Datasets:

mi-rei

/

CT_efficiant

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 III - Nabi-4519 - Extension (QoL Evaluation); BRIEF: The purpose of this study is to look at pharmacoeconomic data for subjects that have received either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies. ; DRUG USED: NicVAX; DRUG CLASS: Vaccine; INDICATION: Smoking Cessation; TARGET: Immune System, Nicotinic Acetylcholine Receptors (nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Nabi Biopharmaceuticals; CRITERIA: Inclusion Criteria: - Subjects who are eligible for randomization or have not reached Week 12 in Nabi-4514 or Nabi-4515 studies. - Subjects who agree to participate in health-related quality of life study. Exclusion Criteria: - Subjects who are unable to complete a HRQoL questionnaire because of inability to understand the language or due to mental impairment. ; PRIMARY OUTCOME: To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period.; SECONDARY OUTCOME 1: To estimate utility scores for use in further health-economic models.[/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 - Pediatric; BRIEF: The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism. ; DRUG USED: Namenda XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Autism Spectrum Disorders (Autism); TARGET: NMDA Glutamate Receptor, Serotonin 5-HT3 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Males or females ages 6 to 12 years - Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 & 3). - A knowledgeable caregiver capable of providing reliable information about the patients condition, able to attend all clinic visits with the patient - Patients over age 12, only if they completed Study MEM-PK-21 Exclusion Criteria: - Medical history of active epilepsy/seizure disorder except simple febrile seizures - Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study ; PRIMARY OUTCOME: Extent of Absorption of Memantine (Part One); SECONDARY OUTCOME 1: Core Autism Treatment Scale-Improvement: Total Score[/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 - BLISS-76 (US/EU); BRIEF: The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease. ; DRUG USED: Benlysta; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: B-cell activating factor (BAFF); THERAPY: Combination; LEAD SPONSOR: Human Genome Sciences Inc.; CRITERIA: Key Inclusion Criteria: - Clinical diagnosis of SLE by ACR criteria. - Active SLE disease. - Autoantibody-positive. - On stable SLE treatment regimen. Key Exclusion Criteria: - Pregnant or nursing - Have received treatment with any B cell targeted therapy. - Have received treatment with a biological investigational agent in the past year. - Have received IV cyclophosphamide within 180 days of Day 0. - Have severe lupus kidney disease. - Have active central nervous system (CNS) lupus. - Have required management of acute or chronic infections within the past 60 days. - Have current drug or alcohol abuse or dependence. - Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C. ; PRIMARY OUTCOME: SLE Responder Index (SRI) Response Rate at Week 52; SECONDARY OUTCOME 1: SRI Response Rate at Week 76[/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 - 2- or 3-Dose Regimens - Young Adults; BRIEF: This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents. ; DRUG USED: Trumenba; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study. - Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. - Male or female subject aged ≥11 and <19 years at the time of enrollment. - Available for the entire study period and can be reached by telephone. - Healthy subject as determined by medical history, physical examination, and judgment of the investigator. - All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination.For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study. - Negative urine pregnancy test for female subjects. Exclusion Criteria: - Previous vaccination with any meningococcal serogroup B vaccine. - A previous anaphylactic reaction to any vaccine or vaccine-related component. - Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. - A known or suspected disease of the immune system or those receiving immunosuppressive therapy. - History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. - Significant neurological disorder or history of seizure (excluding simple febrile seizure). - Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination. - Current chronic use of systemic antibiotics. - Participation in other studies during study participation. Participation in purely observational studies is acceptable. - Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination. - Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. - Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. - Subject is pregnant or breastfeeding. - Subject is a direct descendant of study site or Pfizer personnel ; PRIMARY OUTCOME: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants; SECONDARY OUTCOME 1: Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants[/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/Ipilimumab (PD-L1 Expression >= 50%); BRIEF: The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as REGN2810/chemo/ipi) with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells. ; DRUG USED: Libtayo; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or stage IV disease, who received no prior systemic treatment for recurrent or metastatic NSCLC 2. Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample which has not previously been irradiated 3. Expression of PD-L1 in ≥50% of tumor cells determined by the commercially available assay performed by the central laboratory 4. At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 6. Anticipated life expectancy of at least 3 months Key Exclusion Criteria: 1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime 2. Active or untreated brain metastases or spinal cord compression 3. Patients with tumors tested positive for Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions 4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent 5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years 6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs) 7. Previous treatment with idelalisib at any time (ZYDELIG®) 8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Progression-Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessments; SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Open-Label (Pediatric); BRIEF: This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis. ; DRUG USED: E6005; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: Prostaglandin E Receptor 4 (PTGER4); THERAPY: Monotherapy; LEAD SPONSOR: Dermavant Sciences GmbH; CRITERIA: Inclusion Criteria: 1. Male and female pediatric patients aged 2 to 11 with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria. 2. Patients with atopic dermatitis covering > 25% of the body surface area and with an Investigator Global Assessment of disease severity of 2 or greater at baseline. 3. Minimum body weight of 10 kg. 4. Females of childbearing potential and male patients, who are engaging in sexual activity that could lead to pregnancy, must use the following adequate birth control methods while on study and for 2 weeks after stopping study drug. Acceptable contraception methods are: - Male or male partner with vasectomy OR - Male condom, AND partner use of one of the contraceptive options below: - Spermicide - Contraceptive subdermal implant that meets effectiveness criteria including a <1% rate of failure per year, as stated in the product label - Intrauterine device or intrauterine system that meets effectiveness criteria including a <1% rate of failure per year, as stated in the product label - Oral Contraceptive, either combined or progestogen alone - Injectable progestogen - Contraceptive vaginal ring - Percutaneous contraceptive patches These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The Investigator is responsible for ensuring that patients understand how to properly use these methods of contraception. Nonchildbearing potential is defined as premenarchal or premenopausal females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy; or hysteroscopic sterilization. Documented verbal history from the patient is acceptable. Patients who are abstinent are eligible, but they must use one of the birth control methods listed above if they start engaging in sexual activity that could lead to pregnancy during the study. Female patients of childbearing potential must have a negative pregnancy test at screening and Baseline (Day 0). 5. History of atopic dermatitis and stable disease for at least 1 month according to the patient or caregiver. 6. Patient or patients parent(s)/legal representative must be capable of giving written informed consent or verbal assent, as applicable, which includes compliance with the requirements and restrictions listed in the consent/assent form; written informed consent must be obtained prior to any study related procedures. Exclusion Criteria: 1. A positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis C antibody result, or positive human immunodeficiency virus (HIV) antibody at Screening. 2. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN). 3. Screening total bilirubin > 1.5x ULN; total bilirubin > ULN and ≤ 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%. 4. Patients with a skin condition such as Kaposis varicelliform eruption, scabies, molluscum contagiosum, impetigo, psoriasis, severe acne, connective tissue disorder, or Nethertons syndrome, or any other disease that could impact study evaluations. 5. Use of any prohibited medication. Prohibited concomitant medications, therapy, etc. during the defined period are as listed in the bullets below. If a patient requires any of these medications throughout the study period, he/she may be excluded from or discontinued from the study, at the discretion of the Investigator and medical monitor. - From 6 months prior to the first application of study drugs to the completion of the Follow-up visit or discontinuation: - Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis factor [TNF] inhibitors, anti-immunoglobulin [Ig]E antibodies, anti-CD20 antibodies, anti-interleukin [IL]-4 receptor). - From 28 days prior to the first application of study drug until the completion of the Follow-up visit or discontinuation: - Corticosteroid preparations (oral, injection, and suppository preparations) and topical corticosteroids that were classified as super-high potency (clobetasol propionate). Eye drops and nasal preparations are allowed. Inhaled preparations are allowed if used for a stable condition and at stable dose for ≥ 28 days before Screening, and are continued at the same dose throughout the study. - Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, azathioprine, tacrolimus, etc.); - Excessive sun exposure, tanning booth, other ultraviolet (UV) light source and phototherapy including psoralen and ultraviolet A (PUVA) therapy. - From 14 days prior to the first application of the study drug to the completion of the Follow-up visit or discontinuation: - Herbal medicines for atopic dermatitis (topical and oral preparations), unless specifically approved by the Sponsor; - Eucrisa™ (crisaborole) and any other topical phosphodiesterase 4 (PDE4) inhibitor; - Tacrolimus and pimecrolimus cream and/or ointment; - Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone). Eye drops and nasal preparations are allowed. - From 7 days prior to the first application of the study drug to the completion of the Follow- up visit or discontinuation: - Oral or intravenous antibiotics, antifungal or antivirus medications - Antihistamines/anti-allergics (oral, topical and injections): diphenhydramine, chlorpheniramine maleate, hydroxyzine). NOTE: The following antihistamines are allowed: - Loratadine, fexofenadine hydrochloride, cetirizine hydrochloride 6. Pregnant or lactating females. 7. History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates their participation. 8. The patient has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer). 9. Current or a history of cancer within 5 years. 10. Patients with active infection in atopic dermatitis areas requiring antibiotics, antifungals, or antiviral agents within 7 days of Baseline (Day 0). 11. Patients with pruritus due to conditions other than atopic dermatitis that, in the opinion of the Investigator, would either interfere with study evaluations or affect the safety of the patient. 12. Patients with advanced disease or recent abnormal laboratory test values that could affect the safety of the patient or the implementation of this study. 13. History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to PDE4 inhibitors. 14. Prior exposure to RVT-501. 15. Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities or laboratory abnormalities that will affect the health of the patient or interfere with interpretation of the results. 16. The patient has excessive sun exposure, is planning a trip to a sunny climate that would involve excessive sun exposure, or used tanning booths within 28 days prior to Baseline (Day 0) or is not willing to minimize natural and artificial sunlight exposure during the study. ; PRIMARY OUTCOME: Frequency and severity of adverse events (local and systemic); SECONDARY OUTCOME 1: Efficacy - Investigators Global Assessment (IGA)[/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 - CALGB 10503; BRIEF: This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back. ; DRUG USED: Dacogen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA Methyltransferase (DNMT); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Unequivocal histologic diagnosis of AML (> 20% blasts in the bone marrow based on the World Health Organization [WHO] and/or French American British [FAB] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there were no bone marrow biopsy showing myelodysplastic syndrome (MDS) > 3 months prior to enrollment; patients with therapy-related AML are eligible if they have been free of their primary disease and have not received any chemotherapy for at least 2 years - No prior 5-azacitidine or decitabine therapy - No prior treatment for leukemia or myelodysplastic syndrome with four permissible exceptions: - Emergency leukapheresis - Emergency treatment for hyperleukocytosis with hydroxyurea - Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only) - Growth factor/cytokine support ; PRIMARY OUTCOME: Number of Participants Who Completed Maintenance Decitabine.; 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 - ATLAS Ext.; BRIEF: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN). ; DRUG USED: BIIB023; DRUG CLASS: Biologic; INDICATION: Lupus Nephritis; TARGET: TWEAK/TWEAK receptor; THERAPY: Combination; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue BIIB023 or placebo study treatment. - Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment. Key Exclusion Criteria: - Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects participation. The Investigator must re-review the subjects medical fitness for participation and consider any diseases that would preclude treatment under this protocol. - Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201. - Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding. - Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subjects ability to comply with the protocol. - Other unspecified reasons that, in the opinion of the Investigator or Biogen, makes the subject unsuitable for enrollment. NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply. ; PRIMARY OUTCOME: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs); 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 - ENLIGHTEN-1; BRIEF: This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia. ; DRUG USED: Lybalvi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 4 (D4) Receptor, Histamine H1 Receptor (HRH1), Opioid receptors, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Alkermes, Inc.; CRITERIA: Inclusion Criteria: - Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2 - Meets criteria for the diagnosis of schizophrenia - Resides in a stable living situation when not hospitalized - Is willing and able to provide government-issued identification - Additional criteria may apply Exclusion Criteria: - Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening - Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms - Subject poses a current suicide risk - Subject has a history of treatment resistance - Subject has a history of poor or inadequate response to treatment with olanzapine - Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening - Subject has a diagnosis of moderate or severe alcohol or drug use disorder - Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening - Additional criteria may apply ; PRIMARY OUTCOME: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4; SECONDARY OUTCOME 1: Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - BISCAY (w/Durvalumab); BRIEF: This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment. This study is modular in design, allowing evaluation of the safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as monotherapy and as combinations of different novel anti-cancer agents. The study will consist of a number of study modules (sub-studies), each evaluating the safety and tolerability of a specific agent or combination. ; DRUG USED: ABSK091; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria for all Modules: 1. Metastatic MIBC 2. 2nd/3rd line 3. Failed adjuvant/neo-adjuvant chemotherapy <1 yr 4. 1 lesion ≥10 mm at baseline in the longest diameter suitable for accurate repeated measurement 5. WHO perf. status 0-1 For Module A: 1. M/F ≥25 2. Confirmation of FGFR3 mutation or FGFR fusion For Module B: 1. Hgb ≥10 g/dL 2. Deleterious mutation, deletion or truncation in any HRR genes For Module C: 1. Tumour harbours a deletion or inactivating mutation of the CDKN2A or RB1 genes and/or amplification of CCNE1, MYC, MYCL or MYCN genes For Module E: 1. Contraception must be sustained throughout treatment with vistusertib and 16 wks after last dose For Module F: 1. Adequate organ and marrow function, defined as Leukocytes ≥3.0x10(exp9)/L; ANC ≥1.5x10(exp9)/L; platelets ≥100x10(exp9)/L 2. Contraceptive measures must be sustained throughout treatment with AZD9150 and for 180 days after the last dose. Exclusion Criteria for all Modules: 1. Immunotherapy, chemotherapy, anticancer agents, radiotherapy <4 weeks, or radiotherapy for palliation <2 weeks, any study drugs <30 days. 2. Major surgery <4 weeks 3. Unresolved toxicities from prior therapy 4. Concurrent chemotherapy, immunotherapy, biologic or hormonal therapy 5. Immunosuppressive drugs <28 days 6. Any of the following: Autoimmune disease ≤2 yr; IBD; primary immunodeficiency; organ transplant requiring immunosuppressives 7. Spinal cord compression or brain metastases, treated and stable & not requiring steroids for at least 4 weeks 8. Severe or uncontrolled systemic disease 9. Any of the following: Mean QTc ≥470 ms; abnormalities in resting ECG; factors that increase the risk of QTc prolongation or arrhythmia; uncontrolled hyper/hypotension; LVEF <55%; atrial fibrillation; NYHA Grade II-IV; severe valvular disease; uncontrolled angina; stroke/TIA <6 months; acute coronary syndrome <6 months 10. Any of the following laboratory values: ANC <1.5x10(exp9)/L; Platelets <100x10(exp9)/L; Hgb <9.0 g/dL; ALT >2.5xULN or >5xULN with liver mets; Total bilirubin >1.5 times ULN or with Gilberts disease ≥2×ULN; Creatinine >1.5xULN concurrent with creatinine clearance <50 mL/min; Corrected Ca >ULN, PO4 >ULN 11. Active infection including tuberculosis, hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus. Patients with a past or resolved HBV infection are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 12. Live attenuated vaccination <30 days For Module A: 1. Prior exposure to: Nitrosourea or mitomycin C <6 weeks; any agent with FGFR inhibition as its primary pharmacology; AZD4547; potent inhibitors/inducers of CYP3A4, inhibitors of CYP2D6 or substrates of CYP3A4 <2 wks 2. Ophthalmological criteria: RPED; laser treatment or intraocular injection for macular degeneration; age-related macular degeneration; retinal vein occlusion; retinal degenerative disease; other clinically relevant chorioretinal defect 3. Refractory nausea/vomiting, chronic GI diseases, or previous bowel resection For Module B: 1. Transfusion <120 days 2. Concurrent medications that are strong inhibitors of cytochrome P450 (CYP) 3A (CYP3A) or strong inducers of CYP3A4. 3. Previous treatment with PARP inhibitor, including olaparib 4. Patients with history of MDS or AML For Module C: 1. Prior exposure to any of the following: Nitrosourea or mitomycin C <6 wks; any agent with Wee1 inhibition as its primary pharmacology; prior treatment with AZD1775 2. Any drugs or products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with narrow therapeutic index, or moderate to strong inhibitors/inducers of CYP3A4 3. Herbal preparations 4. Refractory nausea and vomiting or chronic GI diseases 5. Cardiac disease <6 months For Module E: 1. Minor surgery <14 days of first dose 2. Exposure to specific substrates of OATP1B1, OATP1B3, MATE1 and MATE2K <5x half-life before treatment. Exposure to strong/moderate inhibitors/inducers of CYP3A4/5, Pgp (MDR1) and BRCP if taken within washout periods before the first dose 3. Haemopoietic growth factors (filgrastim, sargramostim, GM-CSF) <14 days prior to treatment 4. Other mTOR inhibitors 5. Renal disease or renal tubular acidosis 6. Uncontrolled Type 1 or 2 diabetes For Module F: 1. AST ≤ 2.5xULN or ≤5xULN with liver metastases For Module G: 1. Have had prior treatment with a MEK, Ras or Raf inhibitor. 2. Any of the following ophthalmic criteria: Current or past history of central serous retinopathy, detachment of retinal pigmented epithelium, or retinal vein occlusion; intraocular pressure (IOP) >21 mmHg; uncontrolled glaucoma (irrespective of IOP) 3. Baseline left ventricular ejection fraction (LVEF) <55% measured by echocardiogram (ECHO) or, if allowed, a multigated acquisition (MUGA) scan. Appropriate correction to be used if a MUGA is performed. 4. Previous moderate or severe impairment of LVEF (<45% on echocardiography or equivalent on MUGA) even if full recovery has occurred. 5. Male or female patients with reproductive potential and, as judged by the investigator, are not employing an effective method of birth control and female patients who are breastfeeding. 6. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 7. Receiving or have received systemic therapy with nitrosoureas, mitomycin or suramin within 6 weeks prior to starting study treatment. ; PRIMARY OUTCOME: Module A: The frequency and nature of adverse events related to AZD4547 monotherapy.; SECONDARY OUTCOME 1: Objective response rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - HR+/HER2 non-amp (w/CX-072); BRIEF: A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC ; DRUG USED: CX-2009; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), CD166/ALCAM, Microtubules (Tubulin); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: CytomX Therapeutics; CRITERIA: INCLUSION CRITERIA: - Arm A: inoperable, locally advanced or metastatic HR-positive/HER2-negative breast cancer. Patients must have received 0 to 2 prior cytotoxic chemotherapy in the inoperable, locally advanced, or metastatic setting - Arm B and Arm C: inoperable, locally advanced or metastatic TNBC; archival or fresh tumor tissue must have high CD166 expression by immunohistochemistry (IHC). Patients must have received 1 - 3 prior lines of therapy for inoperable, locally advanced, or metastatic TNBC - Arm C only: Patients must be Programmed Death Ligand 1 (PD-L1) positive by an FDA-approved test. For patients who have received prior checkpoint inhibitors (CPI) therapy: if the CPI was the most recent treatment given prior to enrollment into this study, the patient must not have progressed within 120 days of the first dose of the CPI - Measurable disease per RECIST v1.1 - Adults, at least 18 years of age - Eastern Cooperative Oncology Group performance status of 0 or 1 - Adequate baseline Laboratory Values - Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control at least 1 month prior to first dose, during study treatment, and for a period of 50 days after the last dose of CX-2009 and 105 days after the last dose of CX-072 (Arm C). - Patients with brain metastases that are ≤ 1 cm, are asymptomatic, and require no treatment may be eligible after discussion with Medical Monitor. - Additional inclusion criteria may apply EXCLUSION CRITERIA: - History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator present a low risk for recurrence - Untreated symptomatic brain and/or leptomeningeal metastases - Unresolved prior therapy-related acute toxicity Grade > 1, including neuropathy. Alopecia and other nonacute toxicities are not exclusionary - Active or chronic corneal disorder - Serious concurrent illness - History of allogeneic tissue/solid organ transplant, stem cell transplant, or bone marrow transplant - Arm C only: - History of or current active autoimmune diseases - History of myocarditis regardless of the cause - History of intolerance to prior immune CPI therapy defined as the need to discontinue treatment due to an immune-related Adverse Event (AE) - Immunosuppressive therapy including chronic systemic steroid (≥ 10 mg daily prednisone equivalents) within 14 days of Cycle 1 Day 1 (C1D1). However, patients who require brief courses of steroids (eg, as prophylaxis for IV contrast or for treatment of an allergic reaction) may be eligible with Medical Monitor approval. Inhaled or topical steroids are permitted. - History of severe allergic or anaphylactic reactions to previous monoclonal antibody (mAb) therapy or known hypersensitivity to any component of Probody therapeutic - Prior treatment with maytansinoid-containing drug conjugates (eg, DM1 or DM4 antibody drug conjugate, including trastuzumab emtansine) - Pregnant or breastfeeding - Additional exclusion criteria may apply ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Investigator-assessed Progression-Free Survival (PFS)[/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; BRIEF: This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer. ; DRUG USED: IRX4204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Retinoid X receptors (RXRs); THERAPY: Monotherapy; LEAD SPONSOR: Io Therapeutics; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed prostate cancer - Documented progression on at least one prior hormone treatment, AND at least one taxane based chemotherapy regimen, or patients refusal of chemotherapy treatment - Male, Age > 18 years - ECOG (Eastern Cooperative Oncology Group) performance score of 0-2 - Adequate bone marrow, renal and hepatic function - Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter Exclusion Criteria: - Prior treatment with NRX 194204 or bexarotene (Targretin) - Presence of parenchymal brain metastases - History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months - Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment - Known HIV or hepatitis B or C infection - Life expectancy < 3 months - Patients with any history of thyroid disease, pituitary disease or treatment with thyroid replacement hormone - Patients with a history of pancreatitis or at significant risk of developing pancreatitis ; PRIMARY OUTCOME: Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - BSX-002; BRIEF: Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies. Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population ; DRUG USED: Simulect; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: IL-2 Receptor (IL-2R) ; THERAPY: Combination; LEAD SPONSOR: Cerimon Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Previously met eligibility criteria in the previous basiliximab UC study 2. Must have a total Mayo score at entry consistent with clinical response or clinical remission. 3. Signed a current IRB/IEC-approved informed consent form 4. Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug. 5. Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years. Exclusion Criteria: 1. Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features: - Heart rate > 90 beats/min at rest - Temperature > 37.8 degrees C - Hemoglobin < 10.5 g/dL 2. Subject is currently receiving a restricted/prohibited concomitant medication 3. Subject has undergone colectomy (total, or subtotal) 4. Subject is pregnant or breast-feeding 5. Prior noncompliance with previous study visit schedule and requirements ; PRIMARY OUTCOME: Assess the safety of basiliximab in subjects with ulcerative colitis; SECONDARY OUTCOME 1: Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population[/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 - Recurrent Symptomatic Ascites; BRIEF: The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites. ; DRUG USED: Removab; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Cluster of Differentiation 3 (CD3), Epithelial cell surface antigen (Ep-CAM)/ CD326; THERAPY: Monotherapy; LEAD SPONSOR: Neovii Biotech; CRITERIA: Inclusion Criteria: - Signed and dated informed consent - Histologically confirmed diagnosis of epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer; any stage at diagnosis [International Federation of Gynecology and Obstetrics (FIGO) Stages I through IV]. - Progression on or ≤ 12 months after primary platinum-based systemic or intraperitoneal (IP) chemotherapy OR relapse following reinduction ≥ 12 months after primary chemotherapy. - Have refused, failed, or have been deemed not suitable candidates for gemcitabine or liposomal doxorubicin. - Recurrent symptomatic malignant ascites requiring therapeutic paracentesis - At least 1 therapeutic paracentesis within 4 weeks prior to baseline paracentesis - Age ≥ 18 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Life expectancy ≥ 16 weeks - Serum creatinine ≤ 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin ≤ 1.5 x ULN - Absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3 - Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility). - Willingness of patients of childbearing potential to use an effective contraceptive method (i.e., oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion. Exclusion Criteria: - Acute or chronic systemic infection - Exposure to investigational drugs, chemotherapy or radiotherapy 21 days prior to the first dose of catumaxomab - Major surgery 2 weeks prior to first dose - Previous treatment with mouse or rat antibodies - Known or suspected hypersensitivity to catumaxomab or other monoclonal antibodies - Body mass index (BMI) < 19 (body weight after paracentesis to be used for calculation of BMI) - Serum albumin level < 2.0 g/dL - Reduced nutritional status requiring predominantly parenteral nutrition (> 50% of energy intake). Permanent naso-gastric (NG) feeding tube. - Ileus in a location that precludes paracentesis - Extensive liver metastases (> 70% organ volume comprises malignancy) - Documented brain metastases - History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia 3 months prior to the first dose of catumaxomab - Portal vein obstruction or portal vein thrombosis diagnosed by computed tomography (CT) scan at screening - Persistent massive pleural effusion or inadequate respiratory function of any other etiology (except if related to ascites symptoms) in the opinion of the investigator - Any other condition which, according to the investigator, results in an undue risk to the patient by participating in the study - Prior exposure to catumaxomab ; PRIMARY OUTCOME: The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.; SECONDARY OUTCOME 1: Puncture/Paracentesis-free Survival (PuFS)[/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 - KCP-330-003; BRIEF: The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st generation tablets. ; DRUG USED: Xpovio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sarcoma; TARGET: Exportin-1/CRM1/XPO1, Immune System, Interferon-beta (IFNb), SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Karyopharm Therapeutics Inc; CRITERIA: Inclusion Criteria: 1. Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma. Patients with sarcoma of small round blue cell tumor types are allowed. Gastrointestinal stromal tumors (GIST) are excluded. 2. Patients must have received at least one prior anticancer regimen for metastatic disease unless there is no other therapy available and evidence of progressive disease on study entry. Patients with stable disease will be included if there has been failure to respond to another drug(s) within the previous 3 months Exclusion Criteria: 1. Patients with known liver metastases 2. Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of therapy 3. Patients with known brain metastasis 4. Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data 5. Patients with known intolerance to low or high fat meals 6. In the opinion of the investigator, patients who are significantly below their ideal body weight ; PRIMARY OUTCOME: Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor; SECONDARY OUTCOME 1: Percentage of Participants With Best Overall Response According to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Criteria[/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 - ASPIRE; BRIEF: The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in participants with hemophilia A. ; DRUG USED: Eloctate; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bioverativ Therapeutics Inc.; CRITERIA: Key Inclusion Criteria: - Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965, NCT01458106 and NCT02502149) - Ability to understand purposes and risks of the study and to provide signed and dated informed consent (or assent, as applicable). Key Exclusion Criteria: - Confirmed positive high-titer inhibitor (≥5.00 BU/mL). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Number of Participants With Any Positive Inhibitor Development; SECONDARY OUTCOME 1: Annualized Bleeding Rate (ABR)[/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 - Japan; BRIEF: The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis. ; DRUG USED: Reclast; DRUG CLASS: Non-NME; INDICATION: Osteoporosis / Osteopenia; TARGET: Osteoclast; THERAPY: Monotherapy; LEAD SPONSOR: Asahi Kasei Pharma Corporation; CRITERIA: Inclusion Criteria: - Patients diagnosed with primary osteoporosis - Patients who have vertebral fractures at the time of screening Exclusion Criteria: - Patients diagnosed with secondary osteoporosis - Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study ; PRIMARY OUTCOME: New vertebral fractures; SECONDARY OUTCOME 1: Vertebral fractures (worsening and new)[/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/Azacitidine (High Risk MDS); BRIEF: Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods. ; DRUG USED: Mocetinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Histone Deacetylase (HDAC); THERAPY: Combination; LEAD SPONSOR: Mirati Therapeutics Inc.; CRITERIA: Inclusion Criteria: Diagnosis of intermediate- or high-risk (IPSS criteria) myelodysplastic syndrome. Cohort 1: Any prior treatment, enrollment complete. Cohort 2: Limited or no prior treatment for MDS. Prior treatment should not include hypomethylating agents such as azacitidine or decitabine, or HDAC inhibitors. ECOG Performance Status 0 or 1. Exclusion Criteria: Current or history of small, moderate or large pericardial effusion, tamponade and/or pericarditis. Significant cardiac abnormalities such as recent myocardial infarction, congestive heart failure ≥ Class 3, or symptomatic, uncontrolled atrial fibrillation, atrial flutter or sinus tachycardia. Prolonged QT/QTc interval. Other active cancer excluding basal cell carcinoma or cervical intraepithelial neoplasia. ; PRIMARY OUTCOME: Number of subjects with adverse events, including pericardial events, as a measure of safety; SECONDARY OUTCOME 1: Number of subjects experiencing clinical disease response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - MTD; BRIEF: The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis. ; DRUG USED: Belapectin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Galectin-3; THERAPY: Monotherapy; LEAD SPONSOR: Galectin Therapeutics Inc.; CRITERIA: Inclusion Criteria: Subjects meeting all of the following criteria will be considered for admission to the study: 1. Institutional Review Board (IRB approved written Informed Consent and privacy language as per national regulation (eg, Health Insurance Portability and Accountability Act [HIPAA] Authorization for US sites) must be obtained from the subject or legally authorized representative prior to any study related procedures, including screening evaluations and tests. 2. Subject is ≥ 18 years of age and < 75 years old at the time of consent. 3. Subject has had a percutaneous liver biopsy within 12 months from Screening that shows a definitive diagnosis of NASH with advanced (Brunt stage 3) hepatic fibrosis. 4. Sexually active males and females of childbearing potential must agree to use adequate contraception (condoms, intra-uterine contraceptive device, implants, injectables, sexual abstinence or vasectomized partner) throughout their participation in this study and for 30 days after the last dose of study drug. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to the first dose. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-child-bearing potential. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Subject is a pregnant or lactating female. 2. Subject with current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening. Significant alcohol consumption is defined as more than 20 gram per day in females and more than 30 grams per day in males, on average (a standard drink in the US is considered to be 14 grams of alcohol). 3. Subject is unable to reliably quantify alcohol consumption based upon local study physician judgment. 4. Subject uses drugs historically associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the year prior to Screening. 5. Subject requires use of drugs with a narrow therapeutic window metabolized by CYP3A4 such as fast acting opioids (alfentanil and fentanyl), immunosuppressive drugs (cyclosporine, sirolimus, and tacrolimus), some cardiovascular agents (ergotamine, quinidine and dihydroergotamine), and select psychotropic agents (pimozide). 6. Subject has prior or has planned (during the study period) bariatric surgery (eg, gastroplasty, Roux-en-Y gastric bypass). 7. Subject has concurrent infection including diagnoses of fever of unknown origin and evidence of possible central line sepsis (subjects must be afebrile at the start of therapy). 8. Subject with a platelet count below 100,000/mm3 at Screening. 9. Subject with clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities at Screening: 1. Serum albumin less than 3.5 grams/deciliter (g/dL). 2. An INR greater than 1.1. 3. Direct bilirubin greater than 1.3 milligrams per deciliter (mg/dL). 10. Subject has a history of bleeding esophageal varices, ascites or hepatic encephalopathy 11. Subject has a history of hepatitis C. Patients found on screening to have hepatitis C antibody, even if PCR negative for HCV RNA, are excluded from this study. 12. Subject has evidence of other forms of chronic liver disease: 1. Hepatitis B as defined by presence of hepatitis B surface antigen. 2. Evidence of ongoing autoimmune liver disease as defined by compatible liver histology. 3. Primary biliary cirrhosis as defined by the presence of at least 2 of these criteria (i) Biochemical evidence of cholestasis based mainly on alkaline phosphatase elevation (ii) Presence of anti-mitochondrial antibody (iii) Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts. 4. Primary sclerosing cholangitis. 5. Wilsons disease as defined by ceruloplasmin below the limits of normal and compatible liver histology. 6. Alpha-1-antitrypsin deficiency as defined by diagnostic features in liver histology (confirmed by alpha-1 antitrypsin level less than normal; exclusion at the discretion of the study physician). 7. History of hemochromatosis or iron overload as defined by presence of 3+ or 4+ stainable iron on liver biopsy. 8. Drug-induced liver disease as defined on the basis of typical exposure and history. 9. Known bile duct obstruction. 10. Suspected or proven liver cancer. 11. Any other type of liver disease other than NASH. 13. Subject with serum ALT greater than 300 units per liter (U/L) at Screening. 14. Subject with serum creatinine of 1.5 mg/dL or greater at Screening. 15. Subject using of any prescription or over-the-counter medication or herbal remedy that are believed to improve or treat NASH or liver disease or obesity during the period beginning 30 days prior to randomization. Subjects who are using Vitamin E or omega-3 fatty acids may continue their use. 16. Subject had major surgery within 8 weeks prior to Day 0, significant traumatic injury, or anticipation of need for major surgical procedure during the course of the study. 17. Subject with a history of biliary diversion. 18. Subject with known positivity for Human Immunodeficiency Virus infection. 19. Subject with an active, serious medical disease with likely life expectancy of less than 5 years. 20. Subject with active substance abuse, including inhaled or injection drugs, in the year prior to Screening. 21. Subject who has clinically significant and uncontrolled cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 12 months prior to Day 0. 22. Subject has participated in an investigational new drug (IND) trial in the 30 days before randomization. 23. Subject has a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study. 24. Subject has any other condition which, in the opinion of the Investigator, would impede compliance or hinder completion of the study. 25. Subject has been previously exposed to GR MD 02. 26. Subject with known allergies to the study drug or any of its excipients. 27. Subject with malignant disease (other than basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix) with at least 5 years of follow-up showing no recurrence. 28. Subject has an abnormal chest x-ray indicative of acute or chronic lung disease on screening examination. ; PRIMARY OUTCOME: Primary objective is to characterize safety for GR-MD-02 administered intravenously to subjects w/ biopsy-proven NASH w/ advanced liver fibrosis. Specifically assessed by number of subjects experiencing TEAEs.; SECONDARY OUTCOME 1: A secondary objective is to characterize the first-dose PK profile of GR-MD-02. The PK profile is assessed by the AUC (area under the plasma concentration versus time curve) and Cmax (peak plasma concentration) of GR-MD-02.[/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 - DLBCL; BRIEF: Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study. ; DRUG USED: Pidilizumab; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Immune System, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: CureTech Ltd; CRITERIA: Inclusion Criteria: 1. Patients age is 18 years or older, both genders. 2. Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage. 3. The lymphoma is chemosensitive. 4. The lymphoma did not progress since pre-transplant chemotherapy. 5. ECOG performance status 0-1. Exclusion Criteria: 1. Serious other illness. 2. Active autoimmune disease. 3. Type 1 diabetes. 4. Known immune deficiency. 5. Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma. 6. Active bacterial, fungal, or viral infection. 7. Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia. 8. Pregnant or nursing (positive pregnancy test). 9. Other concurrent clinical study or investigational therapy. ; PRIMARY OUTCOME: Progression-free Survival; 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 III - Paclitaxel/Carboplatin; BRIEF: To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel ; DRUG USED: ProMune ; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Toll-like receptor 9 (TLR9); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV - No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs - Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1 Exclusion Criteria: - Small cell or carcinoid lung cancer - Known Central Nervous System (CNS) metastasis - Pre-existing auto-immune or antibody mediated diseases ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Overall Objective 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 IIIb - IMMerge; BRIEF: The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. ; DRUG USED: Skyrizi; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit - Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis - Subject must be a candidate for systemic therapy as assessed by the investigator; - Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound. Exclusion Criteria: - History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis; - Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines. - Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold) - History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix - Previous exposure to risankizumab - Previous exposure to secukinumab ; PRIMARY OUTCOME: Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16; SECONDARY OUTCOME 1: Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Keloid Removal (1401); BRIEF: To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision. ; DRUG USED: RXI-109; DRUG CLASS: New Molecular Entity (NME); INDICATION: Wound Healing; TARGET: Connective Tissue Growth Factor (CTGF); THERAPY: Monotherapy; LEAD SPONSOR: RXi Pharmaceuticals, Corp.; CRITERIA: Inclusion Criteria: - Adults, 21-55 years of age. - Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso. - Keloids to be excised must have been present for > 1 year. Exclusion Criteria: - Use of tobacco or nicotine-containing products - Pregnant or lactating - Post-menopausal or full hysterectomy ; PRIMARY OUTCOME: Reduction in the recurrence of a keloid after keloid excision; SECONDARY OUTCOME 1: Safety of RXI-109[/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 - MERCURY 3 (EU); BRIEF: The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure ; DRUG USED: Rocklatan; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Prostaglandin F receptor (FP)/PGF2 alpha receptor , Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Must be 18 years of age or older. 2. Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable). 3. Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators. 4. Medicated intraocular pressure ≥ 17 mmHg in at least one eye and < 28mmHg in both eyes at screening visit. 5. Unmedicated (post-washout) IOP >20mmHg in at least one eye and < 36mmHg in both eyes at 2 qualification visits at 08:00 hour, 2-7 days apart. At the second qualification visit, have IOP >17mmHg in at least one eye and < 36mmHg in both eyes at 10:00 and 16:00 hours. Note: For purposes of determining eligibility of subjects to be enrolled, the non-integral IOP mean number will be used. Any non-integral mean IOP number should not be rounded. If only one eye qualifies at the second qualification visit it MUST be the same eye that qualified on the first visit and this will be the study eye for the duration of the study. 6. Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200 or better Snellen visual acuity in each eye). 7. Be able and willing to give signed informed consent and follow study instruction. 8. Women must be either of non-childbearing potential, or women with childbearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study. 9. Women of childbearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective contraception during the study and for 3 months after the last dose of study medication. 10. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use an effective form of contraception from time of randomization and for 3 months following the last dose of study medication. 11. In France, a subject will be eligible for inclusion in this study only if either affiliated to or as a beneficiary of a social security number. Exclusion Criteria: Ophthalmic: 1. Clinically significant ocular disease (e.g., corneal edema, uveitis, or severe keratoconjunctivitis sicca) which might interfere with interpretation of the study efficacy endpoints or with safety assessments, including subjects with glaucomatous damage so severe that washout of ocular hypotensive medications for 4 weeks or longer if needed is not judged safe as it would put the subject at risk for further vision loss. 2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles i.e. Grade 2 Shaffer (Chan 1981) or less extreme narrow angle with complete or partial closure. Note: Previous laser peripheral iridotomy is NOT acceptable. 3. Intraocular pressure ≥ 36mmHg (unmedicated) in either eye (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combination medications, for the purpose of this exclusion criterion, count as one medication. However, subjects currently taking 2 fixed dose combination products are excluded. 4. Treatment-naïve subjects. 5. Prior treatment with GANFORT® topical eye drops where the subjects IOP did not achieve the target IOP and was considered either a therapeutic failure or to have insufficient response. Subjects currently (immediately prior to screening visit) being treated with GANFORT® are excluded from the study. 6. Known hypersensitivity to any component of the investigational formulations to be used (e.g., benzalkonium chloride) or to fluorescein. 7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye. 8. Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty). 9. Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening. 10. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, current evidence or history of herpes simplex or zoster keratitis in either eye at screening. 11. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications which must have been the same medication for 30 days prior to screening (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study), as prescribed by the Investigator. 12. Mean central corneal thickness greater than 620μm at screening. 13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g., keratoconus). Systemic: 14. Clinically significant abnormalities in laboratory tests at screening. 15. Known hypersensitivity or contraindication to GANFORT® (Appendix 3 Marketed Product Medication Information Section 4.3) and to β-adrenoceptor antagonists (e.g. Chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third-degree heart block or congestive heart failure, cardiac failure, cardiac shock and severe diabetes). 16. Clinically significant systemic disease which might interfere with the study. 17. Participation in any investigational study within 30 days prior to screening. 18. Systemic medication including corticosteroid containing drugs that could have a substantial effect on IOP which HAVE NOT been maintained at a consistent dose and regime within 30 days prior to screening, and are anticipated to change in dose and/or regime during the study. 19. Use of topical steroid containing medications on the face or in or around the eyes will exclude the subject (see Section 5.6 Concomitant Medications). 20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable and highly effective form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal (1 year without menses with appropriate clinical profile, e.g. age appropriate, > 45 years in the absence of HRT. In questionable cases the subject must have FSH value > 40mIU/mL and an estradiol value < 40pg/mL (< 140pmol/L)) or three months post-surgical sterilization. 21. Vulnerable subjects such as minors, adults under legal protection or unable to express their consent (e.g. hospitalized persons in coma), persons deprived of liberty (prisoners from jails), or persons subject to psychiatric care. ; PRIMARY OUTCOME: Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - vs. Enteral Nimodipine; BRIEF: Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage. ; DRUG USED: EG-1962; DRUG CLASS: Non-NME; INDICATION: Subarachnoid Hemorrhage; TARGET: Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: Edge Therapeutics Inc; CRITERIA: Inclusion Criteria: 1. Ruptured saccular aneurysm repaired by neurosurgical clipping 2. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale 3. WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair Exclusion Criteria: 1. Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm 2. Angiographic vasospasm prior to randomization 3. Evidence of cerebral infarction with neurological deficit ; PRIMARY OUTCOME: Incidence and severity of adverse events; SECONDARY OUTCOME 1: Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Bunionectomy (Study 022); BRIEF: This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery. ; DRUG USED: MoxDuo IR; DRUG CLASS: Non-NME; INDICATION: Acute Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: QRxPharma Inc.; CRITERIA: Inclusion Criteria: - Patient is male or female and at least 18 years of age. - Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment. - Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery. - To be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point Likert scale or 4 or more on the 11 point NPRS scale). - At least 40% of study subjects will be 60 years of age or older. Exclusion Criteria: - In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that would jeopardize the patients well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments. - Used opiates continuously (including tramadol) for more than ten days in the past year. - Hypersensitivity or poor tolerance to acetaminophen. - Currently receiving any medications that are not at a stable dose (the same dose for > 2 months prior to date of surgery). - Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003. - Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia). - Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit). ; PRIMARY OUTCOME: Differences in desaturation events per standardized time unit; SECONDARY OUTCOME 1: Difference in efficacy between Q8003 and its components (morphine and oxycodone)[/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 - Prevention of Bacterial Vaginosis Recurrence; BRIEF: This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence when compared to placebo. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo. ; DRUG USED: Lactin V; DRUG CLASS: Biologic; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Microbiota (flora, microbiome) excluding the digestive tract; THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Allergy and Infectious Diseases (NIAID); CRITERIA: Inclusion Criteria: 1. Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures 2. Untreated BV (asymptomatic or symptomatic) as diagnosed during the screening visit defined by >/=3 Amsel criteria. Note: Amsel criteria include the following: --Homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; --Vaginal pH >4.5; --Positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide (KOH) is added to a sample of vaginal discharge; --Presence of clue cells (>20% on microscopy). 3. Untreated BV(asymptomatic or symptomatic) as confirmed in the laboratory using the Nugent scoring system (Nugent Score >/= 4) 4. Otherwise healthy pre-menopausal women 18-45 years of age on the day of screening 5. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of a long-acting progestin or continuous use of oral contraceptives 6. Willing to be asked questions about personal medical health and sexual history. 7. Willing to apply study agent vaginally and comply with study examinations. 8. Agree to abstain from sexual intercourse during the first 5 consecutive days of study product administration, 12 hours prior to study visits and for 12 hours after each study product application 9. Agree to abstain from the use of any other intravaginal product throughout the trial period from the time of screening through Visit 7 (Week 24, Day 168) Note: Intravaginal products include contraceptive creams such as Gynol II, gels, foams, sponges, lubricants not approved by the study investigators, and douches. Limit use of tampons during menstruation to unscented products. 10. Must be of non-childbearing potential or if of childbearing potential, must agree to use a reliable method of birth control for the duration of the study Note: Reliable methods of birth control include tubal ligation, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable or implantable), IUD, condoms or abstinence. Exclusion Criteria: 1. Urogenital infection at screening Note: Urogenital infection includes urinary tract infection, Trichomonas (T.) vaginalis, Neisseria (N.) gonorrhoeae, Chlamydia (C.) trachomatis, Treponema (T.) pallidum, or vulvo-vaginal candidiasis. 2. Diagnosis of two or more outbreaks of N. gonorrhoeae, C. trachomatis, T. pallidum, T. vaginalis, or herpes simplex virus (herpes genitalis) within 6 months prior to screening 3. Positive for syphilis or HIV at screening 4. Current pregnancy or within 2 months of last pregnancy and/or currently breastfeeding**. Criteria will be assessed at screening and enrollment. 5. Vaginal or systemic antibiotic or antifungal therapy (other than MetroGel given as part of study procedures) within 21 days of screening or within 30 days of enrollment** 6. Use of disulfiram within past 2 weeks or other contraindication to use of MetroGel** 7. Any condition requiring regular periodic use of systemic antibiotics during participation in the trial 8. Active genital herpes lesion** (if not resolved by enrollment)** 9. Investigational drug use other than LACTIN-V within 30 days or 10 half-lives of the drug, whichever is longer, of enrollment visit** 10. Other planned participation in an investigational drug study while participating in this study** 11. Menopause defined as more than 12 consecutive months of amenorrhea without another known cause including pregnancy 12. IUD insertion or removal, pelvic surgery, cervical cryotherapy or cervical laser treatment within the last 2 months prior to screening 13. Use of vaginal ring (eg, NuvaRing) within 3 days of screening or during the course of the study** 14. Failure to complete 5 days of MetroGel with the last dose taken no later than 48 hours prior to randomization*** 15. Use of new long-acting hormonal treatments. Participant may be enrolled if stable (>3 months) on existing therapy as determined by the principal investigator** 16. Known allergy to any component of LACTIN-V/placebo or MetroGel or to nitroimidazole derivatives or latex (condoms) 17. Any social, medical, or psychiatric condition, including history of drug or alcohol abuse that in the opinion of the investigator would make it unlikely for the participant to comply with the study ** Note: Criteria will be assessed at screening and enrollment. ***Note: Criteria will be assessed at enrollment ; PRIMARY OUTCOME: The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm.; SECONDARY OUTCOME 1: The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Study 001 (Refractory Tumors); BRIEF: The purpose of this study is to determine the tolerability of ME-344, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors. ; DRUG USED: ME-344; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC, Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: MEI Pharma, Inc.; CRITERIA: Inclusion Criteria: - Provision of informed consent - Male or female ≥ 18 years of age - Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives. - ECOG Performance status 0-1 (Appendix A) - A minimum life expectancy of 12 weeks - Adequate bone marrow, hepatic and renal function as evidenced by: - Absolute neutrophil count (ANC) > 1.5 x 109/L - Platelet count > 100 x 109/L - Hemoglobin > 9.0 g/dL - Serum bilirubin < 1.5 x ULN - AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases - Serum creatinine < 1.5 x ULN - Adequate cardiac function as evidenced by: - CK-MB within normal levels at baseline - Troponin T within normal levels at baseline - The average QTc from triplicate screening ECGs (every 5 minutes over a total of 15 minutes) must be < 470 msec to be eligible for the study. (If a patient has an average QTc interval >470 msec at screening, the screening ECG may be repeated twice (at least 24 hours apart). - LV Ejection Fraction > lower limit of institutional normal level - All potentially fertile patients will agree to use an effective form of contraception during the study and for 30 days following the last dose of ME-344 (an effective form of contraception is defined as an oral contraceptive or a double barrier method). - At least 4 weeks must have elapsed prior to Day 1 Cycle 1 since prior chemotherapy (6 weeks for nitrosourea or mitomycin C), investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to ≤ NCI-CTCAE Grade 1. - At least 21 days must have elapsed prior to Day 1 Cycle 1, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for limited palliative radiotherapy, defined as a course of therapy encompassing <25% total bone marrow volume and not exceeding 30 Gy. Exclusion Criteria: - Patients who are pregnant or breastfeeding - Tumor involvement of the Central Nervous System (CNS): - Patients with treated and stable CNS metastases may be eligible to participate after discussion and approval from the Medical Monitor - Uncontrolled infection or systemic disease. - Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months. - Any major surgery, radiotherapy, or immunotherapy within the last 21 days. Limited palliative radiation, defined as encompassing <25% of total bone marrow volume and not exceeding a total dose of 30 Gy, within the last 14 days. - Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential or delayed toxicity within the last 2 weeks. - No concurrent systemic chemotherapy or biologic therapy is allowed. - Known hypersensitivity to any components of ME-344 study drug product. - Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both). - History of solid organ transplantation. - Psychiatric disorder or social or geographic situation that would preclude study participation. ; PRIMARY OUTCOME: Dose limiting toxicity; SECONDARY OUTCOME 1: 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- w/Pembrolizumab (Massachusetts General Hospital/NCI); BRIEF: Cancers attract myeloid-derived suppressor cells (MDSCs) that prevent our own immune responses from destroying the cancer. This study will be the first study to begin to determine if the newly discovered drug SX-682 can block cancers from attracting MDSCs. This first study will enroll participants with melanoma, as melanoma cancer has been shown to be able to attract MDSCs. The study will begin to determine if SX-682 is a safe and effective treatment of melanoma. It is thought that SX-682 will block MDSCs from going to the cancer, and thus will allow a patients own immune system to attack the cancer. The first participants enrolled in the study will receive for 21 days SX-682 as monotherapy. After 21 days participants will receive pembrolizumab therapy (an approved immunotherapy for melanoma) in combination with SX-682 for up to approximately 2 years. Once the safe dose level of SX-682 in combination with pembrolizumab is determined, the remaining participants will be enrolled at the highest safe dose level of SX-682, in combination with pembrolizumab. These participants will receive the combination therapy and be evaluated in the study for approximately 2 years. ; DRUG USED: SX-682; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Chemokine (C-X-C motif) Receptor 1 (CXCR1) / IL8R , Chemokine (C-X-C motif) Receptor 2 (CXCR2) / IL-8 receptor, Chemokine Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Syntrix Biosystems, Inc.; CRITERIA: Inclusion Criteria: 1. Written Informed Consent and HIPAA Authorization 1. Subjects must have the nature of the study explained to them. 2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, pharmacokinetic collections, and other requirements of the study. 3. Subjects must provide a signed and dated IRB/IEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. 4. Subjects must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization. 5. The ICF and HIPAA authorization must be obtained before conducting any procedures that do not form a part of the subjects normal care. 6. After signing the ICF and HIPAA Authorization, subjects will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/exclusion criteria: 2. Target Population 1. Histologically confirmed unresectable Stage III or Stage IV melanoma as per AJCC staging system. (mucosal melanoma is acceptable). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Prior disease progression on anti-PD1 therapy (i.e., anti-PD1 or anti-PD-L1, including prior adjuvant). Prior anti-PD1 therapy must have been completed prior to first dose of SX-682, and all adverse events related to prior therapy have either returned to baseline or stabilized (other than endocrine toxicity for which medical replacement therapy is in place). 4. Must have at least measurable non-CNS disease with at least 1 unidimensional measurable lesion per RECIST v1.1. 5. Pre-treatment tumor tissue (i.e., archived paraffin-embedded) obtained in the metastatic setting or from an unresectable site of disease must be available for biomarker analyses. Biopsy should be excisional, incisional punch or core needle. Fine needle aspirates or other cytology samples are insufficient. 6. Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration. 7. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to first dose: WBC > 3000/µL Neutrophils > 1500/ µL Platelets > 100,000/µL Hemoglobin > 9.0 g/dL (may have been transfused) Creatinine < 1.5 mg/dL AST/ALT < 2.5 X ULN for subject with no liver metastases < 5 X ULN for subjects with liver metastases Bilirubin < 1.5 mg/dL (unless diagnosed with Gilberts syndrome, who can have total bilirubin < 3.0 mg/dL) INR or PT < 1.5 X ULN unless the subject is receiving anticoagulant therapy aPTT or PTT < 1.5 X ULN unless the subject is receiving anticoagulant therapy 8. Calculate and record creatinine clearance using the Cockcroft-Gault formula. 9. No known positivity for human immunodeficiency virus (HIV) (no laboratory testing is required), no active infection with Hepatitis B or Hepatitis C. 10. Life expectancy > 12 weeks. 11. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been treated with SX-682) after obtaining agreement from the medical monitor prior to re-enrolling a subject. If re-enrolled, the subject must be re-consented. 3. Age and Reproductive Status 1. Men and women, ages > 18 years of age. 2. Women of childbearing potential (WOCBP) must use method(s) of contraception (as will be explained in detail) while on study and for 4 months after the last dose of SX-682 or pembrolizumab. A WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes. 3. Women under the age of 62 with a history of being postmenopausal must have a documented serum follicle stimulating hormone, (FSH) level > 40 mIU/mL. 4. Women 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 study drug. 5. Women must not be breastfeeding. 6. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year while on study and for a period at least 6 months after the last dose of study drug. 7. Women who are not of childbearing potential and azoospermic men do not require contraception. Exclusion Criteria: 1. Target Disease Exceptions 1. Active brain metastases or leptomeningeal metastases are eligible if the treating physician determines that immediate CNS specific treatment is unlikely to be required before trial screening/enrollment. Subjects with treated/stable brain metastases are also eligible. An MRI is not required to rule out brain metastases or leptomeningeal metastases. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. 2. Ocular melanoma is excluded (mucosal melanoma is acceptable). 2. Medical History and Concurrent Diseases a) Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results. Specifically: 1. Subjects with active, non-infectious pneumonitis. 2. Subjects with interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. 3. Subjects with clinically significant heart disease that affects normal activities. b) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. c) Subjects with active, known or suspected autoimmune disease. Subjects with 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 are permitted to enroll. d) Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. e) Use of other investigational drugs (drugs not marketed for any indication) within 30 days before study drug administration. f) Use of QT prolonging drugs must be stopped at least two (2) weeks before the start of SX-682 dosing and suspended for the length of the trial. g) Subjects who have had major surgery in the past 4 weeks. h) Subjects who have received a live-virus vaccine within 30 days before study drug administration. 3. Physical and Laboratory Test Findings 1. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. 2. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 3. ECG demonstrating a QTc interval >470 msec or patients with congenital long QT syndrome. 4. Allergies and Adverse Drug Reaction 1. History of allergy to study drug components. 2. History of severe hypersensitivity reaction to any monoclonal antibody 5. Sex and Reproduction Status 1. WOCBP who are pregnant or breastfeeding. 2. Women with a positive serum or urine pregnancy test at enrollment or prior to administration of study medication. 6. Other Exclusion Criteria 1. Prisoners or subjects who are involuntarily incarcerated, or other vulnerable populations (study is exempt from 45 CFR 46 Subparts B, C, and D). 2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. ; PRIMARY OUTCOME: SX-682 Maximum Tolerated Dose (MTD) during Monotherapy Stage; SECONDARY OUTCOME 1: SX-682 dose limiting toxicities (DLTs) during monotherapy[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - UL1104 (US); BRIEF: The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated. ; DRUG USED: Ulipristal Acetate; DRUG CLASS: Non-NME; INDICATION: Uterine Fibroids; TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Watson Pharmaceuticals; CRITERIA: Inclusion Criteria: - Is a pre-menopausal female, 18 - 50 years; - Has documented leiomyoma(s); - Has leiomyoma-related anemia; - Has an endometrial biopsy within the screening period prior to the first dose of the test article which shows no endometrial hyperplasia; - Is willing and able to provide written informed consent and authorization to disclose protected health information. Exclusion Criteria: - Has a history of uterine surgery that would interfere with the study; - Has a condition requiring immediate or intermittent blood transfusions; - Has a known coagulation disorder; - Has a history of uterine, cervix, ovarian, or breast cancer; - Has used a selective progesterone receptor modulator or a gonadotrophin releasing hormone agonist in previous 6 months; - Has received blood transfusion within 8 weeks before the screening visit; - Has abnormal liver functions; - Is pregnant. ; PRIMARY OUTCOME: Change from baseline in hemoglobin levels (g/dL); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/FOLFIRI; BRIEF: The purpose of this study is to assess the effect of concomitant ramucirumab (IMC-1121B) on the pharmacokinetics of irinotecan and its metabolite SN-38 when coadministered with folinic acid and 5-fluorouracil, in participants with advanced malignant solid tumors resistant to standard therapy or for which no standard therapy is available. ; DRUG USED: Cyramza; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Has histologic or cytologic documentation of a malignant solid tumor - Has an advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available - Has resolution to Grade ≤1, per the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v. 4.0), of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Has adequate hematologic, coagulation, and hepatic function - Has serum creatinine ≤ 1.5 x upper limit of normal (ULN) - Urinary protein is <2+ on dipstick or routine urinalysis (UA) at study entry - Women with childbearing potential must have a negative serum or urine pregnancy test - Eligible participants of reproductive potential (both sexes) agree to use adequate method of contraception during the study period and for 12 weeks after the last dose of study medication Exclusion Criteria: - Has received a therapeutic monoclonal antibody within the last 42 days - Has received cytotoxic chemotherapy within the last 21 days - Has received radiotherapy within the last 14 days - Are currently enrolled in, or discontinued within the last 14 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the last 3 months - Has an uncontrolled illness, including, but not limited to uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders - Has experienced any arterial thromboembolic event within the last 6 months - Has known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression - Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy - Has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness - Has received a prior organ or transplantation - Has undergone major surgery within the last 28 days - Has had a serious nonhealing wound, ulcer, or bone fracture within the last 28 days - Has an elective or planned major surgery to be performed during the course of the trial - Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohns disease, ulcerative colitis, or chronic diarrhea - Has experienced a Grade 3 or higher bleeding event within the last 3 months - Has a known history or clinical evidence of Gilberts Syndrome, or is known to have any of the following genotypes: uridine diphosphate glucuronosyltransferase isoform 1A1 (UGT1A1)*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 - Has received clinically relevant inhibitors or inducers of cytochrome P (CYP) 450 CYP3A4/5 or CYP2C9 and/or isoenzymes within the last 3 weeks - Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis ; PRIMARY OUTCOME: Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1; SECONDARY OUTCOME 1: Pharmacokinetics: Cmax of Ramucirumab (IMC-1121B)[/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 - Memorial Sloan Kettering Cancer Center; BRIEF: The purpose of this Phase I study is to test the safety of different doses of specially prepared immune cells (called T cells) collected from blood. The Investigators want to find a safe dose of these modified T cells for patients who have malignant pleural disease. They want to find out what effects these T cells have on the patient and the cancer (MPD). Phase 2 part of the study, the investigators will test the dose in combination with another drug, pembrolizumab, to see what effects the study treatment has on malignant pleural mesothelioma. ; DRUG USED: ATA2271; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Immune System, Mesothelin, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2), T lymphocytes; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Memorial Sloan Kettering Cancer Center; CRITERIA: Inclusion Criteria: - Patients with MPD aged ≥18 years - Karnofsky performance status ≥70% - Patients with malignant pleural disease (MPD), pathologically confirmed at MSKCC (radiographic confirmation is acceptable for screening phase eligibility), and defined as one of the following (patients who have not yet received treatment may enroll in the screening portion only): 1. Malignant pleural mesothelioma - previously treated with at least one prior treatment regimen. 2. Non-small cell lung cancer metastatic to the pleura-previously treated with at least one prior treatment regimen (chemotherapy or targeted agent) and documented progression of disease. Patients with disease outside of the pleura will be discussed among study PI and Co-PIs prior to considered eligible for the study. Disease outside of the pleura must not require any immediate therapy per PIs discretion. 3. Breast cancer metastatic to the pleura- previously treated with at least one prior treatment regimen (chemotherapy or targeted agent) and documented progression of disease. Patients with disease outside of the pleura will be discussed among study PI and Co-PIs prior to be considered eligible for the study. Disease outside of the pleura must not require any immediate therapy per PIs discretion. - Only patients with a diagnosis of malignant pleural mesothelioma will be included in cohort 9 and in the Phase II portion of the study - Expression of mesothelin must be confirmed by meeting one of the following criteria. 1. Mesothelin expression (>10% of the tumor expressing mesothelin) by immunohistochemical (IHC) analysis 2. Elevated serum SMRP levels (>1.0 nM/L). - Free flowing pleural effusion requiring management by placement of a pleural catheter. Patients with a functional pleural catheter already in place are eligible for the study, as long as there are no clinical concerns of infection. OR - No free-flowing pleural effusion: an Interventional Radiologist has agreed that radiology-guided intrapleural or peritumoral injection of the CAR T cells is feasible. - Chemotherapy, targeted therapy (such as a tyrosine kinase inhibitor) or therapeutic radiotherapy must have been completed at least 14 days prior to administration of T cells. Continuation of hormonal therapy (ie for breast cancer) is acceptable. Prior immunotherapy with checkpoint blockade (i.e. PD1 inhibitor, PDL1 inhibitor or CTL4-antagonist or similar agent) must have been completed more than 1 month1prior to the T cell infusion. - Chemotherapy must have been completed at least 7 days prior to leukapheresis - Palliative radiotherapy must be completed at least 2 days prior to administration of cyclophosphamide - Any major thoracic (thoracotomy with lung or esophageal resection) or abdominal (laparotomy with organ resection) operation must have occurred at least 28 days before study enrollment. Patients who have undergone diagnostic VATS or laparoscopy can be included in the study. - All acute toxic effects of any previous therapeutic or palliative radiotherapy, chemotherapy, or surgical procedures must have resolved to grade I or lower according to CTCAE (version 4.0). - Lab requirements (hematology) - White blood cell (WBC) count ≥3000 cells/mm3 - Absolute neutrophil count ≥1500 neutrophils/mm3 - Platelet count ≥100,000 platelets/mm3 Lab requirements (serum chemistry) - Bilirubin ≤ 1.5x upper limit of normal (ULN) - Serum alanine aminotransferase and serum aspartate aminotransferase (ALT/AST) ≤.5x ULN - Serum creatinine ≤ 1.5x ULN or Cr > 1.5x ULN, but calculated clearances of >60 - Negative screen for human immunodeficiency virus (HIV), hepatitis B virus (HBV) antigen, and hepatitis C virus (HCV). If testing was performed during the previous 3 months, there is no need to repeat testing, as long as documentation of results is provided to the study site. Subjects must receive counseling and sign a separate informed consent form for HIV testing. - Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the period of drug administration and for 4 weeks after completion of the last administration of the study drug. An effective form of contraception is defined as oral contraceptives plus 1 form of barrier or double-barrier method contraception (condom with spermicide or condom with diaphragm). - Subjects must be able to understand the potential risks and benefits of the study and must be able to read and provide written, informed consent for the study Exclusion Criteria: - Untreated or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control); patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met: - Presence of measurable or evaluable disease outside of the CNS; - Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study; - Completion of radiotherapy ≥8 weeks prior to the screening radiographic study; - Discontinuation of corticosteroids and anticonvulsants ≥4 weeks prior to the screening radiographic study. - Non-small cell lung cancer metastatic to the pleura that extends outside of the pleura requiring immediate therapy - Breast cancer metastatic to the pleura that extends outside of the pleura requiring immediate therapy - Prior history of seizure disorder - Patients currently receiving treatment for concurrent active malignancy Continuation of hormonal therapy (i.e. for breast cancer) is acceptable. Prior immunotherapy with checkpoint blockade (i.e. PD1 inhibitor, PDL1 inhibitor or CTL4-antagonist or similar agent) must have been completed more than 1 month prior to the T cell infusion. - Autoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohns disease, and temporal arteritis (Patients with a history of hypothyroidism will not be excluded) - History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry - Subjects with left ventricular ejection fraction (LVEF) less than 50% - Patients with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids - Baseline pulse oximetry is less than 92% on Room air - Pregnant or lactating women - An infection requiring antibiotic treatment within 7 days before the start of treatment (day 0) - A requirement for daily systemic corticosteroids for any reason or a requirement for other immunosuppressive or immunomodulatory agents. Topical, nasal, and inhaled steroids are permitted. - Administration of live, attenuated vaccine within 8 weeks before the start of treatment (day 0) and throughout the study - Any other medical condition that, in the opinion of the PI, may interfere with a subjects participation in or compliance with the study ; PRIMARY OUTCOME: Composite measure of severity and number of adverse events (AEs); changes in (clinical laboratory test findings (hematologic and chemistry); and physical examination. (Phase I); SECONDARY OUTCOME 1: Changes in serum levels of the biomarker soluble mesothelin related peptide (SMRP) (Phase I)[/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 - 112264; BRIEF: This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15 milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a follow-up visit around 14 weeks after the last infusion. A total of approximately 294 eligible subjects will be randomised from approximately 37 centers worldwide. The primary objective is to assess the effect of ozanezumab on the physical function and survival of ALS subjects over a treatment period of 48 weeks. Function will be measured using the ALS Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of other clinical outcomes associated with ALS (respiratory function, muscle strength, progression free survival and overall survival) in support of the primary objective. Quality of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole) will also be assessed. ; DRUG USED: Ozanezumab; DRUG CLASS: Biologic; INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Neural Outgrowth Inhibitor (NOGO)-A/Reticulon-4; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Patients with diagnosis of familial or sporadic ALS - Onset of muscle weakness no more than 30 months before screening visit. - Slow Vital Capacity (SVC) of at least 65% predicted for gender, age, ethnicity and height at Screening. - If on riluzole, the dose must have been stable for at least 28 days prior to Baseline visit. - Age 18 - 80 years inclusive. - Female subjects may participate if they are of non-child-bearing potential or if they are of child-bearing potential they must agree to use the approved contraceptive methods - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN. - QTc (both QTcB and QTcF) <450 milliseconds (msec) or <480 msec for subjects with Bundle Branch Block at Screening and Baseline (average from triplicate ECGs). Exclusion Criteria: - Patients with other neuromuscular disorders (including a history of polio) which in the opinion of the investigator could have contributed to the muscular atrophy or weakness caused by ALS - Patients with primary lateral sclerosis, monomelic ALS, ALS Parkinsonism dementia complex. - Patients requiring non-invasive or mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed subject to discussion with Medical Monitor) - Patients on diaphragmatic pacing. - Presence of any of the following clinical conditions: Drug abuse or alcoholism, uncontrolled hypertension, active major infectious disease, unstable psychiatric illness within 90 days of the Screening visit - Subjects, who in the investigators judgement, pose a significant suicide risk. - Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones), positive Hepatitis B surface antigen or Hepatitis C antibody test. - Subjects who have participated in a clinical trial involving receipt of a biopharmaceutical product within 6 months prior to the first dosing day. - Exposure to non-biological experimental agents 1 month or 5 half-lives prior to Baseline visit (whichever is longer). - History of sensitivity to ozanezumab, or components thereof, or a history of other allergies that, in the opinion of the investigator, contraindicates participation in the study. ; PRIMARY OUTCOME: Joint Rank Scores for Combined Analysis of Function (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised [ALSFRS-R] Score) and 48 Week Overall Survival; SECONDARY OUTCOME 1: Change From Baseline in the ALSFRS-R Total Score at Week 48[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - ACN01; BRIEF: This is a Phase 1/2a study. The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers. The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face. ; DRUG USED: Olumacostat Glasaretil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acne; TARGET: Acetyl-CoA carboxylase (ACAC, ACC); THERAPY: Monotherapy; LEAD SPONSOR: Dermira, Inc.; CRITERIA: Phase 1 Inclusion Criteria 1. Signed informed consent 2. Willing to comply with the requirements of the protocol 3. Males or non-pregnant, non-lactating females 4. Age ≥ 18 years 5. Was in good health and free from any clinically significant disease, as determined by the investigator 6. If female and of childbearing potential, was willing to use an accepted method of birth control during study participation and for 30 days after the last application of study drug. Females were considered to be of childbearing potential unless they had been surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), had been diagnosed as infertile, had a same-sex partner or vasectomized male partner, were postmenopausal for at least 1 year, or were abstinent. Acceptable methods of birth control were defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (e.g., condom and spermicide) or an intrauterine device (IUD). The birth control method must have been stable/unchanged for 30 days prior to baseline. 7. If male, was vasectomized or agreed to use an accepted method of birth control with female partner during study participation and for 30 days after the last application of study drug. Phase 1 Exclusion Criteria 1. Females who were pregnant, planning to become pregnant during the course of the study, or were breast-feeding 2. Had a known hypersensitivity to DRM01B or its excipients 3. Had any skin condition that may have interfered with the safety evaluations during the study 4. Had a clinical chemistry or hematology laboratory value at screening that was considered clinically significant, in the opinion of the investigator 5. Participated in an investigational drug study within 30 days prior to screening 6. Were considered a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study. Phase 2a Inclusion Criteria 1. Signed informed consent 2. Willing to comply with the requirements of the protocol 3. Male or non-pregnant, non-lactating females 4. Age ≥ 18 years 5. If female and of childbearing potential, was willing to use an accepted method of birth control during study participation and for 30 days after the last study drug application. Females were considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), had been diagnosed as infertile, had same sex partner or vasectomized male partner, or were postmenopausal for at least 1 year. Acceptable methods of birth control were defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (e.g., condom and spermicide) or an IUD. The birth control method must have been stable/unchanged for 12 weeks prior to baseline and must have remained unchanged during study participation. 6. If male, was vasectomized or agreed to use an accepted method of birth control with female partner during study participation and for 30 days after the last study drug application. 7. Subjects were in good health and free from any disease that, in the opinion of the investigator, would have put the subject at risk during participation in the study. 8. Clinical diagnosis of facial acne vulgaris defined as: - At least 20 inflammatory lesions - At least 20 noninflammatory lesions - IGA of 3 or greater 9. Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face. Topical acne treatments that did not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) were allowed for treatment of acne of the back, shoulders, and chest only. Phase 2a Exclusion Criteria 1. Females who were pregnant, planning to become pregnant during the course of the study, or breast-feeding 2. Had a known hypersensitivity to DRM01B or its excipients 3. Had any skin condition that may have interfered with evaluation of safety or acne vulgaris (e.g., rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis) 4. Had excessive facial hair that would have interfered with diagnosis or assessment of acne vulgaris 5. Had excessive sun exposure, in the opinion of the investigator, or use of tanning booths 6. Had active cystic acne or acne conglobata, acne fulminans, and secondary acne 7. Had 2 or more active nodular lesions 8. Had a clinical chemistry or hematology laboratory value at screening that was considered clinically significant, in the opinion of the investigator 9. Participated in an investigational drug study within 30 days prior to screening 10. Subjects who were a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator 11. Any other condition that, in the judgment of the investigator, would have put the subject at unacceptable risk during participation in the study 12. Treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to baseline 13. Treatment with systemic corticosteroids within 4 weeks prior to baseline (Note: use of intranasal and inhaled corticosteroids was allowed for seasonal allergies and asthma) 14. Treatment with systemic antibiotics, systemic anti-acne drugs, or systemic anti-inflammatory drugs within 4 weeks prior to baseline 15. Prescription topical retinoid use on the face within 4 weeks of baseline (e.g., tretinoin, tazarotene, adapalene). 16. Treatment with a new hormonal therapy or dose change to an existing hormonal therapy within 12 weeks prior to baseline. The dose and frequency of use of any hormonal therapy started more than 12 weeks prior to baseline must have remained unchanged throughout the study. Hormonal therapies included, but were not limited to, estrogenic and progestational agents, such as birth control pills. 17. Prior use of androgen receptor blockers (such as spironolactone or flutamide) 18. Oral retinoid use (e.g., isotretinoin) within 12 months prior to baseline or vitamin A supplements greater than 10,000 units/day within 6 months of baseline 19. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study ; PRIMARY OUTCOME: Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Acti-AICS-001 (EU); BRIEF: The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of the oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of oral corticosteroid dose and stability/improvement of clinical parameters related to asthma in the targeted subject population. Ultimately, the goal is to free subjects with severe asthma from the burden of chronic oral steroid therapy. ; DRUG USED: VR647; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Activaero GmbH; CRITERIA: Inclusion Criteria: - Written informed consent prior to the performance of any study-related procedures - Age ≥ 18 and ≤ 65 year of age Diagnosis of asthma (ATS definition, either allergic or non-allergic) for ≥ 6 months - Asthma treated for at least 3 months with inhaled (ICS) and oral corticosteroids (OCS). Exact baseline level will be measured during the screening period by subject diary entries - FEV1 ≥ 40% or ≤ 79% predicted at the Screening or Baseline Visit - Documented increase of FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 2 years prior to Screening - Mandatory usage of long-acting β-agonists - A negative pregnancy test must be available for any women of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the treatment groups!) - Women of childbearing potential must agree to use a reliable method of contraception from the screening until 4 weeks after study completion or after study drug discontinuation in case study drug treatment is stopped prematurely. - In this study, hormone-based contraceptives alone are not considered as reliable method Exclusion Criteria: - History of allergy or adverse experience with Budesonide - Pregnant women or nursing mothers - Upper respiratory tract infection within 4 weeks of Screening - Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening - Hospitalization for asthma within 3 months of Screening - Use of anti-IgE, methotrexate, oral gold, Dapsone, or i.v. gamma globulin within 3 months of Screening - Treatment with other investigational asthma treatment within 30 days prior to Screening - Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), COPD, chronic bronchitis and emphysema - History of medication noncompliance - History of significant medical illness or condition that in the Investigators opinion places the subject at undue risk by participating in the study - Past episode of anaphylaxis with severe respiratory symptoms - Oral corticosteroid average daily dose exceeding a maximum amount - Currently smoking or history of smoking ≥ 10 pack years - Taking oral or i.v. corticosteroids for any disease indication other than asthma - Abnormal lab values for chemistry tests at Screening that may indicate impaired ability to metabolize and/or excrete Budesonide (AST, ALT > 3 times upper limit of normal range, serum creatinine > 1.5 times upper limit of normal range) ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EXIST-3 Roll-Over; BRIEF: The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3 ; DRUG USED: Afinitor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tuberous Sclerosis Complex (TSC); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Patient is currently enrolled in the Novartis-sponsored EXIST-3 study, receiving everolimus, and has fulfilled all its requirements - Patient is currently benefiting from treatment with everolimus, as determined by the Investigator. - Patient has demonstrated compliance, as assessed by the Investigator,with the parent study protocol requirements. - Patient is willing and able to comply with scheduled visits and treatment plans. - Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study. Key Exclusion Criteria: - Patient has been permanently discontinued from everolimus study treatment in EXIST-3 study - Everolimus is approved for patients with TSC and refractory seizures and is reimbursed in the local country. - Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the purpose of seizure control. ; PRIMARY OUTCOME: Occurances of adverse events and serious adverse events; SECONDARY OUTCOME 1: Percentage of patients with clinical benefit[/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 - Study 104 (SPARTA); BRIEF: The purpose of this study is to determine the safety and tolerability of PRTX-100 when various doses are given 5 times at weekly intervals to patients with active rheumatoid arthritis that are taking methotrexate or leflunomide. The drug is administered in a physicians office via an intravenous infusion. PRTX-100 may be effective in rheumatoid arthritis by suppressing the immune responses. PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this study, cohorts of patients with active RA will receive sequentially higher doses of PRTX-100. There will be an inactive placebo cohort for comparison. Patients who do not attain low RA disease activity, by a commonly used measure, will leave the study at 3 months after their first dose of study drug. ; DRUG USED: PRTX-100; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Lymphocytes, Macrophages; THERAPY: Monotherapy; LEAD SPONSOR: Protalex, Inc.; CRITERIA: Inclusion Criteria: - Active RA with disease duration of not less than 6 months - Concomitant stable methotrexate or leflunomide therapy Exclusion Criteria: - Diagnosis of any other inflammatory arthritis - ACR Functional Classification of IV - Significant systemic involvement secondary to RA (except for secondary Sjogrens syndrome) - History of clincally significant hypogammaglobulinemia, common variable immunodeficiency, or humeral immunodeficientncy - History of active tuberculosis, pro-thrombotic disorder, venous thrombosis requiring anti-coagulation, substance abuse, or serious psychiatric condition - History of allergy or hypersensitivity to aspirin or non-steroidal cyclooxygenase inhibitors, Staphylococcal protein A - History or presence of malignancy (except for surgically treated basal or squamous cell carcinoma of the skin at least 3 months prior to the start of study medication) - Uncontrolled diabetes or Type 1 diabetes - Unstable ischemic heart disease - Serious active or recurrent infection, hepatic cirrhosis, or other medically unstable condition - Systemic autoimmune diseases other than RA (such as systemic lupus erythematosus, scleroderma, inflammatory bowel disease, inflammatory myopathy) - Positive for HIV, hepatitis B surface antigen, or hepatitis C antibody - Pregnant or nursing females - Inadequate hepatic, renal, or hematologic function - Receipt of live vaccine within 5 weeks of start of study medication - Concomitant administration of other biologic or non-biologic DMARDS, corticosteroids, or anti-CD20 antibodies ; PRIMARY OUTCOME: Adverse Events; SECONDARY OUTCOME 1: Disease activity[/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 - M16-156 (Brazil); BRIEF: This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit. - Participant must have been documented as without cirrhosis with METAVIR equivalent fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a liver biopsy, or FibroScan, or FibroTest score. - Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected may have been enrolled if they had a positive test result for anti-HIV antibody at Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline. - Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma (HCC) within 3 months prior to Screening or a negative ultrasound at Screening. Exclusion Criteria: - Current hepatitis B virus (HBV) infection on screening tests. - Any current or past clinical evidence of Child-Pugh B or C classification (score of > 6) or clinical history of liver decompensation including ascites on physical exam, including hepatic encephalopathy or variceal bleeding. - Receipt of any investigational or commercially available anti-HCV agents. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With On-treatment HCV Virologic Failure[/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 - BUTEO (University of Birmingham); BRIEF: This is a phase II study to determine the safety and preliminary efficacy of a human monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its use in the treatment of patients with primary sclerosing cholangitis (PSC). ; DRUG USED: BTT-1023; DRUG CLASS: Biologic; INDICATION: Primary Sclerosing Cholangitis (PSC); TARGET: Amine Oxidase, Copper Containing 3 (AOC3)/Vascular Adhesion Protein 1 (VAP-1)/Semicarbazide-sensitive amine oxidase (SSAO); THERAPY: Monotherapy; LEAD SPONSOR: University of Birmingham; CRITERIA: Inclusion Criteria: 1. Males and females 18 - 75 years of age who are willing and able to provide informed, written consent and comply with all trial requirements 2. Clinical diagnosis of PSC as evident by chronic cholestasis of more than six months duration with either a consistent MRI showing sclerosing cholangitis or a liver biopsy consistent with PSC in the absence of a documented alternative aetiology for sclerosing cholangitis 3. In those with concomitant Inflammatory Bowel Disease, clinical and colonoscopic evidence, (in line with the patients standard of care; within 18 months) of stable disease, without findings of high grade dysplasia 4. In those on treatment with UDCA, therapy must be stable for at least 3 months, and at a dose not greater than 20 mg/kg/day. In those not on treatment with UDCA at the time of screening, a minimum of 8 weeks since the last dose of UDCA should be recorded 5. Serum ALP greater than 1.5 x ULN 6. Stable serum ALP levels (levels must not change by more than 25% from Screening Visit 1 and Screening Visit 2) 7. Female subjects of childbearing potential must have a negative pregnancy test prior to starting trial treatment. For the purposes of this trial, a female subject of childbearing potential is a woman who has not had a hysterectomy, bilateral oophorectomy, or medically-documented ovarian failure. Women ≤ 50 years of age with amenorrhea of any duration will be considered to be of childbearing potential 8. All sexually active women of childbearing potential must agree to use two forms of highly effective method of contraception from the Screening Visit throughout the trial period and for 99 days following the last dose of trial drug. If using hormonal agents the same method must have been used for at least 1 month before trial dosing and subjects must use a barrier method as the other form of contraception. Lactating women must agree to discontinue breast feeding before trial investigational medicinal product administration 9. Men, if not vasectomised, must agree to use barrier contraception (condom plus spermicide) during heterosexual intercourse from screening through to trial completion and for 99 days from the last dose of trial investigational medicinal product 10. Patients must weigh ≥ 40 kg Exclusion Criteria: 1. Presence of documented secondary sclerosing cholangitis on prior clinical investigations 2. Presence of alternative causes of liver disease, that are considered by the Investigator to be the predominant active liver injury at the time of screening, including viral hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis. Patients with possible overlap syndrome with autoimmune hepatitis are excluded if the Investigator considers autoimmune hepatitis as the predominant liver injury 3. AST and ALT >10 x ULN or bilirubin >3 x ULN or INR >1.3 in the absence of anti-coagulants 4. Serum creatinine >130μmol/L or platelet count <50 x 109/L 5. Any evidence of hepatic decompensation past or present, including ascites, episodes of hepatic encephalopathy or variceal bleeding 6. Recent cholangitis within last 90 days or ongoing need for prophylactic antibiotics 7. Pregnancy or breast feeding 8. Harmful alcohol consumption as evaluated by the Investigator 9. Flare in colitis activity within last 90 days requiring intensification of therapy beyond baseline maintenance treatment; use of oral prednisolone >10 mg/day, biologics (i.e. monoclonal antibodies) and or hospitalisation for colitis within 90 days. Prior use of biologics is not a contraindication to screening 10. Diagnosed cholangiocarcinoma or high clinical suspicion of cholangiocarcinoma either clinically or by imaging 11. Concurrent malignancies or invasive cancers diagnosed within past 3 years except for adequately treated basal cell and squamous cell carcinoma of the skin and in situ carcinoma of the uterine cervix 12. Presence of a percutaneous drain or bile duct stent 13. Major surgical procedure within 30 days of screening 14. Prior organ transplantation 15. Known hypersensitivity to the investigational product or any of its formulation excipients 16. Unavailable for follow-up assessment or concern for subjects compliance 17. Participation in an investigational trial of a drug or device within 60 days of screening or 5 half lives of the last dose of investigational drug, where the trial drug half-life is greater than 12 days 18. Any other condition that in the opinion of the Investigator renders the subject a poor risk for inclusion into the trial 19. Positive screening test for tuberculosis (TB) (including T-SPOT.TB TB test), unless respiratory review confirms false positive test results 20. Receipt of live vaccination within 6 weeks prior to Screening Visit 2 21. Known HIV positive status ; PRIMARY OUTCOME: Response at Visit 10 (Day 99): a reduction in serum ALP by 25% or more from baseline to Visit 10 (Day 99); SECONDARY OUTCOME 1: Treatment Compliance (including patient withdrawal)[/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 - 001 - Solid Tumors; BRIEF: The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer. ; DRUG USED: FP-1039; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Fibroblast Growth Factor (FGF), Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy; LEAD SPONSOR: Five Prime Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Subjects with metastatic or locally advanced unresectable solid tumors for which standard curative or supportive measures do not exist or are no longer effective - Male or female 18 years of age or older Exclusion Criteria: - Presence or history of melanoma - Primary brain tumor - Presence or history of glaucoma ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Dose-Finding (Japan); BRIEF: To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia. ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria - Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent - Patients who are experiencing acute exacerbation of psychotic symptoms Exclusion Criteria: - Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product - Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator - Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial) ; PRIMARY OUTCOME: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score; SECONDARY OUTCOME 1: Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Bevacizumab; BRIEF: This randomized phase II trial studies how well bevacizumab with or without anti-endoglin monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by targeting certain cells. ; DRUG USED: TRC105; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Endoglin / Cluster of Differentiation 105 (CD 105); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients must have histologically or cytologically confirmed renal cancer; all histologic subtypes will be eligible - Patients must have metastatic disease which is measurable, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) to >= 20 mm in the long axis by chest x-ray, >= 10 mm in the long axis by spiral computed tomography (CT), magnetic resonance imaging (MRI), calipers, or clinical exam, or >= 15 mm in the short axis for lymph nodes - Patients must have received at least 1 prior systemic therapy for renal cancer but no more than 4 prior therapies; they must have documented intolerance to or progression despite at least 1 systemic therapy; therapy administered in the adjuvant setting counts toward the prior systemic therapy total; if adjuvant therapy is the patients only prior therapy the disease must have recurred during treatment or within 3 months of discontinuation - Allowable prior therapies include VEGF tyrosine kinase inhibitor (TKIs), mammalian target of rapamycin (mTOR) inhibitors, and cytokine therapy (example: interleukin-2 [IL2]) - At least 2 weeks must have elapsed from the last dose of the prior systemic therapy for biologics and 4 weeks for chemotherapy (6 weeks for nitrosoureas or mitomycin C); also note that at least 3 weeks should have elapsed since prior TKI administration - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Life expectancy of greater than 6 months - Leukocytes >= 3,000/mcL - Absolute neutrophil count >= 1,500/mcL - Platelets >= 100,000/mcL - Total bilirubin =< institutional upper limits or normal (except for Gilberts) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal (except subjects with liver metastases, who can have AST/ALT =< 5 x ULN) - Creatinine glomerular filtration rate (GFR) (calculated or measured) > 50 mL/min - Hemoglobin >= 9 g/dL - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; 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 6 months after completion of TRC105 or bevacizumab administration - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have had systemic biologic therapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events related to their prior therapy - Patients who have previously been treated with bevacizumab - Patients who have previously been treated with TRC105 - Patients who are receiving any other investigational agents - Known central nervous system (CNS) disease except for treated brain metastasis; treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (MRI or CT) (stable dose of anticonvulsants are allowed); treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded - History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC105 or bevacizumab - Patients on full-dose anticoagulation will be excluded; antiplatelet therapy will not be exclusionary - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unhealed wound, gastrointestinal fistula, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, cerebrovascular accident - Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother wishes to participate in the study - Patients with a history of bleeding diathesis or inherited coagulopathy are excluded; in addition, those with a history of deep vein thrombosis (DVT) or pulmonary embolus within 1 year and still requiring active anticoagulation will be excluded; those with a more remote history of DVT or pulmonary embolus may be eligible but the risk of recurrent thrombosis should be considered - Patients with history of hereditary hemorrhagic telangiectasis (HHT-1 and HHT-2) - Serious or non-healing wound, ulcer, or bone fracture OR history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1 - Invasive procedures defined as follows: - Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 therapy - Anticipation of need for major surgical procedures during the course of the study - Core biopsy within 7 days prior to day 1 therapy - Patients with clinically significant cardiovascular disease are excluded: - Inadequately controlled hypertension (HTN) (systolic blood pressure [SBP] > 160 mmHg and/or diastolic blood pressure [DBP] > 90 mmHg despite antihypertensive medication) - History of cerebrovascular accident (CVA) within 6 months - Myocardial infarction or unstable angina within 6 months - New York Heart Association grade II or greater congestive heart failure - Serious and inadequately controlled cardiac arrhythmia - Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection) - Clinically significant peripheral vascular disease - Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - Patients with psychiatric illness/social situations that would limit compliance with study requirements will be excluded ; PRIMARY OUTCOME: Progression-free Survival at 24 Weeks; SECONDARY OUTCOME 1: Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Ascending Multiple-Dose (Healthy Subjects); BRIEF: This is a single-center, randomized, double-blind, placebo-controlled, ascending multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days. ; DRUG USED: Resmetirom; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Thyroid hormone receptors (TRs); THERAPY: Monotherapy; LEAD SPONSOR: Madrigal Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - The subject must be willing and able to provide written informed consent. - Healthy, non-smoking, males and females between the ages of 18 and 55 years of age (inclusive). - If female, the subject is of non-child bearing potential (i.e., surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [>12 consecutive months without menses]). Verify by FSH at screening as appropriate. - Body weight > 50 kg and BMI between 18 and 30 kg/m2 (inclusive). - LDL cholesterol ≥ 110mg/dL. Exclusion Criteria: - History of thyroid disorder or abnormal thyroid function tests at screening. Repeat testing is allowed once at the discretion of the Investigator. - History of unexplained syncope. - History of hepatobiliary disease; or AST, ALT or direct bilirubin greater than the upper limit of reference range at screening. - Positive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody. - Abnormal screening ECG: including machine-read QTc >450 msec (confirmed by manual over read), QRS >110 msec, intermittent bundle branch block, frequent premature atrial or premature ventricular contractions, or any rhythm other than normal sinus rhythm which is interpreted by the Investigator to be clinically significant. - History of sensitivity to a similar study drug (e.g., Karo Bio KB2115 or Metabasis MB7811), or a history of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing) unless deemed not clinically significant by the Investigator. - History of sensitivity to thyroid medication. - History of asthma, or intolerance to beta-blockers. - Use of acetaminophen within 7 days before dosing and throughout the study. - History of regular use of tobacco or nicotine containing products within the past 6 months. - Positive urine drug screen or alcohol test at screening or Day -1. ; PRIMARY OUTCOME: Number of Adverse Events as a measure of safety and tolerability of VIA-3196; SECONDARY OUTCOME 1: Plasma concentration of VIA-3196[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Pegasys/Ribavirin (FITNESS); BRIEF: The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone. ; DRUG USED: PF-00868554; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female subjects at least 18 years of age. - HCV seropositive. - HCV RNA >10,000 IU/mL at screening. - HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible. - Treatment naïve (no prior treatment with IFN alfa +/ RBV regimens or investigational anti-HCV agents). - Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis classification. For those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization. - Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis or 2) those subjects with AFP >50 and <100 ng/mL with no evidence of hepatocellular carcinoma. For those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization. Exclusion Criteria: - Co-infection with either HIV or HBV. - Evidence of severe or decompensated liver disease. - Subjects with liver disease unrelated to HCV infection. - Pre-existing medical condition that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling. - Laboratory abnormality at Screening that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling. - Abnormal ECG suggestive of clinically significant cardiac disease or QTc>450msec. - History of organ transplant. - Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent CYP3A4 inhibitors, sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and CYP3A4 inducers. - Active alcohol or substance abuse sufficient, in the Investigators judgment, to prevent adherence to study medication and/or follow up. - Pregnant or nursing females. - Males whose female partner is pregnant. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Viral Response (SVR) at Week 72; SECONDARY OUTCOME 1: Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Lateral Canthal Lines; BRIEF: A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL). ; DRUG USED: DAXI; DRUG CLASS: Biologic; INDICATION: Wrinkles; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Revance Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Provide written informed consent consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed - Be outpatient, male or female subjects, in good general health, 18-65 years old - Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS - Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study. Exclusion Criteria: - Active skin disease, infections, or inflammation at the injection sites - History of clinically significant bleeding disorders - Clinically significant laboratory values at screening that may interfere with a subjects ability to complete the study, as determined by the investigator - Planned or anticipated need for surgery or hospitalization through the end of the study - Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception - Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study ; PRIMARY OUTCOME: Percentage of Participants With None or Mild in LCL Severity at Maximum Smile; 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 Ib/II - MRD+ AML Post-Frontline Induction; BRIEF: This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML. ; DRUG USED: IMGN632; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Antibody-drug Conjugate (ADC), IL-3 (Interleukin-3) Receptor/CD123, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: ImmunoGen, Inc.; CRITERIA: Patient Inclusion Criteria - Patient must be ≥ 18 years of age. - Patients must have confirmed diagnosis of AML (excluding acute promyelocytic leukemia) based on World Health Organization classification (Arber 2016). - Disease characteristics and allowable prior therapy: - Patients must be evaluated for any available standard of care therapies (including induction, consolidation chemotherapy and/or transplant) and, in the opinion of the treating physician, be deemed appropriate for this experimental therapy. - Treatment-naïve (untreated) patients will be allowed in the Expansion Phase for Regimen C (Triplet) (IMGN632 + azacitidine + venetoclax). No prior treatments with hypomethylating agents (HMAs) for MDS are allowed. - Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC]). - Patients may have received prior CD123-targeted therapies, except IMGN632, as long as CD123 remains detectable during screening. - Relapsed or refractory CD123-positive AML patients will be allowed to enroll in the Escalation Phase of Regimens A, B, and C (Triplet) (IMGN632 + azacitidine, venetoclax, or azacitidine + venetoclax, respectively) and relapsed CD123-positive AML patients will be allowed to enroll the Expansion Phase of Regimens A-C. Note: Patients may also have received up to 2 prior lines of therapy, eg, frontline treatment (induction, consolidation [including transplant], and maintenance) and 1 salvage regimen. - Patients enrolling in Regimen D must be in CR (CR/CRh/CRp/CRi) and be MRD+ at the time of screening, confirmed by central laboratory testing. Patients may have no more than 2 prior lines of therapy (which may include stem cell transplant), ie, frontline or first salvage. Note: Fit patients who received intensive treatment (eg 3+7, HiDAC) are eligible for Regimen D Cohort D1. Unfit patients who received non-intensive treatment (eg, HMA, low dose cytarabine) are eligible for Regimen D Cohort D2. - Previous treatment-related toxicities must have resolved to Grade 1 or baseline (excluding alopecia). - For patients enrolling in Regimens A-D, total WBC count must < 25 × 10^9 cells/L. Hydroxyurea may be used to control blood counts before Cycle 1 Day 1, at the discretion of the treating physician, according to institutional practice. During the Escalation Phase in Regimens A-C, hydroxyurea may also be used during Cycle 1. - Liver enzymes (AST and ALT) ≤ 3 × the upper limit of normal (ULN). - Total bilirubin ≤ 1.5 × the ULN; patients with Gilbert syndrome must have total bilirubin < 3.0 × ULN with direct bilirubin < 1.0 × ULN at the time of enrollment. - An estimated glomerular filtration rate (eGFR) of > 30 mL/min/1.73 m2 or creatinine clearance of > 30 mL/min. - Left ventricular ejection fraction (LVEF) ≥ 45% for patients enrolling in Regimens A-D based on locally available assessment, eg, echocardiogram or other modality. - Patients with prior autologous or allogeneic bone marrow transplant are eligible. Patients with an allogeneic transplant must meet the following conditions: The transplant must have been performed more than 120 days before the date of dosing on this study, the patient must not have active ≥ Grade 2 graft versus host disease (GvHD), or extensive chronic GvHD of any severity, and must be off all immunosuppression for at least 2 weeks prior to first dose of IMGN632. - Voluntary written informed consent before performance of any study-related procedure not part of normal medical care. - Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (ie, who have had menses any time in the preceding 12 consecutive months), must agree to use acceptable contraceptive methods while on study drug and for at least 7 months after the last dose of IMGN632. - WCBP must have a negative pregnancy test within 3 days before the first dose of study drug. - Male patients who are able to father children must agree to use acceptable methods of contraception throughout the study and for at least 4 months after the last dose of study drug(s). - Patients with prior malignancy are eligible; however, the patients malignancy must be well-controlled or stable and have completed all systemic chemotherapy and radiotherapy for the prior malignancy at least 6 months before enrollment, and all treatment-related toxicities must have resolved to ≤ Grade 1 (excluding alopecia). Note: patients with prostate cancer or breast cancer on adjuvant hormonal therapy are eligible and may or may not be on long-term maintenance treatment that is unlikely to interfere with study therapy. Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible. - Patients in expansion Cohorts C1 and C2 must be considered ineligible for intensive induction therapy defined by the following: - ≥ 75 years of age OR - < 75 years of age with at least one of the following co-morbidities documented within 28 days of Cycle 1 Day 1: - ECOG performance status of 2 or 3 - History of congestive heart failure requirement treatment or ejection fraction ≤ 50% or chronic stable angina - Diffusing capacity of the lung for carbon monoxide ≤ 65% or forced expiratory volume in 1 second ≤ 65% - Creatinine clearance ≥ 30 mL/min to < 45 mL/min - Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × ULN - Patients in Cohort C1 and C2 must have an ECOG performance status of 0 to 2 for those ≥ 75 years of age OR 0 to 3 for < 75 years of age. Patient Exclusion Criteria - Patients who have received any anticancer therapy, including investigational agents, within 14 days (or within 28 days for checkpoint inhibitors) before drug administration on this study (hydroxyurea is allowed before beginning study treatment). Patients must have recovered to baseline from all acute toxicity from this prior therapy. - Patients who have been previously treated with IMGN632. - Patients with myeloproliferative neoplasm-related secondary AML are excluded from the Dose Expansion Phase of the study. - Patients with active central nervous system (CNS) AML will be excluded. A lumbar puncture does not need to be performed unless there is clinical suspicion of CNS involvement per investigator judgement. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS AML is allowed with the approval of the sponsor. - Patients with a history of sinusoidal obstruction syndrome/venous occlusive disease of the liver. - Myocardial infarction within 6 months before enrollment or New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities before study entry. - Clinically relevant active infection including known active hepatitis B or C, HIV infection, or cytomegalovirus or any other known concurrent infectious disease that, in the judgment of the investigator, would make a patient inappropriate for enrollment into this study (testing not required). - Patients who have undergone a major surgery within 4 weeks (or longer if not fully recovered) before study enrollment. - Serious or poorly controlled medical conditions that could be exacerbated by treatment or that would seriously compromise safety assessment or compliance with the protocol, in the judgment of the investigator. - Women who are pregnant or breastfeeding - Prior known hypersensitivity reactions to monoclonal antibodies (≥ Grade 3). - Prior known hypersensitivity reactions to study drugs and/or any of their excipients. - Patients who have a history of allergy to IMGN632 (or any of its excipients), azacitidine, or venetoclax. ; PRIMARY OUTCOME: Safety and Tolerability; SECONDARY OUTCOME 1: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (Dose Expansion Phase)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - 150005; BRIEF: Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. Researchers want to test this on human papilloma virus (HPV)-associated cancers. Objective: - The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (Anti-HPV E6) can shrink tumors associated with HPV and test the toxicity of this treatment. Eligibility: - Adults age 18-66 with an HPV-16-associated cancer. Design: - Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed - Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti HPV E6 cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} - Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti HPV E6 cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days. ; DRUG USED: E6 TCR; DRUG CLASS: Biologic; INDICATION: Cervical Cancer; TARGET: Human Papillomavirus (HPV), Stem Cells/Other Cell Therapies, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: -INCLUSION CRITERIA 1. Measurable metastatic or refractory/recurrent human papilloma virus (HPV-16+) cancer (determined by in situ hybridization (ISH) or a polymerase chain reaction (PCR)-based test). 2. Patients must be human leukocyte antigens (HLA-A) 02:01-positive. 3. All patients must have received prior first line standard therapy or declined standard therapy, and have been either non-responders (progressive disease) or have recurred. 4. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible. 5. Greater than or equal to 18 years of age and less than or equal to 70 years of age. 6. Able to understand and sign the Informed Consent Document. 7. Willing to sign durable power of attorney 8. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 9. Life expectancy of greater than 3 months. 10. Patients of both genders must be willing to practice birth control from the time of enrollment on this study up to 4 months after treatment. Patients must be willing to undergo testing for HPV-16 prior to becoming pregnant. 11. Women of child bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus. 12. Serology: - Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.) - Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcription polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative. 13. Hematology: - Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim. - White blood cell (WBC) greater than or equal to 3000/mm^3 - Platelet count greater than or equal 100,000/mm^3 - Hemoglobin greater than 8.0 g/dL 14. Chemistry: - Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to 2.5 times the upper limit of normal - Serum creatinine less than or equal to 1.6 mg/dL - Total bilirubin less than or equal to to 1.5 mg/dL, except in patients with Gilberts Syndrome who must have a total bilirubin less than 3.0 mg/dL 15. More than 4 weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen. EXCLUSION CRITERIA: 1. Women of childbearing potential who are pregnant or breastfeeding. There are potentially dangerous side effects of the treatment on the fetus or infant. 2. Active systemic infections (for e.g.: requiring anti-infective treatment), coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. 3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 4. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). 5. Concurrent systemic steroid therapy. 6. History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine. 7. History of coronary revascularization or ischemic symptoms. 8. Documented left ventricular ejection fraction (LVEF) of less than or equal to 45% tested. The following patients will undergo cardiac evaluations a. clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or b. age greater than or equal 60 years old ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Number of Participants With Serious and Non-serious Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - TMS Effects; BRIEF: The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is estimated there will be approximately 15 subjects in the planned study. ; DRUG USED: XEN1101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: Potassium channels; THERAPY: Monotherapy; LEAD SPONSOR: Xenon Pharmaceuticals Inc.; CRITERIA: Key Inclusion Criteria: - Healthy male aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 30.0 kg/m2 - Right-handed only - Must agree to use effective methods of contraception, if applicable - Able to swallow multiple capsules - Able to provide written, personally signed and dated Informed Consent Form Key Exclusion Criteria: - Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subjects ability to participate in the study - Any clinically significant abnormalities in vital signs, ECGs, physical examinations, or laboratory evaluations - Answering yes to any of the questions within the Columbia Suicide Severity Rating Scale Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study - No prescription or over-the-counter (OTC) medications (including multivitamins, herbal or homeopathic preparations 14 days or if applicable/available, 5 half-lives prior to dosing to study end - Any history of severe head trauma - No smoking 60 days prior to dosing to study end ; PRIMARY OUTCOME: Number of participants with adverse events (AEs) as assessed by CTCAE v4.03; SECONDARY OUTCOME 1: Maximum Observed Plasma Concentration (Cmax)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AL012; BRIEF: This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD. ; DRUG USED: MDX; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Alcobra Ltd.; CRITERIA: Inclusion Criteria: - Subject is a man or a non-pregnant, non-lactating woman 18 to 55 years of age, inclusive, at the Screening Visit. - Subject has a diagnosis of ADHD based on criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and DSM5. - Subject has ADHD with at least moderate clinical severity (Clinical Global Impression-Severity [CGI-S]) score of 4 or greater). - Subject has a score on the total ADHD symptom score with adult prompts of the CAARS-Inv of at least 22. - Female subjects of childbearing potential must agree to use an effective contraceptive throughout the study - Subject is able to attend the clinic regularly and reliably. - Subject is able to swallow tablets and capsules. - Subject is able to understand, read, write, and speak English fluently to complete the study-related materials (or Hebrew for Israeli subjects). - Subject is able to understand and sign an informed consent form to participate in the study. Exclusion Criteria: - Subject did not respond in the past to 2 adequate trials of stimulant treatments or 1 adequate trial of atomoxetine treatment (in the investigators judgment). - Subject has any psychiatric condition clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by the investigator . - Subject has a known or suspected human immune deficiency virus-positive status or has diseases such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis. - Subject has a history of an allergy or sensitivity to B-complex vitamins. - Subject has a history of intellectual disability or a history or suspicion of autism spectrum disorder. - Subject has a current Axis I diagnosis (other than ADHD) according to the Structured Clinical Interview for DSM IV Axis I Disorders (SCID) or has a lifetime history of bipolar disorder or psychosis. - Subject has used mega-dose vitamin B6/pyridoxine during the 28 days before the Screening Visit. - Subject has used high-dose supplements of omega-3 fatty acids ≥ 500 mg on at least 1 day or folic acid supplements during the 2 weeks before the Screening Visit. - Subject has used an investigational medication/treatment in the 30 days before the Screening Visit - Subject has used any medication or food supplement that the investigator or the medical monitor considers unacceptable during the 14-day period before randomization. - Subject has a current drug or alcohol dependence or substance abuse disorder according to DSM-IV. Subject should also agree to keep their caffeine intake consistent and refrain from consuming ≥300 mg per day of caffeine (no more than three 8-ounce servings of coffee) during the study. - Subject has suicidality, defined as active ideation, an intent or plan, or any significant lifetime suicidal behavior. Subjects exhibiting history (within previous 12 months) of non-suicidal self-injurious behavior will be excluded. - Subject has taken any prescription or non-prescription ADHD medications during the 14 days (for all psychotropic medications other than fluoxetine) or 28 days (for fluoxetine) before the randomization visit. - Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses - Subject is related to the sponsor, investigator, or study staff. - Subject has any condition that, in the principal investigators opinion, would place the subject at risk or influence the conduct of the study or interpretation of results, - Subject cannot fully comprehend the implications of the protocol, cannot comply with its requirements, or is incapable of following the study schedule for any reason. - Subject is pregnant, lactating, or using an inadequate contraceptive method. - If there is a ≥25% change in the CAARS-Inv results between the Interim visit (off drug) assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. ; PRIMARY OUTCOME: Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks; SECONDARY OUTCOME 1: Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AK001-002; BRIEF: This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated. ; DRUG USED: AK001; DRUG CLASS: Biologic; INDICATION: Nasal Polyposis; TARGET: Mast Cell, Sialic acid-binding Ig-like lectin 8 (SIGLEC8); THERAPY: Monotherapy; LEAD SPONSOR: Allakos Inc.; CRITERIA: Inclusion Criteria: - TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale - History of sinusitis symptoms - SNOT-22 ≥30 - No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings Exclusion Criteria: - Use of systemic corticosteroids within 6 weeks of screening - Chronic use of antibiotic therapy within 3 months prior to Screening - Nasal surgery (including polypectomy) within 6 months prior to Screening - Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half-lives, whichever is longer ; PRIMARY OUTCOME: Change in Total Polys Score (TPS); 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 - 14570A (Adjunctive Therapy); BRIEF: To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD). ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Combination; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The patient is an outpatient consulting a psychiatrist. - The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI). - The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments. - The patient agrees to protocol-defined use of effective contraception. Exclusion Criteria: - The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD. - The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder. - The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE. - The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria). - The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide. - The patient has had neuroleptic malignant syndrome. - The patient has any relevant medical history or current presence of systemic disease. - The patient has, at the Screening Visit an abnormal ECG that is, in the investigators opinion, clinically significant. - The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of IMP. - The patient is, in the investigators opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Full Remission During the Randomised Treatment Period; SECONDARY OUTCOME 1: Full Functional Remission During the Randomised Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HARMONIZE Asia; BRIEF: To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following 24 or 48 hours of initial ZS therapy (10g TID). ; DRUG USED: Lokelma; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperkalemia; TARGET: Potassium; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of informed consent (pre-screening consent) prior to any study specific procedures 2. Female and male patients aged ≥18 and ≤ 90 years 3. Provision of informed consent prior to any study specific procedures 4. Two consecutive i-STAT potassium values, measured 60 minutes (± 10 minutes) apart, both ≥ 5.1 mmol/L and measured within 1 day of the first ZS dose on open-label initial phase Day 1 5. Ability to have repeated blood draws or effective venous catheterization 6. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used Exclusion Criteria: 1. Involvement in the planning and/or conduct of the study 2. Participation in another clinical study with an investigational product during the last 3 months 3. Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardizes the quality of the data to be generated 4. Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venepuncture, or history of severe leukocytosis or thrombocytosis 5. Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug 6. Patients treated with resins,calcium acetate,calcium carbonate, or lanthanum carbonate,within 7 days prior to the first dose of study drug 7. Patients with a life expectancy of less than 3 months 8. Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjects tasks associated with the protocol 9. Female patients who are pregnant, lactating, or planning to become pregnant 10. Patients with diabetic ketoacidosis 11. Known hypersensitivity or previous anaphylaxis to ZS or to components thereof 12. Patients with cardiac arrhythmias that require immediate treatment 13. History of QT prolongation associated with other medications that required discontinuation of that medication. 14. Congenital long QT syndrome 15. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted 16. QTc(f) > 550 msec 17. Patients on dialysis 18. Patients who are blood donors should not donate blood during the study and for 3 months following their last dose of ZS 19. Patients who need hospitalization after taking blood samples on day 1 of the open-label initial phase ; PRIMARY OUTCOME: Least Squares Means of S-K values during the 28-day randomized treatment study phase Study Days 8-29.; SECONDARY OUTCOME 1: Exponential rate of change in S-K levels[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - Study 203 w/Capecitabine (EU); BRIEF: This is a Phase 1b/2, multi-center, open-label, dose escalation (in 2 different dosing schedules [1 and 2]) and dose-confirmation study of eribulin administered in combination with capecitabine. ; DRUG USED: Halaven; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Eisai Limited; CRITERIA: Inclusion Criteria Subjects who meet all of the following criteria will be included in the study: Dose-escalation cohorts (Phase 1b): 1. Histologically or cytologically confirmed cancer that is advanced and/or metastatic 2. Resistant/refractory to approved therapies (defined as progressive disease during or within 6 months after the last anti-cancer therapy) or for whom single agent capecitabine at this dose level and schedule would be a reasonable treatment option in the opinion of the investigator 3. For subjects that previously received capecitabine, all capecitabine related toxicities must have completely resolved 4. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L 5. Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP. 6. Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement. 7. Females of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin (hCG) at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. 8. Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly affective method of contraception (e.g. condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) 9. Life expectancy of greater than 3 months 10. Willing and able to comply with all aspects of the protocol 11. Provide written informed consent 12. Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2 13. Males and females, age greater than or equal to18 years Dose-confirmation cohorts (Phase 2): 1. Histologically or cytologically confirmed carcinoma of the breast that is advanced and/or metastatic 2. Received up to three prior chemotherapy regimens in any setting (sequential neoadjuvant/ adjuvant treatment counting as one regimen) 3. Chemotherapy regimens must have included an anthracycline (unless anthracycline containing chemotherapy is inappropriate) and a taxane, either in combination or in separate regimens 4. No prior treatment with capecitabine in any setting 5. At least one lesion of greater than or equal to 1.5cm in longest diameter for non-lymph nodes and greater than or equal to 1.5cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 7 6. Adequate bone marrow function as evidenced by ANC greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L 7. Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP. 8. Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement. 9. Females of childbearing potential must have a negative urine or serum beta hCG at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD, or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential 10. Life expectancy of greater than 3 months 11. Willing and able to comply with all aspects of the protocol 12. ECOG-PS 0 or 1 13. Females, age greater than or equal to 18 years Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the study: 1. Radiotherapy, chemotherapy, biological therapy or investigational agents within 4 weeks prior to the start of study treatment; subjects must have recovered from any previous therapy related toxicity to less than Grade 1 at study entry (except for stable sensory neuropathy less than or equal to Grade 2 and alopecia) 2. Treatment with mitomycin C or nitrosourea within 6 weeks prior to commencing on study treatment 3. Hormonal treatment within 2 weeks prior to start of study treatment (continued use of antiandrogens and/or gonadorelin analogues for treatment of prostate cancer permitted) 4. Prior participation in an eribulin clinical study, even if not assigned to eribulin treatment 5. Subject with hypersensitivity to halochondrin B and /or halochondrin B chemical derivates or capecitabine or any of the excipients 6. Suspected dihydropyrimidine dehydrogenase (DPD) deficiency 7. Previous radiotherapy encompassing greater than 30% of marrow 8. Previous organ allograft requiring immunosuppression 9. Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed at least 4 weeks earlier 10. Meningeal carcinomatosis 11. Significant cardiovascular impairment (history of congestive heart failure greater than New York Heart Association [NYHA] grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia) 12. Electrocardiogram (ECG) with QT interval corrected for heart rate (QTc) interval greater than 470 msec (as measured either by Bazetts or Fredericias formula) 13. Pre-existing neuropathy greater than Grade 2 14. Anti-coagulant therapy with warfarin or related compounds, other than for line patency, that cannot be changed to heparin-based therapy for the duration of the study 15. Subjects with known positive serology for Human Immunodeficiency Virus (HIV), or Hepatitis B or C 16. Subjects with other significant disease or disorder that, in the Investigators opinion, would exclude the subject from the study 17. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study 18. Unable to swallow tablets ; PRIMARY OUTCOME: Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0); SECONDARY OUTCOME 1: Phase 2: Time to Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - PBTC (Medulloblastoma); BRIEF: This is a multi center, Phase I, Phase II and surgical study of the CX-4945 drug (silmitasertib sodium) for patients with recurrent SHH (Sonic Hedgehog) medulloblastoma ; DRUG USED: Silmitasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Protein kinase CK2/Casein Kinase II; THERAPY: Monotherapy; LEAD SPONSOR: Pediatric Brain Tumor Consortium; CRITERIA: A. Screening Criteria: Subject must have a diagnosis of medulloblastoma that is recurrent or refractory and must have adequate tissue for SHH subgrouping. B. Inclusion Criteria: 1. Phase I Skeletally-immature: a. Patient must be skeletally-immature at the time of study enrollment, defined as females with a bone age < 14 years and males with a bone age < 16 years. Patient must be ≥3 and ≤18 years of age and BSA must meet protocol restrictions. 2. Phase II Skeletally-mature: 1. Patients must be skeletally-mature, defined as females with a bone age ≥14 years and males with a bone age ≥ 16 years OR have a chronological age >18 years. 2. Must have bi-dimensionally measurable disease 3. Surgical Study: 1. Surgical resection must be clinically indicated. 2. Must be ≥3 years. 3. Must be amenable to receiving CX-4945 for 5-7 days prior to surgery 4. All Phases: 1. Must have a diagnosis of SHH medulloblastoma that is recurrent or progressive which was confirmed histologically and subgrouping was completed using a CLIA certified methylation based test. 2. Prior Therapy - Must have received prior therapy which included radiation therapy and recovered from acute treatment related toxicities. - Must have received the last dose of myelosuppressive therapy at least 21 days prior to enrollment and at least 42 days if nitrosourea. - Must have received the last dose of another investigational or biologic agent ≥7 days prior. For agents known to have adverse events occurring beyond 7 days, the period must be extended to accommodate the longer interval. For monoclonal antibodies with prolonged half-lives, at least 3 half-lives must have elapsed. - Must have received last fraction of craniospinal or total body irradiation or radiation to ≥50% of the pelvis >3 months prior to enrollment. Last fraction of focal irradiation must be >4 weeks prior to enrollment. - Must be ≥ 6 months since allogeneic stem cell transplant with no evidence of acute graft vs. host disease. - Must be ≥3 months since autologous stem cell transplant. 3. Must be off all colony-forming growth factors at least 1 week prior to enrollment. Must be off 2 weeks if the subject received a long-acting formulation. 4. If neurological deficits are present, must have been stable for a minimum of 1 week prior to enrollment. • Patients with seizure disorders may be enrolled if seizures are well controlled. 5. Must have a Karnofsky/Lansky Performance status ≥50% 6. Must have adequate organ and marrow function 7. Subjects receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment. 8. Female patients of childbearing potential must have a negative pregnancy test. 9. Patients of child-bearing or child fathering potential must be willing to use medically acceptable form of birth control while treated on this study and for 3 months after drug cessation. 10. Parent or legal guardian must be able to understand and willing to sign the written informed consent. C. Exclusion Criteria: 1. All Phases 1. Nursing mothers due to an unknown but potential risk for adverse events in nursing infants. 2. Patients with a history of any other malignancy with the exception of patients with a secondary brain tumor if the patients prior malignancy has been in remission for at least 5 years from the end of treatment. 3. Patients with any of the following gastrointestinal disorders - difficulty swallowing or active malabsorption, uncontrolled diarrhea, gastritis, ulcerative colitis, Crohns disease or hemorrhagic coloproctitis, history of gastric or small bowel surgery involving any extent of gastric or small bowel resection. 4. Patients with any clinically significant unrelated systemic illness that would compromise the patients ability to tolerate therapy, put them at additional risk for toxicity or interfere with the study procedures or results. 5. Corrected QT (QTc) interval is >480ms 6. Patients who are receiving other anti-cancer or investigational drug therapy 7. Patients who are on warfarin or statins. ; PRIMARY OUTCOME: Phase I: Maximum tolerated dose of CX-4945; SECONDARY OUTCOME 1: Progression free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD; BRIEF: The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers. ; DRUG USED: ALRN-5281; DRUG CLASS: Biologic; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth Hormone Releasing Hormone (GHRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Aileron Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent. 2. Subjects must be in good health as determined by the Investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs and other screening evaluations. 3. Ability to provide written informed consent and complying with all study requirements and restrictions. 4. Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening Exclusion Criteria: 1. History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator 2. Previous treatment with any GH Releasing Hormone (GHRH) analog. 3. Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment. 4. History of cancer within the past five years (excluding non-melanoma skin cancer). 5. History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator. 6. Subjects with a body weight > 120 kg. ; PRIMARY OUTCOME: Incidence of adverse events; SECONDARY OUTCOME 1: Serum IGF-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 - 106372 - US/EU/Asia; BRIEF: The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season. ; DRUG USED: GSK2186877A; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes that they can and will comply with the requirements of the protocol. - A man or woman aged 65 years or older at the time of the vaccination. - Written informed consent obtained from the subject. - Subjects with residence status allowing free mixing with general community. Exclusion Criteria: - Bedridden subjects - Previous vaccination against influenza since February 2008. - Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine. - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Any contra-indication to intramuscular administration of the influenza vaccines. - History of hypersensitivity to a previous dose of influenza vaccine. - History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein. - Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F). ; PRIMARY OUTCOME: Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.; SECONDARY OUTCOME 1: Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.[/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 - COR-ART; BRIEF: Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus rhythm. ; DRUG USED: Vanoxerine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atrial Fibrillation/Flutter; TARGET: Calcium Channel, Dopamine Transporter (DAT), Potassium channels, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Laguna Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - provide written informed consent, - male or female 18 years of age or greater; women of child bearing potential must use adequate contraception - symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms - AF/AFL documented by ECG at the start of study drug administration Exclusion Criteria: - Systolic blood pressure <100 mmHg. - Average heart rate <50 bpm. - Average QTcF (Fridericia correction) >440 ms. - Average QRS interval >140 ms. - Paced atrial or ventricular rhythm on ECG. - Serum potassium <3.5 meq/L (may be corrected prior to randomization). - Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days. - received amiodarone (oral or IV) in prior 3 months. - Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization. - Aortic stenosis with aortic valve area equal to or less than 1.0 cm2. - Rheumatic mitral stenosis with valve area of <1.5 cm2. - Untreated hyperthyroidism. - Acute pericarditis. - AF/AFL as a result of surgery within the last 7 days - History of failed electrical cardioversion - History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes). - History or family history of long QT syndrome. - History of ventricular tachycardia requiring drug or device therapy. - History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF. - Ejection fraction (EF) of 35% or less. ; PRIMARY OUTCOME: Conversion to Sinus Rhythm; 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 - AWARD-PEDS; BRIEF: The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks. ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening. - Have HbA1c >6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5 % to ≤9%. - Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50 kilograms (110 pounds). Exclusion Criteria: - Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome. - A history of, or at risk for pancreatitis. - Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening. - A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg. - Active or treated cancer. - A blood disorder where an accurate HbA1c may not be obtainable. - A female of childbearing age, sexually active and not on birth control. - Pregnant or plan to be pregnant during the study, or breastfeeding. - Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin). - Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day. - Using prescription weight loss medications in the last 30 days, or plan to use. - Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months. ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26; SECONDARY OUTCOME 1: Change From Baseline in HbA1c (Individual Doses) 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 II - SAPPHIRE (Canada); BRIEF: The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic severe PAH on available PAH-targeted medical therapy. ; DRUG USED: Aurora-GT; DRUG CLASS: Biologic; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Nitric Oxide Synthase, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Northern Therapeutics; CRITERIA: Inclusion Criteria: - Age ≥ 18 years, ≤ 80 years - Established diagnosis of PAH due to the following: - Idiopathic or heritable PAH; - Scleroderma associated PAH (limited or diffuse); - Drugs (anorexigens) or toxins; - Congenital heart defects (atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired ≥ 1 years - WHO functional class II, III, or IV on appropriate stable therapy for PAH for at least 3 months prior to the screening period and up until randomization, apart from modification of anticoagulant or diuretic dosages, or small adjustments in prostaglandin dose that are considered by the Investigator to be consistent with stable parenteral therapy. - Able to walk unassisted (oxygen use allowed). Aids for carrying oxygen (such as a wheel chair or walker) are permitted provided they are not also required as mobility aids. - An average 6-Minute Walk Distance (6MWD) of ≥ 125 meters and ≤ 440 meters on two consecutive tests during the Screening period - Previous diagnostic right heart cardiac catheterization (RHC) at the time of PAH diagnosis with findings consistent with PAH: specifically, mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg (at rest); pulmonary vascular resistance (PVR) ≥ 3 WU; pulmonary capillary wedge pressure (PCWP) (or left ventricular end diastolic pressure) ≤12 mmHg if PVR ≥ 3 to < 5 WU, or pulmonary capillary wedge pressure (PCWP) (or left ventricular end diastolic pressure) ≤ 15 mmHg if PVR ≥ 5 WU. If repeat testing has occurred since initial diagnosis, the most recent results should be used. - Echocardiography performed within 12 months prior to the Screening Period confirming a left atrial volume index (LAVI) of ≤ 34 ml/m2 and the absence of any clinically significant left heart disease including evidence of more than mild left-sided valvular heart disease, systolic or diastolic left ventricular dysfunction - Ventilation and perfusion (VQ) nuclear scan performed as part of the initial workup to establish the diagnosis of PAH showing absence (i.e. low probability) of pulmonary embolism. If repeat testing has occurred since initial diagnosis, the most recent results should be used. In the absence of a VQ scan to establish eligibility, a CT angiogram that has been reviewed by a radiologist with expertise in the work up for pulmonary endarterectomy and deemed negative for chronic thromboembolic disease may be used instead. - Pulmonary function tests conducted within 2 years prior to the Screening Period to confirm: total lung capacity (TLC) ≥ 65% the predicted value; and forced expiratory volume at one second (FEV1) of ≥ 65% the predicted value - Must have a resting arterial oxygen saturation (SaO2) ≥88% with or without supplemental oxygen as measured by pulse oximetry at the Screening Visit - Must not be enrolled in an exercise training program for pulmonary rehabilitation within 3 months prior to the Screening Visit and must agree not to enroll in an exercise training program for pulmonary rehabilitation during the Screening Period and the first 6 months of the study. Participants enrolled in an exercise program for pulmonary rehabilitation 3 months prior to screening may enter the study if they agree to maintain their current level of rehabilitation for the first 6 months of the study - Women of child-bearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must be practicing abstinence or using two highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, i.e., less than 1% per year, such as approved hormonal contraceptives, barrier methods [such as a condom or diaphragm] used with a spermicide, or an intrauterine device). Subjects must have a negative ß-hCG pregnancy test during the Screening period and negative urine pregnancy test results at all other study visits - Must be willing and able to comply with study requirements and restrictions. Exclusion Criteria: - Pregnant or lactating - PAH related to any condition not covered under inclusion criteria, including but not limited to pulmonary venous hypertension, pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or chronic thromboembolic pulmonary hypertension - Evidence of more than mild interstitial lung disease on Chest CT within the last 5 years (last 3 years for patients with scleroderma associated PAH) - Treatment with an investigational drug, device or therapy within 3 months prior to the screening period or is scheduled to receive an investigational drug, device or therapy during the course of the study - Any musculoskeletal disease or any other disease that would significantly limit ambulation - Unrepaired or recently repaired (< 1 year) congenital systemic-to-pulmonary shunt other than patent foramen ovale - Patients having three or more of the following four AMBITION study HFpEF risk factors will be excluded: - BMI ≥ 30 kg/m2, - History of essential hypertension, - Diabetes mellitus (any type) - Historical evidence of significant coronary artery disease (CAD) by ANY ONE of the following: - History of MI - History of PCI - Prior coronary angiography evidence of CAD (>50% stenosis in ≥1 vessel) - Previous positive Stress Test - Previous CABG - Stable angina - Creatinine clearance <30 ml/min (using the Cockroft-Gault formula) or requires hemodialysis - Inability to undergo the apheresis procedure due to poor venous access or laboratory tests that are not within acceptable ranges (not including INR for patients on Coumadin) - Childs-Pugh class C liver cirrhosis - Previous atrial septostomy - Any other clinically significant illness or abnormal laboratory values (measured during the screening period) that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data - Anticipated survival less than 1 year due to concomitant disease - History of cancer in the past 5 years (except for low grade and fully resolved non-melanoma skin cancer) - Results during screening consistent with current infection with HIV, Hepatitis B(HBV) or C(HCV), human T-cell lymphotropic virus (HTLV- I/II) or syphilis - Systemic arterial systolic blood pressure < 85 mm Hg - Known allergy to gentamicin or amphotericin - Patients who have participated in any gene therapy study or an angiogenic growth factor protein study - Patients unable to provide informed consent and comply with the visit schedule. ; PRIMARY OUTCOME: Change in 6 Minute Walk Distance (6MWD) from Baseline; SECONDARY OUTCOME 1: Change in 6 Minute Walk Distance (6MWD) from Baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 047; BRIEF: The diagnosis of growth hormone deficiency (GHD) in adults is established by laboratory testing in patients with an appropriate clinical history of hypothalamic pituitary disease. Two tests that are considered to be gold standard tests for the diagnosis of GHD are the insulin tolerance test (ITT) and growth hormone releasing hormone (GHRH) combined with L-arginine (L-ARG). However, these tests are either bothersome (given intravenously) to the patient or are linked with side effects. Therefore, an orally available compound like AEZS-130 (formerly ARD-07), if demonstrated to be safe and providing adequate sensitivity and specificity could be a welcome alternative and/or complement to the current available tests. The intent was to recruit 40 adult GHD (AGHD) patients and 40 healthy control subjects into this trial, but the original sponsor (Ardana Biosciences Ltd.) discontinued the study for financial reasons before this was completed. At the time of withdrawal of GHRH from the market in 2008, 42 AGHD patients and 10 normal controls had completed the study at 9 US sites. This study reactivated to complete the remaining 30 matched control subjects. Additionally upon agreement with the FDA in a Special Protocol Assessment (SPA), 10 additional adult growth hormone deficient and their matched control were planned to be enrolled into this trial for a total treated population of approximatively 100 subjects. ; DRUG USED: Macrilen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AEterna Zentaris; CRITERIA: Inclusion for Matched Control Subjects: - Undergone normal growth and development - Normal serum prolactin (PRL) concentrations - Females should have a history of regular, age-appropriate menses - Males should have normal serum testosterone concentrations - Matched GHD subject already enrolled in study; matched in terms of sex, age, BMI and Estrogen status (women only) Exclusion Criteria for Matched Control Subjects: - Inability or unwillingness to comply with study medication - Pregnancy or lactation - Clinically relevant ECG abnormalities (including QT/QTc interval > 450 ms) at any time prior to dosing at Visit 2 - Treatment with any drugs that might prolong QT/QTc Inclusion criteria dor Adult GHD Subjects: - Confirmed GH deficiency with a low IGF-1 - 3 months of stable treatment for those requiring hormone replacement therapy for hormones deficiencies other than GHD - subjects with hypogonadism must be treated with sex steroid therapy, excluding women over 50 yr of age - women on estrogen therapy, for whatever reason, must be on stable treatment for ar least 3 months prior to study Exclusion criteria for Adult GHD Subjects: - Untreated hypothyroidism - Known hypersensitivity to any excipient in study medication - Inability or unwillingness to comply with study procedures - Intracranial lesions stable for less than 12 months - GH therapy within one month of study entry - Clinically significant cardiovascular, or cerebrovascular disease - Current active malignancy other than non-melanoma skin cancer - Renal or hepatic dysfunction (> 3 x ULN liver function enzymes (LFEs) - aspartate amino transferase (ASAT); alanine amino transferase (ALAT); gamma-glutamyltransferase (GGT) or creatinine > 2x ULN) - Pregnancy or lactation - Active Cushings disease - Clinically relevant ECG abnormalities (including QT/heart rate corrected QT interval (QTc) interval > 450 ms) at any time prior to dosing at Visit 2 - Treatment with any drugs that might prolong QT/QTc ; PRIMARY OUTCOME: Receiver Operating Characteristic (ROC) Analysis on Peak GH (Growth Hormon) Concentrations; SECONDARY OUTCOME 1: Peak Insulin-Like Growth Factor (IGF)-1 Concentration Following 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 - Metastatic PDAC; BRIEF: The main objective of this trial is to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC). ; DRUG USED: Onvansertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: Adenosine (including AMP, ADP, and ATP), Polo-like kinase 1 (Plk1); THERAPY: Monotherapy; LEAD SPONSOR: Cardiff Oncology; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed metastatic PDAC - Has received 1 prior gemcitabine-based chemotherapy as first line therapy for metastatic disease. Progression after completion of neoadjuvant or adjuvant therapy of < 6 months in duration is considered 1 line of therapy for metastatic disease - Has measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 - Must be willing and able to undergo a tissue biopsy at screening; participants who, in the opinion of the investigator, do not have tissue that is accessible for biopsy are excepted from this criterion - Women of childbearing potential: (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation and for 4 months after the last dose of nal-IRI. Male subjects must agree to refrain from sperm donation during the study and for 4 months after the last dose of nal-IRI - Ability to understand and the willingness to sign a written informed consent document. Signed informed consent form must be obtained prior to initiation of study evaluations and/or activities - International Normalized Ratio (INR) < 1.5 unless on warfarin - Participants with prior malignancy and who were treated with no evidence of active disease more than 2 years from initial diagnosis are eligible - Age ≥ 18 years - Participants must have adequate organ and bone marrow function Exclusion Criteria: - Prior treatment with irinotecan, nal-IRI, or investigational PLK1 inhibitor - Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial infarction within 3 months of initiation of therapy - History of interstitial pneumonitis or interstitial lung disease - Participants with microsatellite instability-high (MSI-H) tumors with no prior immune checkpoint inhibitor exposure - Pregnancy or lactation - Participant has active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy - QT interval with Fridericias correction (QTcF) > 470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate electrocardiograms (ECGs). In the case of potentially correctible causes of QT prolongation, (eg, medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility - Planned concomitant use of medications known to prolong the QT/QTc interval - Participant has undergone major surgical resection within 4 weeks prior to enrollment - Participant received radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to study entry - Participant has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the participant to receive an experimental research drugs - Serious psychiatric or medical conditions that could interfere with treatment - Major bleeding in the last 4 weeks - More than 1 prior chemotherapy regimen administered in the metastatic setting - Unable or unwilling to swallow oral medication - Use of strong CYP3A4 or UGT1A1 inhibitors or strong CYP3A4 inducers. Participants currently receiving these agents who are able to switch to alternate therapy are not excluded. Inhibitors should be stopped at least one week prior to the first dose of protocol therapy and inducers should be stopped at least two weeks prior to initiation of protocol therapy. ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)[/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 - B0141006; BRIEF: Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways. This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response. ; DRUG USED: Ajovy; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy male subjects between the ages of 18 and 50 years inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. - Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. - Skintype I-III with a distance from base of scaphoid to antecubital fossa >26cm on their forearms. Exclusion Criteria: - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing). - Use of biologics including any live vaccines within 3 months prior to screening or prior treatment with an antibody in a previous clinical trial or treatment with an immunoglobulin in the past 6 months. - 12-lead ECG demonstrating QTcF >450 msec at screening. - Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessive hairy volar forearms. ; PRIMARY OUTCOME: Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin; SECONDARY OUTCOME 1: Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AFFINITY; BRIEF: The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function. ; DRUG USED: Atrasentan; DRUG CLASS: New Molecular Entity (NME); INDICATION: End-Stage Renal Disease (ESRD); TARGET: Endothelin Receptor Type A (EDNRA); THERAPY: Monotherapy; LEAD SPONSOR: Chinook Therapeutics U.S., Inc.; CRITERIA: Inclusion Criteria: - Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts - Age 18-70 years for patients in the DKD cohort - Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. - For patients enrolling in IgAN Cohort: 1. Biopsy-proven IgA nephropathy 2. UPCR between 0.5 to less than 1.0 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 - For patients enrolling in FSGS Cohort: 1. Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS 2. UPCR > 1.0 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 4. Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks. 5. BMI ≤ 40 kg/m2 - For patients enrolling in Alport syndrome Cohort: 1. Diagnosis of Alport syndrome by genetic testing 2. UPCR > 0.5 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 - For patients enrolling in DKD Cohort: 1. Diagnosis of type 2 diabetes mellitus 2. UACR ≥ 0.5 g/g 3. Screening eGFR ≥ 45 mL/min/1.73 m2 4. Receiving a stable dose of SGLT2 inhibitor for at least 12 weeks - Willing and able to provide informed consent and comply with all study requirements Exclusion Criteria: - Current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy. - History of kidney transplantation or other organ transplantation. - Except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months. - Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator. - History of heart failure or a previous hospital admission for fluid overload. - Clinically significant history of liver disease as assessed by the Investigator. - Hemoglobin below 9 g/dL as measured by the Investigator or blood transfusion for anemia within the past 3 months. - Clinical diagnosis of nephrotic syndrome - Malignancy within the past 5 years. Exception to the criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ. - For women, pregnant, breastfeeding, or intent to become pregnant during the study. - For men, intent to father a child or donate sperm during the study. - Recently received an investigational agent. - Clinically significant unstable or uncontrolled medical condition as assessed by the Investigator. ; PRIMARY OUTCOME: Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD; 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 - PEARL 3 (Study 233); BRIEF: Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia. ; DRUG USED: Latuda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; 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: - Provide written informed consent and aged between 18 and 75 years of age. - Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia. - Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study. - Able and agrees to remain off prior antipsychotic medication for the duration of study. - Good physical health on the basis of medical history, physical examination, and laboratory screening. - Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits. Exclusion Criteria: - Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. - Any chronic organic disease of the CNS (other than schizophrenia). - Used investigational compound within 30 days. - Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. ; PRIMARY OUTCOME: Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase; SECONDARY OUTCOME 1: Secondary Outcome: CGI-S From Baseline to the End of the Double-blind 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 III - SOLITAIRE-IV; BRIEF: This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia. ; DRUG USED: Solithera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Melinta Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Male and female patients ≥ 18 years of age - An acute onset of at least 3 of the following signs and symptoms (new or worsening): 1. Cough 2. Production of purulent sputum 3. Shortness of breath (dyspnea) 4. Chest pain due to pneumonia - At least 1 of the following: 1. Fever 2. Hypothermia 3. Presence of pulmonary rales and/or evidence of pulmonary consolidation - PORT Risk Class II, III, or IV - Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study - Not received any systemic antibiotics during the prior 7 days Exclusion Criteria: - Ventilator-associated pneumonia - Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease - Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms - Fungal pneumonia - Pneumocystis jiroveci pneumonia - Aspiration pneumonia - Other non-infectious causes of pulmonary infiltrates - Primary or metastatic lung cancer - Cystic fibrosis - Active or suspected tuberculosis - HIV or myasthenia gravis ; PRIMARY OUTCOME: Early clinical response rate in the Intent to Treat (ITT) population.; SECONDARY OUTCOME 1: Early clinical response rate in the microITT 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 - Stage IV; BRIEF: RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone. ; DRUG USED: Sprycel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: BCR-ABL Fusion Protein, Src Kinase Family, Tyrosine Kinases; THERAPY: Monotherapy; LEAD SPONSOR: SWOG Cancer Research Network; CRITERIA: DISEASE CHARACTERISTICS: - Diagnosis of breast carcinoma meeting the following criteria: - Stage IV disease - Bone metastasis-predominant disease, defined as the presence of ≥ 1 bone metastasis with or without nonbone (visceral or soft tissue) disease where the number of bone metastases is at least the number of measurable visceral target lesions - Visceral disease that does not cause a reduction in ECOG performance status allowed - Must meet 1 of the following criteria: - Measurable disease within the past 28 days - Nonmeasurable disease with rising serum CA 15-3, CA 27-29, CEA, or CA-125 documented by 2 consecutive measurements taken ≥ 14 days apart with the most recent measurement being within the past 42 days - These measurements need not be consecutive, and the prior measurement could have been months to years prior to the current measurement if the marker is considered by the investigator to reflect disease progression - The second serum marker value must be greater than the institutions upper limit of normal and show ≥ a 20% increase over the first measurement - No symptomatic brain or CNS metastases - Prior CNS or brain metastasis allowed provided it was treated with radiotherapy ≥ 8 weeks ago - No pleural or pericardial effusion - Hormone receptor status known - Estrogen receptor- and/or progesterone receptor-positive disease must have progressed on ≥ 1 hormonal therapy in the metastatic setting PATIENT CHARACTERISTICS: - Male or female - Menopausal status not specified - Zubrod performance status 0-2 - QTc < 450 msec by EKG - Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram with no significant abnormalities within the past 12 weeks for patients on trastuzumab - No active infection requiring systemic therapy - No uncontrolled concurrent condition that would preclude the ability to take oral medication, including the following: - Nausea - Vomiting - Diarrhea - Lack of physical integrity of the upper gastrointestinal tract - Malabsorption syndrome - No clinically significant cardiac disease, including the following: - Congestive heart failure - Symptomatic coronary artery disease - Cardiac arrhythmias not well controlled - Myocardial infarction within the past 12 months - No concurrent active malignancy - Prior malignancies allowed provided the patient is currently disease-free - Not pregnant or nursing - Fertile patients must use effective contraception during and for 3 months after completion of study therapy PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior RankL inhibitor therapy - No more than 1 prior cytotoxic chemotherapy for metastatic disease - At least 3 weeks since prior chemotherapy and recovered - At least 1 week since prior radiotherapy to non-CNS disease and recovered - At least 3 weeks since prior and no concurrent intravenous bisphosphates (e.g., zoledronate) - At least 7 days since prior and no concurrent antiplatelet agents, including any of the following*: - Anticoagulants (e.g., tirofiban, eptifibatide, ticlopidine) - Aspirin or aspirin-containing combinations - Dipyridamole - Epoprostenol - Clopidogrel - Cilostazol - Abciximab NOTE: *Nonsteroidal anti-inflammatory drugs and medically indicated platelet-inhibiting medication allowed - At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: - HIV protease inhibitors (e.g., amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir) - Select antibiotics (e.g., ciprofloxacin, clarithromycin, doxycycline, enoxacin, isoniazid, telithromycin) - Azole antifungals (e.g., itraconazole, ketoconazole, miconazole, voriconazole) - Select anesthetics (e.g., ketamine, propofol) - Hypericum perforatum (St. Johns wort) - Nefazodone - Nicardipine - Diclofenac - Quinidine - Imatinib mesylate - At least 7 days since prior and no concurrent medications that prolong the QTc interval, including any of the following: - Antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide phosphate, amiodarone, sotalol hydrochloride, ibutilide, dofetilide) - Antipsychotic agents (e.g., chlorpromazine, mesoridazine, thioridazine, pimozide, haloperidol, droperidol) - Select antibiotics (e.g., erythromycin, clarithromycin, sparfloxacin, pentamidine) - Narcotic analgesics (e.g., levomethadyl, methadone, domperidone) - Calcium channel blockers (e.g., bepridil, lidoflazine) - Antimalarial agents (e.g., halofantrine, chloroquine) - Parasympathomimetic agents (e.g., cisapride) - Arsenic trioxide - No other concurrent antineoplastic therapy for breast cancer, including any of the following: - Radiotherapy - Chemotherapy - Immunotherapy - Biologic therapy - Hormonal therapy - Gene therapy - No concurrent grapefruit juice consumption - No concurrent short-acting antacid agents within 2 hours of dasatinib administration - Concurrent trastuzumab (Herceptin®) therapy for HER-2 positive patients allowed provided patients have been on continuous trastuzumab for ≥ 12 weeks ; PRIMARY OUTCOME: Progression-free Survival; SECONDARY OUTCOME 1: Response Rate (Complete and Partial, Confirmed and Unconfirmed)[/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 - HCT; BRIEF: This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells. ; DRUG USED: HA-1 TCR; DRUG CLASS: Biologic; INDICATION: Hematologic Cancer; TARGET: Stem Cells/Other Cell Therapies, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Fred Hutchinson Cancer Center; CRITERIA: Inclusion Criteria: - Patient age 0-75 years at the time of enrollment. - Patients must express HLA-A*0201 - Patients must have the HA-1(H) genotype (RS_1801284: A/G, A/A) - Patients must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either: - HLA-A*0201 positive and HA-1(H) negative (RS_1801284: G/G) or - HLA-A*0201 negative - Patients who are currently undergoing or who previously underwent allogeneic HCT for - Acute myeloid leukemia (AML) of any subtype - Acute lymphoid leukemia (ALL) of any subtype - Mixed phenotype/undifferentiated/any other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm - Chronic myeloid leukemia with a history of blast crisis and: - With relapse or refractory disease (>= 5% marrow blasts, or circulating blasts) at any time after HCT - With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but < 5% marrow blasts by morphology, no circulating blasts on >= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT - Myelodysplastic syndrome (MDS) of any subtype - Chronic myelomonocytic leukemia (CMML) - Juvenile myelomonocytic leukemia (JMML) - Patients must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for patients younger than 18 years old - Patients must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion - Patients who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol - A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for patients with low performance status DONOR SELECTION INCLUSION - Donor age >= 18 years - Donors must be able to give informed consent - Patients must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either: - HLA-A*0201 positive and HA-1(H) negative (RS_1801284: G/G) or - HLA-A*0201 negative Exclusion Criteria: - Medical or psychological conditions that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI) - Fertile patients unwilling to use contraception during and for 12 months after treatment - Patients with a life expectancy < 3 months of enrollment from coexisting disease other than leukemia - Patients who develop grade IV acute GVHD or severe chronic GVHD following most recent transplant prior to enrollment on the protocol - The presence of organ toxicities will not necessarily exclude patients from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required DONOR SELECTION EXCLUSION - Donors who are HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection - Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an NMDP-affiliated and qualified donor center and are facilitated by the NMDP. ; PRIMARY OUTCOME: Feasibility of manufacturing minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells; SECONDARY OUTCOME 1: Duration of in vivo persistence of transferred HA-1 T cell receptor (TCR) CD4+ T cells in peripheral blood[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - mRNA-1273-P201; BRIEF: This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-COV-2) vaccine in adults 18 years of age or older. ; DRUG USED: mRNA-1273; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: ModernaTX, Inc.; CRITERIA: Key Inclusion Criteria: Each participant must meet all of the following criteria during the screening period and at Day 1, unless noted otherwise, to be enrolled in this study: 1. Male or female, 18 years of age or older at the time of consent (Screening Visit, Day 0). For Part B, participants must have been previously enrolled in the mRNA-1273 P201 study. 2. Understands and agrees to comply with the study procedures and provides written informed consent. 3. According to the assessment of the investigator, is in good general health and can comply with study procedures. 4. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening (Day 0) without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - Has a negative pregnancy test at Screening (Day 0) and on the day of the first injection (Day 1). - Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1). - Has agreed to continue adequate contraception through 3 months following the second injection (Day 29). - Is not currently breastfeeding. Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example: - Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - Intrauterine device - Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route - Sterilization of a female participants monogamous male partner prior to entry into the study Note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. Adequate contraception for male participants is defined as: - Monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - Use of barrier methods and spermicide - History of surgical sterilization - Male participants with partners who have become pregnant prior to Screening are eligible to participate in the study. Additional Key Inclusion Criteria for Part C 1. Participants must have been previously enrolled in the mRNA-1273-P301 study and must have received 2 doses of mRNA-1273 in Part A, has been unblinded and aware of their actual treatment in Study mRNA-1273-P301, must have been compliant in Study mRNA-1273-P301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in Study mRNA-1273-P301 prior to enrollment in this part. Key Exclusion Criteria: Participants meeting any of the following criteria at the Screening Visit (Day 0) or at Day 1, unless noted otherwise, will be excluded from the study: 1. Pregnant or breastfeeding. 2. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. 3. Current treatment with investigational agents for prophylaxis against COVID-19. 4. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigators judgment. 5. Is a healthcare worker or a member of an emergency response team. 6. Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors). 7. History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit (Day 0). 8. History of illegal substance use or alcohol abuse within the past 2 years. This exclusion does not apply to historical cannabis use that was formerly illegal in the participants state but is legal at the time of Screening. 9. Known history of hypertension, or systolic blood pressure >150 millimeter of mercury (mmHg) in participants in Cohort 1 (≥18 to <55 years old) or systolic blood pressure >160 mmHg in participants in Cohort 2 (≥55 years old) at the Screening Visit (Day 0). 10. Known history of hypotension or systolic blood pressure <85 mmHg at the Screening Visit (Day 0). 11. Diabetes mellitus 12. Diagnosis of chronic pulmonary disease (for example, chronic obstructive pulmonary disease, asthma) 13. Chronic cardiovascular disease 14. Resides in a nursing home 15. Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0) 16. Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition. 17. Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the Screening Visit (Day 0) (for corticosteroids ≥20 milligrams (mg)/day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the Screening Visit (Day 0). 18. Anticipating the need for immunosuppressive treatment at any time during participation in the study. 19. Positive serology for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibodies identified at the Screening Visit (Day 0). 20. History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine. 21. Bleeding disorder considered a contraindication to IM injection or phlebotomy. 22. Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer). 23. Has received or plans to receive a licensed vaccine ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection. Licensed influenza vaccines may be received more than 14 days before or after any study injection. 24. Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study. 25. Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study. 26. Participated in an interventional clinical study (other than mRNA-1273 P301) within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study. 27. Is an immediate family member or household member of study personnel Additional Key Exclusion Criteria for Part C 1. Is SARS-CoV-2 positive by Reverse transcription polymerase chain reaction (RT-PCR) (central or local testing) at baseline or at any time during the mRNA-1273-P301 study regardless of the presence or absence of symptoms consistent with COVID-19. 2. Had any SAE in the mRNA-1273-P301 study. ; PRIMARY OUTCOME: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs); SECONDARY OUTCOME 1: Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)[/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 - E. coli (Switzerland); BRIEF: This Phase I multi-center placebo controlled study is conducted in healthy women with a history of recurrent urinary tract infections (UTI) aged between 18 and 70 years. ; DRUG USED: ExPEC Vaccine; DRUG CLASS: Vaccine; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Endotoxin, Escherichia coli (E. coli), Immune System, O-antigen; THERAPY: Monotherapy; LEAD SPONSOR: GlycoVaxyn AG; CRITERIA: Inclusion Criteria: 1. Female subjects with a history of recurrent UTI, which is defined as: ≥ 3 UTI independent episodes in the previous 12 months or ≥ 2 UTI episodes in the last 6 months. At least one UTI during the last 5 years was caused by E. coli (as single pathogen or part of polymicrobial infection) and was culture-confirmed and documented 2. Age ≥ 18 and ≤ 70 years 3. Subjects should be in a healthy state without ongoing or suspected symptomatic UTI at the screening visit and at injection day (V2) 4. General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of the investigator 5. Willingness to participate in the study after all aspects of the protocol have been explained and fully understood, and written informed consent form obtained Exclusion Criteria: 1. History of more than 10 recurrent UTIs in the year before the screening visit 2. Use of any short-term urinary catheter within 7 days prior to screening 3. Use of any permanent catheter within 30 days prior to screening 4. History of any unresolved urinary tract diseases/abnormalities 5. Evidence of impaired immune function 6. Significant cardiovascular, liver, renal diseases and/or insufficiency 7. Uncontrolled diabetes mellitus 8. Significant abnormalities in screening results for hematology, serum chemistry or urinalysis 9. Positive test for HIV, and/or evidence of HBV or HCV 10. BMI >34 11. Previous immune stimulatory therapy for UTI prevention (such as Urovaxom®, Strovac® or Urovac®) in the last 3 months, or planned use during the study period 12. Current use of any medication known to affect immune function (e.g. corticosteroids ≥0.5 mg/kg Body weight/day) 13. Use of UTI-related vaginal estrogen treatment newly started less than 6 months before injection and continuing during the study or planned start during the active study period 14. Use of any antibiotic therapy within 1 week preceding injection 15. Planned use of post-coital antibiotics for UTI prevention during study period 16. Any vaccination planned within 30 days before and 30 days after injection 17. Participation in other clinical trials in the 60 days preceding enrolment and for the duration of the study 18. Previous treatment with immunoglobulins or blood products in the 3 months preceding the injection 19. Known hypersensitivity to any component of the vaccine 20. Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study 21. Acute illness at the time of injection 22. Women of child bearing potential who either have a positive pregnancy test or refuse to use an effective contraception 23. Women who are lactating at any time throughout the study period 24. Subjects with an elective surgical intervention, planned during the study period 25. Any other significant finding that in the opinion of the Investigator would increase the risk of having an adverse outcome from participating in the study ; PRIMARY OUTCOME: Number of subjects experiencing an adverse events; SECONDARY OUTCOME 1: Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb ; BRIEF: The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer. ; DRUG USED: CoFactor; DRUG CLASS: Non-NME; INDICATION: Colorectal Cancer (CRC); TARGET: Thymidylate Synthase; THERAPY: Combination; LEAD SPONSOR: Mast Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma. - Be male or non-pregnant, non-lactating female subjects ≥ 18 years of age. - If female, and of childbearing potential, agree to use adequate contraception (as deemed by the investigator) throughout their participation in this study and for 30 days after discontinuation of study medication. - If, female of childbearing potential, have a negative pregnancy test prior to the start of the study. - Have a life expectancy of at least 6 months. - Have radiologically or clinically measurable disease for response assessment. Presence of ascites or pleural effusion(s) are not acceptable as single sites of response assessment, but may be present if dimensional or other discrete measurable disease is present for evaluation. - Have an ECOG Performance Level of 0-2 (or Karnofsky of 100-70). A lower ECOG or Karnofsky is acceptable only if clearly due to non-oncologic conditions (e.g., prior paraplegia from polio). - Have had no prior chemotherapy for established, metastatic disease. (Subjects may have received adjuvant chemotherapy with fluoropyrimidine therapy). - Have at least 6 months elapsed since prior adjuvant 5-FU or CPT-11 therapy, or Mitomycin C or nitrosourea therapy. - Have had at least an 8 week interval since any prior radiation therapy or 4 weeks since any major surgery. - Have recovered from any toxicities resulting from prior therapies (except for alopecia). - Adequate renal, bone marrow, liver function defined as serum creatinine less than 1.5 times the upper limit of normal, serum bilirubin less than 2 times the upper limit of normal, ANC greater than 1.5 x 109/L, Platelet count greater than 90 x 109/L, SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal. Exclusion Criteria: - Failure by the subject or the subjects legal representative to sign the Informed Consent. - An inability to obtain Informed Consent because of psychiatric or complex medical problems. - Have concurrent infection including diagnoses of FUO or evidence of possible central line sepsis (subjects must be afebrile at the start of therapy). - Have unstable oncologic emergency syndromes: superior vena cava (SVC) syndrome, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc. - Have unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, accelerated hypertension), etc. - Have cerebellar neurologic syndromes such as Parkinsons disease, multiple sclerosis, and amyotonia. - Have a known intolerance to fluoropyrimidine (5-FU, Capecitabine, Floxuridine, UFT) therapy (dihydropyrimidine dehydrogenase deficiency). - Patients with vomiting, diarrhea, or nausea of grade greater than 1. - Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug. ; 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 - JANUS 2; BRIEF: This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: JAK/STAT ; THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the pancreas. - Advanced adenocarcinoma of the pancreas that is inoperable or metastatic. - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy). - ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities. - Radiographically measurable or evaluable disease - An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below: - Criteria: 1. mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L 2. mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L Exclusion Criteria: - Received more than 1 prior regimen for advanced or metastatic disease. - Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment - Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization). - Current or previous other malignancy within 2 years of study entry without sponsor approval - Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), ruxolitinib, or any of their excipients. - Prior treatment with a JAK inhibitor for any indication. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/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 - TWAIN II; BRIEF: This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or 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 - Participant must be 18 to 45 years of age inclusive - Participants with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI) - Disease duration </=10 years - Have a current acute exacerbation of schizophrenia of no more than 8 weeks before screening visit and no current signs of apparent lack of treatment response - At the time of screening, the participant needs to be either hospitalized or requiring inpatient psychiatric care according to clinical judgment. If the participant has been hospitalized for the current exacerbation, the hospitalization has to be of a maximum of 1 week prior to screening. - In previous exacerbations and hospitalizations, the subject has shown a pattern of response to appropriate antipsychotic treatment - Medically stable over a period of 3 months (non-psychiatric conditions) prior to screening visit and not expected to require hospitalization or change of treatment for non-psychiatric conditions for the duration of the study - Screening and baseline CGI-S >/=4 (moderate or worse) - Screening and baseline PANSS total score >= 80 - Based on screening and baseline PANSS, scores of >/= 4 (moderate or worse) on 2 or more of the following items: delusions, conceptual disorganization, unusual thought content, hallucinatory behavior, or suspiciousness/persecution - Body mass index between 18 and 35 kg/m2 inclusive - Male and female participants; female participants 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 Additional inclusion criteria for optional 36-Week Safety Extension Phase - Successful completion of the 12-week treatment period - No signs or symptoms of worsening of the psychiatric or medical status that would preclude the patient from the participation in the 36-Week Safety Extension Phase or affect their ability to comply with the study requirements. Exclusion criteria - Has been inpatient for > 1 week or had any other hospitalization for acute exacerbation of schizophrenia or schizoaffective disorder within the prior 8 weeks or signs of lack of response to antipsychotic treatment - Disease duration > 10 years - Is currently an inpatient on an involuntary basis - Subject answers yes to Suicidal Ideation Item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment within one month from screening or between screening and baseline - Lifetime history of homicidal behavior - Moderate to severe substance use disorder within six months (excluding nicotine) as defined by DSM-5 - Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder) - A prior or current general medical condition that might be impairing cognition or other psychiatric functioning (e.g., migraine headaches requiring prophylaxis treatment, head trauma, dementia, seizure disorder, stroke; or neurodegenerative, inflammatory, infectious, neoplastic, toxic, metabolic, or endocrine conditions) - Clinically significant abnormalities in laboratory safety test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), including a) Aspartate aminotransferase (AST), OR alanine aminotransferase (ALT) 2 x upper limit of normal (ULN), OR total bilirubin > 1.5 ULN with the exception of known Gilbert syndrome. b) Serum creatinine > 1.5 ULN - Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV, untreated), or human immunodeficiency virus (HIV)-1 and -2. HCV participants who have been successfully treated and who test negative for HCV RNA are eligible for entry into the study - Tardive dyskinesia that is moderate to severe or requires treatment - History of neuroleptic malignant syndrome - Average triplicate QTcF interval greater than 450 msec for males and 470 msec for females or other clinically significant abnormality on screening ECG based on centralized reading - Participant for whom risperidone is contraindicated or who have a documented history of lack of response or intolerance to risperidone or paliperidone or participants with known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperdal - Participant treated with a long acting injectable antipsychotic or other antipsychotics that cannot be washed-out within the allotted screening period - History of electro-convulsive therapy (ECT) for any reason - Participant treated with clozapine at any dose within 12 months of screening visit or participants treated with clozapine at 200 mg/day or above at any time; low dose (< 200mg/day) use for insomnia or dyskinesia longer than 12 months prior to screening visit is permitted - Participants currently receiving a psychotropic or other medication used as a psychotropic, which cannot be discontinued during the screening period - Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenorphine, methadone, cocaine and barbiturates. In case of positive urine drug screen for cannabinoids, the participant may be allowed to enter the study if approved by Medical Monitor - Participant has previously received RO6889450 - Participant received an investigational drug within 28 days or five times the half-life of the investigational drug prior to the first study drug administration - 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: Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4; SECONDARY OUTCOME 1: Change From Baseline in PANSS Factor Scores at Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PARALLAX (HFpEF, functional measures); BRIEF: The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF). ; 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) >40% by echo within 6 months prior to study entry or during the screening epoch - Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry - NYHA class II-IV - Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram. - NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF - KCCQ clinical summary score < 75 - Patients on ACEi or ARB therapy must have a history of HTN Exclusion Criteria: - Any prior measurement of LVEF ≤ 40%, under stable conditions - Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry - Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be >40% - Current (within 30 days from Visit 1) acute decompensated HF requiring therapy. - Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696 - History of hypersensitivity to LCZ696 or its components - Patients with a known history of angioedema - Walk distance primarily limited by non-cardiac comorbid conditions at study entry - Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL females, or body mass index (BMI) > 40 kg/m^2. - Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at study entry. - Patients with HbA1c > 7.5% not treated for diabetes - Patients with prior major organ transplant or intent to transplant (ie on transplant list) - eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening - Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at study entry - History or presence of any other disease with a life expectancy of < 3 years - Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12; SECONDARY OUTCOME 1: Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - AC-075-101 (w/ACT-281959); BRIEF: Study Part I is a single-ascending dose study. Healthy male subjects to be included in the study and randomized in 6 dose groups, Groups A-F (8 subjects per group). Of the 8 subjects per group, 6 subjects receive the investigational drug and 2 subjects receive matching placebo. Study Part II is a 3-period, crossover, single dose study. Nine healthy male subjects to be enrolled in one group (Group G). Each subject to receive 2 different formulations of the prodrug and one formulation of the active drug in a randomized sequence. ; DRUG USED: Selatogrel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Adenosine Diphosphate P2Y12 Receptor; THERAPY: Combination; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria: - Signed informed consent in the local language prior to any study-mandated procedure. - Healthy male subjects aged between 18 and 45 years (inclusive) at screening. - No clinically significant findings on the physical examination at screening. - Body mass index of 18.0 to 28.0 kg/m^2 (inclusive) at screening. - Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive), measured on the dominant arm, after 5 minutes in the supine position at screening. - 12-lead electrocardiogram without clinically relevant abnormalities, measured after 5 minutes in the supine position at screening. - Hematology, coagulation, clinical chemistry, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening. - Negative results from urine drug screen at screening. - Baseline value for maximal (at peak) platelet aggregation ≥ 50% light transmission aggregometry upon 20 μM adenosine diphosphate (ADP) activation at screening. - Baseline values of closure time tested with the platelet function analyser 100, for both cartridges Collagen/Epinephrine and Collagen/ADP below the upper limit of the normal range. - Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study. Exclusion Criteria: - Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s). - History or clinical evidence of any disease and/or existence of any surgical or medical condition which would interfere with the absorption, distribution, metabolism, or excretion of the study drug (appendectomy and herniotomy were allowed, while cholecystectomy was not allowed). - Previous history of fainting, collapse, orthostatic hypotension, or vasovagal reactions. - Family or personal history of bleeding (e.g., stroke, major trauma, or surgical intervention), or bleeding disorders (e.g., thrombocytopenia, clotting disturbances, intracranial vascular diseases, peptic ulcers), or reasonable suspicion of vascular malformations. - Platelet count ˂ 120x10^9/L at screening. - Veins unsuitable for intravenous puncture on either arm (e.g., veins that were difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture). - Treatment with another investigational drug within 3 months prior to screening or participation in more than four investigational drug studies within 1 year prior to screening. - History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening. - Excessive caffeine consumption, defined as ≥ 800 mg per day at screening. - Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study. - Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St. Johns Wort) especially acetyl salicylic acid, non-steroidal anti-inflammatory, or any anticoagulant medication (e.g., heparin, warfarin), within 2 weeks prior to (the first) administration of study drug. - Loss of 250 mL or more of blood within 3 months prior to screening. - Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening. - Positive results from the human immunodeficiency virus serology at screening. - Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation in the study or compliance with the protocol. - Legal incapacity or limited legal capacity at screening. ; PRIMARY OUTCOME: Change in supine systolic blood pressure from baseline up to the end of study; SECONDARY OUTCOME 1: Maximum plasma concentration (Cmax) of ACT-246475[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study CS202 (vs. Latanoprost); BRIEF: Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost ; DRUG USED: Rhopressa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. 18 years of age or greater. 2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). 3. Unmedicated (post-washout) Intraocular Pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days a part, and ≥ 22 mm Hg at 10:00 and 16:00 hrs at the second qualification visit. If only one eye meets the IOP criteria it must be the same eye that met the criteria at all the qualification timepoints. 4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200). 5. Able and willing to give signed informed consent and follow study instructions. Exclusion Criteria: Ophthalmic 1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable. 2. IOP > 36 mm Hg. 3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics. 4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s, e.g., laser trabeculoplasty). 5. Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser eye surgery (LASIK), etc.). 6. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months prior to screening. 7. Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis 8. Ocular medication of any kind within 30 days of Visit 0, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 0) or c) lubricating drops for dry eye (which may be used throughout the study). 9. Clinically significant ocular disease (e.g. uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (i.e., cup-disc ratio > 0.8). 10. Central corneal thickness greater than 600 µm. 11. Any abnormality preventing reliable applanation tonometry of either eye. Systemic: 12. Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening. 13. Known hypersensitivity or contraindication to latanoprost. 14. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study. 15. Participation in any investigational study within 30 days prior to screening. 16. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study. 17. Due to the current status of the preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study. ; PRIMARY OUTCOME: Intraocular Pressure (IOP); SECONDARY OUTCOME 1: Extent of Exposure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/ Trastuzumab +/- Cyclophosphamide; BRIEF: This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a 3+3 design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer. ; DRUG USED: MM-302; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), DNA, DNA synthesis, HER2/neu or ErbB-2, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Merrimack Pharmaceuticals; CRITERIA: Inclusion Criteria: - Locally advanced/unresectable or metastatic breast cancer - Eighteen years of age or above - Able to understand and sign an informed consent (or have a legal representative who is able to do so) - Measurable disease according to RECIST v1.1 - ECOG Performance Score of 0 or 1 - Adequate bone marrow, hepatic, renal and cardiac function - Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-302 Exclusion Criteria: - Patients for whom potentially curative anticancer therapy is available - Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing - Symptomatic CNS disease - Known hypersensitivity to any of the components of MM-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies - Received other recent antitumor therapy - Pregnant or breast feeding - Patients with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results ; PRIMARY OUTCOME: The severity and the number of adverse events related to escalating doses of the MM-302.; SECONDARY OUTCOME 1: Objective response rate of MM-302[/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; BRIEF: Myocardial Infarctions (MI) are commonly known as heart attacks. An ST-Segment Elevation Myocardial Infarction (STEMI) is a more severe type of heart attack. Myocardial Infarctions happen when a coronary artery is partially or fully blocked suddenly by a blood clot, causing damage to at least some of the heart muscle being supplied by that artery. In a STEMI, a blood clot completely blocks the coronary artery. This can result in damage to the heart muscle that is supplied by the affected artery. The purpose of the IK-1001 STEMI Study is to evaluate the safety and effectiveness of an investigational study drug (IK-1001). IK-1001 is being studied to determine if it is safe and if it can reduce the amount of damage caused to the heart from a STEMI. Potential subjects may be eligible if they have been diagnosed with a STEMI and undergo a primary percutaneous coronary intervention (PCI, a procedure where a blocked coronary artery is unblocked during a cardiac catheterization), as well as meet other entry criteria. Up to 446 men and women, aged 18-80, will participate in this study at about 50 medical sites around the world. Study participation will last for about six months. Subjects will receive the study drug through an intravenous catheter over three hours during their PCI procedure. Subjects will be monitored in the hospital for approximately three to four days after the PCI. There are three follow-up visits at one, three and six months after the PCI with the study investigator after discharge from the hospital. ; DRUG USED: IK-1001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Potassium channels; THERAPY: Monotherapy; LEAD SPONSOR: Mallinckrodt; CRITERIA: Inclusion Criteria: 1. Presentation to study hospital or institution with diagnosis of STEMI based on clinical and ECG findings (subject presented with ≥ 30 minutes of ischemic chest pain, within 12 hours of symptom onset, and has persistent ST-segment elevation of ≥ 2 mm ST-segment elevation in at least 2 contiguous leads in the ECG. 2. Age between 18 and 80 years (inclusive) 3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form Exclusion Criteria: 1. Prior MI (as determined by subject history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic, or valvular heart disease 2. Cardiac arrest within the past 28 days 3. Requirement for urgent cardiac surgery 4. Previous CABG surgery or PCI 5. Evidence of moderate or severe CHF (Killip Classes III and IV) 6. Any bradyarrhythmia that is expected to require a pacemaker through Day 4 (range 3 to 5 days), thus preventing the MRI 7. Unable to undergo a MRI (including disallowed metallic implants, unable to tolerate gadolinium contrast media, morbid obesity, or severe claustrophobia) 8. Subjects with past or current renal impairment requiring dialysis 9. Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion or hemorrhagic stroke within 6 weeks prior to presentation 10. Known or suspected aortic dissection 11. Subjects who have received treatment for asthma within the past 12 months 12. Prior history of pulmonary disease requiring chronic oxygen therapy 13. Females of childbearing potential 14. Body weight > 150 kg or Body Mass Index (BMI) > 40 kg/m2 15. Medical problem likely to preclude completion of the study 16. Use of investigational drugs or devices within 30 days prior to enrollment into the study 17. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study 18. Known food allergy to sulfite-containing foods and/or any drug allergies to drugs that contain sulfur ; PRIMARY OUTCOME: Creatine Kinase, Muscle and Brain (CK-MB) Troponin T; SECONDARY OUTCOME 1: 12-Lead ECG[/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/Orlistat - RCD; BRIEF: To evaluate the weight loss effect and safety of 400 mg velneperit and 120 mg orlistat administered individually or combined three times per day for 24 weeks while on a reduced calorie diet (RCD) and also to evaluate the steady-state trough concentrations of velneperit (S-2367), velneperit (S-2367) tert-butyl OH, and velneperit (S-2367) tert-butyl OH-O glucuronide following 400 mg of velneperit (S-2367) three times per day and 120 mg of orlistat, either combined or separate. ; DRUG USED: Velneperit; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: Neuropeptide Y (NPY)/Peptide YY (PYY) Receptors; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Shionogi; CRITERIA: Inclusion Criteria: - Males and females between 18 and 65 years of age at the time of informed consent - Body mass index (BMI) of 30.0 to 45.0 kg/m2 inclusive. BMI for study inclusion must be obtained from the Interactive Voice Response System/Web Response System (IVRS/WRS). (Visit 1 body weight and height obtained prior to the single-blind period will be used by the IVRS/WRS in the calculation.) - Weight that has not fluctuated by more than 3% for the 90 days prior to Visit 1 - Non-smoker and no use of tobacco or nicotine products for at least 1 year prior to Visit 1 - Normotensive or acceptable level of hypertension, defined as systolic <160 and diastolic <95 mmHg - No clinically significant laboratory abnormalities - Negative urine drug screen for drugs of abuse - No clinically significant findings on medical history, physical examination, and electrocardiogram (ECG) and no known history of clinically significant ECG abnormalities - Negative serum pregnancy test in women of child-bearing potential (Females must be at least one year post-partum.) - Males either should remain abstinent, be sterile or agree to use an approved method of contraception (which for males includes use of a condom with spermicide) Visit 1 through 12 weeks following the last dose, in addition to having a female partner use an effective form of contraception as noted below - All female subjects must be non-pregnant (confirmed by a negative serum pregnancy test), have no plans of becoming pregnant during the study, and must be at least one year post-partum, non-lactating, postmenopausal, (defined as cessation of regular menstrual periods for at least one year and confirmed by a follicle-stimulating hormone test), or surgically sterile by hysterectomy and/or bilateral oophorectomy or tubal ligation. Females of child-bearing potential must agree to use acceptable forms of birth control including oral, implantable or transdermal contraceptives; or use of one of the following double-barrier methods: intrauterine device with spermicide, diaphragm with spermicide, cervical cap with spermicide, female condom with spermicide, or a male condom with spermicide by the male sexual partner - Able to comply with all required study procedures and schedule - Able to speak and read English - Signed and dated informed consent form prior to any study-related procedures Exclusion Criteria: - Obesity of known endocrine or genetic origin (eg, hypothyroidism, Cushings syndrome or diagnosed polycystic ovarian syndrome) meeting one of the following conditions: - Menstrual irregularity due to oligo- or anovulation - Evidence of hyperandrogenism, whether clinical (hirsutism, acne, or male pattern balding) or biochemical (high serum androgen concentrations) - Exclusion of other causes of hyperandrogenism and menstrual irregularity, such as congenital adrenal hyperplasia, androgen-secreting tumors, and hyperprolactinemia] - History of malignancy within the previous 5 years with the exception of non-melanoma skin cancer or surgically cured cervical cancer - Human immunodeficiency virus (HIV) identified by history or previous HIV test - Any serious medical condition that, in the opinion of the Investigator, would limit the subjects ability to complete and/or participate in this clinical study including any clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs - Known history or evidence of a psychiatric disorder that in the opinion of the investigator would preclude the subject from participating in the trial. Stable or controlled anxiety or depression are permitted. Treatment with an antidepressant or anxiolytic drug is permitted if in accordance with Appendix 4. Subjects with a score of 11 or higher on the depression portion of the Hospital Anxiety and Depression Scale are excluded. - Subjects with pancreatitis or chronic pancreatic inflammation - History of Type 1 or Type 2 diabetes mellitus as defined by HbA1c > 6.5% or blood glucose values of > 126 mg/dl or treated Type 2 diabetes mellitus - Any weight gain during the single-blind lead-in period (Visit 1 and Visit 3) - History of surgical or device (eg, gastric bypass) intervention for obesity surgery, stomach banding surgery, or any other surgical procedure(s) that attempt to promote/aid weight loss. Note: Liposuction will be allowed if done more than 90 days prior to screening - History of alcoholism or drug addiction/substance abuse within 1 year of Visit 1. Note: No alcohol consumption is permitted within 48 hours prior to blood collections for analysis of lipid profiles. - Abnormal thyroid stimulating hormone level at screening - Subjects with hypothyroidism - Subjects with genetic hematologic disease or trait with or without manifestation of disease. - Use of chronic medications/products within 90 days prior to Visit 1 or during the study that are known to cause weight gain. Investigators will discuss with the Sponsors Medical Monitor any concomitant medications about which they are uncertain. - Use of systemic corticosteroids or Depo Provera® - History of fenfluramine or dexfenfluramine (Fen-Phen) administration (except with a prior documented echocardiogram showing no valvular abnormalities.) - History of participation in any weight loss program within 90 days prior to Visit 1 - Participation in any weight loss medication/product study in which receipt of weight loss medication/product occurred within 90 days prior to Visit 1 - Use of any prescription or nonprescription over the counter medication/product or herbal/phytotherapeutic/plant-derived medications/products for weight loss, appetite suppression, weight control or treat obesity (includes investigational products) within 90 days prior to Visit 1 or during the study - Subjects with cholestasis or chronic malabsorption - Donation of blood or blood products 90 days prior to Visit 1 or during the study - Exposure to an investigative medication within the past 30 days or 5 half-lives, whichever is longer or concurrent participation in any clinical trial - Previous velneperit (S-2367) or other neuropeptide Y (NPY) Y5 agonist or antagonist use - Any acute or chronic condition that, in the opinion of the Investigator, would limit the subjects ability to complete and/or participate in this clinical study - Positive Hepatitis B or C serology ; PRIMARY OUTCOME: The primary efficacy endpoint was the change from baseline in body weight (kg) over the 168-day (24-week) double-blind treatment period, where baseline body weight was defined as the last measurement prior to randomization; SECONDARY OUTCOME 1: Efficacy analysis: The proportion of subjects with (a) a 5% decrease in body weight at Visit 7 and Visit 10 and (b) percent change in body weight from baseline to each study visit was summarized by treatment group[/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 - PLX-COV-01 (Severe); BRIEF: This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications. ; DRUG USED: PLX Cells; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Pluristem Ltd.; CRITERIA: Key Inclusion Criteria: - Willing and able to provide written informed consent, or with a legal representative who can provide informed consent. - Male or non-pregnant female adult 40-80 years of age at time of enrollment. - Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization. - Meets definition of ARDS according to Berlin criteria. Key Exclusion Criteria: - Body weight under 55 kg (121 lbs) - Serum creatinine level of over 1.5 mg/dL at time of randomization. - Total Bilirubin ≥2 mg/dL at time of randomization. - Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin. - Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization. - Chronic Obstructive Pulmonary disease GOLD stage above II. ; PRIMARY OUTCOME: Number of ventilator free days; SECONDARY OUTCOME 1: All-cause mortality[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - CaNCaP02 (Cambridge University); BRIEF: Patients with localised prostate cancer can be treated by radical prostatectomy (prostate gland removal surgery) or radiotherapy. Around 15% of men with prostate cancer are diagnosed with high risk disease meaning they are more likely to suffer treatment failure, disease progression and mortality. To date little progress has been made towards identifying effective treatment strategies that might delay or prevent disease recurrence in this patient population. Better identification of patients at high risk of relapse and improvements in therapy are therefore research priorities. A protein named Mammalian Target of Rapamycin (mTOR) is known to play an important role in the development of prostate cancer. mTOR forms two protein complexes (mTORC1 and mTORC2) and sends signals helping cancer cells to grow while controlling their energy use. Blocking the function of mTOR, with an inhibitor such as AZD2014, might shut down the supply of energy supply to tumour cells leading to reduced cell growth and potentially slowing the progression of the disease. The purpose of this study is to investigate the molecular pharmacology of AZD2014 treatment given to patients with prostate cancer prior to radical prostatectomy. The feasibility, safety and tolerability of a short course of AZD2014 will also be assessed. ; DRUG USED: Vistusertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Cambridge University Hospitals NHS Foundation Trust; CRITERIA: Inclusion Criteria: - Men aged 18 years old or older - ECOG performance status of 0 or 1 - Clinical diagnosis of Intermediate (one or more of stage T2, or PSA >10ng/mL, or Gleason score of at least 7) or High Risk Prostate Cancer (one or more of stage T2c, or PSA >20ng/mL, or Gleason score of at least 8) - Patient suitable for radical prostatectomy, following discussion at specialist MDT and subsequent review by surgical team - Willing to use barrier contraceptive method, e.g. condom & spermicide - Adequate bone marrow reserve or organ function (as specified in the study protocol) - Normal chest radiograph and oxygen saturations, OR normal CT thorax Exclusion Criteria: - Contraindication to AZD2014 (as specified in the study protocol) - Patients who have experienced any of the following procedures in the past 12 months: coronary artery bypass graft; angioplasty; vascular stent; myocardial infarction; angina pectoris; congestive heart failure (New York Heart Association grade of 2 or above); ventricular arrhythmias requiring continuous therapy; supraventricular arrhythmias including atrial fibrillation, which are uncontrolled; haemorrhagic or thrombotic stroke including transient ischaemic attacks or any other CNS bleeding. - Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 28 days of starting study treatment. - Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study - Potent or moderate inhibitors and inducers of CYP2C8 if taken within the stated wash-out period: Gemfibrozil, trimethoprim, glitazones, montelukast, deferasirox and quercetin (1-week minimum wash out period) - Any haematopoietic growth factors, e.g. G-CSF, GM-CSF, within 4 weeks prior to receiving study drug - As judged by the Investigator, any evidence of severe or uncontrolled systemic disease (as specified in the study protocol) - Abnormal ECHO or MUGA at baseline - Mean resting QTc of 470msec or above (as per local reading) - Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation, or risk of arrythmic events (examples specified in study protocol). History of Torsades de Pointes. - Patients with Diabetes Type I or uncontrolled Type II as judged by the investigator - Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements. - Unable to provide informed consent ; PRIMARY OUTCOME: To measure the amount of inhibition (percentage change from baseline) in mTORC1 and mTORC2 signalling in tumour samples from men with early, high-risk prostate cancer after AZD2014 treatment; SECONDARY OUTCOME 1: To determine the incidence of adverse events due to AZD2014 given prior to radical prostatectomy[/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 - JADE Mono-2; BRIEF: B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment. ; DRUG USED: Cibinqo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - 12 years of age or older with a minimum body weight of 40 kg - Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4) - Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control Exclusion Criteria: - Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study - Prior treatment with JAK inhibitors - Other active nonAD inflammatory skin diseases or conditions affecting skin - Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator - Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception ; PRIMARY OUTCOME: Percentage of Participants Achieving Investigators Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - CRPC (Canada); BRIEF: The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your prostate cancer. The investigators will also watch you carefully for any side effects that PX-866 might cause. ; DRUG USED: PX-866; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: NCIC Clinical Trials Group; CRITERIA: Inclusion Criteria: - Patients must have a histological or cytological diagnosis of adenocarcinoma of the prostate. - All patients must have formalin fixed paraffin embedded tissue (from their primary or metastatic tumour) available for translational studies. - Presence of clinically and/or radiologically documented disease (measureable or non-measurable). All radiology studies must be performed within 28 days prior to registration (within 35 days if negative). - Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present. - Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated. - No prior chemotherapy regimens for recurrent disease For Part A, patients must have progression defined as: PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥ 5 ng/ml and must be performed no longer than 7 days prior to trial registration. OR Radiological Progression: defined as the development of new metastatic lesions with a stable or rising PSA. Patients entered to Part B of the study (after 2nd stage of accrual completed) must have a rise in their PSA while on abiraterone/prednisone continuing at time of registration (≥ 25% higher from baseline or nadir, whichever is lowest). - The PSA must be ≥5 ng/ml at the time of study entry. - ECOG performance of 0, 1 or 2. - Age ≥ 18 years of age. Previous therapy: Surgery: Previous major surgery is permitted provided that it has been at least 14 days prior to patient registration and that wound healing has occurred. Hormonal Therapy: Prior hormone therapy is required. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide). Therapy with LHRH agonist must continue for those prostate cancer patients already receiving this treatment at the time of enrollment. If the patient has discontinued the LHRH agonist, this must be restarted (if not surgically castrated) and the castrate level of testosterone must be present. Prior therapy with CYP17 inhibitors (e.g. abiraterone, ketoconazole) or novel anti-androgens (e.g. MDV3100) is permitted. Part B: Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide). Therapy with LHRH agonist must continue for those prostate cancer patients already receiving this treatment at the time of enrollment. If the patient has discontinued the LHRH agonist, this must be restarted (if not surgically castrated) and the castrate level of testosterone must be present. All patients must currently be receiving abiraterone. Radiation: Prior external beam radiation is permitted provided a minimum of 2 weeks has elapsed between the last dose and enrollment to the trial. Exceptions may be made for low dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG. Prior strontium is not permitted. - Laboratory Requirements (must be done within 7 days prior to registration) Hematology: Granulocytes (AGC) ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Biochemistry: Serum creatinine ≤ 1.5 x UNL Total bilirubin ≤ 1.5 x UNL ALT and AST ≤ 1.5 x UNL Glucose ≤ 8.9 mmol/L (≤ Grade 1) PSA ≥ 5ng/mL -Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested. - Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hours driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up. - In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient registration. Exclusion Criteria: - Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for >=3 years. - Known HIV-positive patients. - Uncontrolled diabetes mellitus. - Patients with upper gastrointestinal or other conditions that would preclude compliance or absorption of oral medication are not eligible. - Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. - Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components. - Patients with history of central nervous system metastases or untreated spinal cord compression. - Patients who have had prior treatment with a PI3 kinase inhibitor. - Men who are not sterile unless they use an adequate method of birth control. - Patients enrolled to Part B must be suitable for continued therapy with abiraterone/prednisone. ; PRIMARY OUTCOME: Lack of Disease Progression at 12 Weeks; SECONDARY OUTCOME 1: PSA 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 - Dose Finding; BRIEF: This study will evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) at primary neoadjuvant setting. In the safety phase I phase, we determined the tolerable dose of IPC-CKM. In this phase 2 we will add intradermal (ID) autologous αDC1 vaccines (known to be nontoxic) to the tolerable IPC-CKM regimen. The effectiveness will be determined by rate of complete pathologic response. ; DRUG USED: Ampligen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Immune System, Toll-like receptor 3 (TLR3); THERAPY: Combination; LEAD SPONSOR: Roswell Park Cancer Institute; CRITERIA: Inclusion Criteria: - Patients must have advanced stage (III-IV) epithelial carcinoma of ovarian, tubal, or peritoneal origin. - Histologic documentation of the original primary tumor is required via the pathology report. - Original tumor blocks from primary diagnosis biopsy will be reviewed by our study pathologist at Magee. - Patients must be receiving neoadjuvant chemotherapy - Patients must be eligible for cancer-related definitive therapy with neoadjuvant chemotherapy - Patients must be chemonaive and receiving therapy in primary first line neoadjuvant setting - Patients must have GOG performance of 0-1 - Patients must be reasonable candidates for interval debulking surgery as well as IP platinum based combination chemotherapy regimen with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal toxicity, or bowel obstruction. - Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to the first date of treatment on this study. - Patient must be willing to undergo leukapheresis - Patients must agree to appropriate clinical monitoring to receive the study regimens. - Patient must have: - Bone marrow function: - Absolute neutrophil count (ANC) greater than or equal to 1,500/µL, equivalent to CTCAE v4 grade 1. - Platelets greater than or equal to 100,000/µL; - hemoglobin greater than or equal to 8.0 g/dL. - Renal function: - creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4 grade 1. - Hepatic function: - Bilirubin less than or equal to 1.5 x ULN (CTCAE v4 grade 1). - SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4 grade 1). - Patients who have signed informed consent and authorization permitting release of personal health information. - Patients must have a GOG Performance Status of 0 or 1. - Exclusion Criteria: - Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohns Disease, multiple sclerosis (MS), ankylosing spondylitis). - Patients with a known allergy to cisplatin or taxane chemotherapy. Patients with carboplatin allergy may be included if they tolerate a test dose of IV cisplatin given in monitored floor conditions. Patients who are allergic to paclitaxel, can be alternatively treated with abraxane. - Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids. - Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies. - Patients with uncontrolled diseases other than cancer will be excluded. - Patients who are pregnant or nursing. - Patients who have contraindications to the use of NSAIDs like chronic renal failure, coronary artery disease, or bleeding ulcers. - Patients with tumors of low malignant potential, except ovarian pseudomyxoma or with no peritoneal disease. - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. - Patients with previous pelvic radiation therapy. ; PRIMARY OUTCOME: Change in the number of CD8+ tumor infiltrating T cells in the peritoneal fluid.; SECONDARY OUTCOME 1: Change in the number of CD3+CD8+ T cells in the peritoneal fluid.[/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 - 1222.39; BRIEF: The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments. ; DRUG USED: Striverdi Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Patients willing to participate with confirmed diagnosis of COPD - 40 years of age or older - having a 10 pack year smoking history - able to perform serial pulmonary function tests - able to use both a Dry powder inhaler (DPI) and Respimat device Exclusion criteria: - Significant other disease - clinically relevant abnormal hematology, chemistry, or urinalysis - history of asthma - diagnosis of thyrotoxicosis - paroxysmal tachycardia related to beta agonists - history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year - active tuberculosis, cystic fibrosis, clinically evident bronchiectasis - significant alcohol or drug abuse - pulmonary resection - taking oral beta adrenergics - taking unstable oral steroids - daytime oxygen - enrolled in rehabilitation program - enrolled in another study or taking investigational products - pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control - those who are not willing to comply with pulmonary medication washouts ; PRIMARY OUTCOME: FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment; SECONDARY OUTCOME 1: Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of 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 III - HAVEN 4; BRIEF: This multicenter, open-label, non-randomized study will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic (PK) run-in part followed by an expansion part. ; DRUG USED: Hemlibra; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor IX, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Body weight greater than or equal to (>/=) 40 kilograms (kg) at screening - Diagnosis of severe congenital hemophilia A or hemophilia A with FVIII inhibitors - Participants using rFVIIa or willing to switch to recombinant activated factor VII (rFVIIa) as primary bypassing agent for the treatment of breakthrough bleeds - FVIII inhibitor test during screening with titer results available prior to first administration of study drug - Participants without FVIII inhibitors, that is with less than (<) 0.6 Bethesda unit per milliliter [BU/mL];< 1.0 BU/mL only for laboratories with an historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL, who completed successful immune tolerance induction (ITI) must have done so at least 5 years before screening and must have no evidence of inhibitor recurrence (permanent or temporary) indicated by detection of an inhibitor greater than (>) 0.6 BU/mL (> 1.0 BU/mL only for laboratories with an historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL) since ITI - Adequate hematologic, hepatic, and renal function Exclusion Criteria: - Inherited or acquired bleeding disorder other than hemophilia A - Ongoing or planned ITI therapy; participants in whom ITI has failed will be eligible with a 72-hour washout period prior to the first emicizumab administration - History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the investigators judgment - Participants who are at high risk for thrombotic microangiopathy (TMA) (for example, have a previous medical or family history of TMA), in the investigators judgment - Previous (within the last 12 months) or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease - Other conditions (for example, certain autoimmune diseases) that may currently increase the risk of bleeding or thrombosis - History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection - Known HIV infection with cluster of differentiation (CD) 4 cells counts <200 cells per microliter (cells/mcL) - Use of systemic immunomodulators (for example, interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy - Concomitant disease, condition, significant abnormality on screening evaluations or laboratory tests, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an additional unacceptable risk in administering study drug to the participant - Pregnancy or lactation or intention to become pregnant during the study - Women with a positive serum pregnancy test result within 7 days prior to initiation of study drug ; PRIMARY OUTCOME: Expansion Part: Annualized Bleeding Rate (ABR) for Treated Bleeds; SECONDARY OUTCOME 1: Expansion Part: Change From Baseline to Week 25 in the Hemophilia A Quality of Life (Haem-A-QoL) Questionnaire Total Score for Adult Participants (≥18 Years of Age)[/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 - 2097.00; BRIEF: This clinical trial will access the toxicity and efficacy of infusion of gene modified cells for patients with Fanconi anemia (FA). Infusion of autologous patient blood stem cells that have been corrected in the laboratory by introduction of the normal gene may improve blood counts in patients with FA. ; DRUG USED: RP-L102; DRUG CLASS: Biologic; INDICATION: Fanconi Anemia; TARGET: Fanconi anemia, complementation group A (FAA, FACA, FANCA); THERAPY: Combination; LEAD SPONSOR: Fred Hutchinson Cancer Center; CRITERIA: Inclusion Criteria: - FA demonstrated by a positive test for increased sensitivity to chromosomal breakage with mitomycin C or diepoxybutane performed by a Clinical Laboratory Improvement Amendments (CLIA) or College of American Pathologists (CAP) approved laboratory - FA complementation group A as determined by somatic cell hybrids, molecular characterization, western blot analysis, acquisition of mitomycin C resistance after in vitro lentiviral transduction with a vector bearing the complementary deoxyribonucleic acid (cDNA) for Fanconi complementation group A, or other clinically certified method of complementation group analysis - Bone marrow analysis demonstrating normal cytogenetics, and no more than 5% of cells with a single clonal abnormality by fluorescence in situ hybridization (FISH) for myelodysplastic syndrome (MDS) panel within 3 months of stem cell collection - Signed informed consent by the patient or legally authorized representative - Absolute neutrophil count >= 0.5 x 10^9/L - Hemoglobin >= 8 g/dL - Platelet count >= 20 x 10^9/L and able to achieve a platelet count of >= 50 x 10^9/L with transfusion support - Adequate hepatic function with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) - Adequate renal function with creatinine (Cre) =< 1.5; if greater, then glomerular filtration rate (GFR) > 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation - Adequate pulmonary function with corrected diffusion capacity of carbon monoxide (DLCO) > 50% in those for whom this study can be performed - For subjects < 17 years of age, Modified Lansky Play-Performance Score of >= 70%; for subjects 17 and older, Karnofsky score of >= 70% Exclusion Criteria: - Non-hematopoietic malignancy where the expected survival is less than 2 years - Myelodysplastic syndrome as defined by World Health Organization (WHO) criteria - Acute myeloid leukemia as defined by WHO criteria - Pregnancy or lactation; females of childbearing potential and males who are admitted to the study will be advised that the study procedures and study drugs may be teratogenic, and they will be required to take adequate measures to prevent conception for the duration of the study - Concurrent enrollment in any other study using an investigational drug - Physical or emotional status that would prevent informed consent, protocol compliance, or adequate follow-up - Patients for whom an human leukocyte antigen (HLA) matched sibling donor bone marrow transplant is being actively pursued will not be eligible for study until it is determined that no sibling donor is available or that a stem cell transplant is not feasible during the time the patient might be on study - No patient will be included in this study as an alternative to a clinically indicated HLA matched sibling donor stem cell transplant - If an HLA matched sibling donor is identified, but stem cell or marrow collection is not feasible (e.g., donor is in utero, is a newborn from whom cord blood was not collected, or is unable to undergo a donation procedure because of ill health), a patient may be included in the study at the discretion of the investigators - Significant associated diseases including documented human immunodeficiency virus (HIV) infection, uncontrolled hypertension (diastolic blood pressures > 95%ile for age), unstable angina, congestive heart failure (> New York [NY] class II), poorly controlled diabetes (hemoglobin A1c [Hgb A1c] > 7%), coronary angioplasty within 6 months, myocardial infarction within the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmia, abnormal coagulation, persistent abnormal urinalysis reflecting intrinsic renal disease - Active ongoing viral, bacterial, or fungal infection ; PRIMARY OUTCOME: Toxicity of gene transfer; SECONDARY OUTCOME 1: Efficacy of G-CSF and plerixafor mobilization in Fanconi anemia (FA) patients[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Post-ZOSTER; BRIEF: The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229). ; DRUG USED: Shingrix; DRUG CLASS: Vaccine; INDICATION: Chickenpox and Shingles - Vaccines and Treatments; TARGET: Immune System, Varicella Zoster Virus (VSV); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, follow-up contacts). Or subjects Legally Acceptable Representative(s) [LAR(s)]/caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, availability for follow-up contacts). - Written informed consent obtained from the subject/Legally Acceptable representative(s) [LAR(s)] of the subject prior to performing any study specific procedure. If the subjects is not capable of giving consent, his/her assent to participate should be obtained to the extent possible. - Subject who previously participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of placebo. - Female subjects of non-childbearing potential may be enrolled in the study. - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. - Female subjects of childbearing potential may be enrolled in the study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination and - has agreed to continue adequate contraception during the entire treatment period* and for 2 months after completion of the vaccination series. - treatment period refers to vaccination days and the interval between them. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use up to 30 days post Dose 2. - Previous vaccination against Varicella Zoster virus (VZV) or HZ. - Planned administration of VZV or HZ vaccination during the study (including an investigational or non-registered vaccine), with the exception of the study vaccine. - Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant for seasonal or pandemic flus). These may be administered up to 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine - Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose and up to 30 days post Dose 2. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. Inhaled, topical and intra-articular corticosteroids are allowed. - Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab) within six months prior to the first vaccine dose up to 30 days post Dose 2. - Concurrently participating in another clinical study, at the time of enrolment or planned participation up to the 30 days post second dose, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, Human Immunodeficiency Virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. - Active HZ infection at the time of enrolment (i.e. HZ lesions not completely crusted over). - Pregnant or lactating female. - Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. - Any condition which in the judgment of the investigator would make intramuscular injection unsafe. ; PRIMARY OUTCOME: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs); SECONDARY OUTCOME 1: Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/ Zelboraf; BRIEF: - An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with Advanced or Inoperable Malignant Melanoma with BRAF Mutation - The primary objective is to determine the safety, maximum tolerated dose (MTD), and dose limiting toxicity (DLT) of the co-administration of P1446A-05 with vemurafenib, in melanoma patients with BRAF mutation ; DRUG USED: Voruciclib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Combination; LEAD SPONSOR: Piramal Enterprises Limited; CRITERIA: Inclusion Criteria: 1. Patients having histologically confirmed unresectable (Stage III) or metastatic (Stage IV) malignant melanoma with a positive BRAF mutation result determined by Roche CoDx or local CLIA-certified analysis 2. Patients naïve to a selective BRAF inhibitor therapy or must have progressed after therapy on a selective BRAF inhibitor. For patients entering the protocol progressing on vemurafenib therapy, they must be tolerant of the 960 mg po bid dose. 3. Tumor biopsies are optional in this study except for patients entering the mandatory biopsy cohorts. Nevertheless tumor biopsies are encouraged, especially in patients with accessible tumors for biopsy to include the collection of formalin-fixed, paraffin-embedded (FFPE) and fresh- frozen tissue (FF) as outlined in the biomarker sections of the protocol. Willingness of patient to give consent of biopsy, should be ascertained 4. Patients of ≥ 18 years of age 5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or1 6. Patients with measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) 7. Patients must have normal organ and adequate marrow function 8. Patients with ability to swallow and retain oral medication 9. Women of childbearing potential and men willing to agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilized. 10. Negative serum pregnancy test within 10 days prior to commencement of therapy dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. 11. Ability to understand and the willingness to offer a written Informed Consent document prior to the screening procedures for participation into the study - For Extension phase- - For patients entering the protocol progressing on vemurafenib therapy, they must be tolerant of the vemurafenib dose selected for the extension phase Exclusion Criteria: 1. Prior malignancy (within the last 2 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the patient has been disease-free for at least 2 years 2. Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy (one week for BRAF inhibitor for melanoma) or surgery within 4 weeks (6 weeks for monoclonal antibodies, radioactive monoclonal antibodies or any radio-or toxin-immunoconjugates) before Day 1 of Investigational product administration and have not recovered (to < Grade 1) from the toxic effects from any prior therapy 3. Patients having received any other investigational agents within 4 weeks prior to Day 1 of Investigational product administration and have not recovered completely (to < Grade 1) from the side effects of the earlier investigational agent 4. Anticipated administration of any anti-cancer therapies (chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, surgery, and/or tumor embolisation) other than those administered in this study such as BRAF inhibitor 5. Patients with symptomatic or untreated leptomeningeal or brain metastases, or spinal cord compression [patients with previous brain metastases will be allowed to enter the trial if metastases have been surgically removed or all known sites of metastases have been treated with stereotactic high dose radiosurgery. Patients must be off corticosteroids for at least one month and have a stable lesion with verification by imaging (CT/MRI) within 28 days prior to Day 1 of Investigational product administration] 6. Patients with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic diarrheal condition, refractory nausea, vomiting or any other condition that will interfere significantly with the absorption of study drugs 7. Patients with mean QTc interval >480 msec at screening 8. Treatment with drugs with potential to cause dysrhythmias including but not limited to terfenadine, quinidine, procainamide, diisopyramide, sotalol, probucol, bepridil, haloperidol, risperidone and/or indapamide 9. Patients on warfarin treatment 10. Any condition for which participation in this study as judged by the Investigator to be detrimental to the patient with (such as) inter-current illness including, but not limited to ongoing or active infection, New York Heart Association functional classification class III, or IV heart failure; unstable angina pectoris; cardiac arrhythmia; history of myocardial infarction; uncontrolled hypertension (blood pressure above 160/100 mm Hg despite antihypertensive treatment); coronary artery bypass graft; cerebrovascular accident; transient ischemic attack or pulmonary embolism during the previous 6 months or psychiatric illness/social situations that would jeopardize compliance with study requirements 11. Patients with a known immediate or delayed hypersensitivity reaction or idiosyncrasy to any other medication chemically related to P1446A-05 or vemurafenib, or excipients considered to be clinically significant by the investigator 12. Nursing woman 13. Patients with known HIV positivity or AIDS- related illness, or active Hepatitis B virus, and active Hepatitis C virus 14. Patients taking drugs known to prolong the QTc interval who cannot be switched to an alternative drug. For Extension phase- 1. Patients with active second malignancy will be eligible as long as they do not need systemic therapy for the second malignancy 2. Patients with active brain metastases will be included in the study as long as the tumor size is less than 1 cm without the requirement of steroid use for neurological symptoms 3. Patients with evaluable metastatic disease will be allowed even if there is no measurable disease per RECIST 1.1. In this case patients with many sub centimeter in-transit skin/SQ nodules will be eligible for the biopsy cohort. ; PRIMARY OUTCOME: Maximum Tolerated Dose and Dose Limiting Toxicity; SECONDARY OUTCOME 1: Tumor Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/Cisplatin/Gemcitabine (Korea/Taiwan/Singapore); BRIEF: The study intends to evaluate the following objectives in patients with advanced or metastatic biliary tract cancer who have not received systemic therapy for advanced/metastatic disease. Primary Objectives: Phase 1B - To determine the maximum tolerated dose (MTD), as determined by dose-limiting toxicities (DLTs), and to characterise the safety profile of Varlitinib in combination with Gemcitabine and Cisplatin. Phase 2A - To further evaluate the safety and tolerability of Varlitinib in combination with Gemcitabine and Cisplatin at the recommended phase 2 dose (RP2D). - To provide a preliminary assessment of the clinical activity of Varlitinib in combination with Gemcitabine and Cisplatin at the RP2D as measured by Objective Response Rate (ORR) and progression-free survival (PFS) (based on RECIST v1.1) Phase 2B - To compare the efficacy of Varlitinib in combination with Gemcitabine and Cisplatin to placebo in combination with Gemcitabine and Cisplatin as measured by progression-free survival (based on RECIST v1.1). ; DRUG USED: Varlitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Biliary Tract Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: ASLAN Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Patient of respective countrys legal age or older at the time of written informed consent. 2. Patient must be able to understand and willing to provide informed consent for participation in the study and donation of tumour tissue (archival or fresh) for evaluation of relevant exploratory endpoints. 3. Patient must have histologically or cytologically confirmed advanced (unresectable) or metastatic biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or carcinoma of the Ampulla of Vater, with no prior systemic therapy for advanced/metastatic disease. This includes clinical diagnosis of biliary tract cancer with histological confirmation of adenocarcinoma. 4. For phase 1B and 2A only: Presence of radiologically measured disease with at least one, not previously irradiated, measurable lesion according to RECIST v.1.1. 5. No evidence of clinically significant biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below or equal to 1.5 x upper level of normal (ULN). 6. Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Patient with adequate organ and haematological function prior to first dose of study medication: a. Haematological function, as follows: i. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L ii. Platelet count ≥ 100 x 109/L iii. Haemoglobin level ≥ 10 g/dl b. Renal functions, as follows: i. Serum creatinine ≤ 1.5x ULN or eGFR > 60 ml/min/1.73m2 c. Hepatic function, as follows: i. Total bilirubin ≤ 1.5 x ULN ii. AST and ALT ≤ 5 x ULN Exclusion Criteria: 1. Patients with radiation or local treatment 6 weeks prior to screening for the target lesion(s). 2. Patients with major surgical procedures within 21 days prior to screening. 3. Patients with known brain metastases. 4. Patients with malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications which in the opinion of the Investigator could jeopardize the validity of the study results. Any extent of stomach resection will be excluded. 5. Pre-existing peripheral sensory neuropathy ≥ grade 2 according to CTCAE (v.4.03). 6. Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, diabetes, hypertension, or psychiatric illness/social situations that would limit compliance with study requirements. 7. Patients with any history of other malignancy unless in remission for more than 1 year prior to screening (Non-melanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary). 8. Patients with a known history of HIV, decompensated cirrhosis, HCV infection, and for phase 1B: HBV infection with detectable HBV deoxyribonucleic acid (DNA) or abnormal transaminase; for phase 2A & 2B: HBV infection with HBV DNA exceeding 2000 IU/mL. 9. Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease or any other condition, which, in the opinion of the investigator, could jeopardise the safety of the patient or the validity of the study results. 10. Patients with known history of drug addiction within last 1 year. 11. Patients who may need continuous treatment with proton pump inhibitors or strong CYP3A4 inhibitors during the study period. 12. Female patients who are pregnant or breast-feeding. 13. Patients who have received any investigational drug (or have used an investigational device) within the last 14 days before receiving the first dose of study medication. 14. Patients who have received immunotherapy for cancer, including but not limited to immune checkpoint inhibitors, monoclonal antibody, cancer vaccine, and cell therapy. 15. Patient with unresolved or unstable serious toxicity (≥ CTCAE 4.03 Grade 2) from prior administration of another investigational drug and/or prior cancer treatment. 16. Have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or have a history of interstitial lung disease or current interstitial lung disease. ; PRIMARY OUTCOME: Phase 1B: Maximum tolerated dose (MTD) of Varlitinib; SECONDARY OUTCOME 1: Objective Response Rate (ORR)(Phase 1B)[/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 - Transition From Zolpidem; BRIEF: The primary objective of the study is to evaluate the proportion of adult [greater than or equal to (>=) 18 years] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition to lemborexant 5 milligram (mg) (LEM5) or 10 mg (LEM10) after 2 weeks of receiving LEM. ; DRUG USED: Dayvigo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Insomnia; TARGET: Hypocretin/orexin receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria: 1. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th ed (DSM-5) criteria for Insomnia Disorder, either currently or prior to zolpidem use, as follows: - Complains of dissatisfaction with nighttime sleep, in the form of difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep - Frequency of complaint >=3 times per week - Duration of complaint >=3 months - Associated with complaint of daytime impairment 2. Reports spending at least 7 hours in bed per night 3. History of intermittent [taking zolpidem at least 3 or 4 nights per week], or frequent use (at least 5 nights per week) of ZOL-IR or ZOL-ER, for at least 1 month 4. Confirmation of intermittent or frequent use of zolpidem (based on review of drug use data). Intermittent use is defined as taking zolpidem at least 3 but fewer than 5 nights per week, for at least 2 weeks each of the 3-week Screening Period. Frequent use is defined as taking zolpidem at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period 5. Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night 6. Willing not to start another pharmacologic treatment for the management of insomnia during the participants participation in the study Exclusion Criteria: 1. Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive serum pregnancy test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug 2. Females of childbearing potential who: Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following: - total abstinence (if it is their preferred and usual lifestyle) - an intrauterine device or intrauterine hormone-releasing system (IUS) - a contraceptive implant - an oral contraceptive (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation) - have a vasectomized partner with confirmed azoospermia - Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing) 3. Any history of moderate or severe obstructive sleep apnea (OSA) 4. Current evidence of a clinically significant, active respiratory disorder other than mild OSA. This includes bronchiectasis, emphysema, asthma, chronic obstructive pulmonary disease or any other pulmonary disorder identified by review of medical history or physical examination, and which in the opinion of the investigator, could compromise the participants safety or interfere with study assessments 5. A current diagnosis of periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia as follows: - STOP-Bang score >=5 (participants previously diagnosed with mild OSA are not excluded) - International Restless Legs Scale (IRLS) score >=16 6. Habitually naps during the day more than 3 times per week 7. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy 8. Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior (eg, making phone calls or preparing and eating food while sleeping), whether spontaneous or associated with a pharmacological sleep agent 9. Takes a dose of ZOL-IR greater (>)10 mg per night, or ZOL-ER >12.5 mg per night 10. Takes a dose of zolpidem that is lower than what is prescribed 11. Reports having altered zolpidem tablets 12. Unwilling to forgo alcohol consumption within 3 hours of bedtime for the duration of participation in the study 13. Used any prohibited prescription or over-the-counter concomitant medications within 1-week or 5 half-lives, whichever is longer, before the first dose of study medication (A list of prohibited concomitant medications is presented in the protocol) 14. Used any pharmacologic modality of treatment for insomnia other than zolpidem, including marijuana, within 1-week or 5 half-lives, whichever is longer, before the Screening Period 15. A prolonged difference between QTc corrected by Fridericias formulas (QTcF) interval [QTcF >450 millisecond (ms)] as demonstrated by a repeated electrocardiogram 16. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (ie, answering Yes to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS]) 17. Any lifetime suicidal behavior (per the Suicidal Behavior section of the C-SSRS) 18. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, and renal disease) that in the opinion of the investigator(s) could affect the participants safety or interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participants occupation or activities are also excluded 19. Hypersensitivity to LEM or any of the excipients 20. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participants ability to safely complete the study 21. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery, which requires only local anesthesia and which can be undertaken as a day case without inpatient stay postoperatively, need not result in exclusion if in the opinion of the investigator this operation does not interfere with the study procedures and patient safety 22. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2 years 23. History of drug or alcohol dependency or abuse within approximately the last 2 years 24. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 times the half-life, whichever is longer, preceding informed consent 25. Previously participated in any clinical trial of LEM ; PRIMARY OUTCOME: Percentage of Overall Participants Who Transitioned to LEM at the End of the Titration Period of Core Study; SECONDARY OUTCOME 1: Percentage of Participants Who Transitioned to LEM at the End of the 2-Week Titration Period of Core Study Within Each Cohort[/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 - 20WS; BRIEF: The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet than a placebo. ; DRUG USED: Sublingual Cannabidiol (Pure Green); DRUG CLASS: Non-NME; INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Cannabinoid reuptake/Endocannabinoid system, Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pure Green; CRITERIA: Inclusion Criteria: 1. Subject is at least 21 years of age; 2. Subject has a diagnosis of diabetic neuropathic pain of the feet determined by the subjects primary care physician or related health care provider. 3. Subject has a mean pain scale score of ≥ 5 recorded in the 7 days prior to randomization. 4. If female, the subject is postmenopausal (> 1 year), surgically sterile (> 3 months), had a hysterectomy, or is currently using 2 effective forms of birth control. 5. Subject has not taken marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and agrees to not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study. 6. If subject is currently taking gabapentin, pregabalin, or duloxetine, subject must be willing to and completes a 7-day washout of these medications prior to randomization. 7. Subject has not taken any NSAIDs and/or acetaminophen for at least 2 days prior to randomization. 8. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document. 9. Subject is willing to use an electronic diary to enter trial information for 29 days. Exclusion Criteria: 1. Subject is pregnant or lactating; 2. Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes; 3. Subject has a known allergy to active or inert ingredients of the investigational product; 4. Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drugs effects (examples include: Cannabis or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS)); 5. Subject is taking marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and does not promise that they will not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study; 6. Subject currently resides in the state of Nebraska, Idaho, Iowa, or South Dakota. 7. Subject is currently being treated with antibiotics for sinus, throat, or lung infections; 8. Subject has shortness of breath associated with allergies; 9. Subject has uncontrolled asthma; 10. Subject has a fever and/or productive cough; 11. Subject has unstable angina, uncontrolled hypertension; 12. Subject currently or has a history of congestive heart failure; 13. Subject has any other unstable medical condition; 14. Subject has a personal or family history of schizophrenia; 15. Subject has a personal history or currently has suicidal ideation or attempted suicide; 16. Subject has a major neurological disorder, such as dementia, Parkinsons disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures. 17. Subject has taken pharmaceutical pain medicine of any kind, or has taken a NSAID and/or acetaminophen, within 2 days of randomization. 18. Subject has taken gabapentin, pregabalin, or duloxetine within 7 days prior to randomization or is unwilling to stop these medications. 19. Subject has an allergy to, or has an intolerance to, NSAIDs or acetaminophen. 20. Subject is currently taking any form of opioids. 21. Subject has a history of substance or alcohol abuse. 22. Subject has clinically significant illness, including cardiovascular disorders. 23. Subject has any condition in which the investigator believes will confound the data of the study or could put the subject at risk of harm. 24. Subject does not have access to a smart phone or does not know how to use a smart phone application. ; PRIMARY OUTCOME: Incidence of treatment-related adverse events as assessed by CTCAE v4.0; SECONDARY OUTCOME 1: Pain as assessed by Numerical Pain Rating Scale (NPRS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Elderly; BRIEF: This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants. ; DRUG USED: CY6463; DRUG CLASS: Unknown; INDICATION: Neurology - Other; TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Tisento Therapeutics; CRITERIA: Inclusion Criteria: - Subject is an ambulatory adult at least 65 years old at the screening visit - Subject is in good health and has no clinically significant findings on physical examination - Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state. - Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol - Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug - Other inclusion criteria per protocol Exclusion Criteria: - Any active or unstable clinically significant medical condition - Other exclusion criteria per protocol ; PRIMARY OUTCOME: Change From Baseline in Cerebral Blood Flow (CBF) at Day 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/III - Severe to Critical (w/ARDS); BRIEF: This is a Phase 2/3, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of FP-025 in adult patients with severe to critical COVID 19 with associated ARDS. ; DRUG USED: FP-025; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: MMP-12 or HME (matrix metalloproteinase inhibitor-12) ; THERAPY: Monotherapy; LEAD SPONSOR: Foresee Pharmaceuticals Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Is willing to provide informed consent (or has a legally authorized representative [LAR] willing to provide informed consent) and is willing and able (or has an LAR willing and able) to comply with the protocol required therapy, monitoring, and follow-up; 2. Is a male or female aged ≥ 18 years; 3. Has a COVID-19 diagnosis confirmed by a documented, positive severe acute respiratory syndrome (SARS) CoV-2 reverse transcriptase polymerase chain reaction test (or equivalent test) immediately prior to or during the current hospitalization; 4. Is hospitalized with severe to critical COVID 19 within a 72-hour period prior to the Screening Visit and meeting the following characteristics: - Diagnosed with ARDS based on the Berlin criteria as follows: - Respiratory symptoms developed within 1 week of a known clinical insult or new or worsening respiratory symptoms developed during the past week; - Chest radiograph or computed tomography scan shows bilateral opacities not fully explained by pleural effusions, lobar or lung collapse, or pulmonary nodules; and - Respiratory failure is not fully explained by cardiac failure or fluid overload; and - Requiring at least 1 of the following: - Endotracheal intubation and mechanical ventilation; - Oxygen delivered by high flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates > 20 L/minute with a fraction of delivered oxygen ≥ 0.5); - Non invasive positive pressure ventilation; or - Clinical diagnosis of respiratory failure (ie, the clinical need for 1 of the preceding therapies, but preceding therapies are unable to be administered in the setting of resource limitations); 5. If female, is post-menopausal for at least 1 year, surgically sterile (documented by medical record), or a woman of childbearing potential (WCBP) who agrees to use a highly effective method of birth control (ie, method with a failure rate < 1% per year) from enrollment until 30 days following the last dose of study drug. Highly effective methods of birth control are defined as follows: complete sexual abstinence, intrauterine device, intrauterine hormone-releasing system, progestogen-only hormonal contraception (implant, injectable, or oral), and combined (estrogen and progestogen) contraception (oral, intravaginal, or transdermal); 6. If a WCBP, must have a negative serum human chorionic gonadotropin pregnancy test at the Screening Visit, and must agree to monthly urine pregnancy tests during the study; and 7. If male, must be surgically sterile for at least 1 year prior to the Screening Visit (documented by medical record), or must agree to use a double barrier approach (eg, condoms with spermicide) during sexual intercourse between the Screening Visit and at least 90 days after administration of the last dose of study drug. Male patients must ensure that non pregnant female partners of childbearing potential comply with the contraception requirements in Inclusion Criterion 5. Exclusion Criteria: 1. Is not expected to survive more than 24 hours; 2. Is on extracorporeal membrane oxygenation (ECMO) at the Screening Visit; 3. Has an underlying clinical condition where, in the opinion of the Investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, Duchenne muscular dystrophy, or rapidly progressive pulmonary fibrosis); 4. Has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the American Thoracic Society 2018 guidelines; 5. Has known active tuberculosis (TB), a history of incompletely treated TB, and/or suspected or known extrapulmonary TB; 6. Has Child Pugh Class B or C active liver disease or an alanine aminotransferase or aspartate aminotransferase level > 4 x the upper limit of normal at the Screening Visit; 7. Has moderate to severe renal insufficiency, defined as an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, at the Screening Visit or requires hemodialysis; 8. Has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, and/or completely resected carcinoma in situ of any type); 9. Has an uncontrolled systemic or local autoimmune or inflammatory disease besides COVID 19; 10. Has evidence of an active concurrent non COVID 19 pneumonia (requiring additional antimicrobial treatment) caused by a known or suspected bacterial pathogen, respiratory syncytial virus (RSV), influenza virus, SARS CoV 1, Middle East respiratory syndrome CoV, aspergillus, mucormycosis causing fungi, or other pulmonary pathogen(s); Note: A viral respiratory panel will be administered at the Screening Visit to determine eligibility. At a minimum, the panel will evaluate for RSV, influenza A, and influenza B. 11. Has received any other investigational therapeutic products within 4 weeks or 5 half-lives, whichever is longer, prior to randomization; 12. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection; 13. Has a known serious allergic reaction or hypersensitivity to any components of FP-025; 14. Is pregnant or breastfeeding; 15. Has a history of drug or alcohol abuse within the past 2 years; 16. Is currently on another systemic immunomodulatory therapy that is not considered standard of care treatment for COVID 19 (eg, calcineurin inhibitor, hydroxychloroquine, anti cytokine therapy, or Janus kinase inhibitor); or Note: Corticosteroids, including dexamethasone, in doses used for standard of care treatment for COVID 19 are allowed. Note: Corticosteroids that are being used for other indications are also allowed as long as the daily prednisone (or other corticosteroid equivalent) dose is ≤ 10 mg. Inhaled corticosteroids and nasal corticosteroids are also acceptable. Note: As therapies for COVID-19 are rapidly evolving, other medications that may be considered standard of care can be considered with prior approval from the Sponsor or Medical Monitor. 17. Has any other condition that, in the opinion of the Investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or that would place the patient at undue risk by participating in the study. ; PRIMARY OUTCOME: The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation; SECONDARY OUTCOME 1: Percentage of Patients on Invasive Mechanical Ventilation[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD/MAD; BRIEF: This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7049389 following oral administration in healthy volunteers and chronic HBV infected participants. Part 3 is a non-randomized, non-controlled, open-label part to assess the efficacy and safety of RO7049389 when administered in combination with standard-of-care therapies for up to 48 weeks in nucleos(t)ide (NUC)-suppressed and treatment-naive chronic hepatitis B (CHB) participants. ; DRUG USED: RG7907; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Hepatitis B/HBV, Viral Capsid; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: Part 1- Healthy Volunteers only: - Absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead Electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis - A Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2) inclusive - Female participants must be either surgically sterile or post-menopausal for at least one year - For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm Part 2- Chronic HBV-infected participants only: - A BMI between 18 to 30 kg/m^2 inclusive - Chronic Hepatitis B infection, defined as positive test for Hepatitis B surface antigen (HBsAg) for more than 6 months prior to randomization - HBV DNA at screening greater than or equal to (>/=) 2 × 10^4 international units per milliliter (IU/mL) for Hepatitis B e antigen (HBeAg) positive participants, or >/=2 × 10^3 IU/mL for HBeAg-negative participants - Liver biopsy, fibroscan or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection with absence of extensive bridging fibrosis and absence of cirrhosis - For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm - For women of childbearing potential: agreement to remain abstinent or use non-hormonal contraceptive methods that result in a failure rate of less than (<)1 percent (%) per year during the treatment period and for at least 3 months after the last dose of study drug Part 3- Chronic HBV Participants Only: - A BMI between 18 to 32 kg/m^2 inclusive - Chronic hepatitis B infection, defined as positive test for HBsAg or HBV DNA, or positive HBeAg, for more than 6 months prior to screening - For Cohorts only enrolling NUC-suppressed CHB participants (e.g. POM Cohort A), participants must have been treated with a single NUC (entecavir, tenofovir alafenamide, or tenofovir disoproxil fumarate) for at least 12 months. Participants must be on the same NUC therapy for at least 3 months prior to screening - For Cohorts only enrolling anti-HBV treatment-naive and immune-active participants (e.g. POM Cohort B and Cohort C), previous anti-HBV treatments <30 days in total, and did not receive any anti-HBV treatments within 3 months prior to the first study dose - Liver biopsy, fibroscan, or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection with absence of extensive bridging fibrosis and absence of cirrhosis - For men: agreement to remain abstinent or use contraceptive measures, and agree to refrain from donating sperm - For women of childbearing potential: agreement to remain abstinent or to use two approved contraceptive methods during the study and for at least 6 months after the last dose of study drug Exclusion Criteria: Part 1- Healthy Volunteers only: - History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis - History of Gilberts syndrome - Participants who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration - Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies - Any clinically significant concomitant diseases or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study - Positive test at screening of any of the following: Hepatitis A (HAV IgM Ab), Hepatitis B (HBsAg), Hepatitis C (HCV RNA or HCV Ab) or human immunodeficiency virus (HIV Ab) - Acute narrow-angle glaucoma (for MAD-midazolam cohorts) Part 2- Chronic HBV-infected participants only: - History or other evidence of bleeding from esophageal varices - Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, hepatic encephalopathy - History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic steatohepatitis, etc.) - Documented history or other evidence of metabolic liver disease within one year of randomization - Positive test for hepatitis A (IgM anti-HAV), hepatitis C, hepatitis D, or human immunodeficiency virus - History of or suspicion of hepatocellular carcinoma or alphafetoprotein >/= Upper limit of normal (ULN) at screening - History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric or neurological disease - History of organ transplantation - Previous or concurrent HBV treatments in the past 6 months - Significant acute infection (e.g., influenza, local infection) or any other clinically significant illness within 2 weeks of randomization Part 3- Chronic Hepatitis B Participants Only: - History or other evidence of bleeding from esophageal varices - Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, or hepatic encephalopathy - History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic statohepatitis, etc.) - History of thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests - Documented history or other evidence of metabolic liver disease within one year of screening - Positive test for hepatitis A (IgM anti-HAV), hepatitis C, hepatitis D, HEV, or HIV - Diagnosed or suspected hepatocellular carcinoma - History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric, or neurological disease - History of organ transplantation - Significant acute infection (e.g. influenza, local infection) or any other clinically significant illness within 2 weeks of screening ; PRIMARY OUTCOME: Part 1: Percentage of Participants With Adverse Events; SECONDARY OUTCOME 1: Part 1b- Food-Effect SAD Cohort: Cmax of RO7049389[/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: This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients. ; DRUG USED: LCQ908; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Diglycerol Acyltransferase (DGAT); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Written informed consent. - Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3). - No prior therapy or inadequate response to therapy for hepatitis C. - Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2. Exclusion Criteria: - Use of other investigational drugs within at least 30 days of enrollment - Women of child-bearing potential. Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Measure: Change in hepatitis C viral load as assessed by PCR; SECONDARY OUTCOME 1: Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Chronic Bronchitis; BRIEF: To test the hypothesis that treatment with the inverse agonist nadolol will improve smoking cessation in patients with chronic cough associated with long-term smoking, with or without airflow obstruction, including those with established chronic obstructive pulmonary disease (COPD) (chronic bronchitis dominant) or non-obstructive chronic bronchitis (NCB), compared to placebo and standard of care, while undergoing a validated smoking cessation program. ; DRUG USED: INV102; DRUG CLASS: Non-NME; INDICATION: Smoking Cessation; TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Invion, Inc.; CRITERIA: Inclusion Criteria: Potential study participants will be referred from approved smoking cessation programs or be willing to enter a smoking cessation program administered by the participating sites. Individuals who meet all of the following criteria at Visit 1 are eligible for enrollment as study participants: 1. Active cigarette-smoking males and females between the ages of 18-70 with chronic cough associated with long-term smoking, with or without airflow obstruction, including Non-obstructive chronic bronchitis (NCB) or physician-diagnosed COPD (chronic bronchitis dominant), as defined by the American Thoracic Society. 2. Committed desire to quit smoking in conjunction with participation in an approved smoking cessation program administered by the participating sites. Enrollment in the smoking cessation program must take place prior to Visit 3 (third dose escalation visit). 3. Diagnosis of COPD (chronic bronchitis dominant) or NCB, or presenting with chronic cough associated with long-term smoking. 4. Pre-bronchodilator FEV1 greater than 55% of predicted 5. Baseline blood pressure ≥ 110/65mm Hg 6. Baseline heart rate ≥ 60 beats/min. 7. Smoking at least 10 cigarettes per day prior to participation in the approved smoking cessation program. 8. Self-reported prior failure(s) to quit smoking during participation in a smoking cessation program. 9. Able to complete diary cards and comply with study procedures. 10. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study. Exclusion Criteria: Subjects who meet ANY of the following criteria are not eligible for enrollment: 1. Diagnosis of asthma, cystic fibrosis, or PiZZ emphysema 2. Inability or unwillingness to give written informed consent 3. History of upper/lower respiratory tract infection, COPD exacerbation requiring systemic steroids, antibiotics, and or ER visit or urgent care within 6 weeks of Visit 1 4. History of adverse reaction or allergy to nadolol 5. History of neurological, hepatic, renal, or other medical conditions that may interfere with the interpretation of data or the patients participation in the study or may increase safety concerns 6. History of cardiovascular diseases including uncontrolled hypertension (BP >160/100), ischemic heart disease, congestive heart failure (NYHA III or IV), valvular heart disease or cardiomyopathy 7. Known allergy or sensitivity to atropine or ipratropium bromide 8. Documented or self-reported current history of alcoholism or drug abuse 9. Participation in another research trial within 30 days of starting this trial 10. Unwillingness or inability to comply with study procedures 11. Inability to swallow the study medication 12. Pregnant or nursing 13. Current use of any OTC remedies containing pseudoephedrine, ephedrine-based or containing dietary or herbal supplements. 14. Scheduled for surgery requiring general anaesthesia 15. Referred for smoking cessation without serious commitment to quit ; PRIMARY OUTCOME: Change From Baseline in the Average Number of Cigarettes Smoked Per Day; 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 - QoL; BRIEF: Primary Objective: To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants Secondary Objective: To document the Health-Related Quality of Life of aflibercept in this participants population ; DRUG USED: Zaltrap; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Histologically or cytologically proven adenocarcinoma of the colon or rectum. - Metastatic disease. - Eastern Cooperative Oncology Group performance status 0-1. - One and only one prior chemotherapeutic regimen for metastatic disease. This prior chemotherapy was an oxaliplatin containing regimen. Participants must had progressed during or after the oxaliplatin based chemotherapy. Participants relapsed within 6 months of completion of oxaliplatin adjuvant chemotherapy were eligible. - Signed written informed consent obtained prior to inclusion. Exclusion criteria: - Prior therapy with irinotecan. - Inadequate bone marrow, liver and renal function: neutrophils < 1.5x109/L, platelets < 100x109/L, hemoglobin < 9.0 g/dL, total bilirubin >1.5 x upper normal limit (ULN), transaminases >3 x ULN (unless liver metastasis are present), alkaline phosphatase >3 x ULN (unless liver metastasis are present), serum creatinine > 1.5 x ULN. - Less than 4 weeks from prior radiotherapy, prior chemotherapy, prior major surgery (or until the surgical wound were fully healed). - Treatment with any investigational drug within the prior 30 days. - Treatment with concomitant anticonvulsivant agents that were CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days. - History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease. - Prior malignancy (other than colorectal) including prior malignancy from which the participants had been disease free for < 5 years (except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix). - Any of the following within 6 months prior to study inclusion: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, severe congestive heart failure, stroke or transient ischemic attack. - Any of the following within 3 months prior study inclusion: severe gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event. - Occurrence of deep vein thrombosis within 4 weeks, prior to study inclusion. - Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment. - Known dihydropyrimidine dehydrogenase deficiency. - Predisposing colonic or small bowel disorders in which the symptoms were uncontrolled. - Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, unresolved bowel obstruction/sub-obstruction, more than hemicolectomy, extensive small intestine resection with chronic diarrhea. - Known Gilberts syndrome. - Unresolved or unstable toxicity from any prior anti cancer therapy at the time of inclusion. - History of anaphylaxis or known intolerance to atropine sulphate or loperamide or appropriate antiemetics to be administered in conjunction with FOLFIRI (irinotecan, 5-Fluorouracil, leucovorin). - Severe acute or chronic medical condition, which could impair the ability of the participants to participate to the study. - Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria > 500 mg/24-h. - Uncontrolled hypertension within 3 months prior to study inclusion. - Participants on anticoagulant therapy with unstable dose of warfarin and/or had an out-of-therapeutic range INR within the 4 weeks prior to study inclusion. - Evidence of clinically significant bleeding predisposition or underlying coagulopathy, non-healing wound. - Pregnant or breast-feeding women. - Participants with reproductive potential who were not agree to use an accepted effective method of contraception. The above information wass not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Mean Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 Score): Global Health Status[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MCL w/RCHOP (ECOG/NCI Sponsored); BRIEF: RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma. ; DRUG USED: Zevalin; DRUG CLASS: Biologic; INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 20 (CD20), Radiopharmaceutical; THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20 - Stage II-IV disease - Measurable or evaluable disease - Measurable disease defined as at least 1 bidimensionally measurable lesion at least 2 cm by imaging scan - A spleen at least 17 cm or having discrete filling defects by CT scan will constitute evaluable disease provided that no explanation other than lymphomatous involvement (e.g., portal hypertension or other liver disease) is likely - No known CNS lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - WBC greater than 2,500/mm^3* - Platelet count greater than 100,000/mm^3* NOTE: *Unless due to disease in bone marrow Hepatic - Bilirubin less than 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma) - ALT and AST no greater than 2.5 times upper limit of normal (unless due to liver involvement by lymphoma) Renal - Creatinine less than 2.0 mg/dL - Calcium no greater than 11.5 mg/dL Cardiovascular - LVEF greater than 45% Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 year after study participation - HIV negative - No other malignancy except treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer or any other surgically cured malignancy from which the patient has been disease-free for at least 3 years - No other concurrent serious medical condition or active infection that would preclude ability to deliver standard prednisone, cyclophosphamide, doxorubicin, and vincristine (CHOP) chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy Chemotherapy - No prior chemotherapy Endocrine therapy - Prior corticosteroids allowed provided the course was no more than 2 weeks in duration Radiotherapy - No prior radiotherapy Surgery - Not specified ; 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 Ib - Europe; BRIEF: The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901) ; DRUG USED: Elacestrant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta), Selective Estrogen Receptor Degrader (SERD); THERAPY: Monotherapy; LEAD SPONSOR: Stemline Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: 1. Patients with histologically-proven, ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, inoperative, and/or mBC 2. Tumor progression after ≥ 6 months of at least 1 line of hormonal systemic treatment (SERM, SERD, or aromatase inhibitor) in the metastatic setting 3. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1 or clinically evaluable disease 4. Greater than or equal to 18 years of age 5. Patients must be post-menopausal 6. Life expectancy >3 months Key Exclusion Criteria: 1. Greater than 3 lines of endocrine therapy for metastatic disease. 2. Prior anti-cancer treatment or investigational drug therapy within the following windows: 1. Tamoxifen or fulvestrant therapy < 42 days before 1st 18FES-PET scan 2. Any other anti-cancer endocrine therapy < 14 days before 1st dose of study drug 3. Any chemotherapy < 28 days before 1st dose of study drug 4. Any investigational drug therapy < 28 days or 3 half-lives (whichever is longer) prior to the 1st dose of study drug 2. Patients with untreated or symptomatic central nervous system (brain) metastases 3. Patients with known endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding, or cysts ; PRIMARY OUTCOME: Effect of ER Binding after RAD1901 treatment; SECONDARY OUTCOME 1: Correlation of FES uptake after RAD1901 treatment to clinical response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Telaprevir and Ribavirin (Null Responders; GT1); BRIEF: The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin. ; DRUG USED: Miravirsen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: miR-122; THERAPY: Combination; LEAD SPONSOR: Santaris Pharma A/S; CRITERIA: Inclusion Criteria: - Diagnosis of chronic hepatitis C genotype 1 infection - BMI 18 and 38 kg/m2 - Null responder to pegylated interferon alpha and ribavirin Exclusion Criteria: - Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) - Significant liver disease in addition to hepatitis C - Decompensated liver disease medical history or current clinical features - Histologic evidence of hepatic cirrhosis - Concurrent clinically significant medical diagnosis (other than CHC) - Concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation) - Clinically significant illness within 30 days preceding entry into the study - Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication - History of clinically significant allergic drug reactions ; PRIMARY OUTCOME: The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.; SECONDARY OUTCOME 1: The proportion of subjects with undetectable HCV RNA levels at end of treatment.[/INST]No</s>