Datasets:

mi-rei

/

CT_II-III_efficent_5k

like 0

<s>[INST]<<SYS>>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 - 50 or 200 mg; BRIEF: A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study, to evaluate the effects of two doses of seladelpar/MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA) ; DRUG USED: Seladelpar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: PPAR delta; THERAPY: Monotherapy; LEAD SPONSOR: CymaBay Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Must have given written informed consent (signed and dated) and any authorizations required by local law 2. 18 to 75 years old (inclusive) 3. Male or female with a diagnosis of PBC, by at least two of the following criteria: - History of AP above ULN for at least six months - Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies - Documented liver biopsy result consistent with PBC 4. On a stable and recommended dose of UDCA for the past twelve months 5. AP ≥ 1.67 × ULN 6. For females of reproductive potential, use of at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose. For male subjects, use of appropriate contraception (e.g., condoms), so their female partners of reproductive potential do not become pregnant during the study and for at least two weeks after the last dose Exclusion Criteria: 1. A medical condition, other than PBC, that in the investigators opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment) 2. AST or ALT > 3 × ULN 3. Total bilirubin > 2 × ULN 4. Auto-immune hepatitis 5. Primary sclerosing cholangitis 6. Known history of alpha-1-Antitrypsin deficiency 7. Known history of chronic viral hepatitis 8. Creatine kinase above ULN 9. Serum creatinine above ULN 10. For females, pregnancy or breast-feeding 11. Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening 12. Current use of fibrates, including fenofibrates, or simvastatin 13. Use of an experimental treatment for PBC 14. Use of experimental or unapproved immunosuppressant 15. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator ; PRIMARY OUTCOME: Serum Alkaline Phosphatase (AP); SECONDARY OUTCOME 1: Composite Endpoint of AP and Bilirubin[/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 - BOFT-0117; BRIEF: To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis ; DRUG USED: Blexten; DRUG CLASS: New Molecular Entity (NME); INDICATION: Allergic Conjunctivitis (Ophthalmology); TARGET: Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Faes Farma, S.A.; CRITERIA: Key Inclusion Criteria: - be at least 18 years old - be willing and able to avoid all disallowed medications and contact lenses - must have a pregnancy test if of childbearing potential - must be able to read an eye chart from 10 feet away Key Exclusion Criteria: - must not have any allergies to the study medications - must not have any ocular or non ocular condition that investigator feels will interfere with study parameters - must not have used immunotherapy in the last 2 years - must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial ; PRIMARY OUTCOME: Ocular Itching; 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 - IFN-Free w/ABT-450/Ritonavir +/- ABT-267 (AVIATOR); BRIEF: This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV). ; DRUG USED: Exviera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Males and females 18-70 years old, inclusive - Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control - Chronic hepatitis C virus (HCV), genotype 1 infection - Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12) - No evidence of liver cirrhosis Exclusion Criteria: - Significant liver disease with any cause other than HCV as the primary cause - Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody - Positive screen for drugs and alcohol - Significant sensitivity to any drug - Use of contraindicated or prohibited medications within 1 month of dosing - Abnormal laboratory tests ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin[/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 - w/Toripalimab; BRIEF: An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of APG-1387 in combination with toripalimab. A phase II study of 3 cohorts will be included. ; DRUG USED: APG-1387; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: IAPs (Inhibitor of apoptosis proteins); THERAPY: Combination; LEAD SPONSOR: Ascentage Pharma Group Inc.; CRITERIA: Inclusion Criteria: 1. Histopathologically confirmed advanced solid tumors 1. For phase II CRC group only: Patients with histologically confirmed microsatellite stable (detected by immunohistochemistry, PCR or NGS methods) advanced colorectal cancer. 2. For phase II NPC group only: Patients with histologically or cytologically confirmed advanced NPC. 3. For phase II NSCLC group only: Patients with histologically confirmed or cytologically confirmed advanced non-small cell lung cancer together with wild-type EGFR/ALK/ROS1 (first or second-generation sequencing results are allowed). 2. Patients who have failed standard antitumor therapy. 3. At least one evaluable lesion according to RECIST 1.1 criteria. 4. Age greater than 18 years, both men and women. 5. ECOG: 0 to 1. 6. Expected survival ≥ 3 months. 7. The function of vital organs meets the following criteria (no blood components and cell growth factors are allowed 2 weeks before the start of study treatment): 1. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; 2. Platelets ≥ 100 × 10^9/L; 3. Hemoglobin ≥ 90 g/L; 4. Serum albumin ≥ 30 g/L; 5. Total bilirubin ≤ 1.5 x the upper limit of normal(ULN), ALT and AST ≤ 2.5 x ULN; if there is liver metastasis, ALT and AST ≤ 5 x ULN; 6. Serum creatinine ≤ 1.5 x ULN ; or if Serum creatinine >1.5 x UL, 24-hour creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); 8. Patients with asymptomatic brain metastases (not requiring pharmacological control) or brain metastases that have been stable for more than 28 days after treatment. 9. Patients must have recovered to Grade 1 or less from adverse reactions resulting from prior antineoplastic therapy (except alopecia and sensory neuropathy not exceeding Grade 2). 10. Males, women of childbearing potential (postmenopausal women who must have been postmenopausal for at least 12 months to be considered of non-childbearing potential) and their partners voluntarily use contraception deemed effective by the investigator during treatment and for at least three months after the last dose of study drug. 11. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures. 12. Patients must be voluntary and able to complete study procedures and follow-up examinations. Exclusion Criteria: 1. Cytotoxic chemotherapy, radiation therapy, surgery (except minor surgery), anticancer therapy with hormone therapy (except hormone for hypothyroidism or estrogen replacement therapy (ERT)), or any clinical study treatment within 28 days prior to the first dose of study drug; or clinically significant tumor embolism or tumor lysis syndrome (TLS). 2. Immunotherapy, biologic therapy or anti-TNFa therapy within 28 days or 5 half-lives (whichever is shorter) prior to receiving the first dose of study drug. 3. Patients who have received targeted therapy within 28 days prior to first dose of study drug. 4. Prior treatment with anti PD-1, anti PD-L1, or anti PD-L2 agents (Phase II CRC cohort only). 5. Patients have an immunodeficiency diagnosis or are receiving chronic systemic steroid therapy (daily dose of more than 10 mg prednisone equivalent) or any form of immunosuppressive therapy 7 days prior to the first dose of trial treatment. 6. Patients have any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, decreased thyroid function (can be included if hormone replacement therapy is effective); patients with vitiligo or asthma that has been completely relieved in childhood and does not require any intervention after adulthood can be included, and patients with asthma requiring bronchodilators for medical intervention cannot be included. 7. Patient has an active infection or unexplained fever > 38.5。C within 2 weeks prior to the first dose (subjects may be enrolled due to tumor generated fever as judged by the investigator). 8. Any evidence of a past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroids, or clinically active interstitial lung disease. 9. Hepatic decompensation. 10. Evidence of any severe or uncontrolled systemic disease; various chronic active infections such as hepatitis B (evidence of hepatitis activity such as HBV-DNA ≥ 104 copies/mL or 2000 IU/mL), hepatitis C, and HIV. 11. Any of the following cardiac criteria: Mean QTc> 470 msec at rest during screening; Any clinically important abnormality in rhythm, conduction, or morphology of the resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block); Congenital long QT syndrome or family history of long QT syndrome. 12. Uncontrolled hypertension (requiring 2 or more medications to control blood pressure); Unstable cardiac pain; Angina pectoris within 3 months of study entry; Congestive heart failure (NYHA class II or higher); Previous myocardial infarction (NSTEMI or STEMI) within 6 months of study entry; Serious cardiac arrhythmia requiring medical attention; Serious hepatic, renal, gastrointestinal, or metabolic disease. 13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to APG-1387 or toripalimab or their constituents. 14. Have received a live vaccine within 28 days prior to the first dose of investigational product. Live vaccines include but are not limited to the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin vaccine (BCG) and typhoid. Injectable seasonal influenza vaccines are usually inactivated viral vaccines and are therefore allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed. 15. Patients who have not sufficiently recovered after surgical treatment as judged by the investigator. Patients with major surgery within 28 days prior to the first dose of study drug and minor surgery within 7 days prior to the start of the study. 16. Pregnant or lactating female patients. 17. The subject has other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases (including mental illness) requiring concomitant treatment, severe abnormalities in laboratory tests, family or social factors, conditions that may affect the safety of the subject or the collection of trial data, etc. ; PRIMARY OUTCOME: Recommended Phase 2 dose(RP2D) (Applicable for: phase I stage in various solid tumor types).; SECONDARY OUTCOME 1: Overall Response (Applicable for: phase I stage in various solid tumor types)[/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 - SL0023; BRIEF: The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus. ; DRUG USED: Dapirolizumab Pegol; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: CD40 Ligand (CD40L) / gp39; THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma S.P.R.L.; CRITERIA: Inclusion Criteria: - Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria - Moderate to severe SLE disease activity - Evidence for at least 1 of the following SLE markers: - Anti-dsDNA antibodies confirmed by central laboratory or - Low complement confirmed by central laboratory or - Antinuclear antibody (ANA) titer of >= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for extractable nuclear antigen (anti-ENA) confirmed by central laboratory - The subject is receiving stable SLE standard-of-care medication Exclusion Criteria: - Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE - Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments. - New or worsening Class III or IV lupus nephritis - Chronic kidney failure stage 3b - Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study - Clinically significant active or latent infection (eg. chronic viral hepatitis B or C) - Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection - Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug - History of thromboembolic events within 12 months of screening - Subject has used protocol defined prohibited medications ; PRIMARY OUTCOME: Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24; SECONDARY OUTCOME 1: The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - FALCI; BRIEF: Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: - To evaluate the efficacy of OZ439/FQ: - To determine the incidence of recrudescence and re-infection. - To determine the time to relief of fever and parasite clearance. - To evaluate the safety and tolerability of OZ439/FQ in adults and children. - To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. - To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites. ; DRUG USED: OZ439/Ferroquine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Malaria; TARGET: Hemozoin, Plasmodium; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: Male or female participant aged greater than (>) 6 months old and <70 years old: - Cohort 1 = 14 years < age <70 years and body weight greater than or equal to (>=) 35 kilogram (kg). - Cohort 2 = 5 years < age less than or equal to (<=) 14 years. - Cohort 3 = 2 years < age <=5 years. - Cohort 4 = 6 months < age <=2 years. Body weight >=5 kg and <=90 kg. Presence of mono-infection by Plasmodium falciparum with: - Fever, as defined by axillary temperature >=37.5 degrees Celsius (°C) or oral/rectal/tympanic temperature >=38°C, or history of fever in the previous 24 hours (history of fever must be documented) and, - Microscopically (blood smear) confirmed parasite infection, ranging from 1000 to 100 000 asexual parasites/microliter of blood. Informed consent form signed by the participant or by the legally acceptable representative of the minor participant. Exclusion criteria: Presence of severe malaria. Anti-malarial treatment: - With piperaquine-based compound, mefloquine, naphthoquine or sulphadoxine/pyrimethamine (SP) within the previous 6 weeks (after their inhibition of new infections had fallen below 50%). - With amodiaquine or chloroquine within the previous 4 weeks. - With quinine, halofantrine, lumefantrine-based compounds and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days. - With any herbal products or traditional medicines, within the past 7 days. Known history or evidence of clinically significant disorders. Previous treatment within 5 times the half-life or within the last 14 days, whichever the longest which are: P-glycoprotein substrates, Cytochrome P450 (CYP) 2D6 main substrates and/or strong CYP2C or CYP3A inhibitors and/or moderate inhibitors but inhibiting both CYP2C and CYP3A and/or CYP inducers. Mixed plasmodium infection. Severe vomiting. Severe malnutrition. Laboratory parameters with clinically significant abnormalities and/or reaching critical values. For Liver Function Test. Aspartate aminotransferase (>2 [upper limit of normal] ULN), or alanine aminotransferase (>2 ULN) or total bilirubin >1.5 ULN. Presence of Hepatitis A Immunoglobulin M, Hepatitis B surface antigen or Hepatitis C antibody. Had received an investigational drug within the past 4 weeks. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance. Measles and yellow fever vaccine injection within the last 15 days and or planned for the 28 days after randomization. Female participant of child bearing potential not willing to use an effective contraceptive(s) method(s) for the duration of the study. Positive serum or urine beta-human chorionic gonadotropin pregnancy test at study screening for female participants of childbearing potential. Breastfeeding women. Male participant having a partner of child bearing potential not willing to use an effective method of birth control during the study treatment period. Splenectomized participants or presence of surgical scar on left hypochondrium. Participant unable to drink. Known history of hypersensitivity, allergic or anaphylactoid reactions to ferroquine or other amino-quinolines or to OZ439 or OZ277 or to any of the excipients. Family history of sudden death or of congenital prolongation of the Corrected QT (QTc) interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval e.g., participants with a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia. QTc using Fridericias formula >450 millisecond at screening or pre-dose. Hypokalemia (<3.5 millimoles per liter [mmol/L]), hypocalcemia (<2.0 mmol/L) or hypomagnesemia (<0.5 mmol/L) at screening or pre-dose. Any treatment known to induce a lengthening of QT interval. The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Adequate Clinical and Parasitological Response (ACPR) at Day 28: African <=5 Years Per Protocol Population at Day 28 (PP28); SECONDARY OUTCOME 1: Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: African >5 Years Per Protocol Population at Day 28 (A5PP28)[/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 - MAPK Pathway Aberrations; BRIEF: This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent, progressive, or refractory melanoma or other solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway. ; DRUG USED: DAY101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Day One Biopharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Signed informed consent by patients ≥ 18 years of age and, assent for patients ≥ 12 up to < 18 years of age - Patients must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1) - Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required - If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging Substudy A-specific inclusion criterion: - Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or agency. Substudy B-specific inclusion criterion: - Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) through a tumor or liquid biopsy as assessed by genomic sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency. Exclusion Criteria: - Known presence of concurrent activating mutation - Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO) Substudy A-specific exclusion criterion: - Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy ; PRIMARY OUTCOME: Phase 1b: Determine the safety of tovorafenib in combination with other therapies; SECONDARY OUTCOME 1: Phase 1b: Assess efficacy of tovorafenib in combination with other therapies[/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/Keytruda; BRIEF: This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic). The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer. This is a multi-cohort study. ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria - Participants must have - Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) who either - a) have not yet received frontline therapy for metastatic disease and without prior exposure to anti PD-1/PD-L1 or - b) are relapsed/refractory with progression on anti PD-1/PD therapy. - Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a PD-1 inhibitor - Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet received frontline therapy for metastatic disease and without prior exposure to a PD-1/PD-L1 inhibitor. - Cohorts 1-4 only: Melanoma participants must be currently on PD-1 checkpoint inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of PD-1 CPI containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 CPI therapy must be the immediate prior line of treatment. - Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria. - Have received at least 2 doses of an approved PD-1 inhibitor. - Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by RECIST v1.1. - Progressive disease has been documented within 90 days from the last dose of PD-1 inhibitor. - Participants with melanoma will need iRECIST confirmation of progression with a second assessment at least four weeks after the initial date of progressive disease - NSCLC participants on PD-1 inhibitor containing therapy for less than 90 days will need iRECIST confirmation of progression at least 4 weeks after the initial date of progressive disease - Tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained. - An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or less than 1 Exclusion Criteria - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Prior immunosuppressive chemotherapy, any immunotherapy other than a PD-1 inhibitor within 4 weeks of first study drug dose. - History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. ; PRIMARY OUTCOME: Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria; SECONDARY OUTCOME 1: Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/5-Azacytidine or Low Dose Cytarabine (M.D. Anderson); BRIEF: This phase I/II trial studies the side effects and best dose of quizartinib when given in combination with azacitidine or cytarabine in treating patients with acute myeloid leukemia or myelodysplastic syndrome that have come back (relapsed) or are not responding to treatment (refractory). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine and cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving quizartinib with azacitidine or cytarabine may work better in patients with acute myeloid leukemia or myelodysplastic syndrome. ; DRUG USED: Quizartinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: - PHASE I - Refractory or relapsed disease defined as follows: patients with MDS or chronic myelomonocytic leukemia (CMML) should have failed prior therapy (e.g., with a hypomethylating agent, clofarabine, and/or with lenalidomide); patients with AML should have failed any prior induction therapy or have relapsed after prior therapy; patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The World Health Organization (WHO) classification will be used for AML; patients with any of the eligible diagnoses who have received no prior therapy are eligible if not candidates to receive standard intensive therapy (i.e., high-dose cytarabine-based chemotherapy). - Patients are eligible regardless of their FLT3 mutation status. - PHASE II - COHORT 2A: Patients with MDS, CMML or AML who are either: age 60 years or older and newly diagnosed, previously untreated. Prior therapy with hydroxyurea or single agent ara-C for the purpose of control of white blood cells (WBC) is acceptable.; age 18 years or older and with refractory or relapse disease who have received no more than one prior treatment regimen and will be receiving first salvage. For this purpose, a second induction cycle with the same drugs used during the first cycle, consolidation chemotherapy or stem cell transplant in complete remission (CR) (or complete response with incomplete platelet recovery [CRp] or complete response with incomplete bone marrow recovery [CRi]) will be considered part of the prior regimen. Prior therapy for MDS (or other malignancies) is not considered a prior regimen for AML in patients who progress from MDS (or other malignancies). - COHORT 2A: Patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The WHO classification will be used for AML. - COHORT 2A: Patients must have evidence of FLT3 ITD in their most recent assessment. - COHORT 2B: Patients with MDS, CMML or AML who are either: Age 60 years or older and newly diagnosed, previously untreated. Prior therapy with hydroxyurea or single agent ara-C for the purpose of control of WBC is acceptable or age 18 years or older and with refractory or relapse disease who have received no more than two prior treatment regimens and will be receiving second salvage, or who have received a prior SCT and will be receiving their first salvage. For this purposes, a second induction cycle with the same drugs used during the first cycle, consolidation chemotherapy or stem cell transplant in CR (or CRp or CRi) will be considered part of the prior regimen. Prior therapy for MDS (or other malignancies) is not considered a prior regimen for AML in patients who progress from MDS (or other malignancies) - COHORT 2B: Patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The WHO classification will be used for AML - COHORT 2B: Patients must have no evidence of FLT3 mutations in their most recent assessment - PHASE I AND II - Eastern Cooperative Oncology Group (ECOG) performance status =< 2. - Bilirubin =< 2 x upper limit of normal (ULN). - Alanine aminotransferase (ALT) =< 2.5 x ULN. - For patients with suspected liver infiltration from leukemia ALT should be =< 5 ULN. - Creatinine =< 2 x ULN. - Serum potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits. - Patients must provide written informed consent. - Patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the toxic effects of that therapy to at least grade 1. Use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. The additional days of hydrea after 28 is permitted as clinically indicated, on case by case basis after discussion with the principal investigator (PI). Other agents given transiently with the intention to control rapid proliferation such as 1-2 doses of single agent ara-C or few doses of sorafenib are also allowed. - Women of childbearing potential must practice contraception. Women considered not of childbearing potential include any of the following: no menses for at least 2 years or menses within 2 years but amenorrheic for at least 2 months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least 3 months. Females of childbearing potential should practice effective methods of contraception. Effective methods of contraception include barrier methods (e.g., condoms, diaphragm), spermicidal jelly or foam, oral, depo provera, or injectable contraceptives, intrauterine devices, tubal ligation, and abstinence. Male patients with female partners who are of childbearing potential should also practice contraception. - Negative urine or serum pregnancy test. Exclusion Criteria: - Patients with known allergy or hypersensitivity to quizartinib, mannitol, AZA, cytarabine or any of their components. - Serum potassium < 3.5 mEq/L despite supplementation, or > 5.5 mEq/L. - Serum magnesium above or below the institutional normal limit despite adequate management. - Serum calcium (corrected for albumin levels) above or below institutional normal limit despite adequate management. - Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib. - Patients with any other known disease concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, cardiovascular disease including congestive heart failure, myocardial infarction within 6 months and poorly controlled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study. Patients with current active malignancies or any remission for < 6 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may have active disease or be in remission for less than 6 months. - Patients with a known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis. - Patients who have had any major surgical procedure within 14 days of day 1. - Patients with known malignant disease of the central nervous system. - Impaired cardiac function including any of the following: screening electrocardiography (ECG) with a corrected QT (QTc) > 450 msec. The QTc interval will be calculated by Fridericias correction factor (QTcF) at screening and on day 5 prior to the first dose of AC220. The QTcF will be derived from the average QTcF in triplicate; if QTcF > 450 msec on day 5, AC220 will not be given; patients with congenital long QT syndrome; history or presence of sustained ventricular tachycardia requiring medical intervention; any history of clinically significant ventricular fibrillation or torsades de pointes; Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker); sustained heart rate of < 50/minute on pre-entry ECG; right bundle branch block + left anterior hemiblock (bifascicular block); patients with myocardial infarction or unstable angina within 6 months prior to starting study drug; congestive heart failure (CHF) New York (NY) Heart Association class III or IV. Atrial fibrillation documented within 2 weeks prior to first dose of study drug; patients who require treatment with concomitant drugs that prolong QT/QTc interval or strong CYP3A4 inhibitors or inducers with the exception of antibiotics, antifungals, and antivirals that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject. - Known family history of congenital long QT syndrome. ; PRIMARY OUTCOME: Maximum tolerated dose of quizartinib (Phase I); SECONDARY OUTCOME 1: Incidence of adverse events (Phase II)[/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 - A2214; BRIEF: It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in patients with non-chronic migraine having more than 3 and less than 12 migraine attacks per 4 weeks. ; DRUG USED: BGG492; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: AMPA-type glutamate receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female smoking and non-smoking subjects of 18 to 65 years of age (inclusive) - Patients diagnosed with non-chronic migraine with or without aura of duration of at least 12 months prior to the study start - Patient diagnosed with migraine (according to the International Headache Society categories 1.1 and with equal to/more than 3 and equal to/ less than 12 migraine attacks per 4 weeks for each of the last 6 months preceding the Screening - Patients willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance Exclusion Criteria: - Patients diagnosed with basilar, ophthalmoplegic or hemiplegic migraine as shown in the current/past medical history. - Patients having an experience of non-migraine headaches on more than 6 days per 4 weeks in the past 6 months prior to study start - Patients receiving regular treatment during the four (4) weeks preceding the Baseline with psychoactive drugs (e.g. hypnotics, benzodiazepines, neuroleptics) except antidepressants (eg. SSRIs, SNRIs, Tri- or Tetracyclics). - Patients receiving migraine prevention medications during past three (3) months preceding Baseline - Patients receiving topiramate as migraine prevention medication during past six (6) months preceding Baseline - Patients receiving metamizole as acute treatment of migraine during past three (3) months preceding Baseline - Patients using (or having used within four (4) weeks before the treatment start) drug treatments that are potent inhibitors of OATP transporters (e.g. rifampin). - Any psychiatric condition (e.g., schizophrenia, dementia, bipolar disorder) as shown in the past medical history prior to study start - Patients with recent (within the last three [3] years prior to study start) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, orthostatic hypotension etc.). - Pregnant or nursing (lactating) women. Baselines (1 and 2). - Patients with history of drug or alcohol abuse within the 12 months prior to dosing Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Frequency of migraine attacks; SECONDARY OUTCOME 1: Number of migraine attacks[/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 - 1042-0600 (Adult Partial-Onset); BRIEF: The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. Catamenial epilepsy refers to a relationship between seizure frequency and a womans menstrual cycle, where the number of seizures increases around the time of a womans menstrual cycle. ; DRUG USED: Ganaxolone; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Marinus Pharmaceuticals; CRITERIA: INCLUSION CRITERIA: - Diagnosis of epilepsy with POS with or without secondary generalized seizures according to the International League Against Epilepsy [ILAE] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and CT or MRI of the brain to rule out progressive structural lesions and EEG with results consistent with partial-onset epilepsy. - During the 8 week baseline period preceding randomization visit (Visit 4), participants should have a documented seizure frequency of ≥ 3CPS per 4 weeks on average. - Participants should not be seizure free for more than 28 consecutive days during treatment with a stable dose of AEDs [Note: Participants with historically sufficiently high seizure frequency who fall short 1 seizure in any 4 weeks period or with a seizure-free period > 28 consecutive days may be allowed to enter the study after discussion with the Medical Monitor. Prolongation of the screening period for questionable cases may also be allowed by the Medical Monitor.] - Treatment with a stable dose of up to 3 (FDA approved) current AEDs for 1 month prior to screening. - Maintenance of current AEDs without a change in dosing for the duration of study. - Concomitant vigabatrin not permitted; - Felbamate is allowed if the participant has been on felbamate for at least 18 months and has stable laboratory tests) for the course of the study. [Note: A shorter period for stable laboratory results may be allowed by the Medical Monitor, depending on the extent of dose change and the half-life of the AED.] - Participants receiving treatment with a vagal nerve stimulator (VNS) may be included as long as the VNS has been in place for at least 12 months prior to entry into the study, the VNS battery is not due for replacement during 0600 subject participation, and stimulation parameters have been kept constant for 1 month prior to screening. VNS will be counted as 1 of the 3 concomitant AEDs. - Male or female, 18 to 69 years of age (inclusive). [Note: Participants who are > 69 years of age but are of good health condition may be allowed to enter the study after discussion with and approval by the Medical Monitor.] - A 12-lead electrocardiogram (ECG) w/o clinically significant abnormalities. - Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study. - Able to participate for the full term of study. - Able to keep a seizure & medication diary throughout the course of the study. - Sexually active women of childbearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine sample collected at the initial screening visit. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). An oral contraceptive alone is not considered adequate for the purpose of this study. Use of oral contraceptives in combination with another method (eg, a spermicidal cream) is acceptable.in participants who are not sexually active, abstinence is an acceptable form of birth control and serum β-HCG must be tested per protocol. - Participants with a history of depression who are stable and may be taking 1 anti-depressant medication. EXCLUSION CRITERIA: - Presence of non-motor simple partial seizures only. - History of pseudoseizures in the last 5 years. - History of a primary generalized seizure in the last 5 years. - Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed). - Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease. - Status epilepticus within the last year prior to randomization. - Clinically unstable psychiatric disorder within the last 2 years. - Suicidal attempt within the last 5 years or current significant suicidal ideation. - History of psychosis within the last 5 years. [Note: Participants who suffered a psychosis that can well be explained by exogenous factors may be allowed to enter the study after discussion with and approval by the Medical Monitor.] - Current use of neuroleptics for psychosis. - A significant medical or surgical condition at screening which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems or other conditions that would place the subject at increased risk. - Known sensitivity or allergy to progesterone or related steroid compounds. - History of drug use or alcohol abuse within the past 5 years. - Sexually active WCBP who are unwilling to use a double-barrier method and establish that they are currently not pregnant by submitting to a pregnancy test. - Females who are currently breastfeeding. - history of chronic noncompliance with drug regimens. - Exposure to any other investigational drug or device within 30 days prior to screening. - Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels > 3 times upper limits of normal (ULN) at screening. - Benzodiazepines may be used intermittently for the control of seizure clustering as a one time rescue up to a maximum of 4 occasions as follows: - Participants who need benzodiazepines for control of seizures more than once per month or more than 4 times total during the Titration and Maintenance Phases will be discontinued. - Once during the Titration Phase - No more than once per month during the Maintenance Phase - Each occasion may be a period of 24 hours, during which up to 3 doses of benzodiazepine may be used. - If a participant is taking a benzodiazepine chronically for epilepsy and non-epilepsy conditions, it will be counted as 1 of the 3 AEDs and the dose cannot be changed during the study. - Participant has history of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted. - Inability to withhold grapefruit and grapefruit juice from diet for the entire clinical trial. ; PRIMARY OUTCOME: Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10; SECONDARY OUTCOME 1: Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10[/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 - NINDS; BRIEF: This study will examine the safety and effectiveness of alemtuzumab (Campath® (Registered Trademark)) for improving muscle strength in patients with sporadic inclusion body myositis (s-IBM). The most common inflammatory muscle disease in people over the age of 50, s-IBM progresses steadily, leading to severe weakness and wasting of the muscles in the arms and legs. The cause of s-IBM is not known, but it may be an autoimmune disease, in which the bodys immune cells (white blood cells) attack and destroy parts of muscle. Alemtuzumab is a laboratory-made antibody currently approved to treat certain leukemias. It has also been used to treat patients with autoimmune conditions such as rheumatoid arthritis, vasculitis, multiple sclerosis, and tissue rejection associated with transplantation. Alemtuzumab destroys white blood cells that have a protein called CD52 on their surface and that might be among the cells attacking muscle. Patients with s-IBM are eligible for this study. Candidates are screened with physical and neurological examinations, blood tests, and an electrocardiogram. Participants undergo the following tests and procedures: - Campath administration: Patients are admitted to the NIH Clinical Center for 1 to 1-1/2 weeks for intravenous infusions of Campath, given every other day for a total of 4 infusions. - Follow-up visits after infusions: Patients are monitored for up to 1 year with periodic blood tests, physical and neurological examinations, medical history, muscle strength measurements, and a review of symptoms, including the ability to perform daily living activities. - Lymphapheresis: Patients undergo this procedure for collecting large numbers of white blood cells twice - once at the beginning of the study and again after 6 months. Blood is removed through a needle in an arm vein and flows through a machine that separates it into its components by centrifugation (spinning). The white cells and plasma are removed and the red cells and platelets are returned to the patients through the same needle or through another needle in the other arm. - Muscle biopsy: Muscle biopsies are done in the operating room under local anesthetic. A small incision is made in the thigh or upper arm and a small piece of muscle is removed. Biopsies are done at the beginning of the study and again after 6 months. ; DRUG USED: Campath; DRUG CLASS: Biologic; INDICATION: Sporadic Inclusion Body Myositis (sIBM); TARGET: Cluster of Differentiation 52 (CD52); THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Neurological Disorders and Stroke (NINDS); CRITERIA: - Only patients who are currently enrolled in protocol 02-N-0121 Study of Immune Dysregulation in Patients with Sporadic Inclusion Body Myositis (s-IBM) will be considered for enrollment in protocol 04-N-0133. INCLUSION CRITERIA: Patients with confirmed diagnosis of s-IBM willing to undergo therapy with Alemtuzumab. Willingness and legal ability to give and sign informed study consent. Willingness to travel to the Clinical Center for planned studies and treatment as required by protocol. Men and women of reproductive potential must agree to use an acceptable method of birth control during and for six months after completion of treatment. Availability of tissue for testing. This will include muscle and peripheral blood lymphocytes isolated through routine lymphocytapheresis or phlebotomy. EXCLUSION CRITERIA: Immunosuppressive drug therapy at the time of or 6 months prior to enrollment. Specifically, candidates may not be taking Prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide methotrexate, or other agents whose concomitant use may enhance the toxicity of Alemtuzumab. Any medical or personal difficulties that precludes serial follow-up visits. Any active malignancy. Significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol. Platelet count less than 100,000/mm(3). Hemoglobin less than 9.0 mg/dl. Any known immunodeficiency syndrome included HIV infection. Any history of cardiac insufficiency, major vascular disease, or unstable coronary artery disease. Any history of systemic or pulmonary edema. Any history of previous treatment with monoclonal antibodies or sensitivity to the study drug (Alemtuzumab), pre-medication regimen, or prophylactic agents. History of chronic hypotension (SBP less than 100 mmHg). Any medical condition that would likely increase the risk of side effects of the study drug or confound the interpretation of the data including active infections. Pregnancy and active nursing (breast feeding). History of uncontrolled thyroid disease or a history of autoimmune thyroiditis. ; PRIMARY OUTCOME: Change in the muscle strength at 6 months by 15%.; 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 - 000185; BRIEF: This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic constipation. The purpose of the study is to compare the effects of daily single-dose oral elobixibat and placebo for 7 days on colonic motor effects. ; DRUG USED: Elobixibat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Ileal Bile Acid Transporter (IBAT)/Apical Sodium-dependent Bile Acid Transporter (ASBT); THERAPY: Monotherapy; LEAD SPONSOR: Ferring Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female 18-65 years of age - Body Mass Index of 18-40 kg/m2 - Diagnosis of constipation for 12 or more weeks with symptom onset at least 6 months prior to the diagnosis and insufficient criteria to fulfill a diagnosis of irritable bowel syndrome (IBS), as defined by the Rome III criteria for Functional Constipation - Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the trial period Exclusion Criteria: - Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal (GI) disorders. - Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, selective serotonin reuptake inhibitor and newer antidepressants - Use of drugs or agents within the past 2 weeks that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, and other CNS depressants - The patient has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening - Clinical evidence (including physical exam) of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the trial. Any candidate participants with such disorder mentioned will be referred to their general physician - The Hospital Anxiety and Depression Scale (HADS) will be used to exclude patients with significant affective disorders ; PRIMARY OUTCOME: Number of postprandial High Amplitude Propagated Contractions (HAPCs); SECONDARY OUTCOME 1: Fasting colonic tone[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 231 (Japan); BRIEF: The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed and maintained during 4 weeks. ; DRUG USED: Fycompa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: AMPA-type glutamate receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Co., Ltd.; CRITERIA: Inclusion criteria: 1. Male or female aged between 20 and 64 years old. 2. Patients diagnosed with partial seizure (including secondarily generalized seizure). 3. Patients who have at least 3 counts of partial seizures during the previous 4 weeks prior to observation start and no seizure-free for 21 days during 8 weeks before the treatment start based on medical records. Simple partial seizure without motor signs will not be counted. 4. Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years. 5. Patients treated with stable doses of up to three AEDs. Only one cytochrome P450 (CYP) 3A4 inducer shown below will be allowed for concomitant use: - Carbamazepine - Phenytoin - Phenobarbital - Primidone 6. Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks. Exclusion criteria: 1. Patients with present or a history of Lennox-Gastaut syndrome. 2. Patients with present generalized seizures (e.g., absence, myoclonic). 3. Patients with a history of status epilepticus within 1 year. 4. Patients with seizure clusters where individual seizure cannot be counted within 8 weeks. 5. Patients with a history of psychogenic seizure. 6. Patients who underwent surgical operation for epilepsy within 2 years. 7. Patients using rescue benzodiazepines at least twice in a 4-week duration within 8 weeks (if 1 or 2 doses over 24-hour period considered one-time rescue). 8. Patients whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at enrollment in observation period exceeds 1.5-fold the upper limit of normal (ULN), but those whose ALT or AST are constantly higher than ULN, they can enroll if ALT or AST remain in 3-fold the ULN. 9. Patients with significant active hematological disease; white blood cell (WBC) count </=2500/uL or neutrophil count </=1000 uL. 10. Patients on anti-psychotics or who have psychotic disorder and/or psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of suicidal attempt within 2 years. 11. Patients who operate heavy equipment or drive should not be recruited into the study. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - MET+ w/Child Pugh Class A (Germany); BRIEF: This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced hepatocellular carcinoma (HCC) with child Pugh Class A liver function who have failed sorafenib treatment. ; DRUG USED: Tepmetko; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy; LEAD SPONSOR: Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: - Histologically confirmed HCC - Child Pugh Class A liver function score - For Phase 2 only: MET+ status - Male or female, 18 years of age or older - Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (inclusive) - Availability of a pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples) taken after the subject has discontinued sorafenib and within 28 days before the day of first dosing with MSC2156119J. From the pretreatment biopsy either a formalin-fixed (formalin fixation is mandatory) paraffin-embedded block with tumor tissue (preferred) or at least 15 unstained slides must be sent to the central laboratory prior to enrollment. An associated pathology report must also be sent with the sample - Previously treated with sorafenib for greater than or equal to 4 weeks and discontinued sorafenib treatment at least 14 days prior to Day 1 due to either intolerance or radiographic progression - Signed and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures - Life expectancy of at least 3 months as judged by the investigator Exclusion Criteria: - Prior systemic anticancer treatment for advanced HCC (except for sorafenib as described in the inclusion criteria) - Prior treatment with any agent targeting the hepatocyte growth factor (HGF)/c-Met pathway - Local-regional therapy within 4 weeks before Day 1 - Impaired cardiac function - Other protocol defined exclusion criteria could apply ; PRIMARY OUTCOME: Phase 1b: Number of Participants Experiencing Dose Limiting Toxicity (DLT) According to National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) for Adverse Events (AEs) Version 4.0; SECONDARY OUTCOME 1: Phase 1b and Phase 2: Time to Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Orthopedic Trauma Wounds (DOD); BRIEF: The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings. ; DRUG USED: NanoDOX Hydrogel; DRUG CLASS: Non-NME; INDICATION: Wound Healing; TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: NanoSHIFT LLC; CRITERIA: Inclusion Criteria: - Be 18 years of age or older - Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline - Agree to use a double-barrier method of contraception during their participation in this study - condoms (with spermicide) and hormonal contraceptives OR - condoms (with spermicide) and intrauterine device OR - intrauterine device and hormonal contraceptives OR - Abstains from sexual intercourse during their participation in this study - Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant - Have a full-thickness trauma wound that is between 1.2cm2 and 24cm2 at initial screening - Be able to apply study drug to their wound, or have a reliable and capable caregiver do it - Subjects will have adequate blood flow to the wound as defined by transcutaneous oxygen tension (TcpO2) of >30mmHg recorded over intact epidermis at the wound margin. Exclusion Criteria: - Less than 18 years of age - Pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control. - Allergic to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative - Tested positive for a doxycycline-resistant infection - Have undergone treatment with systemic corticosteroid or immunosuppressive therapy in the past 2 months - Currently undergoing dialysis for renal failure - Have participated in another clinical research trial within the last 30 days - Subject has wounds resulting from any cause other than trauma (diabetes, electrical burn, arterial insufficiency, chemical or radiation insult) - Active or previous (within 60 days prior to the study screening visit) chemotherapy - Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by investigational drug or placebo - Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits - The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements. - History of sickle cell anemia - History of infection with Human Immunodeficiency Virus - History of other immunodeficiency disorders - Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females) ; PRIMARY OUTCOME: Determine the effect of NanoDOX Hydrogel on the healing rates of open traumatic orthopedic wounds with and without vacuum assisted closure therapy.; SECONDARY OUTCOME 1: Analyze the molecular changes in proinflammatory cytokine levels and bioburden that occur in traumatic orthopedic and soft tissue wounds[/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 - On Dialysis; BRIEF: The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis. ; DRUG USED: Oxabact; DRUG CLASS: Biologic; INDICATION: Hyperoxaluria; TARGET: Oxalate; THERAPY: Monotherapy; LEAD SPONSOR: OxThera; CRITERIA: Inclusion Criteria: 1. Signed informed consent (as applicable for the age of the subject). An appendix to the informed consent will be signed by patients continuing on treatment after week 14. 2. Male or female subjects ≥ 2 years of age. Subjects have to be able to swallow size 4 capsules twice daily for 6 weeks, or use a gastric tube that allows for administration of size 4 capsules. 3. A diagnosis of PH (as determined by standard diagnostic methods). 4. Patient should be on a stable dialysis regimen for at least two weeks before baseline. 5. Pre-dialysis plasma oxalate ≥40 micromole/L. 6. Patients receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must remain on the stable dose during the study. Patients not receiving vitamin B6 at study entry must be willing to refrain from initiating vitamin B6 during study participation. Exclusion Criteria: 7. Inability to swallow size 4 capsules twice daily for 6 weeks or using a gastric tube not suited for administration of size 4 capsules via the tube. 8. Ongoing treatment with immunosuppressive medication. 9. The existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome. 10. Use of antibiotics to which O. formigenes is sensitive, including current antibiotic use, or antibiotics use within 14 days of initiating study medication. 11. Current treatment with a separate ascorbic acid preparation. Standard of care vitamin supplement for patients on dialysis is allowed. 12. Pregnancy. 13. Women of childbearing potential who are not using adequate contraceptive precautions. Sexually active females, unless surgically sterile or at least 2 years post-menopausal, must be using a highly effective contraception (including oral, transdermal, injectable, or implanted contraceptives, IUD, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of OC5 and must agree to continue using such precautions during the clinical study. 14. Presence of a medical condition that the Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures. 15. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to the first dose of OC5 or not willing to forego other forms of investigational treatment during this study. ; PRIMARY OUTCOME: Change in Pre Dialysis Plasma Oxalate (Total Plasma Oxalate) Level During Treatment With OC5 Compared With Baseline.; SECONDARY OUTCOME 1: Change in Pre Dialysis Plasma Oxalate (Free Plasma Oxalate) Level During Study Compared With Baseline.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SPIMM-203; BRIEF: This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial ; DRUG USED: Elamipretide (Systemic Delivery); DRUG CLASS: New Molecular Entity (NME); INDICATION: Mitochondrial Respiratory-Chain Diseases; TARGET: Mitochondria, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Stealth BioTherapeutics Inc.; CRITERIA: Inclusion Criteria: - Investigator determines the subject can, and subject agrees to, adhere to the trial requirements for the length of the trial including self-administration (by subject or trained caregiver) of the study drug - Subject completed the End-of-Study Visit in SPIMM-202 Exclusion Criteria: - Subject has any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all trial requirements - Subject has received any investigational compound (excluding elamipretide) and/or has participated in another interventional clinical trial within 30 days prior to the SPIMM-203 Baseline Visit (excluding SPIMM-202) or is concurrently enrolled in any non-interventional research of any type judged to be scientifically or medically incompatible with the trial as deemed by the Investigator in consultation with the Sponsor - Subject experienced an adverse reaction attributed to study drug resulting in permanent discontinuation of study drug in the SPIMM-202 trial. - Female subjects who are pregnant, planning to become pregnant, or lactating - Subject has undergone an in-patient hospitalization within the 1 month prior to the SPIMM-203 Baseline Visit ; PRIMARY OUTCOME: Distance Walked on Six Minute Walk Test; SECONDARY OUTCOME 1: EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)[/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-B2; BRIEF: The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study. ; 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 HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic). - Participant has received pre-study induction therapy with up to and including a maximum of 8 cycles of a taxane (docetaxel, paclitaxel, or nab-paclitaxel), plus trastuzumab and pertuzumab. 4 or 5 cycles of induction therapy are permitted if discontinuation of taxane was due to taxane toxicity. Of note, participants enrolled in Part 1 of this study received 4-6 cycles of pre-study induction therapy. - Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Participant has adequate bone marrow and organ function - Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or as determined by a Novartis designated central laboratory. Exclusion Criteria: - Participant with inflammatory breast cancer at screening. - Participant with evidence of disease progression during the pre-study induction therapy and prior to first dose of alpelisib (or alpelisib/alpelisib matching-placebo for Part 2) - Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c. - Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis - Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events - Participant has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN). - Participant has currently documented pneumonitis/interstitial lung disease Other protocol-defined Inclusion/Exclusion may apply. ; PRIMARY OUTCOME: Part 1: Incidence of dose limiting toxicities (DLTs) for each dose level; SECONDARY OUTCOME 1: Part 1: Alpelisib concentrations by timepoint and dose level[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CALM (VLA-007); BRIEF: The purpose of this study is to assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months as monitored via immune-related Response Criteria [irRECIST 1.1] (revised Response Evaluation Criteria In Solid Tumors [RECIST] 1.1). ; DRUG USED: Cavatak (Intratumoral); DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, Intercellular Adhesion Molecule-1 (ICAM-1), Oncolytic Virus Therapy, Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Viralytics; CRITERIA: Inclusion Criteria: 1. Patient with histologically proven stage IIIc or stage IV melanoma who fails to qualify for curative surgery and who bears one or more tumors that are accessible for direct injection 2. Patient must have had no more than one previous systemic regimen for management of melanoma; however, adjuvant chemotherapy administered 6 months or longer before entering the trial does not count as a line of treatment 3. Absence of circulating serum neutralizing antibodies to CVA21 (titer < 1:16) 4. At least one tumor 0.5 to 10 cm in the longest diameter must be suitable for injection and at least one tumor must be equal to or greater than 1 cm and qualified to be a target lesion for RECIST 1.1 criteria 5. Patient must have adequate hematologic, hepatic and renal function, defined as: - Absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L - Bilirubin < 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) < 2.5 x ULN - Serum creatinine < 1.5 x ULN; if > 1.5 x ULN, it must be confirmed that creatinine clearance > 30 mL/minute 6. Serum lactate dehydrogenase (LDH) levels < or = 1.5 x ULN 7. Male or female age 18 years or older 8. Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 or 1 9. Estimated life expectancy of more than 6 months 10. Recovered from prior therapy with at least 4 weeks since the last exposure to chemotherapy or radiotherapy 11. Patient is able and willing to provide written informed consent to participate in the study 12. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males. A negative pregnancy test is required in female patients of childbearing potential. Exclusion Criteria: 1. Mucosal or ocular primary tumors 2. Bone metastases 3. Greater than 3 visceral metastases 4. Any visceral metastases > 10 cm 5. Serum anti-CVA21 neutralizing titer of > 1:16 at baseline 6. Presence of any central nervous system (CNS) tumor that has not been stable for at least 3 months off corticosteroids and confirmed by imaging 7. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion into a major vessel in the case of necrosis 8. Only measurable tumor had prior local radiotherapy without subsequent nodule progression 9. Patient has received chemotherapy within the last 4 weeks prior to first injection 10. ECOG score greater than 1 11. Estimated life expectancy of less than 6 months 12. Pregnancy or breastfeeding 13. Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g., prednisolone > 7.5 mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons within the past 4 weeks prior to screening 14. Positive serology for human immunodeficiency virus (HIV), hepatitis B or C 15. Full dose anticoagulation or a history of bleeding diathesis or poorly controlled bleeding in the last month prior to screening 16. Previous splenectomy 17. Presence of uncontrolled infection 18. Presence of unstable neurological disease 19. Any uncontrolled medical condition that, in the opinion of the investigator, is likely to place the patient at unacceptable risk during the study or reduce his/her ability to complete the study 20. Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks prior to screening 21. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent 22. Participation in any previous melanoma immunotherapy trial within 1 month prior to entry to this trial or any trial of any other investigational agent within the last month prior to entry to this trial 23. Active infections or serious general medical conditions 24. Patients with previous malignancies should only be permitted if they have been in a continued state of no evidence of disease for at least 5 years with the exception of adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal cell/squamous cell skin cancer 25. Known allergy to treatment medication or its excipients and/or to the contrast medium ; PRIMARY OUTCOME: Percentage of Participants With Immune-related Progression-Free Survival (irPFS) at 6 Months; SECONDARY OUTCOME 1: Durable 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 - w/SoC Treatment; 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: - Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay - Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (for example, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including participants admitted to the Intensive Care Unit (ICU) - Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours after onset of influenza symptoms - Being on invasive mechanical ventilation or having a peripheral capillary oxygen saturation (SpO2) less than (<)94 percent (%) on room air during screening. Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than or equal to (>=)3% from pre-influenza SpO2 during screening - Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4 Exclusion Criteria: - Received more than 3 doses of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one 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, any history of a lung transplant) - Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients ; PRIMARY OUTCOME: Number of Participants With Hospital Recovery Scale on Day 6; SECONDARY OUTCOME 1: Time to Hospital Discharge[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Idarubicin/Cytarabine (AML/MDS); BRIEF: The goal of this clinical research study is to find the highest tolerable dose of nivolumab that can be give in combination with idarubicin and cytarabine in patients with MDS and AML. The safety and effectiveness of this drug combination will also be studied. This is an investigational study. Nivolumab is not FDA-approved or commercially available. Idarubicin is FDA-approved and commercially available for the treatment of patients with AML. Cytarabine is FDA approved and commercially available for treatment of patient with AML. The use of these drugs in combination is investigational. The study doctor can explain how the drugs are designed to work. Up to 75 patients will take part in this study. All will be enrolled at MD Anderson. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts), or 2) high risk MDS (defined as the presence of 10% blasts). 2. Patients aged 18 to 60 years are eligible. Patients older than 60 who are deemed fit to receive intensive chemotherapy by the treating physician are eligible after discussion with the PI. 3. In the Phase I portion, patients with relapsed or refractory AML/MDS are also eligible, as per the treating physicians discretion. 4. For the Phase II portion of the study, patients must be chemo-naive, i.e. not have received any prior chemotherapy (except hydrea or one dose of ara-C </= 2g) for AML or MDS. They could have received hypomethylator agents, transfusions, hematopoietic growth factors or vitamins. Temporary prior measures such as apheresis or hydrea or one dose of ara-C </= 2g in order to safely control hyperleucocytosis prior to enrollment. 5. Serum biochemical values with the following limits unless considered due to leukemia: ---Creatinine </= 1.5 mg/dl --- total bilirubin </= 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder --- transaminases (SG PT) </= 2.5 x upper limit of normal (ULN). 6. Ability to take oral medication. 7. Ability to understand and provide signed informed consent. 8. Baseline test of ejection fraction must be >/= 50%. 9. Performance status < 3, unless directly related to disease process as determined by the Principal Investigator. Exclusion Criteria: 1. Subjects with APL. 2. Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results. 3. Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study. --- Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. --- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab. --- Women must not be breastfeeding. 4. Continued:Men who are sexually active with WOCBP must use acceptable birth control methods. Acceptable birth control methods include: oral or injectable hormonal birth control, intrauterine devices(IUDS), and double barrier methods (for example a condom in combination with spermicide). Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception. 5. Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months. 6. History of cardiac ventricular arrhythmias requiring anti-arrhythmic therapy within past 3 months. 7. Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. 8. Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug. 9. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug. 10. Active clinically serious and uncontrolled infection > CTCAE Grade 2 uncontrolled with antibiotics. 11. Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. 12. Patients should be excluded if they are known to be positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. 13. Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 14. History of allergy to study drug components. 15. Prior immune checkpoint targeting drugs (e.g., anti PD1, and PDL1, anti-kir, anti CD137...etc) ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) of Nivolumab; SECONDARY OUTCOME 1: Event-Free Survival (EFS)[/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 - TRAILBLAZER-ALZ 2; BRIEF: The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimers disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. ; DRUG USED: Donanemab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months - MMSE score of 20 to 28 (inclusive) at baseline - Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort - Meet 18F florbetapir PET scan (central read) criteria - Have a study partner who will provide written informed consent to participate Exclusion Criteria: - Contraindication to MRI or PET scans - Current treatment with immunoglobulin G (IgG) therapy ; PRIMARY OUTCOME: Change from Baseline on the integrated Alzheimers Disease Rating Scale (iADRS); SECONDARY OUTCOME 1: Change from Baseline on the Mini Mental State Examination (MMSE) Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 0303 (Japan); BRIEF: This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently. ; DRUG USED: Roxadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Independent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Chronic kidney disease with an estimated glomerular filtration rate (as calculated by the Japanese GFR estimation equation) of =<89 mL/min/1.73 m2, and not required dialysis for 3 months since study completion - The mean of two Hb values at screening test and Hb test (at least one week apart form the screening test) is <10.0 g/dL, with a difference of ≤1.0 g/dL between the two values - Both TSAT>=5% and ferritin >=30 ng/mL at screening test - Serum folate ≥4.0 ng/mL and Vitamin B12 ≥180 pg/mL at screening test Exclusion Criteria: - Proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment - Immunological disease with severe inflammation as assessed by the Investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, Sjogrens syndrome, celiac disease, etc). - Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or evidence of active gastroparesis. - Uncontrollable hypertension (more than one third blood pressure values of diastolic BP >100 mmHg within 16 weeks prior to screening test including) - Congestive heart failure (NYHA classification III or higher) - Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before screening test - Positive for any of the following: anti-hepatitis C virus antibody (anti-HCV Ab); hepatitis B surface antigen (HBsAg); or human immunodeficiency virus (HIV) - Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc) - Using ESA, anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before screening test ; PRIMARY OUTCOME: Rate of rise in Hb (g/dL/week) at Week 6; SECONDARY OUTCOME 1: Percentage of cumulative number of responder patients[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - INTR@PID LUNG 024; BRIEF: The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy. ; DRUG USED: Bintrafusp Alfa; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2), Transforming Growth Factor-beta (TGF-beta) Receptor; THERAPY: Combination; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Participants greater than or equals to (>=) 18 years of age inclusive at the time of signing the informed consent - Participants who have histologically confirmed diagnosis of Stage IV NSCLC: 1. Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC 2. Participants who had disease progression on previous treatment with Programmed death-ligand 1 (PD- L1) inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D, as long as therapy was completed at least 28 days of the first study intervention. - Have measurable disease based on Response evaluation criteria in solid tumors (RECIST) 1.1 - Have a life expectancy of at least 3 months - Availability of archived tumor material (less than [<] 6 months old) adequate for biomarker analysis is mandatory at Screening, central laboratory confirmation is required. Fresh biopsies should be collected if archived tumor material is not available - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study entry and date of first dose Exclusion Criteria: - The participants tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation,ROS1 rearrangement, or BRAF V600E mutation or anaplastic lymphoma kinase (ALK) positive, if targeted therapy is locally approved - Mixed small cell with NSCLC cancer histology - Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (RT) of > 30 gray (Gy) within 6 months prior to the first dose of study intervention - Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks after the end of the RT and, have no evidence of new or enlarging brain metastases evaluated by imaging, preferably brain magnetic resonance imaging (MRI) - Known severe hypersensitivity to study intervention or any components in their formulations - For participants in Cohort A, B and C: Has received prior systemic therapy for Stage IV NSCLC, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) - Unable to tolerate computed tomography (CT) or MRI in the opinion of the Investigator and/or allergy to contrast material. ; PRIMARY OUTCOME: Number of Participants With Dose-Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator (IRC)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Monotherapy (201); BRIEF: The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo. ; DRUG USED: Ocaliva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: Farnesoid X receptor (FXR)/NR1H4 ; THERAPY: Monotherapy; LEAD SPONSOR: Intercept Pharmaceuticals; CRITERIA: Inclusion Criteria: - Female participants must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use 1 effective method of contraception with all sexual partners during the study and for 14 days after the end of dosing. - Male participants must be prepared to use 1 effective method of contraception with all sexual partners during the study during the study unless they had a prior vasectomy. - Proven or likely PBC, as demonstrated by the participant presenting with at least 2 of the following 3 diagnostic factors: - History of increased alkaline phosphatase (ALP) levels for at least 6 months; - Positive antimitochondrial antibody titer (>1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive); - Liver biopsy consistent with PBC - Screening ALP level between 1.5 and 10 × upper limit of normal (ULN). Exclusion Criteria: - Administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid, colchicine, methotrexate, azathioprine, or systemic corticosteroids. - Screening conjugated (direct) bilirubin >2 × ULN. - Screening alanine aminotransferase or aspartate aminotransferase >5 × ULN. - Screening serum creatinine >133 micromoles/liter (1.5 mg/deciliter). History or presence of hepatic decompensation (for example, variceal bleeds, encephalopathy, or poorly controlled ascites). - History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus infection, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis. - Pregnancy. ; PRIMARY OUTCOME: DB Phase: Mean Percent Change In Serum Alkaline Phosphatase (ALP) From Baseline To Day 85; SECONDARY OUTCOME 1: DB Phase: Mean Percent Change In Gamma-glutamyl Transferase (GGT) From Baseline To Day 85[/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 - fliGHt; BRIEF: A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Australia, and New Zealand. ; DRUG USED: Skytrofa; DRUG CLASS: Biologic; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth hormone receptor (GHR); THERAPY: Monotherapy; LEAD SPONSOR: Ascendis Pharma Endocrinology Division A/S; CRITERIA: Inclusion Criteria: 1. Investigator-determined GHD diagnosis prior to the historical initiation of daily hGH therapy. 2. 6 months to 17 years old, inclusive, at Visit 1 1. If 3 to 17 years old, are taking daily hGH at a dose of ≥ 0.20 mg hGH/kg/week for at least 13 weeks but no more than 130 weeks prior to Visit 1 2. If ≥ 6 months but < 3 years old, are either hGH treatment-naïve or are taking daily hGH at a dose of ≥ 0.20mg hGH/kg/week for no more than 130 weeks prior to Visit 1 3. Tanner stage < 5 at Visit 1 4. Open epiphyses (bone age ≤14.0 years for females or ≤16.0 years for males) 5. Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC Exclusion Criteria: 1. Weight of < 5.5 kg or > 80 kg at Visit 1 2. Females of child-bearing potential 3. History of malignant disease 4. Any clinically significant abnormality likely to affect growth or the ability to evaluate growth (eg, chronic diseases or conditions such as renal insufficiency, spinal cord irradiation, hypothyroidism, active celiac disease, malnutrition or psychosocial dwarfism) 5. Poorly-controlled diabetes mellitus (HbA1c >8.0%) or diabetic complications 6. Known neutralizing antibodies against hGH 7. Major medical conditions, unless approved by Medical Monitor 8. Pregnancy 9. Presence of contraindications to hGH treatment 10. Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver) 11. Participation in any other trial of an investigational agent within 30 days prior to Visit 1 12. Prior exposure to investigational hGH ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]; SECONDARY OUTCOME 1: Annualized Height Velocity (AHV) at 26 Weeks of Weekly Lonapegsomatropin Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - GEN-01 (w/Zelboraf, Bevacizumab); BRIEF: This phase 2 clinical trial randomizes patients with BRAF mutant melanoma to either (1) standard of care (SOC) - BRAF inhibitor vemurafenib in combination with MEK inhibitor cobimetinib; or, (2) SOC plus bevacizumab, an anti-VEGF antibody that suppresses new blood vessel formation and can stimulate the immune system. Previous clinical studies in melanoma have shown that bevacizumab may improve clinical benefit (progression free survival) if combined with ipilimumab or abraxane. Preclinical studies suggest that VEGF increase plays a role in resistance to BRAF inhibitors. This randomized study will ask whether the addition of bevacizumab to targeted therapy SOC in BRAF mutant melanoma can improve response rates and clinical benefit. Patients may have received no therapy for advanced disease or up to 2 prior therapies, excluding BRAF and MEK inhibitors. ; DRUG USED: Cotellic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Melanoma Research Foundation Breakthrough Consortium; CRITERIA: Inclusion Criteria: 1. Patients must have histological or cytological confirmed melanoma that is metastatic or unresectable stage IIIc and clearly progressive. 2. Patients must have melanoma that is documented to contain a BRAFV600E or BRAFV600K mutation by a FDA-approved test. 3. Age >= 18 years. 4. Women must not be pregnant due to the fact that the effects of vemurafenib, cobimetinib, and/or bevacizumab on the developing human fetus are unknown. For this reason and because antiangiogenic agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence; defined in Appendix G) prior to study entry and for the duration of study participation. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. 5. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 6. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with bevacizumab, cobimetinib, and vemurafenib, female participants who are breastfeeding must agree to discontinue nursing prior to Day 1 of the study. 7. Patients must have measurable disease as defined in Section 10.1 (cutaneous lesions measuring at least 1 cm will be considered measurable). Baseline CT or MRI scans of measurable disease sites must be performed within 4 weeks of study entry. 8. Patients must have discontinued immunotherapy or other systemic therapy including investigational agents at least 4 weeks prior to entering the study and have recovered from adverse events due to those agents. Patients must agree to not receive any other investigational agents during study participation. 9. Patients must have an ECOG performance status of 0, 1, or 2. 10. Patients must have the following baseline laboratory values: 1. White Blood Count > 3,000/mm3 2. Absolute Neutrophil Count > 1,500/mm3 3. Platelet Count > 100,000/mm3 4. Serum creatinine < 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl)> 40ml/min (CrCl= Wt (kg) x (140-age)*/72 x Cr. level, *female x 0.85) 5. Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN for patients with documented liver metastases) 6. Alkaline Phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement) 7. International Normalized Ratio (INR) < 1.5 and aPTT within 1.1 x ULN 8. Total Bilirubin < 1.5 x ULN 9. UPC ratio < 1.0 at screening or 24 hours urine protein < 1 gm (Appendix D) 11. Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients may not have received more than 2 prior systemic treatment regimens for distant metastatic disease. The following prior therapy is permitted in either the adjuvant or metastatic disease setting, provided treatment is discontinued at least 4 weeks prior to initiating study treatment: 1. Immunotherapy, such as interferon, interleukin-2, GM-CSF, ipilimumab, anti-PD1 or other experimental agent. 2. Cytotoxic chemotherapy, such as dacarbazine, temozolomide, carboplatin +/-paclitaxel. 2. Patients may not have had radiation therapy within the last 4 weeks prior to initiation of study treatment. 3. Patients who have had prior VEGF pathway inhibitor, BRAF or MEK inhibitor therapy are ineligible. 4. Patients must have no clinical evidence of active brain metastasis. Patients with a history of brain metastases must meet all of the following criteria: 1. Have completed treatment greater than 4 weeks prior to enrollment. 2. Have CNS lesions that are confirmed to be stable or regressing on imaging since the time of the last CNS treatment including the pre-treatment CT or MRI scan for this trial. 3. Patients must have no residual neurologic symptoms while taking no steroids, a stable or decreasing dose of steroids, or a stable dose of anti-seizure medication for the 2 weeks prior to enrollment. 5. Patients must not have other concurrent uncontrolled malignancies, defined as a malignancy that currently requires therapy or other intervention. Patients with suspected cuSCCs should have them excised prior to study registration. Surgical resection should not be performed within 7 days of starting protocol therapy. 6. Patients may not have had a major surgical procedure, open biopsy (excluding skin cancer resection, cutaneous/subcutaneous melanoma metastasis resection or biopsy or vascular access device insertion), or significant traumatic injury within 28 days prior to Day 1, or have an anticipated need for major surgical procedure or a planned elective surgical procedure during the course of the study. 7. Patients may not have had a core biopsy, skin cancer resection, or other minor surgical procedure, including placement of a vascular access device, within 7 days prior to Day 1 of the protocol. 8. Patients must not have a serious intercurrent illness including, but not limited to: 1. Ongoing or active infection requiring parental antibiotics on Day 1 2. A history of malabsorption or other condition that would interfere with absorption of vemurafenib or cobimetinib. 3. History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 4. History of congenital long QT syndrome or mean corrected QTc interval > 450 msec at baseline 5. Clinically significant cardiovascular disease, defined as any of the following conditions: i. Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) ii. Prior history of hypertensive crisis or hypertensive encephalopathy iii. Myocardial infarction within 6 months iv. Unstable angina v. New York heart association grade II or greater congestive heart failure (Appendix C) vi. Serious cardiac arrhythmia requiring medication vii. LVEF < 50% or below institutional limit of normal f) History of stroke of TIAs within 6 months prior to Day 1 g) Grade II or greater peripheral vascular disease within 1 year prior to study entry or other significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 h) Serious, non-healing wound, active ulcer, or untreated bone fracture i) History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 j) Known hypersensitivity to any component of bevacizumab k) Known CNS disease, except for stable or regressing brain metastases. l) Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) m) Psychiatric illness/social situations that would limit compliance with study requirements. n) Significant ocular issues including history of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration. The risk factors for RVO are listed below. Patients should be excluded if they have the following conditions: 1. Uncontrolled glaucoma with intra-ocular pressures >21mm Hg 2. Serum cholesterol >= Grade 2 3. Hypertriglyceridemia >= Grade 2 4. Hyperglycemia (fasting) >= Grade 2 9. Patients must not have the following foods/ supplements at least 7 days prior to initiation of and during study treatment: 1. St. Johns wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer) 2. Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor). 10. Because patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with bevacizumab, vemurafenib and cobimetinib. ; PRIMARY OUTCOME: Maximum Tolerated Dose; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Effect on Heroin and Nicotine; BRIEF: The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be used as an adjunct to agonist-based treatment. ; DRUG USED: OMS405; DRUG CLASS: New Molecular Entity (NME); INDICATION: Substance Use Disorder; TARGET: PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: New York State Psychiatric Institute; CRITERIA: Inclusion Criteria: - 21-55 years of age - Physically healthy - Able to perform study procedures Exclusion Criteria: - Pregnancy - Physical dependence on any other drugs besides caffeine, heroin and nicotine ; PRIMARY OUTCOME: Drugs Break Point; SECONDARY OUTCOME 1: Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.[/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 - 13-110-0006; BRIEF: The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome. ; DRUG USED: Visomitin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Eye (Ophthalmology); TARGET: Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: Mitotech, SA; CRITERIA: Inclusion Criteria: - Be male or female of any race, at least 18 years of age - Have provided written informed consent - Have a reported history of dry eye syndrome - Have a history of use or desire to use eye drops for dry eye Exclusion Criteria: - Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters - Have previously had LASIK surgery within the last 12 months - Have used Restasis® within 30 days of Visit 1 - Be a woman who is pregnant, nursing or planning a pregnancy - Be unwilling to submit a urine pregnancy test if of childbearing potential - Have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride - Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1 - Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subjects participation in the study ; PRIMARY OUTCOME: Inferior Corneal Fluorescein Staining; 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 - inTandem5 (Young Adults); BRIEF: This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen. ; 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 had given written informed consent. - Young adult participants >=18 to <=30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent. - Participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). - At Screening, must had A1C >= 9.0%. - Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary. - Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test. Exclusion Criteria: - Any prior use of LX4211/sotagliflozin. - Use of antidiabetic agent other than insulin or insulin analogue at the time of screening. - Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period. - Chronic systemic corticosteroid use. - Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator. - History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit. - History of severe hypoglycemic event within 1 month prior to the Screening Visit. ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1C (A1C) at Week 12; SECONDARY OUTCOME 1: Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - MK-8591-016; BRIEF: This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection ; DRUG USED: Islatravir; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV Prevention; TARGET: Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Is in general good health with acceptable laboratory values at screening - Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization - Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable) - Use contraceptives consistent with local regulations - Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP) - A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test. Exclusion Criteria: - Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator - Has an active diagnosis of hepatitis due to any cause - Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. - Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to Day 1 through the duration of the study. - Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to Day1 through the duration of the study. - Has previously been randomized in a study and received islatravir (MK-8591). - Female is expecting to conceive or donate eggs at any time during the study - Has QTc interval (using Fridericia correction) >450 msec (for males) or >460 msec (for females) or deemed clinically abnormal by the investigator. ; PRIMARY OUTCOME: Number of Participants With ≥1 Adverse Event (AE) Through Week 36; SECONDARY OUTCOME 1: Area Under the Plasma Concentration-time Curve From Dosing to 672 Hours Postdose (AUC0-672) of Plasma ISL[/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 - CF-203; BRIEF: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness. ; DRUG USED: Bronchitol; DRUG CLASS: Non-NME; INDICATION: Cystic Fibrosis (CF); TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Pharmaxis; CRITERIA: Inclusion Criteria: - Known diagnosis of cystic fibrosis (sweat test or genotype) - Of either gender - Aged between 8 and 18 years - Have a baseline FEV1 of <70% of the predicted normal value - Currently taking rhDNase for at least 4 weeks Exclusion Criteria: - Currently active asthma, uncontrolled hypertension, colonised with Burkholderia cepacia or MRSA - Listed for transplantation - Known intolerance to mannitol, rhDNase or bronchodilators ; PRIMARY OUTCOME: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase; SECONDARY OUTCOME 1: to compare mannitol to rhDNase on FVC[/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 - Japan (0304); BRIEF: This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia. ; DRUG USED: Roxadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Patients who diagnosed as a end-stage kidney disease (ESKD) and are receiving stable chronic maintenance dialysis 3 times per week for ≥ 12 weeks - Patients who are receiving ESA for at least 8 weeks and the dose of ESA is within the dose range of ESA label - Hb value at screening test is ≥10.0 g/dL - Receiving hemodialysis via arteriovenous fistula (AVF) or arteriovenous graft (AVG) or via permanent catheter - Most recent two Hb values before dialysis during washout period must be both <9.5 g/dL and one of two Hb values must be tested on first visit of the week Exclusion Criteria: - Proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment - Immunological disease with severe inflammation as assessed by the Investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, Sjogrens syndrome, celiac disease, etc) - Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or active gastroparesis - Uncontrollable hypertension (SBP ≥160 mmHg and DBP ≥110 mmHg, before dialysis, at screening test) - Congestive heart failure (NYHA classification III or higher) - Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before 1st registration - Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab) - Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc) - Pure red cell aplasia - Using anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before 1st registration ; PRIMARY OUTCOME: Rate of rise in hemoglobin (g/dL/week); SECONDARY OUTCOME 1: Cumulative number of responder patients[/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 - BR1-130; BRIEF: The purpose of this study is to demonstrate the Sensitivity and Specificity of SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging (CE-CT and/or CE MRI)/clinical data as truth standard. ; DRUG USED: Lumason; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) - Imaging; TARGET: Blood plasma; THERAPY: Monotherapy; LEAD SPONSOR: Bracco Diagnostics, Inc; CRITERIA: Inclusion Criteria: - Male/female. - Provides written Informed Consent and is willing to comply with protocol requirements. - Is at least 18 years of age. - Has at least 1 FLL (target lesion) requiring work-up for characterization. Target lesions may include those: Incidentally detected, In subjects with chronic hepatitis or liver cirrhosis, In subjects with known history of malignancy. - Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the SonoVue® administration OR - In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a CE-CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of SonoVue®. Exclusion Criteria: - Has an acoustic window insufficient for adequate ultrasound examination of the liver. - Has a FLL that cannot be identified with unenhanced ultrasound. - Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion. - Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®. - Has previously been enrolled in and completed this study. - Known right to left cardiac shunt, bidirectional or transient. - Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®). - Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc. - Has received an investigational compound within 30 days before admission into this study. - Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations. - Is determined by the Investigator that the subject is clinically unsuitable for the study. - Is a pregnant or lactating female. Exclude the possibility of pregnancy by: testing on site at the institution serum βHCG within 24 hours prior to the start of SonoVue® administration, surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses. ; PRIMARY OUTCOME: Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard; SECONDARY OUTCOME 1: Accuracy: Percentage of True Positive and True Negative Among All Lesions[/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 - TWAIN I; BRIEF: This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder. ; DRUG USED: Ralmitaront; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Trace Amine Associated Receptor 1 (TAAR1); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI) - Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or pure D2 antagonist(s), or a D2 partial agonist for a minimum of 6 months and receiving no more than two antipsychotics - Medically stable during the 3 months prior to study entry - Participant is an outpatient with no psychiatric hospitalizations within the prior 6 months - PANSS negative symptom factor score of 18 or higher - The following rating on items of the PANSS: (a) less than 5 on G8 (uncooperativeness), P1 (delusions), P3 (hallucinations), P4 (excitement/hyperactivity), and P6 (suspiciousness/persecution); (b) less than 4 on P7 (hostility), and G14 (poor impulse control) - Has an informant who is considered reliable by the Investigator - Body mass index (BMI) between 18-40 kg/m2 inclusive - Female participants are eligible to participate if not pregnant, not breastfeeding and agree to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug Exclusion Criteria: - Moderate to severe substance use disorder within six months of study entry (excluding nicotine or caffeine) as defined by DSM-5 - Extrapyramidal symptom rating scale (ESRS-A CGI) subscore greater than or equal to 3 - Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder) - PANSS item G6 (depression) greater than or equal to 5 - Significant risk of suicide or harming him- or herself or others according to the Investigators judgment - A prior or current general medical condition that might be impairing cognition or other psychiatric functioning - Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or HIV-1 and HIV-2. HCV antibody positive participants are eligible if HCV RNA is negative - Tardive dyskinesia that is moderate to severe or requires treatment - History of neuroleptic malignant syndrome - Average triplicate Fridericias Correction Formula (QTcF) interval greater than 450 milliseconds (msec) for males and 470 msec for females or other clinically significant abnormality on screening electrocardiogram (ECG) based on centralized reading - Clinically significant abnormalities in laboratory safety test results - Significant or unstable physical condition that in the investigators judgment might require a change in medication or hospitalization during the course of the study - On more than one antidepressant, or if on one antidepressant, a change in dose within 28 days prior to screening - History of clozapine treatment - History of treatment with electroconvulsive therapy (ECT) - Concomitant use of prohibited medications - Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenomorphine, methadone, cannabinoids, cocaine, and barbiturates - Receipt of an investigational drug within 28 days or five times the half-life of the investigational drug (whichever is longer) before the first study drug administration - Donation of blood over 400 mL within 3 months prior to screening - Diagnosis of COVID-19 infection (confirmed or presumptive) 4 weeks prior to screening or during screening. Participants can be re-screened after 4 weeks of full recovery in addition to Investigator and/or institutional approval to enroll ; PRIMARY OUTCOME: Change from Baseline at Week 12 in Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore; SECONDARY OUTCOME 1: Change from Baseline in Clinical Global Impression Severity (CGI-S) Overall Scores[/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 - JUPITER06; BRIEF: This is one randomized, double-blind, multi-center, placebo-controlled phase III study. The objective of this study is to compare the effectiveness and safety of JS001 combined with paclitaxel and cisplatin(TP regimen )with placebo combined with TP regimen in patients with advanced or metastatic Esophageal Squamous Cell Carcinoma(ESCC )who have not received systemic chemotherapy previously. About 500 patients with advanced or metastatic ESCC who have not received chemotherapy previously will be enrolled in this study and 1:1 randomized into JS001 combined with TP group and placebo combined with TP group (i.e., 250 patients each in group A and B) The sample size was calculated based on the dual-endpoint of primary effectiveness endpoint (progression-free survival, PFS, as evaluated by BIRC per RECIST v1.1 criteria) and overall survival (OS). The hierarchical testing will be used for PFS and OS analysis at the overall significance level of two-sided 0.05, that is, all α levels (two-sided 0.05) will be firstly used for the hypothesis test of PFS; if the null hypothesis of PFS is rejected, the hypothesis test of OS will be performed at the two-sided significance level of 0.05. For PFS, it will be expected to observe 283 PFS events in 500 patients enrolled about 24 months after randomization of the first subject, thereby there is 85% statistical power to detect an improved PFS for JS001 in combination with TP versus placebo in combination with TP in subject with advanced or metastatic ESCC who had not previously received chemotherapy at the two-sided significance level of 0.05 (corresponding hazard ratio (HR) =0.7); for OS, it will be expected to observe 366 OS events in 500 patients enrolled about 39 months after randomization of the first subject, thereby there is 85% statistical power to detect an improved OS for JS001 in combination with TP versus placebo in combination with TP in subject with advanced or metastatic ESCC who had not previously received chemotherapy at the two-sided significance level of 0.05 (corresponding hazard ratio (HR) =0.73). It is planned to performed an interim analysis of OS at the time of PFS analysis (about 24 months after randomization of the first subject). ; DRUG USED: Toripalimab; DRUG CLASS: Biologic; INDICATION: Esophageal Cancer; TARGET: Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Shanghai Junshi Bioscience Co., Ltd.; CRITERIA: Inclusion Criteria： Inclusion criteria for oesophageal cancer Histologically or cytologically diagnosed locally advanced / recurrent or metastatic ESCC without radical treatment; No prior systemic anti-tumor therapy for recurrent or metastatic tumor. No recurrence at least 6 months from the end of last treatment in the patients previously receiving adjuvant, neoadjuvant chemotherapy/radiotherapy/chemoradiotherapy and radical therapy for non-metastatic disease (No recurrence at least 12 months from the end of last treatment in the patients previously receiving adjuvant chemotherapy/chemoradiotherapy with TP regimen); No risk of major hemorrhage or esophageal fistula, for example, large ulcer at the lesion is considered as the risk for major hemorrhage and esophageal fistula, the patient is not suitable to be enrolled. Subjects with tumor directly invading adjacent organs such as the aorta or trachea (T4b disease) should be closely assessed for risk of hemorrhage or fistula and consult the sponsor prior to enrollment. General requirements for inclusion: Signed informed consent; Male or female aged 18 to 70 years ECOG score 0 or 1; Expected survival longer than 3 months; Agreement upon providing previously reserved tumor tissue specimen or biopsied tumor lesion tissue for biomarker analysis. At least one measurable lesion in accordance with RECIST 1.1 (only when clear progression of disease occurs after radiotherapy for the previously irradiated lesion, the lesion can be used as measurable lesion). Good organ function level: Hematology: neutrophil ≥1.5×10^9/L, hemoglobin ≥9 g/dL and platelet ≥100×10^9/L. Hepatic function: bilirubin ≤1.5 time of upper limit of normal (ULN) (patients who are known to have Gilbert disease and serum bilirubin level ≤3 times of ULN can be enrolled), AST and ALT ≤2.5 times of ULN (in case of hepatic metastasis, AST /ALT≤5 times of ULN), and alkaline phosphatase≤3 times of ULN (in case of hepatic or bone metastasis, ALP≤5 times of ULN); albumin ≥3g / dL; International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN. Renal function: serum creatinine ≤1.5 × ULN or estimated glomerular filtration rate in accordance with Cockcroft-Gault formula: creatinine clearance ≥60 mL/min ((140 - age)x(weight，kg)x(0.85，for women))/(72 x(serum creatinine，mg/dL)) Or: ((140 - age)x(weight，kg)x(0.85，for women))/(0.818 x(serum creatinine，μmol/L)) Women who meet the following criteria are eligible to be included and participate in the study: No childbearing potential (e.g., physiologically infertile), women meeting any one of the following conditions: Having undergone uterectomy, Having undergone bilateral oophorectomy (oophorectomy), Having undergone ligation of bilateral fallopian tubes, or Postmenopause (total duration of menopause ≥1 year). Having childbearing potential, serum pregnancy test negative at screening (within 7 days prior to the first dose of study drug), and adequate contraceptive measures taken prior to entry in the study and throughout the study, until 60 days after the last dose of the study drug. The adequate contraceptive measure taken continuously in accordance with the instruction on the contraceptive product and physicians guidance is defined as below: Any intrauterine device confirmed to have a failure rate for contraception less than 1% per year Dual barrier contraception is defined as the condom with spermicidal gel, foam, suppository or film; or diaphragma with spermicide; or male condom and diaphragma. Exclusion Criteria Cancer-specific exclusion criteria: Active or untreated CNS metastasis determined through CT or magnetic resonance imaging (MRI) evaluation in screening period and previous radiological evaluation (e.g., brain or leptomeningeal metastasis). Patients who have received previous treatment of brain or meningeal metastases, who have been stabilized for at least 2 months and discontinued systemic hormone therapy (> 10 mg/d of prednisone or equivalent) for > 4 weeks prior to randomization; Uncontrolled tumor related pain; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once per month or more frequent); indewlling catheter (e.g. PleurX®) is allowed; Uncontrollable or symptomatic hypercalcemia (ionized calcium>1.5 mmol/L or calcium >12 mg/dL or corrected serum calcium >ULN); History of malignant tumors except esophageal cancer within 5 years prior to randomization, but except the malignant tumors that risk of metastasis or death can be neglected [e.g., expected 5-year survival rate> 90%], and are expected to be cured after treatment, for example, appropriately treated carcinoma in situ of cervix, basal or squamous cell skin cancer, local prostate cancer treated with radical operation, and ductal carcinoma in situ treated with radical operation; Palliative Radiotherapy within 4 weeks prior to enrollment, or radiopharmaceutical therapy within 8 weeks, however, except locally palliative radiotherapy for bone metastatic lesions; in case of symptomatic lesion suitable for palliative chemotherapy, the therapy should be given prior to enrollment. The effect of previous radiotherapy has been recovered. The shortest recovery period is not required; Subjects with bone metastases of multiple vertebra are prone to fractures and may cause risk of paraplegia, except for Subjects who are assessed as stable and do not need to be treated for the time being evaluated by a specialist. Subjects with advanced tumors spreading to vital organs and being in risk of developing life-threatening complications in the short term ( eg. metastatic disease burden of liver ≥ 50% of total liver volume). Subjects with known complete obstruction under endoscopy requiring interventions or surgery to remove obstruction and who have undergone tracheal or esophageal stenting; Subjects whose BMI are less than 17.5, or body weight decrease >10% within 2 months prior to first dose of study treatment (considering changes of massive pleural effusion and ascites) or with severe malnutrition as indicated by other indicators. General medical exclusion criteria: Women who are pregnant or lactating, or plan to be pregnant during the study; History of serious allergic reaction, anaphylactoid or other hypersensitive reactions to chimeric or humanized antibody or fusion protein; Known allergy or hypersensitivity to the biological products manufactured from Chinese hamster ovary cells or any component of JS001 preparation; History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegeners granulomatosis, Sjogrens syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, glomerulonephritis; Patients with hypothyroidism who receive stable-dose thyroid hormone replacement therapy can be enrolled in this study (the replacement therapy for hypothyroidism is seen in Appendix 6); Patients with type I diabetes whose blood glucose can be controlled through stable-dose insulin can be enrolled in this study; Patients with eczema, psoriasis, chronic lichen simplex or only the dermatological manifestations of vitiligo (e.g., patients with psoriatic arthritis will be excluded from the study) are allowed to be enrolled in this study if they meet the following conditions: The coverage area of rashes must be lower than 10% of body surface area (BSA); The disease has been sufficiently controlled at baseline and only low-potency topical steroid therapy is needed; No acute exacerbation of underlying diseases in the past 12 months [no need of PUVA (Psoralen plus ultraviolet A radiation), methotrexate, retinol, biological preparation, oral calcineurin inhibitor, high-potency or oral steroid therapy]. History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterative bronchiolitis), drug induced pneumonia, idiopathic pneumonia interstitial pneumonia or evidence of active pneumonia found during chest CT scanning for screening; Patients with positive result of human immunodeficiency virus (HIV) test Patients with hepatitis B (known positive HBV surface antigen HBsAg and HBV DNA ≥1000 cps/ml or 200 IU/ml or higher than upper limit of normal at each study site) or hepatitis C: Subjects with previous hepatitis B virus (HBV) infection can be included in this study. Such subjects must undergo HBV deoxyribonucleic acid (DNA) testing prior to randomization, and can participate in this study only when HBV DNA is negative (HBV DNA ˂1000 cps/mL or 200 IU/mL or below the upper limit of its normal value); In patients with positive hepatitis C virus (HCV) antibody, only the patients with negative polymerase chain reaction (PCR) HCV ribonucleic acid (RNA) can participate in this study. Patients with active pulmonary tuberculosis (clinical diagnosis includes clinical history, physical examination and radiological findings, as well as the TB test performed in accordance with local medical routines); Serious infection within 4 weeks prior to randomization, including but not limited to the infection complications, bacteremia and severe pneumonia requiring hospitalization; Oral or intravenous antibiotics within two weeks prior to randomization; patients receiving preventive antibiotic therapy (e.g., for prevention of urinary tract infection or prevention of exacerbation of chronic obstructive pulmonary disease) can be enrolled. Important cardiovascular diseases, e.g., heart disease defined by New York Heart Association (Grade II or above), myocardial infarction within three months prior to randomization, unstable arrhythmia, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack; patients with known coronary artery disease, congestive heart failure not meeting the above criteria or left ventricular ejection fraction < 50% must receive the regimen that is considered by the attending physician as the optimal for stabilizing therapy, and can consult a cardiologist when necessary; Major surgery (except for diagnostic operation) within 28 weeks prior to randomization or expected major surgery during the study; Previous allogeneic bone marrow transplantation or solid organ transplantation. Use of attenuated live vaccine within 4 weeks prior to randomization, or plan to use such attenuated live vaccine during the study Any other disease, metabolic disorder, physical examination finding or abnormal laboratory examination, with the reason to suspect that it can lead to contraindicated use of the investigational product, or affect reliability of the study results, or place the patient at high risk; Exclusion criteria related to medications: Patients who have previously received any approved Chinese patent medicine as anti-tumor indication within 2 weeks before first dose of study drug; Subjects treated with other investigational product or participation in the clinical study for other therapeutic objectives within 28 days prior to randomization (including signature of ICF for other trials, and failure of screening); Previous use of immune checkpoint blocking therapy, for example, anti-programmed death receptor -1 (anti-PD-1) and anti-PD-L1 antibody and other therapeutic antibody; Use of systemic immunostimulator therapy [including but not limited to interferon (IFN) or interleukin-2] within 2 weeks or 5 half-lives (t1/2) prior to randomization, whichever comes later; vaccination of cancer vaccine is allowed in previous treatment; Use of systemic immunosuppressive drugs (>10 mg/d Prednisone or equivalent drug) within two weeks prior to randomization, including but not limited to Prednisone, Cyclophosphamide, azathioprine, methotrexate, thalidomide and tumor necrosis factor (TNF); Patients who have received short-term, low-dose, systemic immunosuppressant (e.g., one single dose of Dexamethasone for nausea) can participate in this study after discussion by investigators and medical monitor and approval by medical monitor; Patients who use inhaled corticosteroids for treatment of chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for treatment of orthostatic hypotension and low-dose glucocorticoid (≤10mg /d Prednisone or equivalent drug) supplement for treatment of hypoadrenocorticism can be enrolled. Patients who have previously received the hematopoietic growth factors (e.g. granulocyte colony-stimulating factor (G-CSF) and erythropoietin) or blood transfusion within 2 week before randomization. Exclusion criteria related to chemotherapy: History of allergy to cisplatin, carboplatin or other platinum-based compounds; Grade 2 or above peripheral neuropathy in accordance with common terminology criteria for adverse event (CTCAE) v5.0. ; PRIMARY OUTCOME: PFS; SECONDARY OUTCOME 1: ORR(overall response rate)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Moderate-to-Severe ; BRIEF: The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis. ; DRUG USED: Mirikizumab; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria: - plaque psoriasis involving ≥10% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline - sPGA score of ≥3 at screening and baseline - Candidate for biologic treatment for psoriasis. Exclusion Criteria: - Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data. - Breastfeeding or nursing (lactating) women. - Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. - Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study. - Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results. - Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline. - Have received topical psoriasis treatment within 14 days prior to baseline. - Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 8 weeks prior to baseline. - Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted). ; PRIMARY OUTCOME: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90); SECONDARY OUTCOME 1: Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Bendamustine; BRIEF: This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation. ; DRUG USED: Brukinsa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Combination; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation 2. Histologically confirmed diagnosis of MCL 3. No prior systemic treatments for MCL 4. Measurable disease by CT/MRI 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Adequate marrow and organ function Key Exclusion Criteria: 1. Known central nervous system involvement by lymphoma 2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant 3. Clinically significant cardiovascular disease 4. History of severe bleeding disorder 5. Unable to swallow capsules or disease significantly affecting gastrointestinal function 6. Active fungal, bacterial and/or viral infection requiring systemic therapy 7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Progression-free survival (PFS) determined by independent central review; SECONDARY OUTCOME 1: PFS by investigator[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Highdes (Positive Crossmatch Test); BRIEF: The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific Antibodies (DSAs) and thereby convert a positive crossmatch test to negative. ; DRUG USED: IdeS; DRUG CLASS: Biologic; INDICATION: Kidney Transplant Rejection; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Hansa Biopharma AB; CRITERIA: Inclusion Criteria: - Patients on the kidney transplant waitlist who have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. The breadth and strength of sensitization will predict an extremely low likelihood of successful desensitization or kidney paired donation. - Patients with a live or deceased donor with a positive crossmatch test. Exclusion Criteria: - Previous treatment with IdeS - Previous high dose IVIg treatment (2 g/kg BW) within 28 days prior to IdeS treatment - Lactating or pregnant females - Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception - HIV-positive patients - Patients with clinical signs of HBV or HCV infection - Patients with active tuberculosis - A significantly abnormal general serum screening lab result according to the investigators judgement. Hgb cannot be < 6.0 g/dL - Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD - Individuals deemed unable to comply with the protocol - Patients with clinical signs of CMV or EBV infection - Patients with a history of major thrombotic events, patients with active peripheral vascular disease or patients with proven hypercoagulable conditions - Patients should not have received investigational drugs within 4 half-lives (or similar) - Known allergy/sensitivity to IdeS infusions - Patients who have a live donor and test positive for ImmunoCap anti-IdeS IgE ; PRIMARY OUTCOME: Number of Patients With Crossmatch Conversion (Positive to Negative); SECONDARY OUTCOME 1: Number of Patients With Donor Specific Antibodies With an MFI Value >3000[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - ACTION II; BRIEF: The primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living. The secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following: measures of independence, activities of daily living, neurologic function, quality of life, cognition, and safety and tolerability ; DRUG USED: Tysabri; DRUG CLASS: Biologic; INDICATION: Ischemic Stroke; TARGET: Integrin Alpha-4 beta-1/VLA-4, Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation. - Score of 5 to 23 points, inclusive, on the NIHSS at Screening for subjects initiating treatment ≤9 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization. - Score of 5 to 15 points, inclusive, on the NIHSS at Screening for subjects initiating treatment >9 to ≤24 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization. - Prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet. - For those subjects who underwent a cranial MRI, there is at least 1 acute infarct with a diameter of ≥2 cm on baseline brain diffusion-weighted imaging. Key Exclusion Criteria: - Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care. - Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary. - Severe stroke defined by imaging criteria based on either one of the following: - Alberta Stroke Program Early CT (ASPECT) score of 0 to 4 based on head CT or - Acute infarct volume on MRI diffusion weighed imaging greater than or equal to 70 mL - Seizure at the onset of stroke. - Known history of prior treatment with natalizumab. - Known history of active viral hepatitis B or C. - Signs and symptoms of active or acute infection. NOTE: Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Composite Global Measure of Functional Disability Excellent Outcome at Day 90; SECONDARY OUTCOME 1: Percentage of Participants With Excellent Outcome in mRS Score at Day 90[/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 - ASTRID OLE; BRIEF: This open-label extension study, for subjects from the G201002 study, will provide additional long-term safety and tolerability data for GTx-024. All subjects in this study will receive GTx-024 3 mg orally, once daily. ; DRUG USED: Enobosarm; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Incontinence; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: GTx; CRITERIA: Inclusion Criteria: - Be an eligible subject from G201002, where an eligible subject is defined as: 1. one of the first 225 subjects who were randomly assigned to the placebo group in G201002 and who have completed the required treatment and durability periods of that study, or; 2. any subject from 226 onwards, who was randomly assigned to any treatment group and who completed the required treatment and follow-up periods of that study - Be able to read, understand, and provide written, dated, informed consent prior to enrollment in the current study and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information - Provide written consent to participate in the study within the following timeframes: 1. for G201002 Subjects 1-225, within 30 days after unblinding of G201002 (subjects who consent to participate in G201003 will be allowed to discontinue from that study and consent to this study upon unblinding of G201002) 2. for G201002 Subjects 226-493, within 30 days of completing both the treatment and follow-up periods of G201002 - Agree to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the study Exclusion Criteria: - Starts any new treatment (medication, pelvic floor physical therapy, or other treatment known to impact the pelvic floor) after completing G201002 that is known or suspected to affect lower urinary tract function, including vaginal rejuvenation - Subject is currently taking systemic sex-hormone products (excludes intravaginal application of estradiol topical/tablet agents and hormones delivered via vaginal rings) - Has a current cancer diagnosis (with the exception of nonmelanoma skin cancer) or any history of breast or endometrial cancer - Has a known history or current episode of: 1. New York Heart Association Stage ≥ 2 hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) at screening and/or baseline. Subjects with hypertension that has been treated and controlled with medication for ≥ 2 weeks prior to screening are eligible for participation 2. Recent myocardial infarction or arterial or venous thromboembolic event (within 1 year) or a history of more than 1 myocardial infarction or arterial or venous thromboembolic event 3. Cardiac-related syncopal event within the past year 4. Cardio or cerebral vascular disease requiring surgical intervention (e.g., bypass surgery, angioplasty). For subjects with previous stent placement, please contact the medical monitor 5. Congestive heart failure of Stage > 2 according to New York Heart Association criteria 6. Angina pectoris - Has a current or past history of any physical condition that, in the investigators opinion, might put the subject at risk, impact the absorption of the study drug, or interfere with interpretation of study ; PRIMARY OUTCOME: Safety of GTx-024, adverse events; SECONDARY OUTCOME 1: Efficacy of GTx-024, stress incontinence[/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 - 131797; BRIEF: This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer. ; DRUG USED: Detectnet; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuroendocrine Tumors (NET) - Imaging; TARGET: Somatostatin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Radiomedix, Inc.; CRITERIA: Inclusion Criteria: - Confirmed or suspicion of NET based on histology/ biopsy report. - Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET - CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date. Exclusion Criteria: - Pregnant, planning to be pregnant within the next two weeks - Inability to provide written consent. - Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug. ; PRIMARY OUTCOME: Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor; SECONDARY OUTCOME 1: Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging[/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 - CHARMS; BRIEF: Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life and if the immune system is weakened, like after a transplant, they can cause life threatening infections. Patients enrolled on this study will have had an infection with one or more of the following viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), BK virus, JC virus, adenovirus or HHV6 (Human Herpes Virus 6). Investigators want to see if they can use a kind of white blood cell called T cells to treat infections of these viruses after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated multivirus-specific T cells (VSTs) from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen multivirus-specific T cells from healthy donors to treat virus infections after bone marrow transplant and now have improved the production method to make it safer and target more viruses. In this study, investigators want to find out if they can use these banked VSTs to fight infections caused by the viruses mentioned above. ; DRUG USED: Viralym-M; DRUG CLASS: Biologic; INDICATION: Antiviral - Other Treatments; TARGET: Epstein Barr Virus (EBV), Human Cytomegalovirus (HCMV), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: AlloVir; CRITERIA: Inclusion Criteria: For Initial VSTs and subsequent infusions: patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus, EBV, BK virus and/or HHV6 infection/disease persistent or recurrent despite 14 days of standard therapy OR after failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy. Patients with persistent JC virus infection will be eligible as well. 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood. 2. Treatment of the following persistent or relapsed infections despite standard therapy; 1. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet or cidofovir. - CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination. - CMV infection: defined as the presence of CMV positivity as detected by PCR or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx. - Failure of antiviral therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or pp65 antigenemia after 7 days of antiviral therapy. 2. Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function. - Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx. - Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, DFA or culture from two or more sites such as stool or blood or urine or nasopharynx. - Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy. 3. EBV: For treatment of persistent EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor. - EBV infection: defined as Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR,Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood. - Failure of therapy is defined as: Increase or less than 50% response at sites of disease for EBV lymphoma OR, Increase or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease after 1st dose of rituximab. 4. BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide. No clear standard treatment is defined. Cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy. In small trials leflunomide had activity against BK virus, therefore we will consider this agent an acceptable alternative to cidofovir, given the absence of a clear first line option. - BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine. - BK virus disease is defined as the presence of BK virus detectable by culture or PCR in blood or urine or other body fluids and symptoms of disease including, but not limited to persistent microscopic or macroscopic hematuria or detectable BK virus in more than one site. - Failure of therapy is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay) or worsening hematuria after 7 days of antiviral therapy. 5. HHV6: Treatment of persistent HHV6 infection or disease despite antiviral treatment with ganciclovir, cidofovir and foscarnet. No clear standard treatment is defined. Ganciclovir, cidofovir and foscarnet all have variable in vitro activity against HHV-6, and may have a role in treating HHV-6-associated disease - therefore antiviral treatment with one or more of these agents will we acceptable initial therapy. - HHV6 virus infection is defined as the presence of elevated HHV-6 levels as detected by PCR or positive culture in one site such as CSF or blood. - HHV6 disease is defined as defined as the presence of HHV6 detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of HHV6 encephalitis OR detectable HHV6 by PCR or culture in more than one site. - Failure of therapy is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy. 6. JC virus: Treatment of progressive or persistent JC virus infection or disease without suitable alternative treatment option. Pepmixes specific for antigens on adenovirus, EBV, CMV, HHV6 and BK virus are used to generate our multivirus-specific VSTs. No pepmix specific for the rare JC virus is used for generation of these CTLs, however given the high homology (>90%) between JC and BK and the fact that BK virus-specific T cells targeting VP1 and Large T (as targeted in our multivirus VSTs) have been administered to treat JCV-PML, resulting in viral clearance from the cerebrospinal fluid it is likely that our VSTs are efficacious against JC virus. Given the current lack of treatment options for JC virus infection or reactivation after HSCT and the risk of progression to JML, which is almost uniformly fatal, and the apparent activity of BK virus-directed T cells against JC virus infected cells, we propose including patients with progressive or persistent JC virus on this study, unless a suitable alternative therapy is available. - JC virus infection is defined as the presence of elevated JC virus levels as detected by PCR or positive culture in one site such as CSF or blood. - JC virus disease is defined as defined as the presence of JC virus detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of PML OR detectable JC virus by PCR or culture in more than one site. 3. Patients with multiple CMV, EBV, Adenovirus, HHV6 and BK virus infections are eligible given that each infection is persistent despite standard therapy as defined above. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll. 4. Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent). 5. HgB>8.0 6. Pulse oximetry of > 90% on room air 7. Available multivirus-specific VSTs 8. Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen). 9. Written informed consent and/or signed assent line from patient, parent or guardian. Exclusion Criteria: 1. Patients receiving ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment. 2. Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 3. Patients who are less than 28 days removed from their allogeneic hematopoietic stem cell transplant or who have received donor lymphocyte infusions (DLI) within 28 days. 4. Patients with active acute GVHD grades II-IV. 5. Active and uncontrolled relapse of malignancy ; PRIMARY OUTCOME: Number of Patients Where a Suitable VST Line Could be Found; SECONDARY OUTCOME 1: Number of Participants With a Viral Response at 42 Days[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Treatment-Naive Adolescents; BRIEF: The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B). The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg. ; DRUG USED: Genvoya; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Cytochrome p450, DNA polymerase, HIV Integrase, Reverse Transcriptase; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Cohort 1 - 12 years to < 18 years of age at baseline - Weight greater than or equal to 35 kg (77 lbs) - Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0) - Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV) - No prior use of any approved or experimental anti-HIV-1 drug for any length of time - Cohort 2 - 6 years to < 12 years of age at baseline - Weight greater than or equal to 25 kg (55 lbs) - Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR. - Cohort 3 - Age at baseline: ≥ 2 years old - Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs) - Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR Key Exclusion Criteria: - Hepatitis B or hepatitis C virus infection - Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit. - Individuals experiencing decompensated cirrhosis - Pregnant or lactating females Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1); SECONDARY OUTCOME 1: PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/IIa - MAD (002); BRIEF: The purpose of this study in patients with schizophrenia is to evaluate the safety, tolerability, and pharmacokinetics of 3 doses (low, mid, high) of APN1125 compared with placebo when administered as repeated daily oral doses. ; DRUG USED: APN1125; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Nicotinic Acetylcholine Receptors (nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: CoMentis; CRITERIA: Inclusion Criteria: - Males and females of any race - 18 to 45 years of age, inclusive - Diagnosed with schizophrenia, as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), in a non-acute (e.g., chronic) phase and clinically stable for at least 12 weeks before screening - Currently on a stable second-generation anti-psychotic regimen (stable dose and medication for 12 weeks) - Subjects (male and female) of childbearing potential must use two effective methods of contraception starting from the time of providing informed consent throughout the duration of the study and for 3 months after discharge - Women of childbearing potential must have a negative pregnancy test at screening and at admission Exclusion Criteria: - Clinically significant abnormal serum electrolytes (sodium, potassium, calcium, and magnesium) after repeat testing - Insulin-dependent diabetes or insufficiently controlled diabetes mellitus in the judgment of the Investigator - Renal insufficiency with serum creatinine >1.6 mg/dL Malignant tumor within the 5 years before Screening with the exception of treated squamous and basal cell carcinoma, cervical carcinoma in situ, or brachytherapy for localized prostate cancer - Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study - Unstable medical condition that is clinically significant in the judgment of the Investigator - Body mass index (BMI) >38 kg/m^2 at Screening ALT or AST >1.5 times the upper limit of normal - Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 and/or 2 antibodies - Untreated clinically significant hypo- or hyperthyroidism; treated hypo- or hyperthyroidism should be stable for at least 8 weeks prior to Screening - History of myocardial infarction or unstable angina within 6 months before Screening - Cardiovascular disease history including symptomatic hypotension (supine systolic blood pressure [SBP] <90 mmHg or supine diastolic blood pressure [DBP] <60 mmHg), symptomatic orthostatic hypotension (orthostatic change in SBP >20 mmHg or DBP >15 mmHg), or hypertension (supine SBP >160 mmHg or supine DBP >95 mmHg ) or significant cardiac arrhythmia (in the judgment of the Investigator) - Clinically significant abnormality on Screening or Baseline electrocardiogram (ECG), including but not necessarily limited to a confirmed QTcF (QT interval corrected for heart rate using Fridericias formula) interval value >450 msec for males or >470 msec for females - Current treatment with more than 2 atypical antipsychotics Psychiatric hospitalization due to breakthrough psychotic symptoms or acute exacerbations within 3 months before Day -1. Subjects with a recent social hospitalization may be screened after consultation with the Medical Monitor. - Subjects with other DSM-5 disorders are ineligible if the comorbid condition is clinically unstable or has been the primary focus of treatment within 3 months prior to Screening - Subjects meeting DSM-5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine- or caffeine-related disorders) within 6 months prior to Screening - Urine drug screen (UDS) positive for drugs of abuse (excluding prescribed benzodiazepines) or positive alcohol breath test at Screening and/or Baseline (may be repeated once if, in the judgment of the Investigator, the subject does not meet DSM-5 criteria for moderate to severe substance abuse disorder) - Significant suicide risk as defined by 1) suicidal ideations as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the year prior to Screening or Baseline, 2) suicidal behaviors within the 2 years prior to Screening, or 3) Investigator assessment - History of stroke, brain tumor, subdural hematoma, Parkinsons Disease, dementia or other clinically significant neurological condition - Head trauma with loss of consciousness within 12 months prior to Screening - Active acute or chronic CNS infection - History of a seizure disorder - Immunosuppressants, including systemic corticosteroids (administered at an immunosuppressant dose in the judgment of the Investigator) (Note: Inhaled, nasal, or topical steroid use for allergy or other inflammation is permitted) - Any drugs with CNS activity (Note: Occasional (as needed) use of a sedative-hypnotic (e.g., benzodiazepine or nonbenzodiazepine [e.g., zolpidem, zaleplon, zopiclone, and eszopiclone]) as a sleep aid and stable second generation psychotics are permitted) - Prohibited antipsychotic medications (e.g., clozapine or typical, first-generation antipsychotics) - Excessive alcohol consumption (regular alcohol intake 14 units per week or more) or has a history of alcohol use disorder. Use of alcohol up to 48 hours before admission to the EPCU is not allowed. - Failure or inability to perform Screening or Baseline assessments - Exposure to an experimental drug or experimental medical device within 2 months before Screening, or an experimental biologic within 3 months before Screening ; PRIMARY OUTCOME: Assessment of safety and tolerability of APN1125 in subjects with schizophrenia via adverse events; SECONDARY OUTCOME 1: Maximum observed plasma APN1125 concentration (Cmax)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Extension Study (Anemia); BRIEF: Study A536-05 is an open-label extension study for patients previously enrolled in study A536-03 (ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and tolerability of ACE-536 in patients with low or intermediate-1 risk MDS. ; DRUG USED: Reblozyl; DRUG CLASS: Biologic; INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Transforming Growth Factor-beta (TGF-beta) and Superfamily; THERAPY: Monotherapy; LEAD SPONSOR: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; CRITERIA: Inclusion Criteria: - Completion of the treatment period in the base study A536-03 (ClinicalTrials.gov Identifier: NCT01749514) - Adequate birth control measures - Patient is able to adhere to the study visit schedule, understand and comply with all protocol requirements. - Patient understands and is able to provide written informed consent. In addition, patients with treatment interruption (defined as patients who complete their end-of-study visit in A536-03 and cannot directly roll over to A536-05) must also meet the following criteria: - Documented diagnosis of idiopathic/de novo MDS or non-proliferative chronic myelomonocytic leukemia (CMML) according to the World Health Organization (WHO) criteria 2 (white blood count (WBC) < 13,000/μL) that meets International Prognostic Scoring System (IPSS) classification (Appendix 2) of low or intermediate-1 risk disease as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC) obtained during screening; - Anemia defined as: - Mean hemoglobin concentration < 10.0 g/dL of 2 measurements (one performed within one day prior to Cycle 1 Day 1 and the other performed 7-28 days prior to Cycle 1 Day 1), for non-transfusion dependent (NTD) patients (defined as having received ˂ 4 units of red blood cells (RBCs) within 8 weeks prior to Cycle 1 Day 1), OR - Transfusion Dependent (TD), defined as having received ≥ 4 units of RBCs within 8 weeks prior to Cycle 1 Day 1. - Platelet count ≥ 30 x 109/L - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia) - Adequate renal (creatinine ≤ 2.0 x upper limit of normal [ULN]) and hepatic (total bilirubin < 2 x ULN and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN) function Exclusion Criteria: - Discontinuation/withdrawal from the base study A536-03 (due to patient request, patient unwillingness or inability to comply with the protocol, pregnancy, use of prohibited medication [e.g. azacitidine], medical reason or adverse event (AE), hypersensitivity reaction to the study drug, at the discretion of the sponsor, or loss to follow-up) prior to completion of the treatment period - Prior treatment with azacitidine or decitabine - Treatment within 28 days prior to Cycle 1 Day 1 with: - an erythropoiesis-stimulating agent (ESA), - Granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF), - Lenalidomide - Iron chelation therapy if initiated within 56 days prior to Cycle 1 Day 1 - Treatment with another investigational drug (including sotatercept [ACE-011]) or device, or approved therapy for investigational use ≤ 28 days prior to Cycle 1 Day 1, or if the half-life of the previous investigational product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer - Major surgery within 28 days prior to Cycle 1 Day 1. Patients must have completely recovered from any previous surgery prior to Cycle 1 Day 1 - Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B (HBV) or active infectious hepatitis C (HCV) - Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 150 mm Hg or diastolic blood pressure (DBP) ≥ 100 mm Hg - Pregnant or lactating females - History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational drug - Any other condition not specifically noted above which, in the judgment of the investigator, would preclude the patient from participating in the study ; PRIMARY OUTCOME: To evaluate the long-term safety and tolerability of ACE-536 in patients with low or intermediate-1 risk MDS who were previously enrolled in study A536-03; SECONDARY OUTCOME 1: Erythroid response in non-transfusion dependent (NTD) patients[/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 - ATLAS-OLE; BRIEF: Primary Objective: To characterize the long-term safety and tolerability of fitusiran Secondary Objectives: - To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of: - Bleeding episodes - Spontaneous bleeding episodes - Joint bleeding episodes - To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age ; DRUG USED: Fitusiran; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion criteria : - Participant must be at least 12 years of age inclusive, at the time of signing the informed consent - Participants with severe hemophilia A or B who have completed a Phase 3 fitusiran clinical trial - Male - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participants legally authorized representative Exclusion criteria: - Completion of a surgical procedure within 14 days prior to screening, or currently receiving additional factor concentrate or BPA infusion for postoperative hemostasis - Current participation in immune tolerance induction treatment (ITI) - Current use of factor concentrates or bypassing agents (BPAs) as regularly administered prophylaxis designed to prevent spontaneous bleeding episodes except for participants requiring factor concentrates or BPAs prophylaxis during the study dosing pause period - Use of compounds other than factor concentrates or BPAs for hemophilia treatment - Current or prior participation in a gene therapy trial - Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) >1.5 × upper limit of normal reference range (ULN) for patients who are naïve to fitusiran at study start; ALT and/or AST > 5 x ULN for patients who were in the fitusiran arm in the parent study - Additional exclusions for participants not currently participating in a fitusiran trial at the time of enrollment in the lower dose cohort: - Clinically significant liver disease - History of arterial or venous thromboembolism The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Number of participants with treatment emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Annualized bleeding rate (ABR)[/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 - w/Perjeta/Docetaxel; BRIEF: This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400. ; DRUG USED: Herceptin Hylecta; DRUG CLASS: Biosimilar; INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection. Patients with measurable and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 are eligible. - HER2-positive disease (defined as either immunohistochemistry [IHC] 3 + or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor or metastatic site if primary tumor not available - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 - Left ventricular ejection fraction (LVEF) of at least 50% - Negative serum pregnancy test result at baseline and use of effective contraception as defined by the protocol Exclusion Criteria: - Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease. Note: Prior to study entry, up to two lines of hormonal therapy for metastatic or locally recurrent disease are permitted, one of which may be in combination with everolimus. - Disease-free interval of less than 6 months from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of breast cancer - Previous approved or investigative anti-HER2 agents as neoadjuvant or adjuvant therapy for any breast cancer treatment, except Herceptin - History of persistent Grade 2 or higher hematological toxicity resulting from previous adjuvant or neoadjuvant therapy - Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment - Current peripheral neuropathy of Grade 3 or greater - History of other malignancy within the last 5 years prior to first dose of study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma - Inadequate organ function - Uncontrolled hypertension with or without medication - Clinically significant cardiovascular disease - History of LVEF decline to below 50% during or after prior Herceptin neo-adjuvant or adjuvant therapy - Current known infection with HIV, hepatitis B virus, or hepatitis C virus - Severe uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or that would put the patient at high risk for treatment-related complications, including severe pulmonary conditions/illness - Pregnant or lactating women - Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy - History of receiving any investigational treatment within 28 days prior to first dose of study drug administration (dosing) or concurrent participation in any interventional clinical trial ; PRIMARY OUTCOME: Incidence of adverse events (AEs); SECONDARY OUTCOME 1: Progression-free survival, tumor assessments according to RECIST v1.1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - NSCLC; BRIEF: The purpose of this study was to determine an effective and safe dose of sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia (CIA) in participants with metastatic non-small cell lung cancer (NSCLC) who are being treated with first-line platinum based chemotherapy. ; DRUG USED: Sotatercept; DRUG CLASS: Biologic; INDICATION: Anemia Due to Oncology Treatment; TARGET: Activin A, Transforming Growth Factor-beta (TGF-beta) and Superfamily; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: 1. Men and women >18 years of age 2. Part 1: Histologically confirmed (cytology or biopsy) solid tumor malignancy, excluding those solid tumors treated with curative intent. Part 2: Histologically confirmed non-small cell lung cancer 3. Documented metastatic disease 4. Measurable or non-measurable disease evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 5. All of the following laboratory values: - Hemoglobin ≥6.5 to <11.0 g/dL (≥65 to <110 g/L), due to chemotherapy-induced anemia - Absolute neutrophil count ≥500/mm^3 - Platelet count ≥75,000/mm^3 (>2 hours since prior platelet transfusion - Adequate renal function - creatinine clearance ≥40mL/min or ≥50 mL/min if cisplatin is concomitantly administered and - urine protein / creatinine ratio ≤1.0; or ≤2.0 if bevacizumab (Avastin®) is concomitantly administered - Hepatic function (bilirubin <1.5 x upper limits of normal (ULN); AST and ALT <3.0 x ULN and ≤5.0 ULN for participants with liver metastases) 6. Participants must have received: - at least one cycle and up to 4 cycles (q3w schedule) of platinum-based chemotherapy and be randomized prior to receiving Cycle 5 OR - at least one cycle and up to 3 months (depending upon regimen) of platinum-based chemotherapy 7. >28 days since previous treatment with ESA 8. >14 days since last red blood cell transfusions 9. Eastern Oncology Cooperative Group (ECOG) Performance status 0-2 10. For females of childbearing potential, highly effective method of birth control for at least 28 days before starting study, during participation and at least 112 days following last dose of sotatercept 11. Males must use latex condom or non-latex condom not made of (animal) membrane during any sexual contact with female of childbearing potential 12. Life expectancy of >3 months 13. Willing to adhere to study visit schedule 14. Understand and voluntarily sign informed consent Exclusion Criteria: Part 2 only, history of prior regimen(s)of platinum-based chemotherapy for metastatic NSCLC and/or history of adjuvant platinum-based chemotherapy with last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic NSCLC. 1. National Cancer Institute Common Terminology for Adverse Events Grade >3 toxicity 2. Prior radiation to >20% of whole skeleton 3. Prior regimen(s) of platinum based chemotherapy for metastatic disease and/or history of adjuvant platinum-based chemotherapy with the last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic disease 4. Central nervous system metastases 5. Clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic, or genitourinary disease unrelated to underlying malignancy 6. Classification of 3 or higher heart failure (as classified by New York Heart Association) 7. History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke, if not stable on anticoagulants and/or one of these events occurring in past 6 months 8. Diagnosis of a myeloid malignancy or known history of myelodysplasia 9. Recent history (within 14 days of Day 1) of IV/oral antibiotics due to post septic episode 10. Uncontrolled hypertension. Controlled hypertension is considered clinically stable, and systolic blood pressure (SBP) must be <150 mmHg and diastolic blood pressure (DBP) must be < 00 mmHg. 11. Known human immunodeficiency virus (HIV) 12. Known active hepatitis B or C antibody 13. Iron deficiency 14. History of anemia as a result of inherited hemoglobinopathy 15. History of anemia due to autoimmune or hereditary hemolysis or gastrointestinal bleeding 16. Received treatment with another investigational drug or device within 28 days prior to Day 1, or if the half life of the previous product is known, within 5 times the half life prior to dosing, whichever may be longer. 17. Any prior use of sotatercept. 18. Pregnant or lactating females or females planning to become pregnant 19. History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product (Refer to the Investigators Brochure for further information). 20. Major surgery within 30 days prior to Day 1 (participants must have completely recovered from any previous surgery prior to Day 1). ; PRIMARY OUTCOME: Number of Participants Who Experienced a Hematopoietic Response; SECONDARY OUTCOME 1: Number of Participants Who Experienced One or More Adverse Events (AEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 302 (South Korea); BRIEF: The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4. ; DRUG USED: Fexuprazan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Daewoong Pharmaceutical Co. LTD.; CRITERIA: Inclusion Criteria: 1. Subjects aged between 20 and 75 years 2. Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD 3. Subjects who had experienced major symptom within 3 months 4. Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week 5. Subjects who is able to understand and follow the instructions 6. Subjects who voluntarily signed written informed consent form Exclusion Criteria: 1. Subjects who have Barretts esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy 2. Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1 3. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months 4. Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery 5. Subjects with Zollinger-Ellison syndrome 6. Subjects with eosinophilic esophagitis 7. Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease . ; PRIMARY OUTCOME: 1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week; SECONDARY OUTCOME 1: Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 701; BRIEF: In this study, patients with severe coronavirus disease 2019 (COVID-19) infection will be randomized to receive duvelisib or a placebo. Participants will be enrolled at Emory University Hospital and will be identified and recruited by their treating physician and research team. ; DRUG USED: Copiktra; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: p110 delta/PIK3CD, p110 gamma/PIK3CG, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Emory University; CRITERIA: Inclusion Criteria: - Hospitalized in participating facility. - Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan). - Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment. Note - An exception must be requested to the Sponsor if ≥72 hours since positive test. - Symptoms suggestive of severe systemic illness with COVID-19, such as respiratory rate > 30 breaths per minute, heart rate >125 beats per minute, oxygen saturation (O2 sat) in the blood of <93% on room air at sea level or the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2)< 300 - 18 years of age or older - Patients with hematological parameters at screening consistent with < grade 2 NCI CTCAE v5.0 toxicity: hemoglobin >8 g/dL, platelet count >50,000 K/mcl, an absolute neutrophil count (ANC) >1,000/mm3, and an absolute lymphocyte count (ALC) >500/mm3. - Patients with laboratory measurements of liver function at screening consistent with < grade 2 NCI CTCAE v5.0 toxicity: alanine aminotransferase (ALT) < 5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) < 5 times ULN; and bilirubin < 3 times ULN. - The effects of duvelisib on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) must have a negative serum or urine pr5egnancy test prior to starting therapy. WOCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from enrollment into this study until at least 60 days after the first dose of duvelisib. A woman of childbearing potential (WOCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 months after completion of duvelisib administration. WOCBP must have a negative pregnancy test within 24 hours of the first dose of duvelisib. - The patient must be willing to comply with fertility requirements as below: - Total abstinence (when this is in line with the usual practice and lifestyle of the patient) will be accepted. Periodic abstinence (i.e., calendar, ovulation, post-ovulation methods) and withdrawals are not acceptable forms - If a female participant is of reproductive potential, the participant (and her partner) must agree to use of one of the following combinations of birth control during the study and for 2 months after the last dose of study drug (or tubal ligation as a single method): - Use of a double-barrier method of contraception: condoms (male or female) and a diaphragm or cervical cap with spermicide; - Use of an IUD and a barrier method: condoms (male or female, with or without spermicide) or a diaphragm or cervical cap with spermicide; - Tubal ligation. - Women who are post-menopausal, defined as age greater than 45 and no menses for at least 24 consecutive months, or who have had a hysterectomy, are considered not of reproductive potential. - Males must agree to using contraception during the study and for 2 months after the last dose of study drug or have undergone a male sterilization procedure (at least 6 months prior to screening. - Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of contraception that comparable efficacy (failure rate <1%). In case of oral contraception, the woman should be stable on the same pill for a minimum of 3 months prior to enrollment on the study. - Patients must agree not to donate blood, sperm/ova or any other organs while taking protocol therapy and for at least 2 weeks after stopping treatment. - Willingness and ability of the patient to comply with scheduled visits, drug administration plan, protocol specified laboratory tests, other study procedures and study restrictions - Evidence of personally signed informed consent indicating that the subject is aware of the life-threatening nature of the disease and has been informed on the procedures to be followed, the experimental nature of the therapy, alternative, potential risks and discomforts, potential benefits and other pertinent aspects of study participation. Exclusion Criteria: - Patients requiring mechanical ventilation (intubation or Bi-PAP) at the time randomization. - Patients receiving any investigational drugs other than drugs or therapies to treat COVID-19, with the exception of investigational immune-modulatory drugs as per section 5.4. - Pregnant women are excluded from this study because duvelisib is agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with duvelisib, breastfeeding should be discontinued before starting study drug and breastfeeding should not be resumed until at least 1 month after last dose of study drug. - Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19 - Known contraindication to duvelisib - Patients with hepatic cirrhosis as defined by symptomatic liver dysfunction; liver fibrosis by biopsy; ALT > 5 times ULN, AST> 5 times ULN, or bilirubin > 3 times ULN. - Patients with autoimmune diseases or patients on chronic immunosuppressive medications at the time of hospital admission or screening. ; PRIMARY OUTCOME: Number of Participants Requiring Mechanical Ventilation or Dying; SECONDARY OUTCOME 1: Days to Recovery[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - JAVELIN PARP MEDLEY; BRIEF: Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC). ; DRUG USED: Bavencio; 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 diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent in adult patients with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC, CRPC, and other advanced solid tumors with a BRCA or ATM gene defect - Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period. - Minimum age in Japan is 20 years. - ECOG performance status 0 or 1. - Resolved acute effects of prior therapy - Adequate bone marrow, renal, and liver function. - Negative serum pregnancy test at screening. - Pregnant, breastfeeding females or female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 30 days after the last dose of avelumab and for at least 7 months after the last dose of talazoparib; fertile male patients must use a condom during treatment and for at least 4 months after the last dose of talazoparib. - Signed and dated informed consent. Exclusion Criteria: - Prior treatment with a PARP inhibitor. - Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2 NSCLC patients prior treatment with anti-PD-1/L1 is allowed - Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis). - Major surgery within 4 weeks prior to study enrollment. - Current use of immunosuppressive medication at the time of study enrollment. - Known prior or suspected hypersensitivity to investigational products. - Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis. - Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. - Prior organ transplantation including allogenic stem-cell transplantation. - Vaccination within 4 weeks of study enrollment and while on trial is prohibited except for administration of inactivated vaccines. - Diagnosis of Myelodysplastic Syndrome. - Patients with known brain metastases requiring steroids. - Participation in other studies involving investigational drug(s) within 4 weeks prior to study participation and/or during study participation. - Persisting toxicity related to prior therapy >Grade 1 - Known HIV or AIDs-related illness. - Positive HBV or HCV test indicating acute or chronic infection. - Active infection requiring systemic therapy. - Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study entry; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication. - Current or anticipated use within 7 days prior to first dose of study drug, or anticipated use during the study of a strong P-gp inhibitor. - Other acute or chronic medical or psychiatric conditions. ; PRIMARY OUTCOME: Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Japanese Adults; BRIEF: The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL, MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI). ; DRUG USED: Recarbrio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Intra-Abdominal Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - requires hospitalization and treatment with IV antibiotic therapy for complicated intraabdominal infection (cIAI) or complicated urinary tract infection (cUTI). Per-protocol diagnostic criteria apply to the qualifying infection types. - infection is known or thought to be caused by microorganisms susceptible to the IV study therapy - baseline specimen for primary infection site culture obtained at operative procedure in Screening period or at Baseline for cIAI participants, and within 48 hours before initiation of IV study drug for cUTI participants - female or male who is not of reproductive potential, or female or male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner from the time of consent through completion of the study, by practicing abstinence from heterosexual activity or using acceptable contraception during heterosexual activity. Exclusion Criteria: - received any amount of effective antibiotic therapy after obtaining the culture for admission to the study and before administration of the first dose of IV study therapy - received treatment with systemic effective antibiotics for >24 hours within the 72 hours before initiation of study therapy - has a concurrent infection, including endocarditis, osteomyelitis, meningitis, or prosthetic joint infection, that would interfere with evaluation of response to IMI/REL - has a cIAI or cUTI due to a confirmed fungal pathogen - has a cUTI that meets any of the following: 1) complete obstruction of any portion of the urinary tract, 2) known ileal loop, 3) intractable vesico-ureteral reflux, 4) presence of indwelling urinary catheter which cannot be removed at study entry - has a cIAI that meets any of the following: 1) infection that should be managed by Staged Abdominal Repair (STAR) or open abdomen therapy, 2) infection limited to the hollow viscus - history of serious allergy, hypersensitivity, or any serious reaction to any carbapenem, cephalosporin, penicillin or other beta-lactam agent, or other beta-lactamase inhibitors - female who is pregnant or is expecting to conceive, is breastfeeding, or plans to breastfeed before completion of the study - history of a seizure disorder - anticipates to be treated with valproic acid, concomitant IV or an oral antimicrobial considered effective to the index pathogen, in addition to the study treatment - is receiving immunosuppressive therapy, including high-dose corticosteroids - is undergoing hemodialysis or peritoneal dialysis - participated in any other clinical study involving an investigational or experimental medication during the previous 30 days before Screening. ; PRIMARY OUTCOME: Percentage of Participants Experiencing ≥1 Adverse Events (AE); SECONDARY OUTCOME 1: Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure 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 - TURANDOT (CECOG; HER2-); BRIEF: First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Central European Cooperative Oncology Group; CRITERIA: Inclusion Criteria 1. Written informed consent obtained prior to any study-specific procedure. 2. Age ≥18 years. 3. Able to comply with the protocol. 4. Histologically or cytologically confirmed, HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent. 5. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2. 6. Life expectancy more than 12 weeks. 7. Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was: - Taxane-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization. - Anthracycline-based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin. 8. Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that: - no more than 30% of marrow-bearing bone was irradiated - the last fraction of radiotherapy was administered ≥ 3 weeks prior to randomization. 9. Adequate left ventricular ejection function (LVEF) at baseline, defined as LVEF ≥ 50% by either echocardiogram or multigated acquisition scan (MUGA). 10. Adequate hematological function - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelet count ≥ 100 x 109/L - Hemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level). 11. Adequate liver function - Total bilirubin ≤ 1.25 x upper normal limit (ULN) - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 x ULN in patients without liver metastases; < 5.0 x ULN in patients with liver metastases. 12. Adequate renal function - Serum creatinine ≤ 1.25 x ULN or calculated creatinine clearance ≥ 50 mL/min. - Urine dipstick for proteinuria < +2. Patients discovered to have ≥ +2 proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours 13. The use of full-dose oral or parenteral anticoagulants is permitted as long as the patient has been on a stable level of anticoagulation for at least two weeks at the time of randomization - Patients on heparin treatment should have a baseline activated partial thromboplastin time (aPTT) between 1.5 - 2.5 times ULN or patients value before starting heparin treatment - Patients on low molecular weight heparins (LMWH) should receive daily dose of 1.5 - 2 mg/kg (of enoxaparin) or appropriate doses of the correspondent anticoagulant, according to package insert - Patients on coumarin derivatives should have an international normalized ratio (INR) between 2.0 and 3.0 assessed at baseline in two consecutive measurements 1-4 days apart - Patients not receiving anticoagulant medication must have an INR ≤ 1.5 and aPTT ≤ 1.5 times ULN within 7 days prior to randomization Exclusion Criteria 1. Previous chemotherapy for metastatic or locally recurrent breast cancer. 2. Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 3 weeks prior to randomization. 3. Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned above). 4. Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix. 5. Pre-existing peripheral neuropathy NCI CTCAE grade > 2 at randomization. 6. Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases (even if previously treated). If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to randomization to rule out spinal / CNS metastases. 7. History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures). 8. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment. 9. Minor surgical procedures, including insertion of an indwelling catheter, within 24 hours prior to randomization. 10. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day). 11. Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids). 12. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. 13. Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg). 14. Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication. 15. Non-healing wound, active peptic ulcer or bone fracture. 16. History of abdominal fistula, or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of randomization. 17. Active infection requiring i.v. antibiotics at randomization. 18. Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. 19. Women of childbearing potential (< 2 years after the last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of study drug. 20. Men who do not agree to use effective contraception during the study and for a period of 6 months following the last administration of study drug. 21. Current or recent (within 28 days of randomization) treatment with another investigational drug or participation in another investigational study 22. Clinically significant malabsorption syndrome or inability to take oral medication. 23. Psychiatric disability judged by the Investigator to be interfering with compliance for oral drug intake. 24. Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine. 25. Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications. 26. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency or prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) 27. Known hypersensitivity to any of the study drugs (including 5-FU) or excipients. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. History of hypersensitivity reactions with drugs formulated in Cremophor® EL (polyoxyethylated castor oil), or previous therapy with bevacizumab. ; PRIMARY OUTCOME: Overall Survival (PP Population); SECONDARY OUTCOME 1: Observation Time (ITT Population)[/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 - EU; BRIEF: The principal aim of this study is to obtain safety and tolerability data when SEN0014196 is administered orally over 12 weeks to male and female patients with Huntingtons Disease. ; DRUG USED: SEN196; DRUG CLASS: New Molecular Entity (NME); INDICATION: Huntingtons Disease; TARGET: SIRT1; THERAPY: Monotherapy; LEAD SPONSOR: Siena Biotech S.p.A.; CRITERIA: Inclusion Criteria: - Genetically confirmed, manifest HD (CAG repeat length ≥ 36) and motor signs of HD (including motor score of the UHDRS ≥ 5). - Clinical Stages I to III (Total Functional Capacity Subscale Score [TFC] of ≥ 3). - Patients must be anticipated to be ambulatory and able to attend outpatient visits for the duration of the study. - Patients must be aged ≥ 30 years and ≤ 70 years. - Body mass index between 18 and 31 kg/m2 inclusive, and a body weight greater than 50 kg. - Patients must be able to give informed consent or have a legal representative who can consent on their behalf. Patients must be able to comply with trial procedures. - Patients must have no clinically significant and relevant medical or psychiatric history that could affect the conduct of the study and evaluation of the data, as ascertained by the Investigator through detailed medical history and screening assessments. - Male patients must agree to use condoms during the entire duration of the study and for 3 months following the last dose of study drug. - Females of childbearing potential (last menses less than 1 year prior to enrolment). Exclusion Criteria: - Participation in a study with an investigational drug within 30 days of the Baseline Visit. - Any prior or concomitant use of Class I or Class II histone deacetylase (HDAC) inhibitors such as Zolinza®/vorinostat or belinostat. - Clinical evidence of significant or unstable medical illness in the Investigators judgement, including screening transaminases (AST or ALT) ≥ 3 times the upper limit of normal (ULN), or an estimated GFR < 60 mL/min, or unexplained proteinuria or microscopic haematuria in an uncontaminated sample obtained at Screening and confirmed on repeat testing. - QTcF interval >450 ms in men and >470 ms in women or PR >220 ms, or other clinically relevant abnormal ECG findings - Women who are pregnant or breastfeeding. - Clinically significant abnormalities in the screening laboratory studies which, in the opinion of the Investigator, would interfere with participation in the study. - Current evidence or history (within 1 year of baseline) of psychosis, hallucinations or delusions, including major depression with psychotic features, as defined in the DSM-IV-TR. Patients currently experiencing mild depression, or moderate depression which is adequately and appropriately treated in the judgment of the Investigator, can participate if depression is not expected to interfere with study participation. - Suicide risk, as determined by meeting any of the following criteria: - A suicide attempt within the past year or suicidal ideation within 60 days of the Baseline Visit (Day 1). - Significant risk of suicide, as judged by the Principal Investigator, based on the psychiatric interview or information collected in the C-SSRS. - Current diagnosis or history (within 1 year of baseline) of any alcohol or substance abuse (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. - Known allergy to any ingredient in the study drug (active and/or placebo). - A history of malignancy of any type within 2 years prior to screening. A history of surgically excised non-melanoma skin cancers is permitted. - Any relevant condition, behaviour, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the patient unsuitable for entry into the study. ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: Short-term clinical effects[/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 - vs. Sorafenib (Korea/Taiwan); BRIEF: This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients ; DRUG USED: Ofev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Fibroblast Growth Factor Receptor (FGFR) , Platelet-derived growth factor receptor (PDGFR), Src Kinase Family, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed, which is not amenable to curative surgery or loco-regional therapy 2. Age 18 years or older 3. Eastern Cooperative Group performance score of 2 or less 4. Child-Pugh score of 7 or less 5. Written informed consent in accordance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) and local legislation Exclusion criteria: 1. Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase II) 2. More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase I) 3. Uncontrolled or refractory ascites to adequate medical therapy 4. Bilirubin greater than 1.5 times upper limit of normal 5. Aspartate amino transferase or alanine amino transferase greater than 5 times upper limit of normal 6. Absolute neutrophil count less than 1500/microliter 7. Platelet count less than 75000/microliter 8. Hemoglobin less than 9 g/dL 9. Serum creatinine greater than 1.5 times upper limit of normal ; PRIMARY OUTCOME: Maximum Tolerated Dose in Phase I; SECONDARY OUTCOME 1: Time to Progression (TTP) in Phase II (Follow-up Analyses)[/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 - 1002 (Single Dose); BRIEF: This research study is being carried out to study a new way to possibly treat human immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases. The CCR5 gene is required for certain types of HIV to enter into and infect T-cells. T cells are one of the white blood cells used by the body to fight HIV. The most important of these are called CD4+ T-cells Some people are born without the CCR5 gene on their T-Cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 genes on their T-cells and their HIV disease is less severe and is slower to cause disease (AIDS). The purpose of this research study is to find out whether SB-728-T is safe to give to humans and find out how this affects HIV. ; DRUG USED: SB-728-T; DRUG CLASS: Biologic; INDICATION: HIV / AIDS; TARGET: Chemokine Receptor 5 (CCR5), Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Sangamo Therapeutics; CRITERIA: Inclusion Criteria: - Documented HIV infection - CD4+ T-cell count >500 cell per millimeter cubed (cells/mm3) - CD4+ T-cell nadir of >400 cells/mm3 - HIV viral load >1,000 copies per milliliter (mL) Exclusion Criteria: - Any viral hepatitis - Acute HIV infection - HIV viral load >1,000,000 copies/mL - Active or recent (prior 6 months) AIDS defining complication - Any HIV medications within the past 12 weeks - Cancer or malignancy that has not been in remission for at least 5 years with the exception of successfully treated basal cell carcinoma of the skin - Current diagnosis of NYHA grade 3 or 4 congestive heart failure or uncontrolled angina or arrhythmias - History of bleeding problems - Use of chronic steroids in past 30 days - Pregnant or breast feeding - Active drug or alcohol abuse - Serious illness in past 30 days - Currently participating in another clinical trail or any prior gene therapy ; PRIMARY OUTCOME: Evaluate the safety and tolerability of SB-728-T cells infusion in HIV-1 positive subjects; SECONDARY OUTCOME 1: Evaluate persistence of HIV as measured by HIV-1 RNA,[/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 - BP29937; BRIEF: This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke. ; DRUG USED: Basmisanil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ischemic Stroke; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Radiologic assessment confirming an acute middle cerebral artery ischemic stroke - Index stroke occurred within the past 3-4 days - Inpatient males and females - Severe hemiparesis or hemiplegia defined by FMMS score less than or equal to (</=) 35 - Sufficient speech, vision and hearing to participate in study evaluations Exclusion Criteria: - NIHSS greater than (>) 20 - Severe aphasia that prevents a participant from following directions in rehabilitation - Significant deficit from prior strokes or pre-existing motor deficit - History of epilepsy, neurosurgery, severe head trauma or central nervous system infections that have residual symptomatology or have required treatment in the last 12 months - Known or suspected clinical seizure post-index stroke - History of pre-existing dementia or use of medications for dementia - History of clinically significant pre-existing psychiatric conditions within 12 months prior to stroke - Due to undergo carotid surgery within the next 4 months - Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 6 times the half-life (whichever is longer) - Clinically relevant medical conditions that would likely interfere with the study conduct and scheduled assessments - Contraindication to magnetic resonance imaging (MRI) or conditions which render interpretation of MRI difficult ; PRIMARY OUTCOME: Change From Baseline in FMMS Score at Day 90; SECONDARY OUTCOME 1: Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90[/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 - FERWON_NEPHRO; BRIEF: Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA). ; DRUG USED: Monoferric; DRUG CLASS: Non-NME; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Independent; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Pharmacosmos A/S; CRITERIA: Inclusion Criteria includes: 1. Men and women, ≥ 18 years 2. Hb ≤ 11 g/dL 3. Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model 4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 % 5. Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation 6. Willingness to participate and signing the informed consent form Exclusion Criteria includes: 1. Anaemia predominantly caused by factors other than IDA 2. Hemochromatosis or other iron storage disorders 3. Previous serious hypersensitivity reactions to any IV iron compounds 4. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy 5. Undergoing dialysis for treatment of CKD 6. Planned surgical procedure within the trial period 7. Decompensated liver cirrhosis or active hepatitis 8. Alcohol or drug abuse within the past 6 month. 9. Pregnant or nursing women. ; PRIMARY OUTCOME: Change in Hemoglobin (Hb) From Baseline to Week 8; SECONDARY OUTCOME 1: Composite Cardiovascular Adverse Events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - Healthy Patients; BRIEF: The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers. The second stage of this study is a prospective, randomized, single-blinded, placebo-controlled study of safety, tolerability, and early efficacy in patients with enteric hyperoxaluria. ; DRUG USED: NOV-001; DRUG CLASS: Biologic; INDICATION: Hyperoxaluria; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Novome Biotechnologies Inc; CRITERIA: Stage 1 Key Inclusion Criteria: - Ages 18 to 55 - Body mass index (BMI) < 38 kg/m2. - Healthy as defined by no clinically relevant abnormalities being identified by a detailed medical history, physical examination, and clinical laboratory tests. - If woman of child-bearing potential, must not be pregnant, and must also agree to use an appropriate highly-effective contraceptive. - Willing and able to comply with all study requirements, including duration of stay at inpatient unit, dietary restrictions, daily study product administration, pregnancy testing and contraception (if applicable), stool collections, and blood and urine collections. Stage 1 Key Exclusion Criteria: - Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 at Screening. - Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of the need for such antibiotics during the Screening or treatment periods of the study. - Current or history of any clinically significant medical illness or disorder the Investigator considers should exclude the subject from the study. - Participation in any investigational intervention study within 30 days prior to study product administration in this study. - Known hypersensitivity to omeprazole. - Applicable only to certain study groups depending on emerging Stage 1 data: no current or anticipated use during the screening or treatment periods of the study of medications that have the potential for drug-drug interactions (DDI) with omeprazole. Stage 2 Key Inclusion Criteria: - Ages 18 to 65. - Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery or to biliopancreatic diversion with duodenal switch (BPD-DS) surgery. - 24-Hour urinary oxalate (UOx) ≥ 60 mg. - If woman of child-bearing potential, must not be pregnant and must also agree to use an appropriate highly effective contraceptive method. - Must, in the opinion of the Investigator, be in otherwise good health. - Willing and able to comply with all study requirements, including dietary restrictions, daily study product administration, pregnancy testing and contraception (if applicable), stool collections, and blood and 24-hour urine collections. Stage 2 Key Exclusion Criteria: - Chronic kidney disease with eGFR < 30 mL/min/1.73 m2 at Screening. - Evidence of current acute renal injury or ongoing clinically significant renal disease. - Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of the need for such antibiotics during the Screening or treatment periods of the study (topical antibiotics are permissible.) - Taking during the study any treatment for hyperoxaluria except for NOV-001, other than stable treatments for the management of kidney stones. - Taking Vitamin C ≥ 300 mg/day for > 10 days within 7 days prior to Screening; unwilling or unable to discontinue and/or avoid Vitamin C supplementation for the duration of study product treatment. - Known active autoimmune disorder or other condition requiring high dose of systemic corticosteroids (i.e., > 10 mg/day prednisone or equivalent) or other immunosuppressant therapy. - Current or history of any clinically significant medical illness or disorder other than enteric hyperoxaluria that the Investigator considers should exclude the patient from the study. - Participation in any investigational intervention study within 30 days prior to study product administration in this study. - Known hypersensitivity to omeprazole. ; PRIMARY OUTCOME: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - PURSUE; BRIEF: An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy ; DRUG USED: Axumin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer - Imaging; TARGET: Radiopharmaceutical, Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Blue Earth Diagnostics; CRITERIA: Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 2. Previous history of solid tumor brain metastasis of any origin 3. Histopathological confirmation of the primary solid tumor or a metastatic site 4. Previous radiation therapy of brain metastatic lesion(s) 5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis 6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for craniotomy Exclusion Criteria: 1. Patients with a history of active hematological malignancy ; PRIMARY OUTCOME: Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds; SECONDARY OUTCOME 1: Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - E4Relief (Chiltern); BRIEF: This dose-finding study is being conducted to select the daily oral dose of estetrol (E4) for the treatment of vasomotor symptoms (VMS) in post-menopausal women. ; DRUG USED: Donesta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Menopause (including Hormone Replacement Therapy [HRT]); TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Donesta Bioscience; CRITERIA: Inclusion Criteria: - Women presenting at least 7 moderate to severe hot flushes/day or at least 50 moderate to severe hot flushes/week in the week preceding randomization. - Body Mass Index (BMI) between 18.0 and 35.0 kg/m², inclusive. - Post-menopausal status. - Intact uterus. - Negative pregnancy test. - Good physical and mental health. - Subject has provided signed and dated written informed consent before admission to the study. - Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions. Exclusion Criteria: - Uterine disease or any medical conditions associated with an increase in endometrial thickness. - Any history of malignancy with the exception of basal cell (excluded if within the prior 2 years) or squamous cell (excluded if within the prior one year) carcinoma of the skin. Any clinically significant findings at the breast examination and/or on mammography suspicious of breast malignancy that would require additional clinical testing to rule out breast cancer. - Abnormal cervical Pap smear. - Systolic blood pressure (BP) outside the range 90 to 140 mmHg, diastolic BP outside the range 60 to 90 mmHg, and/or heart rate outside the range 40 to 100 bpm. - Any clinically significant abnormality identified on the screening 12-lead ECG. - History of venous or arterial thromboembolic disease, history of known coagulopathy or abnormal coagulation factors. - Diabetes mellitus with poor glycaemic control. - Dyslipoproteinaemia at screening. - Smoking >10 cigarettes/day. - Presence or history of gallbladder disease, unless cholecystectomy has been performed. - Systemic lupus erythematosus. - Multiple sclerosis. - Acute or chronic liver disease. - Acute or chronic renal impairment. - Uncontrolled thyroid disorders. - Use of oestrogen or progestin containing drug(s). - Use of non-hormonal treatments to reduce hot flushes. - History or presence of allergy or intolerance to any component of the investigational product. - History of alcohol or substance abuse or dependence in the 12 months before screening as determined by the Investigator. - Sponsor, CRO or Investigators site personnel or their relatives directly affiliated with this study. - Subjects with known or suspected history of a clinically significant systemic diseases, unstable medical disorders, life-threatening disease or current malignancies that would pose a risk to the subject in the opinion of the Investigator. - Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last 3 months (90 days) prior to study entry. - Is judged by the Investigator to be unsuitable for any reason. ; PRIMARY OUTCOME: Change in weekly frequency of moderate to severe VMS from baseline to week 4.; SECONDARY OUTCOME 1: Change from baseline to week 12 in genitourinary symptoms (GSM) of menopause[/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/Metformin IR; BRIEF: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control ; DRUG USED: Kombiglyze XR; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK), Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Subjects with type 2 diabetes mellitus; 2. HbA1c ≥8% but ≤12%; 3.Fasting C-peptide ≥1.0 ng/ml; 4. Subject will be drug naïve; 5. Body mass index ≤40 kg/m2. Exclusion Criteria: 1. Symptoms of poorly controlled diabetes; 2. Chronic or repeated intermittent corticosteroid treatment ; 3. Calculated creatinine clearance <60 ml/min or serum creatinine >132.6 μmol/L (>1.5 mg/dL) for men, >123.8 μmol/L (>1.4 mg/dL) for women; 4. Creatine Kinase ≥3x ULN; 5.Abnormal TSH value at screening will be further evaluated by free T4, subjects with an abnormal free T4 will be excluded; 6. History of administration of any antihyperglycaemic therapy for a total of 28 days or for more than three consecutive days or a total of seven non-consecutive days during the eight weeks prior to screening; 7. Current treatment with a strong CYP3A4/5 inhibitor; 8. Prior treatment with saxagliptin or any DPP-4 inhibitor; 9. Significant or history of cardiovascular disease, renal disease, psychiatric disorders, Immunocompromised individuals, hemoglobinopathies, liver disease, Pancreatitis. ; PRIMARY OUTCOME: Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue; SECONDARY OUTCOME 1: Glycemic Response Defined as HbA1c < 7.0% at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CXA-cUTI-10-04 - vs. Levofloxacin; BRIEF: This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis). ; DRUG USED: Zerbaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Inclusion Criteria: 1. Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines). 2. Be males or females ≥ 18 years of age 3. If female, subject is non-lactating, and is either: 1. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or 2. Of childbearing potential and is practicing a barrier method of birth control (e.g., a diaphragm or contraceptive sponge) along with 1 of the following methods: oral or parenteral contraceptives (for 3 months prior to study drug administration), or a vasectomized partner. Or, subject is practicing abstinence from sexual intercourse. Subjects must be willing to practice these methods for the duration of the trial and for at least 35 days after last dose of study medication. 4. Males are required to practice reliable birth control methods (condom or other barrier device) during the conduct of the study and for at least 35 days after last dose of study medication. 5. Pyuria (white blood cell [WBC] count > 10/μL in unspun urine or ≥ 10 per high power field in spun urine). 6. Clinical signs and/or symptoms of cUTI, either of: 1. Pyelonephritis, as indicated by at least 2 of the following: - Documented fever (oral temperature > 38°C) accompanied by patient symptoms of rigors, chills, or warmth; - Flank pain; - Costovertebral angle tenderness or suprapubic tenderness on physical exam; or - nausea or vomiting; OR 2. Complicated lower UTI, as indicated by at least 2 of the following: - At least 2 of the following new or worsening symptoms of cUTI: - Dysuria; urinary frequency or urinary urgency; - Documented fever (oral temperature > 38°C) accompanied by patient symptoms of rigors, chills, or warmth; - Suprapubic pain or flank pain; - Costovertebral angle tenderness or suprapubic tenderness on physical exam; or - Nausea or vomiting; plus, - At least 1 of the following complicating factors: - Males with documented history of urinary retention; - Indwelling urinary catheter that is scheduled to be removed during IV study therapy and before the EOT; - Current obstructive uropathy that is scheduled to be medically or surgically relieved during IV study therapy and before the EOT; or - Any functional or anatomical abnormality of the urogenital tract (including anatomic malformations or neurogenic bladder) with voiding disturbance resulting in at least 100 mL residual urine. 7. Have a pretreatment baseline urine culture specimen obtained within 24 hours before the start of administration of the first dose of study drug. NOTE: Subjects may be enrolled in this study and start IV study drug therapy before the Investigator knows the results of the baseline urine culture. 8. Require IV antibacterial therapy for the treatment of the presumed cUTI. Exclusion Criteria: 1. Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam or quinilone antibacterial (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment) 2. Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e.g., vancomycin, linezolid] are allowed.) 3. Receipt of any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug. 4. Receipt of any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the study-qualifying pretreatment baseline urine is obtained (exceptions: subjects with an active cUTI who have received prior antibiotics may be enrolled provided a minimum of 48 hours have elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for cUTI who present with signs and symptoms consistent with an active new cUTI may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture). 5. Intractable urinary infection at baseline that the Investigator anticipates would require more than 7 days of study drug therapy. 6. Complete, permanent obstruction of the urinary tract. 7. Confirmed fungal urinary tract infection at time of randomization (with ≥ 103 fungal CFU/mL). 8. Permanent indwelling bladder catheter or urinary stent including nephrostomy. 9. Suspected or confirmed perinephric or intrarenal abscess. 10. Suspected or confirmed prostatitis. 11. Ileal loop or known vesico-ureteral reflux. 12. Severe impairment of renal function including an estimated CrCl < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours). 13. Current urinary catheter that is not scheduled to be removed before the EOT (intermittent straight catheterization during the IV study drug administration period is acceptable). 14. Any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data. 15. Any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, and septic shock. 16. Immunocompromising condition, including established AIDS, hematological malignancy, or bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, or the administration of corticosteroids equivalent to or greater than 40 mg of prednisone per day administered continuously for more than 14 days preceding randomization. 17. One or more of the following laboratory abnormalities in baseline specimens: aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase, or total bilirubin level greater than 3 times the upper limit of normal (ULN), absolute neutrophil count less than 500/μL, platelet count less than 40,000/μL, or hematocrit less than 20%. 18. Participation in any clinical study of an investigational product within 30 days prior to the proposed first day of study drug. 19. Previous participation in any study of CXA-101 or CXA-201. 20. Women who are pregnant or nursing. ; PRIMARY OUTCOME: The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population; SECONDARY OUTCOME 1: The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.[/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 - 01; BRIEF: The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors ; DRUG USED: HuMax-AXL ADC; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Antibody-drug Conjugate (ADC), Axl Receptor Tyrosine Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Genmab; CRITERIA: Inclusion Criteria: 1. For the dose escalation part: Patients with selected, relapsed or refractory solid tumors who have failed available standard therapy or who are not candidates for standard therapy. For the expansion part: Patients with advanced and/or metastatic solid tumors who are not candidates for standard therapy 2. Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST). 3. For the expansion patients must provide a tumor tissue sample from archival tissue or fresh biopsy at enrolment 4. Age ≥ 18 years. 5. Acceptable renal function 6. Acceptable liver function 7. Acceptable hematological status 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 9. Life expectancy of at least three months. 10. Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last infusion of HuMax-AXL-ADC 11. Patients must provide a signed informed consent form before any trial relates activities are carried out. Exclusion Criteria: 1. Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 4 weeks prior to first IMP administration. 2. Have clinically significant cardiac disease 3. Known congestive heart failure and/ or a known decreased cardiac ejection fraction of < 45%. A baseline QT interval as corrected by Fridericias formula (QTcF) > 480 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block. 4. Uncontrolled hypertension 5. Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first IMP administration. 6. Have received a cumulative dose of corticosteroid > 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first Investigational Medicinal Product (IMP) administration. 7. History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial. 8. Major surgery within four weeks before first IMP administration. 9. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke. 10. Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within five half-lives but maximum four weeks before first infusion. Accepted exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist. 11. Prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. 12. Radiotherapy within 14 days prior to first IMP administration. 13. Known past or current malignancy other than inclusion diagnosis, except for: - Cervical carcinoma of Stage 1B or less. - Non-invasive basal cell or squamous cell skin carcinoma. - Non-invasive, superficial bladder cancer. - Prostate cancer with a current prostate specific antigen (PSA) level < 0.1 ng/mL. - Breast cancer in BRCA1 or BRCA2 positive ovarian cancer patients. - Any curable cancer with a complete response (CR) of > 2 years duration. 14. Melanoma patients with an lactate dehydrogenase (LDH) ≥ 3 x upper limit normal (ULN). 15. Ongoing significant, uncontrolled medical condition including: o Serious, non-healing wound, skin ulcer (of any grade), or bone fracture. 16. Grade 2 or higher peripheral neuropathy. 17. Clinically significant active viral, bacterial or fungal infection 18. Known human immunodeficiency virus seropositivity. 19. Known positive serology for hepatitis B (unless due to vaccination or passive immunization due to immunoglobulin therapy) 20. Known positive serology for hepatitis C (unless due to immunoglobulin therapy) 21. Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the trial or evaluation of the trial result 22. History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of IMP 23. Body weight < 40 kg 24. Women who are pregnant or breast feeding. 25. Pulmonary hemorrhage or hemoptysis > 2.5 ml blood within 6 weeks unless cause has been addressed and is medically resolved. 26. History of acute pneumonitis. ; PRIMARY OUTCOME: Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part; SECONDARY OUTCOME 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part[/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 - KTN23106; BRIEF: The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma. ; DRUG USED: Karenitecin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: BioNumerik Pharmaceuticals, Inc.; CRITERIA: - Confirmed diagnosis of malignant melanoma - Measurable disease - Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN - No prior treatment with other camptothecin drug. - ≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C - ECOG Performance Status 0-1 - Negative pregnancy test for female patients ; PRIMARY OUTCOME: Overall Response; SECONDARY OUTCOME 1: Objective Tumor Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PRONTO-T1D; BRIEF: The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D). ; DRUG USED: Lyumjev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year. - HbA1c of ≥7.0 and ≤9.5%. - Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin. - Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin. Exclusion Criteria: - Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening. - Have had more than 1 severe hypoglycemic episode within 6 months of screening. - Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening. - Have clinically significant gastrointestinal disease. ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26; SECONDARY OUTCOME 1: Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26[/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 - RESOLUTE; BRIEF: The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). Participants will be treated in sequential, dose-level cohorts. ; DRUG USED: SPK-3006; DRUG CLASS: Biologic; INDICATION: Pompe Disease; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Spark Therapeutics; CRITERIA: Inclusion Criteria: - Provide written informed consent; - Males and Females ≥18 years of age with late-onset Pompe disease; - Received ERT for at least the previous 24 months - Have clinically moderate, late-onset Pompe disease characteristics; - Agree to use reliable contraception. Exclusion Criteria: - Active hepatitis B and/or C; - Significant underlying liver disease; - Human immunodeficiency virus (HIV) infection; - Prior hypersensitivity to rhGAA; - Pre-existing anti-AAV neutralizing antibody titers; - High titer antibody responses to rhGAA; - Requires any invasive ventilation or requires noninvasive ventilation while awake and upright; - Received any prior vector or gene transfer agent; - Active malignancy (except non-melanoma skin cancer); - History of liver cancer; - Pregnant or nursing women; - Any evidence of active infection at the time of SPK-3006 infusion. ; PRIMARY OUTCOME: Number of adverse and serious adverse events (AEs/SAEs), including clinically significant abnormal laboratory values.; 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 - PRO-SID; BRIEF: Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia ; DRUG USED: Panzyga; DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Octapharma; CRITERIA: Inclusion Criteria: 1. Treatment-naïve or relapsed/refractory CLL patients undergoing CLL antineoplastic treatment. Diagnosis of B-cell CLL established according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and documented within medical records. 2. Hypogammaglobulinemia (IgG levels <5 g/L) as confirmed by the Central Laboratory. 3. ≥18 years of age. 4. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted. Exclusion Criteria: 1. IgG treatment within 3 months prior to Screening. 2. Antibiotic prophylaxis and/or treatment within 7 days prior to Baseline (with the exception of trimethoprim-sulfamethoxazole [TMP/SMX], diaminodiphenyl sulfone [dapsone] and pentamidine inhalation). 3. Current major infection or >1 major infection in the previous 6 months before Baseline. 4. History of anaphylaxis or severe systemic response to immunoglobulin, blood or plasma-derived products or any Panzyga component. 5. History of a non-CLL malignancy or other medical condition with life-expectancy of less than two years. 6. Severe liver disease, with signs of ascites and/or hepatic encephalopathy. 7. Severe kidney disease (as defined by estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2). 8. Body weight >140 kg. 9. Eastern Cooperative Oncology Group (ECOG) performance score of >2 (Appendix 1). 10. Female patients of childbearing potential unwilling to use a protocol-required method of contraception (as per protocol section 7.3.9 b) from the Screening Visit throughout the study treatment period and for 30 days following the last dose of study drug. 11. Human immunodeficiency virus (HIV) infection at Screening (defined for the study as positive HIV antibody test). 12. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while undergoing CLL therapy, and patients with active HBV, defined as high HBV titers. 13. Uncontrolled hepatitis C infection at Screening (defined for the study as positive hepatitis virus C [HCV] polymerase chain reaction [PCR]). 14. Pregnant and lactating women. 15. Subjects with a history of thromboembolic events (TEE) such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV) within 6 months before Baseline. 16. Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids) or other forbidden medication during the entire study duration after study enrollment. 17. Participation in another interventional clinical trial that is either blinded or involves an investigational (not approved) product within 3 months before Baseline or during the course of the clinical study. Participation in observational clinical trials or open-label trials involving an approved product may be permitted after consultation with the medical monitor. 18. Known IgA deficiency with antibodies to IgA. 19. Known blood hyperviscosity, or other hypercoagulable states. 20. Patients unable or unwilling to understand or comply with the study protocol. ; PRIMARY OUTCOME: Occurrence of major infections; SECONDARY OUTCOME 1: Overall infection rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Case Western Reserve University (TRAILBLAZER); BRIEF: A Comparative Study of Autologous CD4+ T Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 versus ex vivo Expanded Unmodified Autologous CD4+ T Cells in Treated HIV-1 Infected Subjects ; DRUG USED: SB-728-T; DRUG CLASS: Biologic; INDICATION: HIV / AIDS; TARGET: Chemokine Receptor 5 (CCR5), Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: University of Cincinnati; CRITERIA: Inclusion Criteria: 1. Written informed consent signed and dated by study subject. 2. Men or women, including trans men or women, ≥18 and ≤70 years of age. 3. For persons born male who have not been surgically sterilized, willingness to abstain from sexual activity that could result in conception for 90 days after the cyclophosphamide administration visit. 4. HIV-1 infection, documented by any FDA-approved ELISA, EIA, or rapid antibody detection method, and confirmed by a second FDA-approved antibody-based test or by a positive FDA-approved HIV RNA detection assay. FDA-approved HIV-1 RNA detection assay alone constitutes proof of HIV-1 infection assuming there is documentation of >199 copies/mL of HIV-1 RNA in the absence of antiretroviral therapy. 5. Adequate venous access for leukapheresis, as documented by standard clinical procedures at each site. 6. The following laboratory values at screening: 1. Absolute neutrophil count (ANC) > 1500/mm3 2. Hemoglobin level ≥11 g/dL 3. Platelet count ≥150,000/mm3 4. Serum creatinine <1.5 mg/dL 5. AST and ALT ≤2.5 times the upper limit of normal 6. CD4+ T cell count > 350 cells/mm3 7. HIV-1 RNA <50 copies/mL performed with an ultrasensitive HIV-1 PCR assay. 8. Urine red blood cell (RBC) counts within the normal range used by each institution. 9. INR ≤1.5 and PTT ≤2xULN 7. Willing to comply with study-mandated evaluations. 8. All participants must have received combination antiretroviral therapy, and had plasma HIV RNA levels <50 copies/mL for at least 48 weeks. Subjects who had intermittent isolated episodes of detectable low-level viremia <500 copies RNA/mL flanked by values <50 copies/mL will remain eligible. 9. On stable antiretroviral medication (no changes to treatment and no missed dose for >7 continuous days within 4 weeks of screening) and willing to continue on current antiretroviral therapy, unless a change is medically indicated, for the duration of the study. Note: Changes in formulation or a single within-class, single-agent change are permitted in the last 48 weeks but not within 12 weeks of study entry. Exclusion Criteria: 1. Women and persons born female regardless of gender identity with childbearing potential. These participants are considered to be of childbearing potential if they are postmenarchial, have an intact uterus and at least one ovary, and have had at least one menstrual period in the past two years. Participants who have had a documented bilateral tubal ligation or a hysterectomy are not considered to be of childbearing potential. 2. Previous gene therapy using an integrating vector. NOTE: For the purposes of the TRAILBLAZER protocol, only therapies that a) are expected to modify the host genome durably or broadly, and b) are delivered using a vector defined by FDA as having a propensity for integration or the potential for latency/reactivation meet this exclusion criterion. The following are examples of products and vectors that DO NOT meet this exclusion criteria: - Plasmid DNA products - RNA products - Poxvirus-vectored products - Adenovirus-vectored products - Replication-negative adeno-associated virus-vectored products - Prophylactic or therapeutic HIV vaccines that use one of these delivery mechanisms 3. Allergy or hypersensitivity to study product excipients (human serum albumin, DMSO and Dextran 40). 4. An antiretroviral regimen including maraviroc or any CCR5 inhibitor within 4 weeks prior to screening. Presence or absence of the following exclusion criteria will be assessed at screening, but participants who develop any of these criteria at any time between screening and the planned infusion time will be excluded: 5. Acute or chronic hepatitis C infection, defined as a positive plasma HCV RNA using any FDA-approved qualitative or quantitative test in a participant with a positive HCV antibody (HCV RNA testing is not required in participants with a negative HCV antibody) at screening. Participants who have completed a course of antiviral treatment for hepatitis C and have a confirmed plasma HCV RNA level below the limit of detection of the assay 12 weeks or longer after completion of therapy will be eligible. Note: Individuals that have undetectable HCV RNA in the absence of treatment that cleared infection spontaneously are also considered eligible to participate. 6. Acute or chronic hepatitis B infection, defined as a positive HBV surface antigen or a positive HBV DNA at screening. 7. Any prior AIDS-defining condition within the past 5 years, except a history of CD4+ T cell count below 200 cells/mm3. NOTE: The terms AIDS encephalopathy and wasting syndrome are often recorded on medical records to indicate constellations of signs and symptoms that may not formally meet the current diagnostic criteria for AIDS-related dementia or AIDS-associated wasting syndrome, respectively. Therefore, the principal investigators will determine whether in their opinion, a reported history of these conditions truly corresponds to an AIDS-defining syndrome meeting this criterion. 8. Any active cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low-grade (0 or 1) anal or cervical intraepithelial neoplasia. 9. Diagnosis of New York Heart Association (NYHA) grade 3 or 4 congestive heart failure, uncontrolled angina or uncontrolled arrhythmias. 10. Corrected QT interval (QTc) >470 msec (by any formula). 11. History or any features on physical examination indicative of a bleeding diathesis. 12. Use of chronic corticosteroids, hydroxyurea, or immune-modulating agents (e.g., interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to screening or for any period extending to within 30 days prior to the planned infusion date. NOTE: Use of inhaled or topical steroids is not exclusionary. 13. Breastfeeding or pregnant. 14. Continued need for use of aspirin, warfarin or any other medication likely to affect platelet function or other aspects of blood coagulation significantly that cannot be held during the 7-day period prior to each of the leukapheresis procedures (or tissue/CSF sampling procedures for participating subjects) or that maintains biological activity beyond 7 days after discontinuation. 15. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. 16. Presence at screening of a serious and persistent illness requiring a new systemic treatment expected to last beyond the planned date of infusion and/or hospitalization within 30 days prior to the planned date of infusion. NOTE: A participant who has required a hospital admission within the 30 days prior to infusion may be allowed to proceed if, in the judgement of the principal investigators, the condition requiring admission has resolved completely and is not expected to recur or worsen during study participation. Examples include scenarios such as: a removed kidney stone; inpatient hydration for food poisoning; observation for atypical chest pain; a minor traumatic injury; etc. 17. Planned or actual vaccine administration within 4 weeks prior to infusion. Note: Receipt of a COVID-19 vaccine authorized under an FDA EUA, in general, should not disqualify potential participants. Vaccination should be avoided in the 4 weeks prior to and after the administration of cyclophosphamide. In addition, vaccination should be avoided 2 weeks prior to study leukapheresis or large volume blood draw. 18. Intercurrent illness that in the opinion of the investigator may compromise the safety of the participant or interfere with study objectives. 19. Current use of zidovudine within 30 days of planned infusion of cyclophosphamide. 20. Current active chronic liver disease (e.g., cirrhosis or non-alcoholic steatohepatitis) within 30 days of study enrollment. Note: In addition, for the purpose of the TRAILBLAZER clinical trial, chronic active liver disease means a confirmed diagnosis of cirrhosis of the liver or non-alcoholic steatohepatitis with elevated liver transaminases (confirmed) above the upper limit of normal. The presence of fat (steatosis or NAFLD) in the liver by imaging (in the absence of indication of disease, e.g., elevated transaminases) is not a contraindication to enrollment in the trial. Individuals diagnosed with fatty liver disease that have normal transaminases may be permitted to enroll in the study. The use of FDA approved medications to treat chronic fatty liver disease is a contraindication to enrollment. The use of non-FDA approved interventions, vitamins or supplements is not a contraindication to enrollment. 21. A history of urinary outflow obstruction as documented by a history of enlarged prostate on physical exam, use of medications to treat outflow obstruction (e.g., tamsulosin), or elevated urinary residual volume. Note: urinary outflow obstruction is defined as requiring placement of a drainage catheter to relieve a urinary obstruction. Documented enlargement of the prostate in the absence of urinary obstruction is not a contraindication to enrollment in the trial. The use of FDA approved medications to treat urinary frequency (e.g., tamsulosin) in the absence of proven urinary obstruction is not a contraindication to enrollment. 22. A history of active or latent tuberculosis, regardless of treatment history. 23. Individuals with limited antiretroviral treatment options (less than 2 new classes) by history because of prior known resistance mutations to antiretrovirals. Note: Investigators should consider prior treatment history for HIV and known resistance mutations to ensure that a potential participant has an acceptable alternative treatment regimen should they develop treatment failure while on study. 24. Inability, in the opinion of the investigator, to avoid potential exposure to Covid-19 in the two weeks after the receipt of cyclophosphamide. Note: Participants may go out into public to conduct essential activities but will be strongly encouraged to wear a mask, use appropriate social distancing and hand hygiene when going outside their home during that 14 day interval. 25. Any other condition that, in the opinion of the clinical investigator or sponsor, might compromise any aspect of this trial. For participants in the rectosigmoid biopsy program only: 1. Major GI tract surgery within 45 days prior to the planned date of the baseline visit. Minor procedures involving only the anal canal such as condyloma ablations, hemorrhoidectomy, and anoscopy are permitted if cleared by the responsible surgeon. 2. Abnormalities of the colorectal mucosa, or significant colorectal symptoms, which in the opinion of the clinician represent a contraindication to biopsy (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa). For participants in the lymph node biopsy program at sites doing open biopsies only: 1. BMI greater than 35 at screening. 2. Anatomical condition that would prevent surgical access to either inguinal area, such as scar tissue, active skin condition affecting the area, or foreign material. 3. Known hypersensitivity to local anesthetic agents. 4. Contraindication for the use of epinephrine-containing local anesthetic formulations. 5. Presence of pacemaker, implantable defibrillator, or other medical device thought to be susceptible to electromagnetic interference from electrocautery. For participants in the lymph node biopsy program at sites doing lymph node aspirates only: 1. Anatomical condition that would prevent surgical access to either inguinal area, such as scar tissue, active skin condition affecting the area, or foreign material. 2. Known hypersensitivity to local anesthetic agents. 3. Contraindication for the use of epinephrine-containing local anesthetic formulations. For participants in the CSF sampling program only: 1. Any condition that could prevent access to the subarachnoid space or obscure the anatomical landmarks for lumbar puncture, such as scar tissue, active skin condition affecting the area, or foreign material. 2. Known hypersensitivity to local anesthetic agents. 3. Known space-occupying central nervous system lesion, unless cleared by the treating physician. ; PRIMARY OUTCOME: Difference in the magnitude of change in intact provirus from before infusion to 96 weeks after infusion between the two study arms.; SECONDARY OUTCOME 1: Difference in the magnitude of change in intact provirus from before infusion to 48 weeks after infusion between the two study arms.[/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 - 12 Weeks; BRIEF: Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with potentially life-threatening bleeding. This study will evaluate the safety and recommended (best) amount or level of Factor XIII in a patients blood. Factor XIII Concentrate (Human) is given to people whose blood is lacking Factor XIII. Factor XIII Concentrate (Human) works by assisting your blood in the usual clotting process, thereby preventing bleeding. ; DRUG USED: Corifact; DRUG CLASS: Biologic; INDICATION: Factor XIII Deficiency; TARGET: Fibrin (Coagulation Factor Ia) ; THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Written informed consent/assent for study participation obtained before undergoing any study-specific procedures - Documented congenital FXIII deficiency that requires prophylactic treatment with a FXIII containing product. - Males and females of any age with congenital FXIII deficiency. - Received full hepatitis B vaccination and/or is hepatitis B surface antibody positive Exclusion Criteria: - Diagnosis of acquired FXIII deficiency - Administration of a FXIII-containing product, including blood transfusions or other blood products within 4 weeks prior to the planned Day 0 - Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency - Known or suspected to have antibodies towards FXIII - Use of any other investigational medicinal product within 4 weeks prior to the Baseline Visit (Day 0) - Positive result at screening for human immunodeficiency virus (HIV) - Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration >2.5 times the upper limit of normal - Fibrinogen < lower limit of normal - Active bleeding - Pregnant or breast-feeding - Intention to become pregnant during the course of the study - Female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study - Surgical procedure anticipated during the study period - Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance ; PRIMARY OUTCOME: Peak FXIII Concentration at Steady State; SECONDARY OUTCOME 1: Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - CBSDH; BRIEF: Homocystinuria caused by Cystathionine Beta-Synthase (CBS) Deficiency is a rare autosomal-recessive metabolic condition characterized by an excess of homocysteine (Hcy) in the plasma, tissues and urine. It is due to reduced or absent activity of the CBS enzyme, and is also known as classical homocystinuria. The symptoms associated with homocystinuria are variable in severity and time of onset across patients. Some affected individuals may have mild signs of the disorder; others may have multi-systemic involvement including potentially life-threatening complications. Homocystinuria can affect many different organ systems of the body; the four most commonly involved are the eyes, central nervous system, skeleton, and the vascular system. The current approaches to treatment of homocystinuria patients include a highly restrictive diet and use of dietary supplements. Lifetime compliance with this diet is poor. Pegtibatinase (TVT-058) represents a novel therapeutic approach that incorporates the use of a modified version of the native, human CBS (hCBS) enzyme. The goal of treatment is to introduce the CBS enzyme into circulation, resulting in reduced Hcy levels, increased cystathionine (Cth) and cysteine (Cys) levels. ; DRUG USED: TVT-058; DRUG CLASS: Biologic; INDICATION: Homocystinuria; TARGET: Cystathionine beta-synthase (CBS), Homocysteine; THERAPY: Monotherapy; LEAD SPONSOR: Travere Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of homocystinuria based on genetic confirmation and plasma tHcy ≥50 micromoles and documentation of previous tHcy level ≥80 micromoles - Willing and able to provide written, signed informed consent and to comply with all study related procedures. - Subjects born biologically as female who are of child-bearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. Subjects born biologically as male who identify as female and are not of childbearing potential are not required to undergo pregnancy tests - Sexually active subjects who have childbearing potential or those who have partners of childbearing potential must be willing to use acceptable methods of contraception while on the study and for 4 weeks after the end of study - Willing to maintain a stable diet with no significant modifications while on study and complete a daily diet diary. Exclusion Criteria: - Previous exposure to pegtibatinase and/or previous participation in a clinical trial that included administration of pegtibatinase - Use of any investigational product or investigational medical device within 30 days prior to Screening, or while on study - Use or planned use of any injectable drugs containing PEG (other than pegtibatinase or COVID-19 vaccines), including medroxyprogesterone (eg, Depo-Provera) injection, within 3 months prior to Screening and during study participation - Known hypersensitivity to PEG-containing product or any components of pegtibatinase - A positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody - A history of organ transplantation, chronic immunosuppressive therapy, or substance abuse - Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) or to breastfeed at any time during the study - Concurrent disease or condition or planned major surgery that would interfere with study participation or safety in the opinion of the investigator. - Any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study - Major surgery planned during the study period ; PRIMARY OUTCOME: Incidence of AEs; SECONDARY OUTCOME 1: Changes in pegtibatinase 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 - HIV/HCV; BRIEF: The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug. ; DRUG USED: Incivek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (>) 1000 international units per milliliter (IU/mL) - Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse - Population B: Peg-IFN/RBV prior null or partial responder - Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration - Participant must have positive HIV antibody at Screening - Participant must have a diagnosis of HIV-1 infection >6 months before Screening - Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening: - Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine) - Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components - Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components - Boosted atazanavir plus Epzicom®, or equivalent components - Raltegravir plus Truvada®, or equivalent components - Raltegravir plus Epzicom®, or equivalent components - Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol - Laboratory values within acceptable ranges at Screening as specified in the protocol Exclusion Criteria: - Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1 - Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides - Contraindications to any planned HAART component as per the respective drug labeling information - Contraindications to Peg-IFN or RBV - Evidence of hepatic decompensation - Clinical suspicion of acute hepatitis - Any other cause of liver disease in addition to hepatitis C - History of organ transplantation (except cornea and skin) - Autoimmune-mediated disease - Participated in any investigational drug study within 90 days before Day 1 - Previous treatment with an HCV protease inhibitor ; PRIMARY OUTCOME: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - B-cell Lymphomas (w/Imbruvica); BRIEF: The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies. ; DRUG USED: Ublituximab; DRUG CLASS: Biologic; INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: TG Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed. - Refractory to or relapsed after at least 1 prior treatment regimen - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: - Any major surgery, chemotherapy or immunotherapy within the last 21 days - Known hepatitis B virus, hepatitis C virus or HIV infection - Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded. - Richters transformation, prolymphocytic leukemia or primary central nervous system lymphoma ; PRIMARY OUTCOME: To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies; SECONDARY OUTCOME 1: Overall Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - MMPOWER; BRIEF: Phase 1/2, multi-center, randomized, double-blind, multiple ascending dose, placebo-controlled study that enrolled 36 subjects with mitochondrial myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient population. ; DRUG USED: Elamipretide (Systemic Delivery); DRUG CLASS: New Molecular Entity (NME); INDICATION: Mitochondrial Respiratory-Chain Diseases; TARGET: Mitochondria, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Stealth BioTherapeutics Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of mitochondrial disease believed to impair the mitochondrial respiratory chain. - Eligibility requires prior genetic confirmation of mitochondrial disease. - Diagnosis of mitochondrial myopathy judged by the Investigators to be due to existing mitochondrial disease. - Must be able to complete a Screening Visit 6MWT. - Body mass index (BMI) score >15.0 and <35.0 kg/m2 at Screening Visit. - Women of childbearing potential must agree to use birth control as specified in the protocol from the date they sign the ICF until two months after the last dose of study drug. Exclusion Criteria: - Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements. - Had any exclusionary Newcastle Mitochondrial Disease Adult Scale (NMDAS) scores at Screening Visit. - Hospitalized (admitted as in-patient) within 1 month prior to the Baseline Visit. - A history of type 1 diabetes mellitus (T1DM). - Uncontrolled Type 1 (T1DM) or Type 2 diabetes mellitus (T2DM), in the opinion of the investigator. - A creatinine clearance <45 mL/min as calculated by the Cockcroft Gault equation. - Requires pacemaker, defibrillator, or has undergone cardiac surgery within 2 years of Screening Visit. - QTc elongation defined as a QTc >450 msec in male subjects and >480 msec in female subjects. - Uncontrolled hypertension (>160 mmHg systolic or >100 mmHg diastolic) at Screening Visit. - History of rhabdomyolysis defined as an acute rise in the serum creatine phosphokinase (CPK) value that, in the opinion of the investigator, caused clinically significant symptoms. - Serum sodium more than 5 meq/L below the reference lower limit of normal at Screening Visit. - Participated in another interventional clinical trial within 3 months of the screening visit or is currently enrolled in a non-interventional clinical trial judged by the Investigator to be incompatible with the current trial. - Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Change in Distance Walked (Meters) on the 6-minute Walk Test (6MWT); SECONDARY OUTCOME 1: Change in Maximum Oxygen Uptake (ml/kg/Min)[/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 - Advanced Malignancies; BRIEF: The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3). ; DRUG USED: Pemazyre; DRUG CLASS: New Molecular Entity (NME); INDICATION: Biliary Tract Cancer; TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: 1. Male or female subjects, age 18 years or older on day of signing consent 2. Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subjects fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy 3. Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant) 4. Life expectancy > 12 weeks 5. Eastern Cooperative Oncology Group (ECOG) performance status: - Part 1: 0 or 1 - Part 2 and 3: 0, 1, or 2 Exclusion Criteria: 1. Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug 2. Prior receipt of a selective FGFR inhibitor 3. History of a calcium/phosphate homeostasis disorder 4. History and/or current evidence of ectopic mineralization/calcification 5. Current evidence of corneal disorder/keratopathy 6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range 7. Prior radiotherapy within 2 weeks of study treatment ; PRIMARY OUTCOME: Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE); SECONDARY OUTCOME 1: Part 2: Overall Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CARE (vs. Colistin); BRIEF: This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in the treatment of patients with bloodstream infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP) due to CRE. An additional cohort of patients with BSI, HABP, VABP, complicated urinary tract infection (cUTI), or acute pyelonephritis (AP) due to CRE, not eligible for inclusion in the other cohort, were enrolled into a single arm (Cohort 2) and treated with plazomicin-based therapy. Therapeutic drug management (TDM) was used to help ensure that plazomicin exposures lie within an acceptable range of the target mean steady-state area under the curve (AUC). ; DRUG USED: Zemdri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial); TARGET: Cell Membrane, Gram-Negative Bacteria, Protein synthesis; THERAPY: Combination; LEAD SPONSOR: Achaogen, Inc.; CRITERIA: Key Inclusion Criteria: - Cohort 1: APACHE II score between 15 and 30, inclusive; Cohort 2: BSI, HABP, VABP patients with an APACHE II score ≤30 (cUTI and AP patients do not need to have their APACHE II score calculated) - Positive culture that was collected ≤96 hours prior to randomization indicating a CRE infection, or a high likelihood of a CRE infection - Diagnosis of BSI as defined by at least one of the following: fever, hypothermia, new onset arterial hypotension, elevated total peripheral white blood cell (WBC) count, increased immature neutrophils (band forms), or leukopenia - Or, diagnosis of HABP defined as clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic-care facility, or acquired within 7 days after being discharged from a hospitalization of ≥3 days duration - Or, diagnosis of VABP defined by clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous mechanical ventilation - Or, diagnosis of cUTI or AP defined by clinical signs and symptoms consistent with cUTI or AP assessed within 24 hours prior to enrollment Key Exclusion Criteria: - Cohorts 1 and 2 BSI, HABP, and VABP patients: receipt of more than 72 hours of potentially effective antibacterial therapy; Cohort 2: cUTI and AP patients: receipt of any potentially effective antibacterial therapy in the 48 hours prior to enrollment - Cohort 1 only: knowledge that index CRE infection is resistant to colistin prior to randomization - Objective clinical evidence for any of the following clinical syndromes that necessitates study therapy for greater than 14 days: endovascular infection including endocarditis, osteomyelitis, prosthetic joint infection, meningitis and/or other central nervous system infections - Objective clinical evidence of infectious involvement of intravascular material potentially due to the study qualifying pathogen and not intended to be removed within 4 calendar days of the initial positive culture - HABP or VABP patients only: pulmonary disease that precludes evaluation of therapeutic response including known bronchial obstruction or a history of post-obstructive pneumonia, tracheobronchitis, primary lung cancer or malignancies metastatic to the lung, bronchiectasis, known or suspected active tuberculosis - cUTI or AP patients only: renal abscess, chronic bacterial prostatitis, orchitis or epididymitis, polycystic kidney disease, one functional kidney, vesicoureteral reflux, renal transplant, cystectomy or ileal loop surgery, fungal UTI or complete, permanent obstruction of the urinary tract - Patients in acute renal failure at the time of randomization - Patients receiving intermittent hemodialysis (IHD) at the time of screening - Pregnant or breastfeeding female patient ; PRIMARY OUTCOME: Percentage of Patients With All Cause Mortality (ACM) at Day 28 or Significant Disease-Related Complication (SDRC) in the Microbiological Modified Intent to Treat (mMITT) Population in Cohort 1; SECONDARY OUTCOME 1: Percentage of Patients With ACM at Day 28 in the mMITT Population in Cohort 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 - vs. Humira; BRIEF: To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in patients with moderate to severe chronic plaque psoriasis. ; DRUG USED: Cyltezo; DRUG CLASS: Biosimilar; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Males and females aged >=18 to =<80 years who have a diagnosis of moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug (a self-reported diagnosis confirmed by the investigator is acceptable), and which has been stable for the last 2 months with no changes in morphology or significant flares at both Screening and Baseline (Randomization): - involved body surface area (BSA) >= 10% and - Psoriasis Area and Severity Index (PASI) score >= 12 and - static Physicians Global Assessment (sPGA) score of >= 3. - Participants of reproductive potential (childbearing potential ) must be willing and able to use highly effective methods of birth control per International Council for Harmonization (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly during the trial and for 6 months following completion or discontinuation from the trial medication. - Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial. - Patients who are candidates for systemic therapy. Exclusion criteria: - Active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigators judgment. - Previous treatment with more than 1 biological agent, or adalimumab or adalimumab biosimilar. No prior biologic exposure within last 6 months of screening. - Patients with a significant disease other than psoriasis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, hematological, autoimmune or gastrointestinal disorders). - Major surgery performed within 12 weeks prior to randomization or planned within 6 months after screening, e.g., total hip replacement. - Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix. - Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s). - Chronic alcohol or drug abuse - Women who are pregnant, nursing, or who plan to become pregnant during the course of this study or within the period at least 6 months following completion or discontinuation from the trial. - Forms of psoriasis (e.g., pustular, erythrodermic and guttate) other than chronic plaque psoriasis. Drug-induced psoriasis (i.e., new onset or current exacerbation from e.g., beta blockers or lithium). - Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection or a positive HIV test at screening (per the investigator discretion and where mandated by local authorities). - Known chronic or relevant acute tuberculosis; no evidence of active tuberculosis. - Known clinically significant coronary artery disease, significant cardiac arrhythmias, moderate to severe congestive heart failure (New York Heart Association Classes III or IV) or interstitial lung disease observed on chest X-ray. - History of a severe allergic reaction, anaphylactic reaction, or hypersensitivity to a previously used biological drug or its excipients. - Positive serology for hepatitis B virus (HBV) or hepatitis C virus (HCV). - Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit; patients who are expecting to receive any live/attenuated virus or bacterial vaccinations during the trial or up to 3 months after the last dose of trial drug. - Any treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial. - Known active infection of any kind (excluding fungal infections of nail beds), any major episode of infection requiring hospitalization or treatment with intravenous (i.v.) anti infectives within 4 weeks of the Screening Visit - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) at Screening. - Hemoglobin < 8.0 g/dL at Screening. - Platelets < 100,000/µL at Screening. - Leukocyte count < 4000/µL at Screening. - Creatinine clearance < 60 mL/min/1.73 m2 at Screening. - Patients with a history of any clinically significant adverse reaction to murine or chimeric proteins, or natural rubber and latex, including serious allergic reactions. ; PRIMARY OUTCOME: The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16; SECONDARY OUTCOME 1: The Percentage of Patients With a PASI 75 Response at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Monotherapy (HER2+); BRIEF: This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. ; DRUG USED: KOS-862; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - women >=18 years; - locally advanced or metastatic breast cancer; - HER-2 overexpression (FISH + or IHC 3+); - >=1 measurable lesion; - up to one prior anthracycline-based chemotherapy regimen in a metastatic setting. Exclusion Criteria: - pre-existing neuropathy >=grade 2; - known CNS metastases; - congestive heart failure, or myocardial infarction within the last 6 months; - previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix. ; PRIMARY OUTCOME: Phase I: Number of Participants with a Dose-Limiting Toxicity; SECONDARY OUTCOME 1: Phase II: Duration of Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TVEC-325; BRIEF: The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec. ; DRUG USED: Imlygic; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: 1. Provided informed consent prior to initiation of any study-specific activities/procedures 2. Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended 3. Candidate for intralesional therapy 4. Measurable disease with greatest diameter ≥ 10 mm 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate organ function Other Inclusion Criteria May Apply Exclusion Criteria: 1. Clinically active cerebral metastases. 2. Bone metastases 3. Primary ocular or mucosal melanoma 4. Active herpetic skin lesions or prior complications of herpes simplex virus type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis) 5. Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use 6. Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec 7. Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception Other Exclusion Criteria May Apply ; PRIMARY OUTCOME: Odds Ratio of Baseline Intratumoral CD8+ Cell Density and Objective Response Rate; SECONDARY OUTCOME 1: Odds Ratio of Baseline Intratumoral CD8+ Cell Density and Durable Response Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Hepatic Lipid and Glycogen Content; BRIEF: The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin. ; DRUG USED: IONIS-GCGRRx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ionis Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male or female, age 18 to 75 - BMI ≥ 25.0 kg/m2 < 36.0 kg/m2 - HbA1c ≥ 7.5% and ≤ 10.5% - Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. Patients on a stable dose of metformin plus a sulfonylurea (SU) or metformin plus a dipeptidyl peptidase-IV (DPPIV) inhibitor for a minimum of 3 months prior to Screening evaluation may be allowed - Agree to conduct home-based (fasted) blood glucose testing as directed Exclusion Criteria: - Clinically significant abnormalities in medical history or physical exam - Show evidence of uncorrected hypothyroidism or hyperthyroidism - History of liver transplantation or renal dialysis - History of liver disease - History of greater than 3 episodes of severe hypoglycemia within 6 months of screening - Treatment with any other antidiabetic drug(s) other than metformin, SU or DPPIV within 3 months of screening - History of diabetic ketoacidosis - Any other significant illness or condition that may interfere with the patient participating or completing the study - Inability or unwillingness to comply with protocol or study procedures - ; PRIMARY OUTCOME: Change in fasting hepatic glycogen content; SECONDARY OUTCOME 1: Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory 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 II - 049 (LHRH+, Triple Negative); BRIEF: This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer. ; DRUG USED: Zoptrex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: DNA, DNA synthesis, Gonadotropin-Releasing Hormone (GnRH) Receptor, Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: AEterna Zentaris; CRITERIA: Inclusion Criteria: 1. Women ≥ 18 years of age 2. Histologically documented breast cancer (either primary or metastatic site) that is (i) ER-negative (0), (ii) PR-negative (0), and (iii) HER2-negative, defined by IHC (immunohistochemistry; IHC 0/1, non-overexpressing) or FISH (fluorescence in situ hybridization; FISH negative) or CISH (chromogen in situ hybridization; CISH negative). 3. Expression of LHRH receptor confirmed by IHC on archival (or current biopsy of breast tumor or metastatic site) breast cancer tissue 4. Progressive disease after failure of 1 to 3 prior chemotherapy regimens for recurrent or metastatic (Stage IV) disease (prior adjuvant/neoadjuvant therapy is allowed) 5. Measurable disease by RECIST 1.1 criteria; at least one target lesion that has not been previously irradiated. Exclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status > 2 2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or recent myocardial infarction (within 6 months of enrollment) 3. Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention 4. Left ventricular ejection fraction (LVEF) < 50 %, determined by echocardiogram or MUGA scan 5. Compromised organ or marrow function as evidenced by any of the following: - thrombocyte count: < 100x109/L - absolute neutrophil count (ANC): < 1.5x109/L - hemoglobin: < 6.0 mmol/L (< 9 g/100 mL) - AS(A)T, AL(A)T: > 2.5 times upper limit of normal range (ULN) (> 5x ULN if clearly related to liver metastases) - bilirubin: > 1.5 mg/dL - creatinine: > 1.5 mg/dL or creatinine clearance < 40 mL/min. 6. Systemic anticancer therapy or radiotherapy within 21 calendar days of the first dose of study drug*) * also excluded are patients with anticipated ongoing concomitant anticancer therapy during the study 7. Prior exposure to anthracyclines or anthracenediones for the treatment of metastatic breast cancer including liposomal doxorubicin (Doxil), doxorubicin, daunorubicin, or mitoxantrone 8. Prior adjuvant anthracyclines with a cumulative anthracycline dose ≥ 300 mg/m2 9. Ongoing therapeutic anticoagulation 10. Patients who are not surgically sterile or post-menopausal must agree to use for the duration of the study reliable methods of birth control defined as: - complete abstinence - any intrauterine device (IUD) with published data showing that the lowest expected failure rate is < 1 % per year, or - any other methods with published data showing that the lowest expected failure rate is less than 1 % per year 11. Investigational therapy within 30 calendar days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). ; PRIMARY OUTCOME: Efficacy of AEZS-108 compared to SSCC as measured by the median time of progression-free survival (PFS).; SECONDARY OUTCOME 1: Efficacy of AEZS-108: overall response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - BP25438; BRIEF: This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. ; DRUG USED: Imgatuzumab; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients, >/= 18 years of age - Carcinoma of the colon and/or rectum - Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease - ECOG performance status 0-1 - Adequate hematological, renal and liver function Exclusion Criteria: - Prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (EGFR) - Prior treatment with irinotecan - Radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief) - CNS metastasis - History of or active autoimmune disorders/conditions ; PRIMARY OUTCOME: Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria; SECONDARY OUTCOME 1: Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RESTORE ext.; BRIEF: ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: ; CRITERIA: ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SAVE-HIP1; BRIEF: The primary objective was to compare the efficacy of once daily [q.d.] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective total hip replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip replacement surgery, and to document AVE5026 exposure in this population. ; DRUG USED: Visamerin/Mulsevo; DRUG CLASS: Non-NME; INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X, Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - Elective total hip replacement surgery or a revision of at least one component of a prosthesis implanted ≥ 6 months prior to study entry. Exclusion Criteria: - Any major orthopedic surgery in the 3 months prior to study start; - Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome; - High risk of bleeding; - Known allergy to heparin or enoxaparin; - Any contra-indications to the performance of venography; - End stage renal disease or patient on dialysis. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or Death From Any Cause; SECONDARY OUTCOME 1: Percentage of Participants Who Experienced Major VTE or All-cause Death[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - Adjunctive to Antidepressants; BRIEF: The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD. ; DRUG USED: Seltorexant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Hypocretin/orexin receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Men or women of non-childbearing potential (WONCBP), aged 18 to 70 years (inclusive). A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. b). Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. c). If reproductive status is questionable, additional evaluation should be considered - Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders- Clinical Trials Version (SCID-CT). In addition their major depressive episode must be deemed valid using the SCID Screening Questionnaire (SSQ) interview administered by remote, independent raters. The length of the current depressive episode must be less than or equal to (<=) 18 months - Have had an inadequate response to at least 1 but no more than 3 antidepressants, administered at an adequate dose and duration in the current episode of depression, as measured by the Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ). An inadequate response is defined as less than (<)50 percent (%) reduction in depressive symptom severity, as assessed by the MGH-ATRQ. An adequate trial is defined as an antidepressant treatment for at least 4 weeks at or above the minimum therapeutic dose specified in the MGH-ATRQ, for any particular antidepressant. The inadequate response must include the participants current antidepressant treatment - Participants receiving monotherapy treatment for depressive symptoms with one of the following selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants, in any formulation: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at or above the minimum therapeutic dose level) for at least 4 weeks, and for no greater than 12 months, at screening. Modification of an effective preexisting therapy should not be made for the explicit purpose of entering a subject into the study - Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (>=)25 (performed by independent, centralized remote raters) at screening and must not demonstrate a clinically significant improvement (that is, an improvement of greater than [>]20% on their MADRS total score) from the screening to baseline visit - Must be otherwise healthy on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening. If the results of the clinical laboratory tests are outside the normal reference ranges, the participant could be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participants source documents and initialed by the investigator Exclusion Criteria: - Has a history of, or current signs and symptoms of, severe renal insufficiency (creatinine clearance <30 milliliter per minute [mL/min]); moderate to severe hepatic insufficiency (Child-Pugh Score 7-9), significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic (including narcolepsy), hematologic, rheumatologic, immunologic or endocrine disorders (including uncontrolled hypo- or hyperthyroidism or diabetes, or insulin-dependent diabetes mellitus). Participants with non-insulin dependent diabetes mellitus who are well-controlled (hemoglobin A1C [HbA1C] <=7.5% and fasting glucose <126 milligram per deciliter [mg/dL] at screening) could be eligible to participate if otherwise medically healthy, and if on a stable regimen of glucose-lowering medications for at least 2 months prior to screening - Has signs and symptoms of Cushings Disease, Addisons Disease, primary amenorrhea, or other evidence of significant medical disorders of the hypothalamic-pituitary-adrenal (HPA) axis - Has a history of lack of response to 3 or more adequate antidepressant treatments, as indicated by no or minimal (<= 25% improvement in symptoms) when treated with an antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 4 weeks) - Has history or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, autism spectrum disorder, or borderline personality disorder, somatoform disorders, chronic fatigue syndrome or fibromyalgia - Has any significant primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias ; PRIMARY OUTCOME: Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score; SECONDARY OUTCOME 1: Change From Baseline in the MADRS Total Score by Baseline Insomnia Severity Index (ISI) Score at Day 42[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PARAGON-HF (HFpEF); BRIEF: The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction. ; DRUG USED: Entresto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Preserved Ejection Fraction (Chronic HFpEF); TARGET: Angiotensin II Receptor Type 1 (AT1), Neutral Endopeptidase/Neprilysin (NEP); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry. - Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry. - Current symptom(s) of HF (NYHA class II-IV) - Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram. - Elevated NT-proBNP Exclusion Criteria: - Any prior measurement of LVEF < 40%. - Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry. - Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF ≥45%. - Current acute decompensated HF requiring therapy. - Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor. - Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2. - Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry. Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.; SECONDARY OUTCOME 1: Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Safety; BRIEF: This is a study where AZD3241 or placebo is given to patients with Parkinsons disease in a blinded and randomized assignment. The main objective is to see if safety and tolerability of the drug is acceptable. ; DRUG USED: Verdiperstat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Myeloperoxidase (MPO); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Each patient must be able and willing to provide signed and dated informed consent prior to the study. - Female and male patients aged 30 to 80 years at the day of enrollment (Visit 1). - Patients must meet the criteria for Diagnosis of idiopathic Parkinsons disease according to the UKPDS Brain Bank criteria (Hughes et al 1992). - Have a modified Hoehn and Yahr stage 1-2.5. - Having no treatment for Parkinsons disease and have no need to add anti-Parkinsons disease treatment during the 14 weeks of study OR are on stable anti-Parkinsons disease medication. Exclusion Criteria: - Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases. - Have undergone surgery for the treatment of Parkinsons disease (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-Parkinsons disease conditions. - Presence of dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes, defined as scoring 2 or more on item 30 of the UPDRS. - Current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e. bipolar disorder or MDD, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study. - Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal (GI) disease, or other major disease as judged by the investigator. ; PRIMARY OUTCOME: Change from baseline in vital signs.; SECONDARY OUTCOME 1: Pharmacokinetics (PK) of AZD3241 in the terms of Cmax, Cmin, and AUC0-t.[/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 - Dana-Farber (w/trastuzumab; brain metastases); BRIEF: This research study is evaluating the effectiveness of the drug called cabozantinib (alone or in combination with trastuzumab) as a possible treatment for advanced breast cancer in which the cancer has spread to the brain. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), FMS-like tyrosine kinase 3 (FLT-3) , Hepatocyte growth factor receptor (c-Met, HGFR), KIT/c-KIT, RET, VEGF Receptor (VEGFR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Dana-Farber Cancer Institute; CRITERIA: Inclusion Criteria: - Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease. - New or progressive CNS lesions, as assessed by the patients treating physician. - For patients who have received prior cranial radiation, no increase in corticosteroid dose in the week prior to the baseline brain MRI - Discontinued prior therapy (with the exception of trastuzumab for patients with HER2+ breast cancer) - Recovery to baseline or ≤ Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy; - The subject has an ECOG performance status of 0 or 1 - Patients must have normal organ and marrow function and laboratory values as follows within 14 days before the first dose of cabozantinib - Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s) - Subjects of childbearing potential must not be pregnant at screening. - Patients on bisphosphonates may continue receiving bisphosphonate therapy during study. Patients wanting to initiate bisphosphonate therapy may do so. - The subject has had an assessment of all known disease sites eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, within 28 days before the first dose of cabozantinib Exclusion Criteria: - The subject has received cabozantinib or another c-Met inhibitor (please note ARQ 197 is not considered a MET inhibitor for purposes of this study given data to suggest it inhibits tubulin) - The subject has uncontrolled, significant intercurrent or recent illness - Leptomeningeal disease as the only site of CNS involvement - Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker, shrapnel, or ocular foreign body - More than 2 seizures over the last 4 weeks prior to study entry - Grade 1 or higher CNS hemorrhage on baseline brain MRI, or history of grade 2 or higher CNS hemorrhage within 12 months - Has experienced clinically-significant GI bleeding within 6 months before first dose of cabozantinib; hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of cabozantinib; any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of cabozantinib - The subject has tumor in contact with, invading or encasing any major blood vessels - The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib - The subject requires concomitant treatment, in therapeutic doses, with anticoagulants. Low dose aspirin (≤ 81 mg/day), low-dose warfarin ( ≤1 mg/day), and prophylactic LMWH are permitted. - The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥1.3 × the laboratory ULN within 7 days before the first dose of cabozantinib. - Inability to swallow intact tablets - Pregnant or lactating females - Diagnosis of another malignancy within 2 years before the first dose of cabozantinib, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy - Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible - The subject is known to be positive for the human immunodeficiency virus (HIV) - Subjects with clinically relevant ongoing complications from prior surgery are not eligible - QTcF > 500 msec on average of screening EKGs performed within 28 days of first dose of cabozantinib. Three EKGs must be performed at screening. If the average of these three consecutive results for QTcF is > 500 msec, the subject is ineligible. - Active infection requiring IV antibiotics at Day 1 of cycle 1 - No prior lapatinib within 7 days prior to initiation of protocol treatment - Receive concurrent investigational agents while on study - Receive any concurrent chemotherapy, radiotherapy, or hormonal therapy while on study - Previously identified allergy or hypersensitivity to components of the cabozantinib formulations - The subject requires chronic concomitant treatment with strong CYP3A4 inducers ; PRIMARY OUTCOME: CNS Objective Response Rate (ORR); SECONDARY OUTCOME 1: CNS Volumetric Objective Response Rate (ORR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PoC; BRIEF: A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior. ; DRUG USED: CERC-501; DRUG CLASS: New Molecular Entity (NME); INDICATION: Smoking Cessation; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: 1. Provides written informed consent and agrees to complete required clinic visits 2. Male or female 21 to 60 years of age inclusive 3. Body mass index (BMI) 18.5 to 40 kg/m2 inclusive 4. Heavy Smokers 5. Currently not seeking smoking cessation therapy 6. In otherwise good general health without any unstable medical conditions (as determined by medical history, medication history, physical examination, 12-lead ECG, vital signs, and clinical laboratory testing) 7. Able to read, write, and speak in English 8. Females must be either: - Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or- - Women of childbearing potential (WOCBP) must meet the criteria below: - Uses an acceptable double-barrier method of contraception as determined by the Investigator -and- - Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to dosing on Days 1 and 8 of each treatment period. 9. Male subjects must agree to use a condom if partner is of childbearing potential Exclusion Criteria: Subjects meeting the following criteria are not eligible for the study: 1. Any substance use disorder other than nicotine or caffeine as assessed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) substance use disorder checklist in addition to the Mini-International Neuropsychiatric Interview (MINI) (to capture both DSM-V substance use disorder diagnoses) 2. Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion 3. Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the MINI 4. Current psychiatric conditions that interfere with study conduct, assessment or treatment in any significant fashion, such as major depressive disorder (MDD), eating disorders, post-traumatic stress disorder, etc., without permission of the medical monitor 5. Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition 6. Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Investigator (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.) 7. Clinically significant clinical laboratory test taken during screening, without permission of the Medical Monitor 8. Elevated AST or ALT ≥ 2 times the upper limit of normal (ULN) 9. Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening 10. History of severe allergies or multiple adverse drug reactions 11. Known hypersensitivity to CERC-501 12. Current use of a proton pump inhibitor or histamine 2 blocker without permission of the Medical Monitor 13. Use of any investigational medication within 2 months prior to the start of this study or scheduled to receive an investigational drug other than the study drug during the course of this study ; PRIMARY OUTCOME: Latency; SECONDARY OUTCOME 1: Tobacco Craving[/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 - Smoldering MM; BRIEF: The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM). ; DRUG USED: Darzalex Faspro; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Cluster of Differentiation 38 (CD38); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Diagnosis of high risk smoldering multiple myeloma (SMM) (per International Myeloma Working Group [IMWG] criteria) for less than or equal to (<=) 5 years with measurable disease at the time of randomization, defined as serum M protein greater than or equal to (>=) 10 gram per liter (g/L) or urine M protein >= 200 milligram per 24 hours (mg/24 hours) or involved serum free light chain (FLC) >=100 milligram per liter (mg/L) and abnormal serum FLC ratio - Clonal bone marrow plasma cells (BMPCs) >= 10 percentage (%); and at least 1 of the following risk factors; Serum M protein >= 30 g/L, immunoglobulin (Ig)A SMM, immunoparesis with reduction of 2 uninvolved immunoglobulin isotypes (only IgA, IgM, and IgG should be considered in determination for immunoparesis; IgD and IgE are not considered in this assessment), serum involved: uninvolved FLC ratio >= 8 and less than (<) 100, or clonal BMPCs greater than (>) 50% to <60% with measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 - Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use highly effective method of contraception - A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days prior to randomization - During the study and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction Exclusion Criteria: - Multiple myeloma (MM), requiring treatment, defined by any of the following: 1. Bone lesions (1 or more osteolytic lesions on low-dose whole body computed tomography [LDCT], positron-emission tomography with computed tomography [PET-CT] or CT). Participants who have benign/post-traumatic bone lesions visible on screening images as well as previous imaging, may be considered for inclusion. Details (diagnosis, location, duration) on benign/post-traumatic pre-existing bone lesions that can be seen on the screening images (example [eg.], old fractures) and were also present on previous imaging are to be reported in the case report form (CRF) 2. Hypercalcemia (serum calcium greater than [>]0.25 millimoles per liter [mmol/L] [>1 milligram per deciliter {mg/dL}] higher than upper limit of normal [ULN] or >2.75 mmol/L [>11 mg/dL]). Participants who have clinically stable hypercalcemia attributable to a disease other than multiple myeloma (eg, hyperparathyroidism) may be considered for inclusion after a case by case review by the medical monitor 3. Renal insufficiency, preferably determined by creatinine clearance less than (<)40 milliliter per minute (mL/min) measured or estimated using the Modification of Diet in Renal Disease (MDRD), or serum creatinine >177 micromole per liter (μmol/L). Participants who have clinically stable renal insufficiency attributable to a disease other than multiple myeloma (eg, glomerulonephritis) may be considered for inclusion after a case by case review by the medical monitor 4. Anemia, defined as hemoglobin <10 gram per deciliter (g/dL) or >2 g/dL below lower limit of normal or both; transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted. Participants who have clinically stable anemia attributable to a disease other than multiple myeloma (eg, thalassemia, vitamin B12 deficiency, iron deficiency) may be considered for inclusion after a case by case review by the medical monitor 5. Clonal BMPC percentage >=60% 6. Serum FLC ratio (involved:uninvolved) >=100 (the involved FLC must be >=100 mg/L) 7. More than 1 focal lesion >=5 millimeter (mm) in diameter by magnetic resonance imaging (MRI) - Primary systemic amyloid light-chain (AL) (immunoglobulin light chain) amyloidosis - Exposure to any of the following: 1. Prior exposure to daratumumab or prior exposure to other anti-Cluster of Differentiation 38 (anti-CD38) therapies 2. Prior exposure to approved or investigational treatments for SMM or MM (including but not limited to conventional chemotherapies, immunomodulatory agent [IMiDs], or proteasome inhibitor [PIs]). Stable standard dosing of bisphosphonate and denosumab as indicated for osteoporosis is acceptable 3. Exposure to investigational drug (including investigational vaccines) or invasive investigational medical device for any indication within 4 weeks or 5 half-lives, whichever is longer, before Cycle 1, Day 1 4. Ongoing treatment with corticosteroids with a dose >10 milligram (mg) prednisone or equivalent per day at the time of randomization; or >280 mg cumulative prednisone dose or equivalent for any 4-week period in the year prior to randomization 5. Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab), immunomodulators (eg, abatacept, methotrexate, azathioprine, cyclosporine) or other treatments that are likely to interfere with the study procedures or results - Received treatment (chemotherapy, surgery, et cetera [etc]) for a malignancy (other than SMM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion), which is considered cured with minimal risk of recurrence within 3 years - Medical or psychiatric condition or disease (for example, active systemic disease [including presence of auto-antibodies], uncontrolled diabetes) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study - Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies, hyaluronidase, or other human proteins, or their excipients, or known sensitivity to mammalian-derived products (including dairy allergy) ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Time to Biochemical or Diagnostic (SLiM-CRAB) Progression[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb; BRIEF: This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD. ; DRUG USED: Qelbree; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Nicotinic Acetylcholine Receptors (nAChR) , Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin 5-HT1 receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26. 3. CGI-S score of at least 4 4. Weight of at least 20 kg. 5. Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment. Exclusion Criteria: 1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourettes disorder, or psychosis not otherwise specified. 2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis. 3. Significant systemic disease. 4. Evidence of suicidality within the six months before Screening or at Screening. 5. BMI greater than 95th percentile for the appropriate age and gender. 6. Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP). 7. Substance or alcohol use during the last three months. 8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening. ; PRIMARY OUTCOME: The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV); SECONDARY OUTCOME 1: Effect of SPN-812 on Clinical Global Impression - 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 II - Uncommon EGFR Mutations; BRIEF: This is a research study to find out if a drug called, osimertinib, is safe and effective in treating advanced Non-Small Cell Lung Cancer (NSCLC) by targeting the treatment of epidermal growth factor receptor (EGFR) mutation exon 18 G719X, exon 20 S7681, or exon 21 L861Q. Patients on the study will not have had previous tyrosine kinase inhibitor (TKI) treatment. ; DRUG USED: Tagrisso; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Duke University; CRITERIA: Inclusion Criteria: - EGFR mutations as performed on a CLIA certified laboratory demonstrating EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q. Patients with compound (also referred to as multiple mutations) will be eligible provided the NSCLC demonstrates one of these mutations). - Histological or cytological confirmation diagnosis of Stage 4 NSCLC. - Measurable disease by RECIST 1.1 (please refer to appendix 4) - The following laboratory values obtained ≤ 14 days prior to study initiation. - Hematology: ANC ≥ 1, 500 / ml, platelet count, ≥ 100,000 / ml, hemoglobin ≥ 9.0 g / dl - Hepatic:ALT or ALT < 2.5 times ULN if no demonstrable liver metastases or <5 times ULN in the presence of liver metastases - Total bilirubin < 1.5 times ULN if no liver metastases or < 3 times ULN in the presence of documented Gilberts Syndrome (unconjugated hyperbilirubinaemia) or liver metastases - Renal: Cockcroft-Gault calculated creatinine clearance of ≥ 45 ml/min or creatinine ≤1.5 x ULN - Have normal QT interval on ECG evaluation QT corrected of ≤ 450 ms in males or ≤ 470 ms in females obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine-derived QTc value - Cardiac ejection fraction of ≥ 45% - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1 - Negative pregnancy test done ≤7 days (or per institutional policy) prior to treatment, for women of childbearing potential only. Female must use highly effective contraceptive measures, and must have a negative pregnancy test or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: - Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments. - Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution - Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation - Male subjects must be willing to use barrier contraception - Age ≥ 18 years - Provision of written informed consent prior to any study-specific procedures Exclusion Criteria: - Prior therapy with EGFR TKI therapy - Greater than 2 lines of prior systemic therapy for metastatic non-small cell lung cancer. - Any cytotoxic chemotherapy or other anticancer drugs from previous treatment regimen or clinical study within 14 days of first dose of study drug. - Treatment with an investigational drug within 5 half-lives of the compound - Other active malignancy ≤ 2 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, patients must not be receiving other specific treatment (i.e. hormonal therapy) for their cancer - Prior radiotherapy ≤ 14 days - Untreated symptomatic brain metastases (treated brain metastases are allowed provided > 14 days have elapsed from completion of radiotherapy and patient is neurologically stable as assessed by treating physician). - Malabsorption syndrome, refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib - Detection of concurrent EGFR mutation with exon 20 T790M, exon 19 deletion, exon 21 L858R mutation or exon 20 insertion. Patients with compound (also referred to as multiple mutations) will be excluded if the molecular testing includes one of these mutations. - Active pregnancy or breast-feeding: Pregnant women are excluded from this study because the effects of osimertinib on the development of the fetus are unknown, and there is potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with osimertinib, breastfeeding should be discontinued if the mother is treated with these agents. - Grade ≥ 2 blurred vision, conjunctivitis, corneal ulcer, dry eye, or keratitis ; PRIMARY OUTCOME: Objective Response Rate as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1); SECONDARY OUTCOME 1: Progression Free Survival (PFS) as Measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Acute Treatment - 316 (US); BRIEF: The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. - Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits. - Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits. Exclusion Criteria: - Has previously participated in a Lu AA21004 clinical study. - Has 1 or more the following: - Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV - Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR. - Diagnosis of alcohol or other substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least years prior to screening (participant must also have negative urine drug screen prior to Baseline). - Presence or history of a clinically significant neurological disorder (including epilepsy) - Neurodegenerative disorder. - Any Axis II disorder that might compromise the study. - Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. - Has clinically significant abnormal vital signs as determined by the investigator. - Has an abnormal Electrocardiogram. - Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal. - Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. - Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy. - Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma. - Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. For the purposes of this protocol the following conditions are considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea. - Has a significant risk of suicide according to the investigators opinion. ; PRIMARY OUTCOME: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score; SECONDARY OUTCOME 1: Percentage of Participants With a MADRS Response 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 III - Pediatric Autism; BRIEF: This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting. ; DRUG USED: Latuda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Autism Spectrum Disorders (Autism); TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: - Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects adherence to the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. - Male or female subjects 6 to 17 years of age, inclusive, at the time of consent. - A reliable informant (eg, parent, legal guardian, or caregiver) who has past and current direct knowledge of the subject must accompany the subject at each visit and must oversee the administration of the study drug. - DSM-IV-TR primary diagnosis of autistic disorder confirmation of the diagnosis by a trained clinician (eg, psychiatrist, psychologist, social workers, etc) at the time of screening, by means of the Autism Diagnostic Interview, Revised (ADI-R). - Screening and Baseline ABC irritability subscale score ≥ 18. - Screening and Baseline CGI-S ≥ 4. - Within 5th to 95th percentile for gender specific Growth Charts from Centers for Disease Control (CDC). - No clinically relevant abnormal laboratory values. - No clinically relevant abnormal vital sign values/findings 1. Females who participate in this study: - are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR- - practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR- •are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken. - Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken. - In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol (See Table 4 for study drug tablet size). - Able to adhere to protocol-specified meal requirements during dosing. - Have a stable living arrangement for at least 3 months prior to screening. - Non-pharmacologic therapy (eg, behavior modification) must be stable for at least 4 weeks before screening and consistent throughout the study. Exclusion Criteria: - Subjects with profound intellectual disability. - Current diagnosis of bipolar disorder, psychosis, schizophrenia or major depression, or childhood disintegrative disorder as confirmed by the MINI-Kid (as appropriate) at screening. Confirmed genetic disorders with cognitive and behavioral disturbances are also exclusionary. - Clinically significant neurological, metabolic (including type 1 and type 2 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study. Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening. - Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood- eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary. - If the subject has a history of seizures, the subjects must not currently be taking any antiepileptic drugs (AEDs) and be seizure-free for at least 6 months. - Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study. - A history or presence of abnormal ECG, which in the investigators opinion is clinically significant. Screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read. - Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes, severe dystonia, or moderate to severe tardive dyskinesia. - Clinically significant alcohol abuse/dependence or drug abuse/dependence based on Mini International Neuropsychiatric Interview for children and adolescents (MINI-Kid) criteria within the last 6 months prior to screening. - Clinically significant orthostatic hypotension (ie, a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4 minutes of standing up). - Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone. - Positive test results at screening for: 1. Urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, cannabinoids, methamphetamine, and methadone). However, a positive test for amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result in exclusion of subjects if the investigator determines that the positive test is as a result of prescription medicine(s). 2. Pregnancy test (only in female subjects ≥ 11 years old). - Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C. - Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to study drug administration. - Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to randomization. - Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to screening, whichever is longer. - Subject has received treatment with antidepressants within 3 days, fluoxetine hydrochloride at any time within 21 days, an MAO inhibitor within 21 days of randomization or clozapine within 120 days of randomization. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization. - Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine or fluvoxamine, within 3 days prior to randomization. - Females who are pregnant, lactating, or likely to become pregnant during the study. - Donation of whole blood within 60 days prior to randomization. - Has a prolactin concentration greater than or equal to 100 ng/mL at screening. - Subject is considered by the investigator to be at imminent risk of suicide during the study. Subject has a history of one or more serious suicide attempts (based on the investigators judgment) in the 12 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation. - Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation. - Subject requires use of concomitant medications that are potent inducers or inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system (Appendix C) from signing informed consent until follow-up. ; PRIMARY OUTCOME: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6; SECONDARY OUTCOME 1: Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6[/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 - POC (Acute Kidney Injury); BRIEF: The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI. ; DRUG USED: CRMD-001; DRUG CLASS: Non-NME; INDICATION: Renal Disease / Renal Failure; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: CorMedix; CRITERIA: Inclusion Criteria: 1. Age 18 or older 2. eGFR of < 60 ml/min/1.73 m2 3. Presence of at least one additional risk factor: - Diabetes Mellitus - Age ≥ 75 years - Left Ventricular Ejection Fraction ≤ 40% Exclusion Criteria: 1. End-Stage Renal Disease 2. Recent change in serum creatinine 3. Primary PCI for STEMI 4. Currently receiving mechanical ventilation 5. Severe heart failure of cardiogenic shock 6. Requirement for inotropic support (prior 30 days) 7. Sustained hypertension > or = 200/110 8. Subject not expected to live for 90 days 9. Anticipated use of ioxaglate or iohexol 10. Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid 11. Absolute neutrophil count < 1500 12. Hemoglobin < 8 gm/dL ; PRIMARY OUTCOME: Biomarker evidence of Acute Kidney injury; SECONDARY OUTCOME 1: Incidence of Acute Kidney Injury[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Chemotherapy (Triple Negative); BRIEF: The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer. ; DRUG USED: Sutent; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast 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: - Recurrent or metastatic breast cancer - Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status - Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting - Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease Exclusion Criteria: - More than two chemotherapy regimens for advanced disease - Uncontrolled/symptomatic spread of cancer to the brain ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Proportion of Participants With Objective Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EMPhASIS; BRIEF: This is a Phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of 2 once-daily oral doses of IMU-838 (vidofludimus calcium), a small molecule inhibitor of dihydroorotate dehydrogenase (DHODH), 30 mg/day and 45 mg/day in the main study, cohort 1 (and 10 mg/day for the patients in the cohort 2 substudy), in patients with RRMS and evidence of active disease. The trial consists of a screening period, a blinded 24-week main treatment period, and an optional initially blinded, then open-label extended treatment period of up to 9.5 years. About 40 centers are planned to participate in Romania, Bulgaria, Ukraine, and Poland; potential additional centers in Hungary and Croatia were not used. The study started with 195 patients in the main group (cohort 1) planned to be randomized 1:1:1 to treatment with 30 mg/day or 45 mg/day IMU-838, or placebo (65 patients each) in the main treatment period. During the extended treatment period, patients were initially re-randomized so that patients previously on placebo were re-randomized 1:1 to treatment with 30 g/day or 45 mg/day IMU-838, all other patients were re-randomized to the same treatment they previously received. With approval of Protocol Version 3.0, a sub-study patient group (cohort 2) has been added with up to 60 patients, randomized to placebo or 10 mg IMU-838 for 24 weeks after which the option is available to continue into the extended treatment period and the recommended dose of 30 mg/day. However, based on discussion between investigator and patient 45 mg/day IMU-838/day may also be used. ; DRUG USED: IMU-838; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Dihydroorotate Dehydrogenase (DHODH), DNA synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Immunic AG; CRITERIA: Inclusion criteria for the main treatment period 1. Male or female patient (age ≥18 to 55 years, inclusive) 2. Diagnosis of RRMS according to the revised McDonald criteria (2017) Note: The diagnosis of MS (including dissemination in time) must have been established before the patient is screened for the trial. 3. Disease activity evidenced - by either at least 2 relapses in the last 24 months, or at least 1 relapse in the last 12 months before randomization (relapses must have been assessed and documented by a physician in the patient files), AND - ≥1 documented Gd+ MS-related brain lesion, in the last 6 months before informed consent (date of MRI examination as well as copy of MRI report or representative image has to be available and accessible as patient source data at the study site) 4. Expanded Disability Status Scale (EDSS) score between 0 and 4.0 (inclusive) at Screening Visit 1 5. Female patients - must be of non-child-bearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening Visit 1) or post menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or - if of child-bearing potential, must have a negative pregnancy test at Screening Visit 1 (blood test) and before the first IMP intake (Day 0 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (see below) together with a barrier method between trial consent and 30 days after the last intake of the of the IMP. Highly effective forms of birth control are those with a failure rate less than 1% per year and include: - oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation - oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation - intrauterine device or intrauterine hormone-releasing system - bilateral tubal occlusion - vasectomized partner (i.e. the patients male partner underwent effective surgical sterilization before the female patient entered the clinical trial and is the sole sexual partner of the female patient during the clinical trial) - sexual abstinence (acceptable only if it is the patients usual form of birth control/lifestyle choice; periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods] and withdrawal are no acceptable methods of contraception) Barrier methods of contraception include: - Condom - Occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository 6. Male patients must agree not to father a child or to donate sperm starting at Screening Visit 1, throughout the clinical trial and for 30 days after the last intake of the IMP. Male patients must also - abstain from sexual intercourse with a female partner (acceptable only if it is the patients usual form of birth control/lifestyle choice), or - use adequate barrier contraception during treatment with the IMP and until at least 30 days after the last intake of the IMP, and - if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 5 - if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP 7. Willingness and ability to comply with the protocol 8. Written informed consent given prior to any trial-related procedure Inclusion criteria for optional extended treatment period 1. Completed 24 weeks of main treatment 2. Baseline MRI and Week 24 MRI, as well as 2 additional post-dose MRIs Continuation criteria for optional extended treatment period 1. In case the initial Week 24 MRI was not evaluated at least partially assessable, availability of a repeated Week 24 MRI 2. Week 24 MRI (initial or repeated one, if applicable) evaluated at least partially assessable Exclusion criteria MS-related exclusion criteria 1. Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis 2. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from these 3. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or MOG-associated encephalomyelitis (i.e. presence of anti-NMO [aquaporin-4] antibodies or anti-MOG-antibodies) 4. MS types other than RRMS 5. Any MRI finding, atypical for MS, including but not limited to a longitudinally extensive spinal cord lesion 6. Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease) 7. An MS relapse within 30 days before Screening Visit 1 and/or during the screening period (until Day 0) Therapy exclusion criteria 8. Any previous or current use of the following MS treatments: monoclonal antibodies (natalizumab, alemtuzumab, daclizumab, ocrelizumab, anti-CD4, rituximab or belimumab, including their biosimilars), total lymphoid irradiation, bone marrow transplantation, stem cell transplantation, or any use of DHODH inhibitors, including teriflunomide (Aubagio™) or leflunomide (Arava™) 9. Any use of the following MS treatments within 12 months before the date of informed consent: any cytokine (other than interferon) or anti-cytokine therapy, intravenous immunoglobulin, mitoxantrone, cytotoxic or immunosuppressive therapy (including, but not limited to azathioprine and cyclophosphamide, excluding only systemic corticosteroids or adrenocorticotrophic hormone [ACTH]), tofacitinib, methotrexate, mycophenolate mofetil, mycophenolate sodium, fingolimod, any calcineurin inhibitors (e.g. tacrolimus, cyclosporine, or pimecrolimus) 10. Any use of the following MS treatments within 30 days before the date of informed consent: interferon-β, glatiramer acetate, dimethyl fumarate and plasmapheresis 11. Within 30 days before the baseline MRI: Use of systemic corticosteroids (intravenous or oral) or ACTH 12. Use of the following concomitant medications is prohibited at Screening Visit 1 and throughout the duration of the trial: - any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid - treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafinib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib - any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogs - use of rosuvastatin at daily doses higher than 10 mg 13. Use of any investigational product within 8 weeks or 5 x the respective half-life before the date of informed consent, whichever is longer, and throughout the duration of the trial Immune response exclusion criteria 14. Conditions negatively affecting the immune response such as previous organ transplant 15. Clinically significantly low lymphocyte and/or neutrophil count (Common Terminology Criteria for AEs Grade of 2 or higher), i.e. - lymphocyte count <800/mm³ (0.8 x 109/L), and/or - neutrophil count <1,500/mm³ (1.5 x 109/L) 16. History of chronic systemic infections within 6 months before the date of informed consent, including but not limited to tuberculosis, human immunodeficiency virus (HIV), hepatitis B or C 17. Positive IFNγ release assay for Mycobacterium tuberculosis at Screening Visit 1 18. Positive hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (HBcAb), positive HCV-antibody (HCV-Ab) and/or HIV-antigen-antibody test at Screening Visit 1 19. Any live vaccinations within 30 days before the date of informed consent except for the influenza vaccine Other medical history and concomitant disease exclusion criteria 20. Presence of the following laboratory values at Screening Visit 1: - platelet count <100,000/mm³ (<100 109/L) - serum creatinine >1.5 x ULN - total bilirubin, ALT, or GGT >1.5 x ULN - Serum uric acid levels at Screening Visit 1 >1.2 x ULN (for women >6.8 mg/dL, for men >8.4 mg/dL) - indirect (unconjugated) bilirubin >1.2 x ULN (i.e. >1.1 mg/dL) 21. Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis, including hereditary hyperoxaluria or hereditary hyperuricemia 22. History or clinical diagnosis of gout 23. Renal impairment defined as estimated glomerular filtration rate ≤60 mL/min/1.73m² 24. Known or suspected Gilbert syndrome 25. Diagnosis or suspected liver function impairment which may cause fluctuating liver function tests during this trial, as assessed by the investigator 26. History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (New York Heart Association [NYHA] class 3 or 4) Note: NYHA class 3: Cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. NYHA class 4: Cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. 27. Clinically relevant, severe pulmonary diseases, uncontrolled hypertension, or poorly controlled diabetes 28. Concurrent malignancy or prior malignancy within the previous 10 years except for the following: adequately-treated non-melanoma skin cancer and adequately-treated cervical cancer 29. History or presence of any major medical or psychiatric illness (such as severe depression, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the patient or could affect adherence with the trial protocol 30. Epilepsy or seizures not adequately controlled by treatment 31. Any other substantial medical condition that in the opinion of the investigator could create undue risk to the patient or could affect adherence with the trial protocol General exclusion criteria 32. Current or past (within 12 months of Screening Visit 1) alcohol or drug abuse 33. Any condition that would prevent the patient from undergoing an MRI scan, including: - claustrophobic conditions - unable to receive Gd-based MRI-contrast agents due to history of hypersensitivity to Gd based contrast agents, or severe renal insufficiency - presence of metallic implants incompatible with brain MRI 34. Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to understand the patient information and informed consent form 35. Pregnant or breastfeeding 36. An employee of an investigator or sponsor or an immediate relative of an investigator 37. Patients institutionalized due to judicial or administrative order Exclusion criteria for optional extended treatment period 1. Any ongoing, clinically significant (as assessed by the investigator) treatment-emergent (started after intake of IMP) AE or laboratory abnormality (including blood chemistry and urinalysis) 2. Significant treatment or trial non-compliance during the main treatment period (as assessed by the investigator), and/or inability or unwillingness to follow instructions by trial personnel 3. Treatment compliance <70% during the main treatment period 4. Significant protocol deviations during the main treatment period that are assessed by the investigator to negatively affect further patient cooperation in this trial ; PRIMARY OUTCOME: Difference Between 45 mg/Day IMU-838 and Placebo in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions; SECONDARY OUTCOME 1: Difference Between 30 mg/Day IMU-838 and Placebo in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - 003 (Lactose Intolerance); BRIEF: RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products). ; DRUG USED: RP-G28; DRUG CLASS: New Molecular Entity (NME); INDICATION: Food Allergies; TARGET: Bacteria-miscellaneous; THERAPY: Monotherapy; LEAD SPONSOR: Ritter Pharmaceuticals, Inc.; CRITERIA: Inclusion/Exclusion Criteria: - Female subjects must be non pregnant, and non lactating. Females of childbearing potential must use adequate birth control during study participation - Medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance. - Must be free from any disorder known to be associated with gastrointestinal disease: irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohns disease (CD), Celiac disease, diverticulitis, chronic constipation, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, small intestine bacterial overgrowth syndrome (SIBO), active gastric or duodenal ulcers, or history of severe ulcers. - Must be nicotine free. ; PRIMARY OUTCOME: Change from baseline in abdominal pain; SECONDARY OUTCOME 1: [/INST]No</s>