction > 0.15x 10^9/L - Platelets >50x 10^9/L unless explained by lymphoma at the discretion of the CPI - Haemoglobin ≥ 80 g/L (may be transfusion supported) 9. Have acceptable organ function within 7 days prior to registration, defined as: - Serum creatinine ≤1.5 x ULN, or a calculated creatinine clearance of at least 50 mL/min using the Cockcroft-Gault equation (see appendix 1) or a 24-hour urine collection - AST or ALT ≤3.0 x ULN - Bilirubin ≤ 1.5 x ULN (with the exception of patients with Gilberts syndrome. Patients with Gilberts syndrome may be included if their total bilirubin is ≤3.0 x ULN and direct bilirubin ≤1.5 x ULN). - aPTT and PT ≤ 1.5x ULN - Adequate pulmonary function defined as: - No or mild dyspnea (≤ grade 1) - Oxygen saturation measured by pulse oximetry ≥ 90 percent on room air 10. Female patients of childbearing potential and non-sterile male patients (with partners of childbearing potential) must agree to use highly effective methods of contraception from registration on the study to 30 days after the last dose of ibrutinib and 12 months after Tisagenlecleucel infusion and until Tisagenlecleucel is no longer present by qPCR on two consecutive tests (whichever is later): - Total abstinence from sexual intercourse when this is in line with the preferred and usual life style of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception - Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks prior to registration. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment - Male sterilisation (at least 6 months prior to screening). For female patients on the study, the vasectomised male partner should be the sole partner for that patient - Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before enrolment into this study. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential. 11. Female patients of childbearing potential must have a negative serum (beta-human chorionic gonadotropin (β-hCG) or urine pregnancy test within 7 days of registration 12. Sexually active male patients must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 30 days after the last dose of ibrutinib or 12 months after Tisagenlecleucel infusion and until Tisagenlecleucel is no longer present by qPCR on two consecutive tests Exclusion Criteria: - Patients who meet any of the following criteria will be excluded from study entry: 1. Prior allogeneic transplantation 2. Autologous transplantation within 6 weeks prior to registration 3. Active and uncontrolled autoimmune cytopenias 4. Active central nervous system involvement with MCL 5. Previous treatment with adoptive T-cell therapy 6. Receipt of a non BTK-inhibitor investigational medical product within the last 30 days prior to planned leukapheresis 7. Receipt of a non-anti CD20- monoclonal antibody with anti-neoplastic intent within 30 days prior to planned leukapheresis 8. Receipt of steroids >20mg prednisolone or equivalent in the fortnight prior to planned leukapheresis 9. Requirement for ongoing therapy with: - Potent CYP3A inhibitors (e.g. indinavir, ketoconazole, clarithromycin) - Potent CYP3A inducers (e.g. rifampin, phenytoin, carbamazepine) - Vitamin K antagonists (e.g. warfarin or equivalent) - Antiretroviral medications 10. Consumption within 3 days prior to registration: - Grapefruit or grapefruit products - Seville oranges - Star fruit 11. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of screening or class III to IV cardiac disease as defined by the New York Heart Association Functional Classification 12. Active neurological disorders of clinical relevance (e.g. epilepsy, severe brain injury, dementia, Parkinsons disease or autoimmune/inflammatory disorders (e.g. Guillain-Barre syndrome, motor neurone disease, chronic inflammatory demyelinating polyneuropathy) 13. Other significant life-threatening illness or medical condition which, in the investigators opinion, could compromise the subjects safety, interfere with absorption or metabolism of study drug, or put the study outcomes at undue risk 14. History of other active malignancy, with the exception of: - Adequately treated in situ carcinoma of the cervix or breast - Adequately treated basal cell carcinoma of skin or localised squamous cell carcinoma of the skin - Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and without evidence of recurrence for at least 2 years prior to registration 15. History of human immunodeficiency (HIV) or active hepatitis C virus or active hepatitis B virus. NOTE: Serology must be repeated at the pre-conditioning stage prior to infusion with Tisagenlecleucel. 16. Clinically significant active infection confirmed by clinical evidence, imaging or positive laboratory tests (e.g. blood cultures, viral DNA/RNA by PCR) 17. Receipt of live, attenuated vaccines within 4 weeks of registration 18. Major surgery within 4 weeks prior to registration 19. Pregnant or nursing (lactating) women. Note: Women of child-bearing potential must have a negative serum pregnancy test performed within 24 hours before leukapheresis, lymphodepletion (if performed) and prior to Tisagenlecleucel infusion. 20. Known hypersensitivity to the excipients of Tisagenlecleucel or to any product to be given to the patient as per the study protocol (e.g. tocilizumab and lymphodepleting agents) ; PRIMARY OUTCOME: Estimate complete response (CR) rate at month 4 following the infusion of Tisagenlecleucel using the Lugano criteria; SECONDARY OUTCOME 1: Evaluate safety of combination therapy with Tisagenlecleucel and ibrutinib through monitoring of the incidence, nature and severity of adverse events (graded according to NCI CTCAE v5.0), SAEs, dose interruptions and dose reductions of ibrutinib[/INST]No</s>

<s>[INST]<<SYS>>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 - 2203; BRIEF: multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome ; DRUG USED: Signifor; DRUG CLASS: Non-NME; INDICATION: Dumping Syndrome; TARGET: Somatostatin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria:. - Male or female patients ≥ 18 years of age. - Post-gastric or esophageal bypass surgery, matching one of the criteria below: - Bariatric surgery: more than 6 months before signing the informed consent - Esophageal cancer surgery: were disease free at study entry - Gastric cancer surgery: were at stage 0 or I and were disease free at study entry - Patient with a documented diagnosis of Dumping Syndrome defined as having: - History of/or active symptoms associated with dumping syndrome (e.g. post-prandial tachycardia, bloating, diarrhea) and - Documented history of hypoglycemia based on either: - glucose <50 mg/dL or 2.8 mmol/L on a sporadic or scheduled blood analysis -or - glucose value <60 mg/dL or ≤ 3.3 mmol/L at 90, 120, 150 or 180 min during an OGTT - Patients had at least one glucose level <60 mg/dL (or ≤ 3.3 mmol/L) at 90, 120, 150 or 180 min during the 3-hour OGTT at screening. - Patients with esophageal cancer with a negative computed tomography (CT) or Magnetic resonance imaging (MRI) scan (neck, thoracic, and upper abdominal) and albumin ≥ 3.5 g/dl at baseline. - Patients with gastric cancer with a negative CT or MRI scan (total abdomen). - Karnofsky Performance Status ≥ 60 (i.e. required occasional assistance, but was able to care for most of their personal needs) - Patients who received other therapies for dumping syndrome (such as acarbose, gama guar, pectin) must have stopped all treatments and had a wash out period prior to signing the informed consent (i.e. at least 2 weeks between last previous therapy and first dose of study medication in this study). - Patients who had provided signed written informed consent prior to study participation. Exclusion Criteria: - Bariatric patients who had lap band. - Patients with a current diagnosis of diabetes mellitus. - Patients who had failed treatment with somatostatin analogues for dumping syndrome in the past. - Patients who had been treated with somatostatin analogues in the past, must have had an appropriate interval between the last administration of somatostatin analogues treatment and the study drug as follows - Octreotide sc for ≥ 72 hours - Octreotide LAR for ≥ 56 days (8 weeks) - Lanreotide Autogel for ≥ 98 days (14 weeks) - Lanreotide SR ≥ 28 days (4 weeks) - Patients who were already treated with pasireotide. - Patients who had a known hypersensitivity to somatostatin analogues. - Patients who were receiving anti-cancer therapy (chemotherapy and/or radiotherapy). - Patients who had any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: - Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot). An HIV test was not required; however, previous medical history was reviewed. - Non-malignant medical illnesses that were uncontrolled or whose control may have been jeopardized by the treatment with this study treatment. - Life-threatening autoimmune and ischemic disorders. - Patients with the presence of active or suspected acute or chronic uncontrolled infection. Inadequate end organ function as defined by: - Inadequate bone marrow function: - White blood cells (WBC) <2.5 x 109/L - Absolute neutrophil count <1.5 x 109/L - Platelets <100 x 109/L - Hemoglobin <9 g/dL - International normalized ratio (INR) ≥ 1.3 - Serum creatinine >2.0 mg/dL - Alkaline phosphatase (ALP) >2.5 x upper limit of normal (ULN) - Serum total bilirubin >1.5 x ULN - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 x ULN - History of liver disease, such as cirrhosis or chronic active hepatitis B and C. - Presence of Hepatitis B surface antigen (HbsAg) and/ or presence of Hepatitis C antibody test (anti-Hepatitis C Virus). ; PRIMARY OUTCOME: Response Rate in Plasma Glucose Level; SECONDARY OUTCOME 1: Response Rate in Plasma Glucose Level[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CHIME 4 (OLE); BRIEF: Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study are invited to participate in this study. This is a Phase 3 open label extension (OLE) study with the objective of collecting long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD, when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects will be treated with SPN-810.Subjects will be given a choice to extend participation in this study every 6 months for up to 36 months. ; DRUG USED: SPN-810; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine 2 (D2) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301or 810P302 or discontinued early from the previous study during the maintenance phase and allowed to enroll only after consultation between the Investigator, the Medical Monitor and the Sponsor. 2. Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs). 3. Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302. 4. Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants). 5. Weight of at least 20 kg. 6. Written Informed Consent obtained from the subjects parent or LAR, and written Informed Assent obtained from the subject if appropriate. Exclusion Criteria: 1. Body Mass Index (BMI) in 99th percentile or above. 2. Clinically significant change in health status, safety concern or any other reason that, in the opinion of the Sponsor or the Investigator, would prevent the subject from participating in this study or successfully completing this study. 3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males). 4. Current substance or alcohol use. 5. Suicidal thoughts or behaviors confirmed at last visit in the previous double-blind randomized study. ; PRIMARY OUTCOME: Adverse Events will be summarized at the subject and event level. Treatment Emergent Adverse Events (TEAEs) will be summarized by severity and relationship. TEAE incidence table will be listed and summarized by group of optimized doses.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - SOLUTION; BRIEF: The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails. ; DRUG USED: Luliconazole 10%; DRUG CLASS: Non-NME; INDICATION: Fungal Infections - Non-Systemic; TARGET: Ergosterol biosynthesis; THERAPY: Monotherapy; LEAD SPONSOR: Topica Pharmaceuticals; CRITERIA: Inclusion Criteria: - Subjects of either gender, any race and between the ages of 18 and 70 inclusive - Subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (DSO) - Subjects must be free of any disease that in the Investigators opinion might interfere with the study evaluations or jeopardize the subjects safety Exclusion Criteria: - Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution - Subjects who are currently participating or have recently participated in another investigational medication or device study ; PRIMARY OUTCOME: The proportion of subjects who achieve complete cure of the target great toenail; 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 - Long Term Safety Study; BRIEF: This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD). ; DRUG USED: ASN002; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: JAK/STAT , Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: Asana BioSciences; CRITERIA: Inclusion Criteria - Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study - Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigators judgment. - Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study. - Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse - Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. - Subjects must be willing to comply with all study procedures and must be available for the duration of the study. - Subject has a body mass index (BMI) ≤ 38 kg/m2. Exclusion Criteria - Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. - Subject has clinically infected atopic dermatitis. - A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer - Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments. - Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past. - Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator. ; PRIMARY OUTCOME: Change From Baseline in Eczema Area Severity Index (EASI) Score; SECONDARY OUTCOME 1: Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (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 - STRIDE-1 (TRD); BRIEF: To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD. Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period. ; DRUG USED: AXS-05; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine Reuptake, Nicotinic Acetylcholine Receptors (nAChR) , NMDA Glutamate Receptor, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Receptors - Unspecified, Sigma-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Axsome Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Currently meets DSM-V criteria for MDD - History of inadequate response to 1 or 2 adequate antidepressant treatments - Body mass index (BMI) between 18 and 40 kg/m2, inclusive - Agree to use adequate method of contraception for the duration of the study - Additional criteria may apply Key Exclusion Criteria: - Suicide risk - Treatment with any investigational drug within 6 months - History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study - Additional criteria may apply ; PRIMARY OUTCOME: Montgomery-Åsberg Depression Rating Scale (MADRS) total score; SECONDARY OUTCOME 1: Clinical Global Impressions-Severity (CGI-S)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CEDAR; BRIEF: This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration. ; DRUG USED: Darpin; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Diagnosis of age-related macular degeneration in at least 1 eye - Best corrected visual acuity of 20/40 to 20/320 in the study eye - Best corrected visual acuity of 20/200 or better in the non-study eye Exclusion Criteria: - History of vitrectomy, macular surgery, or glaucoma surgery in the study eye - Cataract or refractive surgery in the study eye within the last 3 months ; PRIMARY OUTCOME: Percentage of Participants With Stable Vision at Week 52; SECONDARY OUTCOME 1: Mean Change From Baseline in BCVA in the Study Eye at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 307 (Symptomatic GERD); BRIEF: The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD). ; DRUG USED: AcipHex ER; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: KEY INCLUSION CRITERIA: Male or female, ages 18 through 75 years will be included in the study. Females should be either of nonchildbearing potential or of childbearing potential. Females of childbearing potential must have negative serum and urine pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Women using hormonal contraceptives must also be using an additional approved method of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Pregnant or lactating females are excluded. Subjects must have a history of heartburn, identified as their main complaint, for 6 months or longer.Subjects must have documentation of a minimum of 5 moderate to severe heartburn episodes, 3 of which occur during the daytime and 1 of which occurs during the nighttime, during the last 7 days before randomization. Subjects must be able to read, write, and understand the language of the symptom dairy. KEY EXCLUSION CRITERIA: Subjects will be excluded from the study if they are found to have erosive esophagitis during esophagogastroduodenoscopy (EGD) at Screening, current or a history of esophageal motility disorders, current or a history of Barretts esophagus, current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications), current or a history of Zollinger-Ellison syndrome and acid hypersecretory conditions, or current gastric or duodenal ulcer. Subjects will be excluded if they are found to have current or a history of cancer, with the exception of fully excised skin basal cell carcinoma, inflammatory bowel disease, a history of esophageal, gastric and duodenal surgery, except simple closure of a perforated ulcer. Subjects will be excluded who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>=20 mg/day prednisone or equivalent), or aspirin (>325 mg/day). Female subjects will be excluded who are pregnant, lactating, or have a positive B-human gonadotropin test at Screening/Baseline. Subjects will be excluded who are known to be human immunodeficiency virus (HIV) positive, have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial. Subjects who are unwilling to provide informed consent will be excluded. ; PRIMARY OUTCOME: Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4; SECONDARY OUTCOME 1: Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4[/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 - LP0105-1020; BRIEF: This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel ; DRUG USED: Picato Gel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Mitochondria, Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities Exclusion Criteria: - Location of the treatment area (trunk (except chest) or extremities) - within 5 cm of an incompletely healed wound, - within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) - Prior treatment with ingenol mebutate within the selected treatment area - Lesions in the treatment area that have: - atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous horns) and/or, - recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions) ; PRIMARY OUTCOME: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs); SECONDARY OUTCOME 1: Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation)[/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 - RESPONSE 2; BRIEF: This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polycythemia Vera (PV); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, Non-palpable spleen, Phlebotomy dependent, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2. Exclusion Criteria: Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, excluding specific skin cancers, Previously received treatment with a JAK inhibitor, Being treated with any investigational agent, Women who are pregnant or nursing. Other inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Number of Participants Achieving Hematocrit (Hct) Control at Week 28; SECONDARY OUTCOME 1: Number of Participants Achieving a Complete Hematological Remission at Week 28[/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 - B7471008 (18-49 y/o); BRIEF: This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC. ; DRUG USED: Prevnar 20; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: 1. Male or female adults ≥18 and <50 years of age. 2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product. 3. Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children. Exclusion Criteria: 1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigators opinion, excludes the subject from participating in the study. 3. History of microbiologically proven invasive disease caused by S pneumoniae. 4. Pregnant female subjects or breastfeeding female subjects (known or suspected). ; PRIMARY OUTCOME: Percentage of Participants With Local Reactions Within 10 Days After Vaccination; SECONDARY OUTCOME 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/Ib - IVY; BRIEF: This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy. ; DRUG USED: Pegilodecakin; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: IL-10 (Interleukin-10) and IL-10 Receptor (IL-10R); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: Part A Escalation Cohorts: o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts: - Tumors with all histological diagnosis or tissue origin may be enrolled - Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease. - Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC) - At least 18 years of age - Performance Status of 0 or 1 - Adequate organ function Exclusion Criteria: - Hematologic malignancies - Pregnant or lactating - Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders - Myocardial infarction within the last 6 months - Unstable angina, or unstable cardiac arrhythmia requiring medication - Surgery within the last 28 days - Systemic fungal, bacterial, viral, or other infection - History of bleeding diathesis within the last 6 months - Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B ; PRIMARY OUTCOME: Safety and tolerability as measured by incidence of adverse events; SECONDARY OUTCOME 1: Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)[/INST]No</s>

<s>[INST]<<SYS>>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 - Abdominoplasty; BRIEF: The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty. ; DRUG USED: Olinvyk; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Trevena Inc.; CRITERIA: Inclusion Criteria: - >=18 and <=65 years of age. - Plans to undergo an abdominoplasty procedure with no additional collateral procedures. - Is able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure. Exclusion Criteria: - ASA Physical Status Classification System classification of P3 or worse. - Has surgical or post-surgical complications. - Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs. - Has previously participated in another TRV130 clinical study. ; PRIMARY OUTCOME: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo; SECONDARY OUTCOME 1: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine[/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 purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy. ; DRUG USED: Efpeglenatide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Hanmi Pharmaceutical Company Limited; CRITERIA: Inclusion Criteria: - Is male or female and 18 to 65 years of age, inclusive, at screening - Has a history of T2DM and a stable dose of metformin - Has HbA1c levels at screening between 7% and 10% Exclusion Criteria: - Is pregnant or lactating - Has type 1 diabetes - Has a significant change in body weight in the 3 months before screening - Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening - Has an estimated glomerular filtration rate rate <75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 <estimated glomerular filtration rate <90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio >30 mg/g. - Has alanine aminotransferase or aspartate aminotransferase values >2.0 × upper limit of normal or total bilirubin >1.5 × upper limit of normal unless the subject has a known history of Gilberts syndrome - Has fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) or >250 mg/dL (>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredricksons Type I, IV or V hyperlipidemia will be excluded. - Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding - Has any acute illness within 5 days before first study drug administration - Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis - Is a heavy tobacco user(more than 10 cigarettes a day) - Is a heavy alcohol user - Has a positive screen for drugs of abuse ; PRIMARY OUTCOME: Number of subjects with adverse events as a measure of safety and tolerability; SECONDARY OUTCOME 1: The pharmacokinetics in repeat-dose[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PEP0208; BRIEF: The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer. ; DRUG USED: Onivyde; DRUG CLASS: Non-NME; INDICATION: Pancreatic Cancer; TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: PharmaEngine; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas - Metastatic disease - Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen - Karnofsky performance status equal or more than 70 Exclusion Criteria: - With active CNS metastases - With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1) - Major surgery or radiotherapy within 4 weeks - Prior participation in any investigational drug study within 4 weeks - With prior irinotecan treatment ; PRIMARY OUTCOME: Survival Rate; SECONDARY OUTCOME 1: other efficacy endpoints[/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 - ACE-CL-001; BRIEF: This study is evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). ; DRUG USED: Calquence; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Acerta Pharma BV; CRITERIA: Inclusion Criteria: 1. Men and women ≥ 18 years of age with a confirmed diagnosis of CLL/SLL, which has relapsed after, or been refractory to, ≥ 2 previous treatments for CLL/SLL. 2. Must have measurable CLL/SLL defined as ≥ 1 lymph node ≥ 2 cm as measured in the longest diameter. 3. Active disease meeting ≥ 1 of the following International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for requiring treatment: 1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL). 2. Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly. 3. Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy. 4. Progressive lymphocytosis with an increase of > 50% over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. The LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In participants with initial blood lymphocyte counts of < 30 X 10^9/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded. 5. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy. 6. Constitutional symptoms documented in the participants chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs: i. Unintentional weight loss ≥ 10% within the previous 6 months before screening. ii. Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before screening without evidence of infection. iii. Night sweats for > 1 month before screening without evidence of infection. 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 5. Agreement to use highly effective methods of contraception during the study and for 2 days after the last dose of study drug if sexually active and able to bear or beget children (see Section 3.7.9 for list of highly effective methods of contraception). 6. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty. 7. 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 participant privacy regulations). Inclusion Criteria for Treatment Subgroups 1. Treatment Naive only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL, who require treatment per National Cancer Institute (NCI) or International Working Group guidelines and a) do not want to receive chemoimmunotherapy or b) have comorbidities that would preclude chemoimmunotherapy. 2. Ibrutinib Intolerant only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL who are not tolerating ibrutinib due to ibrutinib-related AEs. 3. Richters Syndrome/Prolymphocytic Leukemia Transformation only: Men and women ≥ 18 years of age and biopsy proven diffuse large B cell lymphoma (DLBCL) Richters transformation or prolymphocytic leukemia transformation. 4. Ibrutinib relapsed/refractory (R/R) only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL whose best response after 2 cycles of ibrutinib therapy was stable disease or nonresponse or who initially responded to ibrutinib therapy and now have signs of clinical progression. Exclusion Criteria: 1. Prior malignancy, except for adequately treated basal cell, squamous cell skin cancer or in situ cervical cancer. Participants with other prior malignancies from which the participant has been disease free for ≥ 2 years may be included if approved by the medical monitor. 2. A life-threatening illness, medical condition or organ system dysfunction which, in the investigators opinion, could compromise the participants safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk. 3. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) ≤ 40%. 4. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. 5. Any immunotherapy within 4 weeks of first dose of study drug. 6. For participants with recent chemotherapy or experimental therapy the first dose of study drug must occur after 5 times the half-life of the agent(s). 7. Relapsed after, or refractory to, prior BTK inhibitor therapy (Note: Does not apply to Ibrutinib R/R or Richters Syndrome Group). 8. Any history of Richters transformation (Note: Does not apply to Richters Syndrome Group). 10. Central nervous system (CNS) involvement by lymphoma. 11. Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation. 12. Known history of human immunodeficiency virus (HIV) or serologic status indicating active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection or any uncontrolled active systemic infection. Participants with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before enrollment. Those who are hepatitis B surface antigen positive or hepatitis B PCR positive and those who are hepatitis C PCR positive will be excluded. 13. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenic purpura (ITP) defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (> 20 mg daily of prednisone daily or equivalent). 14. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug. 15. Requires treatment with proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). 16. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug. 17. Major surgery within 4 weeks before first dose of study drug. 18. ANC < 0.75 x 10^9/L or platelet count < 50 x 10^9/L unless there is bone marrow involvement. 19. Total bilirubin > 1.5 x upper limit of normal (ULN) (total bilirubin ≤ 2.5 x ULN allowed in participants with autoimmune hemolytic anemia that is otherwise controlled); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN unless disease related. 20. Serum amylase > 1.5 x ULN or serum lipase > 1.5 x ULN. 21. Significant screening electrocardiogram (ECG) abnormalities including, 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, or QTc ≥ 480 ms. 22. Cardiac troponin I levels above the limit of normal as specified by the manufacturer. 23. Breast feeding or pregnant. 24. History of bleeding diathesis (eg, hemophilia, von Willebrand disease). 25. Concurrent participation in another therapeutic clinical trial. 26. Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault [(140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female]. 27. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening. ; PRIMARY OUTCOME: Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1; SECONDARY OUTCOME 1: Percentage of Participants With Objective Response (OR) as Assessed by the Investigator[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia/Ib - Canada; BRIEF: This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals ; DRUG USED: CC-31244; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Monotherapy; LEAD SPONSOR: Cocrystal Pharma, Inc.; CRITERIA: Main Inclusion Criteria: HV and HCV INFECTED SUBJECTS: - Male or female aged ≥ 18 to ≤ 65 years; - Body mass index ≥ 18.5 to ≤ 35.0 kg/m2; - Body weight ≥ 50 kg; - Negative screening for alcohol and drugs of abuse; - Normal results on 12-lead electrocardiogram (ECG); - For females, negative result on a pregnancy test. HCV INFECTED SUBJECTS: - HCV treatment-naïve subjects must have not received prior direct acting agent (DAA) treatment for hepatitis C infection; - Documented clinical history compatible with chronic hepatitis C; - HCV Genotype 1 by HCV genotyping performed at Screening; - Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening; - Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest, F2 or lower) within one year prior to study), if these are not available, do a FibroTest at screening, which must be F2 or lower. Main Exclusion Criteria: HV and HCV INFECTED SUBJECTS: - Females who are pregnant or are lactating; - Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV); - Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator; - Positive screen result for drugs of abuse or alcohol on Day -1. Use of other investigational drugs within 60 days of dosing; - Subject with intestinal malabsorption; - Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities; - Serum creatinine > upper limit of normal (ULN); - Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. HEALTHY VOLUNTEERS: - Positive screen for anti-HCV antibody HCV INFECTED SUBJECTS: - Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis; - History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency; - History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC; - Active clinically significant diseases. ; PRIMARY OUTCOME: Number of treatment emergent adverse events (AE); SECONDARY OUTCOME 1: Measure plasma levels of CDI-31244 after SD[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/Carboplatin; BRIEF: This study seeks to (i) determine the safe dose of CYT997 when given in combination with carboplatin in patients with relapsed glioblastoma multiforme (glioma) and (ii) to determine whether the combination of CYT997 with carboplatin is a useful treatment for glioma. ; DRUG USED: CYT997; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Angiogenesis, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Patients must have histologically-confirmed glioblastoma multiforme that has progressed after initial surgery, radiation therapy and temozolomide chemotherapy. - Measurable tumour must be present on gadolinium-enhanced MRI - At least 3 months must have elapsed from completing radiation to minimize the possibility of pseudo-progression. - At least 4 weeks since prior chemotherapy (6 weeks if the last regimen included bischloroethylnitrosourea (BCNU) or Chloroethyl-Cyclohexyl-NitrosoUrea (CCNU)). - Age ≥ 18 years. - If patients are taking steroids, the dose must be stable for = 7 days. - Eastern Cooperative Oncology Group (ECOG) performance status = 2. - Life expectancy of greater than 2 months. - Patients must have adequate organ and marrow function as defined below: - Absolute neutrophil count = 1.5 × 109/L - Platelet count = 100 × 109/L - Total bilirubin within normal limits - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 5 × upper limit of normal (ULN) - Creatinine within normal limits OR creatinine clearance = 60 mL/min/1.73 m2 for patients with creatinine levels above normal - Normal left ventricular ejection fraction on a gated blood pool scan or echocardiogram - Must agree to use adequate contraceptive measures if indicated - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have received any other investigational agent in the preceding four weeks prior to commencing therapy in this study. - Patients who have been previously treated with carboplatin. - Patients who have been previously treated with bevacizumab or other anti-angiogenesis or vascular-disrupting agents - Patients who are receiving enzyme-inducing anticonvulsant drugs (EIACD) such as phenytoin or carbamazepine. - Patients with a history of allergic reactions attributed to compounds of similar chemical composition to CYT997 or other agents used in the study. - Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant or lactating women. - Patients with immune deficiency, including HIV-positive patients. - Patients with uncontrolled diarrhoea despite optimal medication and those with any history of acute gastrointestinal bleeding. - Patients who are unable or unwilling to undergo MRI scanning - Patients with the following conditions/treatments will be excluded: - Myocardial infarction (MI) or stroke within 6 months - History of stroke or transient ischemic attacks (TIAs) - Unstable angina pectoris or acute ischemic changes on ECG - History of diabetic retinopathy - Symptomatic peripheral arterial disease o Major surgery in the last 4 weeks - Evidence of intra-tumoural haemorrhage on imaging, except for stable grade-1 post-operative haemorrhage. - Current therapeutic anti-coagulation with warfarin or a heparin (excludes lowdose prophylactic heparin). - Uncontrolled hypertension - The need for any anti-arrhythmic drugs - Presence of luminal stenosis of 50% or more in any of the extracranial or intracranial arteries supplying the brain, as measured by magnetic resonance angiography (MRA) at baseline. - Patients with a baseline prolongation of the QTc interval of Common Terminology Criteria (CTC) grade 1 (QTc > 0.45- 0.47 sec) or greater. - Patients with impaired cardiac function or clinically significant cardiac diseases, including any one of the following: - Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram; - complete left bundle branch block; - obligate use of a cardiac pacemaker; - congenital long QT syndrome; - history or presence of ventricular tachyarrhythmia; - presence of unstable atrial fibrillation (ventricular response > 100 bpm) Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria; - clinically significant resting bradycardia (< 50 bpm); - right bundle branch block + left anterior hemiblock (bifascicular block); - angina pectoris = 3 months prior to starting study drug; - acute MI = 3 months prior to starting study drug; or - other clinically significant heart disease (e.g., congestive heart failure (CHF), uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen). - Patients currently receiving treatment with medications known to prolong the QTc interval and/or to induce Torsades de Pointes arrhythmia. ; PRIMARY OUTCOME: Safety and tolerability of escalating doses of CYT997 when given in combination with standard carboplatin therapy (Phase Ib component); 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 Ib - MAD; BRIEF: Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose production characteristic of type 2 diabetes mellitus that is a major contributor to hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with type 2 diabetes mellitus. ; DRUG USED: RVT-1502; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ligand Pharmaceuticals; CRITERIA: INCLUSION CRITERIA: Part 1 1. Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment. 2. Willing and able to provide written informed consent. 3. Not diabetic and has a fasting plasma glucose (FPG) between 70 mg/dL and 105 mg/dL, inclusive. 4. Good health with no significant concomitant pathology based on medical history, physical examination, electrocardiogram (ECG), routine laboratory tests (chemistry, hematology, lipid profile, international normalized ratio, and urinalysis), and vital signs. Part 2 1. Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment. 2. Willing and able to provide written informed consent. 3. Has T2DM according to American Diabetes Association criteria. 4. Currently on stable metformin therapy (unchanged dose for greater than or equal to 12 weeks prior to screening). At the discretion of the investigator, subjects who are drug naïve or whose metformin dose has not been stable for at least 12 weeks at screening, may be started on metformin or have their metformin dose stabilized. Following 12 weeks of stable metformin, they may undergo re screening including assessment of HbA1c and FPG (inclusion criteria 5 and 6). 5. Has an HbA1c level between 6.5% and 10.5% at screening. One retest is permitted. 6. Venous FPG is 125 mg/dL and 260 mg/dL at screening and either the Day -1 venous FPG or the Day 1 capillary blood glucose (CBG) is 115 mg/dL and 260 mg/dL. One retest is permitted. 7. Has a body mass index between 20 and 45 kg/m2, inclusive. EXCLUSION CRITERIA: Part 1 1. Has a recent history of drug and/or alcohol abuse. 2. Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions as specified in the protocol. 3. Unwilling to comply with restrictions on strenuous exercise as specified in the protocol. 4. Has history of clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data. 5. Has liver transaminase levels (aspartate transaminase [AST] or alanine transaminase [ALT]) >10% of the upper limit of normal (ULN), or has creatine kinase (CK) levels >2 × ULN at screening or admission to clinic (Day -1). 6. Has a plasma triglyceride level >400 mg/dL. If triglyceride level is between 400 mg/dL and 500 mg/dL. 7. Has a recent history of uncontrolled high blood pressure or has systolic blood pressure <90 mmHg or >140 mmHg or diastolic blood pressure <60 mmHg or >90 mmHg at screening. 8. Is taking prescription or non-prescription drugs, vitamins, herbal, and dietary supplements, within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, or is unwilling to refrain from taking any such medication until after the last protocol-specified blood sample. The use of acetaminophen, not to exceed a total daily dose of 1 g, is permitted up to 24 hours prior to admission to the investigational site and then prohibited until after the last protocol-specified blood sample. The use of stable hormone replacement medication by women, topical steroids, and stable thyroid medication is permitted. Part 2 1. Has a history of hypoglycemic unawareness or recurrent hypoglycemia requiring assistance. 2. Has liver transaminase levels (AST or ALT) >10% × ULN, or has CK levels >1.5 × ULN at screening or admission to clinic (Day -1). 3. Has history of clinically significant cardiovascular, pulmonary, renal, endocrine (other than T2DM), hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data. 4. Has a recent history of uncontrolled high blood pressure or has systolic blood pressure <90 mmHg or >140 mmHg or diastolic blood pressure <60 mmHg or >90 mmHg at screening. One retest of blood pressure within 24 hours is permissible at the discretion of the Investigator. Therapy for hypertension (beta blockers excluded) that has been stable for at least one month prior to screening is permitted. At the Investigators discretion, one anti-hypertensive medication (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, hydrochlorothiazide, or dihydropyridine calcium-channel blocker) may be initiated, or the dosage of a current antihypertensive medication up titrated, in a subject with blood pressure slightly above the eligibility criterion at screening. After at least 4 weeks of stable blood pressure treatment, if the subjects blood pressure has decreased to within the 140/90 mmHg limit, the subject will be fully reassessed for eligibility. 5. Has received insulin for more than 6 consecutive days within 6 months prior to screening or has received insulin within 3 months prior to screening. 6. Has been treated with peroxisome proliferator-activated receptor gamma agonist, incretin therapy, amylin mimetics, or sodium-glucose linked transporter-2 inhibitor therapy within 12 weeks prior to screening; treatment with other diabetic medications (excluding metformin) within 3 weeks prior to screening. 7. Is taking concomitant medications. At least 3 months of stable therapy for thyroid replacement and hypercholesterolemia (gemfibrozil, Welchol, and cholestyramine are not permitted) and at least 4 weeks of stable hypertension medications (as described above) and low dose aspirin are permitted. ; PRIMARY OUTCOME: Number of participants with one or more drug related adverse events or serious adverse events; SECONDARY OUTCOME 1: Pharmacokinetic (PK) profile (area under the concentration curve (AUC) of LGD-6972 after repeat oral doses in NHS and in subjects with T2DM[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Dose-finding (Brazil); BRIEF: A Phase II open-label, randomized, parallel group, 2 sites (Brazil), designed to evaluate the safety and efficacy of 3 doses of study drug for the treatment of the MPS II. ; DRUG USED: JR-141; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis II (MPS II; Hunter Syndrome); TARGET: Sulfated alpha-L-iduronic acid; THERAPY: Monotherapy; LEAD SPONSOR: JCR Pharmaceuticals Co., Ltd.; CRITERIA: Inclusion Criteria: - Males with confirmed diagnosis of MPS II, based on deficient activity of IDS in leucocytes or fibroblasts and/or pathogenic mutations identified in the IDS gene (if enzyme diagnosis was in dried blood spots or plasma, molecular genetics confirmation is mandatory). - One of the following age groups: 1. 0 to 3 years and 11 months old (6 patients, 2 in each dose) 2. 4 years to 7 years and 11 months old (6 patients, 2 in each dose) 3. 8 years or older (6 patients, 2 in each dose) - Capable of providing written consent by himself, unless the patient is under the age of 18 years at the time of informed consent process, or it is not possible to obtain consent from the patient himself due to his intellectual disabilities associated with MPS II. - In the case of a patient who is under the age of 18 years or from whom it is not possible to obtain consent due to his intellectual disabilities associated with MSP II, he may be included if written consent can be provided by legal representative; however written consent should be obtained from the patient himself too, wherever possible. - Naïve patients or patients who are receiving enzyme replacement therapy with idursulfase could be included if provided treatment has been stable in the last 6 months and agree to interrupt the treatment at least one week before the first study drug infusion, and agree in suspending this treatment for the duration of the trial. Exclusion Criteria: - Refusal to sign the informed consent form. - Unable to perform the study procedures, except for neurocognitive testing. - Previous engrafted BMT/HSCT. - Surgical or other major medical intervention planned to occur before week 26. - Participation in a clinical trial with an investigational drug in the last 12 months. - Judged by the investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking a position for lumber puncture due to joint contracture or those who are likely to experience difficulty breathing during the lumbar puncture process. - Judged by the investigator or subinvestigator to be ineligible to participate in the study due to a history of a serious drug allergy or sensitivity. - Otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study out of consideration for the subject safety. ; PRIMARY OUTCOME: Number of participants with Adverse Events; SECONDARY OUTCOME 1: Plasma Pharmacokinetic parameter [Maximum Plasma Concentration [Cmax]][/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers; BRIEF: Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects. After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28. Subjects will return on day 56 for the final visit. ; DRUG USED: Zika Vaccine (Themis); DRUG CLASS: Vaccine; INDICATION: Zika Virus Disease; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Themis Bioscience GmbH; CRITERIA: Inclusion Criteria: - healthy volunteers aged 18 to 55 - subjects of child bearing potential must perform reliable method of contraception Exclusion Criteria: - immune deficiency, history of HIV, HBV, HCV - drug addiction - vaccination within 4 weeks prior to study or planned vaccination during study - prior receipt of any Zika vaccine - recent infection 1 week prior to screening - relevant medical history interfering with aim of study - neoplastic disease, hematological malignancy - history of autoimmune disease - psychological condition that affects ability to participate in the study - history of severe adverse reactions to vaccine administration - history of anaphylaxis - allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator - use of immunosuppressive drugs within 30 days before screening or planned use during study - receipt of blood products within 120 days before screening or planned use during study - pregnancy, unreliable contraception method - decision of the investigator - regular blood plasma donor ; PRIMARY OUTCOME: Immunogenicity: Functional anti-Zika antibodies as measured by PRNT; 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 - 101; BRIEF: In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated 2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses. ; DRUG USED: VLA1601; DRUG CLASS: Vaccine; INDICATION: Zika Virus Disease; TARGET: Immune System, Viral Antigens; THERAPY: Monotherapy; LEAD SPONSOR: Valneva Austria GmbH; CRITERIA: Inclusion Criteria: 1. Subject is 18 to 49 years of age on the day of screening (Visit 0); 2. Subject has a Body Mass Index (BMI) of ≥18.5 and <30 kg/m2 on the day of screening (Visit 0); 3. Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures; 4. Subject is generally healthy as determined by the Investigators clinical judgment based on medical history, physical examination and screening laboratory tests; 5. If subject is of childbearing potential: i. Subject has a negative serum pregnancy test at screening (Visit 0); ii. Subject agrees to employ adequate birth control measures for the duration of the study. This includes one of the following measures: 1. Hormonal contraceptives (e.g. implants, birth control pills, patches) since ≥30 days prior to first vaccination; 2. Intrauterine device; 3. Barrier type of birth control measure (e.g. condoms, diaphragms, cervical caps); 4. Vasectomy in the male sex partner ≥3 months prior to first vaccination; Exclusion Criteria: 1. Subject has a history of known flavivirus infection, or vaccination with a licensed or investigational flavivirus vaccine; 2. Subject has plans to receive a licensed flavivirus vaccine during the course of the study; 3. Subject has plans to travel to areas (including within the US) with active ZIKV, Japanese Encephalitis Virus (JEV), Dengue Virus (DENV) or Yellow Fever Virus (YFV) transmission during the course of the study or has travelled to a flavivirus-endemic area within 4 weeks prior to study enrollment; 4. Subject is seropositive to ZIKV, JEV, DENV or West Nile virus (WNV); 5. Subject has received an inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to vaccination in this study; 6. Subject has clinically significant abnormal laboratory values, as determined by the Investigator, at screening (Visit 0); 7. Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); 8. Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological (including Guillain-Barré syndrome), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder; 9. Subject has a disease or is undergoing a form of treatment or was undergoing a form of treatment within 4 weeks prior to study enrollment (i.e. subject randomized) that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled (low dose), intranasal or topical steroids is permitted); 10. Subject has a history of severe hypersensitivity reactions or anaphylaxis; 11. Subject has a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications); 12. Subject had acute febrile infections within two weeks prior to vaccination in this study; 13. Subject has donated blood within 30 days or received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or plans to donate blood or use blood products during the course of the study; 14. Subject has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating; 15. Subject is currently enrolled or has participated in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IMP or investigational device during the course of this study; 16. Subject has plans to become pregnant during the course of the study, or is pregnant (positive serum pregnancy test at screening) or lactating at the time of study enrollment; 17. Subject has a known or suspected problem with alcohol or drug abuse as determined by the Investigator; 18. Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities); 19. Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study; 20. Subject has any condition that, in the opinion of the Investigator, may compromise the subjects well-being, might interfere with evaluation of study endpoints, or would limit the subjects ability to complete the study. ; PRIMARY OUTCOME: Rate of subjects with solicited adverse events including injection site and systemic reactions; SECONDARY OUTCOME 1: Rate of subjects with solicited adverse events including injection site and systemic reactions[/INST]No</s>

<s>[INST]<<SYS>>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 - MERIT (EU) (MT-06); BRIEF: The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits. Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet. Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications. ; DRUG USED: Odactra; DRUG CLASS: Biologic; INDICATION: Allergic Rhinitis; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: ALK-Abelló A/S; CRITERIA: Inclusion Criteria: - A history of house dust mite allergy - Use of symptomatice medication for treatment of house dust mite allergy - Positive skin prick test to mites - Positive specific IgE Exclusion Criteria: - History of uncontrolled asthma - Overlapping symptomatice allergies - Previous treatment with immunotherapy ; PRIMARY OUTCOME: Evaluation of allergy symptoms and use of symptomatic medication; 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/III - N-MOmentum; BRIEF: To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD. ; DRUG USED: Uplizna; DRUG CLASS: Biologic; INDICATION: Neuromyelitis Optica (Devics Syndrome, NMO); TARGET: Cluster of Differentiation 19 (CD19); THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: 1. Men and women 18 years or older with diagnosis of NMO/NMOSD 2. Confirmation of NMO/NMOSD status: 1. AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years 2. AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years 3. Able and willing to give written informed consent and comply with the requirements of the study protocol. 4. EDSS <= 7.5 (8 in special circumstances) 5. Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product. Exclusion Criteria: 1. Lactating and pregnant females 2. Treatment with any investigational agent within 4 weeks of screening 3. Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy. 4. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization. 5. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization 6. Receipt of the following at any time prior to randomization: 1. Alemtuzumab 2. Total lymphoid irradiation 3. Bone marrow transplant 4. T-cell vaccination therapy 7. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal. 8. Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization. 9. Receipt of any of the following within 3 months prior to randomization: 1. Natalizumab (Tysabri®). 2. Cyclosporin 3. Methotrexate 4. Mitoxantrone 5. Cyclophosphamide 6. Tocilizumab 7. Eculizumab 10. History of Hepatitis B and/or Hepatitis C (Hep B/C at screening) 11. Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection 12. History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization 13. Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days ; PRIMARY OUTCOME: Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP; SECONDARY OUTCOME 1: Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of 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 II - Pediatric (FA-A); BRIEF: The objective of this study is to assess the therapeutic efficacy of a hematopoietic cell-based gene therapy for patients with Fanconi anemia, subtype A (FA-A). Hematopoietic stem cells from mobilized peripheral blood of patients with FA-A will be transduced ex vivo (outside the body) with a lentiviral vector carrying the FANCA gene. After transduction, the corrected stem cells will be infused intravenously back to the patient with the goal of preventing bone marrow failure. ; DRUG USED: RP-L102; DRUG CLASS: Biologic; INDICATION: Fanconi Anemia; TARGET: Fanconi anemia, complementation group A (FAA, FACA, FANCA); THERAPY: Monotherapy; LEAD SPONSOR: Rocket Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Fanconi anemia as diagnosed by chromosomal fragility assay of cultured lymphocytes in the presence of DEB or a similar DNA-crosslinking agent 2. Patients of the complementation group FA-A 3. Minimum age: 1 year and a minimum weight of 8 kg 4. At least 30 CD34+ cells/μL are determined in one bone marrow (BM) aspiration within 3 months prior to CD34+ cell collection OR (see subsequent criterion) 5. If the number of CD34+ cells/ μL in BM is in the range of 10-29, peripheral blood (PB) parameters should meet two of the three following criteria: - Hemoglobin: ≥11g/dL - Neutrophils: ≥900 cells/μL - Platelets: ≥60,000 cells/μL 6. Provide informed consent in accordance with current legislation 7. Women of childbearing age must have a negative urine pregnancy test at the baseline visit, and accept the use of an effective contraception method during participation in the trial Exclusion Criteria: 1. Subjects with an available and medically eligible HLA-identical sibling donor. 2. Evidence of myelodysplastic syndrome or leukemia, or cytogenetic abnormalities other than those reported as variant(s) of normal in BM aspirate analysis. This assessment should be made by valid studies conducted within the 3 months before the subject commences the stem cell mobilization/collection procedures of the clinical trial. 3. Subjects with somatic mosaicism associated with stable or improved counts in all PB cell lineages. (If T-lymphocyte chromosomal fragility analysis indicates potential mosaicism, a medically significant decrease (≥1 NCI CTCAE grade) in at least one blood lineage over time must be documented to enable eligibility, as should <5% resistance of bone marrow colony forming cells (CFCs) to 10nM MMC; whenever possible potential mosaicism should also be evaluated by gene sequencing of MMC-resistant CFCs). 4. Lansky performance status ≤60%. 5. Any concomitant disease or condition that, in the opinion of the Principal Investigator, renders the subject unfit to participate in the study. 6. Pre-existing sensory or motor impairment ≥grade 2 according to the criteria of the NCI. 7. Pregnant or breastfeeding women. 8. Hepatic dysfunction as defined by either: - Bilirubin >3.0 × the upper limit of normal (ULN) or - Alanine aminotransferase (ALT) > 5.0 × ULN or - Aspartate aminotransferase (AST) > 5.0 × ULN For subjects with bilirubin, ALT or AST above ULN, a workup to identify the etiology of liver abnormality should be conducted prior to confirmation of eligibility as stipulated in exclusion criterion 5, including evaluation of viral hepatitis, iron overload, drug injury or other causes. 9. Renal dysfunction requiring either hemodialysis or peritoneal dialysis. 10. Pulmonary dysfunction as defined by either: - Need for supplemental oxygen during the prior 2 weeks in absence of acute infection or - Oxygen saturation by pulse oximetry <90%. 11. Evidence of active metastatic or locoregionally advanced malignancy for which survival is anticipated to be less than 3 years. 12. Subject is receiving androgens (i.e. danazol, oxymetholone). 13. Subject is receiving other investigational therapy for treatment/prevention of FA-associated bone marrow failure. ; PRIMARY OUTCOME: Phenotypic correction of bone marrow colony forming units after infusion of RP-L102; SECONDARY OUTCOME 1: Phenotypic correction of T-lymphocytes in peripheral blood after infusion of RP-L102[/INST]No</s>

<s>[INST]<<SYS>>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 - CHEST-1; BRIEF: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). ; DRUG USED: Adempas; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery. Exclusion Criteria: - All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension. ; PRIMARY OUTCOME: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16; SECONDARY OUTCOME 1: Pulmonary Vascular Resistance (PVR) - Change From Baseline to 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 - CD-003; BRIEF: To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohns disease who are refractory to one or more standard Crohns disease therapies. ; DRUG USED: PDA-001; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Celularity Incorporated; CRITERIA: Inclusion Criteria: - • Males and females 18 - 75 years of age at the time of signing the informed consent document. - Minimum weight of subject is 40 kg at screening. - Subject must have inflammatory Crohns Disease (CD) diagnosed at least 6 months but no greater than 15 years prior to treatment with Investigational Product (IP). - Subject must have confirmation of ongoing CD by ileocolonoscopy at screening. - Subject must have a Crohns Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 as assessed between Visit 1 and Visit 2. Exclusion Criteria: - Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study including but not limited to - Liver Function Tests Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 2.5 x the upper limit of normal at screening. - Serum creatinine concentration > 2.0 mg/dl at screening. Alkaline phosphatase > 2.5 x the upper limit of normal at screening. - Bilirubin level > 2 mg/dL (unless subject has known Gilberts disease). - Pregnant or lactating females. - Morbidly obese subjects Body Mass Index (BMI) > 35 at screening). - Subject has untreated chronic infection including Clostridium difficile toxin positive at screening or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP (other than a treated urinary tract infection or drained perianal abscess). Note: Stable doses of antibiotics used to treat Crohns Disease are allowed. - Subject has organic heart disease (eg, congestive heart failure), clinically significant arrhythmia or clinically significant abnormal findings on Electrocardiograms (ECG). - Subject has a history of other malignancies within 5 years (except basal cell carcinoma of the skin that is surgically cured, remote history of cancer now considered cured or positive Pap smear with subsequent negative follow up). - Subject has had a stricture of the bowel requiring hospitalization within 182 days prior to treatment with IP. - Subject has had bowel surgery other than perianal (for example, fistulotomy, seton placement, or abscess drainage) or previous abscess drainage within 182 days prior to treatment with IP. - Subject has had any surgery within 28 days prior to treatment with IP. - Subject has a colostomy, ileostomy or ileal pouch anal anastomosis. - Subject has received an investigational agent -an agent or device not approved by FDA for marketed use in any indication-within 90 days (or 5 half-lives, whichever is longer) prior to treatment with investigational product. - Subject has received previous cell therapy. - Subject is expecting to have elective surgery at any time between Visit 1 (screening) and Visit 7 (end of induction phase). - Subject has concurrent diagnosis of ulcerative colitis. - Subjects with protein C or S deficiency. - Subjects with prior history of thrombophlebitis or other pathological arterial or venous thrombosis. ; PRIMARY OUTCOME: Adverse Events; SECONDARY OUTCOME 1: Clinical Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LUTS; BRIEF: The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH. ; DRUG USED: Udenafil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Benign Prostatic Hyperplasia (BPH); TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Monotherapy; LEAD SPONSOR: Warner Chilcott; CRITERIA: Inclusion Criteria: - History of LUTS for ≥6 months secondary to BPH - Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening Exclusion Criteria: - ; PRIMARY OUTCOME: Change from Baseline in Total IPSS (International Prostate Symptom Score); SECONDARY OUTCOME 1: Change from Baseline Total IPSS[/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 - w/Standard Induction Therapy; BRIEF: This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, 7+3) and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone. ; DRUG USED: DSTAT; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Chemokine (C-X-C motif) Ligand 12 (CXCL12)/Stromal Cell-Derived Factor 1 (SDF-1), Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Combination; LEAD SPONSOR: Chimerix; CRITERIA: Inclusion Criteria: Subjects had to meet all the following criteria to be eligible for enrollment in this study: 1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML). 2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: Subjects who met any of the following criteria were not eligible for enrollment in this study: 1. Had acute promyelocytic leukemia 2. Had prior chemotherapy for AML. 3. Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome. 4. Had central nervous system (CNS) leukemia. ; PRIMARY OUTCOME: Number of Subjects Who Achieved Morphologic Complete Remission; SECONDARY OUTCOME 1: Duration of Event-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/II - TIGER-X (US); BRIEF: Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation. ; DRUG USED: Rociletinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Clovis Oncology, Inc.; CRITERIA: Inclusion Criteria - All patients must meet the following inclusion criteria: 1. Metastatic or unresectable locally advanced NSCLC 2. Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion 3. Biopsy of either primary or metastatic tumor tissue within 60 days of dosing 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 5. Minimum age of 18 years 6. Adequate hematological and biological function 7. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation Phase 2 Cohorts must also meet the following inclusion criteria: - Disease progression confirmed by radiologic assessment while on treatment with EGFR- TKI Or - Disease progression confirmed by radiologic assessment while on treatment with the first single agent EGFR TKI and - Documented evidence of T790M mutation in EGFR following disease progression on the first single agent EGFR TKI. - Measureable disease according to RECIST Version 1.1 Exclusion Criteria - Any of the following criteria will exclude patients from study participation: 1. Documented evidence of an Exon 20 insertion activating mutation in the EGFR gene 2. Active second malignancy 3. Known pre-existing interstitial lung disease 4. Patients with Leptomeningeal carcinomatosis are excluded. Other CNS metastases are only permitted if treated, asymptomatic and stable (not requiring steroids for at least 4 weeks prior to start of study treatment). 5. Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib 6. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib 7. Prior treatment with rociletinib or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR 8. Certain cardiac abnormalities or history 9. Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib 10. Females who are pregnant or breastfeeding 11. Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib 12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study 13. Any other reason the investigator considers the patient should not participate in the study ; PRIMARY OUTCOME: Percentage of T790M Positive Patients With Confirmed Response Per Investigator; SECONDARY OUTCOME 1: Overall Survival (OS) Determined by Investigator Assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Critical Limb Ischemia; BRIEF: The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia. ; DRUG USED: Engensis; DRUG CLASS: Biologic; INDICATION: Peripheral Arterial Disease (PAD); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy; LEAD SPONSOR: Helixmith Co., Ltd.; CRITERIA: Inclusion Criteria: - Male or female, between 18 and 90 years of age; - Diagnosis of critical limb ischemia (Rutherford Class 4 or 5), including: - A resting ankle systolic pressure (in either the dorsalis pedis or posterior tibial arteries) of ≤ 70 mmHg in the affected limb; or - A resting toe systolic pressure of ≤ 50 mmHg in the affected limb; or - For patients in which measurement of ankle systolic pressure is not feasible (e.g. vessel calcification and non-compressibility); TcPO2 ≤ 30 mmHg; - Poor or suboptimal candidate for bypass graft surgery or percutaneous angioplasty; - Pain at rest, and/or ischemic ulcers, and/or focal gangrene (< 3 cm2) for a minimum of 2 weeks, - Significant stenosis (≥ 75%) of one or more of the following arteries: superficial femoral, popliteal, or two or more infra-popliteal arteries as verified by angiography within 12 months prior to enrollment; - Be willing to maintain current drug therapy for peripheral arterial disease throughout the course of the study including an anti-platelet and statin treatment unless not tolerated; - Clinically stable on optimized medical regimen for >30 days - Be capable of understanding and complying with the protocol and signing the informed consent document prior to being subjected to any study related procedures; - Women who are surgically sterile or at least 1 year postmenopausal or who have been practicing adequate contraception for at least 12 weeks prior to entering the study. If the subject is of child-bearing potential, she must have a negative urine pregnancy test result prior to study enrollment and must agree to repeat pregnancy screening tests during the study. If the subject or the subjects partner(s) is of child bearing potential, the subject and the subjects partner(s) must agree to use a double barrier method of birth control while participating in this study. Exclusion Criteria: - Subjects who have undergone a successful revascularization procedure or sympathectomy within 12 weeks prior to study entry. A clinically unsuccessful revascularization procedure is defined as one in which: - the target vessel re-occludes (≥50%, as verified by a second angiogram. Duplex ultrasonography can be used to determine vessel patency if the patient cannot tolerate a second angiogram), or - the target vessel remains patent, but there is no resolution of symptoms 6 weeks after the procedure (e.g. no evidence of ulcer healing, no improvement in pressures, no reduction in resting pain); - Subjects that will require an amputation in the target leg within 4 weeks of randomization; - Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon in the extremity planned for treatment; - Heart Failure with a NYHA classification of III or IV; - Stroke (NIH scale >2) or myocardial infarction within last 3 months; - Unstable angina - Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) > 200 mmHg or diastolic BP (DBP) > 110 mmHg at baseline/screening evaluation; - Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination; - Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buergers disease); - Subjects with advanced liver disease including decompensated cirrhosis, jaundice, ascites or bleeding varices; - Subjects currently receiving immunosuppressive medications chemotherapy, or radiation therapy; - Positive HIV or HTLV at screening; - Active Hepatitis B or C infection as determined by Hepatitis B surface antibody (HBsAb), Hepatitis B core antibody (IgG and IgM; HBcAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV), at Screening; - Specific laboratory values at Screening including: Hemoglobin < 8.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, AST and/or ALT > 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary; - Patients with a recent history (< 5 years) of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings; - Elevated PSA unless prostate cancer has been excluded; - Subjects with any co- morbid conditions likely to interfere with assessment of safety or efficacy or with an estimated life expectancy of less than 6 months - Subjects requiring > 81 mg daily of acetylsalicylic acid; If > 81 mg are taken at screening, subjects may be enrolled if willing/able to switch to another medication; - Subjects requiring regular COX-2 inhibitor drug(s) or high dose steroids (excepting inhaled steroids); - Major psychiatric disorder in past 6 months; - History of drug or alcohol abuse / dependence in the past 2 years; - Use of an investigational drug or treatment in past 12 months; concurrent participation in investigational protocol or unapproved therapeutics and - Unable or unwilling to give informed consent. ; PRIMARY OUTCOME: The primary study endpoint is to assess the safety of IM administration of VM202 in subjects with moderate or high-risk CLI; SECONDARY OUTCOME 1: Change in tissue oxygenation (TcPO2) from baseline to 9 months and 12 months following the first 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 IIb - IFN-Free w/BMS-650032/BMS-791325; BRIEF: The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin ; 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: Inclusion Criteria: - Men and women, ages ≥18 years of age - Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment - Subjects should have chronic hepatitis C (CHC) as documented by: 1. Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or 2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis) - HCV genotype 1a, 1b or 4 only - HCV RNA viral load of ≥10,000 IU/mL at screening - Have one of the following: 1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR 2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR 3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis - Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive - Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening Exclusion Criteria: - Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures) - History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis - 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 enrollment - Documented or suspected hepatocellular carcinoma (HCC) - Positive for hepatitis B surface antigen (HBsAg) - Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies - Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN) - Total Bilirubin ≥2 mg/dL ; PRIMARY OUTCOME: Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12); SECONDARY OUTCOME 1: Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)[/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 - Pre-Treated Stage Ib-IVa; BRIEF: The purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria. ; DRUG USED: Quisinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cutaneous T-Cell Lymphoma (CTCL) - NHL; TARGET: Histone Deacetylase (HDAC); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Histopathologically confirmed cutaneous T-cell lymphoma (CTCL), either mycosis fungoides or sezary syndrome Stage Ib-IVa - Relapsed or refractory (unresponsive) disease following at least 1 prior systemic therapy for CTCL, except psoralen and long-wave ultraviolet radiation (it is considered skin-directed therapy and not systemic therapy) - Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 28 days - Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) 1 cm or greater than 1 cm in the longest diameter laboratory function tests and bone marrow test - Agrees to protocol defined use of effective contraception - Adequate laboratory function tests and bone marrow test Exclusion Criteria: - Prior histone-deacetylase inhibitor therapy for CTCL - Concurrent systemic corticosteroid dose greater than 10 mg per day of prednisone or equivalent (stable use of 10 mg or less than 10 mg per day of prednisone for 1 month or more before study entry is allowed) - Major surgery or radiotherapy within 3 weeks before the start of the study medication - Unstable angina or heart attack within the preceding 12 months, congestive heart failure New York Heart Association Class II-IV, known presence of dilated, hypertrophic, or restrictive cardiomyopathy - Inadequate gastrointestinal absorption status - Use of potent inhibitors of CYP3A4/A5 - Positive human immunodeficiency virus ; PRIMARY OUTCOME: Number of participants who will achieve overall cutaneous Response Rate (RR) based on modified Severity Weighted Assessment Tool (mSWAT) criteria; SECONDARY OUTCOME 1: Number of participants who will achieve global Response Rate (RR) based on based on consensus global response score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - STAYCIS (NIAID Sponsored); BRIEF: Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients. Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance. ; DRUG USED: Lipitor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: HMG CoA Reductase (HMGR); THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Allergy and Infectious Diseases (NIAID); CRITERIA: Inclusion Criteria: - Clinically isolated syndrome (CIS) as defined by an acute or subacute well-defined neurological event lasting at least 48 hours and consistent with MS (i.e., optic neuritis, spinal cord syndrome, brainstem/cerebellar syndromes). Other causes for optic neuritis other than CIS must be ruled out by an ophthalmologist. Patients with other clinically silent abnormal findings found upon neurological examination that are not attributable to the presenting symptom are not excluded. - Onset of CIS symptoms occurring within 90 days of randomization - Abnormal, unenhanced brain MRI with 2 or more clinically silent T2 lesions greater than or equal to 3 mm in diameter, at least one of which is periventricular in location or ovoid in shape - Willing to use acceptable methods of contraception - Have received 3 to 5 days of corticosteroid therapy within 60 days of CIS onset Exclusion Criteria: - Definite diagnosis of MS according to McDonald criteria - Previous history of neurological symptoms lasting more than 48 hours. Patients with a history of neurological symptoms lasting less than 48 hours will not be excluded. - Prior use of interferon, glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis anytime prior to study entry - Use of interferon preparations (unless as specified by the protocol), glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis during the study - Use of cyclosporine, fibric acid derivatives, niacin, erythromycin, or azole antifungal during the study - Received more than 5 g of methylprednisolone (or the equivalent of other IV corticosteroid) prior to study screening - Use of a cholesterol-lowering agent during the 3 months prior to study screening or need for such agents during the study - Previous history of severe side effects with statin therapy - Prior exposure to total lymphoid irradiation - History of substance abuse in the 12 months prior to study screening - History of systemic illness or medical condition that would limit the likelihood of completing the MRI procedures or would interfere with the measurement of a therapeutic effect - Implanted pacemakers, cochlear implants, defibrillators, or metallic objects on or inside the body - Uncontrolled hypertension, asthma, known malignancy other than skin cancer, symptomatic cardiac disease, epilepsy, insulin-dependent diabetes, or symptoms that can only be explained by systemic lupus erythematosus (SLE) or other autoimmune diseases - Active liver disease - Major medical illnesses or psychiatric impairment that in the investigators opinion could interfere with the study - History of severe depression or suicidal ideation within 1 year of study entry - Pregnancy or breastfeeding ; PRIMARY OUTCOME: The Occurrence of ≥ 3 New T2 Lesions With or Without Gd+ Enhancement or Clinical Exacerbation Through 12 Months.; SECONDARY OUTCOME 1: Proportion of Participants Who Are Diagnosed With Multiple Sclerosis According to the McDonald Criteria[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia/Ib - AB-836-001; BRIEF: This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects. ; DRUG USED: AB-836; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Hepatitis B/HBV; THERAPY: Monotherapy; LEAD SPONSOR: Arbutus Biopharma Corporation; CRITERIA: Inclusion Criteria: - Healthy Subjects 1. Male and Female (not of childbearing potential in Part 1 and 2a) subjects between 18 and 45 years old 2. Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results. 3. BMI of 18-32 kg/m2. - CHB Subjects: 1. Male or female between 18 and 65 years old. 2. Chronic HBV infection documented as a positive HBsAg, HBV DNA, or HBeAg test at least 6 months prior to the Screening Visit, or a historical liver biopsy consistent with chronic HBV infection 3. For cohort F, G, H: 1. HBV DNA ≥2,000 IU/mL at Screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment). 2. ALT ≤ 5x ULN 4. For Cohort I: 1. HBV DNA <LLOQ at Screening 2. Subjects must have been receiving either TAF, TDF, or ETV consistently for ≥6 months prior to Day 1 and are willing to continue with the same NA treatment through the final study visit. 3. ALT ≤ 2.5 x ULN 5. HbsAg ≥250 IU/mL at screening Exclusion Criteria: - CHB Subjects 1. Advanced fibrosis, cirrhosis or other signs of advanced liver disease as assessed by clinical history, ultrasound or FibroScan, or history of cirrhosis or any clinically significant medical condition associated with chronic liver disease. 2. Co-infection with HIV or other non-B hepatitis viruses. 3. Any clinically significant or unstable medical condition or illness that could confound study findings. 4. Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are pregnant or breastfeeding. 5. Previous treatment with a capsid inhibitor, core inhibitor, or core protein assembly modifier [CpAM or CAM]) within 6 months of the Day 1 visit, or prior treatment with an HBV-targeted siRNA or antisense oligonucleotide compound at any time. ; PRIMARY OUTCOME: Incidence of 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 IIIb - CERTAIN; BRIEF: To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years Exclusion Criteria: - All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient - Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial - Patients must not have received any previous biological therapy for rheumatoid arthritis (RA) ; PRIMARY OUTCOME: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24; SECONDARY OUTCOME 1: 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - NOMID (NAIMS); BRIEF: This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological, cutaneous and arthropathy (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, eye problems, and learning difficulties. Immune suppressing medicines commonly used to treat other pediatric rheumatologic diseases do not suppress NOMID symptoms and, if used long-term and in high doses, can cause harmful side effects. Anakinra, approved by The Food and Drug Administration for treating rheumatoid arthritis in adults, blocks a substance called IL-1 that may be an important factor in causing the inflammation in NOMID. ; DRUG USED: Kineret; DRUG CLASS: Biologic; INDICATION: Cryopyrin (CIAS1)-Associated Periodic Syndromes (CAPS); TARGET: IL-1 Receptor (IL-1R); THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); CRITERIA: -INCLUSION CRITERIA: 1. There is no age limitation. 2. Patients fulfill at least 2 of the following 3 clinical manifestations: - Typical NOMID rash - CNS involvement (papilledema, CSF pleocytosis, sensorineural hearing loss) - Typical arthropathic changes on radiograph (epiphyseal and/or patellar overgrowth. 3. Onset of manifestations of NOMID/CINCA at less than or equal to 6 months of age. 4. Stable dose of steroids, NSAIDs, DMARDs for 4 weeks prior to enrollment visit. 5. Washout period for biologics: 6 half-lives before anakinra administration for all drugs with anti TNF properties. For etanercept (6 half-lives=24 days) this calculates to drug discontinuation 3 days before enrollment into the observation period, for infliximab and adalimumab (6 half-lives=48 days) drug will be discontinued 27 before the observation period, and for thalidomide (6 half-lives=3 days) drug will be discontinued for 3 days prior to anakinra administration. 6. Patients or legal guardians ability and willingness to give informed consent. 7. Females of childbearing potential (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication. Women of childbearing age and men able to father a child, who are sexually active, will be asked to use a form of effective birth control, including abstinence. 8. Negative PPD test using 5 T.U. intradermal testing per CDC guidelines with exception of inclusion criteria #9 below. 9. Patients with latent TB (positive PPD test) must have adequate therapy for TB initiated prior to first dose of study medication as recommended in published guidelines. EXCLUSION CRITERIA: 1. Having received live virus vaccine during 3 months prior to baseline visit (1st visit to NIH). 2. Patients with active infections or a history of pulmonary TB infection with or without documented adequate therapy, Patients with current active TB, or recent close exposure to an individual with active TB are excluded from the study. 3. Positive testing for HIV, Hepatitis B or C known or documented at screening, enrollment or baseline visit. 4. Have a history of or concomitant diagnosis of congestive heart failure. 5. History of malignancy. 6. Recent use of IL-1 antagonist within the last three months or prior use of anti CD4 antibody. 7. Known hypersensitivity to E. coli derived products or any components of anakinra. 8. Presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, SLE in addition to NOMID/CINCA). 9. Presence of the following at enrollment visit: ALT or AST greater than 2.0 x upper limit of normal (ULN) of the local laboratories values, creatinine greater than 1.5 xULN, WBC less than 3.6x10(9)/l; platelet count less than 150,000 mm(3). 10. Enrollment in any other investigational clinical study or receiving an investigational agent, or has not yet completed at least 4 weeks since ending another investigational device or drug trial. 11. Subjects for whom there is concern about compliance with the protocol procedures by subject and/or parent/s and legally acceptable representative/s. 12. Lactating females or pregnant females. 13. Patients with asthma will only be included after evaluation by a pulmonary and infectious disease consultation. ; PRIMARY OUTCOME: Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches); 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 - SWOG-S0910; BRIEF: RATIONALE: Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving epratuzumab together with cytarabine and clofarabine may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab together with cytarabine and clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia. ; DRUG USED: Epratuzumab; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Cluster of Differentiation 22 (CD22); THERAPY: Combination; LEAD SPONSOR: SWOG Cancer Research Network; CRITERIA: DISEASE CHARACTERISTICS: - Morphologically confirmed precursor B-cell acute lymphoblastic leukemia (ALL) (non T-cell) - Must have evidence of disease in bone marrow or peripheral blood - Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T cell, or mixed B/T cell) - Must have ≥ 5% lymphoblasts present in the blood or bone marrow - At least 20% of marrow and/or peripheral blood lymphoblasts must be CD22+ by flow cytometry - Co-expression of myeloid antigens (CD13 and CD33) allowed - Patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible - Philadelphia (Ph) chromosome-negative disease - Patients with unknown Ph status by cytogenetics or FISH and unknown BCR/ABL status by PCR are eligible for study registration, but must be removed from study therapy if found to be Ph+ or BCR/ABL+ after study registration - Refractory to a standard induction regimen that included vincristine and prednisone or high-dose cytarabine or mitoxantrone OR relapsed after successful prior induction therapy - Any number of prior induction therapies or any number of remissions achieved are allowed - No M0 acute myeloid leukemia, mixed lineage leukemia, or L3 (Burkitt) leukemia - No active CNS involvement by clinical evaluation - Patients with a documented history of CNS involvement of ALL or with clinical signs or symptoms consistent with CNS involvement of ALL must undergo a lumbar puncture that is negative for CNS involvement of ALL - Patients < 22 years of age must be willing to receive prophylactic intrathecal chemotherapy - Must be registered on SWOG-9007 Cytogenetic Studies in Leukemia Patients (closed as of 07/01/2010) PATIENT CHARACTERISTICS: - Zubrod performance status 0-2 - Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 60 mL/min - AST and ALT ≤ 2.5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 times ULN - Bilirubin ≤ 1.5 times ULN - Not pregnant or nursing - Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment - HIV-positive patients are eligible (at the discretion of the investigator) provided the following criteria are met: - No history of AIDS-defining conditions - CD4 cell count > 350/mm³ - If on antiretroviral agents, must not include zidovudine or stavudine - Willing to receive prophylaxis for pneumocystis jirovecii pneumonia during study therapy (regardless of CD4 cell count) until the CD4 cell count is > 200/mm³ after completion of study treatment - Prior malignancy (other than ALL) allowed provided it is in remission and there are no plans to treat the malignancy at the time of study registration - No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs or symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment - No neuropathy (cranial, motor or sensory) ≥ grade 2 PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Any number of prior therapies allowed - More than 90 days since prior allogeneic bone marrow transplant (BMT) - No concurrent immunosuppression therapy for the treatment of graft-vs-host disease (GVHD) - No acute GVHD ≥ grade 2, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity - Prior autologous BMT allowed - No concurrent immunosuppression therapy for the treatment of GVHD - More than 14 days since prior chemotherapy, investigational agents, or major surgery and recovered - Maintenance therapy with steroids, vincristine, and/or anti-metabolite agents, including but not limited to, mercaptopurine, thioguanine, and methotrexate allowed - Concurrent hydroxyurea to reduce WBC to a reasonable level (as deemed by the treating physician) allowed - No prior clofarabine or epratuzumab - No other concurrent cytotoxic therapy or investigational therapy - No concurrent alternative medications (e.g., herbal or botanical medications for anticancer purposes) - Concurrent participation on SWOG-S9910 Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary allowed (closed as of 07/01/2010) ; PRIMARY OUTCOME: Complete Remission; SECONDARY OUTCOME 1: Number of Patients With Grade 3 Through 5 Treatment-Related 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 IIb - Kinect Study; BRIEF: The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms. ; DRUG USED: Ingrezza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tardive Dyskinesia; TARGET: Vesicular monamine transporters (VMATs); THERAPY: Monotherapy; LEAD SPONSOR: Neurocrine Biosciences; CRITERIA: Inclusion Criteria: - Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening. - Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status. - Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study. - Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. - Female subjects must not be pregnant. - Be in good general health and expected to complete the clinical study as designed. - Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive). - Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine. - Have a negative alcohol breath test at screening and study start. Exclusion Criteria: - Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening. - Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary). - Have a known history of neuroleptic malignant syndrome. - Have a significant risk of suicidal or violent behavior. - Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine. - Receiving medication for the treatment of tardive dyskinesia. - Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result. - Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study. - Have an allergy, hypersensitivity, or intolerance to tetrabenazine. - Have had previous exposure with NBI-98854. ; PRIMARY OUTCOME: Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6; SECONDARY OUTCOME 1: Clinical Global Impression - Global Improvement of TD (CGI-TD)[/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 - Long-Term Study; BRIEF: This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste). ; DRUG USED: Plumiaz; DRUG CLASS: Non-NME; INDICATION: Seizure Disorders (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Acorda Therapeutics; CRITERIA: Inclusion Criteria: - Diagnosis of drug-resistant epilepsy - Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED) - Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit - A caregiver must consent to participate together with the subject for purposes of observation and data collection - The caregiver must be present when the investigational product is administered - Screening body weight between 26 to 111 kg, inclusive Exclusion Criteria: - Female subject who is pregnant, breastfeeding, or planning to become pregnant - Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam - Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components - Positive screening test for ethanol or other drugs of abuse - Unable to receive medications intranasally ; PRIMARY OUTCOME: Olfactory Changes as Measured by the Smell Identification Test (SIT); 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 - Healthy Volunteers (US); BRIEF: The primary objective of this study is to evaluate the effect of filgotinib on a mixed organic anion transporting polypeptide/cytochrome P450 3A (OATP/CYP3A), OATP/ breast cancer resistance protein (BCRP), and OATP substrates using phenotypic probes. ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug. - Have a calculated body mass index (BMI) of greater than or equal to (≥) 19.0 and less than or equal to (≤) 30.0 kilogram per meter square (kg/m^2) at screening. - Have a creatinine clearance (CLcr) ≥ 90 milliliters per minute (mL/min) (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening and upon admission. - Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at clinic admission. - Male participants must be surgically sterile. - Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. - Screening laboratory evaluations and 12-lead electrocardiogram (ECG) evaluations must be without clinically significant abnormalities as assessed by the investigator. - Have liver biometric tests such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin below the upper limit of normal at screening. - Must be willing and able to comply with all study requirements. - Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs. - Participants must not have donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug. Key Exclusion Criteria: - Positive serum pregnancy test (Female participants). - Lactating female. - Have received any investigational drug/device within 30 days prior to study dosing (or within 5 half-lives of the drug, whichever is longer). - Have current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance or participant safety, or a positive drug or alcohol test at screening or admission. - Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening. - Have positive Coronavirus Disease 2019 (COVID-19) Real-Time Reverse. - Transcriptase-Polymerase Chain Reaction (RT-PCR) testing on screening and admission. - Have poor venous access that limits phlebotomy. Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS; SECONDARY OUTCOME 1: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TNBC; BRIEF: This study is designed to evaluate the preliminary anti-tumor activity and tolerability of PF-03084014 when administered as a single agent in the treatment of patients with advanced triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for genomic alterations in Notch receptors (NA-) ; DRUG USED: Nirogacestat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Gamma-secretase; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Histological or cytological diagnosis of triple negative breast cancer (TNBC) with evidence of a) metastatic or b) locally recurrent advanced disease that is not amenable to resection or radiotherapy with curative intent. - Availability of an original diagnostic tumor tissue or the most recent metastatic tumor biopsies (archival biopsy or de novo biopsy) and a peripheral blood sample for Notch receptors genomic profiling Exclusion Criteria: - Known brain metastases. - Prior treatment with gamma secretase inhibitor or other Notch signaling inhibitor. ; PRIMARY OUTCOME: Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+); SECONDARY OUTCOME 1: OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)[/INST]No</s>

<s>[INST]<<SYS>>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 - 20100761 - Dose Effect; BRIEF: This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. ; DRUG USED: ARRY-403; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Hexokinase/Glucokinase; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Age 18 to 75 years, inclusive - Diagnosis of type 2 diabetes mellitus - HbA1c levels 7.5% to 11.0%, inclusive, at screening - Fasting C-peptide levels ≥ 0.2 nmol/L at screening - BMI ≥ 25 to < 45 kg/m2 at screening - Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization - If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization - Subject has provided informed consent. Exclusion Criteria: - History of type 1 diabetes - History of significant weight gain or loss (> 10%) during the 4 weeks before randomization - Use of any weight loss medication (over the counter or prescription) within 60 days of randomization - Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization - Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization - Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months - Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness - Evidence of active infections that can interfere with the study - Presence of clinically significant organ system disease that is not stabilized or may interfere with the study - Currently receiving immunosuppressive therapy - History of positive HIV, chronic hepatitis B or C, or cirrhosis - Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening. - History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption - Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation - Poorly controlled hypertension defined as diastolic pressure > 100 mm Hg or systolic pressure > 160 mm Hg (assessed on two separate occasions during the screening period) - Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease-free state since treatment) - Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization ; PRIMARY OUTCOME: To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin; SECONDARY OUTCOME 1: To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test[/INST]No</s>

<s>[INST]<<SYS>>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 - Arteriovenous Graft Surgery; BRIEF: A study to evaluate the efficacy of SRM003 treatment versus participating sites standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease. It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury. ; DRUG USED: SHP613; DRUG CLASS: Biologic; INDICATION: End-Stage Renal Disease (ESRD); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: 1. Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female. 2. Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization. 3. Subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent prosthetic expanded polytetrafluoroethylene AVG placed in the upper extremity. 4. Subject must have a life expectancy of at least 78 weeks after randomization. 5. Subject must be able to understand and be willing to complete all study requirements. Exclusion Criteria: 1. Subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 78 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 78 weeks and is unwilling to change transplant list status to hold for 3 months after randomization. 2. Subject has had more than 3 access placement surgeries (defined as a new access, not a revision) in the target limb. 3. Subject has medical conditions and diseases that may cause non-compliance with the protocol 4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products. 5. Subject has a history of intravenous drug use within 6 months prior to screening 6. Subject is morbidly obese, defined as having a body mass index >40. 7. Pregnant or nursing woman, or plans to become pregnant during the study. ; PRIMARY OUTCOME: Percentage of Participants With Loss of Unassisted Primary Patency; SECONDARY OUTCOME 1: Percentage of Participants With Loss of Assisted Primary Patency[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SIRROUND-H; BRIEF: The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening - Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline - Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate - Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent - C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening Exclusion Criteria: - Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept - Has ever used tofacitinib therapy or any other JAK inhibitor - Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration - Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable ; PRIMARY OUTCOME: Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - B-cell Lymphomas (w/Revlimid); BRIEF: The purpose of this study is to determine whether ublituximab in combination with lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies who have relapsed or are refractory after CD20 directed antibody therapy. ; DRUG USED: Ublituximab; DRUG CLASS: Biologic; INDICATION: Marginal Zone Lymphoma - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: TG Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Relapsed or refractory B-cell non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) - Participants must have received at least one prior line of therapy with an anti-CD20 antibody (i.e. rituximab, ofatumumab, etc.) or an anti-CD20 antibody containing regimen - Measurable or evaluable Disease - Eastern Cooperative Oncology Group performance status 0, 1 or 2 - Participants ineligible for high dose or combination chemotherapy + stem cell transplant - No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology - All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® Exclusion Criteria: - Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry - Prior autologous or allogeneic stem cell transplantation within 6 months of study entry - History of severe hypersensitivity or anaphylaxis to prior murine or mouse/human chimeric antibodies, or to any component of ublituximab, or with prior lenalidomide or thalidomide - Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements - History of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to Day 1 of Cycle 1 - Pregnant women ; PRIMARY OUTCOME: Maximum Tolerated Dose acceptable for participants; SECONDARY OUTCOME 1: Efficacy[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AcSé; BRIEF: This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of nivolumab monotherapy in 6 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: UNICANCER; CRITERIA: Inclusion Criteria: 1. Patient information sheet and written informed consent form signed. 2. Histologically confirmed diagnosis of a pathology corresponding to one of the following selected cancer types: - Non-clear cell renal-cell carcinomas: papillary renal cell carcinoma (pRCC, type I, type II and non-classified pRCC), chromophobe RCC (ChRCC), renal medullary carcinoma (RMC), collecting duct/Bellini duct carcinoma (CDC), microphthalmia-associated transcription (MiT) family translocation renal cell carcinoma (tRCC), renal cell carcinoma with a prominent sarcomatoid component (sarcRCC).From the 51st patient included in this cohort, only the following histological type will be selected: collecting duct/Bellini duct carcinoma (CDC). - Rare head and neck cancers: principal and accessory salivary gland tumours, facial tissue tumours. - Rare skin cancers: adnexal carcinomas, basal cell carcinoma resistant to vismodegib.From the 51st patient included in this cohort, only the following histological type will be selected: Basal Cell carcinoma. - Non-colorectal cancers with microsatellite instability determined locally by immunohistochemistry or polymerase chain-reaction (PCR) - Squamous cell carcinoma of penis. - Any non MSI-high cancer with POLE exonucleasic domain mutation (somatic or germline) in hotspots (codons 286, 411, 424 and 459) or other germline or somatic variants with high probability of pathogenesis according to in silico assessment by the INCa ad hoc biology group. 3. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator. 4. Aged ≥18 years old. 5. Measurable disease according to RECIST v1.1 guidelines for solid tumours. 6. Able to provide a formalin fixed/paraffin embedded (FFPE) biopsy sample of a metastatic site or primitive tumour tissue. Note: Patients for whom suitable archived biopsy material is not available must be willing to undergo a biopsy of a tumour lesion prior to study entry, unless this is medically contraindicated (e.g. site inaccessible or patient safety concerns). 7. Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments. 8. Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to NCI-CTCAE criteria, v 4.0) with the exception of Grade 2 alopecia. 9. Adequate hematologic function (absolute neutrophil count (ANC) ≥1.0 x10⁹/L, platelets ≥100 x10⁹/L, haemoglobin (Hb) ≥9 g/L) measured within 14 days of treatment initiation. 10. Adequate renal function (creatinine clearance ≥50 mL/min using the glomerular filtration rate (MDRD) or CKI EPI method) measured within 14 days of treatment initiation. 11. Adequate hepatic function (serum bilirubin ≤1.5 x the reference upper limit of normal (ULN) unless due to Gilberts syndrome; aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 x ULN) measured within 14 days of treatment initiation. For patients with documented liver metastasis ASAT/ALAT ≤5 x ULN is acceptable. 12. Strictly normal blood levels of calcium and magnesium, measured within 14 days of treatment initiation. 13. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤1. 14. Estimated life expectancy ≥90 days. 15. Patients who are sexually active must agree to use a medically accepted method of contraception (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner, for participating women; condoms for participating men) or practice complete abstinence, beginning 14 days before the first administration of investigational product (IP), while on treatment and for at least 5 months after the last administration of IP for female patients, and 7 months after the last administration of IP for male patients. 16. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to the first administration of IP. If urine test results are positive or cannot be confirmed as negative, a serum pregnancy test will be required. 17. Women who are breastfeeding should discontinue nursing prior to the first administration of IP and for at least 90 days after the last administration of IP. 18. Patients must be affiliated to a Social Security System or equivalent. Exclusion Criteria: 1. Prior treatment with an anti-PD1 or anti-PD-L1 antibody 2. Eligible, and willing, to participate in a clinical trial of an alternative anticancer therapy targeting their disease which is open to accrual in France. 3. Concurrent steroid medication at a dose greater than prednisone 10 mg/day or equivalent. 4. Has 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 5. History of (non-infectious) pneumonitis that required steroids, or current pneumonitis. 6. History of severe hypersensitivity reaction to any monoclonal antibody therapy 7. Radiotherapy (except for brain and extremities) within 21 days prior to the first administration of IP. 8. Treatment with other investigational drugs or participation in another clinical trial within 21 days prior to the first administration of IP or concomitantly with the trial. 9. Has known symptomatic central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. 10. Has known carcinomatous meningitis or a history of leptomeningeal disease. 11. Serum creatinine >1.5 x ULN or glomerular filtration rate (GFR) <50 mL/min. 12. Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix. 13. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy. 14. Active or chronic hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies), or a known history of active Tuberculosis bacillus. 15. Has received a live vaccine within 30 days of planned start of study treatment. Note: Seasonal influenza vaccines for injection are generally inactivated vaccines and are allowed. 16. Active alcohol or drug abuse. 17. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule. 18. Any condition which in the Investigators opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol. ; PRIMARY OUTCOME: Objective response rate; SECONDARY OUTCOME 1: Progression-free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PK/PD Study; BRIEF: The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia. ; DRUG USED: Sutimlimab; DRUG CLASS: Biologic; INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Bioverativ, a Sanofi company; CRITERIA: Inclusion Criteria Part A: - Chronic immune thrombocytopenia (ITP) (ITP lasting for greater than or equal to ([>=] 12 months) as defined in the protocol - Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) - No history of a coagulation disorder - Hemoglobin level greater than (>) 10 gram per deciliter (g/dL) (following blood transfusion is acceptable) and normal white blood cell (WBC) and neutrophil counts (elevated WBC/absolute neutrophil count [ANC] attributed to steroid treatment is acceptable) - Eastern Cooperative Oncology Group (ECOG) performance status grade less than or equal to (<=) 2 - Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitis, including serogroup B meningococcus [where available], Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years of enrollment - Adequate intravenous (IV) access Part B: - Able to comprehend and to give informed consent for Part B - History of ITP and previously treated with at least 1 dose of BIVV009 in Part A - Evidence of treatment efficacy to BIVV009 as defined by a platelet count > 30*10^9/L on at least 1 occasion OR a doubling of the platelet count from baseline - Participants who have completed the 21-week Part A treatment period but have not reached the Part A End of Study (EOS) visit must have evidence of ongoing or recurrent thrombocytopenia during the Part A safety follow-up/washout period as demonstrated by a platelet count less than (<) 50*10^9/L or a >= 50 percent (%) decrease in platelet count over < 1 week Exclusion Criteria: Part A: - Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his/her participation in this study - Clinically relevant infection of any kind within the preceding month of enrollment - History of venous or arterial thrombosis within the preceding year of enrollment - Use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants within 1 week of enrollment - Clinical diagnosis of systemic lupus erythematosus (SLE) or other active autoimmune disorders associated with anti-nuclear antibodies (ANAs) including those that are medically controlled, at Screening (other than ITP) - Secondary immune thrombocytopenia from any cause including lymphoma, chronic lymphocytic leukemia, and drug-induced thrombocytopenia - Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening - Positive human immunodeficiency virus (HIV) test result prior to or at Screening Part B: - Presence of unacceptable side effects or toxicity associated with BIVV009 (including prior hypersensitivity reactions to BIVV009) such that there is an unfavorable risk-benefit assessment for continued treatment with BIVV009 in the opinion of the Investigator and/or Sponsor - For participants who have completed the 9-week safety follow-up/washout period and final study visit before entry into Part B, a positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening. Patients who have undergone hepatitis C antiviral therapy may be allowed if they are documented to be negative for hepatitis C virus ribonucleic acid (RNA) on at least 2 occasions separated by at least 3 months (including 1 RNA test at least 6 months after completion of antiviral therapy) and are also negative for hepatitis C virus RNA at Screening - Use of prescribed or over-the-counter medications, supplements, vitamins, and/or herbal remedies within 2 weeks before the first dose of BIVV009 in Part B, which in the judgment of the Investigator may adversely affect the participants welfare or the integrity of the study results (excluding hormonal contraception in female participants) - If previously treated with rituximab, the last dose of rituximab was administered < 12 weeks before the first dose of BIVV009 in Part B - Clinical diagnosis of systemic lupus erythematosus (SLE) or other active autoimmune disorders associated with anti-nuclear antibodies (ANA), including those that are medically controlled, at Screening (other than ITP). Positive ANAs at screening that are not associated with an autoimmune disorder (other than ITP) may be allowed if present for >= 28 days without associated clinically relevant symptoms ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events; SECONDARY OUTCOME 1: Part A: Change From Baseline in Peripheral Blood Platelet Count at Part A End of Treatment (A-EOT)[/INST]No</s>

<s>[INST]<<SYS>>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 - MABc Study (US); BRIEF: The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc) ; DRUG USED: Nuzyra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Tract Infections (Excluding Pneumonia) (Antibacterial); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Paratek Pharmaceuticals Inc; CRITERIA: Key Inclusion Criteria: - Has a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc - Has at least 2 of the following NTM-infection symptoms present at Screening and Baseline: chronic cough, coughing up blood (hemoptysis), wheezing, chest pain, frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue, fever, night sweats, poor appetite, and/or weight loss. - At least 1 positive pulmonary (sputum) culture for MABc in the 6 months prior to Screening and 1 positive culture at Screening - Radiographic evidence of MABc infection via computed tomography (CT) scan of the chest within 3 months prior to Screening - In the opinion of the investigator, guideline-directed antibiotic therapy for treatment of MABc will not be required within the next 3 months, and a delay, in order for the subject to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable - Additional inclusion criteria as per protocol Key Exclusion Criteria: - Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC - Has received systemic or inhaled antibiotic therapy (other than chronic macrolide therapy) within 4 weeks prior to Screening - Has any of the following medical conditions: - Active pulmonary malignancy, or any type of malignancy requiring chemotherapy or radiation within 1 year prior to Screening - Active allergic bronchopulmonary mycosis, or any other condition requiring chronic treatment with systemic corticosteroids within 90 days prior to Screening - Radiologic evidence of cavitary disease - Known active pulmonary tuberculosis - Cystic fibrosis - History of lung transplantation - Another advanced lung disease with a known percent predicted forced expiratory volume in 1 second < 30%. - Disseminated or extra-pulmonary NTM disease - Has been previously treated with omadacycline - Has a history of hypersensitivity or allergic reaction to tetracyclines - Additional exclusion criteria as per protocol ; PRIMARY OUTCOME: Clinical Response on NTM Symptom Assessment Scale at Day 84; SECONDARY OUTCOME 1: Change from baseline in the total score of the Quality of Life - Bronchiectasis (QOL-B) questionnaire[/INST]No</s>

<s>[INST]<<SYS>>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 - CL304 (Osteomalacia); BRIEF: The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV). ; DRUG USED: Crysvita; DRUG CLASS: Biologic; INDICATION: X-Linked Hypophosphatemia (XLH); TARGET: Fibroblast Growth Factor (FGF); THERAPY: Monotherapy; LEAD SPONSOR: Kyowa Kirin, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female, aged 18 - 65 years, inclusive 2. Diagnosis of XLH supported by classic clinical features of adult XLH (such as short stature or bowed legs), and at least one of the following at Screening: - Documented phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX) PHEX mutation in either the patient or in a directly related family member with appropriate X-linked inheritance - Serum intact FGF23 (iFGF23) level > 30 pg/mL by Kainos assay 3. Biochemical findings consistent with XLH based on overnight fasting (min. 8 hours): - Serum phosphorus < 2.5 mg/dL at Screening - Ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate (TmP/GFR) < 2.5 mg/dL at Screening 4. Presence of skeletal pain attributed to XLH/osteomalacia, as defined by a score of ≥ 4 on the Brief Pain Inventory question 3 (BPI-Q3, Worst Pain) at Screening. (Skeletal pain that, in the opinion of the investigator, is attributed solely to causes other than XLH/osteomalacia-for example, back pain or joint pain in the presence of severe osteoarthritis by radiograph in that anatomical location-in the absence of any skeletal pain likely attributed to XLH/osteomalacia should not be considered for eligibility) 5. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) or estimated glomerular filtration rate (eGFR) eGFR of 45 to <60 mL/min at Screening with confirmation that the renal insufficiency is not due to nephrocalcinosis 6. Provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures. If the subject in a minor, provide written assent and have a legally authorized representative willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any research-related procedures 7. Willing to provide access to prior medical records for the collection of biochemical and radiographic data and disease history 8. Females of child-bearing potential must have a negative urine pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not to be of childbearing potential include those who have been in menopause for at least two years prior to Screening, or have had tubal ligation at least one year prior to Screening, or have had a total hysterectomy or bilateral salpingo-oophorectomy. 9. Participants of child-bearing potential or with partners of child-bearing potential who have not undergone a total hysterectomy or a bilateral salpingo-oophorectomy and are sexually active must consent to use two effective methods of contraception as determined by the site investigator (i.e. oral hormonal contraceptives, patch hormonal contraceptives, vaginal ring, intrauterine device, physical double-barrier methods, surgical hysterectomy, vasectomy, tubal ligation, or true abstinence) from the period following the signing of the informed consent through 12 weeks after last dose of study drug 10. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments Exclusion Criteria: 1. Use of any pharmacologic vitamin D metabolite or analog (e.g. calcitriol, doxercalciferol, and paricalcitol) within the 2 years before Screening 2. Use of oral phosphate within 2 years before Screening 3. Use of aluminum hydroxide antacids, acetazolamides, and thiazides within 7 days prior to Screening 4. Use of bisphosphonates in the 2 years prior to Screening 5. Use of denosumab in the 6 months prior to Screening 6. Use of teriparatide in the 2 months prior to Screening 7. Chronic use of systemic corticosteroids defined as more than 10 days in the 2 months prior to Screening 8. Corrected serum calcium level ≥ 10.8 mg/dL (2.7 mmol/L) at Screening 9. Serum intact parathyroid hormone (iPTH) ≥ 2.5 times the upper limit of normal (ULN) at Screening 10. Use of medication to suppress parathyroid hormone (PTH) (cinacalcet for example) within 60 days prior to Screening 11. Prothrombin time/Partial thromboplastin time (PT/PTT) outside the normal range at Screening 12. Evidence of any disease or use of anticoagulant medication (such as warfarin, heparin, direct thrombin inhibitors, or Xa inhibitors (xabans) that, in the opinion of the investigator, cannot be discontinued) that may increase the risk of bleeding during the biopsy procedure 13. Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study 14. Unable or unwilling to withhold prohibited medications throughout the study 15. Documented dependence on narcotics 16. Use of KRN23, or any other therapeutic monoclonal antibody within 90 days prior to Screening 17. Use of investigational product or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments. OR, in Japan, use of any investigational product or investigational medical device within 4 months prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments. 18. Presence or history of any hypersensitivity, allergic or anaphylactic reactions to any monoclonal antibody or KRN23 excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects 19. History of allergic reaction or adverse reactions to tetracycline or demeclocycline 20. Prior history of positive test for human immunodeficiency virus antibody, hepatitis B surface antigen, and/or hepatitis C antibody 21. History of recurrent infection (other than dental abscesses, which are known to be associated with XLH) or predisposition to infection, or of known immunodeficiency 22. Presence of malignant neoplasm (except basal cell carcinoma) 23. Presence of a concurrent disease or condition that would interfere with study participation or affect safety 24. Presence or history of 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: Percent Change From Baseline in OV/BV at Week 48; SECONDARY OUTCOME 1: Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the Lower Limit of Normal (LLN) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CONVERT; BRIEF: In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug. ; DRUG USED: BAY-1213790; DRUG CLASS: Biologic; INDICATION: End-Stage Renal Disease (ESRD); TARGET: Coagulation Factor XI; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Participants must be at least 18 years of age - Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator - Body weight of at least 50 kg - Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: - Recent (<6 months before screening) clinically significant bleeding - Hemoglobin (Hb) < 9.0 g/dL at screening - Platelet count < 100 x 10^9/L - aPTT or PT > ULN (upper limit of normal) - Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total - Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥ 180 mmHg) - Known intracranial neoplasm, arteriovenous malformation or aneurysm - Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C - Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis) - Recent (<3 months before screening) major surgery or scheduled major surgery during study participation - Scheduled living donor renal transplant during study participation - Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher - Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day - Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure ; PRIMARY OUTCOME: Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC); SECONDARY OUTCOME 1: Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus 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 - MAPLE; BRIEF: The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD). ; DRUG USED: Darpin; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Male or female participants, 50 years of age or older at the time of informed consent - Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye - BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye Exclusion Criteria: - Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye) - Previous or concurrent macular laser treatment (study eye) - Cataract or refractive surgery within 3 months prior to baseline (study eye) ; PRIMARY OUTCOME: Percentage of Participants With Stable Vision; SECONDARY OUTCOME 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye[/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 - 204; BRIEF: This is a pharmacodynamics study of emixustat hydrochloride in subjects with macular atrophy secondary to Stargardt disease. ; DRUG USED: ACU-4429; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stargardt Disease (Ophthalmology); TARGET: RPE65 (Retinal pigment epithelium-specific 65 kDa protein); THERAPY: Monotherapy; LEAD SPONSOR: Kubota Vision Inc.; CRITERIA: Inclusion Criteria, including, but not limited to: - Clinical diagnosis of macular atrophy (MA) secondary to Stargardt disease (STGD) in one or both eyes - At least 2 pathogenic mutations of the ABCA4 gene - Early Treatment Diabetic Retinopathy Study BCVA of ≥ 20 letters (approximately ≥ 20/400 Snellen) in the study eye - Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of MA in the study eye - Able and willing to provide written informed consent before undergoing any study-related procedures - Able to reliably administer oral medication by self or with available assistance Exclusion Criteria, including, but not limited to: - Macular atrophy associated with a condition other than STGD in either eye. - Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function. - History of any intraocular or ocular surface surgery in either eye within 3 months of screening. - Current or previous participation in an interventional study to treat STGD using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin A derivative ≤3 months prior to screening. - Pre-specified laboratory abnormalities at screening - Presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator may contraindicate the use of an investigational drug and place the subject at risk - Current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening - History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening. - Anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation. - Electrocardiogram with a clinically significant abnormal finding - Female subjects who are pregnant or lactating - Female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug ; PRIMARY OUTCOME: Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram; SECONDARY OUTCOME 1: Percentage of Subjects With Adverse Events, by Severity and Seriousness[/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/Amlodipine; BRIEF: This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects. ; DRUG USED: Entresto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Neutral Endopeptidase/Neprilysin (NEP); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Written informed consent must be obtained before any study assessment is performed. - Males and females of non-childbearing potential ≥ 18 years of age. - Subjects with mild to moderate essential hypertension, - Untreated subjects must have a mean seated SBP (msSBP) ≥ 130 mmHg and < 180 mmHg at screening. - Pre-treated subjects must have a msSBP ≤ 160 mmHg at screening and < 180 mmHg at the end of the washout period. - Waist circumference ≥ 102 cm (men) and ≥ 88 cm (women); Exclusion criteria: - Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations. - History of angioedema, drug-related or otherwise - History of hypersensitivity to LCZ696, amlodipine, or drugs of similar chemical classes. - Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period. - Type 1 or Type 2 diabetes mellitus. - Dyslipidemia requiring pharmacological therapy with a fibrate or nicotinic acid. - Concomitant use of anti-hypertensives, anti-diabetics, or drugs with effects on glucose or lipid metabolism for the duration of the study. Other protocol defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline in Insulin Sensitivity Index; SECONDARY OUTCOME 1: Local Adipose Tissue Lipolysis, Glycerol Concentrations[/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 - VOYAGE 1; BRIEF: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis. ; DRUG USED: Tremfya; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent - Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline - Have an Investigators Global Assessment (IGA) score >=3 at Screening and at Baseline - Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline - Must be a candidate for either systemic therapy or phototherapy for psoriasis Exclusion Criteria: - Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - Participants who have ever received guselkumab or adalimumab - History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments - Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug ; PRIMARY OUTCOME: Percentage of Participants Who Achieved an Investigators Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved an Investigators Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48[/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 - 2003 (Long Term Safety); BRIEF: This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis. ; DRUG USED: Ozoralizumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Ablynx, a Sanofi company; CRITERIA: Inclusion Criteria: - Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study. Exclusion Criteria: - Pregnant or nursing women. - Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigators judgment, will substantially increase the risk associated with the subjects developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subjects response. ; PRIMARY OUTCOME: Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements.; 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 - ADD201 - w/Carbidopa; BRIEF: Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological disorder characterized by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness, restlessness, talking out of turn, difficulty waiting and interrupting others. ADHD is the second most common neuropsychiatric disorder affecting 4.4% of the US adult population, or between 8-9 million individuals (Kessler et al., 2006). Droxidopa (L-dihydroxyphenylserine (L-DOPS)) is a synthetic catecholamine which is converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE centrally in the CNS and peripherally. Co-treatment with carboxylase inhibitors, such as carbidopa, given with droxidopa, can increase the CNS levels of NE with greater crossing of the blood-brain barrier. Droxidopa has received orphan drug approval by the FDA for the treatment of symptomatic neurogenic orthostatic hypotension in individuals with primary autonomic failure. The half-life of droxidopa is approximately 2-3 hours, resulting in administration thee times daily. As adult ADHD is characterized as a disorder of decreased NE activity in the pre-frontal cortex, it is hypothesized that treating patients with droxidopa (in co-administration of carbidopa) will have a positive effect on adult ADHD. ; DRUG USED: Northera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Alpha Adrenergic Receptors; THERAPY: Combination; LEAD SPONSOR: Chelsea Therapeutics; CRITERIA: Inclusion Criteria: 1. At the time of consent, are between the ages of 18-55, inclusive. 2. Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.2. 3. Concomitant Axis I diagnoses that are allowed include social anxiety disorder or dysthymia which does not require treatment. Psychiatric co-morbidities will be diagnosed with the SCID. 4. Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing. 5. Must be able to swallow capsules. 6. In the opinion of the investigator, the subject must understand and be able, willing and likely to fully comply with the study procedures and restrictions. 7. Must have given signed and dated informed consent in accordance with Good Clinical Practice (GCP) Guidelines. Exclusion Criteria: 1. Lifetime or present history of bipolar or psychotic disorders, that in the investigators opinion, interfere with the diagnosis and/or with the conduct of the study. 2. Uncontrolled comorbid major depressive disorder, anxiety disorder or dysthymia. 3. Women of childbearing potential who are not using a medically accepted contraception. 4. Sexually active males whose partner is a WOCP must agree to use condoms for the duration of the study and for 4 weeks after the last dose. 5. Women who are pregnant, breast feeding, or plan to become pregnant during the course of this study. 6. Clinically significant electrocardiogram or laboratory abnormalities at screening that are deemed exclusionary in the opinion of the Principal Investigator. 7. Subjects taking any psychotropic medication on a regular basis. Subjects will need to be free of all psychotropic medications (one week for psychostimulants, four weeks for all other medications), except for PRN benzodiazepines or hypnotics. Allowed psychiatric co-morbidities include social anxiety disorder or dysthymia which does not require treatment. 8. Subjects with any concurrent chronic or acute illness or unstable medical condition that could, in the opinion of the study physician, confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. Subjects who have a history of mental retardation or severe learning disability will be excluded. 9. Subjects who in the investigators opinion meet any of the exclusionary criteria specified on the FDA label of either Droxidopa or carbidopa. 10. Have uncontrolled hypertension, defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure >110 mmHg or use of ≥2 antihypertensive medications. 11. Known or suspected hypersensitivity to the study medication or any of its ingredients. 12. Have in the investigators opinion any significant cardiac arrhythmia. 13. Any significant systemic, hepatic, cardiac or renal illness. 14. Diabetes mellitus or insipidus. 15. Have a history of closed angle glaucoma. 16. Have a known or suspected current malignancy. Patients with a history of cancer must be symptom- and treatment-free for at least 5 years prior to randomization, with the exception of patients with non-melanoma, non-invasive skin cancers (such as basal cell carcinoma), who should not have had an intervention or recurrence within one year of starting the study. 17. Subjects with known gastrointestinal illness or other gastrointestinal disorder that may, in the investigators opinion, affect the absorption of study drug. 18. In the investigators opinion, have clinically significant abnormalities on clinical examination or laboratory testing. 19. In the investigators opinion, are unable to adequately co-operate because of individual or family situation. 20. Are not able or willing to comply with the study requirements for the duration of the study. 21. Have participated in another clinical trial with an investigational agent (including named patient or compassionate use protocol) within 1 month before the start of the study. 22. Previous enrollment in the study. ; PRIMARY OUTCOME: The primary outcome measure will be changes from baseline in total score on the Adult ADHD Investigator Symptom Rating Scale (AISRS).; SECONDARY OUTCOME 1: Changes in self-report ADHD symptoms on the ASRS v1.1 Symptom Checklist[/INST]No</s>

<s>[INST]<<SYS>>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 - +/-Pembrolizumab; BRIEF: This is a safety and pharmacokinetics study of favezelimab as monotherapy and in combination with pembrolizumab AND favezelimab/pembrolizumab as monotherapy in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive favezelimab as monotherapy or favezelimab in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RP2D), as determined by dose-limiting toxicity, for favezelimab in combination with pembrolizumab or pembrolizumab and lenvatinib in participants with advanced solid tumors. Part B will also assess the efficacy of favezelimab as monotherapy; favezelimab in combination with pembrolizumab with and without chemotherapy; favezelimab in combination with pembrolizumab and lenvatinib; and favezelimab/pembrolizumab as monotherapy in expansion cohorts. Participants who have completed the initial course of treatment and have investigator-determined progressive disease may be eligible for a second course of an additional 17 cycles of study treatment. ; DRUG USED: MK-4280; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: LAG3 (Lymphocyte-Activation Gene)/CD223; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Part A and Part B: Has histologically or cytologically-confirmed metastatic solid tumor. - Has measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1 criteria. - Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. - Demonstrates adequate organ function. - If female, is not pregnant or breastfeeding, and if of child-bearing potential, is willing to use an adequate method of contraception for the course of the study and for at least 180 days after the last dose of chemotherapy, 120 days after the last dose of pembrolizumab or favezelimab, or 30 days after the last dose of lenvatinib, whichever occurs last. - If male with a female partner(s) of child-bearing potential, both must agree to use an adequate method of contraception starting with the first dose of study drug through 95 days after the last dose of study drug. Exclusion Criteria: - Has had chemotherapy, radiation or biological cancer therapy within 4 weeks prior to the first dose of study drug,or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 or 1 from the AEs due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related [ir]AEs). - Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug. - Has received previous treatment with another agent targeting the lymphocyte-activation gene 3 (LAG-3) receptor. - Has received previous treatment with an immunomodulatory therapy (e.g., anti-programmed cell death-1/anti-programmed cell death-ligand 1 [anti-PD-1/anti-PD-L1] or cytotoxic T-lymphocyte-associated protein 4 [CTLA 4] agent) and was discontinued from that therapy due to a Grade 3 or higher irAE. - Is expected to require any other form of antineoplastic therapy while on study. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication. - Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Time frame exceptions include successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer, or other in situ cancers. - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody. - Has an active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy. - Has an active infection requiring therapy. - Has history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Has had a prior stem cell or bone marrow transplant. - Has a known history of or screens positive for Human Immunodeficiency Virus (HIV), active chronic or acute Hepatitis B or Hepatitis C. - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. - Is a regular user as determined by investigator judgement (including recreational use) of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol), at the time of signing informed consent. - Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. - Has clinically significant heart disease that affects normal activities. - Has received a live-virus vaccine within 30 days of planned start of study drug. Seasonal flu vaccines that do not contain live virus are permitted. ; PRIMARY OUTCOME: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Serum Concentration of Favezelimab When Administered as Monotherapy[/INST]No</s>

<s>[INST]<<SYS>>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 - Pediatrics; BRIEF: Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality. The PK, pharmacodynamics (PD), safety and efficacy of IV zanamivir have been evaluated in adults, adolescents and infants more than or equal to (>=) 6 months of age with hospitalized influenza in the IV zanamivir global development program. However, antiviral treatment of neonates and infants under 6 months of age hospitalized with influenza infection remains a medical unmet need. Given the immaturity of the immune system at this age, there are no licensed influenza vaccines for children aged less than six months old. As a requirement of the Pediatric Investigation Plan European Union (EU), GlaxoSmithKline (GSK) will be conducting this open-label, multi-center, single arm, post-marketing authorization study to evaluate the PK and collect safety and tolerability information of IV zanamivir in hospitalized neonates and infants under 6 months of age with confirmed complicated influenza infection. The total duration of study participation for each participant will be up to 24 days with a study treatment period up to 10 days and 14 days of post-treatment follow up. However, for a given participant, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests as assessed by the investigator warrant further treatment. DECTOVA is a trademark of GlaxoSmithKline group of companies. ; DRUG USED: Zanamivir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Influenza Viral Neuraminidase; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Neonates and infants who are aged less than 6 months (corrected age) at the time of the informed consent signed by legally acceptable representative (LAR) of minors. Preterm neonates and infants will be eligible for inclusion but must have reached PMA of at least 28 weeks. - Participants who are hospitalized with influenza infection, confirmed by a positive rapid molecular diagnostic test for influenza, or a local quantitative Reverse transcriptase-polymerase chain reaction (RT-PCR) test and who must have a potential for improvement Participants with negative rapid molecular test result suspected of having influenza can be enrolled following confirmatory testing by quantitative RT-PCR. - Participants with a high risk of altered oral drug absorption, represented by multi-organ dysfunction (dysfunction of at least 2 organs, as defined by the treating physician). (applicable only for Netherlands) - Body weight >=1 kilograms (kg). - No gender restriction. - LAR of minors are willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, Independent Ethics Committees [IECs] or local laws). Exclusion criteria: - Participants who are known or suspected to be hypersensitive to any component of the study medication. - Participants with a disease process which is likely to be irreversible. - Liver function: - Participants who meet the following criteria at Baseline: 1. Alanine transaminase (ALT) >=3 times upper limit of normal (ULN) with bilirubin >=2 times ULN 2. or isolated bilirubin >=2 times ULN and >50 percent (%) direct bilirubin 3. or ALT >=5 times ULN Inclusion of participants with liver function tests that fall outside these criteria must be discussed and agreed with the medical monitor. - Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of benign conditions such as Gilberts syndrome). Inclusion of participants with neonatal hyperbilirubinemia may be considered if appropriately managed according to local guidelines and must be discussed with the medical monitor (Not-applicable for Great Britain). - Participants who require concurrent therapy with another anti influenza drug. - Participants who have participated in a study using an investigational drug within 30 days prior to Baseline. - Child in care (CiC), as defined below: - A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. - The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian. - Participants undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or hemofiltration. - Participants who are positive for severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) as determined by a diagnostic test, at screening ; PRIMARY OUTCOME: Area under the serum concentration-time curve (AUC) of zanamivir; SECONDARY OUTCOME 1: Number of participants with adverse event(s) (AE) and serious adverse event(s) (SAE)[/INST]No</s>

<s>[INST]<<SYS>>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 - KX-ORAX-010; BRIEF: This is a non-blinded, multi-center, open-label, phase 2 study to evaluate the activity, safety, and tolerability of Oraxol in subjects with cutaneous angiosarcoma. ; DRUG USED: Oral Paclitaxel; DRUG CLASS: Non-NME; INDICATION: Sarcoma; TARGET: Microtubules (Tubulin), P-gp; THERAPY: Monotherapy; LEAD SPONSOR: Athenex, Inc.; CRITERIA: Inclusion Criteria: - Willingness and ability to give informed consent, prior to any study-specific procedures and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures - Age of 18 years or older - Histologically-confirmed cutaneous angiosarcoma that is not amenable to curative intent surgery (eg, locally advanced disease and disease for which surgical resection would carry an unacceptable risk of recurrence or morbidity to the subject) - Subjects who have not received taxanes for the treatment of angiosarcoma - Measurable disease per RECIST v.1.1 - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) Grade ≤1 or to that subjects baseline - Adequate organ function as defined by the following criteria: - Adequate renal function as evidenced by serum creatinine ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥50 mL/min per the Cockcroft and Gault formula - Adequate bone marrow function as evidenced by: - absolute neutrophil count (ANC) ≥1.5 × 109/L - hemoglobin ≥9.0 g/dL (<9.0 g/dL is acceptable if it is corrected by transfusion), and - platelet count ≥100 × 109/L - Adequate liver function as evidenced by - total bilirubin within normal limits, - alanine aminotransferase (ALT) ≤3×ULN, and aspartate aminotransferase (AST) ≤3×ULN, - gamma-glutamyl transferase (GGT) ≤10×ULN, and - alkaline phosphatase ≤3×ULN - Able to swallow pills whole and retain oral medications - Sexually active male subjects including men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) must agree to use a condom with spermicide and to not donate sperm from the time of Screening until 6 months following the last dose of Oraxol - Women of non-child bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause (ie, no menstrual bleeding for more than 12 months in a woman aged ≥45 years), OR women of childbearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test must be using a highly effective method of contraception from the time of Screening until 6 months following the last dose of Oraxol. Note: Highly effective methods of contraception that result in a low failure rate (ie, <1% per year) when used consistently and correctly include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. True abstinence, when in line with the preferred and usual lifestyle of the subject, is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of study participation and for 6 months post-Oraxol administration. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, and post-ovulation method) and withdrawal are not acceptable methods of contraception. - Life expectancy of at least 3 months, in the opinion of the Investigator Exclusion Criteria: - Subjects with metastases outside of local lymph node involvement - Concurrent treatment or participation on other therapeutic clinical trial for angiosarcoma. Participation in companion studies sponsored by local institutions, including biological correlates, is permitted. - Women who are pregnant or breastfeeding - Receipt of systemic cytotoxic therapy, including investigational agents, within 14 days or 5 half-lives of the first study dosing day, whichever is longer - Major surgery or trauma within 28 days prior to first dose of investigational product. Note: The following are not considered to be major procedures and are permitted before treatment administration: thoracentesis, paracentesis, catheter placement, port placement, laparoscopy, thoracoscopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, and imaging-guided biopsy for diagnostic purposes - Subjects who have received wide-field radiotherapy to the pelvis ≤3 months (defined as >50% of volume of pelvic bones or equivalent) or limited-field radiation for palliation ≤3 months prior to treatment administration. Angiosarcoma lesions in the radiation field are not evaluable unless they have developed progressive disease following radiation. - History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. - Angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within 3 months prior to treatment administration - Active bleeding or bleeding diathesis actively requiring transfusions; Note: subjects with cutaneous ulcers from angiosarcoma or who have skin lesions with bleeding are allowed to participate. - Thrombolytic use (except to maintain IV catheters) within 10 days prior to treatment administration - Presence of a malabsorption syndrome or major resection of the stomach or small bowel that could affect the absorption of Oraxol - Known active viral or nonviral hepatitis or cirrhosis - Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness - Active infection that requires systemic treatment - Concurrent use of a strong cytochrome P450 (CYP) 3A4 inducer (eg, rifampin or St. Johns Wort) or a strong CYP3A4 inhibitor (eg, ketoconazole) within 14 days prior to treatment administration - Concurrent use of a strong CYP2C8 inhibitor (eg, gemfibrozil) or inducer (eg, rifampin) within 14 days prior to treatment administration - Concurrent use of an oral medication with a narrow therapeutic index known to be a P-glycoprotein (P-gp) substrate within 24 hours prior to treatment administration - Concurrent use of a medication known to be a strong P-gp inhibitor or inducer within 14 days prior to treatment administration - History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor® or history of hypersensitivity-type reaction to polysorbate 80 or other components of the formulation of Oraxol - Other severe acute or chronic medical (including bone marrow suppressive diseases) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, impede the ability of the subject to complete all protocol-specified activities, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for this study ; PRIMARY OUTCOME: Response rate; SECONDARY OUTCOME 1: Incidence of Treatment-Emergent 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 IIa - OX4218s (GI-NET); BRIEF: This study will investigate the safety, symptoms and biomarker response of subjects with biopsy-proven well-differentiated, low-to-intermediate-grade, unresectable, or metastatic pancreatic neuroendocrine tumors (PNETs) or or Gastrointestinal Neuroendocrine tumors (GI-NETs) with elevated biochemical markers who have relapsed during or after receiving prior standard of care therapies, including octreotide, chemotherapy or targeted therapy. ; DRUG USED: Zybrestat (Injectable); DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuroendocrine Tumors (NET); TARGET: VE-cadherin; THERAPY: Monotherapy; LEAD SPONSOR: Mateon Therapeutics; CRITERIA: Inclusion Criteria: - Ability to read, understand and provide written consent to participate in the study - Age ≥ 18 years - Biopsy-proven well-differentiated, low-to-intermediate-grade PNET or GI-NET with elevated (> ULN) biomarkers (serotonin, 5-hydroxyindoleacetic acid (5-HIAA), chromogranin A (CgA), neurokinin A, and neuron-specific enolase (NSE)) - Life expectancy > 12 weeks - Must have received or may still be receiving one or more therapies including octreotide or serotonin synthesis inhibitor (SSI) or other somatostatin analogues - Confirmed progressive disease within 18 months of enrollment on study - Recovered from prior radiation therapy or surgery - Eastern Cooperative Oncology Group (ECOG) performance score 0-2 - Absolute neutrophil count (ANC) ≥ 1,500/µL (without growth factors) - Platelet count ≥ 100,000/µL - Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL (177 µmol/L) - Adequate hepatic function: serum total bilirubin ≤ 2X greater than the upper limit of normal (ULN) (≤ 3X ULN in subjects with liver metastases), aspartate aminotransferase) AST) / alanine aminotransferase (AST) ≤ 2X the ULN for the local reference lab (≤ 5X the ULN for subjects with liver metastases) - Disease that can be assessed (evaluable) with imaging (CT, MRI, PET, radionuclide imaging or other imaging modality) - Women of childbearing potential as well as fertile men and their partners must use an effective method of birth control Exclusion Criteria: - Inadequately controlled hypertension defined as BP > 150/100 mm Hg despite medication - Prior history of hypertensive crisis or hypertensive encephalopathy - Recent history (within 6 months of start of screening) of unstable angina pectoris pattern, myocardial infarction (including non-Q wave MI), or NYHA (New York Heart Association) Class III and IV Congestive Heart Failure (CHF) - Subjects who have clinical evidence of carcinoid-induced heart disease - History of prior cerebrovascular accident (CVA), including transient ischemic attach (TIA) - Known central nervous system (CNS) disease except for treated brain metastasis - History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG - Corrected QT interval (QTc) > 480 msec - Ongoing treatment with any drugs known to prolong the QTc interval, including anti-arrhythmic medications (stable regimen of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class is allowed)) - Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) - Significant vascular disease or recent peripheral arterial thrombosis - Known intolerance of or hypersensitivity to fosbretabulin - History of solid organ transplant or bone marrow transplant - Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subjects ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results - High grade or poorly differentiated NET - NET tumor other than PNET or GI-NET - No elevated biomarker (>ULN) that can be followed - Received regional hepatic infusion therapy within 6 months of enrollment (RFA allowed >6 months prior to enrollment) ; PRIMARY OUTCOME: Number of Participants With Improved, Stable, or Worsened Change In Chromogranin A (CgA) Biomarker Levels From Baseline; SECONDARY OUTCOME 1: Number of Participants With Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) Based on RECIST 1.1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - Low/High Dose; BRIEF: The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD). ; DRUG USED: Serdaxin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: N-Acetylated-Alpha-Linked-Acid-Dipeptidase (NAALADase); THERAPY: Monotherapy; LEAD SPONSOR: Rexahn Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: • Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS). Exclusion Criteria: - Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not willing to practice a reliable method of birth control - Depressive episode duration of less than 1 month - Lifetime history of any psychotic disorders - Anxiety disorders - Significant suicidality - Clinically significant medical conditions ; PRIMARY OUTCOME: Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9; SECONDARY OUTCOME 1: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7[/INST]No</s>

<s>[INST]<<SYS>>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 - 1314.9 (South Korea); BRIEF: Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers. ; DRUG USED: BI 113608; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: -Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, clinical laboratory tests - Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan Chinese; ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China - Caucasian - Age older than 20 and younger than 45 years - Normal lung function testing - Normal peripheral oxygen saturation as determined by non-invasive pulse oxymetry - Body Mass Index more than 18.5 and Body Mass Index less than 25 kg/m2 for Japanese and Chinese - Body Mass Index more than 18.5 and Body Mass Index less than 29.9 kg/m2 for Caucasians - Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation. Exclusion criteria: - Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance - Any evidence of a clinically relevant concomitant disease - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders - Surgery of the gastrointestinal tract (except appendectomy) - Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month - History of relevant orthostatic hypotension, fainting spells or blackouts. - Chronic or relevant acute infections - History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) - Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial - Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial - Participation in another trial with an investigational drug within two months prior to administration or during the trial - Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) - Inability to refrain from smoking on trial days - Alcohol abuse (more than 20 g/day) - Drug abuse - Blood donation (more than 100 mL within four weeks prior to administration or during the trial) - Excessive physical activities (within one week prior to administration or during the trial) - Any laboratory value outside the reference range that is of clinical relevance - Inability to comply with dietary regimen of trial site - A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms); - A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) ; PRIMARY OUTCOME: Number (%) of Subjects With Drug-related Adverse Events; SECONDARY OUTCOME 1: Cmax (Maximum Measured Concentration of the Analyte in Plasma)[/INST]No</s>

<s>[INST]<<SYS>>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 A301; BRIEF: The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters. ; DRUG USED: Daridorexant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Insomnia; TARGET: Hypocretin/orexin receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria: - Signed informed consent prior to any study-mandated procedure; - Male or female aged ≥ 18 years; - Insomnia disorder according to DSM-5 criteria; - Insomnia Severity Index score ≥ 15; - Insufficient sleep quantity as collected subjectively in the sleep diary; - Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake. Exclusion Criteria: - Body mass index below 18.5 or above 40.0 kg/m2; - Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea; - Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study; - Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week; - Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview; - Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years; - For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study; - History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments. - Any circumstances or conditions, which, in the opinion of the investigator, may affect the subjects full participation in the study or compliance with the protocol. ; PRIMARY OUTCOME: Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance); SECONDARY OUTCOME 1: Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)[/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 - Pretreated; BRIEF: This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to determine whether olaparib will have a beneficial effect on the patients cancer by causing a response and increasing the time it takes for the cancer to progress. ; DRUG USED: Lynparza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Patients will have measurable disseminated colorectal cancer that is incurable by surgery - Patients will have had tumor progression following standard combination front-line or second-line chemotherapy. - CRC patients who have relapsed or recurrent disease within six months after completing adjuvant or neoadjuvant chemotherapy Exclusion Criteria: - Previous treatment with PARP inhibitors, including olaparib. - Patients with symptomatic, uncontrolled brain metastases. - Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used). - Patients who are unable to swallow orally administered medication. ; PRIMARY OUTCOME: Tumour Response; 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 - ASTRAL-2 (12 weeks); BRIEF: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection. ; DRUG USED: Epclusa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Willing and able to provide written informed consent - HCV RNA ≥ 10^4 IU/mL - HCV genotype 2 - Chronic HCV infection (≥ 6 months) - Females of childbearing potential must have a negative serum pregnancy test - Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception - Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator. Exclusion Criteria: - Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol; - Screening electrocardiogram (ECG) with clinically significant abnormalities - Laboratory results outside of acceptable ranges at Screening - Pregnant or nursing female or male with pregnant female partner - Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilsons disease, alfa-1 antitrypsin deficiency, cholangitis) - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)[/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; BRIEF: This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer. ; DRUG USED: Dovitinib Lactate; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine (Endometrial) Cancer; TARGET: Fibroblast Growth Factor Receptor (FGFR) , FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy) - Female patients ≥ 18 years old - Documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease - ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2 - At least one measurable lesion as per RECIST Exclusion Criteria: - Previous treatment with an FGFR inhibitor - More than one line of treatment for advanced or metastatic disease - Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors - Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery - Known central nervous system (CNS) metastases - Malignancy within 3 years of study enrollment Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Progression Free Survival (PFS) Rate; SECONDARY OUTCOME 1: Overall Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Long-Term Outcomes Study; BRIEF: This study is a long-term study of ataluren in participants with nonsense mutation Duchenne muscular dystrophy. ; DRUG USED: Translarna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: RNA translation; THERAPY: Monotherapy; LEAD SPONSOR: PTC Therapeutics; CRITERIA: Inclusion Criteria: - Male sex - Age ≥5 years - Phenotypic evidence of Duchenne Muscular Dystrophy - Nonsense point mutation in the dystrophin gene - Use of systemic corticosteroids (prednisone/prednisolone or deflazacort)for a minimum of 12 months immediately prior to start of study treatment, with no significant change in dosage or dosing regimen for a minimum of 3 months immediately prior to start of study treatment - 6MWD ≥150 meters - Ability to perform timed function tests within 30 seconds - Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions. Exclusion Criteria: - Any change in prophylaxis treatment for cardiomyopathy within 1 month prior to start of study treatment. - Ongoing intravenous (IV) aminoglycoside or IV vancomycin therapy. - Prior or ongoing therapy with ataluren. - Known hypersensitivity to any of the ingredients or excipients of the study drug - Exposure to another investigational drug within 6 months prior to start of study treatment, or ongoing participation in any interventional clinical trial. - History of major surgical procedure within 12 weeks prior to start of study treatment, or expectation of major surgical procedure during the 72-week placebo-controlled treatment period. - Requirement for daytime ventilator assistance or any use of invasive mechanical ventilation via tracheostomy. - Uncontrolled clinical symptoms and signs of congestive heart failure - Elevated serum creatinine or cystatin C at screening. ; PRIMARY OUTCOME: Slope of Change in 6-Minute Walk Distance (6MWD) Over 72 Weeks; SECONDARY OUTCOME 1: Change from Baseline to Week 72 in 6MWD[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - TRANSFORM; BRIEF: The primary objective of this study is to evaluate the effect of setanaxib on biochemical response at Week 52 in participants with primary biliary cholangitis (PBC) and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA). ; DRUG USED: Setanaxib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: NADH Oxidase; THERAPY: Monotherapy; LEAD SPONSOR: Calliditas Therapeutics Suisse SA; CRITERIA: Inclusion Criteria: - Male or female participant aged ≥18 years, inclusive at the time of informed consent. - Willing and able to give written informed consent and to comply with the requirements of the study. - Definite or probable primary biliary cholangitis (PBC) diagnosis as demonstrated by the presence of ≥2 of the following 3 diagnostic factors: - Documented history of elevated alkaline phosphatase (ALP) levels ≥1.67×upper limit of normal (ULN) of the local reference range. - Documented history of positive antimitochondrial antibodies (AMA) titer or positive PBC-specific antibodies (anti-GP210 or anti-SP100 or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex]). - Historical liver biopsy consistent with PBC. - Serum ALP ≥1.67×ULN at Screening. - Liver stiffness measured by transient elastography (FibroScan®) of ≥8.8 kilopascals (kPa) and an interquartile range over median ratio (IQR/med) of ≤30% at Screening, are taken with the results expressed in kilopascals). - Ursodeoxycholic acid (UDCA) prescriptional dose use for the past 6 months (at a stable dose for >3 months prior to Screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to Screening). Intolerance to UDCA is defined as participants unable to tolerate the full-labelled dose of UDCA in PBC (13-15 mg/kg) due to frequently reported gastrointestinal symptoms such as diarrhea and abdominal pain. - For participants receiving obeticholic acid (OCA), fenofibrate, or bezafibrate treatment for at least 6 months and stable dose for >3 months prior to Screening. - For participants intolerant to OCA, OCA must have been discontinued >3 months prior to Screening. - For participants previously treated with bezafibrate or fenofibrate, and these agents were discontinued prior to screening, they must have been discontinued >3 months prior to Screening. - Female participants of childbearing potential must use a highly effective method of contraception to prevent pregnancy for ≥4 weeks before Randomization and must agree to continue strict contraception up to 90 days after the last dose of investigational medicinal product (IMP). - For the purposes of this trial, women of childbearing potential are defined as Fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. - Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In female participants who are not using hormonal contraception or hormonal replacement therapy but with suspected menopause and less than 12 months of amenorrhea, a high follicle stimulating hormone (FSH) level in the postmenopausal range will be required at Screening to confirm a postmenopausal state. Confirmation with more than one FSH measurement is required. - Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) - Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) - Intrauterine device - Intrauterine hormone-releasing system - Bilateral tubal occlusion - Vasectomized partner - Sexual abstinence (refraining from heterosexual intercourse during the entire period of risk associate with the study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together. - Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Randomization before dosing. - Male participants with female partners of childbearing potential must be willing to use a condom and require their partner to use a highly effective contraceptive method. This requirement begins at the time of informed consent and ends 90 days after receiving the last dose of IMP. - Male participants must be willing not to donate sperm, and female study participants must be willing not to donate eggs, from Baseline until 90 days after the last dose of IMP. Exclusion Criteria: - A positive pregnancy test or breastfeeding for female participants. - Any historical or current hepatic decompensation event defined as variceal/portal hypertension bleed and/or hepatic encephalopathy, spontaneous bacterial peritonitis, ascites requiring treatment, or liver transplantation list inclusion. - History of liver transplantation, current placement on a liver transplant list or current model for end stage liver disease (MELD) score of ≥12 unless the participant is on anticoagulant therapy, or a Child-Pugh Score of ≥6. - Cirrhosis with complications, including history or presence of hepatocellular carcinoma. - Total bilirubin >2×ULN. In case of total bilirubin elevation >ULN the Screening serum albumin must be within the reference range. - Plasma alanine aminotransferase (ALT) >3×ULN and/or aspartate aminotransferase (AST) >3×ULN. - International normalized ratio (INR) >1.2 unless participant is on anticoagulant therapy. One repeat blood sampling (with analysis by the central laboratory) can be performed at the discretion of the Investigator at Screening Visit 2 for participants who meet this exclusion criterion at Screening Visit 1. If this exclusion criterion is not met at Screening Visit 2, the participant may be eligible for the study. - Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2, as calculated by the central laboratory using the chronic kidney disease-epidemiology collaboration (CKD- EPI) equation. - Thyroid-stimulating hormone >ULN at Screening. One repeat blood sampling (with analysis by the central laboratory) can be performed at the discretion of the Investigator at Screening Visit 2 for participants who meet this exclusion criterion at Screening Visit 1. If this exclusion criterion is not met at Screening Visit 2, the participant may be eligible for the study. - Competing etiology for liver disease (eg, hepatitis C [unless effectively cured of hepatitis C, with a sustained virologic response for at least 6 months prior to Screening], active hepatitis B [HBsAg positive], nonalcoholic steatohepatitis [NASH], alcoholic liver disease, autoimmune hepatitis, autoimmune hepatitis-PBC overlap syndrome, primary sclerosing cholangitis, Gilberts Syndrome). - Medical conditions that could cause nonhepatic increases in ALP (eg, Pagets disease). - Known history of human immunodeficiency virus (HIV) infection. - Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator). - Positive urine drug screen (if not due to prescriptional use of a concomitant medication, as confirmed by the Investigator) at Screening. Participants on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening Visit 1 may be included in the study. Medicinal cannabis and cannabidiol products are not exclusionary and may be allowed if the prescription and diagnosis are reviewed and approved by the Investigator. - Participants receiving prohibited medications within 3 months of Screening Visit 1. - Treatment with any investigational agent within 12 weeks of Screening Visit 1 or 5 half-lives of the IMP (if known) (whichever is longer) or current enrollment in an interventional clinical trial. - Evidence of any of the following cardiac conduction abnormalities: A QTc Fridericia interval >450 milliseconds for males or >470 milliseconds for females, as calculated by the central reader. Participants with a second- or third-degree atrioventricular block are to be excluded. - For participants in the US, in participants treated with or for planned treatment with a pacemaker, implanted cardioverter-defibrillator, or other implanted electronic device, FibroScan® assessments will be prohibited. - History of a malignancy within 5 years of Screening with the following exceptions: - Adequately treated carcinoma in situ of the cervix - Adequately treated basal or squamous cell cancer or other localized nonmelanoma skin cancer. - The occurrence of any acute infection requiring systemic antibiotic therapy within the 2 weeks prior to Screening Visit 1. - A history of bone marrow disorder including aplastic anemia, or any current marked anemia defined as hemoglobin <10.0 g/dL. - Prior treatment with setanaxib or participation in a previous setanaxib clinical trial. - Unstable cardiovascular disease. - Presence of any laboratory abnormality or condition that, in the opinion of the Investigator, could interfere with or compromise a participants treatment, assessment, or compliance with the protocol and/or study procedures. - Any other condition which, in the opinion of the Investigator, constitutes a risk or contraindication for the participation of the participant in the study, or that could interfere with the study objectives, conduct, or evaluation. - Hypersensitivity or intolerance to setanaxib or to any of its excipients or placebo compounds. ; PRIMARY OUTCOME: Proportion of Participants Achieving a Biochemical Response to Setanaxib; SECONDARY OUTCOME 1: Change from Baseline in Fatigue[/INST]No</s>

<s>[INST]<<SYS>>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/Avastin (Weekly Dosing); BRIEF: The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of weekly dosing of CRLX101 (both as monotherapy; (Schedule 1) and in combination with bevacizumab every 2 weeks (Schedule 2) and weekly with a 3 week on / 1 week off schedule in combination with mFOLFOX6 (Schedule 3) to affirm the dose for future clinical studies. ; DRUG USED: NLG207; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Hypoxia Inducible Factor-1 alpha (HIF-1a), Topoisomerase I (Topo-I); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: NewLink Genetics Corporation; CRITERIA: Inclusion Criteria: (All Subjects) - Male or female adult subjects ≥18 years of age - Diagnosis of histologically or cytologically confirmed for: - For Schedule 1 and 2: advanced solid tumor malignancy that is refractory to standard therapy and/or for whom no further standard therapy is available - For Schedule 3: advanced/metastatic tumors for which mFOLFOX6 is appropriate, or advanced/metastatic tumors that may be sensitive to each component of mFOLFOX6 or sensitive to topoisomerase 1 inhibitors including pancreatic, colorectal, esophageal, gastric, bladder or ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC), cholangiocarcinoma, among others - For Schedules 1 and 2: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, For Schedule 3: ECOG Performance Status of 0 or 1 - Life expectancy >12 weeks in the opinion of the Investigator - Subjects with acceptable pre-study* hematology and biochemistry labs ≤3 days prior to Week 1 Day 1 (W1D1) defined as: - absolute neutrophil count (ANC) ≥1.500 cells / µL (1.5 x 10°/L, without growth factor support - platelet count ≥100,000 cells/µL (100 x 10° cells/L), without growth factor support - hemoglobin ≥9 g/dL (90/g/L) - serum total bilirubin ≤1.5 upper limit of normal (ULN), unless Gilberts disease - alanine transaminase (ALT) or aspartate transaminase (AST) ≤2.5 x ULN, (5 x ULN for subjects with liver metastases) - calculated or measured creatinine clearance ≥40 mL/min - NOTE: If screening hematology and biochemistry labs are performed ≤3 days prior to W1D1, additional pre-study labs do not need to be repeated to confirm eligibility. However, if screening hematology and biochemistry labs are performed greater than 3 days prior to W1D1, additional pre-study labs will need to be performed to confirm continued eligibility to ensure labs remain acceptable per protocol - Females of childbearing potential must agree to use two effective methods of contraception (or abstain completely from heterosexual intercourse) from the time of informed consent and for 30 days following last dose of study drug - NOTE: Females of childbearing potential are defined as women physically capable of becoming pregnant unless the female subject cannot have children due to surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Fertile males of childbearing potential are defined as men who are sexually capable to impregnate the female partner even if surgically sterilized (i.e., vasectomy). - highly effective methods of contraception include intra-uterine device (IUD) and hormonal contraception (oral, injectable, patches or implant) - effective methods of contraception include barrier methods (latex condom, diaphragm with spermicide, cervical cap, sponge) - when possible, subjects should be strongly encouraged to include at least one highly effective method of contraception - Male subjects must agree to use appropriate method of barrier contraception (latex condom with a spermicidal agent) or abstain completely from heterosexual intercourse fro the time of informed consent and for 120 days following last dose of study drug unless female partner absolutely cannot have children because of surgery or for other medical reasons - Negative urine pregnancy test - Ability to understand and willingness to sign a written informed consent form - Able to comply with study visit schedule and assessments Exclusion Criteria: (All Subjects) - Subject has received: - chemotherapy or small molecular targeted therapy <2 weeks prior to W1D1 - approved antibody therapy <5 half-lives from W1D1 (or 4 weeks since last therapy, whichever is the shortest) - local palliative radiation <14 days from W1D1 - invasive surgery requiring general anesthesia <30 days from W1D1 - chemotherapy with nitrosoureas or mitomycin C <45 days from W1D1 - Uncontrolled grade 2 or greater toxicity except alopecia related to any prior treatment (i.e., chemotherapy, targeted therapy, radiation or surgery) within 7 days prior to W1D1 unless approved by the Medical Monitor - Prolongation of QT/QTc interval (QTc interval >470) using the Fredericia method of QTc analysis - Women who are pregnant or nursing - Any known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) or any concurrent infection requiring IV antibiotics - Any known clinically significant or concurrent acute liver disease, including viral hepatitis - Primary brain malignant tumors - Subjects with uncontrolled symptomatic central nervous system (CNS) involvement - Subjects requiring steroids at stable dose (>4 mg/day dexamethasone or equivalent) for at least 2 weeks - Uncontrolled hypertension >150/100 mmHg - Concurrent participation in any other investigational therapeutic study, unless non-interventional study and approved by Sponsor - History of stroke, deep venous thrombosis (DVT), transient ischemic attack (TIA), unstable angina, or myocardial infarction within 3 months prior to W1D1 - Uncontrolled concurrent disease or illness including but not limited to: - symptomatic congestive heart failure (NYHA Class III or IV) per the NYHA Classification, unstable angina pectoris, clinically significant cardiac arrhythmia - unstable or untreated cardiac conditions or ejection fraction of <50% as determined by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) - diabetes mellitus (i.e., fasting blood glucose >220 despite acceptable chronic diabetes therapy) - psychiatric illness that would limit compliance with study requirements, as determined by the Investigator - Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for the study. - Known hypersensitivity to any component of CRLX101 or excipient or documented medical condition that would prohibit adequate pre-medication with antihistamine. - Presence of ≥Grade 1 cystitis Exclusion Criteria for Subjects Enrolled in Schedule 2 Only - Minor surgical procedure, excluding placement of a vascular access device, within 24 hours prior to W1D1. - Cardiovascular disease defined as congestive heart failure (NYHA Class II, III, or IV) per the NYHA Classification, angina pectoris requiring nitrate therapy, or myocardial infarction within the last 6 months prior to therapy - Uncontrolled hypertension (defined as the presence of systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg on two separate occasions. Blood pressure must be controlled to a systolic blood pressure <150 mmHg and/or to diastolic blood pressure <100 mmHg prior to study treatment), or any prior history of hypertensive crisis or hypertensive encephalopathy - Peripheral vascular disease >Grade 1 - Known congenital long QT syndrome, history of torsades de pointes or ventricular tachycardia. - Known history of pulmonary hypertension or non-infectious interstitial pneumonitis. - History or evidence of thrombotic or hemorrhagic disorders: including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA), intracerebral hemorrhage or sub- arachnoid hemorrhage ≤ 6 months prior to W1D1 - Chronic daily aspirin >325 mg/day or clopidogrel (>75 mg/day) - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization - Any of the following serious, non-healing conditions:wound, ulcer, or bone fracture - Proteinuria at screening as demonstrated by either: urine dipstick ≥2+ (subjects discovered to have a ≥2+ proteinuria on dipstick urinalysis at baseline should undergo 24-hour urine collection and must demonstrate <1g of protein in 24 hours to be eligible): 24-hour urine collection demonstrates >1g of protein in 24 hours - Immunocompromised subjects, including known seropositivity for human immunodeficiency virus (HIV), or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to hepatitis C virus [anti HCV] with confirmatory testing). [Note: testing is not mandatory to be eligible for the study. However, if a subject is at risk for having undiagnosed hepatitis C virus (HCV) (due to history of injection drug use or due to geographic location for example), testing at screening should be considered] - Chronic treatment with corticosteroids (prednisone >12.5 mg/day or dexamethasone >2 mg/day excluding inhaled steroids Exclusion Criteria for Subjects Enrolled in Schedule 3 Only - Known hypersensitivity to 5FU, oxaliplatin or other platinum agent, or to their excipients - Known dihydropyridine dehydrogenase (DPD) enzyme deficiency (testing not required) - Baseline peripheral neuropathy grade ≥ 2 - Progressive disease within ≤ 6 months of completing an oxaliplatin containing adjuvant therapy - Interstitial lung disease with ongoing signs and symptoms at the time of informed consent ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D); SECONDARY OUTCOME 1: Safety and Tolerability (Weekly Dosing) determined by reported adverse events, serious adverse events, physical exam findings, vital sign measurements,12-lead ECG readings, clinical lab evaluations, and treatment discontinuation due to toxicity.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - COMPOSE II; BRIEF: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure. ; DRUG USED: Cinaciguat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy - Subjects must have the clinical diagnosis of Congestive Heart Failure (CHF) made at least three months prior to enrollment - Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: - dyspnea and - clinical evidence of volume overload Exclusion Criteria: - Acute de-novo heart failure - Acute myocardial infarction and/or myocardial infarction within 30 days - Valvular heart disease requiring surgical intervention during the course of the study - Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease - Primary hypertrophic cardiomyopathy - Acute inflammatory heart disease, eg, acute myocarditis - Unstable angina requiring angiography ; PRIMARY OUTCOME: Pulmonary Capillary Wedge Pressure; SECONDARY OUTCOME 1: Cardiac index (CI)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BOOST (SIMPLE vs. STEPWISE); BRIEF: This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine. ; DRUG USED: Ryzodeg 70/30; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation) - Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time - Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis - Body mass index (BMI) below or equal to 40 kg/m^2 Exclusion Criteria: - Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation) - Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation) - Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator - Life-threatening disease (e.g. cancer) ; PRIMARY OUTCOME: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%); SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 001A; BRIEF: To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of plaque psoriasis ; DRUG USED: AM001; DRUG CLASS: Unknown; INDICATION: Psoriasis; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: AmDerma; CRITERIA: Inclusion Criteria: 1. Subjects must provide written informed consent. 2. Subjects must be male or female, at least 18 years of age. 3. Subjects with a definite diagnosis of plaque psoriasis that is clinically active (for at least 3 months), involving at least 10% and up to 20% of the body surface area (not including the head [ scalp, face], hands, feet, and intertriginous areas). 4. Subjects with an Investigators Global Assessment (IGA) of disease severity of at least moderate severity (score ≥ 3) as an overall assessment. 5. Subjects with a target lesion which has the following characteristics: 1. located on the extremities (i.e., arms or legs ) and has an area of ≥25 cm2; 2. has a minimum plaque erythema of at least moderate severity (PASI grade ≥ 3); 3. has a minimum plaque scaling severity of at least moderate severity (PASI grade ≥ 3); 4. has a minimum plaque elevation of at least moderate severity (PASI grade ≥ 3); 6. If females of childbearing potential, the subject must have a negative urine pregnancy test, and must have been using an acceptable form of birth control for at least two months prior to Visit 1/Screening and are willing to continue birth control throughout the study. 7. Subjects must be willing and able to understand and comply with the requirements of the study, apply the assigned investigational product as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study. 8. Subjects must be in good health, as confirmed by medical history and physical exam, and free from any clinically significant disease/condition, other than plaque psoriasis, that might interfere with the study evaluations. 9. Subjects must be willing to limit sun exposure overall. Subjects are prohibited from sunbathing or intentional tanning or intense sun exposure including the use of tanning booths/lights or other artificial UV light sources throughout the study. Exclusion Criteria: 1. Female subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 2. Subjects who have a current diagnosis of guttate, pustular, inverse, exfoliative, or erythrodermic psoriasis. 3. Subjects who have a history of psoriasis unresponsive to topical treatments. 4. Subjects who have a history of a disorder that may interfere with the evaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, cutaneous lymphoma, etc.). 5. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters. 6. Subjects with unstable medical disorders, life-threatening disease, or current malignancies. 7. Subjects with clinically significant ECG or laboratory abnormalities at Visit 1/Screening (as determined by the Principal Investigator or designee). 8. Subjects who are immunosuppressed. 9. Subjects who have a history of allergy or a known hypersensitivity to any component of the investigational product. 10. Subjects who have been treated with any systemic steroids within the 4 weeks prior to the study entry (intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study, and intra-articular steroid injections are permissible). 11. Subjects who have been treated with systemic or photo antipsoriatic therapies/drugs within 4 weeks prior to study entry including methotrexate, cyclosporine, acitretin and other oral retinoids, broadband or narrowband UVB, PUVA, home or professional tanning lights or other nonprescription UV light sources, photodynamic therapy (PDT), lasers, mycophenalate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-mercaptopurine (6-MP), or etanercept. 12. Subjects who have been treated with biologic therapy other than etanercept within 8 weeks prior to study entry, including adalibumab, infliximab, ustekinumab, golimumab, or rituximab. Vaccines will not be considered an exclusionary biologic treatment. 13. Subjects treated with any other biologic agent not listed here for psoriasis or psoriatic arthritis within 12 weeks. 14. Subjects who have been treated with any topical anti-psoriatic (e.g., salicylic acid, anthralin, tar, etc.,) any topical corticosteroid medications, topical retinoids (e.g., tazarotene, tretinoin), topical Vitamin D analogs (e.g., calcipotriene), topical immunosuppressants (e.g., tacrolimus, pimecrolimus) within 2 weeks prior to study entry. 15. Subjects who have been treated with lithium, antimalarial agents, or quinidine within the 4 weeks prior to study entry. 16. Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken any immunosuppressant medication within 3 months prior to study entry. 17. Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance, in the investigators opinion, with this protocol. 18. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry, and within 120 days for investigational biologic agent. 19. Subjects who have been previously enrolled in this study. ; PRIMARY OUTCOME: Investigators Global Assessment of Disease Severity (IGA); SECONDARY OUTCOME 1: Target Lesion Psoriasis Area Severity Index (PASI)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - vs. Parenteral Docetaxel; BRIEF: This is a multicenter phase IIb study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer, suitable for treatment with a taxane. ; DRUG USED: ModraDoc006; DRUG CLASS: Non-NME; INDICATION: Prostate Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Modra Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically proven prostate cancer with evidence of progressive mCRPC, defined as: 1. Castrate levels of testosterone, defined as ≤ 50 ng/dL (or ≤ 0.50 ng/mL or 1.73 nmol/L) 2. Evidence of progressive metastatic disease as defined by radiographic disease progression or PSA progression 3. With an indication for systemic treatment with docetaxel according to the standard of care 3. Measurable tumour lesions, defined as pelvic and/or extra-pelvic nodal lesions ≥1.5 cm in the short axis or visceral lesions ≥1.0 cm in the longest dimensions and measurable according to RECIST v1.1, bone metastasis as evaluated with 99mTc-methylene diphosphonate (MDP) radionuclide bone scintigraphy 4. Resolution of toxicity of prior therapy to < grade 2 (except for alopecia), as defined by CTCAE v5.0 5. Adequate haematological, renal and hepatic functions: 1. Hemoglobin ≥ 6.0 mmol/l (>9.6 g/dL) 2. ANC ≥ 1.5 x 109 /L 3. Platelet count ≥ 100 x 109 /L 4. Hepatic function defined by serum bilirubin ≤ ULN, ALAT and ASAT ≤ 1.5 x ULN concomitant with alkaline phosphatase ≤ 2.5 × ULN. 5. Renal function defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula, or MDRD). 6. WHO performance status of 0-2 7. Estimated life expectancy of at least 12 weeks 8. Able and willing to swallow oral medication 9. Able and willing to undergo radiologic scans (CT scan) 10. Able and willing to give written informed consent according to local guidelines Exclusion Criteria: 1. Any treatment with investigational drugs, chemotherapy or immunotherapy within 4 weeks prior to receiving the first dose of investigational treatment. Palliative radiotherapy (1x8 Gy dose) is allowed before and during the study, but not in the week prior to start of study treatment. 2. Subjects who have had prior treatment with taxanes. 3. Subjects with symptomatic brain metastases. Subjects asymptomatic in the absence of corticosteroids and anticonvulsant therapy for ≥6 weeks are eligible. Radiotherapy for brain metastasis must have been completed ≥6 weeks prior to start of trial. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Subjects are not permitted to receive anti-epileptic drugs or corticosteroid treatment indicated for brain metastasis. Subjects with a history of leptomeningeal metastases are not eligible. 4. Current malignancies other than mCRPC with exception of adequately treated basal or squamous cell carcinoma of the skin, or adequately treated non-muscular invasive bladder cancer. 5. Absence of highly effective method of contraception as of cycle one day one (C1D1). Men enrolled in this trial must agree to use a highly effective contraceptive method throughout the study. 6. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) 7. Unresolved (>grade 0 as defined by CTCAE version 5.0) gastrointestinal toxicities (pre-existing mucositis, diarrhea or nausea/vomiting) 8. Grade ≥ 2 motor ≥ 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 5.0) 9. Known hypersensitivity to any of the study drugs or excipients or taxanes 10. Concomitant use of P-glycoprotein (P-gp , MDR), CYP3A, OATP1B1, OATP1B3 and MRP2 modulating drugs such as Ca+- entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine and grapefruit juice, concomitant use of HIV medications, other protease inhibitors, (non) nucleoside analogues, or St. Johns wort 11. Bowel obstruction or motility disorder that may influence the resorption of drugs as judged by the treating physician 12. Major surgical procedures within 21 days prior to providing informed consent 13. Active acute or chronic infection, which is not controlled by appropriate medication (at the discretion of the treating physician) 14. Known positivity for Human Immunodeficiency Virus HIV-1 or HIV-2 type 15. Patients with known active infection of hepatitis B, C, or E (patients who are anti-HBC positive but HBsAg negative are eligible to participate in this study) 16. Clinically significant (i.e. active) cardiovascular disease defined as stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina, or congestive heart failure within ≤ 6 months prior to first trial treatment 17. Evidence of any other medical conditions (such as treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, or pulmonary embolism within 4 weeks of randomization, or psychiatric illness, drug or alcohol abuse, physical examination or laboratory findings) that may interfere with the planned treatment, affect subject compliance or place the subject at high risk of treatment-related complications 18. Legal incapacity ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Adverse event profile (Safety)[/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 - BEACON; BRIEF: This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care. ; DRUG USED: Bardoxolone Methyl; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: KEAP1 (Kelch-like ECH-associated protein 1), STAT3 Transcription Factor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: 1. Screening eGFR ≥ 15.0 and < 30.0 mL/min/1.73 m2; 2. A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age; 3. Male or female at least 18 years of age; 4. Treatment with an angiotensin converting enzyme (ACE)inhibitor and/or an angiotensin II receptor blocker (ARB)for at least 6 weeks prior to and during screening. Stable dose 2 weeks prior to and during screening. Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to Screening Visit A; 5. Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be < 90 mm Hg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within this range at two separate time points measured at least 4 days apart during the screening period (blood pressure may be re-evaluated once during an unscheduled visit); 6. Willing to practice methods of birth control (both male and female patients) during the entire study period and for at least 30 days after the last dose of the study drug is ingested; 7. Serum magnesium level must be ≥ 1.3 mEq/L (0.65 mmol/L) at Screening Visit B or during subsequent unscheduled visit during screening (serum magnesium level may be re-evaluated once during an unscheduled visit); 8. Willing and able to cooperate with all aspects of the protocol; 9. Willing and able to give written informed consent for study participation and provide consent for access to medical data according to appropriate local data protection legislation, allowing authorization to access medical records and describe events captured in the endpoints Exclusion Criteria: 1. Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a C-peptide level must confirm type 2 diabetes; 2. Known non-diabetic renal disease (e.g., polycystic kidney disease, focal segmental glomerulosclerosis) [nephrosclerosis superimposed on diabetic kidney disease is acceptable]; 3. Ongoing clinical evidence suggesting non-diabetic renal disease other than nephrosclerosis; 4. History of a renal transplant or a planned transplant from a living donor during the study; 5. Albumin to creatinine ratio (ACR) greater than 3500 mg/g (395.5 mg/mmol); 6. Hemoglobin A1c level > 11.0% (97 mmol/mol) during screening; 7. Acute dialysis or acute kidney injury within 12 weeks prior to screening or during screening; 8. Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 12 weeks following randomization, as assessed by the investigator; 9. Recently active cardiovascular disease defined as: a. Unstable angina pectoris within 12 weeks before study randomization; b. Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 12 weeks before study randomization; c. Cerebrovascular accident, including transient ischemic attack within 12 weeks before study randomization; d. Current diagnosis of Class III or IV New York Heart Association (NYHA) congestive heart failure; 10. Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy; 11. Atrioventricular block, 2o or 3o, not successfully treated with a pacemaker; 12. DAdministration of a contrast agent that may induce nephropathy within 30 days prior to study randomization or planned during the study; 13. Systemic immunosuppression for a total of > 2 weeks, cumulatively, within the 12 weeks prior to randomization or planned during the study; 14. Total bilirubin, aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) levels greater than the upper limit of normal (ULN), or alkaline phosphatase level greater than two times the ULN on ANY screening laboratory test result; 15. Female patients who are pregnant, intend to become pregnant during the study, or are nursing; 16. BMI < 18.5 g/m2 17. Known hypersensitivity to any component of the study drug; 18. Current history of drug or alcohol abuse as assessed by the investigator; 19. Clinically significant infection requiring intravenous administration of antibiotics or hospitalization within 6 weeks of screening or during screening; 20. Hepatitis B surface antigen positive; 21. Diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix or a condition highly likely to transform into malignancy during the course of the study; 22. A clinical condition that in the judgment of the investigator could potentially pose a health risk to the patient while involved in the study; 23. Participation in a clinical study involving any intervention within 30 days prior to randomization, concurrent participation in such a study, or participation in a prior clinical study involving bardoxolone methyl in any form; 24. Unable to communicate or cooperate with the investigator due to language problems, poor mental development or impaired cerebral function. ; PRIMARY OUTCOME: Time-to-first event of the composite endpoint; SECONDARY OUTCOME 1: Rate of change in estimated glomerular filtration rate (eGFR) over the duration of the study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 20929 (US); BRIEF: This is a multi-arm prospective trial that evaluates the ability of a novel imaging radiolabeled agents to detect metastatic cancer in participants with solid tumors using a gallium 68 (68Ga-) or copper 64 (64Cu-) FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors. ; DRUG USED: FAP-2286; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Fibroblast Activation Protein (FAP), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Thomas Hope; CRITERIA: Inclusion Criteria: 1. Age >= 18 years 2. Histopathologically confirmed solid tumors in one of the following cohorts: a. Cohort 1 (n=16): measurable disease is not required for this cohort. i. Agnostic to tumor type. b. Cohort 2 (n=40): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases. i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, or colon cancer. ii. Pathologically confirmed cancer other than noted above (basket subgroup, n=10). c. Cohort 3 (n=30): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases. i. Patients can be imaged at initial staging with what is judged by the treating physician to be high risk disease and where the presence of metastatic disease would greatly impact treatment planning and prognosis. Patients may also be imaged after definitive therapy (surgery, chemotherapy or radiation therapy) if in the determination of the treating physician or investigator there is a high risk of disease recurrence that would also impact treatment plan and/or prognosis. ii. Pathologically confirmed head and neck cancer or bladder cancer. 3. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation. 2. Known pregnancy. ; PRIMARY OUTCOME: Count of participants with treatment-emergent 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 - BP/Heart Rate; BRIEF: The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs). ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening - Glycosylated hemoglobin (HbA1c) value ≥7% and ≤9.5% at screening - Mean blood pressure >90/60 millimeters of mercury (mmHg) and <140/90 mmHg at screening - If treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening - Stable weight for 3 months prior to screening - Body mass index (BMI) greater than or equal to 23 kilogram-meter squared (kg/m^2) - Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions - Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control - Male participants must use a reliable method of birth control Exclusion Criteria: - Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening - Ongoing or history of frequent intermittent tachyarrhythmia - Resting heart rate <60 beats per minute (bpm) or >100 bpm at screening - Work rotating shifts or work during the hours of 2200 to 0700 - Chronic insulin therapy - Use of a glucagon-like peptide 1 (GLP-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening - Nondominant arm circumference >42 centimeter (cm) - Use of drugs to promote weight loss - Chronic use of systemic steroids - Gastric emptying abnormality or bariatric surgery - Hepatitis, other liver disease, or alanine transaminase (ALT) >3 times the upper limit of normal - Acute or chronic pancreatitis - Severe renal impairment - Active autoimmune disease or uncontrolled endocrine abnormality - Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia - Calcitonin value greater than or equal to 20 picograms per milliliter (pg/ml) at screening - Transplanted organ except corneal transplants - Active or untreated cancer or in remission <5 years, except skin, in situ cervical, or prostate cancer - Sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with HbA1c testing ; PRIMARY OUTCOME: Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP); SECONDARY OUTCOME 1: Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)[/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 13370; BRIEF: This study is a multicenter, non-randomized, open-label, Phase 2 study of intravenous LY2090314 in participants with acute leukemia. ; DRUG USED: LY2090314; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Glycogen synthase kinase 3 (GSK-3); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have confirmed diagnosis of one of the following: - Acute myelogenous leukemia (AML) that is refractory or relapsed disease. If participants have acute promyelocytic leukemia (APL), they must have received prior all-trans retinoic acid and arsenic trioxide unless ineligible or intolerant to them - Untreated AML (de novo or arising from a myelodysplastic syndrome). In the opinion of the investigator, the participant should not be a candidate for standard therapy and a clinical trial is a preferred treatment option - Have given written informed consent prior to any study-specific procedures - Have adequate organ function including: - Hepatic: Bilirubin less than or equal to 1.5 times the upper limit of normal (ULN). Alkaline phosphatase (ALP) and transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] less than or equal to 5 times ULN - Renal: Serum creatinine less than or equal to the ULN. No known active renal disease. In rare cases, participants may enter treatment with a serum creatinine greater than the ULN as elevations of serum creatinine may be secondary to dehydration - Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale - Have discontinued all previous approved therapies for acute leukemia, including chemotherapy for at least 14 days, and recovered from the acute effects of therapy. Hydroxyurea used to control peripheral blast count is permitted within the first 2 cycles of treatment on study, but it must be stopped at least 24 hours before study drug administration in Cycle 3 - Are reliable and willing to be available for the duration of the study and are willing to follow study procedures - Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug - Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug - Have an estimated life expectancy of greater than or equal to 6 weeks Exclusion Criteria: - Have received treatment within 14 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication - Participants with chronic myelogenous leukemia (CML) including blast crisis phase - Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging - Have serious pre-existing medical conditions (left to the discretion of the investigator) - Have one of the following abnormalities: QTc (Fridericia corrected) interval >450 milliseconds (msec) on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long QT syndrome, previous history of ventricular tachycardia or unexplained syncope, left bundle branch block, or chronic atrial fibrillation - Have family history of long QT syndrome or sudden death due to ventricular arrhythmia - Concomitant medication that may cause QTc prolongation or induce Torsades de Pointes at the time of study entry - Have systolic blood pressure greater than or equal to 160 millimeter of mercury (mm Hg) and diastolic blood pressure greater than or equal to 100 mm Hg - Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class II or higher or participants with a history of arrhythmia that is symptomatic or requires treatment - Have uncorrected electrolyte disorders including potassium - Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry - Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug - Have uncontrolled systemic infection - Females who are pregnant or lactating - Presence of clinical evidence of viral disease caused by human immunodeficiency virus, hepatitis B, or hepatitis C ; PRIMARY OUTCOME: Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs); SECONDARY OUTCOME 1: Number of Participants With Best Response of Complete Response or Partial Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Low Testosterone Levels; BRIEF: The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels. ; DRUG USED: MVT-602; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypogonadism; TARGET: Gonadotropin-Releasing Hormone (GnRH); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Has total serum testosterone (ST) levels less than 300 ng/dL at Screening. 2. Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening. 3. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the time of signing of informed consent throughout the duration of the study and for 12 weeks after the last dose. Exclusion Criteria: 1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality that may impact the ability of the participant to participate or potentially confound the study results. Participants will be excluded based on: 1. Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening. 2. Is receiving dialysis treatment. 3. Has an American Urological Association (AUA)/ International Prostate Symptom Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram per milliliter (ng/mL) at Screening. 4. Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units per liter (mIU/L) at Screening. 5. Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood pressure >100 mm Hg (if out of range may be repeated once for eligibility determination) at Screening. 6. Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening. 7. Is receiving insulin therapy. 8. Has a hematocrit <30 percent (%) or >48% at Screening. 9. Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1). 2. Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only). 3. Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular disease, such as (but not limited to) Klinefelters syndrome, Kallmanns syndrome, systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilsons disease), or prior pituitary surgery. 4. Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, antiandrogens, clomiphene, or other reproductive hormone-related agents within 6 months prior to Screening. 5. Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA], androstendione, any other androgen, or recombinant human growth hormone) within 1 year of Screening. ; PRIMARY OUTCOME: Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing; SECONDARY OUTCOME 1: Serum Testosterone Cmax: Maximum Observed Plasma Concentration[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - sJIA (Children); BRIEF: A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase time to sJIA flare will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. Once 31 flares are reported the study will be completed. ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Juvenile Rheumatoid Arthritis; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - active sJIA disease according to ILAR criteria before screening and at baseline (Day 1); - Treatment with stable doses of methotrexate (MTX) ≤25 mg/week or ≤20 mg/m2/week, whichever is lower, is permitted; - Treatment with a stable dose of oral prednisone ≤1 mg/kg/day up to a maximum of 30 mg/day, or equivalent, for at least 1 week before the first study drug dose is permitted. Exclusion Criteria: - Previous juvenile idiopathic arthritis (JIA) treatment with tofacitinib. - Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with systemic juvenile idiopathic arthritis (sJIA). Current symptoms or findings of more than minimal pleuritis with sJIA. - Current infection or serious infection within 3 months of study enrollment. ; PRIMARY OUTCOME: Time to flare; SECONDARY OUTCOME 1: Occurrence of disease flare in double-blind phase[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ORA-D-013-1; BRIEF: In this randomized, double-blind, double-dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a 26-week Double-Blind Treatment Extension Period. ; DRUG USED: ORMD-0801; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Oramed, Ltd.; CRITERIA: Inclusion Criteria: - Male and female subjects aged 18 - 75 years. - Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.5% but ≤ 11.0% at Screening. - On a stable dose of at least one and up to three of the following oral glucose-lowering agents: Metformin, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, or sulfonylurea for a period of 3 months prior to Screening. - Body mass index (BMI) of 25-40 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening. - Renal function - GFR ≥ 30 ml/min/1.73 m2. - Females of childbearing potential must: - a. have a negative serum pregnancy test result at Screening. - b. agree to avoid becoming pregnant while receiving IP for at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP. - c. agree to use an acceptable method of contraception at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP. Acceptable methods of contraception are hormonal contraception (contraceptive pill or injection) PLUS an additional barrier method of contraception such as a diaphragm, condom, sponge, or spermicide. - d. In the absence of hormonal contraception, double-barrier methods must be used which include a combination of any two of the following: diaphragm, condom, copper intrauterine device, sponge, or spermicide, and must be used for at least 30 days prior to administration of IP, during the entire study, and for 30 days following their last dose of IP. - e. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subjects preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception. - f. Females who are not of childbearing potential are defined as: - i. Postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); OR - ii. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR - iii. Have a congenital or acquired condition that prevents childbearing. Exclusion Criteria: Subjects with: - Type 1 diabetes. - A history of diabetes mellitus with ketoacidosis or is assessed by the Investigator as possibly having type 1 diabetes mellitus confirmed by a C-peptide < 0.4 ng/mL (0.13 nmol/L) at Screening. - Diabetes attributable to other secondary causes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant). - Treatment involving glucosidase inhibitor, insulin secretagogues (other than sulfonylureas), or GLP-1 receptor agonists within 3 months prior to Visit 1. - A history of >2 episodes of severe hypoglycemia within 6 months prior to Screening. - A history of hypoglycemic unawareness. - A history of unstable angina or myocardial infarction within 6 months prior to Screening, New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure (CHF), valvular heart disease, ventricular cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, coronary angioplasty, stroke or transient ischemic attack (TIA) within 6 months prior to Screening. - A history of uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg. A single repeat measurement will be permitted. - Renal dysfunction: GFR < 30 mL/min/1.73 m2. - Active proliferative retinopathy requiring treatment. - Psychiatric disorders that, per Investigator judgment, may have impact on the safety of the subject or interfere with the subjects participation or compliance in the study. - Laboratory abnormalities at Screening including: - a. C-peptide < 0.4 ng/mL. - b. Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X the upper limit of normal; a single repeat test is allowable. - c. Elevated liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) >3X the upper limit of normal; a single repeat test is allowable. - d. Very high fasting triglyceride levels (>600 mg/dL); a single repeat test is allowable. - e. Any relevant abnormality that would interfere with the efficacy or the safety assessments during study treatment administration. - Positive history of active liver disease (other than non-alcoholic hepatic steatosis), primary biliary cirrhosis, or active symptomatic gallbladder disease. - Positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus ribonucleic acid (RNA). - Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma or carcinoma in situ of the cervix) within the past 5 years prior to Baseline. - Use of the following medications: - a. History of use of any injectable or inhaled, basal, pre-mixed or prandial insulin (greater than 7 days) within 6 months prior to Screening. - b. Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within 6 weeks prior to Screening. - c. Requirements (in the last 12 months), or may require, systemic (oral, intravenous, intramuscular) glucocorticoid therapy for more than 2 weeks during the study period. Intra-articular and/or topical corticosteroids are not considered systemic. - d. Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and immunosuppressive or immunomodulating agents. Inhaled nasal steroids are permissible. - Known allergy to soy. - Involvement in a weight loss program and is not in the maintenance phase, or subject has started weight loss medication (e.g., orlistat or liraglutide) within 3 months prior to Screening. - Prior bariatric surgery. - Subject is pregnant or breast-feeding. - Subject is a user of recreational or illicit drugs or has had a recent history (within 1 year of Screening) of drug or alcohol abuse or dependence. (Note: Alcohol abuse includes heavy alcohol intake as defined by >3 drinks per day or >14 drinks per week or binge drinking) at Screening. Occasional intermittent use of cannabinoid products will be allowed provided that no cannabinoid products have been used during the 1 week prior to each visit. - Contraindications to metformin use as per label. - A history of gastrointestinal disorders (e.g. hypochlorhydria) with the potential to interfere with drug absorption. - Any condition or other factor (at the Investigators discretion) that is deemed unsuitable for subject enrollment into the study. ; PRIMARY OUTCOME: Mean change from baseline in A1C; SECONDARY OUTCOME 1: Mean change in fasting glucose[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Limb Girdle and FSHD (Study 006); BRIEF: ATYR1940-C-006 is a multi-national, multicenter study being conducted at centers in the United States (US) and Europe who participated in Study ATYR1940-C-003 (Stage 1 only) or Study ATYR1940-C-004 (that is, the parent studies). ; DRUG USED: Resolaris; DRUG CLASS: Biologic; INDICATION: Muscular Dystrophy; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: aTyr Pharma, Inc.; CRITERIA: Inclusion Criteria: 1. Enrolled in and completed the treatment period in the parent study. 2. Demonstrated, in the Sponsors and Investigators opinions, acceptable tolerability of ATYR1940. 3. In the Investigators opinion, participant has shown acceptable compliance with ATYR1940 and the study procedures in the parent study and is willing and able to comply with all procedures in the current study. 4. Is, in the opinion of the Investigator and Sponsor, a suitable candidate for continued ATYR1940 treatment. 5. Provide written informed consent or assent after the nature of the study has been explained and prior to the performance of any research-related procedures. Exclusion Criteria: 1. Is expected to require treatment with curcumin or systemic albuterol (intermittent inhaled albuterol is permissible) during study participation; or use of a product that putatively enhances muscle growth (for example, insulin-like growth factor, growth hormone) or activity (for example, Coenzyme Q, Coenzyme A, creatine, L-carnitine) on a chronic basis; or statin treatment initiation or significant adjustment to statin regimen (stable, chronic statin use is permissible). 2. Planned to receive any vaccination during study participation. 3. Abnormal baseline findings, medical condition(s), or laboratory findings that, in the Investigators opinion, might jeopardize the participants safety or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 4. Evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, dermatological, or gastrointestinal disease, or has a condition that requires immediate surgical intervention, other treatment, or may not allow safe participation. 5. If female and of childbearing potential (premenopausal and not surgically sterile), has a positive pregnancy test at entry or is unwilling to use contraception from the time of entry through the 3-month Follow-up visit. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device. 6. If male, is unwilling to use a condom plus spermicide during sexual intercourse from the time of entry through the 1 month Follow-up visit. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Change From Baseline in Creatinine Kinase at Week 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - 04-05; BRIEF: This is an open-label, Phase I study to determine the highest amount of the study drug, ON 01910.Na, that can be safety given to patients with high risk myelodysplastic syndromes (MDS) or refractory leukemias. Patients will receive ON 01910.Na (at a starting dose of 650 mg/m2) intravenously by 3-day continuous infusion once every 2 weeks. Successive courses will use longer infusion times and/or higher doses of the drug until toxicity, effectiveness, or ineffectiveness is recognized. In addition, the amount of drug in the blood will be measured, any antitumor activity will be documented, and the biological effect of ON 01910.Na on cell-cycle pathways will be evaluated in peripheral blood mononuclear cells. ; DRUG USED: Estybon (Intravenous); DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: PI3K/AKT pathway, Polo-like kinase 1 (Plk1); THERAPY: Monotherapy; LEAD SPONSOR: Onconova Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Patient must have histologically documented or cytologically confirmed diagnosis of acute myelocytic leukemia refractory to standard induction treatment, or relapsed after standard therapy - Acute lymphocytic leukemia refractory to induction treatment, or relapsed after effective therapy - Chronic myelocytic leukemia refractory to imatinib therapy or second line tyrosine kinase inhibition, or relapsed after tyrosine kinase inhibition, in chronic, accelerated, or blastic phase - Chronic lymphocytic leukemia refractory to standard therapy, or relapsed in second relapse - A myelodysplastic syndrome (including chronic myelomonocytic leukemia) refractory to a hypomethylating agent - And a int-2 or high myelodysplastic syndrome relapsed after a hypomethylating agent. - Patients may not be eligible for, or must have declined, bone marrow transplantation or other chemotherapeutic regimens known to produce consistent remissions. - There are no hematologic exclusions from treatment. - Patients with prior radiotherapy are eligible unless leukopenia is ascribed to prior radiation treatment, and then entry to study of ON 01910.Na may be initiated when two successive leukocyte counts are rising. - ECOG Performance Status of 0, 1, or 2 if patient is in the dose escalation phase or 0 or 1 if patient is in the dose escalation phase. - Patients may have any hematologic parameters without regard to numbers provided that transfusional support is available and the Investigator stipulates that leukopenia is attributable to disease rather than to prior therapy. - Total bilirubin ≤ 1.5 mg/dL, unless the patient has active hemolysis, or the elevation is secondary to ineffective erythropoiesis. - Serum creatinine ≤ 1.5 mg/dL, or a calculated creatinine clearance of ≥ 60 mL/min/1.73 m2. - Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) while in the study. If a woman becomes pregnant or suspects she is pregnant while on study, her treating physician should be informed immediately. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Patients who have positive blood cultures until they are afebrile for 3 days on antibiotic therapy which will continue. - Patients who have leukopenia attributed to prior chemotherapy until two successive leukocyte counts are increasing. Patients with rapidly rising WBC (e.g. >50% increase over the previous day for 3 consecutive days) or WBC > 40 x 109/L. - Patients who have continuing toxicity other than hematologic from prior therapy until it has resolved to grade 1 or less and will not compromise ON 01910.Na administration. - Patients who are receiving any other investigational agents or concurrent chemotherapy, radiotherapy, or immunotherapy. - Patients receiving corticosteroids or colony-stimulating factors may continue on these treatments. These agents will not be introduced if previously not employed. - Patients with known meningeal infiltration may be included in this clinical trial only if intrathecal therapy and/or radiation has been completed, and cerebrospinal fluid cytology is improved. - Patients with a history of allergic reactions attributable to compounds of similar chemical or biologic composition to ON 01910.Na. - Patients should have no major third space fluid accumulation, ascites requiring active medical management including paracentesis, peripheral bilateral edema, or hyponatremia (serum sodium value less than 134 Meq/L). - Patients with uncontrolled intercurrent illness including, but not limited to uncontrolled ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant and nursing women are excluded from this study. - HIV-positive patients receiving combination anti-retroviral therapy are excluded. ; PRIMARY OUTCOME: Safety data, including laboratory parameters and adverse events, will be collected for all patients in order to determine the qualitative and quantitative toxicity, and reversibility of toxicity, of ON 01910.Na.; SECONDARY OUTCOME 1: To investigate the clinical pharmacology of ON 01910.Na including plasma pharmacokinetics, pharmacodynamics and biological effects on cell-cycle pathways.[/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 - 205 (w/Tarceva); BRIEF: A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1 randomization scheme. ; DRUG USED: Linsitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Combination; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Histologically confirmed locally advanced or metastatic stage IIIB or IV NSCLC - Have experienced Complete Response (CR), Partial Response (PR) or Stable Disease (SD) following completion of 4 cycles of first-line platinum-based chemotherapy and are not progressing at time of entry into study (prior completed first-line combination bevacizumab therapy is permitted; however, current use of maintenance bevacizumab is not permitted. A maximum interval of 28 days between the last day of the treatment cycle and randomization - Patient has recovered from prior chemotherapy-related toxicity to ≤ grade 2 - EGFR mutation status must be confirmed for participation in the study. EGFR analysis can be performed either by central or local laboratory. If analysis is done locally, verifiable documentation confirming the EGFR mutation status must be submitted for review and approval by APGD prior to randomization. If no local result is available, formalin-fixed, paraffin-embedded archival tissue representative of the tumor or in the absence of archival tissue, a fresh tumor tissue sample of sufficient size to perform EGFR mutation analysis must be submitted centrally. Results of the central analysis must be available prior to randomization. Additionally, subjects should provide tissue blocks centrally for biomarker analysis whenever possible. Ideal tissue requirement: block with ≥5 mm2 tumor area sufficient to provide four 4-micron, and five 10-micron sections) - Measurable disease (for those patients with PR or SD after first-line platinum-based chemotherapy) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) - Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) 0 - 1 - Previous adjuvant or neo-adjuvant treatment is permitted - Must be able to take oral medication - Fasting glucose ≤ 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic antihyperglycemic therapy is permitted if the dose has been stable for ≥ 4 weeks at the time of randomization - Adequate hematopoietic, hepatic, and renal function defined as follows: - Neutrophil count ≥ 1.5 x 109/L - Platelet count ≥ 100 x 109/L - Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) - AST and ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if patient has documented liver metastases - Serum creatinine ≤ 1.5 x ULN - Potassium, magnesium and calcium within normal limits (supplementation and retesting is permitted) Female patient must be either: - Of non child bearing potential: - post-menopausal (defined as at least 1 year without any menses) prior to Screening, or - documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening) - Or, if of childbearing potential: - must have a negative urine pregnancy test at Screening, and - must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 30 days after final study drug administration - Female patient must not be breastfeeding at Screening or during the study period and for 30 days after final study drug administration - Female patient must not donate ova starting at Screening and throughout the study period and for 30 days after final study drug administration - Male patient and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 30 days after final study drug administration - Male patient must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration - Prior radiation therapy is permitted provided patients have recovered from acute toxic effects of radiotherapy prior to randomization. A minimum of 28 days must have elapsed between the end of radiotherapy and randomization - Prior surgery is permitted provided that the surgery was performed 21 days prior to randomization and adequate wound healing has occurred prior to randomization - Patients must provide written (signed) informed consent to participate in the study and for use of tumor tissues Exclusion Criteria: - Prior exposure to agents directed at the Human Epidermal Receptor (HER) axis (eg, erlotinib, gefitinib, cetuximab, and trastuzumab) - Malignancies other than NSCLC within past 3 years (exceptions if curatively treated: basal or squamous cell carcinoma of skin; locally advanced prostate cancer; ductal carcinoma in situ of breast; in situ cervical carcinoma; and superficial bladder cancer) - Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy - Prior insulin-like growth factor receptor (IGF-1R) - Prior investigational agent within 21 days prior to randomization - Concurrent use of maintenance bevacizumab - History of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohns disease, ulcerative colitis, etc) - History (within last 180 days) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea) - History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded - Mean QTcF interval > 450 msec based on independent central reviewer analysis of screening visit ECGs - Use of drugs that have a known risk of causing Torsades de Pointes (TdP) are prohibited within 14 days prior to randomization - Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded - Use of potent CYP3A4 inhibitor such as ketoconazole, clarithromycin, atazanavir, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), or voriconazole - Use of proton pump inhibitors such as omeprazole. Use of H2-receptor antagonists such as ranitidine are not excluded - History of cerebrovascular accident (CVA) within 180 days prior to randomization or that resulted in ongoing neurologic instability - Active infection, serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization), or serious chronic illness that would impair the ability of the patient to receive study drug - History of any psychiatric or neurologic condition that might impair the patients ability to understand or to comply with the requirements of the study or to provide informed consent - Pregnant or breast-feeding females - Symptomatic brain metastases that are not stable, require steroids, or that have required radiation and/or other related treatment (e.g., anti-epileptic medication) within 21 days prior to randomization - History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug - Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening or during the course of the study ; PRIMARY OUTCOME: The Progression Free Survival (PFS) of maintenance OSI-906 plus erlotinib, or placebo plus erlotinib in patients with nonprogression following four cycles of first-line platinum-based chemotherapy for advanced NSCLC in the overall population; SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Breast Cancer Metastatic to Brain; BRIEF: The goal of the first part of this clinical research study is to find the highest tolerable dose of TPI-287 in patients with breast cancer that has spread to the brain. The goal of the second part of this study is to learn if TPI-287 can control breast cancer that has spread to the brain. The safety of this drug will also be studied. ; DRUG USED: TPI-287; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Secondary; Metastases); TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Patients must have histologically proven breast cancer with metastatic disease to the brain. 2. Patients must have measurable disease on MRI that has progressed after prior therapy. PD will be defined as a>/= 25% increase in the sum of the products of greatest perpendicular diameters of all measurable disease over the smallest sum observed (since treatment started) on Gd-MRI, the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans. 3. Patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease 4. Patients must be >/=18 years of age. 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. 6. Patients must have adequate bone marrow function as evidenced by an absolute neutrophil count >/=1,500/microliters and a platelet count >/=100,000/microliter, adequate renal function as evidenced by serum creatinine </=2.0 mg/dL, adequate hepatic function as evidenced by serum total bilirubin </=2.0 mg/dL, AST/serum glutamate oxaloacetate transaminase (SGOT) and ALT/serum glutamate pyruvate transaminase (SGPT) </= 3X the upper limit of normal (ULN). 7. Patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of white blood cell count (WBC) and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame. 8. Women of child-bearing potential (i.e. </= 50 years of age or has had menstrual cycle within the past 12 months, if > 50 years of age. If in doubt, check FSH, LH and estradiol level) must have a negative urine or serum pregnancy test at screening. 9. Sexually active patients must agree to use adequate contraception (abstinence or barrier contraceptives must be used throughout the trial and one month after end of treatment) for the duration of the study . 10. Patients or their legal representative must be able to read, understand and sign an informed consent form (ICF). 11. TPI 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their PT, PTT and international normalized ratio (INR). Exclusion Criteria: 1. Patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received EIAEDs within 2 weeks prior to the first dose of study drug. 2. Patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management). 3. Patients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollment 4. Patients who are taking bevacizumab or have taken bevacizumab within the past 2 weeks for treatment of their brain metastases 5. Patients with an active infection (i.e., clinical signs or symptoms, including, but not limited to: bleeding/pustulant skin infections; productive cough associated with fever) on antibiotics or with a fever >/=38.5°C within 3 days prior to registration (i.e. date when the patient signs the consent and/or the patient is registered in CORE). 6. Patients with New York Heart Association (NYHA) Class 3 or 4 congestive heart failure. 7. Patients with known HIV or Hepatitis B or C 8. Patients who are pregnant or lactating or not practicing adequate contraception 9. Patients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patients ability to sign the ICF or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results. 10. Patients who are receiving concomitant systemic therapy for breast cancer. 11. Patients with leptomeningeal disease (LMD) or with a history of LMD will be excluded. ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Trial 14377 (Japan); BRIEF: The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia. ; DRUG USED: Cymbalta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fibromyalgia; TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants fulfilling the following criteria in the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia - Participants with pain rated severity 4 or over by Brief Pain Inventory (BPI) - average pain severity item (Question 3) Exclusion Criteria: - Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators - Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 international units per liter (IU/L) or total bilirubin of not less than 1.6 milligrams per deciliter (mg/dL) - Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis - Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment - Participants with treatment-refractory fibromyalgia - Participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by 3-month or longer drug therapy - Participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency - Participants with an axis I condition according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV), currently or within the past year, except for major depressive disorders - Participants with a lifetime diagnosis of bipolar disorder or schizoaffective disorder; or any other disorder with psychotic symptoms - based on the clinical opinion of the investigator - Participants with personality disorder or mental retardation - Participants with uncontrolled angle closure glaucoma - Participants with present or past history of uncontrolled seizures or convulsion disorders - Participants with suicidal ideation within past 6 months, with suicidal attempt within past 1 year - Participants answering yes to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 6 months (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section) - Participants with past history of multiple episodes of drug allergy - Female participants who are pregnant, lactating, or who want to get pregnant during the study period. Male participants who want his partner to get pregnant - Females of child-bearing potential who cant agree to utilize medically. acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study - Participants with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol, but excluding nicotine and caffeine) within the past 1 year - Participants who have a positive urine drug screen for any substance of abuse (phencyclidine, cocaine, antihypnotic agent, or cannabis) - Participants previously treated with duloxetine ; PRIMARY OUTCOME: Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM); SECONDARY OUTCOME 1: Patients Global Impression of Improvement (PGI-I) at Endpoint[/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 - HER2-Expressing Cancers; BRIEF: This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK). ; DRUG USED: Zanidatamab; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. HER2-expressing cancer as follows: Part 1: - Cohorts 1 - 3: Any locally advanced (unresectable) and/or metastatic HER2-expressing (HER2 1+, 2+, or 3+ by IHC) cancer (including but not limited to breast, gastric, ovarian, colorectal and non-small cell lung) that has progressed after receipt of all therapies known to confer clinical benefit - Cohort 4: - HER2 IHC 2+ /FISH- breast cancer or gastroesophageal adenocarcinoma (GEA) - HER2 IHC 3+ or HER2 IHC 2+ /FISH+ breast cancer or GEA - Any other HER2 IHC 3+ or FISH+ cancer - HER2-overexpressing (3+ by IHC) or HER2-2+ and FISH+ breast cancer must have progressed after prior treatment with trastuzumab, pertuzumab, and T-DM1 - HER2-overexpressing (3+ by IHC) or HER2-2+ and FISH+ GEA must have progressed after prior treatment with trastuzumab - Patients with colorectal cancer must be KRAS wild-type - Patients with NSCLC must have ALK wild-type, EGFR wild-type, and ROS1 fusion negative as determined by standard methods - Cohorts 5 - 6: HER2 IHC 3+ or HER2 IHC 2+ /FISH+ GEA must have progressed after prior treatment with trastuzumab - Cohort 7 (only at selected sites): HER2 IHC 3+, HER2 IHC 2+ /FISH+, or HER2 IHC 2+ /FISH- breast cancer must have progressed after prior treatment with trastuzumab, pertuzumab, and T-DM1 Part 2: Locally advanced (unresectable) and/or metastatic cancer that has progressed after receipt of all therapies known to confer clinical benefit (unless ineligible to receive a specific therapy) as follows: - Cohort 1: HER2 IHC 2+/FISH- breast cancer - Cohort 2: HER2 IHC 3+ or HER2 IHC 2+/FISH+ breast cancer - Cohort 3: HER2 IHC 2+/FISH- GEA - Cohort 4: HER2 IHC 3+ or HER2 IHC 2+/FISH+ GEA - Cohort 5: Any other HER2 IHC 3+ or IHC 2+/FISH+ cancer, including the following: - Cohort 5a: HER2 IHC 3+ or IHC 2+/FISH+ GI cancers other than GEA (patients with colorectal cancer must be KRAS wild-type.) - Cohort 5b: Any other HER2 IHC 3+ or IHC 2+/FISH+ solid tumor types that are not breast or GI cancers (patients with NSCLC must have ALK wild-type, EGFR wild-type, and ROS1 fusion negative as determined by standard methods; patients with ovarian cancers must be KRAS wild type.) Part 3: Locally advanced (unresectable) and/or metastatic cancer as follows: - HER2 IHC 1+ or IHC2+/FISH- breast cancer patients (TGs 1, 2, or 3) who have received at least 1 and no more than 3 prior systemic chemotherapy regimens - HER2 IHC 3+ or IHC 2+/FISH+ breast cancer patients (TGs 1, 2, or 3) who have received prior therapy with trastuzumab, pertuzumab, and T-DM1, at least 1 and no more than 3 prior systemic chemotherapy regimens - HER2 IHC 2+ or 3+ FISH+ or FISH- GEA patients (TGs 1 or 2) who have received at least 1 and no more than 3 prior systemic chemotherapy regimens - HER2 IHC 3+ or IHC 2+/FISH+ GEA patients who have received prior therapy with trastuzumab (TG4; ZW25 + paclitaxel) - HER2 IHC 3+, IHC 2+/FISH+ or otherwise HER2-positive per ASCO/CAP guidelines breast cancer patients who have received prior therapy with trastuzumab, pertuzumab, and T-DM1 (TG5; ZW25 + capecitabine) - HER2 IHC 3+, IHC 2+/FISH+ or otherwise HER2-positive per ASCO/CAP guidelines breast cancer patients (TG6) who have received prior therapy with trastuzumab, pertuzumab, and T-DM1 - HER2 IHC 3+, IHC2+/FISH+, or otherwise HER2-positive per ASCO/CAP guidelines breast cancer patients (TG7) who have received prior therapy with trastuzumab, pertuzumab, and T-DM1 - HER2 IHC 3+, IHC 2+/FISH+, or otherwise HER2-positive per ASCO/CAP guidelines breast cancer patients (TG8) who have received prior therapy with trastuzumab, pertuzumab, and T-DM1 2. ≥ 18 years of age 3. ECOG performance status of 0 or 1 4. Life expectancy of at least 3 months per the investigators assessment. 5. Adequate organ function 6. Adequate cardiac left ventricular function, as defined by a LVEF >/= institutional standard of normal 7. For Part 1 Cohorts 1 - 3: evaluable disease (target or non-target lesions) per RECIST version 1.1. For Part 1 Cohorts 4 - 7, and Parts 2 and 3: measurable disease (target lesions) per RECIST version 1.1 8. Able to provide tumor sample (fresh or archived) 9. For Part 3 TGs 7 and 8 only - based on screening brain MRI, patients must have one of the following: - No evidence of brain metastases - Untreated brain metastases not needing immediate local therapy. For patients with untreated CNS lesions > 2.0 cm on screening contrast brain MRI, discussion with and approval from the medical monitor is required prior to enrollment - Previously treated brain metastases that are either stable since treatment or have progressed since prior local CNS therapy, provided there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator Exclusion Criteria: 1. Experimental therapies within 4 weeks before first ZW25 dosing 2. Treatment with other cancer therapy not otherwise specified within 4 weeks before ZW25 dosing 3. Anthracyclines within 90 days before first ZW25 dosing or lifetime load exceeding 300 mg/m² adriamycin or equivalent 4. Trastuzumab, pertuzumab, lapatinib, or T-DM1 within 3 weeks before first ZW25 dosing 5. Patients in Part 3 TG4 must not have received prior taxanes 6. Patients in Part 3 TG5 must not have received prior capecitabine for metastatic disease or received any prior fam-trastuzumab deruxtecan-nxki (DS-8201a) 7. With the exception of Part 3 TGs 7 and 8, untreated brain metastases (patients with treated brain mets who are off steroids and are stable for at least 1 month at the time of screening are eligible) 8. Pregnant or breast-feeding women 9. History of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in drug formulation 10. Acute or chronic uncontrolled renal disease, pancreatitis or liver disease (with exception of patients with Gilberts Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment) 11. Peripheral neuropathy > Grade 2 12. Clinically significant interstitial lung disease 13. Known active hepatitis B or C or known infection with HIV 14. Immunosuppressive corticosteroids equivalent to > 15mg/day of prednisone within 2 weeks before first ZW25 dose 15. QTc Fridericia (QTcF) > 450 ms 16. Having clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic CHF 17. Having known myocardial infarction or unstable angina within 6 months before first ZW25 dosing 18. Patients in Part 3 TG7 must not have received prior capecitabine or tucatinib for metastatic disease 19. Patients in Part 3 TG8 must not have received prior tucatinib therapy for metastatic disease ; PRIMARY OUTCOME: The proportion of patients who experience dose-limiting toxicities (DLTs) (Part 1); SECONDARY OUTCOME 1: Serum concentrations of ZW25[/INST]No</s>

<s>[INST]<<SYS>>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 - ISLE-1; BRIEF: This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c). ; DRUG USED: HDV-L; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Diasome Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Men and women ≥ 18 yrs. of age 2. Clinical diagnosis of Type 1 diabetes mellitus for at least 12 months 3. Body Mass Index (BMI) ≤ 35 Kg/m2 4. Basal insulin includes insulin Glargine or insulin Detemir 5. Patient should be using bolus insulin defined as 2 to 4 doses of regular human insulin or rapid-acting analog at meals 6. HbA1c ≥ 7.0% and ≤ 10.5% 7. Fasting C-peptide ≤ 0.5 pmol/mL 8. Willingness to adhere to protocol and perform all required tests 9. Willing and able to review and sign the Informed Consent Form. 10. If child bearing age, must use acceptable form of birth control (ligation, 2 forms of birth control) 11. Willing to wear CGM devices and complete diaries. Exclusion Criteria: 1. Total daily insulin dose ≥ 1.5 IU/kg/day. 2. History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that effect HbA1c measurements 3. Evidence of serious complications of diabetes (eg, Symptomatic autonomic neuropathy) 4. Patients who are selected to but are unwilling or unable to participate in the MRI evaluation subset. (These patients may still participate in the non-MRI subset). 5. Significant cardiovascular dysfunction or history within 12 months of Screening, eg, congestive heart failure (New York Heart Association Class III or IV), or clinically significant arrhythmia, myocardial infarction, cardiac surgery; history of valvular heart disease including mild or greater aortic insufficiency, or moderate or greater mitral insufficiency; recurrent syncope, transient ischemic attacks, or cerebrovascular accident 6. Impaired liver function with elevated enzymes > 50% above the normal range at Screening. Patients with elevated liver enzymes may have the test repeated only at Visit 2 on a case-by-case basis at the request of the PI. 7. Creatinine level > 2 mg/dL for men, and > 1.8 mg/dL for women at Screening. 8. Patient on low carbohydrate diet, such as Atkins Diet 9. History of Adrenal supplementation within 3 years of Screening. 10. History of unawareness or SEVERE recurrent hypoglycemia, defined as a patient who is unaware of symptoms of hypoglycemia, or due to autonomic dysfunction, has no inherent warnings of hypoglycemia, and therefore requires outside assistance to rectify any episodes of hypoglycemia 11. Patients treated with systemic corticosteroids (Sporadic use of inhaled, intraarticular, and topical corticosteroids is not considered systemic). 12. Patients with triglyceride levels ≥500 mg/dL at Screening. 13. Patients with a history of cancer within the past 5 years, excluding basal or squamous cell carcinoma localized to the skin. 14. Epilepsy or other physical or medical conditions which could result in non-compliance with the study. 15. Participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study 16. Unwilling to discontinue use of an insulin pump for the duration of the study. 17. Women who are pregnant, nursing, or planning to become pregnant during the course of the study. 18. Patients on NPH as their basal insulin. 19. Positive history of hepatitis A (within 12 months of Screening), or a positive history of hepatitis B, hepatitis C, or HIV at Screening. 20. History of drug addiction and/or alcohol abuse within 12 months of Screening. ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: Change in fasting blood glucose glucose levels[/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 - Open Label Extension Study 314; BRIEF: The purpose of this study is to determine the long-term safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Has completed either study LuAA21004_315 ( NCT01153009), LuAA21004_316 (NCT01163266), or LuAA21004_317 (NCT01179516) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the Week 8 [Lu AA21004_317] or Week 10 [Lu AA21004_315 or Lu AA21004_316] assessment of the preceding protocol). - Suffers from a recurrent major depressive episode) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) at entry into the prior study. - Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this participant according to the opinion of the investigator. - Females of childbearing potential who are sexually active with a nonsterilized male partner agree to routinely use adequate contraception throughout the duration of the study. Exclusion Criteria: - Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study. - In the investigators clinical judgment, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS). - In the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. - Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study. - Has used/uses disallowed concomitant medication. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%; SECONDARY OUTCOME 1: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score[/INST]Yes</s>