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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 - Diabetic; BRIEF: The purpose of the study is to analyse skin blood flow in diabetic patients. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397. The analysis of safety and tolerability are secondary objectives of this study. ; DRUG USED: BAY 1193397; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral Arterial Disease (PAD); TARGET: Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - The informed consent must be signed before any study specific tests or procedures are done (patient must be able to give informed consent, no legal representative allowed) - Patients with a diagnosis of type II diabetes mellitus and PAD (peripheral artery disease) and/or microangiopathy as evidenced by at least one of the following criteria: 1. TBPI (toe / brachial blood pressure index) < 0.7 at screening 2. ischemic or neuro-ischemic DFU (diabetic food ulcer) in medical history (verified by medical records) 3. clinical diagnosis of PAD in medical history (verified by medical records) 4. diagnosis of nephropathy that is most likely due to diabetes mellitus type II 5. diagnosis of diabetic retinopathy 6. diagnosis of diabetic polyneuropathy - Age 55 to 75 years (inclusive) at the screening visit - Non-smokers are preferred for inclusion in this study. If smokers are included, they must refrain from smoking on the days of treatment periods 1, 2, and 3 until all examinations have been performed - Patients are expected to be on stable medication during study conduct. No planned changes in drug therapy during active treatment period of the study (i.e. from treatment period 1 to treatment period 3) is allowed. - Men or confirmed postmenopausal women (defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone [FSH] levels > 40 mIU/mL) or women without childbearing potential based on surgical treatment 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification). Male patients, who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for 12 weeks after receiving the investigational medicinal product and not to act as sperm donor for 12 weeks after dosing. Acceptable methods of contraception include for example: a) condoms (male or female) with or without a spermicidal agent b) diaphragm or cervical cap with spermicide c) intrauterine device d) hormone-based contraception - Ability to understand and follow study related instructions Exclusion Criteria: - Patients with existing lower limb ulcers - Patients with nailfold capillaries at the great toe that are technically difficult to assess - Patients suffering from PAD Fontaine Stage 4 - Patients requiring planned revascularization - Patients suffering from diseases other than diabetes mellitus that are known to lead to disturbances in skin microcirculation or interfering with the method of measurement such as Raynauds disease, collagen vascular disorders , atopic dermatitis, psoriasis - Myocardial infarction, acute coronary syndrome, transient ischemic attack (TIA), stroke, revascularization, angioplasty within 3 months prior to randomization - Any planned surgical intervention during the course of the study - Medical condition or history thereof or any deviation from normal laboratory values that in the opinion of the investigator would impair the ability to complete the planned study procedures. - Any surgical or medical condition which significantly alters absorption, distribution, metabolism or excretion of study drugs, including, but not limited to: history of major gastrointestinal (GI) tract surgery, inflammatory bowel disease, currently active gastritis, pancreatitis, treatment with cholestyramine and colestipol resins - Patients with HbA1c > 12% (> 108 mmol/mol) at the screening visit - Any other condition or therapy, which would make the subject unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months) - Use of alpha- or beta-AR (adrenoreceptor) agonists - Use of alpha-AR antagonists - Use of serotonin/norepinephrine reuptake inhibitors (SNRIs) - Use of tricyclic antidepressants at a dose equivalent of more than 50 mg amitryptyline - No pedicure or nail polish is allowed from screening until the end of the active study period (end of treatment period 3) - Systolic blood pressure below 100 mmHg or above 180 mmHg at the screening visit based on the average of three readings taken from the arm with the highest systolic recordings - Diastolic blood pressure below 50 or above 110 mmHg at the screening visit based on the average of three readings taken from the arm with the highest systolic recordings - Heart rate below 50 or above 100 beats/min at screening (obtained from ECG) - Clinically relevant findings in the physical examination which, in the opinion of the investigator, preclude participation for reasons of the patients safety - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) formula at screening ; PRIMARY OUTCOME: Change in resting capillary blood flow velocity (CBV); SECONDARY OUTCOME 1: Number of subjects with treatment-emergent adverse events (TEAEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD/MAD (Healthy Volunteers); BRIEF: This is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male and female subjects (on non-child bearing potential) will be enrolled to investigate single inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The Clinical trial will involve 42 healthy participants. The trial is expected to last approximately 4 months. ; DRUG USED: Molgradex; DRUG CLASS: Biologic; INDICATION: Pulmonary Alveolar Proteinosis (PAP); TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116; THERAPY: Monotherapy; LEAD SPONSOR: Savara Inc.; CRITERIA: Inclusion Criteria: 1. Healthy, adult, male or female, 18- 55 years of age, inclusive, at screening. 2. Life-long non smoker who has not used nicotine containing products. 3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening. 4. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, spirometry, vital signs, or ECGs, as deemed by the PI. 5. Females must be of non-child bearing potential who must have undergone one of the following sterilization procedures at least 6 months prior to dosing in Part 1 or prior to the first dose in Part 2: - hysteroscopic sterilization; - bilateral tubal ligation or bilateral salpingectomy; - hysterectomy; - bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to dosing in Part 1 or prior to the first dose in Part 2, and FSH serum levels consistent with postmenopausal status as per PIs judgment. 6. A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non vasectomized male). 7. If male must agree not to donate sperm from dosing in Part 1 or from the first dose in Part 2, until 90 days following last dose. 8. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol. Exclusion Criteria: 1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study. 2. History or presence of clinically significant medical condition(s) (including ongoing active infections) or psychiatric condition(s) or disease(s) in the opinion of the PI. 3. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study. 4. Abnormal spirometry test results, in the opinion of the PI. 5. History of severe or unexplained adverse reactions during aerosol delivery of any medicinal product. 6. History or presence of alcoholism or drug abuse within the past 2 years prior to screening. 7. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim or to related compounds (i.e., Growgen®, Leucomax®, Leukine®, Topleucon™). 8. Clinically significant history or presence of ECG abnormalities such as second- or third degree atrioventricular block, evidence, or family history of prolonged QT syndrome. 9. Allergy to bandaids, adhesive dressing, or medical tape. 10. Positive urine drug at screening or check in. 11. Positive alcohol test at check-in. 12. Drink alcohol in excess of 21 units per week for males or 14 units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol. 13. Positive urine cotinine at screening and check-in. 14. Positive results at screening for HIV, HBsAg, or HCV. 15. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening. 16. Seated heart rate is lower than 45 bpm or higher than 99 bpm at screening. 17. QTcF interval is >430 msec (males) or >450 msec (females) at screening or deemed clinically abnormal by the PI. 18. Unable to refrain from or anticipates the use of: - Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing in Part 1 or prior to the first dose in Part 2, and throughout the study. Hormone replacement therapy (HRT) is not permitted in this study and within 3 months prior to screening. During the study paracetamol (up to 2 g per 24 hours) may be administered at the discretion of the PI. - Any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. Johns Wort, for 28 days prior to dosing in Part 1 or prior to the first dose in Part 2, and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/PD interaction with study drug. 19. Have been on a diet incompatible with the on study diet, in the opinion of the PI, within the 28 days prior to the first dose of study drug, and throughout the study. 20. Haemoglobin or total WBC outside the normal range at screening. 21. Donation of blood or plasma within 90 days prior to dosing in Part 1 or prior to the first dose in Part 2. 22. Donation of bone marrow within the last 6 months prior to dosing in Part 1 or prior to the first dose in Part 2. 23. Participation in another clinical trial within 90 days prior to dosing in Part 1 or prior to the first dose in Part 2. ; PRIMARY OUTCOME: Number and severity of treatment-emergent Adverse Events (AEs) following single and multiple inhaled doses of molgramostim; SECONDARY OUTCOME 1: PK parameters: Area under the plasma concentration time curve (AUC), Peak Peak Plasma concentration - Cmax, Time to reach maximum observed serum concentration - tmax[/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 - COG; BRIEF: This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. 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. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively. ; DRUG USED: Epratuzumab; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Cluster of Differentiation 22 (CD22); THERAPY: Combination; LEAD SPONSOR: Childrens Oncology Group; CRITERIA: Inclusion Criteria: - Diagnosis of B lymphoblastic leukemia (B-ALL) - At least 25% expression of CD22 by immunophenotyping - In marrow relapse (M3 bone marrow) with or without associated extramedullary disease as defined by 1 of the following: - In first or later marrow relapse occurring any time after initial diagnosis (part A [closed to accrual as of 10/30/06] or B) - In first, early marrow relapse with or without associated extramedullary disease occurring < 36 months from the time of initial diagnosis (part B only) - No B-cell L3 morphology OR evidence of a regulator gene that codes for a transcription factor (MYC) translocation by molecular or cytogenetic analysis - No Down syndrome - Patients with CNS or other extramedullary site involvement are allowed - Performance status - Karnofsky 50-100% (for patients > 10 years of age) - Performance status - Lansky 50-100% (for patients ≤ 10 years of age) - White Blood Count (WBC) ≤ 50,000/mm^3 (part A only [closed to accrual as of 10/30/06]) - Bilirubin ≤ 1.5 times upper limit of normal unless disease-related (ULN) - Alanine aminotransferase (ALT) ≤ 5 times ULN - Albumin ≥ 2 g/dL - Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min - Creatinine as defined by age as follows: - ≤ 0.5 mg/dL (for patients < 1 year old) - ≤ 0.8 mg/dL (for patients 1 to 5 years old) - ≤ 1.0 mg/dL (for patients 6 to 10 years old) - ≤ 1.2 mg/dL (for patients 11 to 15 years old) - ≤ 1.5 mg/dL (for patients > 15 years old) - Shortening fraction ≥ 27% by echocardiogram - Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) - No dyspnea at rest - No exercise intolerance - Pulse oximetry > 94% - No active or uncontrolled infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Recovered from prior immunotherapy - At least 4 months since prior stem cell transplantation or rescue AND no evidence of active graft-vs-host disease - At least 7 days since prior hematopoietic growth factors - At least 7 days since prior biologic therapy* - No other concurrent immunotherapy - No other concurrent biologic therapy - Recovered from prior chemotherapy - No waiting period for children who relapse while receiving standard ALL maintenance therapy - No prior cumulative anthracycline exposure > 400 mg/m^2* - No concurrent chemotherapy - Recovered from prior radiotherapy - No concurrent radiotherapy - At least 2 days since prior hydroxyurea - No other concurrent investigational drugs - No other concurrent anticancer agents ; PRIMARY OUTCOME: Remission Re-induction (CR2) Rate; SECONDARY OUTCOME 1: Pharmacokinetics[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Chronic Low Back Pain; BRIEF: The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain. ; DRUG USED: Troxyca ER; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Moderate-to-severe chronic low back pain present for at least 3 months. - Require a continuous around-the-clock opioid analgesic for an extended period of time. - Refrain from taking other opioid and non-opioid medications during the study. Exclusion Criteria: - Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention. - Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain. - Active or ongoing or history of alcohol or drug abuse. ; PRIMARY OUTCOME: Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12); SECONDARY OUTCOME 1: Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IBD w/Iron Deficiency Anemia (EU/India); BRIEF: The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb). ; DRUG USED: Monoferric; DRUG CLASS: Non-NME; INDICATION: Anemia; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Pharmacosmos A/S; CRITERIA: Inclusion Criteria: Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following criteria: 1. Men and women, aged more than 18 years. 2. Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohns disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis). 3. Hb <12.0 g/dL (7.45 mmol/L). 4. Transferrin saturation (TfS) <20 %. Exclusion Criteria: 1. Anaemia predominantly caused by other factors than iron deficiency anaemia. 2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis). 3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate). 4. Known hypersensitivity to any excipients in the investigational drug products. 5. Subjects with a history of multiple allergies. 6. Active Intestinal Tuberculosis. 7. Active Intestinal amoebic infections. 8. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper limit normal). 9. Acute infections (assessed by clinical judgement), supplied with white blood cells (WBC) and C-reactive protein (CRP)). 10. Rheumatoid arthritis with symptoms or signs of active joint inflammation. 11. Pregnancy and nursing 12. Extensive active bleeding necessitating blood transfusion. 13. Planned elective surgery during the study. 14. Participation in any other clinical study within 3 months prior to screening. 15. Intolerance to oral iron treatment. 16. Untreated B12 or folate deficiency. 17. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit. 18. Erythropoetin treatment within 8 weeks prior to screening visit. 19. Diagnosis of Hepatitis B and/or C, confirmed by appropriate lab test. 20. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus. 21. History of immunocompromise, including positive HIV test result ; PRIMARY OUTCOME: Change in Hb concentration from baseline to week 8.; SECONDARY OUTCOME 1: Number of subjects who achieve target limits of Hb (men 13-18 g/dL, women 12-16 g/dL) and have change in Hb concentration > 1.0 g/dL and have serum ferritin (100-800µg/L) and have achieved Transferrin saturation (TfS) (20-50 %) at week 2, 4 and 8.[/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 - GMAIS; BRIEF: The purpose of this research study is to determine whether the investigational drug GM602, is effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot blocking the flow of blood through one, or more of the blood vessels supplying the brain) when administered up to 18 hours after symptoms begin. ; DRUG USED: GM602; DRUG CLASS: Biologic; INDICATION: Ischemic Stroke; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Genervon Biopharmaceuticals, LLC; CRITERIA: Inclusion Criteria: - > 18 years old - Be eligible for MRI or CT scan - Have suffered acute ischemic stroke in the middle cerebral artery (MCA) distribution, as verified by the Screening diffusion-weighted imaging (DWI) abnormality and Screening perfusion-weighted imaging pressure-work index (PWI ) abnormality - Have NIH Stroke Scale (NIHSS) score total score of 9-20 inclusive at screening - Have suffered acute ischemic stroke within 18 hours - Have been functionally independent with a Modified Rankin Score (mRS) of 0 or 1 prior to suffering stroke - Patients who received tPA or FDA approved mechanical device can also enroll - completed informed consent form Exclusion Criteria: - Have history of stroke in the past 3 months - Cannot be evaluated using MRI/CT - Have stroke of the brainstem or cerebellum - Have clinical presentation consistent with acute MI by EKG criteria (STEMI) at screening - Have hemorrhage revealed by CT or MRI scan - Have > 1/3 MCA territory HYPER intensity as seen on MRI OR >1/3 MCA territory HYPO intensity as seen on CT - Have blood sugar level >400 mg/DL or<50 mg/dL - Have kidney disease, creatinine > 2.0 - Have had recent (within 90 days) serious head trauma or head trauma with loss of consciousness - Have any prior history of seizure - Have clinically relevant pre-existing neurological deficit (Historical Rankin score ≥ 2) - Have any other known clinically significant medical disorder (cardiovascular, hepatic, renal, endocrine, respiratory, immunological, cancer, AIDS) - Life expectancy of less than 6 months due to comorbid conditions - Women of child bearing potential who are pregnant or breast-feeding or unable to practice birth control during the study period - Have participated in any other trial of an investigational agent within 90 days prior to screening - Informed consent cannot be obtained - Unable to participate in study visits ; PRIMARY OUTCOME: Functional Outcome as measured by the difference in percent change in NIHSS from baseline to 90 days in patients treated with GM602 within 18 hours compared to treated with placebo as primary efficacy endpoint; SECONDARY OUTCOME 1: Functional Outcome as measured by the difference in percent change in NIHSS from baseline to 30 days in patients treated with GM602 compared to treated with placebo[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Study 002 (Expansion Study); BRIEF: This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers. ; DRUG USED: HemaMax; DRUG CLASS: Biologic; INDICATION: Acute Radiation Syndrome (ARS); TARGET: IL-12 (Interleukin-12) and IL-12 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Neumedicines Inc.; CRITERIA: Inclusion Criteria: - Male and Female subjects, who have signed the informed consent form must meet all of the following criteria 1. 18 to 45 years of age 2. Body mass index (BMI) > 19 and < 0 kg/m2 3. Normal ECG, vital signs and laboratory test results 4. Use of effective birth control method and abstinence from sex 5. Negative pregnancy test and drug screen Exclusion Criteria: - Subjects with any of the following characteristics will be considered ineligible: 1. History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease 2. Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB) 3. Current drug or alcohol addiction 4. History of clinically significant allergy of any kind 5. Prior use of IL-12 or HemaMax 6. Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months ; PRIMARY OUTCOME: To determine the safety and tolerability of HemaMax in healthy subjects.; SECONDARY OUTCOME 1: To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects[/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 - Solid Tumors; BRIEF: This phase I dose escalation study is intended to define the safety, tolerability and maximal tolerable dose (MTD) of MT110 in patients with advanced solid tumors. ; DRUG USED: AMG 110; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Cluster of Differentiation 3 (CD3), Epithelial cell surface antigen (Ep-CAM)/ CD326; THERAPY: Monotherapy; LEAD SPONSOR: Amgen Research (Munich) GmbH; CRITERIA: Inclusion Criteria: 1. Locally advanced, recurrent or metastatic solid tumors known to widely express EpCAM and proven histology of the following entities: - Adenocarcinoma of the lung - Small cell lung cancer (SCLC) - Gastric cancer or adenocarcinoma of gastro-esophageal junction - Colorectal cancer (CRC) - Hormone-refractory prostate cancer (HRPC) - Breast cancer - Ovarian cancer Patients must not be amenable to curative therapy. Patients should have exhausted or declined standard therapeutic options and previous therapies should have included at least one course of chemotherapy. 2. Non-measurable disease or at least one measurable tumor lesion as per RECIST criteria 3. Age >/= 18 years 4. ECOG performance status </= 2 5. Life expectancy of at least 3 months 6. Must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, endocrine therapy, immunotherapy, radiotherapy or surgery. - This generally means at least 4 weeks since major surgery, radical radiotherapy or myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin C). - At least 4-5 half-lives (t1/2) must have elapsed since treatment with an investigational agent. - At least 4 weeks since any hormonal therapy (except LHRH agonists for patients with HRPC) prior to initiating MT110 treatment. 7. Ability to understand the patient information and informed consent form 8. Signed and dated written informed consent Exclusion Criteria: 1. Evidence of central nervous system (CNS) metastases on baseline computer tomography (CT) or magnetic resonance imaging (MRI) scan (mandatory for all patients), current or past relevant history of other CNS pathology (except migraine, headache and minor incidental findings in the MRI without any clinical manifestation within the last five years). All minor incidental findings should be discussed with the Sponsors Medical Monitor). 2. Neutrophil count < 1,500/mm3 (= 1.5 x 10^9/l) 3. Platelet count < 100,000/mm3 (= 100 x 10^9/l) 4. White blood cells (WBC) < 3 x10^9/l 5. Hemoglobin < 9.0 g/dl 6. Abnormal renal or hepatic function as defined below: - Alkaline phosphatase (AP)>/= 2.5 x upper limit of normal (ULN) and/or aspartate aminotransferase (AST, SGOT), alanin aminotransferase (ALT, SGPT) >/= 2.0 x ULN or AP, AST and/or ALT >/= 3 x ULN in case of liver metastases; γ-glutamyl transpeptidase (GGT) >/= 5.0 x ULN - Total bilirubin >/= 1.5 x ULN - Creatinine clearance < 50 ml/min calculated by the Cockroft-Gault formula or MDRD (modification of diet in renal disease) - Lipase/amylase > 1.5 x ULN - D-dimer >/= 10 x ULN - Antithrombin activity < 70% - International normalized ratio (INR) > ULN - Partial thromboplastin time (PTT) > ULN 7. Oxygen (O2) saturation of < 92% (under room air condition) 8. Any concurrent anti-neoplastic therapy with the exception of radiotherapy for palliation of symptoms after agreement by the Sponsors Medical Monitor. No radiation is allowed for defined measurable lesions according to RECIST. Patients with HRPC who have received LHRH-agonist therapy for >1 month, should continue agonist therapy. 9. Any concurrent disease, medical or social condition that could affect compliance with the protocol or interpretation of results as judged by the investigator. In particular, patients with the following conditions are not allowed to enter the study: - Autoimmune and inflammatory diseases including vasculitis, rheumatoid arthritis, systemic lupus erythematosus (SLE), multiple sclerosis and similar conditions - Active infection or known bacteremia - Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus - Severe dyspnea or pulmonary dysfunction or need for continuous supportive oxygen inhalation - Insufficient cardiac function defined as NYHA (New York Heart Association) Grade 3 or 4 - History of acute or chronic pancreatitis 10. Chronic systemic corticosteroid therapy longer than 2 months or any other immunosuppressive therapies or stem-cell transplantation. 11. Presence of human anti-murine antibodies (HAMA) or known hypersensitivity to immunoglobulins or to other ingredients of the infusion solution. 12. Pregnant, nursing women or women of childbearing potential who are not willing to use effective forms of contraception during participation in the study and at least three months thereafter. 13. Male patients with partners of child-bearing potential who are not willing to use effective contraception during the trial and for at least three months thereafter, unless surgically sterile. ; PRIMARY OUTCOME: Overall frequency and intensity of adverse events (AEs) (clinical symptoms, laboratory abnormalities, serious adverse events [SAEs] and dose-limiting toxicities); SECONDARY OUTCOME 1: Pharmacokinetics of MT110; T-cell counts, kinetics, and activation status; Serum cytokine concentrations; Immunogenicity; Anti-tumor activity; Other progressive disease (PD) parameters[/INST]No</s>

<s>[INST]<<SYS>>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 - University of Ferrara; BRIEF: Study No.001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy, can be equally controlled by guidelines recommended regular bid treatment with long acting beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol (experimental treatment) versus regular, twice daily 160/4.5 mcg inhaled budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended treatment). ; DRUG USED: Symbicort; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Combination; LEAD SPONSOR: Università degli Studi di Ferrara; CRITERIA: Inclusion Criteria: - Male or female out-patient aged from 18 years to 65 years - Clinical diagnosis of moderate persistent asthma for at least 6 months, according to GINA revised version 2006 guidelines - Post-bronchodilator forced expiratory volume (FEV1) at least 80% of the predicted - Either positive methacholine challenge test (PC20 FEV1< 4mg/ml or PD20 FEV1<0.8 mg) or positive response to the reversibility test in the last year - Asthma either not adequately controlled with low-dose (≤500 mcg beclomethasone or equivalent) inhaled corticosteroids (ICS) or controlled by bid inhaled combination of low-dose ICS/long acting beta-2 agonists (LABA) - A co-operative attitude and ability to be trained to correctly use the dry powder inhalator and to complete the diary cards - Written informed consent obtained Exclusion Criteria: - Inability to carry out pulmonary function testing - Moderate severe asthma associated with reduced lung function - History of near-fatal asthma and/or admission intensive care unit because of asthma - 3 or more courses of oral corticosteroids or hospitalization for asthma during the previous year - Diagnosis of COPD as defined by the GOLD guidelines - Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 8 weeks - Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 pack/years - History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, or cardiac arrhythmias - Diabetes mellitis - Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months - Abnormal ECG - Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g., active peptic ulcer), neurological or haematological autoimmune diseases - Malignancy - Any chronic diseases with prognosis < 2 years - Pregnant or lactating females or not able to exclude pregnancy during the study period - History of alcohol or drug abuse - Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use - Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients - Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study - Patients who received any investigational new drug within the last 12 weeks - Patients who have been previously enrolled in this study ; PRIMARY OUTCOME: comparison between groups of the relative risk for treatment failure; SECONDARY OUTCOME 1: number of treatment failures[/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 - 093; BRIEF: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication. ; DRUG USED: Durysta; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin F receptor (FP)/PGF2 alpha receptor ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: Inclusion Criteria: - Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment. Exclusion Criteria: Exclusion Criteria: - Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months. - Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received. ; PRIMARY OUTCOME: Change from Baseline in IOP at Week 4; SECONDARY OUTCOME 1: IOP change from baseline at Week 8[/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 - Rectal Adenocarcinoma; BRIEF: This is a phase I study incorporating bavituximab into the care of patients with rectal adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no reference therapy as we are trying to identify the MTD of bavituximab in this combination. ; DRUG USED: Bavituximab; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Phosphatidylserine; THERAPY: Combination; LEAD SPONSOR: University of Texas Southwestern Medical Center; CRITERIA: Inclusion Criteria: - Biopsy-proven invasive adenocarcinoma of the rectum, stage T3-4 and/or node-positive (AJCC stage II or III). For the purpose of this study, a tumor is located in the rectum when its distal edge is located within 12cm of the anal verge. The distal edge of the tumor can be delineated by digital examination or endoscopic examination, including colonoscopy, although rigid proctoscopy is preferred. - Age > 18 years. - Performance status of 0 or 1 on the ECOG scale is required (See Appendix 1). - Adequate organ and marrow function as defined below: - leukocytes ≥ 3,000/mcL - absolute neutrophil count ≥ 1,500/mcL - platelets ≥ 100,000/mcl - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal - creatinine <1.5 X institutional upper limits of normal - aPTT ≤1.5 X institutional upper limits of normal - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: - Has not undergone a hysterectomy or bilateral oophorectomy; - or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). - Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: - Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia). - Bleeding 1. Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding (excluding bleeding from rectal tumor), and hemoptysis within the 12 months before screening. If clinically significant bleeding has occurred within 12 months of screening but the cause has been identified and adequately treated (e.g., cystitis, ulcer), then this exclusion criterion does not apply. 2. Minor biopsy-related bleeding lasting < 24 hours and resolved at least 1 week before Study Day 1 is allowed. - Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) within 6 months of screening. - Ongoing therapy with oral or parenteral anticoagulants; low-dose anticoagulation to maintain patency of lines is allowed. - Concurrent estrogens, anti-estrogens or progesterone compounds. - Any prior radiation for rectal cancer. - Symptomatic or clinically active brain metastases. - Major surgery within 4 weeks of Study Day 1. - Pregnant or nursing women. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of blood clotting abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements. - Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of screening. - Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis. - Known hypersensitivity to any components of the treatments. - History of malignancy other than non-melanoma skin cancers within 5 years prior to study enrollment. - Subjects receiving other investigational agents thirty days prior to study treatment or during treatment. - History of inflammatory bowel disease ; PRIMARY OUTCOME: dose-limiting toxicities (DLT); SECONDARY OUTCOME 1: adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - PLIANT; BRIEF: The present trial is designed to determine whether pre-treatment with PledOx lowers the frequency and severity of side effects from FOLFOX6 administration in patients with metastatic colorectal cancer. The efficacy of PledOx will be assessed when added to FOLFOX6 chemotherapy as first line treatment of metastatic colorectal cancer. This study was performed in multiple parts/phases. Part 1 was an open dose-escalation study with the doses 2, 5 and 10 micromol/kg of calmangafodipir. No study outcomes were planned for this part. In part 2a, participants randomly received either Placebo, 2 or 10 micromol/kg of calmangafodipir. In part 2b, participants randomly received either Placebo, 2 or 5 micromol/kg of calmangafodipir. The overall intent of the study was to compare the effect of antioxidant agent PledOx against placebo in one of three different doses/combinations (2 micromol/kg, 5/10 micromol/kg, 2/5/10 micromol/kg vs. placebo, in the first 8 cycles of FOLFOX6 treatment ; DRUG USED: PledOx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chemotherapy Induced Peripheral Neuropathy (CIPN); TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Combination; LEAD SPONSOR: Egetis Therapeutics; CRITERIA: Inclusion Criteria: - Advanced metastatic colorectal (stage IV) cancer verified by biopsy - Patients may have received up to three previous treatment lines of chemotherapy, which may include fluoropyrimidine, irinotecan and targeted therapies. The last dose of antitumor drug must be given at least 4 weeks prior to inclusion and all toxicity (except alopecia and fatigue) resolved. Patients may also be chemotherapy-naïve, have received prior adjuvant treatment but no previous treatment with oxaliplatin - CT-scan or MRI of thorax, abdomen and pelvis; within ≤4 weeks before start of chemotherapy - Evaluable disease and one measurable site of disease according to RECIST 1.1 criteria (at least 10mm for CT-scan or MRI) - Neurological examination with no significant pathological findings - ≥18 years - WHO performance status 0≤2 and Life expectancy ≥ 3 months - Adequate haematological function, Hb ≥ 100 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L - Adequate renal and hepatic functions: creatinine clearance >50 cc/min, total bilirubin ≤ 1.5 times ULN, ASAT and ALAT ≤ 3 times ULN (ASAT and ALAT ≤ 5 times ULN in case of liver metastases) - INR ≤1.5 times ULN, unless receiving therapeutic anticoagulation - Negative pregnancy test for females of child-producing potential - Written informed consent given Exclusion Criteria: - Tumours other than colorectal adenocarcinomas (within the previous 5 years) except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix - Evidence of central nervous system metastases - Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohns disease or ulcerative colitis - History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure, myocardial infarction or unstable angina in the past six (6) months prior to Day 1 of treatment and serious arrhythmias requiring medication for treatment - Prolonged QTC interval >450 msec - Known history of stroke or cerebrovascular accident in the past six (6) months - Severe diarrhoea - Chronic infection or uncontrolled serious illness causing immunodeficiency - Any uncontrolled serious illness or medical condition - Received mangafodipir at any time - Welders, mine workers or other workers in occupations (current or past) where high manganese exposure is likely - Pre-existing neurodegenerative disease (Parkinsons, Alzheimers, Huntingtons etc.) or neuromuscular disorder (Multiple sclerosis, Amyotrophic lateral sclerosis, Polio, hereditary neuromuscular disease) - Major psychiatric disorder (major depression, psychosis) - Participation in another clinical study with an investigational medicinal product within 1 month prior to inclusion. - Blood manganese concentration values >18.3 μg/L at screening ; PRIMARY OUTCOME: Number of Patients With Neuropathy Grade 2 or Higher (According to the Oxaliplatin Specific Sanofi Scale (OSSS) Criteria Related Paraesthesia/Dysaesthesia); 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 - PTC (BRAF V600+); BRIEF: This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs. ; DRUG USED: Zelboraf; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thyroid Cancer; TARGET: Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult participants. >/= 18 years of age - Histologically confirmed metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective; participants whose tumors exhibit areas of other histology may be enrolled, provided the tumor histology remains predominantly papillary - Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test) - Radioactive Iodine resistant disease - Prior therapy excluding (Cohort 1, TKI Naive) or including (Cohort 2, TKI Experienced) TKI - Clinically relevant disease progression according to RECIST criteria within the prior 14 months - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate hematological, renal and liver function Exclusion Criteria: - Histological diagnosis other than papillary PTC, including squamous cell variants of PTC or PTC with areas of squamous metaplasia - Active or untreated central nervous system metastases - History of or known carcinomatous meningitis - Anticipated or ongoing administration of any anti-cancer therapies other than those administered in the study - Active squamous cell skin cancer that has not been excised or adequately healed post excision - Previous treatment with any agent that specifically and selectively targets the MEK or BRAF pathway - Prior radiotherapy to the only measurable lesion - Clinically relevant cardio-vascular disease or event within the prior 6 months ; PRIMARY OUTCOME: Best Overall Response Rate in TKI-Naive Participants; SECONDARY OUTCOME 1: Best Overall Response Rate in TKI-Experienced Participants[/INST]No</s>

<s>[INST]<<SYS>>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 - China; BRIEF: This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity. ; DRUG USED: CGX1321; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Curegenix Inc.; CRITERIA: Inclusion Criteria: - Histologically-diagnosed advanced Gl tumors, such as colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, bile duct carcinoma, hepatocellular carcinoma, esophageal carcinoma that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment - Eastern Cooperative Oncology Group (ECOG) score of 0 - 1 - Minimum estimated life expectancy of 3 months - Adequate organ function - Recovery from prior treatment-related toxicities - Ability to swallow capsules - Willingness for subjects of reproductive potential to use adequate methods of contraception during and for 3 months after study treatment Exclusion Criteria: - Prior exposure to a WNT inhibitor - Received previous therapy for malignancy within 21 days - Major surgery within 4 weeks of first dose of study drug - Radiotherapy within 2 weeks of first dose of study drug - Significant GI or variceal bleeding or subdural hematoma within 3 months of treatment start - Uncontrolled central nervous system metastases or leptomeningeal metastases - Requirement for immunosuppressive agents (must be off for at least 7 days) - Currently receiving medications that are known CYP3A4/5 inhibitors. Patients currently receiving medications of known inducers of CYP3A4/5 or substrates of CYP2C8/9 and CYP1A2 may be excluded. - Bone abnormalities - Hypercalcemia - Cardiac abnormalities - Known human immunodeficiency virus positive, or active hepatitis A, B or C - History of additional prior malignancy with the exception of surgically cured carcinomas such as skin, prostate, bladder, thyroid, cervix or other carcinomas in situ - Active systemic infection requiring intravenous antibiotics within 2 weeks of treatment start - Pregnancy or lactation ; PRIMARY OUTCOME: Number of participants with adverse events and/or abnormal laboratory values that are related to treatment; SECONDARY OUTCOME 1: CGX1321 maximum or peak concentration[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - FMF; BRIEF: Establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever. ; DRUG USED: Ilaris; DRUG CLASS: Biologic; INDICATION: Inflammatory Disorders; TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female patients between 12 and 75 years of age with active type 1 FMF disease (according to Tel-Hashomer criteria for diagnosis of FMF) despite colchicine therapy (1.5 to 2.0 mg/day). - Patients who are intolerant to effective doses of colchicine (1.5 to 2 mg/day) - Patients with demonstrated minimum 1 typical acute attack per month and genetic confirmation of diagnosis (with at least one of the known MEFV gene exon 10 mutations). Patients with manifested amyloidosis are excluded. - Patients must have a historical data showing a frequency of at least 1 attack/month within the last 3 months before they can be enter the run-in period. - Patients must have type 1 disease characterized by recurrent and short episodes of inflammation and serositis with an average of at least 1 documented acute FMF attack per month during the previous 6 months and lasting approximately 12 to 72 hours. - Patients treated with IL-1 therapies must complete washout and have experienced at least 2 attacks since (e.g. Anakinra: 3 day washout; Rilonacept: 3 week washout) - Patients treated with anti-TNF drugs must undergo appropriate washout. Prior to randomization, use of Etanercept must be discontinued for 4 weeks or use of Adalimumab or Infliximab must be discontinued for 8 weeks. - Female subjects of childbearing potential must be using two acceptable methods of contraception - Patients treated with Interferon therapies must complete 1 month washout period. Exclusion Criteria: - Patients with end-organ dysfunction due to amyloidosis (e.g. existing biopsy proven amyloidosis or proteinuria > 0.5 gram per day) - Patients taking steroids within 1 month prior to baseline - Presence or history of any other inflammatory rheumatic disease - Positive PPD test (according to local guidance) where a latent or active TB infection cannot be excluded via Quantiferon (T-Spot or radiographic imaging if needed). - Patients who are pregnant or lactating - Presence of any active or chronic infection or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 30 days or oral antibiotics within 14 days prior to screening - History or a malignancy within the last 5 years, except for successfully excised squamous or basal cell carcinoma of the skin Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period.; SECONDARY OUTCOME 1: To assess the effect of canakinumab with regard to percentage of patients with no attacks in month 3.[/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 - ACOUSTICS (Adolescents); BRIEF: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab (High or Low) or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period. ; DRUG USED: Lebrikizumab; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1 - Bronchodilator response during screening - Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3 - On high dose ICS therapy for >/= 6 months prior to Visit 1 - On an eligible second controller medication for 6 months prior to Visit 1 - Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization - Demonstrated adherence with controller medication during the screening period Exclusion Criteria: - History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection - Maintenance oral corticosteroid therapy within 3 months prior to Visit 1 - Treatment with systemic (oral, intravenous [IV], or intramuscular [IM]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period - Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study - Infection that meets the following criteria: Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening - History of active tuberculosis requiring treatment - Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection - Evidence of acute or chronic hepatitis or known liver cirrhosis - History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma - Diagnosis or history of malignancy or current evaluation for potential malignancy - Current smoker or former smoker with a history of greater than (>) 10 pack-years - History of alcohol or drug abuse - Past and/or current use of any anti- interleukin (IL) -13 or anti-IL-4/IL-13 therapy, including lebrikizumab - Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1 - Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening - History of bronchial thermoplasty ; PRIMARY OUTCOME: Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period; SECONDARY OUTCOME 1: Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Week 52[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PK Study; BRIEF: This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male and female participants with stable mild, moderate or severe renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in adult male and female participants with stable end-stage renal disease undergoing hemodialysis. ; DRUG USED: Nacubactam; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Body Mass Index (BMI) between 18 and 38 kilograms per square-meter (kg/m^2) and body weight of at least 45 kilograms (kg) Control group participants, Part 1 only: - Normal renal function based on creatinine clearance greater than or equal to (>=) 90 milliliters per minute (mL/min) at the Screening visit - Healthy for age-group, as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) Participants with renal impairment, Part 1 only: - Reduced renal function based on estimated creatinine clearance at the Screening visit. Creatinine clearance can be estimated from serum creatinine concentration at the Screening visit using the Cockcroft-Gault equation, or be a historical measured value obtained within the preceding 3 months. Participants with severe, moderate or mild renal impairment must have creatinine clearance of less than or equal to (<=) 29, 30 to 59, or 60 to 89 mL/min, respectively - Stable renal function. The stability of renal function will be confirmed by two determinations of serum creatinine separated by at least 7 days (one of which can be a historical value within the last 3 months). Renal function will be considered stable if the 2 serum creatinine values differ by <=30 percent (%) of the lower value Participants with end-stage renal disease in Part 2 only: - Reduced renal function with a clinical diagnosis of end-stage renal disease requiring renal replacement therapy - Receiving hemodialysis for more than 3 months at the time of the Screening visit Exclusion Criteria: - Recipient of a renal transplant (Part 1 only) - Presence of renal carcinoma, or acute renal disease caused by infection or drug toxicity - Nephrotic syndrome (defined as plasma albumin less than [<] 3 grams per deciliter [g/dL] and/or proteinuria greater than [>] 3 grams per day [g/day]) - Hemoglobin concentration <10 g/dL, or <9 g/dL for participants with end-stage renal disease - Potassium concentration >5.5 millimoles per liter (mmol/L) - Clinically significant liver disease - Uncontrolled blood pressure - Any condition associated with intra-vascular volume depletion - Any unstable clinically significant disease - Any other ongoing condition or disease (apart from renal dysfunction), or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study, place the participant at undue risk or interfere with the ability of the participant to complete the study - Major surgery or significant traumatic injury <28 days prior to the first administration (excluding biopsies), or anticipation of the need for major surgery during study treatment - Recent history of alcoholism, drug abuse, or addiction within the last year prior to screening - Positive test at Screening of any of the following: Hepatitis A, Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) - Clinically significant change in disease status as judged by the investigator, or any major illness within the 4 weeks prior to the Screening visit, or febrile illness within 14 days prior to the Screening visit - Use of prohibited medications, or alteration to a concomitant medication treatment regimen considered relevant by the investigator within 14 days before the Screening visit - Known history of clinically significant hypersensitivity or severe allergic reaction to any drug, in particular antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams) - Participation in another clinical study with an investigational drug or device within the 1 month preceding the Screening vist - Donation or loss of over 500 milliliters (mL) of blood within the 3 months before the Screening visit ; PRIMARY OUTCOME: Total Body Clearance (CL) of RO7079901 Using Plasma Concentration Data; SECONDARY OUTCOME 1: Area Under the Plasma Concentration-Time Curve From Time 0 to infinity (AUC0-inf) of RO7079901[/INST]No</s>

<s>[INST]<<SYS>>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/Bevacizumab (Study 18); BRIEF: The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide (TMZ) therapy and that has progressed following prior bevacizumab therapy. ; DRUG USED: TPI-287; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Cortice Biosciences, Inc.; CRITERIA: Inclusion Criteria: 1. Histologically proven GBM 2. Disease progression following radiation & TMZ 3. 1st progression of GBM on bevacizumab-containing regimen or within 8 weeks of discontinuing bevacizumab. In either case, must have received a minimum of 8 weeks (4 infusions) of bevacizumab. 4. Baseline MRI must be performed after subject signs informed consent form (ICF), within 17 days of Day 1, & on steroid dosage that has been stable or decreasing for at least 5 days 5. Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery & subject has recovered from surgery 6. Life expectancy >12 weeks 7. Eighteen years old or older 8. KPS equal to or greater than 70 9. Recovered from toxic effects of prior therapy to < Grade 2 toxicity per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1. Minimum duration required between prior therapy & Day 1 is: 1. At least 12 weeks from completion of radiation therapy except if there is unequivocal evidence for tumor recurrence in which case at least 4 weeks 2. 4 weeks from prior cytotoxic therapy 3. 4 weeks from prior experimental drug 4. 6 weeks from nitrosoureas 5. 3 weeks from procarbazine 6. 1 week for non-cytotoxic agents (e.g., interferon, tamoxifen, & cis-retinoic acid) 7. 14 days from last dose of bevacizumab 10. Adequate bone marrow function [absolute neutrophil count (ANC) > 1,500/mm3 & platelet count of > 100,000/mm3], adequate liver function [alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <3 x upper limit normal (ULN), alkaline phosphatase <2 x ULN, & total bilirubin <1.5 mg/dL], & adequate renal function (BUN & creatinine <1.5 x ULN) 11. Minimum hemoglobin of 9 g/dL 12. Males & women of childbearing potential must agree to abstain from sex or use an adequate method of contraception for duration of study & for 6 months after last dose of study drug 13. Signed & dated ICF prior to Screening evaluations Exclusion Criteria: 1. Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor 2. Evidence or suspicion of disease metastatic to sites remote from supratentorial brain 3. Prior treatment with anti-vascular endothelial growth factor (VEGF) drugs other than bevacizumab 4. Prior treatment with tyrosine-kinase inhibitors targeting VEGF, platelet-derived growth factor, fibroblast growth factor, tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 (TIE-2), or angiopoietin (or their receptors) 5. Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin (mTOR) inhibitors 6. Prior treatment with TPI 287 7. Treatment with Enzyme-Inducing Anti-Epileptic Drugs within 2 weeks prior to Day 1 8. Treatment with drugs or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4 or 2C8 within 2 weeks prior to Day 1 9. Received more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, dose counts against total dose limit. 10. Prior taxane, vincristine, or other microtubule inhibitor chemotherapies for treatment of GBM or other malignancy 11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during course of study 12. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 13. Any condition, including the presence of clinically significant laboratory abnormalities, which places subject at unacceptable risk if he/she were to participate in study or confounds the ability to interpret data from study, including: 1. Active infection including known AIDS or Hepatitis C or with a fever ≥38.5°C within 3 days prior to study enrollment 2. Diseases or conditions that obscure toxicity or dangerously alter drug metabolism 3. Serious intercurrent medical illness (e.g., symptomatic congestive heart failure) 14. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent subject from providing informed consent 15. Inadequately controlled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg) 16. Prior history of hypertensive crisis or hypertensive encephalopathy 17. New York Heart Association Grade II or greater congestive heart failure 18. History of myocardial infarction or unstable angina within 6 months prior to Day 1 19. History of stroke or transient ischemic attack within 6 months prior to Day 1 20. Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 21. History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 22. Evidence of bleeding diathesis or significant coagulopathy (in absence of therapeutic anticoagulation) 23. Grade 2 or higher peripheral neuropathy per NCI CTCAE 24. History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 25. Serious, non-healing wound, active ulcer, or untreated bone fracture 26. Proteinuria at Screening. Subjects with a urine dipstick protein ≥ 2+ at Screening will undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible. 27. Known hypersensitivity to any inactive ingredient of bevacizumab 28. Known hypersensitivity to any inactive ingredient of TPI 287 29. Pregnancy (positive pregnancy test) or lactation 30. Inability to comply with protocol or study procedures 31. Previously or currently enrolled in Protocol No. TPI-287-17 ; PRIMARY OUTCOME: Safety of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab as measured by AEs, physical/neurologic exam, KPS, weight, vital signs, hematology, serum chemistry, & urinalysis; SECONDARY OUTCOME 1: Efficacy of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab as measured by median progression free survival (PFS), overall response rate, & PFS rate at 4 & 6 months (PFS4 & PFS6)[/INST]No</s>

<s>[INST]<<SYS>>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 - 002 (Healthy/Obese Males); BRIEF: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8521. Part 1 primary hypothesis: Administration of single subcutaneous (SC) doses of MK-8521 is sufficiently safe and well- tolerated in healthy participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation. Part 2: Administration of multiple once daily SC doses of MK-8521 is sufficiently safe and well-tolerated in healthy lean and obese participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation. ; DRUG USED: MK-8521; DRUG CLASS: Unknown; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Males of either 18 to 45 or 45 to 70 years of age depending on the component of the study - Body Mass Index between either 18-25 or 30-40 kg/m^2 depending on the component of the study - Is in good health - Is a non-smoker and/or has not used nicotine for at least 3 months Exclusion Criteria: - Is mentally or legally incapacitated, has significant emotional problems or has a history of psychiatric disorders in the past 5 years - Has a history of the following abnormalities or diseases: endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological. - History of cancer - History of significant multiple or severe allergies or has had an anaphylactic reaction or significant intolerability to drugs or food - Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) - Had major surgery, donated or lost 1 unit (500 mL) of blood or participated in another study within prior 4 weeks - Has irritable bowel disease or recurrent nausea, vomiting, diarrhea or abdominal pain - History of acute or chronic pancreatitis - Uses 2 weeks prior to trial, or anticipates using during trial, medications, drugs or herbal remedies such as St. Johns Wort - Consumes greater than 3 glasses of alcohol per day - Consumes greater than 6 servings of caffeinated beverages per day - Regularly uses illicit drugs or has a history of drug (including alcohol) abuse within prior 3 months - Has known hypersensitivity to glucagon or any glucagon like peptide 1 (GLP-1) receptor agonist - Is unwilling/unable to consume standardized meals and/or is on a carbohydrate restricted diet - Has history of hypersensitivity to pharmacologic insulins ; PRIMARY OUTCOME: Number of Participants Who Experienced at Least One Adverse Event (AE) (Part 1); SECONDARY OUTCOME 1: Change From Baseline in Time-weighted Average From 0 to 24 Hrs (TWA0-24hr) of Heart Rate (HR) After a Single Dose of MK-8521 (Part 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 - Systemic Sclerosis w/ Interstitial Lung Disease; BRIEF: The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease. ; DRUG USED: Pomalyst; DRUG CLASS: New Molecular Entity (NME); INDICATION: Scleroderma; TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria - Male or females between 18 and 80 years of age (inclusive) at the time of consent. - Diagnosis of systemic sclerosis (SSC) as defined by American College of Rheumatology (ACR) criteria. - Onset of the first non-Raynauds manifestation of SSC within 7 years of Screening. - Subjects are required to meet at least one of the following 2 pulmonary-related criteria to be eligible for the study:. i) FVC readings ≥ 70% and ≤ 80% at Screening and Baseline (Visit 2) with a documented history of either or both of:. A. A ≥ 5% decrease (expressed as percent predicted or in liters) in FVC in the 24-month period prior to Baseline (Visit 2) based on 3 or more assessments. Two assessments may be done during the Screening phase provided the assessments are completed at least 2 weeks apart. B. A high resolution computed tomography (HRCT) fibrosis score > 20%. ii) Forced vital capacity (FVC) ≥ 45% and <70% at Screening and Baseline (Visit 2) [with or without a documented pre-specified FVC decline or fibrosis score]. - FVC at Baseline (Visit 2) within 5% of the FVC measured at Screening. - Carbon monoxide diffusing capacity (DLco) ≥ 35% and ≤ 80% of predicted value at Screening. - Abnormalities on High-Resolution CT consistent with parenchymal changes encountered in SSc: honeycombing or reticular changes with or without ground glass. Exclusion Criteria - Oxygen saturation (SpO2) < 92% (room air [sea level] at rest) at Screening or Baseline. - Known diagnosis of obstructive lung disease as defined by forced expiratory volume (FEV1)/FVC ratio < 0.7. - Diagnosis of pulmonary arterial hypertension (PAH) requiring treatment. - Known diagnosis of other significant respiratory disorders (e.g., asthma, tuberculosis, sarcoidosis, aspergillosis, chronic bronchitis, neoplastic disease, cystic fibrosis, etc.). - Current clinical diagnosis of another inflammatory connective tissue disease (eg, systemic lupus erythematosus, rheumatoid arthritis, primary Sjogrens syndrome, etc.). Subjects having Sjogrens syndrome secondary to SSc are eligible. - Pregnant or lactating females. - History of a thromboembolic event (eg, deep vein thrombosis, thrombotic cerebrovascular or cardiovascular events). - History or current diagnosis of peripheral neuropathy. - Use of concomitant medication(s) which could increase the risk for developing deep vein thrombosis, including sex steroid-based contraceptives (oral, injectable or implanted) and hormone replacement therapies, if use of a low-dose aspirin regimen is contraindicated. - Additional concomitant medications which prolong the QT/QTc interval (measure of hearts electrical cycle) during the course of the study. - Use of any anti-coagulant or anti-thrombotic medications (other than low dose-aspirin [≤ 100 mg/day]). - Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 10 mg/day [mean dose] or equivalent), including but not limited to azathioprine, cyclophosphamide, methotrexate, mycophenolate and cyclosporine within 28 days (4 weeks) of Screening. - Use of any biologic agent within 84 days (12 weeks) or 5 half-lives of Screening. In the case of rituximab, use within 168 days (24 weeks) of Screening or no recovery of CD20-positive B lymphocytes if the last dose of rituximab has been more than 24 weeks prior to Screening. - Use of bosentan, ambrisentan, sildenafil, tadalafil and macitentan for PAH within 28 days (4 weeks) of Screening. - Use of medications (e.g., D-penicillamine, Potaba) with putative scleroderma disease-modifying properties within 4 weeks of Screening. - Use of melphalan within 52 weeks of Screening. - Use of any investigational drug within 4 weeks of Screening or 5 pharmacodynamic/pharmacokinetic half-lives if known (whichever is longer). - Smoking of cigars, pipes or cigarettes within 24 weeks of Screening. - Other protocol-defined Inclusion/Exclusion criteria apply. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EPIK-B3 (w/Nab-Paclitaxel; aTNBC); BRIEF: The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2) ; DRUG USED: Piqray; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: p110 alpha/PIK3CA, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy), or metastatic (stage IV) TNBC - Participant has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present Part B1: Participants must have measurable disease - Participant has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation - Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Participant has received no more than one line of therapy for metastatic disease - Participant has adequate bone marrow and organ function Exclusion Criteria: - Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor - Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients - Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia - Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening - Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c - Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion - Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis - Participant has currently documented pneumonitis/interstitial lung disease - Participant has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS) - Participant with unresolved osteonecrosis of the jaw Other protocol-defined inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Progression-free Survival (PFS) Per Investigator Assessment in Study Part A; SECONDARY OUTCOME 1: Overall Survival (OS) in Study Part A[/INST]No</s>

<s>[INST]<<SYS>>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/UDCA; BRIEF: The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis. ; DRUG USED: Aldafermin; DRUG CLASS: Biologic; INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Combination; LEAD SPONSOR: NGM Biopharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - Males or females, between 18 and 75 years of age, inclusive - PBC diagnosis consistent with AASLD and EASL guidelines - Stable dose of UDCA Exclusion Criteria: - Chronic liver disease of a non-PBC etiology - Evidence of clinically significant hepatic decompensation ; PRIMARY OUTCOME: Absolute change in plasma ALP from Baseline to Day 28; SECONDARY OUTCOME 1: Absolute change in bilirubin from Baseline to Day 28[/INST]No</s>

<s>[INST]<<SYS>>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 - BID vs OD; BRIEF: This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs. ; 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: - Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1) - Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors - HbA1c 7.0% - 10.0% - Body mass index (BMI) less than or equal to 40.0 kg/m^2 Exclusion Criteria: - Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria - Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty - Chronic disorder or disease which might jeopardise safety or compliance - Malignant neoplasms - Recurrent severe hypoglycaemia ; PRIMARY OUTCOME: Change From Baseline in HbA1c (%); 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 - w/Gemcitabine; BRIEF: A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients ; DRUG USED: Zepzelca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: DNA; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: PharmaMar; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed unresectable NSCLC - Patients must have failed one prior line of CT-based therapy for unresectable disease - Age between 18 and 75 years - Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1 - Adequate hematological, renal, metabolic and hepatic function - At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy - Negative pregnancy test for pre-menopausal women Exclusion Criteria: - Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled infection, pleural or pericardial effusions, myopathy, limitation of the patients ability to comply with the treatment or to follow-up the protocol, any other major illness - Histological features of neuroendocrine or bronchioalveolar differentiation. - Unknown epidermal growth factor receptor (EGFR)mutation status or previously known EGFR mutated status in patients with adenocarcinoma. - Prior or concurrent invasive malignant disease, unless in complete remission for more than three years. - Significant cancer-related weight loss (≥10%)within four weeks prior to treatment start - Prior treatment with docetaxel-containing therapy - Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement - Paraneoplastic syndromes ; PRIMARY OUTCOME: Progression-free Survival Rate at Four Months (PFS4); 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 II (Czech Republic); BRIEF: Inflammation of the pancreas often leads to severe damage not only to the pancreas but also to other organs in the abdomen as well as to complications in organs further away like the lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe inflammation of the pancreas, can mitigate the development of processes that can lead to serious complications of this disease. ; DRUG USED: DP-b99; DRUG CLASS: Non-NME; INDICATION: Pancreatitis; TARGET: Metal ions (e.g., Ca2+, Cu2+, Zn2+, and Fe2/3+); THERAPY: Monotherapy; LEAD SPONSOR: D-Pharm Ltd.; CRITERIA: Inclusion Criteria: - Male or female subject. - Age 18 years or higher. - First in a lifetime episode of acute pancreatitis. - Diagnosis of acute pancreatitis based on 2 of the following 3 criteria: (1) typical upper abdominal pain; (2) elevation of serum amylase and/or lipase at least 3 times the upper limit of normal; (3) contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis - History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must exclude a stone obstruction at the time of study screening). - BISAP score of 3 or higher - Study treatment initiation is possible within 48 h of symptom onset - Ability to provide informed consent Exclusion Criteria: - Drug-induced, viral, hereditary or post-ERCP pancreatitis. - Recurrent episode of pancreatitis. - CT evidence of pancreatic necrosis at study entry. - Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter less than 6 mm (above 80 years, less than 8 mm) with gallbladder in situ. - Severe chronic renal failure (Modification of Diet in Renal Disease formula 30 mL/min or dependency on renal dialysis). - High likelihood for an invasive intra-biliary tract intervention (e.g. ERCP) in the coming week. - Class II or greater New York Heart Association heart failure. - Oxygen-dependent chronic obstructive pulmonary disease (COPD). - Cirrhosis of the liver. - Severe anemia (hemoglobin less than 8 g/dL). - Hematocrit below 35 % or above 45 % at study entry (fluids may be administered to correct the hematocrit before randomisation as long as study treatment starts within 48 hours of symptoms onset). - Serum alanine aminotransferase above 250 IU/L at study entry. - Clinical suspicion of ascending cholangitis at study entry. - Active gastrointestinal bleeding. - Current malignancy not in remission (other than basal cell carcinoma of skin). - Altered mental status. - Current breastfeeding or pregnancy. - Female of childbearing potential (less than 2 years postmenopausal or not surgically sterilized) who is not willing to use adequate and effective birth control measures - Known hypersensitivity to any component of the investigational product. - Dependent relationship with the investigator or the sponsor. - Participation in an investigational drug study during this clinical trial or within 30 days prior to start of this clinical trial ; PRIMARY OUTCOME: C-reactive protein serum concentration; 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 (Japan); BRIEF: Primary objective: To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab (Part II) in Japanese subjects. Secondary objectives: - To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles (total vWF:Ag concentration levels [vWF:Ag], coagulation factor VIII [FVIII:C], and ristocetin cofactor activity [RICO]) after single i.v. or s.c. administration of caplacizumab in Japanese and White subjects. - To evaluate the immunogenicity of caplacizumab (anti-drug antibodies [ADA]) in Japanese subjects. ; DRUG USED: Cablivi; DRUG CLASS: Biologic; INDICATION: Thrombotic Thrombocytopenic Purpura (TTP); TARGET: Von Willebrand Factor (vWF); THERAPY: Monotherapy; LEAD SPONSOR: Ablynx, a Sanofi company; CRITERIA: Inclusion Criteria: - BMI between ≥18 kg/m² and <30 kg/m² at time of screening - Body weight between ≥45 kg and <100 kg - Baseline vWF:Ag between ≥60% and <170% (0.6-1.7 IU/mL) Exclusion Criteria: - History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, von Willebrands disease, vascular purpura, bleeding gums and/or frequent nose bleeding, easy/spontaneous bruises, meno- or metrorrhagia, history of gastrointestinal bleeding or excessive bleeding after minor injury such as shaving. - Family history of congenital vascular malformation (e.g., Marfans Syndrome) and/or bleeding disorder (e.g., hemophilia, von Willebrands disease, Christmas disease) - Any surgical intervention (including tooth extraction) or trauma within the 4 weeks preceding screening for the study or any planned surgical intervention during the participation in the study - Treatment with vitamin K, direct oral anticoagulant (DOAC), warfarin, high dose heparin within 2 weeks before screening ; PRIMARY OUTCOME: The number of treatment-emergent adverse events (Safety and Tolerability); SECONDARY OUTCOME 1: Pharmacokinetics: concentration of caplacizumab in plasma[/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 - Cutaneous/Systemic; BRIEF: The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). The secondary goal of this study was to assess the pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of action), immune response, and clinical response. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Lupus Nephritis; TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Centocor Research & Development, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of cutaneous lupus erythematosus (CLE, including subacute cutaneous lupus erythematosus, discoid lupus erythematosus, or lupus erythematosus tumidus) or systemic lupus erythematosus (SLE) - Had a body weight less than or equal to 100 kg - Patients in Part A who were taking systemic medications for CLE had to be on a stable dose for 4 weeks before the first study agent infusion - Patients in Part B taking systemic medications for SLE had to be on a stable dose for at least 3 months before the first study agent infusion - Given informed consent and willing and able to adhere to the study visit schedule and other protocol requirements; agreed to avoid alcohol intake; and took adequate measures to prevent pregnancy Exclusion Criteria: - Significant history of or concurrent medical condition (other than lupus) - Use of specific previous or concurrent medications or investigational therapies - Known or suspected allergy to the study agent or it constituents, having recently donated blood, or having any significant laboratory test values requiring intervention - Patients with SLE in Part B could not have active central nervous system lupus ; PRIMARY OUTCOME: Number of participants with adverse events; SECONDARY OUTCOME 1: Pharmacodynamics evaluations[/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 - CLEVER; BRIEF: This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver. ; DRUG USED: Cavatak (IV); DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, Intercellular Adhesion Molecule-1 (ICAM-1), Oncolytic Virus Therapy, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: Viralytics; CRITERIA: Inclusion Criteria: 1. Histologic or cytologically confirmed diagnosis of uveal melanoma with measurable disease (based on RECIST 1.1 criteria) in the liver (by CT, PET/CT or MRI) at the time of screening. 2. Patients that have had prior treatment must show disease progression during or following the last treatment according to RECIST 1.1 criteria. 3. Men and women ≥ 18 years of age. 4. The subject has a life expectancy of greater than 12 weeks. 5. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. Adequate organ function as defined by and obtained within 28 days of starting treatment: - Absolute neutrophil count ≥ 1,500 /mcl - WBC ≥ 3.0 x 10e9/L - Platelets ≥ 100,000 /mcl - Hemoglobin ≥ 9 g/dL - Creatinine ≤ 1.5 x ULN - Albumin > 3 g/dL - Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin > 1.5 x ULN - AST and ALT ≤ 5 x ULN - INR or PT ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants. - aPTT ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants. 7. Prior therapy with an immune checkpoint inhibitor therapy is allowable. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment. 8. Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 9. Female and Male subjects of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study drug through 4 weeks after the last dose of study drug. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. 10. The subject is capable of understanding and complying with protocol requirements. 11. The subject or the subjects legally acceptable representative provides written, informed consent prior to the initiation of any study procedures. Exclusion Criteria: 1. The subject is a candidate for surgery or loco-regional treatment with curative intent. 2. Subjects with active (i.e. symptomatic or growing) central nervous system (CNS) metastases. Subjects with CNS metastases are eligible if the metastases have been treated with surgery and/or radiotherapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable. 3. Known additional malignancy that is progressing or requires active treatment. Exceptions include cutaneous squamous cell or basal cell carcinoma that has undergone potentially curative therapy or in-situ cervical cancer. 4. Known history of Human Immunodeficiency Virus (HIV, HIV 1/2 antibodies), known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected). 5. Current systemic steroid therapy other than physiologic replacement (i.e. prednisone ≤ 10 mg or equivalent). Inhaled or topical steroid use is allowed. 6. Active auto-immune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed. 7. Active colitis or previous immune-mediated colitis that has not resolved to grade 1 or less. 8. Chemotherapy, targeted small molecule therapy, radiation therapy, hormonal treatment or immunotherapy within 21 days prior to initiation of treatment. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment. Subjects must have resolution of toxic effect(s) of the most recent therapy to Grade 1 or less. Exceptions are subjects with ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy who are permitted in the study. If the subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or any complications from the intervention. 9. Pregnancy, breastfeeding, or expectation to conceive or father children within the projected duration of the trial, starting with the screening visit through 4 weeks after the last dose of study treatment. 10. Known sensitivity to any of the products or components to be administered during dosing. 11. Participation in a study of an investigational agent or device within 4 weeks of Day 1. 12. Subjects with any other concurrent, uncontrolled illness, including known psychiatric or substance abuse disorders which may interfere with the ability of the subject to cooperate and participate in the trial. Other examples of such conditions would include unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA) within 6 months of study entry. 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subjects participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 14. Patients with tumors lying close to an airway, major blood vessel or spinal cord that, in the opinion of the investigator, could cause occlusion or compression in the case of swelling, or erosion into a major vessel in the case of necrosis. ; PRIMARY OUTCOME: Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE.; SECONDARY OUTCOME 1: Overall Response Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - inTandem2 (Europe); BRIEF: This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy. ; DRUG USED: Zynquista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participant who gave written informed consent to participate in the study in accordance with local regulations. - Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent. - Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). - Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol. - At the Screening Visit, A1C was between 7.0% to 11.0%. - Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test. Exclusion Criteria: - Use of antidiabetic agent other than insulin or insulin analog at the time of screening. - Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening. - Chronic systemic corticosteroid use. - Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator. ; PRIMARY OUTCOME: Change From Baseline in A1C at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III (0127) - Burkholderia; BRIEF: The purpose of this research study was to determine if an experimental drug called Aztreonam for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections in patients with cystic fibrosis (CF). Spirometry was used to assess pulmonary function, and the revised Cystic Fibrosis Questionnaire (CFQ-R) was used to assess quality of life. The CFQ-R is a validated, patient-reported outcome tool used to measure health-related quality of life for children and adults with CF. The study consisted of a 24-week randomized phase, and a 24-week open-label phase. Primary and secondary efficacy analyses were conducted for the 24-week randomized phase only. Safety data were collected for both the randomized and open-label phases. ; DRUG USED: Cayston; DRUG CLASS: Non-NME; INDICATION: Cystic Fibrosis (CF); TARGET: Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: 1. Male or female ≥ 6 years of age 2. Subjects with CF as diagnosed by one of the following: - Documented sweat chloride ≥ 60 milliequivalent (mEq)/L by quantitative pilocarpine iontophoresis test - Documented sweat sodium ≥ 60 mmol/L - Two well-characterized genetic mutations in the CF transmembrane conductance regulator (CFTR) gene - Abnormal nasal potential difference (NPD) with accompanying symptoms characteristic of CF 3. Chronic infection with Burkholderia spp. defined by: - One sputum (or bronchoalveolar lavage) culture positive for Burkholderia spp. within 6 months prior to baseline assessment, - At least 50% of sputum (or bronchoalveolar lavage) cultures collected at least one month apart over the previous 12 months prior to baseline assessment positive for Burkholderia spp. (minimum of 2 positive cultures), and - At least one positive sputum (or bronchoalveolar lavage) culture (obtained at any point in time) confirmed to be Burkholderia spp. by the Cystic Fibrosis Foundation (CFF) Burkholderia cepacia Research Laboratory and Repository at the University of Michigan (or equivalent Canadian reference laboratory). 4. Concomitant aerosolized antibiotic treatment: subjects receiving intermittent (alternating month on/month off) aerosolized antibiotic treatment were eligible, but must have been at least 1 week into their off-treatment cycle at the time of baseline assessment. Subjects receiving continuous aerosolized antibiotic treatment were eligible without restriction on their aerosolized antibiotic treatment. 5. Chest radiograph, computed tomography (CT), or magnetic resonance imaging (MRI) (most recent, obtained within 90 days of screening) without significant acute findings (eg, infiltrates [lobar or diffuse interstitial], pleural effusion, pneumothorax), and no significant intercurrent illness; chronic, stable findings (eg, chronic scarring or atelectasis) were allowed. 6. Subjects (and parent/guardian as required) must have been able to provide written informed consent/assent prior to any study-related procedures, 7. Ability to perform reproducible pulmonary function tests 8. Sexually active females of childbearing potential must have agreed to use a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of study drug. A highly effective method of birth control was defined as a method that would result in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), or a vasectomized partner. Exclusion Criteria: 1. Administration of any investigational drug or use of any investigational device within 28 days of randomization/baseline and within six half-lives of the investigational drug (whichever is longer) 2. Administration of AZLI treatment within the 28 days prior to randomization/baseline 3. Known local or systemic hypersensitivity to monobactam antibiotics 4. History of lung transplantation 5. Abnormal renal or hepatic function results at most recent test within the previous 90 days, defined as: - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of the normal range (ULN) - Serum creatinine > 2 times ULN 6. Known portal hypertension or complications of CF hepatopathy 7. Positive urine pregnancy test (confirmed by serum pregnancy test) at screening; all women of childbearing potential were tested 8. Any female of childbearing potential who was lactating or not practicing a highly effective method of birth control as defined in the protocol 9. Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with subject treatment, assessment or compliance with the protocol ; PRIMARY OUTCOME: AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24; SECONDARY OUTCOME 1: Total Number of Systemic and/or Inhaled Antibiotic Courses for Respiratory Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3003; BRIEF: The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind treatment portion where subjects will be randomly assigned to one of three doses of study medication (2.4 mg total daily dose of lofexidine, 3.2 mg total daily dose of lofexidine, or placebo) followed by an optional open-label treatment period where subjects will be inpatient or outpatient and receive lofexidine at variable dosing for up to an additional 7 days. The Investigator hypothesizes that subjects will achieve maximum treatment effect with tolerable side effects at the 3.2 mg total daily dose and that both the 3.2 mg and 2.4 total daily doses will show better efficacy over placebo in treating symptoms of acute opioid withdrawal. ; DRUG USED: Lucemyra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Substance Use Disorder; TARGET: Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy; LEAD SPONSOR: USWM, LLC (dba US WorldMeds); CRITERIA: Inclusion Criteria: - Male or female at least 18 years of age. - Currently dependence, according to the Mini International Neuropsychiatric Interview (M.I.N.I.) [17, 18], on any opioid with a half-life similar to heroin or morphine, including Vicodin®, Lortab®, Lorcet®, Percocet®, Percodan®, Tylox®, or Hydrocodone (by any route of administration), or oxycodone (oxycodone and oxycodone time-released formulation when crushed and snorted, injected or swallowed after chewing). - Seeking treatment for opioid dependence. - Score of ≥2 on the Objective Opiate Withdrawal Scale (OOWS-Handelsman) at Baseline. - Reported use of heroin, morphine, or any opioid with a half-life similar to heroin or morphine for at least 21 of the past 30 days. - Urine toxicology screen positive for opioids but negative for methadone and buprenorphine. - Females of childbearing potential must agree to using birth control methods and must have had documented proof. - Able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, and pass the study consent quiz with 100% accuracy (if necessary, quiz may be administered more than one time). Exclusion Criteria: - Female subject who is pregnant or lactating. - Self-reported use of methadone or buprenorphine in the past 14 days. - Serious medical illnesses including, but not limited to: seizures, pancreatic disease, liver disease, exposure to a hepatitis virus, and positive hepatitis results. - Psychiatric disorder, based on the M.I.N.I., including but not limited to dementia or any disorder that, in the opinion of the study physician requires ongoing treatment that would make study participation unsafe or which would make treatment compliance difficult. - Self-reported acquired immune deficiency syndrome (AIDS) or self-reported human immunodeficiency virus (HIV) positive status and taking retroviral medications currently or within the past 4 weeks. - Abnormal cardiovascular exam at screening and before randomization, including any of the following: clinically significant abnormal electrocardiogram (ECG) (e.g., second or third degree heart block, uncontrolled arrhythmia, or QTcF interval greater than 450 msec for males and greater than 470 msec for females); heart rate less than 55 bpm or symptomatic bradycardia; systolic blood pressure (SBP) less than 95 mmHg or symptomatic hypotension; diastolic blood pressure (DBP) less than 65 mmHg; blood pressure (BP) greater than 155/95 mmHg; and prior history of myocardial infarction. - Clinically significant abnormal laboratory values. - Requiring any of the following medications currently or within the past 4 weeks: psychotropics (including sedatives/hypnotics, antidepressants, neuroleptics), prescription analgesics (excluding those listed in inclusion criterion #2 above), anticonvulsants, antihypertensives, antiarrhythmics, antiretroviral, and cholesterol lowering medications. Nicotine replacement therapy (patch, inhaler, gum, or nasal spray) will be allowed for nicotine-dependent subjects. Note: Use of a short-acting benzodiazepine (e.g., oxazepam) for insomnia during Days 8 14 will not disqualify a subject. - Currently dependent (based on the M.I.N.I.) on any psychoactive substance (other than that listed in inclusion criterion #2, caffeine or nicotine) that requires detoxification. - Donated blood within the last 8 weeks. - Participated in an investigational drug study within the past 3 months. - Has poor veins that even a single venipuncture cannot be obtained during screening. - Active tuberculosis (positive tuberculin test and/or confirmatory diagnostic chest x-ray). - Active syphilis. ; PRIMARY OUTCOME: Difference Between the Overall Means From Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) Scores; SECONDARY OUTCOME 1: Completion Status[/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 - 2695 (Japan); BRIEF: Primary Objective: To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan Secondary Objective: To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on: - HbA1c (Glycated hemoglobin A1c) reduction; - Fasting plasma glucose; - Body weight. ; DRUG USED: Adlyxin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Patients with type 2 diabetes mellitus diagnosed for at least 2 months. - Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 to be washed out during the run-in period at least for 6 weeks; - Signed written informed consent. Exclusion criteria: - At screening - age <20 years; - HbA1c <7% or >9.5% (for patients on OAD <6.5% or >8.5%); - fasting plasma glucose >250 mg/dL (>13.9 mmol/L); - Use of more than one OAD within 3 months prior to screening; - Use of Thiazolidinedione (TZD) within 6 months prior to screening; - Use of insulin within 3 months prior to screening; Note: Short time use (≤10 days) of insulin due to acute illness or surgery (eg, infectious disease) is allowed. - Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP-1 receptor agonist; - Type 1 diabetes mellitus - Women of childbearing potential with no effective contraceptive method; - Pregnancy or lactation; - Laboratory findings at the time of screening: oAmylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN); - ALT >3 ULN; - Calcitonin ≥20 pg/mL (5.9 pmol/L); - Positive serum pregnancy test in women of childbearing potential; - History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease; - Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes); - Allergic reaction to metacresol. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.; SECONDARY OUTCOME 1: Absolute change in HbA1c[/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 - N01197; BRIEF: This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study ; DRUG USED: Seletracetam; DRUG CLASS: New Molecular Entity (NME); INDICATION: Seizure Disorders (Epilepsy); TARGET: SV2A synaptic vesicle protein; THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - A signed and dated IRB/IEC approved written informed consent form - Male/female age 18 years (16 years where permitted) to 65 years - Minimum body weight of 40 kg - Patients having participated in a previous seletracetam study - Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible. Exclusion Criteria: - Ongoing psychiatric disease other than mild controlled disorders - Subject with clinically significant abnormalities in laboratory tests or ECG - Poor compliance with visit schedule or medication intake in a previous seletracetam study - Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment ; PRIMARY OUTCOME: Safety profile of seletracetam; SECONDARY OUTCOME 1: Reduction in seizure frequency[/INST]No</s>

<s>[INST]<<SYS>>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 - 065-02 (w/Venetoclax); BRIEF: A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) ; DRUG USED: CYC065; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Combination; LEAD SPONSOR: Cyclacel Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - CLL that is relapsed or refractory to BTK inhibitors and is on a stable dose of venetoclax - ECOG 0-2 - Adequate bone marrow function - Adequate renal function - Adequate liver function - INR <=1.2 in patients not receiving chronic anticoagulation - At least 4 weeks from prior cytotoxic chemotherapy - At least 4 weeks from major surgery - Agree to practice effective contraception Exclusion Criteria: - Known CLL involvement in CNS that is symptomatic and active - currently receiving radiotherapy, biological therapy, or any other investigational agents - Uncontrolled intercurrent illness - Pregnant or lactating - Known to be HIV-positive - Known active hepatitis B and/or hepatitis C infection ; PRIMARY OUTCOME: Number of patients who experience dose-limiting toxicity (DLT); SECONDARY OUTCOME 1: Pharmacokinetic effect[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OI (Extension); BRIEF: To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753). ; DRUG USED: Prolia; DRUG CLASS: Biologic; INDICATION: Osteogenesis Imperfecta (OI); TARGET: RANK Ligand (RANKL); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subject has provided informed consent/assent prior to initiation of any Study 20170534 specific activities/procedures. Subjects legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. - Subject is currently/was enrolled in Study 20130173 and - completed the 20130173 End of Study (EOS) visit (regardless of completing or ending investigational product early) OR - did not reconsent/reassent to transition to 3-month dosing regimen on Study 20130173 OR - early terminated from Study 20130173 as a result of meeting bone mineral density (BMD) Z-score investigational product stopping criteria. Exclusion Criteria: - Treatment with any prohibited proscribed medications while receiving denosumab. Eligibility into study treatment with alternative osteoporosis medication/s of investigators choice, follow guidelines per the specific alternative osteoporosis medication/s selected. For subjects off-treatment (observation only), no prohibited medications apply. - Subjects currently receiving treatment in another investigational device or drug study other than Study 20130173. Other investigational procedures while participating in this study are excluded. - For subjects expected to receive investigational product (denosumab) at study day 1: Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 months after the last dose of denosumab. Females of childbearing potential (Tanner Stage greater than or equal to 2) should only be included in the study after a negative highly sensitive urine or serum pregnancy test. For study treatment with alternative osteoporosis medication/s of investigators choice, follow guidelines per the specific alternative osteoporosis medication/s selected. For Subjects off-treatment (observation only), no exclusion applies. - For subjects expected to receive investigational product (denosumab) at study day 1: Female subjects of childbearing potential unwilling to practice true sexual abstinence (refrain from heterosexual intercourse) or use 1 highly effective method of contraception during treatment and for an additional 5 months after the last dose of investigational product (denosumab). For study treatment with alternative osteoporosis medication/s of investigators choice, follow contraception guidelines per the specific alternative osteoporosis medication/s selected. For subjects not receiving any investigational product (observation only), no contraception required. - History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. ; PRIMARY OUTCOME: Number of Participants With Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest; SECONDARY OUTCOME 1: Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - DUET-2; BRIEF: This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors. ; DRUG USED: XmAb20717; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Cluster of Differentiation 3 (CD3), Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Xencor, Inc.; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of one of the following advanced solid tumors: PART A (Dose Escalation Cohorts) 1. Melanoma; 2. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC); 3. Hepatocellular carcinoma; 4. Urothelial carcinoma; 5. Squamous cell carcinoma of the head and neck; 6. Renal cell carcinoma (clear cell predominant type); 7. Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma; 8. Non-small cell lung carcinoma; 9. Gastric or gastroesophageal junction adenocarcinoma 10. Mesothelioma; 11. High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung 12. Cervical cancer; 13. Squamous cell carcinoma of the anus PART B (Dose Expansion Cohorts): 1. Melanoma 2. Renal cell carcinoma (clear cell predominant type) 3. Non-small cell lung carcinoma 4. Castrate-resistant adenocarcinoma of the prostate, defined as progressive disease after surgical castration, or progression in the setting of medical androgen ablation with a castrate level of testosterone (< 50 ng/dL) 5. Nasopharyngeal carcinoma 6. Cholangiocarcinoma 7. Basal cell carcinoma 8. Squamous cell carcinoma of the anus 9. Mesothelioma 10. Ovarian or fallopian tube carcinoma 11. Malignant adnexal neoplasms (including, but not limited to, sebaceous carcinoma, trichilemmal carcinoma, pilomatrix carcinoma, eccrine carcinoma, hidradenocarcinoma, adnexal carcinoma with divergent differentiation, papillary digital eccrine adenocarcinoma, microcystic adnexal carcinoma, and clear cell eccrine carcinoma) 12. Thymoma 13. Thymic carcinoma 14. Squamous cell carcinoma of the penis 15. Neuroendocrine carcinoma 16. Vulvar cancer 17. Non-squamous cell salivary gland carcinoma (except adenoid cystic carcinoma) 18. Subjects with other solid tumors for which there is published evidence of anti-tumor activity with anti-PD1/PDL1 and/or anti-CTLA4-directed therapy but for which there is no FDA-approved anti-PD1/PDL1 or CTLA4-directed checkpoint inhibitor treatment may be eligible for Part B after approval by the Medical Monitor. - All subjects cancer must have progressed after treatment with all standard therapies or have no appropriate available therapies. - Subjects, except those with adenocarcinoma of the prostate, must have measurable disease by RECIST 1.1. - Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue - ECOG performance status of 0 - 1 - Subjects with adenocarcinoma of the prostate must have evaluable disease (measurable or nonmeasurable lesions) by PCWG3. Exclusion Criteria: - Subjects currently receiving other anticancer therapies, with the exception of subjects with adenocarcinoma of the prostate, who may continue luteinizing hormone-releasing hormone (LHRH) analogue therapy. - Treatment with any CTLA4 antibody within 6 weeks of the start of study drug. - Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the start of study drug. - Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort dependent). - Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.). Subjects with prostate cancer may continue LHRH analogue therapy. - A life-threatening (Grade 4) immune-mediated AE related to prior immunotherapy. - Failure to recover from any immune-related toxicity from prior cancer therapy to ≤ Grade 1, except if previous immune-related endocrinopathy is medically managed with hormone replacement therapy only. - Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2. - Have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging, are clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. - Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs). - Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted). - Receipt of an organ allograft. - Prior treatment with any checkpoint inhibitor therapy regimen that targets both PD1/L1 and CTLA-4. ; PRIMARY OUTCOME: Determine the safety and tolerability profile of XmAb20717; 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 - C-SURGE; BRIEF: This is a randomized, multicenter, 2-part, open-label trial of the combination regimen of grazoprevir (GZR [MK-5172]; 100mg), uprifosbuvir (UPR [MK-3682]; 450 mg) and ruzasvir (RZR [MK-8408]; 60 mg) with and without Ribavirin (RBV) in cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) previously failing a direct-acting antiviral regimen (DAA). The combination regimen, referred to as MK-3682B, will be administered as two fixed-dose combination (FDC) tablets, given once-daily. The study will evaluate the efficacy of MK-3682B with or without RBV as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy. ; DRUG USED: Uprifosbuvir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: Part A - Has documented chronic HCV GT1 or HCV GT3 infection with no evidence of non-typeable or mixed genotype. - Has documented relapse, defined as having HCV RNA target not detected at end-of-treatment, but HCV RNA quantifiable during follow-up, after treatment with one of the following DAA regimens either by approved dosage and duration or by completion of a clinical trial: GT1: SOF/LDV ± RBV; GT1: GZR/EBR ± RBV; GT3: SOF + RBV; GT3: SOF + PR; GT3: SOF + DCV ± RBV; GT3: SOF/LDV ± RBV. - Is otherwise healthy. - If male, be not of reproductive potential or agree to avoid impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug, through 6 months after taking the last dose of study drug (or longer if dictated by local regulations), by complying with one of the following: (1) practice abstinence from heterosexual activity or (2) use (or have their partner use) two forms of acceptable contraception during heterosexual activity which may include oral contraceptives. Part B - Has documented chronic HCV GT1, GT2, GT3, GT4, GT5, GT6 infection with no evidence of non-typeable or mixed genotype. - Has documented virologic failure, defined as having quantifiable HCV RNA at any time after completion of HCV therapy with a DAA regimen either by approved dosage and duration or by completion of a clinical trial that was not attributed to re-infection: GT1, GT2, GT4, GT5, or GT6: any prior all-oral DAA regimens; GT3: any prior all-oral DAA regimen or SOF/PR. Participants [Parts A and B] who previously failed PR treatment, with or without simepravir (SIM), boceprevir (BOC), or telaprevir (TPV), prior to receiving DAA therapy, may also be enrolled. Parts A and B - Has HCV RNA ≥ 10,000 IU/mL in peripheral blood at enrollment. - Has either absence of cirrhosis or presence of compensated cirrhosis. - If female, be not of reproductive potential or agree to avoid becoming pregnant beginning at least 2 weeks prior to administration of the initial dose of study drug, through either 6 months [Part A] or 14 days [Part B] after taking the last dose of study drug (or longer if dictated by local regulations), by complying with one of the following: (1) practice abstinence from heterosexual activity or (2) use (or have their partner use) two forms of acceptable contraception during heterosexual activity which may include oral contraceptives. - For HIV co-infected participants: 1) have documented HIV-1 infection [Part A] or HIV infection [Part B]; 2) either not be currently on antiretroviral therapy (ART) with no plans to initiate ART while participating in this study or have well controlled HIV on ART; and 3) have at least one viable antiretroviral regimen alternative beyond their current regimen in the event of HIV virologic failure and the development of anti-retroviral drug resistance [Part A]. Exclusion Criteria: Part A - Has previously received a DAA containing regimen other than the permitted regimens listed above. - Did not complete their prior DAA therapy due to intolerance to the DAA regimen or who failed the DAA regimen for reasons other than relapse (e.g., virologic breakthrough, rebound or non-response, non-compliance, lost to follow-up, withdrew consent). - Is a male whose female partner(s) is/are pregnant or is a male who is expecting to donate sperm or planning to impregnate female partner(s) from at least two weeks prior to Day 1 through at least 6 months after last dose of study drug, or longer if dictated by local regulations. - Has personal or family history of Torsade de pointes. - Has chronic pulmonary disease. - Has an hemoglobinopathy. - Has central nervous system (CNS) trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, or cerebral spinal fluid (CSF) leak; prior brain hemorrhage and/or intracranial aneurysms (whether adequately repaired or not). - Has current or history of seizure disorder unless seizure was >10 years ago, a single isolated event, no history of or current use of anti-seizure medications, and a documented normal neurological examination at Day 1. - Has history of stroke or transient ischemic attack. Part B - Did not complete their prior DAA therapy due to intolerance to the DAA regimen or who failed the DAA regimen for reasons other than virologic failure. - Has any major medical condition, clinically-significant illness (other than HCV), pretrial laboratory or ECG abnormality, or history of any illness that might interfere with treatment, assessment, compliance or pose additional risk in administering study drug to the participant. Parts A and B - Is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures. - Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease. - Has cirrhosis classified as Child-Pugh Class B or C or has a Pugh-Turcotte score >6 - Is co-infected with hepatitis B virus (HBV) - For participants with HIV, has a history of opportunistic infection in the 6 months prior to screening. - Has a history of malignancy ≤5 years prior to enrollment except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy. - Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC. - Is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study (trial treatment period). Participants participating in MK-5172-017 (NCT01667081) may be enrolled in this study, MK- 3682-021. - Has clinically-relevant drug or alcohol abuse within 12 months of screening - Is a female and is pregnant or breastfeeding or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 through at least 6 months [Part A] or 14 days [Part B] after last dose of study drug, or longer if dictated by local regulations. - Has organ transplants (including hematopoietic stem cell transplants) other than cornea and hair. - Has history of gastric surgery or history of malabsorption disorders. - Has current or history of any clinically significant cardiac abnormalities/dysfunction. - Has medical/surgical conditions that may result in a need for hospitalization during the period of the study. - Has a medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the study - Has evidence of history of chronic hepatitis not caused by HCV. Participants with history of acute non-HCV-related hepatitis, that resolved >6 months before study entry, may be enrolled. ; PRIMARY OUTCOME: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12); 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 - HER2+ (U.S.); BRIEF: The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens. ; DRUG USED: Poziotinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Histopathologically confirmed primary breast cancer with metastatic lesions. 2. Confirmed HER2 overexpression or gene-amplified tumor 3. At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine 4. Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1) 5. Participant is at least 18, and ≤90 years of age. 6. Adequate hematologic, hepatic, and renal function 7. Eastern Cooperative Oncology Group (ECOG) performance status <= 2 Exclusion Criteria: 1. Previous treatment with poziotinib prior to study participation 2. Brain metastases that are symptomatic or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 15 days of enrollment. 3. Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or investigational treatment within 15 days, except for hormone therapy, palliative therapy, or supportive therapy. 4. History of congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment. 5. Cardiac ejection fraction <50% 6. History of other malignancies within the last 5 years 7. Participant is pregnant or breast-feeding. 8. Unable to take drugs orally ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/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 - GETGOAL-O (w/Basal Insulin and/or Oral Antidiabetic); BRIEF: Primary objective: - To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen. Main secondary objective: - To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects). Other secondary objectives: - To assess the effect of lixisenatide compared to placebo after 24-week treatment on: - Fasting plasma glucose (FPG); - During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion; - 7-point Self-monitored plasma glucose (SMPG) profile; - Body weight; - Change in total daily dose of basal insulin (if taken); - Percentage of participants requiring rescue therapy - Safety and tolerability; - To assess lixisenatide pharmacokinetic profile; - To assess anti-lixisenatide antibody development. ; DRUG USED: Adlyxin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Older participants, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic pharmaceutical treatment regimen. - Signed written informed consent. Exclusion criteria: - At screening HbA1c ≤7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older participants and that this was the responsibility of the investigator to include the participant based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia). - At screening participants on both basal insulin and sulfonylurea or basal insulin and meglitinides. - At screening FPG >250 mg/dL (>13.9 mmol/L). - Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit. - Type 2 diabetes mellitus diagnosed less than 1 year prior to screening. - Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening. - Treatment within the 3 months preceding the screening with other anti-diabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea (except glibenclamide >10mg, gliclazide >160mg), meglitinides (except repaglinide >6mg), pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population. - Participants who had been on an approved or an investigational Glucagon-like peptide 1 (GLP-1) medication (exenatide, liraglutide, lixisenatide or others). - History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening. - BMI <22 or >40 kg/m^2. - Malnutrition assessed clinically by the investigator or any sub-investigator and by Mini-Nutritional Assessment-Short Form (MNA-SF) score <12 in countries (the judgment of the investigator prevails on questionnaires scores). - Cognitive disorder and dementia assessed clinically by the investigator or any sub investigator and by Mini Mental State Examination (MMSE) score <24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that affected the participants ability to participate in the study. - Participant who had a glomerular filtration rate (eGFR) (using the Modification of Diet in Renal Disease (MDRD) formula <30ml/min/1.73m^2). - Participant with severe or uncontrolled disease, or any clinically significant abnormality identified on physical examination or investigational clinical procedure that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrains efficacy assessment. - Laboratory findings at the time of screening: - Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times ULN - Calcitonin >20 pg/mL (5.9 pmol/L). - Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) and not controlled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening. - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease. - Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposed to medullary thyroid cancer (e.g., multiple endocrine neoplasia syndromes). The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Absolute Change in HbA1c From Baseline to Week 24; SECONDARY OUTCOME 1: Change in 2-Hour PPG From Baseline to 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 IIa - CY 4021 (Evidence of Effect); BRIEF: The primary objective of this study is to demonstrate a pharmacodynamic effect of CK 2017357 on measures of skeletal muscle function or fatigability in patients with ALS. ; DRUG USED: Tirasemtiv; DRUG CLASS: New Molecular Entity (NME); INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Troponin; THERAPY: Monotherapy; LEAD SPONSOR: Cytokinetics; CRITERIA: Inclusion Criteria For enrollment, patients were required to satisfy all of the following criteria at baseline: 1. Able to comprehend and willing to sign an Informed Consent Form (ICF) 1. A diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria) (Brooks, Miller et al. 2000) 2. Males or females 18 years of age or older 3. Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive 4. Maximum voluntary grip strength in at least one hand between 10 and 40 pounds (females) or 10 and 60 pounds (males) 5. Able to swallow capsules with water 6. Upright Slow Vital Capacity (SVC) > 40% of predicted for age, height, and sex [See Appendix 16.6.1] 7. Able to perform pulmonary function tests 8. Pre-study clinical laboratory findings (including troponin I [TnI] and creatine phosphokinase [CPK]) within normal range, or, if outside of the normal range, deemed not clinically significant by the Investigator 9. For female patients only: The patient is post-menopausal (≥ 1 year) or sterilized, or if she is of childbearing potential, she is not breastfeeding, her pregnancy test is negative, she has no intention to become pregnant during the course of the study, and she is using contraceptive drugs or devices for the duration of the study and for 10 weeks after the end of the study. For male patients only: Male patients agree for the duration of the study and 10 weeks after the end of the study to use a condom during sexual intercourse with female partners who are of reproductive potential and to have female partners use an additional effective means of contraception (e.g., diaphragm plus spermicide or oral contraceptives) or the male patient must agree to abstain from sexual intercourse for 10 weeks after the end of the study. Exclusion Criteria Patients satisfying any of the following criteria at baseline were excluded from enrollment: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) 2. Life expectancy < 3 months 3. Participation in any trial in which receipt of investigational study drug occurred within 30 days prior to dosing 4. Any prior treatment with CK-2017357 5. In the opinion of the Investigator, the patient is not suitable to participate in the study ; PRIMARY OUTCOME: ALSFRS-R; SECONDARY OUTCOME 1: Characterize the relationship, if any, between the plasma concentration of CK-2017357 and ALSFRS-R.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Liberty AD PRESCHOOL (Ages <u>></u>6 Mos. to <6 Years); BRIEF: This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD). ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria - Diagnosis of atopic dermatitis (AD) according to the American Academy of Dermatology consensus criteria at the screening visit - Participants with documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) - IGA score at screening and baseline visits - part A: IGA = 4 - part B: IGA ≥3 - EASI score at screening and baseline visits - part A: EASI ≥21 - part B: EASI ≥16 - Body Surface Area (BSA) involvement at screening and baseline visits - part A: ≥15% - part B: ≥10% - At least 11 (of a total of 14*) applications of a topical emollient (moisturizer) during the 7 consecutive days immediately before the baseline visit (not including the day of randomization) (for part B of the study only) - Baseline worst scratch/itch score weekly average score for maximum scratch/itch intensity ≥4 (for part B of the study only) - At least 11 (of a total of 14) daily applications of low potency TCS during the 2-week TCS standardization period (beginning on day -14) leading up to the baseline visit (for part B of the study only). Key Exclusion Criteria - Prior treatment with dupilumab - History of important side effects of low potency topical corticosteroids (only applicable for part B of the study) - Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit - Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit - Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit. - Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening - History of malignancy at any time before the baseline visit - Diagnosed active endoparasitic infections or at high risk of these infections - Severe concomitant illness(es) that, in the investigators judgment, would adversely affect the patients participation in the study - Body weight <5 kg or ≥30 kg at baseline (only applicable part B of the study) Note: Other protocol defined Inclusion/ Exclusion criteria apply ; PRIMARY OUTCOME: Part A: Maximum Observed Serum Concentration (Cmax) of Functional Dupilumab; SECONDARY OUTCOME 1: Part A: Number of Participants With Serious TEAEs and Severe TEAEs[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3849/CFTR Mutation (6 Years and Older); BRIEF: This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation. ; DRUG USED: Kalydeco; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of CF based on protocol-specified clinical features and at least one of the following: increased sweat chloride level, identification of 2 CF causing mutations, or demonstration of abnormal nasal epithelial ion transport. - A 3849 + 10KB C→T or D1152H mutation on at least 1 CFTR allele. - FEV1 ≥40% of predicted and ≤105% of predicted at screening. Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. - History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. - Ongoing or prior participation in an investigational drug study within 30 days before the Screening Visit. - Protocol-specified abnormal laboratory values at the Screening Visit - For subjects <18 years of age at the Screening Visit, evidence of cataract/lens opacity determined to be clinically significant by the ophthalmologist or optometrist during the ophthalmologic examination (OE) at the Screening Visit. - Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A, including consumption of certain herbal medications and certain fruit and fruit juices, within 14 days before Day 1. - Pregnant, breastfeeding, or planning to become pregnant during the study. - Sexually active subjects of reproductive potential must be willing to use appropriate contraception. ; PRIMARY OUTCOME: Change in Lung Clearance Index 2.5 (LCI2.5); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - FUNDAMANT (CO 18700 Ext.); BRIEF: This follow-up study continues to observe patients who have completed the phase 1 trial of AADvac1, for another 18 months. Long-term safety and behavior of the immune response to AADvac1 over time are the main points of interest. AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is the main constituent of neurofibrillary tangles (NFTs), and is intended to be a disease-modifying treatment for Alzheimers disease, i.e. to halt its progress. As this study is a Phase I study focused on tolerability and safety, efficacy will be assessed in an exploratory manner. ; DRUG USED: AADvac1; DRUG CLASS: Vaccine; INDICATION: Alzheimers Disease (AD); TARGET: Immune System, Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: Axon Neuroscience SE; CRITERIA: Inclusion Criteria: 1. Completion of visit V8 of the AADvac1 phase I study AXON CO 18700 (EUDRACT 2012-003916-29). 2. Informed consent capability (as determined by an independent neurologist/psychiatrist). 3. Written informed consent signed and dated by the patient and the caregiver. 4. Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits 5. Adequate visual and auditory abilities and language skills to allow neuropsychological testing. 6. Female patients are only eligible for the study if they are either surgically sterile or at least 2 years postmenopausal. 7. Sexually active males must be using reliable contraception methods (i.e. condoms) or be surgically sterile. Exclusion Criteria: 1. Pregnant women. 2. Participation in another clinical trial during the course of this study. 3. Contraindication for MRI imaging such as MRI-incompatible metallic endoprosthesis or MRI-incompatible stent implantation 4. History and/or presence of autoimmune disease, if considered relevant by the investigator. 5. Significant systemic illness (e.g., chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, congenital long QT syndrome, other deficiencies), if considered relevant by the investigator. 6. Current treatment with immunosuppressive drugs. ; PRIMARY OUTCOME: Tolerability and safety profile of AADvac1 in patients with mild-to-moderate Alzheimers disease; SECONDARY OUTCOME 1: Immunogenicity of AADvac1[/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 - GalaxyDMD (OLE); BRIEF: The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD. ; DRUG USED: Edasalonexent; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Diglycerol Acyltransferase (DGAT), IkappaB kinase (IKK), NF-Kappa B (nuclear factor kappa-light-chain-enhancer of activated B cells) ; THERAPY: Monotherapy; LEAD SPONSOR: Catabasis Pharmaceuticals; CRITERIA: For Patients who Completed CAT-1004-201 or CAT-1004-301: Inclusion Criteria: - Written consent/assent by patient and/or legal guardian as per regional and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements - Completion of either CAT-1004-201 or CAT-1004-301 Exclusion Criteria: - In the Investigators opinion, unwilling or unable for any reason to complete all study assessments and laboratory tests and comply with scheduled visits, administration of drug, and all other study procedures For Siblings of Patients who Completed CAT-1004-201 or CAT-1004-301: Inclusion Criteria: - Written consent/assent by patient and/or legal guardian as per regional and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements - A sibling of a patient who completed either CAT-1004-201 or CAT-1004-301 - Diagnosis of DMD based on a clinical phenotype with increased serum creatine kinase (CK) and documentation of mutation(s) in the dystrophin gene known to be associated with a DMD phenotype - Followed by a doctor or medical professional who coordinates Duchenne care on a regular basis and willingness to disclose patients study participation with medical professionals Exclusion Criteria: - Use of oral corticosteroids at screening; use of inhaled, intranasal, and topical corticosteroids is permitted - Use of another investigational drug, idebenone, or dystrophin-focused therapy within 4 weeks. Exception: Patients who are currently on or plan to initiate treatment with approved oligonucleotide exon-skipping therapies, and expected to continue treatment throughout the study, will be eligible - Use of the following within 4 weeks prior to Day 1: immunosuppressive therapy, anticoagulants, cyclosporine, dihydroergotamine, ergotamine, fentanyl, alfentanil, pimozide, quinidine, sirolimus or tacrolimus - Use of human growth hormone within 3 months prior to Day 1 - Other prior or ongoing significant medical conditions ; PRIMARY OUTCOME: Safety and tolerability of long-term treatment with edasalonexent measured by number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); SECONDARY OUTCOME 1: Durability of effects of edasalonexent on physical function as measured by the North Star Ambulatory Assessment (NSAA)[/INST]No</s>

<s>[INST]<<SYS>>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 - STARTRK-NG; BRIEF: This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions. ; DRUG USED: Rozlytrek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Anaplastic lymphoma kinase (ALK), ROS kinase, Trk (Tropomyosin Receptor Kinase) Receptors, Tyrosine Kinases; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: 1. Disease status: - Phase 1 portion (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 - Phase 2 portion: - Part B: Participants must have measurable or evaluable disease, as defined by RANO - Part C (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale - Part D: Participants must have measurable or evaluable disease, as defined by RECIST v1.1 - Part E (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale or RANO 2. Tumor type: - Phase 1 portion: * Part A: Relapsed or refractory extracranial solid tumors - Phase 2 portion - Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method - Part D: Extracranial solid tumors (including NB) with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method 3. Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse 4. Archival tumor tissue from diagnosis or, preferably, at relapse 5. Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks 6. Prior therapy: Participants must have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options for solid tumors and primary CNS tumors that are neurotrophic tyrosine receptor kinase (NTRK) or ROS1 fusion-positive 7. Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment 8. Adequate organ and neurologic function 9. Females of childbearing potential must have a negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Agreement to remain abstinent or use use combined contraceptive methods prior to study entry, for the duration of study participation and in the following 90 days after discontinuation of study treatment. 10. For male participants with a female partner of childbearing potential or a pregnant female partner: Agreement to remain abstinent or use a condom during the treatment period and for at least 3 months after the last dose of study drug Exclusion Criteria: 1. Receiving other experimental therapy 2. Known congenital long QT syndrome 3. History of recent (3 months) symptomatic congestive heart failure or ejection fraction ≤50% at screening 4. Known active infections 5. Familial or personal history of congenital bone disorders, bone metabolism alterations or osteopenia 6. Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose. 7. Prior treatment with approved or investigational TRK or ROS1 inhibitors 8. Known hypersensitivity to entrectinib or any of the other excipients of the investigational medicinal product 9. Patients with NB with bone marrow space-only disease 10. Incomplete recovery from acute effects of any surgery prior to treatment. 11. Active gastrointestinal disease or other malabsorption syndromes that would impact drug absorption. 12. Other severe acute or chronic medical or psychiatric condition or lab abnormality that may increase the risk associated with study participation, drug administration or may interfere with the interpretation of study results. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03[/INST]No</s>

<s>[INST]<<SYS>>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 - FSD201 COVID-19; BRIEF: This study will measure the effect of FSD201 (ultramicronized PEA) + SoC vs placebo + SoC on Day 28, on disease progression in the confirmed coronavirus disease 2019 (COVID-19) patient population. ; DRUG USED: FSD201; DRUG CLASS: Non-NME; INDICATION: COVID-19 Treatment; TARGET: Cannabinoid-2 (CB2) receptor, Mast Cell; THERAPY: Monotherapy; LEAD SPONSOR: FSD Pharma, Inc.; CRITERIA: Inclusion Criteria: - Must be willing and able to give informed consent to participate in the study - Has admitted to a hospital and has a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test by standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test - Has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19 on Day 1 such as the presence of fever (greater than or equal to (>=)38.0 degree Celsius [>=100.4 degree fahrenheit] by any route), feeling hot, feeling sweaty, headache, malaise, fatigue, muscle pain, diarrhea, nausea, vomiting, cough, sore throat, or shortness of breath upon exertion and/or at rest, or respiratory distress - Has the presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID-19 on Day 1. A. Moderate: (1) Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate >=20 breaths per minute, SpO2 >93% on room air at sea level, heart rate >=90 beats per minute. (2) No clinical signs indicative of severe or critical COVID-19. B. Severe: (1) Clinical signs suggestive of severe systemic illness with COVID-19, such as respiratory rate >=30 breaths per minute, heart rate >=125 beats per minute, SpO2 less than or equal to (<=) 93% on room air at sea level or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) less than (<)300, heart rate >=125 beats per minute. (2) No criteria met for critical COVID-19 - Has either normal renal function or mild or moderate renal impairment: estimated creatinine clearance >30 milliliters per minute (mL/min) on Day 1 - Able to swallow the study drug (tablets) - Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with one of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: (a) Vasectomy with documentation of azoospermia. (b) Sexual abstinence. (c) Male condom plus partner use of one of the contraceptive - WOCBP must agree to comply with one of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: (a) Sexual abstinence (b) Use of one of the contraceptive options (c) Vasectomy of male partner with documentation of azoospermia Exclusion Criteria: - The participant, in the opinion of the investigator, is not likely to survive for >=48 hours beyond Day 1 - Has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1 - Has a documented current liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) at screening or on Day 1 - Has a Child Pugh score >= C - Has a documented medical history of infection with human immunodeficiency virus or hepatitis A, B, or C at screening or on Day 1 - Has a documented active infection with tuberculosis at screening or on Day 1 - Has clinically significant ECG abnormalities at screening or on Day 1 - Requires dialysis or is on any renal replacement therapies at screening or on Day 1 - A female participant who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening - Receiving alpha-blockers, combined alpha/beta blockers, antihistamines, or any drugs that will affect the levels of cytokines released due to immune stress - Has received any immunoglobulins within 6 months of screening or planned administration of any immunoglobulins during the screening and/or treatment periods - Has a known history of drug abuse within 6 months of study start that would interfere with the participants participation in the study - Has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation - Has participated in and/or plan to participate in another clinical study - Will be transferred to another hospital which is not a study site within 72 hours - Cannot read and speak either English or Spanish Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With Disease Progression at Day 28; SECONDARY OUTCOME 1: Percentage of Participants With Disease Resolution at Day 28[/INST]No</s>

<s>[INST]<<SYS>>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 - APDS/PASLI (OLE); BRIEF: This study is designed to provide long-term CDZ173 treatment, a selective PI3Kδ inhibitor, to the patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI who participated in the CCDZ173X2201 study or who were treated previously with PI3Kδ inhibitors other than CDZ173. The study is open-label designed to establish the long-term safety, tolerability, efficay and pharmacokinetics of CDZ173 in the target population. ; DRUG USED: CDZ173; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Immunodeficiencies; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Pharming Technologies B.V.; CRITERIA: Inclusion Criteria: - Written informed consent must be obtained before any assessment is performed. - Paients must have participated in the study CCDZ173X2201 or were treated previously with PI3Kδ inhibitors other than CDZ173. - Patients who are deemed by the Investigator to benefit from PI3Kδ inhibitor therapy. - Patients or their legal representatives (for patients under the age of 18 years) must be able to communicate well with the Investigator, to understand and comply with the requirements of the study. - Documented APDS/PASLI-associated genetic PI3K delta mutation. Exclusion Criteria: - Any medically significant disease or condition that is unrelated to APDS/PASLI Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: To evaluate the long term safety and tolerability of CDZ173 in patients with APDS/PASLI; SECONDARY OUTCOME 1: To evaluate the long term efficacy of CDZ173 to modify health-related quality of life in patients with APDS/PASLI[/INST]No</s>

<s>[INST]<<SYS>>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/Cisplatin/Gemcitabine; BRIEF: The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer. ; DRUG USED: Cyramza; DRUG CLASS: Biologic; INDICATION: Biliary Tract Cancer; TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have an Eastern Cooperative Oncology Group performance status of 0 or 1. - Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) . - Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST). - Have adequate biliary drainage. - Have adequate organ function. - Males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method. - Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose. - Are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations. Exclusion Criteria: - Previous systemic therapy for locally advanced or metastatic disease is not allowed. - Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade >1, or cirrhosis with Child-Pugh Stage B or higher. - Have ongoing or recent (≤6 months) hepatorenal syndrome. - Have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization. - Anticipate having a major surgical procedure during the course of the study. - Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression. - Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. - Have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or diastolic blood pressure ≥90 millimeters of mercury (mm Hg) despite standard medical management. - Have a previous malignancy within 5 years of study entry or a concurrent malignancy. - Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. - Have a known allergy or hypersensitivity reaction to any of the treatment components. - Have a history of uncontrolled hereditary or acquired thrombotic disorder. - Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain. - Have mixed hepatocellular biliary tract cancer histology. - Have a corrected QT interval >470 milliseconds as calculated by the Fridericia equation. ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - GADOT 20/20; BRIEF: The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis . ; DRUG USED: TRS01; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uveitis (Ophthalmology); TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Tarsier Pharma; CRITERIA: Inclusion Criteria: - 18 years of age or older - Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study. - Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation. An eligible subject must have: - Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol. - Must have vision ≥ 20/40 in the non-study eye. - Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol. Exclusion Criteria: - Any form of infectious uveitis - Active retinitis - Cancer or melanoma that is actively treated with immunotherapy - Pregnancy / lactation - Receiving specific medication/interventions as specified per protocol ; PRIMARY OUTCOME: Assessment of Both Systemic and Ocular Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/daclatasvir; BRIEF: The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment. ; DRUG USED: AT-527; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: Atea Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Body mass index (BMI) of 18-35 kg/m2 - Must agree to use protocol-specified methods of contraception - Negative pregnancy test - HCV genotype 1 - Documented history compatible with chronic hepatitis C - HCV RNA ≥ 10,000 IU/mL at Screening. - Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: - Pregnant or breastfeeding - Infected with hepatitis B virus or HIV - Abuse of alcohol or drugs - Prior exposure to any HCV NS5A inhibitor - Cirrhosis - Use of other investigational drugs within 30 days of dosing - Other clinically significant medical conditions or contraindications to daclatasvir ; PRIMARY OUTCOME: Proportion of subjects achieving sustained virologic response (SVR); 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 - FLEX-M (SC) - MTX-Inadequate; BRIEF: The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate. This study is comprised of 3 periods: Period 1: 52-week blinded treatment Period 2: additional 48-week unblinded treatment Period 3: 48-week post-treatment follow-up ; DRUG USED: Tabalumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: B-cell activating factor (BAFF); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years - Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks - At least 8 tender and swollen joints - At least one erosion of a hand or foot joint observed on an X-ray - An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR) - Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody - Woman must not be pregnant, breastfeeding, or become pregnant during the study Exclusion Criteria: - Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks - Steroid injection or intravenous (iv) infusion in the last 6 weeks - Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks - History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD) - History of a serious reaction to other biological DMARDs - History of the use of rituximab or other B cell therapy - Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks - Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide) - Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study - Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA - Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years - Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines) - Hepatitis or human immunodeficiency virus (HIV) - A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months - Symptoms of herpes zoster or herpes simplex within the last month - Active or latent tuberculosis (TB) - Current symptoms of a serious disorder or illness - Use of an investigational drug within the last month - History of the use of rituximab, any other B cell targeted biotherapy, or denosumab ; PRIMARY OUTCOME: Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1001; BRIEF: This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3 study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up. ; DRUG USED: MSRD-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Merz North America, Inc.; CRITERIA: Key Inclusion Criteria: 1. Subjects who are male or female, ≥3 months of age on the date of Baseline Visit. 2. Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the Hanifin and Rajka Diagnosis Criteria for Atopic Dermatitis. 3. Subjects must have an Investigator Global Assessment (IGA) score of ≥2 at baseline. 4. Subjects who have atopic dermatitis covering ≥5% Body Surface Area (BSA) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants). 5. Subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected. Key Exclusion Criteria: 1. Unstable course of Atopic Dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline. 2. Concurrent conditions and history of other diseases. 3. Used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study. 4. Subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease. ; PRIMARY OUTCOME: Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group; SECONDARY OUTCOME 1: Compare the proportion of subjects with an IGA score of 0 or 1 between the MSRD-100 and vehicle at Visit 4[/INST]No</s>

<s>[INST]<<SYS>>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 - CL 04 (Abdominal Adipose Tissue); BRIEF: This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity. ; DRUG USED: LIPO-102; DRUG CLASS: Non-NME; INDICATION: Fat Removal; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Neothetics, Inc; CRITERIA: Inclusion Criteria: - Male or non pregnant female - Good general health - Sufficient abdominal fat for injections - Signed informed consent - BMI greater than or equal to 18 and less than 28 kg/m2 - History of stable weight in past 3 months Exclusion Criteria: - Known hypersensitivity to study drugs - Treatment with an investigational agent within 30 days of first dose ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Photographic assessments[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers (Study 106); BRIEF: This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance ; DRUG USED: Dayvigo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Insomnia; TARGET: Hypocretin/orexin receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria: 1. Healthy, male or female, aged 21 years or older at Screening 2. Regular time spent in bed between 7.0 and 8.5 hours per night 3. Regular bedtime, defined as the time the participant attempts to fall asleep, between 22:00 hours and 01:00 hours, and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 hours and 09:00 hours 4. Body mass index (BMI) ≥18 and <31 kg/m2 at Screening 5. Subjective sleep onset latency (sSOL) <30 minutes and subjective wake after sleep onset (sWASO) <60 minutes on the Sleep Diary 6. At least 3 years of experience driving at least 3000 km per year 7. Holds a valid license to drive a vehicle in the European Union (EU) as confirmed at the Screening visit 8. Has driving ability during the practice driving test that is judged to be adequate by the driving instructor 9. Able to communicate adequately (written and verbal) in either Dutch or English as determined by the investigator Exclusion Criteria: 1. A current complaint or diagnosis of insomnia disorder (per either The Diagnostic and Statistical Manual of Mental Disorders Version IV [DSM-IV] or Version 5 [DSM-5] criteria), sleep-related breathing disorder, periodic limb movement disorder, restless legs or narcolepsy, or an exclusionary score on a subscale of the SLEEP50 2. Habitually naps more than 3 times per week 3. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. 4. Females of childbearing potential who: - Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. - Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexually active during the study period or for 28 days after study drug discontinuation. - Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation. (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]). 5. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation. 6. Clinically significant illness that requires medical treatment between Screening and Baseline 7. Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment 8. Has a QT interval corrected using Fridericias formula interval (QTcF interval) >450 ms demonstrated on repeated ECGs (repeated only if initial ECG showed corrected QT interval (QTc) >450 ms) at Screening or Baseline 9. Has a history of or a family history of congenital QT prolongation or with a history of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome), or uses concomitant medications that prolong the QT/QT interval corrected for heart rate (QTc interval) 10. Has systolic blood pressure (BP) >140 mmHg (age 21-59) or >150 mmHg (age ≥60) or diastolic BP >90 mmHg (all ages) at Screening or Baseline 11. Has a resting heart rate <50 or ≥100 beats/min at Screening or Baseline 12. Has a history of drug or alcohol dependency or abuse (as defined by DSM-5 criteria) within approximately 2 years before Screening 13. Any suicidal ideation with intent with or without a plan within 6 months of the Screening Period (ie, answering Yes to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) 14. Habitually consumes more than 14 drinks per week (females) or more than 21 drinks per week (males) 15. Has a positive alcohol breathalyzer test at Screening or Baseline check-in 16. Smokes more than 6 cigarettes per day habitually and is unwilling to abstain from smoking cigarettes on evenings spent in the clinic until discharge after the driving test 17. Habitually consumes more than 3 cups of caffeinated beverages per day 18. Used any prohibited prescription or over-the-counter (OTC) concomitant medications within 1 week prior to starting the Sleep Diary during the Screening Period 19. Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline or plans for transmeridian travel across more than 3 time zones during the study 20. A positive urine drug test at Screening or unwilling to refrain from use of illegal recreational drugs or marijuana during the study 21. Hypersensitivity to the study drug or any of the excipients or to zopiclone 22. Participated (received investigational product) in another clinical trial less than 1 month (or 5 elimination half-lives of the investigational product) before dosing or is currently enrolled in another clinical study ; PRIMARY OUTCOME: Change of standard deviation of lateral position (SDLP) during an on-road driving test; SECONDARY OUTCOME 1: Number of lapses on the driving test[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ECHO-306 w/Pembrolizumab; BRIEF: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC). ; DRUG USED: Epacadostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation - Measurable disease based on RECIST 1.1 - Life expectancy of at least 3 months. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function per protocol-defined criteria. - Provide tumor tissue sample. Exclusion Criteria: - Known untreated central nervous system metastases and/or carcinomatous meningitis - History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. - Symptomatic ascites or pleural effusion. - Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. - Active autoimmune disease that has required systemic treatment in past 2 years. - Has had an allogeneic tissue/solid organ transplant. - Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority. - Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility. - History or presence of an abnormal electrocardiogram (ECG) that, in the Investigators opinion, is clinically meaningful. - Use of protocol-defined prior/concomitant therapy. ; PRIMARY OUTCOME: Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo; SECONDARY OUTCOME 1: Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 001 (Healthy Adults); BRIEF: This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response. ; DRUG USED: V180; DRUG CLASS: Vaccine; INDICATION: Dengue Fever - Vaccines and Treatments; TARGET: Dengue virus, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Selected Inclusion Criteria: - In good health - Voluntarily agrees to participate by giving written informed consent - Able to read, understand, and complete study questionnaires - Able to complete all scheduled visits and comply with study procedures - Access to a telephone - Agrees to avoid unusual, vigorous exercise from 72 hours before any dose of study vaccine/placebo through 15 days after that dose - Weighs ≥110 pounds (50 kg) and has a body mass index (BMI) of 19 to 32 kg/m^2 - No fever (temperature ≥100.4°F/38.0°C) for 72 hours prior to vaccination - Females of reproductive potential agree to remain abstinent or to use 2 acceptable methods of birth control from enrollment through 6 weeks after the last dose of study vaccine/placebo Selected Exclusion Criteria: - History of receiving any flavivirus vaccine (e.g. Japanese encephalitis, tick-borne encephalitis, or yellow fever) or planned receipt of any such vaccine during the study period - History of any flavivirus infection or serologic evidence of any flavivirus infection, including West Nile, dengue, yellow fever, Saint Louis encephalitis (if available), Kunjin, Murray Valley encephalitis, and Japanese encephalitis - History of residence for a cumulative period of >1 year in a country where dengue, Japanese encephalitis virus, or yellow fever virus is common - Planned travel to an area where dengue is common through 28 days after receiving the last dose of study vaccine/placebo - Known hypersensitivity to any component of the dengue vaccine - Abuse of drugs or alcohol within 12 months prior to screening - Pregnant or breastfeeding, or expecting to conceive in the time from enrollment through 6 weeks after the last dose of study vaccine/placebo - Positive serum test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and/or hepatitis C antibody - Known, suspected, or a history of immunocompromise - History of malignancy within 5 years prior to enrollment - Poorly controlled diabetes mellitus - Use of any immunosuppressive therapy (except topical and inhaled/nebulized steroids) - Receipt of any licensed non-live vaccine within 14 days prior to the first dose of study vaccine/placebo or plans to receive a licensed non-live vaccine during the time between receiving the first dose and 28 days after receiving the last dose of study vaccine/placebo - Receipt of any licensed live vaccine within 30 days prior to the first dose of study vaccine/placebo or plans to receive a licensed live vaccine during the time between receiving the first dose and 28 after receiving the last dose of study vaccine/placebo - Received investigational drugs or vaccines within 2 months prior to the first dose of study vaccine/placebo - History of receiving 1 or more doses of an investigational dengue vaccine - Participation in another clinical study within 42 days prior to enrollment, or plans to participate in another clinical study from enrollment through 1 year after the last dose of study vaccine/placebo - Planned donation of eggs or sperm from the time of enrollment through 28 days after the last dose of study vaccine/placebo - Prior receipt of a blood transfusion or blood products within 6 months prior to the first dose of study vaccine/placebo - Hospitalization for acute illness within 3 months prior to the first dose of vaccine/placebo ; PRIMARY OUTCOME: Seroconversion rate for each serotype; 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 - Dose Ranging (vs. Orlistat); BRIEF: This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide. Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period. ; DRUG USED: Saxenda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2 - Stable body weight (less than 5% selfreported change within the last 3 months) Exclusion Criteria: - Obesity induced by drug treatment - Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial - Type 1 or type 2 diabetes ; PRIMARY OUTCOME: Mean Change From Baseline in Body Weight at Week 20; SECONDARY OUTCOME 1: Mean Change From Baseline in Body Weight at Week 104[/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 - NAV03-12; BRIEF: The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single center, open-label, within-subject study. ; DRUG USED: Lymphoseek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Kaposis Sarcoma - Imaging; TARGET: Macrophages, Mannose, Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Navidea Biopharmaceuticals; CRITERIA: Inclusion Criteria: 1. The subject has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures. 2. The subject is at least 18 years of age at the time of consent. 3. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 2. 4. The subject has a KS stage of T(0), I(0), S(0). 5. The subject has a marker lesion with a confirmed diagnosis of KS (CD 206-expressing cutaneous KS) via punch biopsy. The location of the marker KS lesion will be limited to locations on the extremities: from the shoulder to the metacarpal region or from the groin to the metatarsal region. 6. The subject has a marker KS lesion that is ≥ 1cm in diameter. Exclusion Criteria: 1. The subject is pregnant or lactating. 2. The subject has had prior chemotherapy, immunotherapy, or radiation therapy to the local KS site or regional lymphatic system within one year of enrollment. 3. The subject has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the marker KS lesion. 4. The subject has known sensitivity to dextran. ; PRIMARY OUTCOME: Localization; SECONDARY OUTCOME 1: Time to Localization[/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 - 1222.5; BRIEF: The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood). ; DRUG USED: Striverdi Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion Criteria: 1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe airway obstruction with a post-bronchodilator FEV1 &#61619; 30% of predicted normal and < 80% of predicted normal and a post-bronchodilator FEV1 / FVC < 70% at Visit 1 3. Male or female patients, 40 years of age or older 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded 5. Patients must be able to perform technically acceptable pulmonary function tests and PEFR measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol 6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler (MDI). Exclusion Criteria: Selection of relevant exclusion criteria: 1. Patients with a history of asthma or a total blood eosinophil count 600/mm3. 2. Patients with any of the following conditions: - a diagnosis of thyrotoxicosis - a diagnosis of paroxysmal tachycardia (>100 beats per minute) - 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 Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) 3. Patients with any of the following conditions: - a history of myocardial infarction within 1 year of screening visit (Visit 1) - a diagnosis of clinically relevant cardiac arrhythmia - known active tuberculosis - a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) - a history of life-threatening pulmonary obstruction - a history of cystic fibrosis - clinically evident bronchiectasis - a history of significant alcohol or drug abuse 4. Patients who have undergone thoracotomy with pulmonary resection 5. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits 6. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program 7. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1) 8. Pregnant or nursing women 9. Women of childbearing potential not using a highly effective method of birth control 10. Patients who have previously been randomized in this study or are currently participating in another study 11. Patients who are unable to comply with medication restrictions. ; PRIMARY OUTCOME: Trough FEV1 Response After 4 Weeks; SECONDARY OUTCOME 1: Trough FEV1 Response After 1 Week[/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 - SEARCH (NIAID; Opioid); BRIEF: Background: Opioids are medicines that control pain. But they are often misused, which can lead to illness and death. Opioids increase dopamine to the brain, which makes people feel good and often causes them to crave drugs, leading to misuse and addiction. An investigational drug ANS-6637 may lower the dopamine surge and stop opioid craving. Midazolam is a drug approved for anxiety. Researchers want to give the two drugs together and see if ANS-6637 affects midazolam levels, to help understand how ANS-6637 is used in the body. Objective: To study the safety, tolerability, and effects of ANS-6637 taken with and without midazolam. Eligibility: Healthy adults 18 65 years old Design: Participants will be screened with a medical history, physical exam, and blood and heart tests. Participants who can get pregnant will have a pregnancy test. Participants must agree to use 2 types of birth control during the study, if applicable. Participants will stay at the clinic for 10 days. Meals will be provided. Participants will not be allowed to: Leave NIH campus Eat or drink anything with caffeine, alcohol, or certain juices Use any nicotine or related products (including vaping) Use any medicines (including herbal) During the clinic stay, participants will: Fast overnight several times Have blood drawn most days. Twice, a small tube will be inserted in an arm vein for frequent blood samples. Repeat screening tests and answer questions about their mood several times Get midazolam syrup in water on 1 day Take 6 ANS-6637 tablets by mouth on 5 days Take both study drugs on 1 day A few days later, participants will have a follow-up visit to repeat screening tests and answer questions about their mood. ; DRUG USED: ANS-6637; DRUG CLASS: New Molecular Entity (NME); INDICATION: Substance Use Disorder; TARGET: Aldehyde Dehydrogenase 2 (ALDH2); THERAPY: Combination; LEAD SPONSOR: National Institutes of Health Clinical Center (CC); CRITERIA: -INCLUSION CRITERIA: 1. Must have the ability to understand and must personally sign a written informed consent form, which must be obtained prior to initiation of study procedures. 2. Must be between 18 and 65 years of age, inclusive. 3. Must have discontinued use of nicotine and nicotine containing products including vaping or juuling from 90 days prior to study drug dosing and throughout the study duration. 4. Must be willing to abstain from any food or beverages containing alcohol 72 hours prior to first dose and through follow-up visit. 5. Must be willing to abstain from cannabis 72 hours prior to first dose and through follow-up visit. 6. Must be willing to abstain from caffeine (including tea, coffee, chocolate) or grapefruit, Seville orange juice or other methyl xanthine containing foods (e.g. theophylline, theobromine, tea leaves, yerba mate, kola nuts and guarana berries) 72 hours prior to the first dose and through follow- up visit. 7. Must have a body mass index (BMI) from 19 to 30 kg/m^2 (inclusive) at screening. 8. Must be human immunodeficiency virus type 1 (HIV-1) antibody negative at screening. 9. Must be hepatitis B (HBV) surface antigen negative at screening. 10. Must be hepatitis C (HCV) antibody or RNA negative at screening. 11. Male subjects must refrain from sperm donation from clinic admission, throughout the study period, and continuing for at least 90 days following the last dose of study drug. 12. Subjects 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. 13. Must be willing to comply with contraception guidelines below Contraception: The fetal risks associated with ANS-6637 are not known, but pre- clinical animal data demonstrate some risk. Subjects must agree not to become pregnant or impregnate a female. Females of childbearing potential must have a reproductive risk assessment done to determine the risk of undetectable pregnancy at study start [i.e. sexual and contraceptive history for 30 days preceding screening] pregnancy test at screening and baseline (Day 0). For the duration of the study, subject and their partners must practice two non-hormonal methods of birth control, having begun no less than 30 days, without interruption, prior to screening. They must continue to use both methods until 3 months after stopping the study drug. Two of the three methods of birth control listed below MUST be used, or an alternative combination offering very high efficacy, per the PI, in consultation with the Sponsor Medical Monitor may be considered: - Male or female condoms [but not both] with a spermicide - Diaphragm with a spermicide - Intrauterine device (IUD) If pregnancy is suspected or should occur, subjects must notify the study staff immediately. 14. Must, in the opinion of the Investigator, be in good health based upon medical history and physical examination, and screening laboratory evaluations. 15. Judged to be healthy based on medical history, physical examination, vital signs, and clinical laboratory tests at screening and Day 0: liver function tests (AST, ALT, Tbili) less than or equal to upper limit of normal [ULN], platelets (PLT) >150,000/ microliter, hemoglobin (Hgb) >13 g/dL (males); >12 g/dL (females), CK less than or equal to 2x ULN, Amylase/lipase < ULN, thyroid function tests [TSH and T4] within normal range, fasting total cholesterol <240 mg/dL, or fasting triglycerides <240 mg/dL, per DAIDS AE table and Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials AE table for total bilirubin [Tbili] only. 16. Must be willing and able to comply with all study requirements. EXCLUSION CRITERIA: 1. Therapy with any prescription, over-the-counter (OTC), herbal, or holistic medications, including hormonal contraceptives by any route, within 5 half- lives of the agent prior to receipt of any study medications will not be permitted with the following exception: Intermittent or short-course therapy (<14 days) with prescription or OTC medications, herbals, or holistic medications within the screening period prior to starting study drugs may be permitted after review by the investigators on a case-by-case basis for potential drug interactions. Receipt of influenza vaccination will be allowed prior to, during, and/or after the study. 2. Have any serious or active medical, surgical, or psychiatric conditions which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. 3. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to screening. 4. Have current, or a history of mild to severe alcohol use, cannabis or other substance use disorder including any use of illicit drugs as defined by DSM-5 criteria, within 12 months of first study dose 5. Renal impairment (chronic renal insufficiency of any chronic kidney disease stage, or acute renal failure not induced by drug therapy defined as eGFR <90 ml/min) 6. Have a positive urine drug test (ethanol, cannabis, barbiturates, cocaine, opiates, or amphetamines) at Screening or Day 0. 7. History of flushing or intolerance related to alcohol consumption using the NIAAA screening assessment questionnaire tool for alcohol flushing 8. Inability to obtain venous access for sample collection. 9. Have a history of significant drug sensitivity or drug allergy to any benzodiazepines. 10. Known hypersensitivity to formulation excipients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. 11. Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies). 12. Presence or history of clinically significant cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities. 13. Have clinically significant ECG abnormalities or any of the following ECG abnormalities at Screening: PR >220 msec; QRS >120 msec; QTcF >450 msec; HR <40 beats per minute; second or third degree heart block. 14. Have a history or family history of Long QT Syndrome, Brugada syndrome, Wolfe-Parkinson-White Syndrome, or have a family history of sudden cardiac death or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years. 15. Have history of syncope, palpitations, unexplained dizziness or chronic nausea or headaches. 16. Have an implanted defibrillator or pacemaker. 17. Have a history of liver disease, including Gilberts Disease. 18. Any clinically significant electrolyte abnormality (outside of NIH normal reference ranges) at screening (e.g., hypokalemia, hypocalcemia, hypomagnesemia) or any condition that could lead to abnormal electrolyte disturbances (eg, eating disorder). 19. Have a history of taking dopamine antagonists/anti-psychotics. 20. Are unable to comply with study requirements. 21. Positive urine toxicology screen ; PRIMARY OUTCOME: Pharmacokinetics - Time to Maximum Concentration of Midazolam Alone; 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 - 002.01; BRIEF: This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis. The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis. ; DRUG USED: Neihulizumab; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: P-selectin glycoprotein ligand-1 (PSGL-1), Selectins; THERAPY: Monotherapy; LEAD SPONSOR: AbGenomics B.V Taiwan Branch; CRITERIA: Inclusion Criteria: 1. Age 18 to 75 (inclusive), males or females 2. Body weight < 140 kg 3. Patients with stable moderate to severe plaque-type psoriasis, no significant changes within the past 6 months, involving ≥ 10% body surface area, with disease severity PASI ≥ 10 at screening visit and visit 2. 4. Psoriasis disease duration of at least 6 months prior to screening 5. Patients must be candidates for systemic psoriasis treatment or phototherapy 6. Patient must give informed consent and sign an approved consent form prior to any study procedures 7. Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year). Exclusion Criteria: 1. Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis 2. Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion) 3. HIV infection or a known HIV-related Malignancy. 4. Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded. 5. Tuberculosis or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects previously received BCG vaccination or cannot receive TST can participate in the study after showing negative responses in Interferon-Gamma Release Assays (IGRA). 6. History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma and carcinoma in situ of the cervix uteri. 7. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients 8. Use of biologic agents or investigational drug within 8-12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment 9. Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of the study 10. Current alcohol abuse 11. Current drug abuse or positive drug screen at screening visit. Subjects with legitimate medically supervised uses of the drugs which are not excluded for other reasons can be enrolled. 12. Any blood donation or significant blood loss within 4 weeks prior to Visit 2 13. Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial) 14. Patients with any of the following laboratory values at screening and are considered clinically significant by the investigators: - Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range) - ALT, AST and/or total bilirubin > 2.5xULN - Serum creatinine > 1.5x ULN 15. Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigators medical assessment at screening ; PRIMARY OUTCOME: 75% reduction in the Psoriasis Area Severity Index (PASI 75); SECONDARY OUTCOME 1: Number of participants with abnormal Physical Examination finding[/INST]No</s>

<s>[INST]<<SYS>>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 - REMAP-CAP; BRIEF: REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America. ; DRUG USED: TRV027; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Angiotensin II Receptor Type 1 (AT1); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: UMC Utrecht; CRITERIA: REMAP-CAP PLATFORM INCLUSION CRITERIA: 1. Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with: 1. symptoms or signs or both that are consistent with lower respiratory tract infection AND 2. Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate) 2. Up to 48 hours after ICU admission, receiving organ support with one or more of: 1. Non-invasive or Invasive ventilatory support; 2. Receiving infusion of vasopressor or inotropes or both PLATFORM EXCLUSION CRITERIA: 1. Healthcare-associated pneumonia: 1. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days 2. Resident of a nursing home or long term care facility 2. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment 3. Previous participation in this REMAP within the last 90 days REMAP-COVID PLATFORM INCLUSION CRITERIA 1. Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection. REMAP-COVID PLATFORM EXCLUSION CRITERIA 1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment 2. Patient is expected to be discharged from hospital today or tomorrow 3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection. 4. Previous participation in this REMAP within the last 90 days DOMAIN-SPECIFIC ELIGIBLE CRITERIA: Each domain may have additional eligibility criteria. Refer to the study website for more information (www.remapcap.org). ; PRIMARY OUTCOME: All-cause mortality; SECONDARY OUTCOME 1: ICU Mortality[/INST]No</s>

<s>[INST]<<SYS>>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 - COMMAND-4 (w/Pegasys/RBV, GT 1 or 4); BRIEF: The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV). ; 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: - Participants chronically infected with HCV Genotype 4 - HCV RNA viral load of ≥ 10,000 IU/mL - No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent - Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted Exclusion Criteria: - Evidence of decompensated liver disease - Documented or suspected Hepatocellular carcinoma (HCC) - Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening ; PRIMARY OUTCOME: Percentage of Participants With 12 Week Sustained Virologic Response (SVR12); SECONDARY OUTCOME 1: Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)[/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 - LEAP2IT (w/Cerezyme, Type 3); BRIEF: Part 1: Biomarker evaluation/screening phase Primary Objectives: - Evaluate cerebrospinal fluid (CSF) biomarkers in adult Gaucher disease Type 3 (GD3) patients that distinguish GD3 from adult Gaucher disease Type 1 (GD1) patients - Screen adult GD3 patients who qualify for treatment with venglustat in Parts 2, Part 3, and Part 4 Parts 2 and 3: Combination treatment phases Primary objectives: - Evaluate short-term (Part 2) and long-term (Part 3) safety and tolerability of venglustat in combination with Cerezyme in adult GD3 patients - Evaluate the change in CSF central nervous system (CNS) biomarkers (glucosylceramide [GL-1] and lyso-glucosylceramide [lyso-GL-1]) from adult GD3 patients receiving venglustat in combination with Cerezyme (Part 2 only) Part 4: Extended treatment phase with monotherapy Primary objectives: • Evaluate safety and tolerability of venglustat monotherapy in adult GD3 patients who have remained systemically stable on venglustat in combination with Cerezyme Parts 2 and 3: Combination treatment phases Secondary Objectives: - Evaluate the pharmacokinetics (PK) of venglustat in adult GD3 patients - Explore the efficacy of venglustat in combination with Cerezyme in infiltrative lung disease (ILD) in adult GD3 patients (Part 2 only) - Explore the efficacy of venglustat in combination with Cerezyme in systemic disease in adult GD3 patients - Explore the efficacy of venglustat in combination with Cerezyme on neurological function in adult GD3 patients - Explore plasma biomarkers (lyso-GL-1 and GL-1) in adult GD3 patients - Explore CSF biomarkers other than lyso-GL-1 and GL-1 in adult GD3 patients (Part 2 only) Part 4: Extended treatment phase with monotherapy Secondary objectives: - Explore the efficacy of venglustat in systemic disease in adult GD3 patients - Explore the efficacy of venglustat on neurological function in adult GD3 patients - Explore plasma biomarkers (lyso-GL-1 and GL-1) in adult GD3 patients ; DRUG USED: Venglustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gauchers Disease; TARGET: Glucosylceramide Synthase; THERAPY: Combination; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion Criteria: GD3 and GD1 patients must meet the following criteria to be eligible for this study: - GD1 participant is ≥18 and ≤40 years of age. - GD3 participant is ≥18 years of age. - Participant must provide written informed consent prior to any study-related procedures being performed. - Participant has a clinical diagnosis of Gaucher disease Type 1 (GD1) or Gaucher disease Type 3 (GD3) and documented deficiency of acid beta-glucosidase activity confirming this diagnosis. - Participant has received ERT (Cerezyme or other ERT; as deemed appropriate by local regulations) for at least 3 years prior to enrollment, on a stable dose for at least 6 months and is within the therapeutic goals defined below, and is deemed clinically stable for at least 1 year by the Investigator. - Participant has reached Gaucher disease therapeutic goals defined as all of the following to be eligible for this study: - Hemoglobin level of ≥11.0 g/dL for females and ≥12.0 g/dL for males. - Platelet count ≥100,000/mm3. - Spleen volume <10 multiples of normal (MN), or total splenectomy (provided the splenectomy occurred >3 years prior to randomization). - Liver volume <1.5 MN. - No bone crisis and free of symptomatic bone disease such as bone pain attributable to osteonecrosis and/or pathological fractures within 3 months prior to screening. - Participant has maintained GD therapeutic goals defined as all of the following to be eligible for entering Part 4 of this study: - Hemoglobin level of ≥11.0 g/dL for females and ≥12.0 g/dL for males - Platelet count ≥100 000/mm3 - Spleen volume <10 multiples of normal (MN), or total splenectomy - Liver volume <1.5 MN - No bone crisis and free of symptomatic bone disease such as bone pain attributable to osteonecrosis and/or pathological fractures within 3 months prior to entering Part 4 - Participant, if female and of childbearing potential, must have a negative pregnancy test [urine beta-human chorionic gonadotropin (β-hCG)] at baseline. - If participant has a history of seizures, except for myoclonic seizures, they are well controlled under appropriate medication not identified as a strong or moderate inducer or inhibitor of cytochrome P450 (CYP) 3A. - Participant is willing to abstain from consumption of grapefruit, grapefruit juice, or grapefruit containing products for 72 hours prior to administration of the first dose of venglustat and for the duration of the treatment period. - Oculomotor apraxia characterized by a horizontal saccade abnormality. - Female participants of childbearing potential and male patients must be willing to practice true abstinence in line with their preferred and usual lifestyle, or use 2 acceptable effective methods of contraception for the duration of the study and for at least 6 weeks for females and 90 days for males following their last dose of venglustat. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: - Substrate reduction therapy or chaperone therapy for GD within 6 months prior to enrollment. - Participant has had a partial or total splenectomy within 3 years prior to randomization. - Participant is blood transfusion-dependent. - Prior esophageal varices or liver infarction or current liver enzymes (alanine aminotransferase [ALT]/ aspartate aminotransferase [AST]) or total bilirubin >2 times the upper limit of normal, unless the patient has a diagnosis of Gilbert Syndrome. - Participant has any clinically significant disease, other than GD, including cardiovascular (congenital cardiac defect, coronary artery disease, valve disease or left sided heart failure; clinically significant arrhythmias or conduction defect), hepatic, gastrointestinal, pulmonary, neurologic, endocrine, metabolic (eg, hypokalemia, hypomagnesemia) or psychiatric disease, other medical conditions, or serious intercurrent illnesses that may preclude participation. - Participant has renal insufficiency, as defined by an estimated glomerular filtration rate <30 mL/min/1.73m2 at the screening visit. - Participant has received an investigational product within 30 days prior to enrollment. - Participant has a history of cancer, with the exception of basal cell carcinoma. - Participant has myoclonic seizures. - Participant is pregnant or lactating. - Participant has, according to World Health Organization (WHO) Grading, a cortical cataract > one-quarter of the lens circumference (Grade cortical cataract-2) or a posterior subcapsular cataract >2 mm (Grade posterior subcapsular cataract-2). Patients with nuclear cataracts will not be excluded. - Participant requires use of invasive ventilatory support. - Participant requires use of noninvasive ventilator support while awake for longer than 12 hours daily. - Participant is unable to receive treatment with Cerezyme due to a known hypersensitivity or is unwilling to receive Cerezyme treatment to ensure maintenance of Gaucher treatment goals. - Participant is currently receiving potentially cataractogenic medications (corticosteroids, psoralens used in dermatology with ultraviolet light therapy [PUVA], typical antipsychotics, and glaucoma medications) or any medication that may worsen the vision of a patient with cataract (eg, alphaadrenergic glaucoma medications). - Participant has received strong or moderate inducers or inhibitors of CYP3A within 15 days or 5 half-lives from screening, whichever is longer, prior to enrolment in Part 2. This also includes the consumption of grapefruit, grapefruit juice, or grapefruit containing products within 72 hours of starting venglustat administration in Parts 2 and 3. - Participant is scheduled for in-patient hospitalization including elective surgery, during the study. - Participant has had a major organ transplant (e.g., bone marrow or liver). - Participant, in the opinion of the investigator, is unable to adhere to the requirements of the study or unable to undergo study assessments (e.g., contraindications for magnetic resonance imaging). ; PRIMARY OUTCOME: Number of patients with Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Assessment of pharmacodynamic (PD) parameter: Lyso-glucosylceramide (lyso-GL1) and glucosylceramide (GL-1) 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 - FUTURE 4; BRIEF: The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria. - Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative. - Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis. - Inadequate control of symptoms with NSAID. - Other protocol-defined inclusion criteria do apply. Exclusion Criteria: - Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics. - Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications. - Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα. - Previous treatment with any cell-depleting therapies. ; PRIMARY OUTCOME: Number of Participants With American College of Rheumatology 20 (ACR20) Response; SECONDARY OUTCOME 1: Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - P08067 (Aged 5-65); BRIEF: This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season. ; DRUG USED: Grastek; DRUG CLASS: Biologic; INDICATION: Allergic Rhinitis; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: ALK-Abelló A/S; CRITERIA: Inclusion Criteria: - Must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma) - Must have a positive skin prick test response to Phleum pratense (Timothy grass) - Must be positive for specific immunoglobulin E (IgE) against Phleum pratense (Timothy grass) - Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at Screening - Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor Exclusion Criteria: - Has a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen during or potentially overlapping the GPS - Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed - Has received an immunosuppressive treatment within 3 months prior to the Screening Visit - Has a clinical history of severe asthma - Has a history of anaphylaxis with cardiorespiratory symptoms - Has a history of self-injectable epinephrine use - Has a history of chronic urticaria and angioedema - Has a clinical history of chronic sinusitis during the 2 years prior to the Screening Visit - Has current severe atopic dermatitis - Is breast-feeding, pregnant, or intending to become pregnant - Had previous treatment by immunotherapy with any grass pollen allergen for more than 1 month within the 5 years prior to the Screening Visit - Ongoing treatment with any specific immunotherapy at the time of the Screening Visit - Has a known history of allergy, hypersensitivity or intolerance to the ingredients of the study drug (except for Phleum pratense), rescue medications, or self-injectable epinephrine - Has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Specific examples include but are not limited to hypertension being treated with beta blockers, coronary artery disease, arrhythmia, stroke, ocular conditions requiring topical beta blockers, any condition requiring the use of beta blockers - Has used any investigational drugs within 30 days of the Screening Visit - Is participating in any other clinical study - Is a family member of the investigational study staff conducting this study - Is unable to meet medication washout requirements - Is unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the GPS, which in the opinion of the investigator will compromise the data - Has a clinically significant abnormal vital sign or laboratory value that would preclude participation in the study ; PRIMARY OUTCOME: Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS); SECONDARY OUTCOME 1: Average Rhinoconjunctivitis DSS Over the Entire GPS[/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 - P05692 - 26wk Extension; BRIEF: Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion criteria: - Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment - Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691 Exclusion criteria: - A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subjects continuation into this long-term extension trial - A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691 - A participant must not be at imminent risk of self-harm or harm to others ; PRIMARY OUTCOME: Number of participants experiencing clinical and laboratory adverse events (AEs); 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 - SHINE (COG0201); BRIEF: This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimers Disease (AD). ; DRUG USED: Elayta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Cognition Therapeutics; CRITERIA: Inclusion Criteria: 1. Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimers disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record. i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed. ii) Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap. 2. Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable 3. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimers disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number 4). An historical MRI, up to 1 year prior to screening, may be used as long as there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.). 4. MMSE 18-26 inclusive. Exclusion Criteria: 1. Screening MRI (or historical MRI, if applicable) of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility.. 2. Clinical or laboratory findings consistent with: 1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntingtons disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.). 2. Other neurodegenerative condition (Parkinsons disease, amyotrophic lateral sclerosis, etc.). 3. Seizure disorder. 4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.). 3. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry. 4. Clinically significant, advanced or unstable disease that may interfere with outcome evaluations. ; PRIMARY OUTCOME: Number of study participants with treatment related adverse events and serious 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 I/II - KEYNOTE-0036 (w/Utomilumab); BRIEF: This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in patients with solid tumors. ; DRUG USED: Keytruda; 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: Pfizer; CRITERIA: Inclusion Criteria: - Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available. - Measurable disease per RECIST v1.1. - Adequate bone marrow, renal and liver functioning Exclusion Criteria: - CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis. - History of any of the following toxicities associated with a prior immunotherapy: - Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy; - Grade 2 hepatic function related adverse event that persisted more than 1 week, was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy - Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism. - History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD). ; PRIMARY OUTCOME: Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475; SECONDARY OUTCOME 1: Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities)[/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 - w/SoC Treatment (At Risk Patient Population); BRIEF: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment. ; DRUG USED: JNJ-3872; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Influenza Virus, Polymerase Basic Protein 2 (PB2), RNA polymerase; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least moderate if the symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre-existed as determined by subjects ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: a) Respiratory symptoms: cough, sore throat, nasal congestion b) Systemic symptoms: headache, body aches or pain, feverishness, fatigue - Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay - Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for an anticipated duration of less than (<)24 hours is not considered hospitalization as long as a determination of the need for hospitalization has not been made - Enrollment and initiation of study drug treatment less than or equal to (<=)72 hours after onset of influenza symptoms - Participants 13 to 65 years of age, inclusive must also have at least 1 of the following: a) Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung disease [COPD] or cystic fibrosis); c) Weakened immune system due to disease or medication (for example, participants with human immunodeficiency virus [HIV], cancer, or chronic liver or kidney disease [presence of kidney damage for >3 months, defined by structural or functional abnormalities of the kidney, with or without decreased GFR manifested by: pathological abnormalities; OR markers of kidney damage, including abnormalities in the composition of the blood or urine or abnormalities in imaging tests], or participants taking chronic systemic steroids) Exclusion Criteria: - Received more than (>)1 dose of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir >1 day prior to screening - Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive) - Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome - Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy - Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, history of a lung transplant) ; PRIMARY OUTCOME: Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ); SECONDARY OUTCOME 1: Number of Participants Hospitalized After Treatment Initiation[/INST]No</s>

<s>[INST]<<SYS>>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 - DISCOVERY; BRIEF: This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies ; DRUG USED: Empaveli; DRUG CLASS: New Molecular Entity (NME); INDICATION: C3 Glomerulopathy (C3G), including Dense Deposit Disease (DDD) and C3 Glomerulonephritis (C3GN); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Apellis Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Patients of at least 18 years of age at screening (16 years of age for C3G), able to provide written informed consent, and able to understand and comply with all scheduled procedures and other requirements of the study by the opinion of Principal Investigator (PI) - Patients must have a diagnosis of IgAN, LN, Primary MN, or C3G confirmed by renal biopsy and required measurements performed prior to study participation - IgAN: Prior biopsy results for C3 and C4d staining should be made available - LN: Diagnostic biopsy showing proliferative focal, diffuse, or membranous lesions (Class III, IV or V, respectively) by renal biopsy. Subject should have either a biopsy in the last 6 months, or evidence of disease activity (nephritic changes on urinalysis or nephrotic changes) - Primary MN: PLA2R positive titer plus nephrotic range proteinuria (defined as uPCR >2350 mg/g) - C3G plus one of the following: Low serum C3 level or historical renal biopsy within the last 3 years - Have proteinuria >750 mg/g (calculated by uPCR on 24 hour urine collection) collected during the first screening visit (Visit 3a). - eGFR≥30mL/min/1.73 m2 calculated by CKD-EPI creatinine equation at screening visit 3a and currently not on dialysis - Must have stable or worsening renal disease, on stable and optimized treatment, in the opinion of the PI, for at least 2 months prior to the first dose of APL-2 (Visit 4); treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives and/or anti-proteinurics. - Willing to receive vaccinations against Neisseria meningitidis at least 2 weeks prior to dosing on Day 1 with a booster on Day 56 (for both vaccinations) and Pneumococcal and Hib vaccines at least 2 weeks prior to dosing on Day 1. Exclusion Criteria: - Absolute neutrophil count <1000 cells/mm3 at screening Visits 3a and 3b - ALT or AST >3.0 x the upper limit of normal at screening Visits 3a and 3b - Previous treatment with APL-2 - History of solid organ transplant - Diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at screening Visits 3a and 3b (previous HBV or HCV diagnosis cleared by treatment is allowed) - Renal disease secondary to another condition (e.g. infection, malignancy, monoclonal gammopathy, or a medication) - Presence or suspicion of active bacterial or viral infection or severe recurrent bacterial infections - Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period - Unwillingness to receive or intolerant of SC infusions of study medication or known allergy to ingredients in APL-2. ; PRIMARY OUTCOME: Proteinuria; SECONDARY OUTCOME 1: Changes of Disease Specific Biomarkers (serum C3 levels, AH50 and C3a concentrations, serum albumin levels)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ION-1 (+/- RBV, GT1, Treatment-naive); BRIEF: The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection. ; DRUG USED: Harvoni; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Age ≥ 18, with chronic genotype 1 HCV infection - HCV treatment-naive - HCV RNA > 10,000 IU/mL at screening - Cirrhosis determination; a liver biopsy may be required - Screening laboratory values within defined thresholds - Use of two effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: - Pregnant or nursing female or male with pregnant female partner - Co-infection with HIV or hepatitis B virus (HBV) - Current or prior history of clinical hepatic decompensation - Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers) - Chronic use of systemic immunosuppressive agents - History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug[/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 - Post-Surgical Dental Pain; BRIEF: Efficacy, Tolerability, Safety and Pharmacokinetic Study of DFN-15 in Post-Surgical Dental Pain. ; DRUG USED: Elyxyb; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Cyclooxygenase 2 (COX2) / Prostaglandin-Endoperoxide Synthase 2 (PTGS2); THERAPY: Monotherapy; LEAD SPONSOR: Dr. Reddys Laboratories Limited; CRITERIA: Inclusion Criteria: 1. Subjects scheduled to undergo elective bilateral lower (mandibular) third molar extraction under local anesthesia. 2. Subjects must be generally healthy, ambulatory, able to understand and willing to comply with study procedures, study restrictions, assessments, and requirements per the discretion of the investigator. 3. Subjects must voluntarily sign written informed consent prior to any study-specific procedures. 4. Subjects must have a body mass index (BMI) greater than or equal to 19.0 to less than or equal to 35.0 Exclusion Criteria: 1. History of migraine or frequent headaches, low back pain, or other acute or chronic pain conditions. 2. Acute illness or unresolved local infection prior to surgery that can interfere with the conduct of the study. 3. Positive results on urine drug screen or alcohol breath test indicative of illicit drug (Cocaine Metabolites, Marijuana (THC), MDMA (Ecstasy) and Phencyclidine) or alcohol abuse at screening and/or prior to extraction procedure. 4. Positive results for the following (prescription included): Amphetamines, Barbiturates, Benzodiazepines, Methadone, Methamphetamine, Opiates, Oxycodone, and Tricyclic Antidepressants. 5. Frequent use of nicotine-containing products. 6. Excessive intake of caffeine-containing foods or beverages within 48 hours prior to surgery. 7. Routinely uses pain medication. 8. Currently taking any corticosteroid chronically (except for an inhaled steroid for pulmonary disease, and local topical or ophthalmic steroid) or has taken systemic corticosteroids within 4 weeks of the proposed date of surgery. 9. Currently taking central nervous system active drugs such as hypnotics, sedatives, monoamine oxidase inhibitors, sympathomimetic amines, benzodiazepines, tricyclic antidepressants, or serotonin norepinephrine reuptake inhibitors, and anticonvulsants for pain. 10. Donated blood products or had blood loss greater than 500 mL 30 days prior to Screening or between Screening and surgery. 11. Member or relative of study staff or the Sponsor directly involved in the study. 12. Previous participation in this study. 13. Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30 days prior to the Screening visit. 14. Currently receiving or have received within 7 days prior to investigational product administration in the study, any drug (s) that is metabolized by hepatic microsomal enzyme CYP 2D6. 15. Clinically significant disease or disorder which may put the subject at risk, influence the results or the subjects ability to participate in the study. ; PRIMARY OUTCOME: Summed Pain Intensity Difference Over the First Six Hours; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Taiwan (ROS1 and/or ALK); BRIEF: Primary objective: To investigate the objective response rate in patients with ROS1 or ALK over-expressed locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378 Secondary objectives:The progression-free survival ,The disease control rate ,The overall survival ,The toxicity profiles , The correlation between clinical outcomes and the potential predictive biomarker for tumor response ; DRUG USED: Zykadia; DRUG CLASS: New Molecular Entity (NME); INDICATION: Biliary Tract Cancer; TARGET: Anaplastic lymphoma kinase (ALK), IGF-1R (Insulin-like Growth Factor-1 Receptor) , Insulin Receptor, ROS kinase; THERAPY: Monotherapy; LEAD SPONSOR: National Health Research Institutes, Taiwan; CRITERIA: Inclusion Criteria: - 1.Histological or cytologically confirmed diagnosis of intrahepatic or hilar cholangiocarcinoma that demonstrates ALK and/or ROS1 over-expression by IHC (3+). - 2.Locally advanced with inoperable or metastatic disease status - 3.ECOG performance status 0-2. - 4.Aged no less than 20 years and no more than 75 years, at the time of acquisition of informed consent 5.Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ grade 2 (CTCAE v 4.03), provided that concomitant medication is given prior to initiation of treatment with LDK378. Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment. 6.The following laboratory criteria have been met: •Absolute neutrophil count (ANC) ≥1.5 x 109/L - Hemoglobin (Hgb) ≥ 9 g/dL - Platelets ≥ 75 x 109/L - Serum total bilirubin ≤1.5 x upper limit of normal (ULN), except for patients with biliary tract obstruction statis post drainage or stent may be included if total bilirubin ≤3.0 x ULN and direct bilirubin≤ 1.5 x ULN - Aspartate transaminase (AST) < 3.0 x ULN, except for patients with liver metastasis, who are only included if AST < 5 x ULN; alanine transaminase (ALT) < 3.0 x ULN, except for patients with liver metastasis, who are only included if ALT < 5 x ULN - Calculated or measured creatinine clearance (CrCL) ≥ 30 mL/min 7.Patient must have the following laboratory values or have the following laboratory values corrected with supplements to be within normal limits at screening: - Potassium ≥ 1.0 x lower limit of normal (LLN) - Magnesium ≥ 1.0 x LLN - Phosphorus ≥ 1.0 x LLN - Total calcium (corrected for serum albumin) ≥ 1.0 x LLN 8.At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1) 9.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures. Exclusion Criteria: - 1.Patients with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate). 2.Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 1 week prior to study entry to manage CNS symptoms. 3.Prior therapy with LDK378. 4.Other anti-tumor agent such as systemic chemotherapy, immunotherapy or targeted therapy within 2 weeks before the commencement of study treatment. 5.Presence or history of a malignant disease other than cholangiocarcinoma that has been diagnosed and/or required therapy within the past year and is not undergoing active anticancer treatment. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type. 6.Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention). 7.Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:unstable angina within 6 months prior to screening;myocardial infarction within 6 months prior to screening;history of documented congestive heart failure (New York Heart Association functional classification III-IV);uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg, with or without antihypertensive medication ;initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication;other cardiac arrhythmia not controlled with medication;corrected QTc (male: QTc >450 msec; female: QTc> 470 msec ) using Bazett correction on the screening ECG. 8.Impaired GI function or GI disease that may alter absorption of LDK378 or inability to swallow up to five LDK378 capsules daily. 9.Ongoing GI adverse events > grade 2 (e.g. nausea, vomiting, or diarrhea) at the start of the study. 10.Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with LDK378 and for the duration of participation:Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes .Strong inhibitors or strong inducers of CYP3A4/5 ;Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, CYP2C8 and/or CYP2C9 ;Therapeutic doses of warfarin sodium (Coumadin) or any other coumadin-derived anti-coagulant. Anticoagulants not derived from warfarin are allowed (eg, dabigatran, rivaroxaban, apixaban).;increasing doses of corticosteroids;enzyme-inducing anticonvulsive agents;herbal supplements 11.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 12.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after the last dose of study treatment. Highly effective contraception methods include:Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Male sterilization (at least 6 months prior to screening) with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. For female subjects on the study the vasectomized male partner should be the sole partner for that subject. Combination of any two of the following (a+b or a+c or b+c): 1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS). 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. 13.Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of study treatment. Male patients for 3 months should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. ; PRIMARY OUTCOME: objective response rate; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TRIBE (GONO); BRIEF: RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens given together with bevacizumab to see how well they work as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Gruppo Oncologico del Nord-Ovest; CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal cancer - Unresectable metastatic disease - Measurable disease, defined as ≥ 1 measurable lesion according to RECIST criteria - No prior chemotherapy for metastatic disease - No untreated brain metastases, spinal cord compression, or primary brain tumors - No history or evidence of CNS disease by physical examination unless adequately treated (e.g., uncontrolled seizure despite standard medical therapy or history of stroke) PATIENT CHARACTERISTICS: Inclusion criteria: - ECOG performance status (PS) 0-2 (≤ 70 years of age) OR ECOG PS 0 (71-75 years of age) - Life expectancy ≥ 12 weeks - Neutrophils ≥ 1.5 x 10^9/L - Platelet count ≥ 100 x 10^9/L - Hemoglobin > 9 g/dL - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present) - Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present) - Creatinine clearance > 50 mL/min OR serum creatinine ≤ 1.5 times ULN - Proteinuria < 2+ by dipstick OR urine protein ≤ 1 g by 24-hr urine collection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception Exclusion criteria: - Serious, nonhealing wound, ulcer, or bone fracture - Evidence of bleeding diathesis or coagulopathy - Uncontrolled hypertension - Clinically significant (i.e., active) cardiovascular disease, including any of the following: - Cerebrovascular accidents within the past 6 months - Myocardial infarction within the past 6 months - Unstable angina - New York Heart Association class II-IV congestive heart failure - Serious cardiac arrhythmia requiring medication - Known allergy to Chinese hamster ovary cell proteins or any of the components of the study medications - Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix - Symptomatic peripheral neuropathy ≥ grade 1 according to the NCI Common Toxicity Criteria - Lack of physical integrity of the upper gastrointestinal tract - Malabsorption syndrome - Inability to take oral medication - Significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 4 weeks since prior radiotherapy - More than 10 days since prior and no concurrent ongoing treatment with anticoagulants for therapeutic purposes - More than 28 days since prior and no concurrent major surgical procedure - More than 28 days since prior open biopsy - More than 30 days since prior investigational agents - No concurrent chronic daily high-dose acetylsalicylic acid (> 325 mg/day) ; PRIMARY OUTCOME: Progression free survival; SECONDARY OUTCOME 1: Overall response rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GALAXY-2 (w/Docetaxel); BRIEF: The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer. ; DRUG USED: ADX-1612; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Heat Shock Protein 90 (HSP90); THERAPY: Combination; LEAD SPONSOR: Synta Pharmaceuticals Corp.; CRITERIA: Inclusion Criteria: - Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC) - Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1 - Prior therapy defined as 1 prior systemic therapy for advanced disease - Documented disease progression during or following most first line therapy for advanced disease - Adequate hematologic, hepatic, renal function Exclusion Criteria: - Epidermal growth factor receptor (EGFR) mutations - Anaplastic lymphoma kinase (ALK) translocations - Predominantly squamous, adenosquamous or unclear histologic type - Active or untreated central nervous system (CNS) metastases - Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin - Serious cardiac illness or medical conditions - Pregnant or lactating women - Uncontrolled intercurrent illness ; PRIMARY OUTCOME: Overall Survival as of 19 October 2015; SECONDARY OUTCOME 1: Progression-free Survival (PFS) as of 19 October 2015[/INST]No</s>

<s>[INST]<<SYS>>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 - 003 - vs. Liraglutide; BRIEF: This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once daily compared to placebo and another diabetes drug in participants with Type 2 diabetes mellitus (T2DM). This study was modified by a protocol amendment to a 2-part trial to further test the safety and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between participants with T2DM and healthy participants. An additional cohort of T2DM participants and a cohort of non-diabetic obese participants has been added. ; DRUG USED: MK-8521; DRUG CLASS: Unknown; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Male, or female of non-childbearing potential with Type 2 diabetes mellitus (Parts 1 and 2) or non-diabetic (Part 2) - Body mass index (BMI) between: ≥27 and ≤40 kg/m^2 - A1C (average blood sugar for the past 2 to 3 months) value ≥7.0 and ≤11.0 % (Part 1) or ≥ 6.5 and ≤11.0 % (Part 2) at the time of screening (T2DM participants) - A1C value <5.7 at the time of screening (non-diabetic subjects in Part 2 only) - On a stable dose of metformin (≥1000 mg total daily dose) for at least 12 weeks at the time of screening (T2DM participants) Exclusion Criteria: - Mentally or legally incapacitated - History of clinically significant psychiatric disorder of the last 5 years. Participants with situational depression may be enrolled in the trial at the discretion of the Investigator - History of Type 1 diabetes mellitus or a history of ketoacidosis - History of clinically significant gastrointestinal, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases - History of cardiovascular disease or cardiac conduction disorder - History of cancer (malignancy). Exceptions may include adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated ≥10 years prior to the pre-screening visit - History of proliferative diabetic retinopathy or maculopathy - Clinically significant diabetic autonomic neuropathy - QTc interval ≥470 msec (for males) or ≥480 msec (for females) - Clinical significant electrocardiogram (ECG) abnormality - Positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV) - On a weight loss program and is not weight-stable (weight stable is defined history of <5% change in body weight in the last 3 months - On a weight loss medication or has undergone bariatric surgery - Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit - Participated in another investigational trial within 4 weeks prior to the pretrial (screening) visit - History of acute or chronic pancreatitis of any etiology - Mean value for triplicate semi-recumbent systolic blood pressure >160 mm Hg and/or diastolic blood pressure >90 mm Hg (after at least a 10-minute seated rest) and blood pressure is considered unlikely to be below these limits by Day-1 (Randomization) with initiation or adjustment of antihypertensive medication - Event of severe hypoglycemia with seizure or loss of consciousness in the past 12 months - Treated with anti-hyperglycemic agents other than metformin within the last 12 weeks - Previous exposure to any glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. Byetta™, Victoza™ or investigational agents) ; PRIMARY OUTCOME: Number of Participants Experiencing Adverse Events (AEs) in Part 1; SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 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 Ia/Ib - China; BRIEF: This is a first-in-human (FIH), open-label, Phase 1 dose-Escalation Study of MSB2311, a humanized anti-PD-L1 monoclonal antibody, in subjects with advanced solid tumors. Qualified subjects will be enrolled to receive their assigned dose regimen of MSB2311 until disease progression or intolerable toxicity, withdrawal of consent, or end of study, whichever occurs first. The maximum treatment duration is 2 years. During the study, subjects will be evaluated for safety and toxicity, PK/PD, immunogenicity and anti-tumor activity of MSB2311. ; DRUG USED: MSB2311; 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: Suzhou Transcenta Therapeutics Co., Ltd.; CRITERIA: Inclusion Criteria: - Voluntary informed consent, knowledge of the study and willingness to follow and has ability to complete all trial procedures - There is a histologically or cytologically confirmed, locally advanced or metastatic tumor that is not resectable - b period participants shall provide the archive paraffin embedding tumor tissue samples - The eastern United States cooperative tumor group (ECOG) score was 0 or 1 - Expect to survive at least 3 months - Subjects must have measurable lesions (at least 1 lesion) and minimum tumor-specific antigen levels where applicable - If you have received antitumor therapy, you need to meet certain conditions - There are suitable organs and hematopoietic functions - Male subjects and female subjects of child-bearing age shall agree to take effective, investigator-approved contraceptive measures from the date of signing the informed consent until 3 months after the last administration Exclusion Criteria: - The patient has had a malignant tumor other than the tumor treated in this study within 5 years prior to the first administration, unless the medical examiner of the study group and sponsor agrees that the old tumor has been cured or will not metastasise or cause death in this study - Adverse reactions to previous treatments did not return to CTCAE v4.03 rating ≤ 1, except for residual alopecia effect - Patients who had been treated with anti-pd-1 or pd-l1 antibodies, or who had been treated with antibodies/drugs that target any other t-cell co-regulatory proteins within 12 weeks of the first administration of the drug in this study - Patients with primary CNS tumors or CNS metastases known or identified during screening - Subjects with active or pre-existing autoimmune disease that may recur or patients at high risk - Patients who had major surgery in the first 4 weeks of screening and who were expected to have major surgery during the study period including a 28-day screening period - Subjects who require systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment or during the study period - Sudden pulmonary disease, interstitial pulmonary disease or pneumonia, or other uncontrolled systemic disease, including diabetes, pulmonary fibrosis, acute pulmonary disease, cardiovascular disease, including hypertension, except local interstitial pneumonia induced by radiotherapy - A history of human immunodeficiency virus infection, or other acquired or congenital immunodeficiency, or a history of organ transplantation, or stem cell transplantation - Had a history of tuberculosis, or had tuberculosis disease at the time of screening - Patients with chronic hepatitis b or active hepatitis c.Hepatitis b carriers, stable hepatitis b after drug treatment and cured hepatitis c patients can be included in the group - Patients who have been seriously infected within 4 weeks prior to first administration, or who have developed signs or symptoms of any active infection within the previous 2 weeks, or who require antibiotic treatment within the previous 2 weeks;Unexplained fever occurred before the first administration and the body temperature exceeded 38.5℃ - Subjects who have previously been known to have a severe allergic reaction to a macromolecular protein preparation/monoclonal antibody or to any component of the test drug - Immune-related adverse events (irAE) grade ≥3 occurred after receiving immunotherapy - Participated in clinical trials of other drugs within 4 weeks before enrollment - A history of alcohol, drug or substance abuse within the last 1 year - Has a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance - A woman who is pregnant or breastfeeding ; PRIMARY OUTCOME: Safety and tolerability of MSB2311; SECONDARY OUTCOME 1: Area under the plasma concentration versus time curve (AUC) for MSB2311[/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 - TACTAL; BRIEF: Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment, including the standard treatment known for these diseases. This a research study using special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy. This sort of therapy has been used previously to treat Hodgkin or non-Hodgkin lymphomas that show proof of infection with Epstein-Barr virus (EBV), the virus that causes infectious mononucleosis (mono or the kissing disease). EBV is found in cancer cells of up to half of all patients with Hodgkins and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the bodys immune system and escape being killed. Investigators tested whether special white blood cells, called T cells, that were trained to kill EBV-infected cells could affect these tumors, and in many patients it was found that giving these trained T cells caused a complete or partial response. However, many patients do not have EBV in their lymphoma cells; therefore investigators now want to test whether it is possible to direct these special T cells against other types of proteins on the tumor cell surface with similar promising results. The proteins that will be targeted in this study are called tumor associated antigens (TAAs) - these are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells. In this study, we will target five TAAs which commonly show on lymphoma, called: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. This will be done by using special types of T cells called cytotoxic T lymphocytes (CTLs) generated in the lab. In addition, some adult patients will receive a drug called azacytidine before giving the T cells. We hope that the combination helps the T cells work better. ; DRUG USED: MT-401; DRUG CLASS: Biologic; INDICATION: Hematologic Cancer; TARGET: Melanoma antigen-encoding gene (MAGE), NY-ESO-1 (Cancer-testis antigen), PRAME/MAPE/OIP4, Stem Cells/Other Cell Therapies, Survivin, Synovial Sarcoma X (SSX) Breakpoint Family, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Baylor College of Medicine; CRITERIA: Inclusion Criteria: PROCUREMENT: 1. Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma. 2. Life expectancy of 6 weeks or greater. 3. Hgb greater than or equal to 7.0 4. Patient and,or parent,guardian able to give informed consent. TREATMENT: 1. Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma: Group A: Patients greater than or equal to 18 years old - with active disease: - in second or subsequent relapse. - in first relapse for indolent lymphoma after first-line therapy for relapse. - or first relapse if immunosuppressive chemotherapy contraindicated. - primary refractory disease or if persistent disease after first-line therapy of relapse. - or multiply relapsed patients in remission who are at a high risk of relapse. - or the lymphoma is a second malignancy e.g. a Richters transformation of CLL after failing front line therapy. OR Group B: Patients greater than or equal to 18 years old after autologous or syngeneic SCT (as adjuvant therapy). OR Group C: azacytidine plus multiTAA-T cells Patients greater than or equal to 18 years old - with active disease in: - second or subsequent relapse - first relapse for indolent lymphoma after first line therapy for relapse - first relapse if immunosuppressive chemotherapy contraindicated - with primary refractory disease or persistent disease after first line therapy of relapse - or lymphoma as a second malignancy e.g. a Richters transformation of CLL after failing front line therapy OR GROUP D: Patients less than 18 yrs old - with active disease in: - second or subsequent relapse - first relapse for indolent lymphoma after first line therapy for relapse - first relapse if immunosuppressive chemotherapy contraindicated - with primary refractory disease or persistent disease after first line therapy of relapse - with lymphoma as a second malignancy e.g. a Richters transformation of CLL after failing front line therapy 2. Life expectancy of 6 weeks or greater. 3. Pulse oximetry of more than 95 percent on room air in patients who previously received radiation therapy. 4. Karnofsky,Lansky score of 50 or greater. 5. Creatinine 2X or less of upper limit of normal for age. 6. Patients should have been off other investigational therapy for one month prior to entry in this study. 7. Patients should have been off conventional therapy for at least 1 week prior to entry in this study, including rituximab. 8. Patient and,or parent,guardian able to give informed consent. 9. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential should use of at least two forms of contraception unless female has had a hysterectomy or tubal ligation. 10. Bilirubin 2X or less of upper limit of normal, AST 3X or less than the upper limit of normal, and Hgb greater than or equal to 7.0 GROUP C (aza) Only: 11. Platelets greater than 25,000 Exclusion Criteria: PROCUREMENT: 1. Patients with severe intercurrent infection. 2. Patients with active HIV infection at time of procurement (can be pending at the time of blood draw). 3. Patients receiving systemic corticosteroids. TREATMENT: 1. Patients with severe intercurrent infection. 2. Patients receiving systemic corticosteroids. 3. Pregnant breastfeeding. 4. Active viral infection with HIV or hepatitis type B or C. Active infection defined as infectious disease testing indicating that patient blood is reactive for Hep B, C and/or HIV and confirmed using PCR to measure viral load. GROUP C (aza) Only: 5. Abnormal coagulation parameters (PT greater than 15 seconds, PTT greater than 40 seconds, and/or INR greater than 1.5) 6. Significant active cardiac disease within the previous 6 months including: 1. NYHA class 4 CHF 2. Unstable angina 3. Myocardial infarction 7. Known or suspected hypersensitivity to azacitidine or mannitol 8. Patients with advanced malignant hepatic tumors. ; PRIMARY OUTCOME: Assessment of patients with adverse events; SECONDARY OUTCOME 1: Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs[/INST]No</s>

<s>[INST]<<SYS>>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 - SPD489-345 (OLE); BRIEF: To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults ; DRUG USED: Vyvanse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Eating Disorders; TARGET: Dopamine, Norepinephrine (Noradrenaline); THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion criteria: 1. Completion of an antecedent SPD489 BED Double-blind Study 2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED 3. Subject has a body mass index (BMI) of > or =18 and < or =45 Exclusion criteria: 1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. 2. Subject is considered a suicide risk or risk to harm others ; PRIMARY OUTCOME: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety; SECONDARY OUTCOME 1: Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - UNITY 3 (Japan; G1); BRIEF: The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC). ; DRUG USED: Daklinza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Males and females, ≥ 20 years of age - Subjects chronically infected with HCV GT-1 - HCV RNA viral load of ≥ 100,000 IU/mL Exclusion Criteria: - Hepatocellular carcinoma - Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) - Severe or uncontrollable complication ; PRIMARY OUTCOME: Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12; SECONDARY OUTCOME 1: The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV[/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/IFNa; BRIEF: Patients with metastatic renal cell cancer will be enrolled to receive either Trovax® alone or Trovax® plus Interferon Alfa. The study will try to determine whether the use of Trovax® will delay tumor progression. ; DRUG USED: TroVax; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: 5T4 tumor antigen , Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: The Methodist Hospital Research Institute; CRITERIA: Inclusion Criteria: - Locally advanced or metastatic histologically confirmed clear cell or papillary cell renal carcinoma. - Primary tumor surgically removed. - Stable or progressive disease as defined by RECIST criteria. - Age ≥ 18 years. - At least one prior standard of care therapy (IL-2, IFN-α, or approved kinase inhibitor) - At least four weeks from prior use of standard of care therapy. - Karnofsky performance status ≥ 80%. - Corrected Serum Calcium ≥ 10 g/dL. - Patients on stable doses of bisphosphonates (Fosamax, Actonel, Didrocal) that show subsequent tumor progression may continue on this medication; however patients are not allowed to start bisphosphonates within one month prior to starting trial, or throughout the duration of the trial. - Major surgery or radiation therapy completed ≥ 4 weeks prior to treatment. - Clinically immunocompetent. - Free of clinically apparent autoimmune disease. - Absolute lymphocyte count ≥ 500/μL, Absolute neutrophil count ≥ 1200/μL, Platelet count ≥ 100,000/μl, Hemoglobin ≥ 9mg/dL. - No evidence of active ischemia on Electrocardiogram (ECG) - Women must be either post-menopausal, rendered surgically sterile, or using reliable form of contraceptive. - Able to give informed consent and comply with the protocol. Exclusion Criteria: - Prior treatment with TroVax® - No supplements of complementary medicines/botanicals are permitted during study, except for any combination of the following: multivitamins, selenium, lycopene, soy supplements, Vitamin E. - Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. - Participation in any other clinical trial within 30 days. - Cerebral metastasis on MRI Scan. - Currently active second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse. - Serious intercurrent infections or nonmalignant medical illnesses which are uncontrolled. - Psychiatric illnesses that would limit compliance with protocol. - A history of psychosis or clinical depression. - Liver function tests (ALT, AST) more than 1.5 X upper limit of normal (ULN). Bilirubin must be within normal limits. - Creatinine ≥ 1.5 X ULN. - Known allergy to egg proteins. - Known allergy to neomycin. - History of allergic response to previous vaccinia vaccinations. - Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency. - Positive for HIV or Hepatitis B or C. - Clinical indication of reduced cardiac function or an ejection fraction of ≤ 40%. - Pregnancy or lactation - Current chemotherapy, immunotherapy, radiation therapy, or the requirement for radiotherapy. - No investigational or commercial agents or therapies other that those included in the protocol treatment may be administered with the intent to treat malignancy. ; PRIMARY OUTCOME: Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.; SECONDARY OUTCOME 1: Overall survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Study; BRIEF: This is an open-label, Phase 1b study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer. ; DRUG USED: Venadaparib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: Idience Co., Ltd.; CRITERIA: Inclusion Criteria: - Group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach. - Group 2, patients with recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach, who were treated ≥2 times with palliative chemotherapy before screening. - At least 1 evaluable lesion for the dose escalation part and at least 1 measurable lesion according to RECIST v1.1 for the dose expansion part. - Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Exclusion Criteria: - Symptomatic central nervous system or uncontrolled brain metastasis - Carcinomatous meningitis or its history. - For Group 1, patients who are HER 2 positive. - Any other concurrent uncontrolled illness including, but not limited to, active or ongoing symptomatic infection requiring IV antibiotic treatment, uncontrolled diabetes, hepatic, renal, or respiratory illness. - Severe or unstable angina, myocardial infarction or ischemia, symptomatic congestive heart failure, arterial or venous thromboembolism requiring coronary artery bypass graft or stent within the past 6 months or clinically significant cardiac dysrhythmia or New York Heart Association class II ~ IV heart disease within 6 months of randomization. - Uncontrolled hypertension - Immunocompromised patients, such as patients known to be serologically positive for HIV. - Patients with known active Hepatitis B or C infection. - Patients with known active or symptomatic pneumonitis, or history of non-infectious pneumonitis requiring steroids. - Diagnosis of a myelodysplastic syndrome/acute myeloid leukemia or its suspicious characteristics. - Any unresolved clinically significant Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 toxicity - Resting ECG with measurable QTcF > 470 msec on 2 or more time points within a 24-hour period or family history of long QT syndrome. - Current use of a cytochrome P3A4 inhibitor or inducer and strong uridine diphosphate (UDP)-glucuronosyltransferase 1A1 (UGT1A1) inhibitors. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D); 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 - KPG-818-HEM-101; BRIEF: This is a phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, pharmacokinetics and clinical activity of KPG-818 in subjects with hematological malignancies. Approximately 30 patients will be enrolled for dose escalation of 4 dose levels. Indication: Hematological malignancies (multiple myeloma [MM], mantle cell lymphoma [MCL], diffuse large B-cell lymphoma [DLBCL], adult T-cell leukemia-lymphoma [ATL], and indolent non Hodgkin lymphomas such as follicular lymphoma [FL] and chronic lymphocytic leukemia [CLL]/small lymphocytic lymphoma [SLL]). ; DRUG USED: KPG818; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Kangpu Biopharmaceuticals, Ltd.; CRITERIA: Inclusion Criteria: 1. ≥ 18 years of age 2. Willing and able to provide written consent. 3. Willing and able to adhere to the study visit schedule and other protocol requirements. 4. Hematocytological or pathological diagnosis of MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL, etc. 5. Subjects who have relapsed from or are refractory to MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL. 6. Have measurable or assessable disease. 7. Meet the laboratory requirements: 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 9. Males and females of childbearing potential must agree to use at least two methods of contraception and continue until 3 months after the completion of study treatment. Exclusion Criteria: 1. Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Currently enrolled in another clinical study, except observational studies. 3. Has known active central nervous system metastases and/or lymphomatous meningitis. 4. Persisting toxicities related to prior anticancer treatment > Grade 1. 5. Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period. 6. Received live attenuated vaccine within 4 weeks of first dose. 7. Subjects with gastrointestinal disease that may significantly alter the absorption of the study drug. 8. Subjects with a plasma cell leukemia. 9. Subjects with prior history of malignancies, other than MM, lymphoma, or CLL/SLL, unless the subject has been free of the disease for ≥ 5 years. 10. Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide. 11. Has known or suspected hypersensitivity to the excipients contained in the formulation of investigational product (IP). 12. Has been treated with an investigational agent (i.e., an agent not commercially available) within 28 days of initiating IP. 13. Prior treatment of any inhibitors of PD-1 or PD-L1 within 3 months prior to initiating IP. 14. Has any one of the following: - Clinically significant abnormal ECG finding at Screening. - Congestive heart failure. - Myocardial infarction within 12 months prior to initiating IP. - Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris. - Peripheral neuropathy ≥ Grade 2. - Subject has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. Johns Wort or related products within 2 weeks prior to dosing and during the course of study. 15. Has current or prior use of immunosuppressive medication within 14 days prior initiating IP. 16. Subject known to test positive for human immunodeficiency virus, active hepatitis B, or active hepatitis C. 17. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis. 18. Subject is a female who is pregnant, nursing, or breastfeeding. ; PRIMARY OUTCOME: Treatment-Emergent Adverse Events [Safety and Tolerability]; SECONDARY OUTCOME 1: PK profile of KPG-818: maximum observed plasma concentration (Cmax).[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - Combination (w/Temozolomide); BRIEF: In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide resistant) glioma patients. The overall goal of this study is to provide a foundation for future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation and temozolomide, or in combination with vaccine therapies. ; DRUG USED: Indoximod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: IDO (Indoleamine 2,3-dioxygenase), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: NewLink Genetics Corporation; CRITERIA: Inclusion Criteria: - Histologically proven intracranial glioblastoma multiforme (WHO grade IV glioma) or gliosarcoma. In addition, the Phase 1b cohort will include patients with progressive WHO grade III glioma. - Patients will be eligible if the original histology was lower grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made. - Unequivocal radiographic evidence for tumor progression by MRI. It is understood that some patients may be resected prior to enrolling onto protocol - Patients must have completed a course of radiation therapy and at least 2 adjuvant cycles of temozolomide for the phase 2 component. - Patients enrolling onto Cohort 2b who have been taken off bevacizumab must have had at least a 28 day washout from any previous administration of bevacizumab. It is preferred that patients who fail bevacizumab prior to trial entry remain on bevacizumab in the trial. - Prior temozolomide is not required for the phase 1 component; prior radiation is required for the phase 1 arm. - Patients must be on a steroid dose less than or equal to 2 mg of dexamethasone daily (or equivalent), and this dose must not have increased for at least 14 days prior to obtaining the enrollment. - ECOG performance status ≤1 or Karnofsky ≥70%. - Age between 16 - Must be 28 days from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions: - Must be 14 days from administration of non-cytotoxic agents (e.g., bevacizumab (except COHORT 2b), interferon, tamoxifen, thalidomide, cis-retinoic acid, tyrosine kinase inhibitor, etc.). Exclusion Criteria: - Prior invasive malignancy that is not low-grade glioma, high-grade glioma, glioblastoma, or gliosarcoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years. - Patients on the phase 2 portion of the study may not have more than 2 prior regimens for recurrent disease for glioblastoma/gliosarcoma. Patients on the phase 1 portion of the study may not have had more than 3 prior regimens. - Systemic corticosteroid therapy > 2 mg of dexamethasone daily (or equivalent) at study enrollment. - Active or history of autoimmune disease ; PRIMARY OUTCOME: Phase 1: Determine Phase 2 Dosing; SECONDARY OUTCOME 1: Number of Participants with Adverse Events as a Measure of Safety and Tolerability[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - OPH1005; BRIEF: The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy. ; DRUG USED: Fovista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Platelet-derived growth factor (PDGF); THERAPY: Combination; LEAD SPONSOR: Ophthotech Corporation; CRITERIA: Inclusion Criteria: - Subjects of either gender aged ≥ 50 years - All fluorescein angiographic subtypes with presence of active choroidal neovascularization Exclusion Criteria: - Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication - Subjects with subfoveal scar or subfoveal atrophy - Any ocular or periocular infection in the past twelve (12) weeks - History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant ; PRIMARY OUTCOME: Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DUAL VIII (vs. Insulin Glargine Therapy); BRIEF: This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics. ; DRUG USED: Xultophy; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age greater than or equal to 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes mellitus - HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis - Body mass index greater than or equal to 20 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes - Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record) Exclusion Criteria: - Screening calcitonin greater than or equal to 50 ng/L - Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening - Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - History of pancreatitis (acute or chronic) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening - Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids) ; PRIMARY OUTCOME: Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification; SECONDARY OUTCOME 1: Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits[/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 - LISAH - HER2+ Early BC (Austria); BRIEF: This open-label, randomized crossover study evaluated the quality of life, efficacy, and safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper arm of participants with early HER2-positive breast cancer. ; DRUG USED: Herceptin Hylecta; DRUG CLASS: Biosimilar; INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Female and male patients ≥ years of age. - HER2-positive early breast cancer. - Eastern Cooperative Oncology Group (ECOG) performance status 0-1. - Hormonal therapy will be allowed as per institutional guidelines. - Patients must be Herceptin (trastuzumab) naïve. - Left ventricular ejection fraction (LVEF) of ≥ 55%. - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast. - No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant). - Use of concurrent curative radiotherapy will be permitted. Exclusion Criteria: - History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible. - Patients with severe dyspnea at rest or requiring supplementary oxygen therapy. - Patients with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness. - Serious cardiac illness or medical conditions that would preclude the use of Herceptin, specifically, a history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), or diagnosed poorly controlled hypertension. - Pregnant or lactating women. - Women of childbearing potential and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment. - Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy, and immunotherapy, within 28 days prior to the first dose of study treatment. - Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or a history of severe allergic or immunological reactions, eg, difficult to control asthma. - Inadequate bone marrow, hepatic, or renal function. ; PRIMARY OUTCOME: Quality of Life Score; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - AEGIS-I (Acute Myocardial Infarction); BRIEF: This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI). ; DRUG USED: CSL112; DRUG CLASS: Biologic; INDICATION: Atherosclerosis; TARGET: Reverse Cholesterol Transport (RCT); THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last week. Exclusion Criteria: - Ongoing hemodynamic instability - Evidence of hepatobiliary disease - Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis - Evidence of unstable renal function - History of acute kidney injury after previous exposure to an intravenous contrast agent. - Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components - Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study ; PRIMARY OUTCOME: Percent of Participants With Clinically Important Change in Drug-induced Liver Injury; SECONDARY OUTCOME 1: The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)[/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 - OSR-TIGET; BRIEF: OTL-200 is a cryopreserved dispersion for infusion containing autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A (ARSA) gene. MLD is an autosomal recessive lysosomal storage disorder (LSD) characterized by severe and progressive demyelination affecting the central and peripheral nervous system. The aim of this clinical study is to assess the pharmacodynamic effect and long-term clinical efficacy and safety of OTL-200 in Late Juvenile MLD patients. ; DRUG USED: OTL-200; DRUG CLASS: Biologic; INDICATION: Metachromatic Leukodystrophy; TARGET: Galactosyl-3-sulfate ceramides (sulfatides), Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Orchard Therapeutics; CRITERIA: Inclusion Criteria: All the following criteria need to be met: - Documented biochemical and molecular diagnosis of MLD, based on ARSA activity below the normal range and identification of two disease-causing ARSA alleles. Novel mutations will be analyzed with in silico prediction tools and excluded from being known common polymorphisms. In the case of a novel mutation(s), a 24-hour urine collection must show elevated sulfatide levels. - 0/R or R/R genotype or a genotype recognized as associated with the LJ variant of MLD. - a) If symptomatic: age at disease onset between ≥7 and <17 years of age (i.e. before their 17th birthday). OR - b) If pre-symptomatic: participant must be <17 years of age at treatment (i.e. before their 17th birthday) AND must have a sibling with a diagnosis of late-juvenile MLD variant based on age at disease onset (≥7 and <17 years of age i.e. before siblings 17th birthday), with biochemical and molecular diagnosis. - Normal cognitive function as defined by an IQ≥85 on age appropriate cognitive scales. - a) If the participant is <7 years (i.e. before their 7th birthday): normal motor milestones achievement, normal gross motor function according to chronological age and normal neurological examination (if applicable based on the age of the subject, GMFC-MLD = 0) OR b) If participant is ≥7 years: normal gross motor function or mild gross motor function impairment, defined by a GMFC-MLD 0 or 1 (i.e. patient is able to walk independently). NOTE: The following will not be exclusionary if present alone: 1.) Seizures 2.) Signs of the disease revealed at instrumental evaluations (Electroneurography [ENG] and brain MR) - If applicable, participant willing and capable of compliance with contraceptive use requirements. - Participant (or if applicable, parent/legal guardian) providing signed informed consent or assent as applicable Exclusion Criteria: - Documented HIV infection (positive HIV RNA and/or anti-p24 antibodies). - Malignant neoplasia (except localised skin cancer) or a documented history of hereditary cancer syndrome. Participants with a prior successfully treated malignancy and a sufficient follow-up to exclude recurrence (based on oncologist opinion) can be included after discussion and approval by the Medical Monitor. - Myelodysplasia, cytogenetic alterations characteristic of myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) or other serious haematological disorders. - Patients currently enrolled in other interventional trials - Has previously undergone allogeneic HSPC gene therapy (HSPC-GT) and has evidence of residual cells of donor origin. - Previous gene therapy. - Has symptomatic herpes zoster, not responsive to specific treatment. NOTE: Participants with a recent history of herpes zoster may be included in the study. In such cases, inclusion, additional monitoring and treatment of the condition must be discussed and approved by the Medical Monitor. - Evidence of active tuberculosis (TB) based upon medical examination, chest imaging and TB testing. Participants with latent tuberculosis, as documented by medical history and/or TB testing may be included in the study if receiving antibiotic prophylaxis (e.g. isoniazid). Inclusion, monitoring and treatment of TB in such participants must be discussed and approved by the Medical Monitor. - Acute or chronic stable Hepatitis B (HBV) as evidenced by positive Hepatitis B surface antigen (HBsAg) test result at screening or within 3 months prior to onset of conditioning and/or positive HBV DNA. NOTE: Participants with positive Hepatitis B core antibody due to prior resolved disease may be enrolled, only if a confirmatory negative HBsAg and negative Hepatitis B DNA test are obtained. Inclusion, monitoring and treatment of hepatitis in such participants must be discussed and approved by the Medical Monitor. - Presence of positive Hepatitis C RNA test result at screening. NOTE: Patients who have previously tested positive for antibodies to hepatitis C can be treated, provided they demonstrate absence of ongoing infection using a nucleic acid test with a limit of quantification of ≤15 international units/ml. Negative test results are required on at least 3 sequential occasions over a period of at least 4 weeks, after completion of treatment for Hepatitis C, with the final test conducted no more than 3 days prior to cell harvest. Inclusion, monitoring and treatment of hepatitis in such participants must be discussed and approved by the Medical Monitor. - End-organ dysfunction, severe active infection not responsive to treatment, or other severe disease or clinical condition which, in the judgment of the investigator, would make the participant inappropriate for entry into this study. - In addition to the potential infections tested per protocol, the PI should consider testing for other transmissible infectious agents listed in the European Union (EU) Cell and Tissue Directive as clinically appropriate and results must be discussed with the Orchard medical monitor prior to stem cell harvest. - Participants with alanine transferase (ALT) >2x upper limit of normal (ULN) or total bilirubin >1.5xULN may be included only after discussed and agreed with the Orchard medical monitor and considered in the context of the criterion for excluding participants with other severe disease. Isolated elevation of total bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35% of total. ; PRIMARY OUTCOME: Evaluation of OTL-200 Arylsulfatase A (ARSA) activity levels in Cerebrospinal Fluid (CSF); SECONDARY OUTCOME 1: Change in ARSA activity levels in CSF from baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - 1st-Line w/RT+Temozolomide; BRIEF: The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM). ; DRUG USED: Turalio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Macrophage Colony Stimulating Factor 1 (M-CSF1)/M-CSF Receptor/FMS/CD115/CSF-1/CSF1R; THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo, Inc.; CRITERIA: Inclusion Criteria: - Male or female patients ≥18 years old. - Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides. - The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration. - A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1. - Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality. - Patients must receive RT at the participating institution. - Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose. - Karnofsky performance status of ≥70. - Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5x 109/L, Hgb >10 g/dL, platelet count ≥100 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN). - Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements. Exclusion Criteria: - Evidence of recurrent GBM or metastases detected outside of the cranial vault. - Investigational drug use within 28 days of the first dose of PLX3397 or concurrently. - Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment. - Prior radiation or chemotherapy for glioblastoma or glioma. - Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields. - Prior allergic reaction to temozolomide. - History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage. - Active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix. - Chronic active hepatitis B or C. - Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of study drug. - Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigators opinion would be likely to interfere with a patients participation in the study, or with the interpretation of the results. - Women of child-bearing potential who are pregnant or breast feeding. - At Screening QTcF ≥450 msec for males and ≥470 msec for females. ; PRIMARY OUTCOME: Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group; SECONDARY OUTCOME 1: Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 2nd Line; BRIEF: The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival. ; DRUG USED: Sutent; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented - Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion - Evidence of measurable disease by radiographic technique - Adequate organ function. Exclusion Criteria: - Clinically relevant ascites (i.e. requiring paracentesis) - Severe weight loss - NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment - Diagnosis of second malignancy within last 3 years - History of or known brain metastases, spinal cord compression, or carcinomatous meningitis - Known HIV - Serious acute or chronic illness - Current treatment on another clinical trial - Pregnant or breastfeeding ; PRIMARY OUTCOME: Best Overall Response; SECONDARY OUTCOME 1: Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks[/INST]No</s>

<s>[INST]<<SYS>>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 - Neuroblastoma; BRIEF: The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma. ; DRUG USED: AK-01; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuroendocrine Tumors (NET); TARGET: Aurora Kinase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have relapsed/refractory neuroblastoma and have active disease in at least one site: bone, bone marrow or soft tissue. Participants must be able to submit an archival sample of tissue. - Participants must be able to swallow capsules. Exclusion Criteria: - Participants must not have had an allogeneic hematopoietic stem cell, bone marrow, or solid organ transplant. - Participants must not have untreated tumor that has spread to the brain or spinal cord. - Participants must not have a serious active disease other than neuroblastoma. - Participants must not have a condition affecting absorption. - Participants must not have had prior aurora kinase inhibitor exposure. - Participants must not have a known allergy to the study treatment. - Participants must not have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C. ; PRIMARY OUTCOME: Number of Participants with Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668[/INST]No</s>

<s>[INST]<<SYS>>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 - Ten 02; BRIEF: The primary objective of the study is to assess the efficacy of FACTOR X in the prevention of bleeding when given as routine prophylaxis over 12 months. The secondary objectives of the study are: 1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg. 2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26 weeks). ; DRUG USED: Coagadex; DRUG CLASS: Biologic; INDICATION: Factor X (Stuart-Prower Factor) Deficiency; TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bio Products Laboratory; CRITERIA: Inclusion Criteria 1. Children with hereditary severe or moderate FX deficiency (FX:C <5 IU/dL), based on their lowest reliable FX:C recorded. 2. Children under 12 years old, whose parent/guardian has given informed consent. 3. Children with a history of severe bleeding e.g.: intracranial haemorrhage, before starting prophylactic therapy, OR a mutation in the F10 gene causing a documented severe bleeding phenotype. Exclusion Criteria 1. Children must not suffer from clinically significant liver disease, renal disease, or other coagulopathy or thrombophilia 2. Children must have no history or suspicion of inhibitors to factor X. 3. Children who have known or suspected hypersensitivity to the investigational medicinal product or its excipients. 4. Children with a history of unreliability or non-cooperation. 5. Children who are participating or have taken part in another trial within the last 30 days. 6. Children planning more than 4 weeks continuous absence from the locality of the investigational site, between the Screening Visit and the End of Study Visit at approximately 6 months (26 weeks) post-Baseline. ; PRIMARY OUTCOME: The Number of Participants With Excellent Reduction in Bleeding When Given FACTOR X as Routine Prophylaxis Over 6 Months; SECONDARY OUTCOME 1: Safety of FACTOR X: Number of Participants Experiencing Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LAURIET (Moderate); BRIEF: This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate AD. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. There may be up to two study cohorts. ; DRUG USED: Semorinemab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - National Institute on Aging/Alzheimers Association core clinical criteria for probable AD dementia - Evidence of the AD pathological process, by a positive amyloid assessment either on CSF Aβ1-42 as measured on Elecsys β-Amyloid(1-42) Test System OR amyloid PET scan - AD dementia of moderate severity, as defined by a screening MMSE score of 16-21 points, inclusive, and a CDR-GS of 1 or 2 - Availability of a person with sufficient contact with the participant to be able to provide accurate information on the participants cognitive, behavioral and functional ability Exclusion Criteria: - Pregnant or breastfeeding - Inability to tolerate MRI procedures or contraindication to MRI - Contraindication to PET imaging - Residence in a skilled nursing facility - Any serious medical condition or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the patients safe participation in and completion of the study, or bias the assessment of the clinical or mental status of the participant to a significant degree - Any evidence of a condition other than AD that may affect cognition - Substance abuse within the past 2 years - Use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater, or any passive immunotherapy against tau - Use of any passive immunotherapy (immunoglobulin) against Aβ, unless the last dose was at least 1 year prior to screening or any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline - Any other biologic therapy or previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other non-AD neurodegenerative disorder within 1 year of screening - Systemic immunosuppressive therapy within 12 months of screening through the entire study period - Typical antipsychotic or neuroleptic medication within 6 months of screening - Daily treatment with any of the following classes of medication (except for intermittent short-term use): opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally-acting antihistamine or anticholinergic activity - Stimulant medications, unless the dose has been stable within the 6 months prior to screening and is expected to be stable throughout the study ; PRIMARY OUTCOME: Change From Baseline to Last Visit of Double-Blind Treatment Period in Cognitive Function as Measured by the Alzheimers Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11); SECONDARY OUTCOME 1: Change From Baseline to Last Visit of Double-Blind Treatment Period on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)[/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 - INTR@PID BTC 055 (1st Line); BRIEF: Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin. ; DRUG USED: Bintrafusp Alfa; DRUG CLASS: Biologic; INDICATION: Biliary Tract Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2), Transforming Growth Factor-beta (TGF-beta) Receptor; THERAPY: Combination; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC - Participants must have available tumor tissue (primary or metastatic) (archival or fresh biopsies) before the first administration of study treatment - At least 1 measurable lesion according to RECIST 1.1 - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing - Life expectancy of >= 12 weeks, as judged by the Investigator - Adequate hematological function, hepatic function, renal function, coagulation function as defined in the protocol - Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Previous and/or intercurrent cancers - Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression - Participants with symptomatic central nervous system (CNS) metastases - Significant acute or chronic infection including known history of positive test for human immunodeficiency virus (HIV), active tuberculosis, uncontrolled biliary infection and active bacterial or fungal infection requiring systemic therapy (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 Day 1 prior to dosing. - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent - History of or concurrent interstitial lung disease - History of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent (within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization - Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints) - Other protocol defined exclusion criteria could apply ; PRIMARY OUTCOME: Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0[/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 - NS001 (Shoulder Impingement Syndrome); BRIEF: Objective: This purpose of this pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with shoulder impingement syndrome. ; DRUG USED: Synera; DRUG CLASS: Non-NME; INDICATION: Acute Pain; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Injury Care Medical Center; CRITERIA: Inclusion Criteria: - be at least 18 years of age. - have pain associated with shoulder impingement syndrome in a single shoulder (minimum 2-week duration). - have tenderness at the attachment site of the rotator cuff tendons. - have positive Hawkins and Neers signs. - report an average pain intensity score of 4 (on an 11-point scale) over the past 24 hours at the Screening/Baseline visit. Exclusion Criteria: - have used any topically applied pain medication on the target treatment area within 14 days preceding Study Day 1, such as non-steroidal anti-inflammatory drugs (NSAIDs), menthol, methyl salicylate, local anesthetics (including Lidoderm®), or steroids. - have used any injected medication within 60 days preceding Study Day 1, such as local anesthetic (lidocaine) or steroids. - have a clinically significant illness within 14 days of Screening/Day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study. - are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.) - have a history of and/or past diagnosis of severe hepatic disease. - have participated in a clinical trial of an unapproved drug within 30 days prior to screening. - are pregnant, breastfeeding, or a female of childbearing potential and not practicing an acceptable method of birth control. - are unable or unwilling, in the opinion of the investigators, to comply with all study procedures and cooperate fully with research staff. - have filed a disability claim or are currently receiving disability payments for shoulder impingement syndrome. ; PRIMARY OUTCOME: Pain Intensity; SECONDARY OUTCOME 1: Patient Global Assessment of Treatment Satisfaction[/INST]No</s>

<s>[INST]<<SYS>>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 - 009 - Residual Risk; BRIEF: The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Esperion Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL - Fasting mean TG level ≤400 mg/dL - Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily) Exclusion Criteria: - Clinically significant cardiovascular disease within 12 months of screening - Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued - Type 1 diabetes or uncontrolled type 2 diabetes - Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening - History of chronic musculoskeletal symptoms such as fibromyalgia - Uncontrolled hypothyroidism - Liver disease or dysfunction - Renal dysfunction or nephritic syndrome - Gastrointestinal conditions or procedures or surgeries - Hematologic or coagulation disorders or low hemoglobin levels - HIV or AIDS - History of malignancy - History of drug or alcohol abuse within 2 years - Use of experimental or investigational drugs within 30 days of screening - Use of ETC-1002 in a previous clinical study ; PRIMARY OUTCOME: Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C); SECONDARY OUTCOME 1: Percent change in non-high-density lipoprotein cholesterol (non-HDL-C)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIa - STEP 4 (Maintained Weight Loss); BRIEF: This study will look at the change in participants body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking dummy medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or dummy medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age greater than or equal to 18 years at the time of signing informed consent - Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm with the presence of at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease - History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: - Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central laboratory at screening - A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records ; PRIMARY OUTCOME: Change From Randomisation to Week 68 in Body Weight (%); SECONDARY OUTCOME 1: Change in Waist Circumference[/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 - Cardiac Repolarization Interval; BRIEF: The primary objective of this study is to evaluate the effect of supratherapeutic exposures of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel 2). ; DRUG USED: JNJ-64041575; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Syncytial Virus (RSV) Treatment; TARGET: RNA synthesis, RSV, Respiratory Syncytial Virus; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study - Participant must be willing and able to adhere to the prohibitions and restrictions specified in protocol - A female participant must be of non-childbearing potential, defined as either: a) Postmenopausal- A postmenopausal state is defined as no menses for at least 12 months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (> 40 International units per liter [IU/L] or International units/milliliter [mIU/mL]); b) Permanently sterile- Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy - During the study and for a minimum of one spermatogenesis cycle (defined as approximately 90 days) after receiving the (last dose of) study drug, a male participant: a) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository); b) who is sexually active with a pregnant woman must use a condom; c) must agree not to donate sperm - Female partners of male participants must either be surgically sterilized, postmenopausal (amenorrhea for a minimum of 1 year) or, if of childbearing potential, must agree to use at least one of the following contraceptive methods for 90 days following the last dose of study drug: a nonhormonal intrauterine device with spermicide; contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, or oral, implantable, transdermal, or injectable hormonal contraceptives - A female participant must have a negative serum beta human chorionic gonadotropin (b-hCG) pregnancy test at screening and on Day -1 - A female participant must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the (last dose of) study drug - Participants must have a body mass index (BMI); weight (kilogram [kg])/height^2 (meter [m]^2) between 18.0 and 30.0 kg/m^2 (inclusive) at screening - Participants must have a blood pressure (supine after at least 5 minutes rest) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening - Participants must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) Sinus rhythm (heart rate between 45 and 100 beats per minute (bpm), inclusive); b) QT interval corrected for heart rate according to Fridericia (QTcF) interval between 350 milliseconds (ms) and 430 ms for male participants, and between 350 ms and 450 ms for female participants (inclusive); c) QRS interval of <110 ms; d) PR interval <=200 ms; e) Morphology consistent with healthy cardiac conduction and function - Participants must be non-smokers for at least 3 months prior to screening - Participants must be healthy on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality and includes a complete physical examination, medical and surgical history, vital signs, ECGs, and the results of blood biochemistry and hematology tests and a urinalysis performed at screening. If there are abnormalities the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participants source documents and initialed by the Investigator - Participants must have normal values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (<= 1.0*upper limit of laboratory normal range [ULN]) Exclusion Criteria: - Participants has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results - Participants with one or more laboratory abnormalities at screening as defined in the Protocol - Participants with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, heart blocks and incomplete and complete right and left bundle branch blocks - Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements - Participants with a past history of heart arrhythmias (extra systolic beats or tachycardia at rest) or with a history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia or family history of short/long QT syndrome, or sudden unexplained death at a young age [less than or equal to 40 years], drowning or sudden infant death in a first degree relative [that is, sibling, offspring, or biological parent]) - Participants with electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia) of grade 2 or above within 21 days prior to the (first) intake of the study drug - Participants with any skin condition likely to interfere with ECG electrode placement or adhesion - Participants with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues - Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria - Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs - Participants with presence of any febrile illness or symptoms of upper or lower respiratory tract infection in the 14 days before the (first) administration of study drugs - Participant has taken any disallowed therapies as noted in Concomitant Therapy before the planned (first) intake of study drug - Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamine, tetrahydrocannabinol, phencyclidine, and tricyclic antidepressants) at screening - Participant has known allergies, hypersensitivity, or intolerance to ALS-008176, moxifloxacin or its excipients - Participant has known allergy to heparin or history of heparin-induced thrombocytopenia - Participant has donated blood or blood products or had substantial loss of blood (more than 500 milliliter) within 3 months before the (first) administration of study drug or intention to donate blood or blood products during the study - Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned (first) intake of study drug - Participant is a woman who is pregnant or breastfeeding - Participant is a man who plans to father a child while enrolled in this study or within 90 days after the (last) intake of study drug, or who is unwilling to use acceptable methods of contraception as outlined in Protocol - Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive, or other clinically active liver disease, or tests positive for HBsAg or anti HCV at screening - Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or tests positive for HIV-1 or -2 at screening - The participant has preplanned surgery or procedures that would interfere with the conduct of the study - Vulnerable participant (example, incarcerated individuals) - Participant with lack of good/reasonable venous access - Participant is an employee of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, or a family member of the employees or the Investigator, or an employee of the Sponsor - Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments - Participant has previously been dosed with ALS-008176 in more than 3 single-dose studies with ALS-008176 - Participant has previously been dosed with ALS-008176 in a multiple-dose study with ALS 008176 ; PRIMARY OUTCOME: Change from baseline in Corrected QT intervals (QTc); SECONDARY OUTCOME 1: Number of participants with adverse events as a measure of safety and tolerability[/INST]Yes</s>