Datasets:

mi-rei

/

CT_all_phases_small

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 I - Healthy Adults; BRIEF: The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5*10^10 viral particles (vp) and 1*10^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults. ; DRUG USED: Ad26.ZIKV.001; DRUG CLASS: Vaccine; INDICATION: Zika Virus Disease; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Vaccines & Prevention B.V.; CRITERIA: Inclusion Criteria: - Participant must be healthy, without significant medical illness, on the basis of physical examination, medical history, and vital signs performed at screening - Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges, and additionally within the limits representing Food and Drug Administration (FDA) toxicity Grade 1, the participant may be considered eligible only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and reasonable for the population under study. This determination must be recorded in the participants source documents and initialed by the investigator - Participant must agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after the last study vaccine administration - Participant must be willing to provide verifiable identification - All female participants of childbearing potential must have: 1. a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening 2. a negative urine (beta-hCG) pregnancy test immediately prior to each study vaccine administration Exclusion Criteria: - Participant has a known history of flavivirus infection or previous receipt of flavivirus vaccine such as dengue virus (DENV) types 1-4, yellow fever virus (YFV), Japanese encephalitis virus (JEV), and West Nile virus (WNV) - Participant has traveled to an area with active flavivirus transmission (as per Centers for Disease Control and Prevention [CDC]s Zika travel notices) or Zika cautionary areas (Yellow and Red areas) within 4 weeks before screening - Participant has chronic active hepatitis B or hepatitis C virus infection, verified at screening by hepatitis B surface antigen (HBsAg) or hepatitis C antibody, respectively - Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection - Participant received or plans to receive licensed live-attenuated vaccines within 28 days before or after each planned study vaccine administration; licensed inactivated, subunit, or conjugate vaccines within 14 days before or after each planned study vaccine administration ; PRIMARY OUTCOME: Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs); SECONDARY OUTCOME 1: Neutralizing Antibodies to the Vaccine Strain (or Other Strain)[/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 - 1001 (Australia); BRIEF: This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine. ; DRUG USED: CTP-692; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Concert Pharmaceuticals; CRITERIA: Inclusion Criteria: - Must give written and informed consent and any authorizations required by local law. - Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2, inclusive Exclusion Criteria: - Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug - Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody - History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions - Positive drug or alcohol test at screening or prior to the first dose of study drug ; PRIMARY OUTCOME: The number of AEs in participants as a measure of 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 I/II - TRACKER; BRIEF: Topical rVA576 for treatment of atopic keratoconjunctivitis: a randomised placebo-controlled double masked parallel trial (TRACKER) ; DRUG USED: Coversin; DRUG CLASS: Biologic; INDICATION: Allergic Conjunctivitis (Ophthalmology); TARGET: Complement component 5 (C5), Complement Pathway, Leukotriene-B4 Receptor (LTB4R); THERAPY: Monotherapy; LEAD SPONSOR: AKARI Therapeutics; CRITERIA: Inclusion Criteria: 1. Aged 18 and above 2. Diagnosis of moderate to severe AKC with a composite symptom/sign score from one eye of ≥ 22 out of 33 (see Clinical Scoring 17.1) 3. Will have had maximal topical therapy for at least 3 months without improvement but will not currently be receiving systemic immunotherapy. 4. History of atopy other than ocular (dermatitis, asthma, hay fever) 5. Willing to give informed consent 6. Willing to use adequate contraceptive precautions for the duration of the study and for 90 days thereafter 7. Willing to avoid prohibited medications for the duration of the study Exclusion Criteria: 1. Eye surface disease other than AKC 2. Contact lens use during the study 3. Complete or partial tarsorrhaphy. If such a procedure becomes necessary during the course of the trial patients may remain in the trial providing that at least 50% of the eye surface remains visible to slit lamp examination 4. Ankyloblepharon of any degree at entry to the trial 5. Known or suspected ocular malignancy 6. Active ocular infection at entry to the trial. Patients with eye surface bacterial, viral, fungal or protozoal infection may enter the trial after elimination of the infection as confirmed by eye swabs 7. Known or suspected uveitis 8. Participation in any other clinical trial within 1 month of enrolment 9. Use of any of the following prohibited medications: - Eculizumab - Any other investigational complement inhibitor whether systemic or topical (e.g. RA101495) - Montelukast - Zafirlukast - Pranlukast - Zileuton - Hypericum perforatum (St Johns wort) 10. Corneal perforation 11. Glaucoma 12. Pregnancy (females) 13. Breast feeding (females) 14. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom) 15. Failure to satisfy the PI of suitability to participate for any other reason ; PRIMARY OUTCOME: Safety Parameter; SECONDARY OUTCOME 1: Post-instillation comfort[/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 - C006; BRIEF: This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with <3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a 2 week follow-up period. The objectives of this study are: - To assess the efficacy of YKP10811 once daily at relieving constipation and associated symptoms in subjects with chronic idiopathic constipation. - To determine the safety and tolerability of YKP10811 once daily in subjects with chronic idiopathic constipation. ; DRUG USED: YKP10811; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Serotonin 5-HT4 receptor; THERAPY: Monotherapy; LEAD SPONSOR: SK Life Science, Inc.; CRITERIA: Inclusion Criteria: - Patients who meet modified Rome II criteria for Chronic Constipation. - Patients who are male or female, 18 to 65 years of age inclusive. - At Visit 3, patients must have < 3 CSBMs per week and ≤ 5 SBMs per week during the 2-week baseline period. Exclusion Criteria: - Patients who meet Rome II criteria for Irritable Bowel Syndrome (IBS-C). - Patients with constipation that is drug-induced, or secondary to endocrine, metabolic or, surgery. - Patients with a clinically significant diseases that would limit the patients ability to complete and/or participate in the study, including gastrointestinal disorder or surgery, an endocrine abnormality (e.g., diabetes), impaired renal function (GFR of < 55mL/minute/1.73m2), uncontrolled pulmonary diseases (including asthma), uncontrolled cardiovascular disease (a history of myocardial infarction or cerebrovascular accident within 6 months prior to screening) or significant neurological diseases. - Patients with a history of inflammatory bowel disease. - Patients with a history of cancer (other than basal cell or squamous cell carcinoma of the skin completely excised) unless the malignancy has been in complete remission for at least 5 years prior to screening. - Patients who started a special diet and/or an intense physical workout program within 30 days prior to the beginning of the baseline period or who are intending to substantially modify their dietary habits at any time during the study (patients on a stable, continuous regimen of fiber therapy for at least 30 days prior to the pretreatment baseline period are allowed to continue that therapy, provided that they continue at a constant dose throughout the study. - Patients with a history of clinically significant hypersensitivity or allergy (facial swelling, hives, breathing difficulty, Stevens-Johnson syndrome etc), in response to any medication, either prescription or nonprescription including an investigational drug, dietary supplement, or herbal medicine. ; PRIMARY OUTCOME: The proportion of subjects with improved bowel movement frequency; SECONDARY OUTCOME 1: Stool frequency[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SFT/EMC; BRIEF: Phase II, open-label, non-randomized, international multicenter clinical trial with two strata (SFT and EMC). 8 sites in Spain, 5 sites in Italy and 5 sites in France. Patients will receive oral pazopanib at 800 mg once daily continuously. Patients will continue to receive treatment until there is evidence of progressive disease, unacceptable toxicity, non-compliance, withdrawn consent or investigator decision. The main goal is to determine the objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) in patients with unresectable, locally advanced or metastatic solitary fibrous tumor and extraskeletal myxoid chondrosarcoma, using Choi and RECIST 1.1 criteria respectively. ; DRUG USED: Votrient (Oral); DRUG CLASS: New Molecular Entity (NME); INDICATION: Sarcoma; TARGET: KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Grupo Espanol de Investigacion en Sarcomas; CRITERIA: Inclusion Criteria: - Informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up. - Age ≥ 18 years or legal age of consent if greater than 18 years. - Histologic diagnosis of solitary fibrous tumor (stratum 1) or extraskeletal myxoid chondrosarcoma (stratum 2) (unresectable, locally advanced or metastatic disease) confirmed by central pathology review. - Patients with metastatic tumor suitable for complete resection can be recruited. In absence of progressive disease these patients should be treated with the study drug for at least 6 months. - For patients who have received previous anticancer treatments, progressive disease must be demonstrated within 6 months prior to enrollment. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. - Measurable disease according to Choi (SFT) and RECIST 1.1 (EMC) criteria. - Patients could have received a maximum of 4 lines of chemotherapy for metastatic disease prior to trial enrollment. - Patients must be able to swallow and retain the study drug. - Adequate organ system function as defined in protocol. - Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of first dose of study treatment. All patients (both male and female) must agree to use effective contraception methods, as defined in the protocol. - Left ventricular ejection fraction (LVEF) above the lower limit of normal for the institution, either by echocardiogram or MUGA. - Patients in France will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion Criteria: - Prior malignancy, except patients who have had another malignancy and have been disease-free for 10 years, or those with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma. - Central nervous system metastases at baseline, with the exception of patients who have previously-treated central nervous system metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6-month time interval. - Patients who have received previous antiangiogenic agents. - Significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding. - Significant gastrointestinal abnormalities that may affect absorption of investigational product. - Corrected QT interval (QTc) > 480 msecs. - History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting Myocardial infarction Unstable angina Coronary artery bypass graft surgery Symptomatic peripheral vascular disease Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) - Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]. - History of cerebrovascular accident. - Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (catheter placement and similar procedures are not considered to be major surgery). - Evidence of active bleeding or bleeding diathesis. - Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. - Recent hemoptysis (>=½ teaspoon of red blood within 8 weeks before first dose of study drug). - Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patients safety, provision of informed consent, or compliance to study procedures. - Unable or unwilling to discontinue use of prohibited medications listed in the protocol for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study. - Treatment with any of the following anti-cancer therapies: Radiation therapy, surgery or tumor embolization within 28 days prior to the first dose of pazoapnib or Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib - Administration of any non-oncologic drug within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment. - Ongoing toxicity from prior anti-cancer therapy that is >Grade 1 (except anemia, see Table 1 above) and/or that is progressing in severity, except alopecia. - Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib. ; PRIMARY OUTCOME: Objective response rate (ORR); SECONDARY OUTCOME 1: Efficacy of pazopanib[/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 - 009; BRIEF: The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency. ; DRUG USED: VA106483; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Symptoms (e.g. Nocturia, Polyuria); TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Vantia Ltd; CRITERIA: Inclusion Criteria: - Males aged 55 or over - History and/ or symptoms of Nocturia (2 - 5 voids per night) - Generally well (concomitant illness / conditions well controlled) - Serum sodium, potassium, chloride and bicarbonate within normal limits - No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination - Prostate specific antigen (PSA) within the normal range or not considered clinically significant - Ability to comply with the requirements of the study - Written informed consent. Exclusion Criteria: - ; PRIMARY OUTCOME: Change in the mean nocturnal urine voids; SECONDARY OUTCOME 1: Change in the mean nocturnal urine voids[/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 IIIb - Study 1310; BRIEF: This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients. ; DRUG USED: Ruconest; DRUG CLASS: Biologic; INDICATION: Hereditary Angioedema (HAE); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Pharming Technologies B.V.; CRITERIA: Inclusion Criteria: - Aged at least 13 years - Signed written informed consent - Clear clinical and laboratory diagnosis of HAE with baseline plasma level of functional C1INH of less than 50% of normal - Willingness and ability to comply with all protocol procedures - Clinical symptoms of an eligible HAE attack with onset less than 5 hours before the time of initial evaluation Exclusion Criteria: - Medical history of allergy to rabbits or rabbit-derived products (including rhC1INH), or positive anti-rabbit dander IgE test (cut off >0.35 kU/L; ImmunoCap® assay; Phadia or equivalent). - A diagnosis of acquired C1INH deficiency (AAE) - Pregnancy, or breastfeeding, or current intention to become pregnant - Treatment with any investigational drug in the past 30 days - Known or suspected addiction to drug and/or alcohol abuse - Suspicion for an alternate explanation of the symptoms other than acute HAE attack ; PRIMARY OUTCOME: Time to Beginning of Relief of Symptoms; SECONDARY OUTCOME 1: Time to Minimal Symptoms[/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 - TRIDENT-1; BRIEF: Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. ; DRUG USED: Repotrectinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Anaplastic lymphoma kinase (ALK), ROS kinase, Src Kinase Family, Trk (Tropomyosin Receptor Kinase) Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Turning Point Therapeutics, Inc.; CRITERIA: PHASE 1 Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests. 2. ECOG PS 0-1. 3. Age ≥18 (or age ≥ 20 of age as required by local regulation). 4. Capability to swallow capsules intact (without chewing, crushing, or opening). 5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed. 6. Prior cytotoxic chemotherapy is allowed. 7. Prior immunotherapy is allowed. 8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. 9. Patients with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria. 10. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation 11. Life expectancy ≥ 3 months. PHASE 2 Key Inclusion Criteria 1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion. 2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either: 1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility. • Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor. OR 2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation of fusion status by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment will be accepted to determine molecular eligibility. - Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 4. Age ≥12 (or age ≥ 20 as required by local regulation). 5. Willing and able to provide written institutional review board (IRB)/institutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17. 6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible. 7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3 rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all inclusion and exclusion criteria are met. i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors 8. Subjects with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria. 9. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation 10. Life expectancy ≥ 3 months. Key Exclusion Criteria PHASE 1 and PHASE 2 1. Concurrent participation in another therapeutic clinical trial. 2. Symptomatic brain metastases or leptomeningeal involvement. 3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years. 4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry 5. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2 6. Any of the following cardiac criteria: Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) > 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval. 7. Known active infections (bacterial, fungal, viral including HIV positivity). 8. Gastrointestinal disease (e.g., Crohns disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption. 9. Peripheral neuropathy of CTCAE ≥grade 2. 10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded. ; PRIMARY OUTCOME: Dose limiting toxicities (DLTs) (Phase 1); SECONDARY OUTCOME 1: Maximum plasma concentration (CMAX) of repotrectinib (TPX-0005) (Phase 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 - MASTERKEY-115; BRIEF: This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first. ; DRUG USED: Imlygic; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Key Inclusion Criteria: - Age ≥ 18 years with histologically confirmed diagnosis of stage IIIB to IVM1d melanoma and for whom surgery is not recommended. Subjects with stage IVM1d disease may be enrolled with up to 3 cerebral metastases, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy, with no evidence of progression and not requiring steroids for at least 2 months prior to enrollment. - Subjects must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions. - Subjects must have had prior treatment (for at least 2 to 3 consecutive cycles within an 8 week period) with a PD-1 inhibitor and have confirmed disease progression (as defined by RECIST v1.1 criteria). The anti-PD-1 therapy must be the immediate prior line of therapy before enrollment and subjects with disease progression on more than 1 line of anti-PD-1 therapy are not eligible. - ECOG performance status of 0 or 1. - Adequate hematologic, renal, hepatic, and coagulation function. Key Exclusion Criteria: - Subjects considered by the investigator to have rapid clinical progression due to melanoma - Subjects with prior treatment and disease progression on more than 1 line of anti-PD-1 therapy - Stage IVM1d subjects must not have greater than 3 cerebral melanoma metastases, or clinically active cerebral melanoma metastases requiring therapy, and/or carcinomatous meningitis regardless of clinical stability. - Primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states or history of other malignancy within the past 3 years. - Subjects must not have history or evidence of symptomatic autoimmune glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or active autoimmune disease or syndrome requiring systemic treatment in the past 2 years (ie, with use of disease modifying agents, steroids or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression. - Subjects may not have been previously treated with talimogene laherparepvec or any other oncolytic virus. - Subjects must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use. ; PRIMARY OUTCOME: Objective Response Rate (ORR) Per Modified RECIST v1.1; SECONDARY OUTCOME 1: Complete Response Rate (CRR) Per Modified RECIST v1.1[/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 - vs. Vancocin; BRIEF: The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD). ; DRUG USED: Xifaxan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Clostridium difficile-Associated Diarrhea/Infection (CDAD/CDI); TARGET: Gram-Negative Bacteria, RNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: - Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort. - Subject has a positive Clostridium difficile stool toxin assay at screening Exclusion Criteria: - Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months. - Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS]) - Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization. ; PRIMARY OUTCOME: Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea.; SECONDARY OUTCOME 1: Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success[/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 - Islands (Japan); BRIEF: Primary Objectives: - Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with relapsed and refractory multiple myeloma. - Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese patients with relapsed and refractory multiple myeloma. Secondary Objectives: - To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events will be assessed. - To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule. - To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria. - To assess the relationship between baseline CD38 receptor density on multiple myeloma cells and efficacy. ; DRUG USED: Sarclisa; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Cluster of Differentiation 38 (CD38); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Males or females, age 20 years or older. - Patient must have a known diagnosis of symptomatic multiple myeloma. - Patients must have received at least 3 prior lines of therapies OR Patients whose disease is double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI). - Subject must have been responsive (ie, minimal response [MR] or better) to at least one prior line of therapy. - Refractory to the most recently received IMiD or PI included therapy. - Patients with measurable disease defined as at least one of the following: - IgG Type: Serum M-protein ≥1 g/dL (≥10 g/L); - IgA and D Type: Serum M-protein, quantification should be performed; - Urine M-protein ≥200 mg/24 hours. - Patients with a Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Exclusion criteria: - Patients treated with any anti-CD38 agent. - Diagnosed or treated for another malignancy within 5 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. - Prior anticancer therapy (chemotherapy, targeted agents, immunotherapy) within 21 days prior to the first drug infusion unless otherwise specified below: - Alkylating agents (eg, Melphalan) within 28 days prior to the first dose of study treatment. - Steroids treatment (eg, prednisone >10 mg/day orally or equivalent except patients being treated for adrenal insufficiency/replacement therapy or treated for inhalation corticosteroids) within 14 days prior to the first dose of study treatment. - Participated in another clinical trial within 30 days prior to the first dose of study treatment. - Patients treated with systemic radiation therapy within 4 weeks prior to the first dose of study treatment OR Localized radiation therapy within 1 week prior to the first dose of study treatment. - Major surgical procedure within 4 weeks prior to the first dose of study treatment. - Any toxicity Grade ≥2 (excluding alopecia, neutropenia or neuropathy) related to any prior anti-cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. - Neuropathy Grade ≥3 or painful peripheral neuropathy Grade ≥2. - History of significant cardiovascular disease unless the disease within the past 6 months is well-controlled. - Previously received an allogenic stem cell transplant. - Diagnosed Crow-Fukase (POEMS) syndrome OR plasma cell leukemia. - Patients with known or suspected amyloidosis. - Patients with Waldenstroms macroglobulinemia OR Multiple myeloma IgM subtype. - Patients with active infection. - Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection. - Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation. - Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results. - Hypersensitivity or history of intolerance to boron or mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to pre-medication with steroids and H2 blockers or would prohibit further treatment with these agents. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Phase I: Dose Limiting Toxicities (DLT); SECONDARY OUTCOME 1: Number of patients with Treatment-emergent adverse events/serious adverse events (TEAE/SAE)[/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 - GTC AT HD 012-04; BRIEF: Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events. ; DRUG USED: ATryn; DRUG CLASS: Biologic; INDICATION: Anticoagulation; TARGET: Coagulation Factor X, Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: rEVO Biologics; CRITERIA: Inclusion Criteria: 1. Have hereditary antithrombin deficiency (HD) with a personal history of venous thromboembolic events. 2. Have a history of HD that includes 2 or more plasma AT activity values ≤ 60%. 3. Be scheduled to have an elective procedure(s) known to be associated with a high risk for occurrence for DVT. This will include non-pregnant surgical patients or pregnant patients scheduled for caesarean section or delivery induction. 4. Be at least 18 years of age, not exceeding 80 years of age. 5. Have signed an informed consent form. 6. Have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. This applies only to female non-pregnant surgical patients of childbearing potential. 7. Are able to comply with the requirements of the study protocol. In addition, hospitalized pregnant HD patients in active labor and eligible HD patients previously treated with rhAT were allowed entry into the study. Exclusion Criteria: 1. Patients who have a diagnosis of another hereditary thrombophilic disorder (e.g. activated protein C(APC) resistance/Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus anticoagulant) thrombophilic disorder). 2. Patients who have a baseline bilateral ultrasound positive for acute DVT or baseline diagnostic testing (if required) that is positive for a thromboembolic event other than acute DVT. 3. Patients who have a known allergy to goats or goat products. 4. Patients who have participated in a study employing a different investigational drug within 30 days of the start of their participation in the current trial. 5. Patients using fondaparinux sodium or the oral thrombin inhibitor, ximelagatran, or are expected to be treated with fondaparinux sodium or ximelagatran during the study period (up to 7 days after stop of treatment). ; PRIMARY OUTCOME: Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT); 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 IIa - US & Europe; BRIEF: This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks. ; DRUG USED: Quilience; DRUG CLASS: Non-NME; INDICATION: Narcolepsy; TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: NLS Pharmaceutics; CRITERIA: Key Inclusion Criteria: - Males and females between 18 and 65 years of age, inclusive - Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria - Body mass index from 18 to 40 kg/m2, inclusive - Consent to use a medically acceptable method of contraception - Willing and able to provide written informed consent Key Exclusion Criteria: - Female subjects who are pregnant, nursing, or lactating - Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness - History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria - Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness - Use of any medications that could affect the evaluation of cataplexy - Received an investigational drug in the past 30 days or five half-lives (whichever is longer) ; PRIMARY OUTCOME: Change in ESS Score From Baseline to Week 4; SECONDARY OUTCOME 1: Subjects Reported Improved on the Patient Global Impression of Change (PGIc) 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/II - MCC/Extensive-Stage SCLL; BRIEF: This is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies. This study was terminated by the sponsor. No participants enrolled in Part B. ; DRUG USED: XmAb18087; DRUG CLASS: Biologic; INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Cluster of Differentiation 3 (CD3), Somatostatin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Xencor, Inc.; CRITERIA: Inclusion Criteria: - Able to provide written informed consent - Adult participants ≥ 18 years - Disease measurable by RECIST 1.1 criteria using either computed tomography (CT) or magnetic resonance imaging (MRI) scan - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - All participants must have adequate archival tumor sample (slides or archival formalin-fixed paraffin-embedded [FFPE] block[s] containing tumor that has not been previously irradiated - Female participants of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after completion of study. success), or sexual abstinence - Fertile male participants must be willing to practice a highly effective method of birth control for the duration of the study and continuing for 4 weeks after the last dose of XmAb18087 or pembrolizumab (when applicable - Able and willing to complete the entire study according to the study schedule Additional Inclusion Criteria for Part A and Part B Cohorts: • Histologically or cytologically confirmed metastatic MCC or locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy. Additional Inclusion Criteria for Part A Cohorts: • Participants must have progressed on or been ineligible for treatment with anti-PD1 or anti-PDL1 therapy. Additional Inclusion Criteria for Part B Cohorts: • Participants must be eligible to receive pembrolizumab as standard of care. Additional Inclusion Criteria for Part C Cohorts: • Histologically or cytologically confirmed extensive-stage SCLC that has progressed following standard therapies Exclusion Criteria: Additional Exclusion Criteria for Part B Cohorts: XmAb18087 in Combination with Pembrolizumab - Prior treatment with therapeutics directed at anti-programmed cell death 1 (anti-PD1) or anti-programmed cell death ligand 1 (anti-PDL1) - Have severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events; SECONDARY OUTCOME 1: Duration of Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Acne Vulgaris; BRIEF: This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events. ; DRUG USED: Bermekimab; DRUG CLASS: Biologic; INDICATION: Acne; TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: 1. Age: ≥ 18 2. Moderate to moderately severe inflammatory acne vulgaris: - Investigators Global Assessment grade of ≥ 3 and, - ≥ 15 inflammatory lesions (no more than 6 nodules) and, - ≥ 15 non-inflammatory lesions 3. Four week washout period for topical and oral antibiotic treatment 4. Four week washout period for topical retinoids 5. Negative pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize contraception during the study and including 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and including 3 months after study completion. 6. Subjects weighing ≥ 27 kg 7. Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed Exclusion Criteria: 1. A diagnosis of Acne conglobata, acne fulminans, secondary acne, severe nodulocystic acne requiring treatment with isotretinoin, or other dermatologic conditions requiring interfering phototherapy, topical, or systemic treatment. 2. Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer). 3. Men with facial hair that would interfere with assessments 4. History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. 5. Hemoglobin <10.0 g/dL, or WBC <3.0 x 103/mm3, or platelet count <125 x 103/mm3, or creatinine > 1.5mg/dL, or AST/ALT >2 x ULN, or alkaline phosphatase >2 x ULN 6. Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody. 7. History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin. 8. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. 9. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA) 10. Infectious disease: - CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening 11. Immunodeficiency 12. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding 13. Receipt of a live (attenuated) vaccine within 1 month prior to Screening 14. Major surgery within 28 days prior to Day 0 15. Participation in an investigational drug or device trial within 30 days prior to Screening ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: RA-18C3 pharmacokinetics[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/GM-CSF or Imiquimod; BRIEF: This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patients tumor. ; DRUG USED: DPV-001; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Tumor Cells; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: UbiVac; CRITERIA: Inclusion Criteria: - Stage IIIA or IIIB histologically proven non-small cell lung cancer - Completion of definitive therapy - Enrollment from 28 days to 12 weeks from completion of definitive therapy - Toxicities from definitive therapy resolved to less than grade 1 - ECOG performance status 0-1 - Negative pregnancy test in women of childbearing potential - Agree to avoid pregnancy or fathering a child while on study treatment - Ability to give informed consent and comply with protocol - Anticipated survival minimum of 6 months - Prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment - Normal organ and marrow function as defined by specific lab tests - Archived tumor tissue available Exclusion Criteria: - Active autoimmune disease except for vitilogo or hypothyroidism - Active other malignancy - Known HIV+ and/or Hepatitis B or C positive - Medical or psychiatric conditions that would preclude safe participation - Ongoing chemotherapy ; PRIMARY OUTCOME: Identify the regimen that produces the strongest antibody response; SECONDARY OUTCOME 1: Safety[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ASB-03-05; BRIEF: The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline. ; DRUG USED: Naglazyme; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis VI (MPS VI); TARGET: N-Acetylgalactosamine 4-sulfatase; THERAPY: Monotherapy; LEAD SPONSOR: BioMarin Pharmaceutical; CRITERIA: Inclusion Criteria - Patient consent - Patient must be seven years of age or older - Patient must have documented biochemical or genetic proof of MPS VI - The patient must be able to walk independently at least 5 meters and no more than 270 meters in the first 6 minutes, or no more then 400 meters total in 12 minutes, in the screening 12-minute walk test - If female of childbearing potential, patient must have a negative pregnancy test Exclusion Criteria - Patient is under consideration for or has undergone a successful bone marrow transplant (BMT) - Patient refuses or is unable to complete all screening evaluations - Pregnant or lactating patient - Patient has received an investigational drug within 30 days prior to study enrollment - Patient has been previously treated with rhASB - Patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance - The patient has clinically significant spinal cord compression - The patient has known hypersensitivity to rhASB or to components of the active or placebo test solutions ; PRIMARY OUTCOME: Change From Baseline in 12-minute Walk Test at 24 Weeks; SECONDARY OUTCOME 1: Change From Baseline in 3-minute Stair Climb at 24 Weeks[/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 - Adults w/Blood Cancers; BRIEF: The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo. ; 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 the investigator believes can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject. - A male or female, aged 18 years or older at the time of study entry. - Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition. - Life expectancy greater than or equal to 12 months, as assessed by the investigator. - 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 inthe 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. Exclusion Criteria: - Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled). - Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy. - Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure). - Human immunodeficiency virus (HIV) infection by clinical history. - Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subjects underlying disease, is allowed. - Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo. - Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine. - Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. - Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. - Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo). ; PRIMARY OUTCOME: Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations; SECONDARY OUTCOME 1: Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - RAPID (Mayo/NCI); BRIEF: This pilot trial studies how well nanoparticle albumin-bound rapamycin works in treating patients with cancer that as has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced cancer) and that has an abnormality in a protein called mechanistic target of rapamycin (mTOR). Patients with this mutation are identified by genetic testing. Patients then receive nanoparticle albumin-bound rapamycin, which may stop the growth of cancer cells by blocking the mTOR enzyme, which is needed for cell growth and multiplication. Using treatments that target a patients specific mutation may be a more effective treatment than the standard of care treatment. ; DRUG USED: Fyarro; DRUG CLASS: Non-NME; INDICATION: Solid Tumors; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Mayo Clinic; CRITERIA: Inclusion Criteria: - Histologic proof of cancer which is now not amenable to curative standard treatment options - Patient must have received at least 1 prior standard therapy for their disease - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 - Ability to provide informed written consent - Willing to return to enrolling institution for follow-up (active monitoring phase of the study); Note: During the active monitoring phase of a study (i.e., active treatment), participants must be willing to return to the consenting institution for follow-up - Life expectancy >= 84 days (3 months) - Identification of a drug target/targets through molecular profiling performed as a part of routine clinical care and treatment recommendation by the Mayo Clinic Genomics Tumor Board (GTB); NOTE: If profile matches more than 1 treatment arm, final decision for treatment arm assignment to be made by patients treating physician; it will be required for the genomic aberration to be identified through a test in a Clinical Laboratory Improvement Amendments (CLIA) workflow; assays used will range from single gene abnormalities (e.g. fluorescent in situ hybridization [FISH] for human epidermal growth factor receptor 2 [ERBB2] amplifications) to next generation sequencing based gene panels (Foundation One®) to more comprehensive assays such as whole exome sequencing; the Mayo Clinic GTB will serve as the centralized point of data synthesis to allow for assessment of molecular profiling accomplished through a heterogeneous array of tests - Date of Mayo Clinic Genomics Tumor Board review =< 3 months prior to registration - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria (for solid tumors) or equivalent criteria (for patients with non-solid tumor malignancies) - Patient meets all sub-protocol specific criteria of each applicable sub-protocol - Ability to complete questionnaire(s) by themselves or with assistance - SUB-PROTOCOL AIM A: Histological confirmation of renal cell carcinoma, head and neck cancer, endometrial cancer, breast cancer, ovarian cancer, prostate cancer, squamous cell cervical or uterine cancer, or bladder cancer - SUB-PROTOCOL AIM A: Confirmation of advanced cancer with mTOR pathway aberrations as determined through routine clinical care using pathway aberrations performed in a CLIA certified laboratory; cancer genomic profiling tests incorporating next generation sequencing from archival formalin-fixed paraffin-embedded tissue (FFPE) are validated with sensitivities and specificities of 99% and 99%, respectively; in the assay, hybrid-capture-selected deoxyribonucleic acid (DNA) libraries are sequenced to depths targeting > 500 × coverage by non-polymerase chain reaction (PCR) duplicate read pairs, with > 99% of exons at coverage > 100 ×); multiplatform profiling may include immunohistochemistry and in situ hybridization methods with previously established negative/positive cutoffs performed in a CLIA certified lab; at least one pathway aberration must be identified; these must be confirmed in a CLIA certified lab; the potential mTOR aberrations that could be identified are listed below, please note that this list is not all inclusive; if a CLIA validated report lists an mTOR pathway inhibitor as a target drug for a genetic aberration, then it can be considered eligible for the purposes of this study; v-akt murine thymoma viral oncogene homolog 1 (AKT1), MTOR, phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA), tuberous sclerosis (TSC)1, TSC2, retrovirus-associated DNA sequence (Ras) homolog enriched in brain (RHEB), serine/threonine kinase 11 (STK11), neurofibromin (NF)1/2 - SUB-PROTOCOL AIM A: Absolute neutrophil count (ANC) >= 1500/mm^3 - SUB-PROTOCOL AIM A: Platelet count >= 100,000/mm^3 - SUB-PROTOCOL AIM A: Hemoglobin >= 9.0 g/dL - SUB-PROTOCOL AIM A: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) - SUB-PROTOCOL AIM A: Aspartate transaminase (AST); alanine aminotransferase (ALT) =< 1.5 x ULN; NOTE: if subject has tumor involvement in the liver =< 5 X ULN - SUB-PROTOCOL AIM A: Serum cholesterol =< 350 mg/dL - SUB-PROTOCOL AIM A: Serum triglyceride =< 300 mg/dL - SUB-PROTOCOL AIM A: Serum creatinine =< 1.5 x ULN - SUB-PROTOCOL AIM A: Previously treated patients who have failed, unable to tolerate, or refused other available active therapies - SUB-PROTOCOL AIM A: Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 14 days prior to registration and must use two forms of highly effective contraception (also applicable to their partners who are biologically able to conceive) - SUB-PROTOCOL AIM A: Adequate coagulation function as defined by either of the following criteria: - International normalized ratio (INR) =< 1.5 x ULN - For subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the investigators opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy; the INR for these patients may exceed 1.5 x ULN if that is the goal of the anticoagulant therapy Exclusion Criteria: - Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Failure to fully recover from acute, reversible effects of prior chemotherapy (other anti-neoplastic therapy) and radiation therapy to adverse event severity of =< grade 1 - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens - SUB-PROTOCOL AIM A: Any of the following: - Pregnant women - Nursing women - Women of child-bearing potential, who are biologically able to conceive, or men who are able to father a child, not employing two forms of highly effective contraception - Highly effective contraception (e.g., male condom with spermicide, diaphragm with spermicide, intra-uterine device, and total abstinence) must be used by both sexes during the study and must be continued for 6 months after the end of study treatment; Note: Oral, implantable, or injectable hormone contraceptives are not considered effective for this study - SUB-PROTOCOL AIM A: Any of the following treatments: - Chemotherapy within 4 weeks before treatment with nab-rapamycin - Hormonal therapy within 4 weeks before treatment with nab-rapamycin (with the exception of leuprolide, degarelix, or goserelin) - Immunotherapy within 4 weeks before treatment with nab-rapamycin - Radiotherapy within 4 weeks before treatment with nab-rapamycin - Treatment with nitrosoureas, mitomycin, or extensive radiotherapy within 6 weeks before treatment with nab-rapamycin - Immunosuppressive agents within 3 weeks before treatment with nab-rapamycin (except corticosteroids used as antiemetics) - Use of prior mTOR pathway inhibitor therapy - SUB-PROTOCOL AIM A: Patients with a history of interstitial lung disease and/or pneumonia - SUB-PROTOCOL AIM A: Receiving any concomitant antitumor therapy or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) - SUB-PROTOCOL AIM A: History of allergic reactions attributed to compounds of similar chemical or biologic composition including macrolide (e.g. azithromycin, clarithromycin, dirithromycin, and erythromycin) and ketolide antibiotics - SUB-PROTOCOL AIM A: Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) =< 4 weeks prior to registration or failure to recover from side effects of such surgery; exceptions: port placements, nephrectomy, tumor biopsies, and minor surgeries - SUB-PROTOCOL AIM A: Concurrent use of any other approved or investigational anticancer agents which would be considered as a treatment for the primary neoplasm - SUB-PROTOCOL AIM A: Patients with a history of alcoholism, drug addiction or psychotic disorders - SUB-PROTOCOL AIM A: Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HbA1c) > 8% despite adequate therapy; unstable coronary artery disease or myocardial infarction during preceding 6 months; or hypertension uncontrolled by medication - SUB-PROTOCOL AIM A: Patients who required therapeutic doses of anticoagulants ; PRIMARY OUTCOME: Proportion of confirmed responses, evaluated using the RECIST v1.1; SECONDARY OUTCOME 1: Clinical benefit rate defined as the proportion of patients with a confirmed response or stable disease (complete response+partial response+stable disease) divided by the total number of evaluable patients[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - ARRIVE (NAFLD) (UCSD); BRIEF: A subset of patients with NAFLD that have not been extensively studied are those infected with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients with NAFLD and there are no approved treatment options. We plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to examine the efficacy of 600 mg of Aramchol daily (including 200 mg tablet and 400 mg tablet) versus identical placebo given over 12 weeks to improve HIV-associated hepatic steatosis as measured by a validated and accurate magnetic resonance imaging (MRI)-based technique. ; DRUG USED: Aramchol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: ATP-Binding Cassette Transporter 1 (ABCA1), Stearoyl-CoA Desaturase 1 (SCD1); THERAPY: Monotherapy; LEAD SPONSOR: University of California, San Diego; CRITERIA: Inclusion Criteria: 1. Age at entry at least 18 years. 2. And at least one of the following risk factor for more severe liver disease: Hypertriglyceridemia based upon ATP-III guidelines, Increased LDL cholesterol or increased total cholesterol based upon ATP-III guidelines, Decreased HDL cholesterol based upon ATP-III guidelines, Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men, Overweight as defined as BMI: 25 < 30 kg/m2, Obesity as defined BMI ≥ 30 kg/m2, Hyperuricemia based upon ATP-III guidelines, Prediabetes or Diabetes by American Diabetes Association Criteria 3. Lipodystrophy will be confirmed on both clinical and radiologic assessment and defined as: Clinical history and/or exam by the study physician with signs of either facial,temporal, upper or lower extremity lipo-atrophy, Documented abdominal fat accumulation with presence of hepatic steatosis on MRI 4. An MRI-determined fat fraction classification threshold (≥5%) will be used to confirm subjects. MR examinations will include four research sequences (three imaging sequences and one single-voxel spectroscopy sequence) that have been developed and refined by Dr. Sirlin, allowing for the measurement of liver fat fraction and newer candidate MR biomarkers for future NAFLD studies. MR examinations will last 20-30 minutes and will be performed without contrast agents. Subjects will be scanned at 1.5T. To assess sequence repeatability, two sequences per subject, block randomized, will be run three times. For MR elastography, MR imaging will be done which will include placing a vibrating paddle over the abdomen while images are obtained. A comprehensive screening questionnaire will be utilized prior to subjects having an MRI. Experienced research MR technologists will perform MR examinations under the supervision of Dr. Sirlin. 5. History of HIV documented by a previously positive HIV Elisa or PCR. 6. Stable antiretroviral (ART) regimen for at least 12 weeks prior to study inclusion. 7. Written informed consent. Exclusion Criteria: 1. Evidence of another form of liver disease: Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg), Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA in serum, Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy, Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with rimary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis, Wilsons disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilsons disease Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D, Drug-induced liver disease as defined on the basis of typical exposure and history,Bile duct obstruction as shown by imaging studies. 2. Evidence of liver cirrhosis based upon clinical assessment, imaging or any of the following lab abnormalities: INR >1.4, albumin <3.2 g/dL, platelet count <90 x 103/microliter 3. History of excess alcohol ingestion, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1 drink per day or 7 drinks per week) in the previous one year. 4. Contraindications to MRI: The subject has any contraindication to MR imaging, such as patients with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field, the subject has a history of extreme claustrophobia, The subject cannot fit inside the MR scanner cavity, decompensated liver disease, Child-Pugh score greater than or equal to 7 points 6. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months. 7. Recent use (within the last 90 days) of medications to treat hepatic steatosis such as pioglitazone (or medications in the same class) or vitamin E. 8. Use of Aramchol or agents in the same class. 9. Recent use (within the last 90 days) of insulin as an outpatient for management of diabetes. 10. HbA1c > 9 or uncontrolled diabetes. 11. Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease with hypoxia, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator would preclude treatment with Aramchol and adequate follow up. 12. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year. 13. Pregnancy or inability to practice adequate contraception in women of childbearing potential. 14. Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study that is suggestive of liver cancer. 15. HIV specific exclusions: CD4 count of less than 200 cells/μL, Detectable viral load,Changes to ART regimen in the preceding 12 weeks,Lack of alternative ART regimens should the patient experience virologic breakthrough,History of opportunistic infection in the preceding 12 months 16. Symptoms of uncontrolled gastrointestinal disorders involving motility, gastric acid or gastric emptying malabsorption ,Disorders including but not limited to peptic ulcer disease, gastroesophageal reflux, dyspepsia, gastroparesis, chronic diarrhea, chromic constipation, gall bladder disease,pancreatitis, lactose intolerance and celiac disease.Patients who have used anticholinergic or other drugs known to affect gastrointestinal motility within 7 days prior to dosing and throughout the study will also be excluded 17. Patients with hypersensitivity to Aramchol or to any of the excipients in the tablets or with hypersensitivity to cholic acid or bile acid sequestrants 18. Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibility hinder completion of the study. ; PRIMARY OUTCOME: Efficacy of Aramchol 600 mg vs. Placebo in Improving Hepatic Steatosis Assessed by Magnetic Resonance Imaging in Patients With HIV-associated NAFLD; SECONDARY OUTCOME 1: Serum Alanine Aminotransferase (ALT)[/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/GSK2118436; BRIEF: This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single dose GSK2118436 was investigated prior to evaluating combination regimens. In Part B, the range of tolerated dose combinations was identified using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and GSK1120212 were evaluated, based on results from the dose escalation cohorts. In Part D, the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in combination with GSK1120212 was evaluated. ; DRUG USED: Mekinist; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Capable of given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. - Male or female age 18 years or greater; able to swallow and retain oral medication. - BRAF mutation positive melanoma or colorectal cancer; other BRAF mutation positive tumor types may be considered. - Measurable disease according to RECIST version 1.1. - Eastern Cooperative Oncology Group Performance Status of 0 or 1 for Parts A and B. Subjects with Eastern Cooperative Oncology Group Performance Status of 2 or less may be entered into Part C with approval of medical monitor. - Agree to contraception requirements. - Calcium phosphorus product less than 4.0mmol2/L2. - Adequate organ system function. Key Exclusion Criteria: - Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy). - Part A and Part B: Prior exposure to BRAF or MEK inhibitors unless approved by the GSK Medical Monitor. - Part C: Prior exposure to BRAF or MEK inhibitors. Prior anti-cancer therapy in the metastatic setting, with the exception of up to one regimen of chemotherapy and/or interleukin-2 (IL-2). - Part D: Prior exposure to BRAF inhibitors. A washout period of 6 weeks is required for ipilimumab. - Received an investigational anti-cancer drug within 4 weeks or 5 half-lives (whichever is shorter) of study drug administration--- at least 14 days must have passed between the last dose of prior investigational anti-cancer drug and the first dose of study drug. - Current use of a prohibited medication or requires any of these medications during treatment with study drug. - Current use of therapeutic warfarin. - Any major surgery, radiotherapy, or immunotherapy within the last 4 weeks. Limited radiotherapy within the last 2 weeks. - Chemotherapy regimens with delayed toxicity within the last 4 weeks. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks. - Unresolved toxicity greater than National Cancer Institute-Common Terminology Criteria for Adverse Events version 4 Grade 1 from previous anti-cancer therapy except alopecia. - History of retinal vein occlusion, central serous retinopathy or glaucoma. - Predisposing factors to retinal vein occlusion including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy. - Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for retinal vein occlusion or central serous retinopathy. - Intraocular pressure greater than 21mm Hg as measured by tonography. - Glaucoma diagnosed within one month prior to study Day 1. - Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism or excretion of drugs. - Known human immunodeficiency virus, Hepatitis B or Hepatitis C infection. - Primary malignancy of the central nervous system. - Untreated or symptomatic brain metastasis, leptomeningeal disease or spinal cord compression. Subjects who are on a stable dose of corticosteroids for more than 1 month or off corticosteroids for 2 weeks can be enrolled with approval of medical monitor. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs. - Subjects with brain metastases are excluded, unless a. All known lesions must be previously treated with surgery or stereotactic radiosurgery, and- b. Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for ≥90 days prior to first dose on study (must be documented with two consecutive MRI or CT scans using contrast), and c. Asymptomatic with no corticosteroids requirement for ≥ 30 days prior to first dose on study, and d. No enzyme-inducing anticonvulsants for ≥ 30 days prior to first dose on study. - History of alcohol or drug abuse within 6 months prior to screening. - Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol. - QTc interval greater than or equal to 480msecs. - History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks. - Class II, III, or IV heart failure as defined by the New York Heart Association functional classification system. - Abnormal cardiac valve morphology (subjects with minimal abnormalities can be entered on study with approval from the medical monitor. - Treatment refractory hypertension defined as a blood pressure of systolic> 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy - Patients with intra-cardiac defibrillators or permanent pacemakers. - Cardiac metastases - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs or excipients. - Pregnant or lactating female. - Unwillingness or inability to follow the procedures required in the protocol. - Uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity. - Subjects with known glucose 6 phosphate dehydrogenase deficiency. ; PRIMARY OUTCOME: Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib; SECONDARY OUTCOME 1: Part A: Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib[/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 - PTSD; BRIEF: This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects with cPTSD, added to pre-existing treatment that includes prazosin with or without other psychotropic drugs. Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks. Subjects will be evaluated for the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared with the response to placebo. ; DRUG USED: SNC-102; DRUG CLASS: New Molecular Entity (NME); INDICATION: Post-Traumatic Stress Disorder (PTSD); TARGET: GABA Receptors, NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Synchroneuron Inc.; CRITERIA: Inclusion Criteria: - Confirmation of a diagnosis by a Board-Certified psychiatrist of combat-related posttraumatic stress disorder (cPTSD) according to Diagnostic and Statistical Manual (DSM-5) criteria for PTSD and a history linking the symptoms to combat exposure. - Taking prazosin for treatment of cPTSD for a minimum of 4 weeks, on a stable dose for at least 2 weeks, and expected to remain on that dose for the duration of the study. - Having sufficient residual symptoms of PTSD while on the current drug regimen that, in the opinion of the Principal Investigator, additional treatment of the disorder is clinically indicated. - Body mass index of 18-38 kg/m2 inclusive. Exclusion Criteria: - Plans to initiate a new psychotropic medication (other than the study drug) during the period of the study. - Plans to change the dose or discontinue prazosin or a psychotropic medication during the period of the study. - Diagnosis of epilepsy or treatment with an antiepileptic drug. - Use of alcohol or cannabis to the extent that, in the view of the Principal Investigator, it raises a significant risk of medication noncompliance, drinking alcohol after midnight on the days of study visits or missed study visits. Any use of non-prescribed opiates, cocaine, or other street drugs other than cannabis in the month prior to study entry. - Any history of major medical complications of alcohol use including alcoholic hepatitis, cirrhosis of the liver, pancreatitis, alcohol withdrawal seizures, or delirium tremens. - Patients taking moderate, stable doses of oral opiates for chronic pain may be admitted at the discretion of the Principal Investigator. - Current use of a drug other than prazosin with significant alpha-adrenergic blocking effects, if associated with symptomatic orthostatic hypotension. - Current use of cocaine, amphetamine, phencyclidine, or ketamine, documented either by history or by urinary drug screening at Screening and Baseline Visits. Urinary drug screening for ketamine and phencyclidine will conducted off-site by the Study Sponsor if urinary drug screening available at the study site does not include these drugs. Any other drugs identified incidentally on drug screening will warrant exclusion only if the Principal Investigator, in consultation with the Sponsor, judges that their presence could interfere with the objectives of the trial. - Pregnant or lactating female. - Women of childbearing potential, unless the subject agrees to use dual contraceptive methods while on study drug and for 1 month afterward, which, in the opinion of the Principal Investigator, are effective and adequate for that subjects circumstances. - Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that could increase the risk associated with study participation or study drug administration, could interfere with the informed consent process and/or with compliance with the requirements of the study, or could interfere with the interpretation of study results and which, in the Principal Investigators opinion, would make the subject inappropriate for entry into this study. - Use of any non-pharmacologic psychiatric somatic treatment within 4 weeks of baseline, or expected during the course of the study. Such treatments include but are not limited to electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, light therapy, and acupuncture. ; PRIMARY OUTCOME: PTSD symptoms as measured by Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual-5 (CAPS-5); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - MAD (Healthy Volunteers); BRIEF: This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing. ; DRUG USED: CTP-692; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Concert Pharmaceuticals; CRITERIA: Inclusion Criteria: - Healthy adult males and females between 18 and 55 years of age, inclusive - Body weight ≥ 55 kg and body mass index within the range of 18 to 32 kg/m2, inclusive Exclusion Criteria: - Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug - Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody - History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions - Positive drug or alcohol test at screening or prior to the first dose of study drug ; PRIMARY OUTCOME: Number of participants with adverse events as a measure of safety; 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 - CF-203; BRIEF: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness. ; DRUG USED: Bronchitol; DRUG CLASS: Non-NME; INDICATION: Cystic Fibrosis (CF); TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Pharmaxis; CRITERIA: Inclusion Criteria: - Known diagnosis of cystic fibrosis (sweat test or genotype) - Of either gender - Aged between 8 and 18 years - Have a baseline FEV1 of <70% of the predicted normal value - Currently taking rhDNase for at least 4 weeks Exclusion Criteria: - Currently active asthma, uncontrolled hypertension, colonised with Burkholderia cepacia or MRSA - Listed for transplantation - Known intolerance to mannitol, rhDNase or bronchodilators ; PRIMARY OUTCOME: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase; SECONDARY OUTCOME 1: to compare mannitol to rhDNase on FVC[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - vs. Latanoprost; BRIEF: This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension. ; DRUG USED: OPA-6566; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Adenosine A2a Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Kubota Vision Inc.; CRITERIA: Inclusion Criteria: - diagnosis of bilateral primary open-angle glaucoma - diagnosis of ocular hypertension as defined in the protocol Exclusion Criteria: - any form of glaucoma other than primary open-angle glaucoma in either eye - other ocular conditions as defined by the protocol ; PRIMARY OUTCOME: Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine.; SECONDARY OUTCOME 1: Composite of Pharmacokinetics[/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 - BLI-800-301; BRIEF: This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy. ; DRUG USED: SuPrep; DRUG CLASS: Non-NME; INDICATION: Colon Cleansing/Laxatives; TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Braintree Laboratories; CRITERIA: Inclusion Criteria: - Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including: - Evaluation of BE results - GI bleeding - Anemia of unknown etiology - Neoplastic disease surveillance - Endosonography - Inflammatory bowel disease - Unknown diarrhea or constipation etiology - Polypectomy - Laser therapy - Routine Screening - At least 18 years of age - Otherwise in good health, as determined by physical exam and medical history - If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse) - Negative urine pregnancy test at screening, if applicable - In the Investigators judgment, subject is mentally competent to provide informed consent to participate in the study Exclusion Criteria: - Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon. - Subjects with impaired consciousness that predisposes them to pulmonary aspiration. - Subjects who are undergoing colonoscopy for foreign body removal and decompression. - Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors. - Subjects with a history of renal or hepatic insufficiency or congestive heart failure. - Subjects who had previous gastrointestinal surgeries - Subjects who are pregnant or lactating, or intending to become pregnant during the study. - Subjects of childbearing potential who refuse a pregnancy test. - Subjects who are allergic to any preparation components - Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. - Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days. ; PRIMARY OUTCOME: Efficacy - preparation quality using a 4 point scale; SECONDARY OUTCOME 1: Safety - preparation related side effects; laboratory analysis[/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 - CheckMate 9DX; BRIEF: This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Participants with a first diagnosis of HCC who have undergone a curative resection or ablation - Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC - Child-Pugh Score 5 or 6 - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - Any evidence of tumor metastasis or co-existing malignant disease - Participants previously receiving any prior therapy for HCC, including loco-regional therapies - Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation - Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella [MMR]). Other protocol defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Recurrence-free Survival (RFS); 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 III - vs. ActHIB Vaccine (Primary Phase); BRIEF: The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 ; DRUG USED: MenHibrix; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Haemophilus influenzae, Immune System, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. - A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. - Written informed consent obtained from the parent or guardian of the subject. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Born after 36 weeks gestation. - Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment. - Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine. Exclusion criteria: 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. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. - Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). - Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. - In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar. - History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease. - Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. - Major congenital defects or serious chronic illness. - History of any neurologic disorders or seizures. - Acute disease at time of enrollment. - Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. - Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). ; PRIMARY OUTCOME: Number of Subjects Reporting Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DANUBE (w/Tremelimumab); BRIEF: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy. - Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • Creatinine clearance (calculated or measured) <60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination • Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss • CTCAE Grade ≥2 peripheral neuropathy • New York Heart Association ≥Class III heart failure. - Tumor PD-L1 status, with Immunohistochemical (IHC) assay confirmed by a reference laboratory, must be known prior to randomization. Exclusion Criteria: - Prior exposure to immune-mediated therapy, including but not limited to, other anti cytotoxic T-lymphocyte-associated protein 4 (CTLA 4), anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment. - History of allogenic organ transplantation that requires use of immunosuppressive agents. - Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca • Patients with celiac disease controlled by diet alone may be included but only after consultation with AstraZeneca. - Brain metastases or spinal cord compression unless the patients condition is stable and off steroids for at least 14 days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI (preferred)/CT, preferably with IV contrast to access baseline disease status. - Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). - Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection) • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). - Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP. ; PRIMARY OUTCOME: To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set; SECONDARY OUTCOME 1: OS, Full Analysis Set - Durvalumab Monotherapy vs SoC[/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 - AIR-BX2; BRIEF: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days. ; DRUG USED: Cayston; DRUG CLASS: Non-NME; INDICATION: Bronchiectasis; TARGET: Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Male/Female 18 years or older with non-CF bronchiectasis - Chronic sputum production on most days - Positive sputum culture for gram-negative organisms - Must have met lung function requirements Exclusion Criteria: - History of CF - Hospitalized within 14 days prior to joining the study - Previous exposure to AZLI - Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study - Must have met liver and kidney function requirements - Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed) - Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment - Other serious medical conditions. ; PRIMARY OUTCOME: Change in QOL-B Respiratory Symptoms Score at Day 28; SECONDARY OUTCOME 1: Change in QOL-B Respiratory Symptoms Score at Day 84[/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 - TRANSPLANT BRaVE; BRIEF: To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve progression free survival (PFS) and overall survival (OS). ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Hodgkins Lymphoma; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Marjolein Spiering; CRITERIA: Inclusion Criteria: - Histologically confirmed CD30+ classical HL (central pathology review; results not required to enroll the patient in the study), primarily refractory to first line chemotherapy or in first relapse after any polychemotherapy regimen (e.g. ABVD (Adriamycin, bleomycin, vinblastine, and dacarbazine), baseline BEACOPP ( bleomycin, etoposide, Adriamycin, cyclophosphamide, Oncovin, procarbazine, and prednisone) or escalated BEACOPP, or other induction regimens) - In case of relapse, the relapse must be histologically confirmed. In case histology is not possible, at least confirmation of the relapse by fine-needle aspiration is required. - Measurable disease, as defined in Appendix C i.e. CT scans showing at least 2 or more clearly demarcated lesions with a long axis ≥ 1.5 cm and a short axis diameter ≥ 1.0 cm, or 1 clearly demarcated lesion with a long axis ≥ 2.0 cm and a short axis diameter ≥ 1.0 cm. These lesions must be FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-positive - Age ≥ 18 years (upper age limit for auto stem cell transplantation at the discretion of the participating center) - WHO ≤ 2 (see appendix A) - Life expectancy of > 3 months with treatment - No major organ dysfunction, unless HL-related - Total bilirubin < 1.5x ULN (unless due to lymphoma involvement of the liver or a known history of Gilberts syndrome) - ALT/AST < 3x ULN (unless due to lymphoma involvement of the liver; in that case ALT/AST may be elevated up to 5 x ULN) - glomerular filtration rate (GFR) > 60 ml/min as estimated by the Cockcroft&Gault formula (appendix D) - Absolute neutrophil count ≥ 1.5x109/L, unless caused by diffuse bone marrow infiltration by the HL - Platelets ≥ 100x109/L, unless caused by diffuse bone marrow infiltration by the HL - Hemoglobin must be >8 g/dL - Written informed consent - Able to adhere to the study visit schedule and other protocol requirements - Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse. - Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse. - Eligible for high dose chemotherapy and autologous peripheral blood stem cell transplantation - Resolution of toxicities from first-line therapy Exclusion Criteria: - Peripheral sensory or motor neuropathy grade ≥ 2 - Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy - Symptomatic neurologic disease compromising normal activities of daily living or requiring medications - Patients who have been using other investigational agents within at least 5 half lives of the most recent agent used prior to enrollment in the study - Patients who were treated with myelosuppressive chemotherapy or biological therapy ≤ 4 weeks before study inclusion - Female patients who are both lactating and breast feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug or adults of reproductive potential who are not using effective birth control methods. - Patients with any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose - Patients who have a history of another primary malignancy less than 3 years before study inclusion or previously diagnosed with another malignancy and have evidence of residual disease, with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 and carcinoma in situ of the uterine cervix - Patients with known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin. - Patients with known HIV seropositivity, known hepatitis B surface antigen-positivity, or known or suspected active hepatitis C infection - Patients receiving radiation therapy within 8 weeks prior to start of protocol treatment. Emergency radiation therapy is allowed, as long as measurable disease (at non-irradiated sites) persists. - Patients with a serious psychiatric disorder that could, in the investigators opinion, potentially interfere with the completion of treatment according to the protocol - Patients who have any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study such as:Known history of symptomatic congestive heart failure (NYHA III, IV), myocardial infarction ≤ 6 months prior to first study drug - Evidence of current serious uncontrolled cardiac arrhythmia, angina pectoris, electrocardiographic evidence of acute ischemia or active conduction system abnormalities - Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50% - severely impaired pulmonary function as defined as spirometry and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% or less of the normal predicted value and/or O2 saturation that is 90% or less at rest on room air - any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study - nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe hypertension that is not controlled with medical management and thyroid abnormalities when thyroid function cannot be maintained in the normal range by medication ; PRIMARY OUTCOME: rate of patient with grade 4 Adverse Events; SECONDARY OUTCOME 1: (Severe) Adverse Event[/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 - A3921069 - ORAL Start; BRIEF: This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate. ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate. - Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria. - Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL Exclusion Criteria: - Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L - History of any other rheumatic autoimmune disease other than Sjogrens syndrome - No malignancy or history of malignancy - History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug - No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy ; PRIMARY OUTCOME: Modified Total Sharp Score (mTSS) at Month 6; SECONDARY OUTCOME 1: mTSS Score at Baseline, Months 12 and 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/II - NIDCR; BRIEF: This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced the need for pain medication in several animal experiments. It works by destroying nerves that transmit pain information. People at least 18 years of age with severe pain from advanced cancer at or below the level of the chest that cannot be controlled with standard treatments may be eligible for this study. Participants undergo the following procedures: Pretreatment Visit Before beginning treatment with RTX, patients give a medical history and undergo a physical examination that includes: - Electrocardiogram (EKG) - Blood draw - Urinalysis - Neurological examinations - Peak expiratory flow rate (PEFR) - Eye examination - MRI - Urology assessment - Pregnancy test, when appropriate - Questionnaires to collect information on health, personality, mood, pain levels and symptoms. 2-Day Hospitalization Patients are hospitalized for 2 days for RTX injection and monitoring, as follows: - RTX injection: RTX is injected in the operating room under general anesthesia. It is given through a catheter placed in the patient s spine. The catheter is also used to obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord. The fluid is examined to assess drug effects and side effects, chemical changes in the content of the CSF associated with RTX, and how RTX is handled by the body. - Post-injection monitoring, including: - Surveys about symptoms such as pain or weakness - Neurological examinations - Blood and CSF sampling - EKG - AEs Outpatient followup - Vitals - Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after the injection - MRI scans of the head and back, Urology assessment and PEFR on day 15 after the injection - Eye examination - Follow-up phone calls monthly for 6 months ; DRUG USED: Resiniferatoxin; DRUG CLASS: Non-NME; INDICATION: Cancer Pain; TARGET: TRPV1, transient receptor potential vanilloid receptor 1, VR-1; THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Dental and Craniofacial Research (NIDCR); CRITERIA: - INCLUSION CRITERIA: Subject inclusion criteria are based on inadequate control of pain despite best efforts, including appropriate use of analgesic medications. To be enrolled in the study, subjects must meet all of the following criteria: 1. Age 18 years or older. 2. Clinical and histological diagnosis of cancer with disease that has not adequately responded to standard therapies. A pathology report documenting malignancy is required. 3. Subject not currently seeking or receiving potentially curative therapies for cancer (e.g., chemotherapy or immunotherapy). Curative cancer therapy may be sought after the Day 15 clinic visit, and palliative anti-tumor therapy is allowed as long as the subject was established on that therapy prior to enrollment (see exclusion criterion 6). 4. Mean daily worst pain NRS score of greater than or equal to 6 for pain at or below the T6 dermatome (level of the chest) that is associated with a malignant disease. The mean score must be derived from recordings on at least 4 of 7 consecutive days within 3 weeks preceding treatment. 5. Alternative methods of pain control are not sufficiently effective, not indicated, not tolerated, and/or refused by the subject, as determined by the Pain and Palliative Care Service (PPCS). Alternative methods of pain control include, but are not limited to, the following: -Opioids (all routes of administration including neuraxial infusions) -Adjuvant pain medications such as antidepressants, corticosteroids, local anesthetics, and antiseizure medications -Procedures such as catheter or implantable pump placement for delivery of analgesic medication - Prior neurolytic interventions (including intercostal, superior hypogastric, or celiac plexus blocks) - Complementary medicine approaches - Transcutaneous electric nerve stimulation - Radiation therapy 6. Reasonable expectation that the subject will be able to complete the study through the 30-day follow-up. 7. Medical clearance from referring physician consisting of a statement indicating an adequate recovery period from other previous trials/medication. 8. Formal review of the subject s medical records and written approval for his/her inclusion in the study by 3 separate persons: - Principal Investigator (PI) or an Associate Investigator (AI) - Medical oncologist or oncologic surgeon. - A member of the PPCS at the NIH or institutions equivalent at other sites. 10. International normalized ratio (INR; from prothrombin time [PT]) < 1.5 and partial thromboplastin time (PTT) less than or equal to the upper limit of the reference range. The INR and PTT may be corrected (e.g., by administration of blood products, vitamin K, etc.), provided a repeat blood draw confirms that the values meet this inclusion criterion. 10. Platelet count greater than or equal to 50,000/mm^3. Platelets will be transfused as necessary to raise the platelet count to greater than or equal to 100,000/mm^3 prior to dosing. 11. Ability to stop any anticoagulant (e.g., Coumadin) and antiplatelet therapies (e.g., aspirin) before and during IT catheter placement according to accepted medical guidelines.1 12. Ability and willingness to undergo an eye examination. 13. Ability to read, speak, and understand English, and willingness to complete the study tools and forms. 14. For women of childbearing potential and men with partners of childbearing potential, the ability and willingness to use an effective method of contraception during the study. Effective methods of birth control include: - hormonal contraception (birth control pills, injected hormones, or vaginal ring), - intrauterine device, - barrier methods (condom or diaphragm) combined with spermicide, or - surgical sterilization (hysterectomy, tubal ligation, or vasectomy). 15. Availability of a responsible adult to assist with activities of daily living as needed for the subject through the Day 15 visit. 16. Ability to assign a Durable Power of Attorney (DPA) for research and medical care at NIH EXCLUSION CRITERIA: Subjects will be excluded from the study if they meet any of the following criteria: 1. Primary pain source from anatomical regions at T5 dermatome or above. 2. Pain due to causes other than cancer or its treatment that is moderate to severe in intensity. 3. Anatomic abnormality or pathology of the spinal cord and/or intrathecal space on magnetic resonance imaging (MRI) that could increase the risk of adverse effects of intrathecal catheter placement or interfere with CSF flow. 4. Evidence of advanced brain pathology or elevated intracranial pressure as determined by symptoms, history, physical examination (including neurological and eye examination), and/or MRI. 5. Presence of an intrathecal shunt device (e.g., ventriculo-peritoneal and ventriculo-atrial shunts). 6. Anticipating initiation of palliative anti-tumor therapy or significant changes to current palliative anti-tumor therapy before completion of the Day 15 visit. 7. Documented allergy to chili peppers or capsaicin (e.g., hives, wheal). 8. Contraindication to MRI or MRI contrast. 9. Female subjects who are pregnant or lactating. 10. Clinically significant disorder or condition that might interfere with study participation or greatly increase safety risk to the subject, as judged by a study investigator. 11. Planned use of another investigational agent, therapy, or device within 30 days after dosing. 12. Have a history of heart failure or unexplained fainting (syncope). 13. Have an EKG abnormality in which the baseline QTc interval exceeds 450 milliseconds. 14. Have a known family history of long QT syndrome. 15. Have abnormal electrolyte levels (i.e. low potassium) that connot be corrected. 16. Have urinary retention that does not resolve with medical or surgical treatment. 17. Have skin ulceration that does not resolve with medical or surgical treatment. 18. Have a history of seizure activity in the previous month. 19. Have experienced symptoms of opioid toxicity in the past month (i.e. myoclonus, seizures, and/or hallucinations). ; PRIMARY OUTCOME: Investigate the safety and efficacy of RTX administered intrathecally in subjects with severe refractory pain associated with advanced cancer along with ED100, the MTD, or the maximum dose administered, whichever is achieved first during dose es...; SECONDARY OUTCOME 1: Secondary outcome measures will be other surveys of pain, including an assessment of worst daily pain by the visual analog scale, and assessments of function and quality of life.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia - SAD; BRIEF: This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects. ; DRUG USED: PRX003; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: MUC-18/Melanoma Cell Adhesion Molecule/CD146; THERAPY: Monotherapy; LEAD SPONSOR: Prothena Biosciences Limited; CRITERIA: Inclusion Criteria: - Healthy subjects - Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 kg - Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception - Male subjects and their partners of childbearing potential must use contraception Exclusion Criteria: - Positive test for drug of abuse - Past or current history of alcohol abuse - Positive for TB, hepatitis B, hepatitis C or HIV infection ; PRIMARY OUTCOME: Safety and tolerability as determined by number of subjects with adverse events; SECONDARY OUTCOME 1: Immunogenicity as determined by measurement of anti-PRX003 antibodies[/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 - Study 242 (BID Dosing); BRIEF: Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract. The most common symptoms associated with the effects of opioids are constipation and nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of long-term opioid therapy. The primary objective of this study was to compare ADL5945, a MOR antagonist, with placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy for chronic noncancer pain. ; DRUG USED: Bevenopran; DRUG CLASS: New Molecular Entity (NME); INDICATION: Opioid Induced Constipation (OIC); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Key Inclusion Criteria - be a man or woman aged 18 to 75 years, inclusive, at the time of screening - have a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kilograms per square meter (kg/m^2) - be taking a stable daily dose of opioids of ≥30-milligrams (mg) morphine-equivalent total -daily dose for chronic noncancer pain for ≥30 days before screening - have opioid-induced constipation (OIC) by history. Additionally, based on the data collected during the 1-week screening period, participants must have <3 spontaneous bowel movements (SBMs) per week and have experienced ≥1 other bowel movement (BM) symptom (that is, straining to pass a stool, lumpy hard stools or small pellets, or sense of incomplete evacuation after passing a stool) for ≥25% of the total BMs - be willing to discontinue use of all laxatives and stool softeners during the study period except as allowed by the protocol Key Exclusion Criteria - be pregnant, lactating, or planning to become pregnant during the study - have aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen, or serum creatinine results ≥ 2 times the upper limit of normal - have a recent history of myocardial infarction (MI) or unstable angina - have an active malignancy of any type - be taking opioids primarily for fibromyalgia - be taking methadone as a maintenance medication (participants taking methadone for pain may be enrolled) - be taking intrathecal opioids for the management of pain - be taking tramadol, tapentadol, or any mixed agonist/antagonist opioid analgesics as the sole opioid for analgesia - be taking any μ-opioid receptors (MOR) antagonist, including opioids in combination with naloxone, naltrexone, or methylnaltrexone bromide - be taking medical marijuana for pain - have gastrointestinal (GI) or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction - have taken antispasmodics, antidiarrheals, or prokinetics within 7 days before the start of the screening week - be taking nonopioid medications known to cause constipation - be taking antidiarrheals and have an incidence or a history of intermittent diarrhea or loose stools - be unwilling to abstain from grapefruit and grapefruit-containing products - have a history of alcoholism or illicit drug dependence or abuse within 5 years before screening - have positive results on a urine drug screen (excluding opioids) that indicate illicit drug use ; PRIMARY OUTCOME: Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment; 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 - Optogenetics; BRIEF: Non-randomized, open label, Phase 1/2 dose escalation study of BS01, a non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP). ; DRUG USED: BS01; DRUG CLASS: Biologic; INDICATION: Retinitis Pigmentosa (RP) (Ophthalmology); TARGET: Channelrhodopsins; THERAPY: Monotherapy; LEAD SPONSOR: Bionic Sight LLC; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of retinitis pigmentosa - Bare light perception in at least one eye Exclusion Criteria: - Prior receipt of any AAV gene therapy product - Large amplitude nystagmus ; PRIMARY OUTCOME: Primary Outcome Measure; SECONDARY OUTCOME 1: Secondary Outcome Measures[/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 - Study 002; BRIEF: The purpose of this study is to determine whether a new medication called vamorolone is safe and well-tolerated by boys with Duchenne muscular dystrophy (DMD) ages ≥ 4 and < 7 years old. ; DRUG USED: VBP15; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: ReveraGen BioPharma, Inc.; CRITERIA: Inclusion Criteria: 1. Subjects parent or legal guardian has provided written informed consent/Health Insurance Portability and Accountability Act (HIPAA) authorization prior to any study-related procedures; 2. Subject has a confirmed (by Central Genetic Counselor) diagnosis of DMD as defined as: 1. Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, OR 2. Identifiable mutation within the DMD gene (deletion/duplication of one or more exons) where reading frame can be predicted as out-of-frame, and clinical picture consistent with typical DMD, OR 3. Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, other) that is expected to preclude production of the dystrophin protein (i.e. nonsense mutation, deletion/duplication leading to a downstream stop codon), with a typical clinical picture of DMD; 3. Subject is ≥ 4 years and < 7 years of age at time of enrollment in the study; 4. Subject is able to complete the Time to Stand Test (TTSTAND) without assistance, as assessed at the Screening and Baseline Visits; 5. Clinical laboratory test results are within the normal range at the Screening Visit, or if abnormal, are not clinically significant, in the opinion of the Investigator. (Note: Serum gamma glutamyl transferase [GGT], creatinine, and total bilirubin all must be ≤ upper limit of the normal range at the Screening Visit); 6. Subject has evidence of chicken pox immunity as determined by presence of IgG antibodies to varicella, as documented by a positive test result from the testing laboratory at the Screening Visit; and 7. Subject and parent/guardian are willing and able to comply with scheduled visits, study drug administration plan, and study procedures. Exclusion Criteria: 1. Subject has current or history of major renal or hepatic impairment, diabetes mellitus or immunosuppression; 2. Subject has current or history of chronic systemic fungal or viral infections; 3. Subject has had an acute illness within 4 weeks prior to the first dose of study medication; 4. Subject has used mineralocorticoid receptor agents, such as spironolactone, eplerenone, canrenone (canrenoate potassium), prorenone (prorenoate potassium), mexrenone (mexrenoate potassium) within 4 weeks prior to the first dose of study medication; 5. Subject has evidence of symptomatic cardiomyopathy. [Note: Asymptomatic cardiac abnormality on investigation would not be exclusionary]; 6. Subject is currently being treated or has received previous treatment with oral glucocorticoids or other immunosuppressive agents. [Notes: Past transient use of oral glucocorticoids or other oral immunosuppressive agents for no longer than 3 months cumulative, with last use at least 3 months prior to first dose of study medication, will be considered for eligibility on a case-by-case basis. Inhaled and/or topical corticosteroids prescribed for an indication other than DMD are permitted but must be administered at stable dose for at least 3 months prior to study drug administration]; 7. Subject has used idebenone within 4 weeks prior to the first dose of study medication; 8. Subject has an allergy or hypersensitivity to the study medication or to any of its constituents; 9. Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the Investigator; 10. Subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair the assessment of study results, in the opinion of the Investigator; 11. Subject is taking any other investigational drug currently or has taken any other investigational drug within 3 months prior to the start of study treatment; or 12. Subject has previously been enrolled in the study. ; PRIMARY OUTCOME: Overall Summary of Adverse Events as Assessed by CTCAE Version 4.03; SECONDARY OUTCOME 1: Serum Pharmacodynamic Biomarkers (Insulin Resistance)- Fasting Glucose[/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 - ADMA-001; BRIEF: RSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being infected with RSV in the upper respiratory tract. ; DRUG USED: Asceniv; DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: ADMA Biologics, Inc.; CRITERIA: Inclusion Criteria: 1. An IEC/IRB approved written informed consent signed and dated by the patient or by parent(s) or a legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors. 2. Documented Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT), Pulmonary/Cardiac Transplant, Pulmonary Transplant or Liver Transplant within the 2 years prior to randomization to the study drug. 3. Male/Female patients age: (Pediatric) ≥2 years and <16 years at the time of informed consent. 4. Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed consent. 5. Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1. 6. Patients must be actively taking at least one immunosuppressive agent. 7. Patients must have a positive RSV RT-PCR at the time of the randomization procedures. 8. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant by adherence to a reliable contraceptive method for the duration of the study. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation or who have been post-menopausal for at least two years, or are considered to be sterile due to recent chemotherapy. 9. Female patients who are not breast-feeding. 10. Patient/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. able to understand and complete diaries and questionnaires), visit schedules or treatment regimen according to the judgment of the Investigator. Exclusion Criteria: 1. Documented RSV lower respiratory tract infection (respiratory assessment score is greater than 1) as determined by the site investigators or research staff. 2. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support 3. Unstable respiratory status so severe that survival is not expected for longer than 6 months. 4. End organ dysfunction resulting in anticipated survival of less than 6 months. 5. Known to be HIV positive. 6. Administration of any RSV specific products, including palivizumab (Synagis®) in the 3 months prior to randomization procedures. 7. Previous, current, or planned administration of an investigational RSV vaccine. 8. Known hypersensitivity to immunoglobulin. 9. Known Immunoglobulin (IgA) deficiency 10. Known renal impairment requiring any form of dialysis (HD, PD, CRRT). 11. Known hemodynamically significant congenital heart disease. 12. Previous poor compliance with visit schedules. 13. Severe medical, neurological or psychiatric disorders or laboratory values which may have an impact on the safety of the patient. 14. Concurrent participation in other investigational drug product studies; any exception must be approved by the ADMA Biologics Medical Director. ; PRIMARY OUTCOME: Circulating RI-001 Titer; SECONDARY OUTCOME 1: Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.[/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 - RLM-MD-02; BRIEF: This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms. ; DRUG USED: Relamorelin; DRUG CLASS: Biologic; INDICATION: Diabetic Gastroparesis; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Diagnosis of Type 1 or Type 2 diabetes mellitus - Meet the per protocol criteria of diabetic gastroparesis - Compliance with diary - Compliance with the per protocol study treatment dosing instructions Exclusion Criteria: - Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube - Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1) - Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity - History of gastrointestinal disorders that may be similar to gastroparesis - Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus ; PRIMARY OUTCOME: Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS); SECONDARY OUTCOME 1: Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 006 (Acne Vulgaris); BRIEF: This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris. ; DRUG USED: Aczone X; DRUG CLASS: Non-NME; INDICATION: Acne; TARGET: Dihydropteroate Synthetase (DHPS) ; THERAPY: Monotherapy; LEAD SPONSOR: Almirall, S.A.; CRITERIA: Inclusion Criteria: - Diagnosis of acne vulgaris - Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study Exclusion Criteria: - Severe cystic acne, acne conglobata, acne fulminans, or secondary acne - Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Ponds®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week - Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks - Use of birth control pills strictly for acne control ; PRIMARY OUTCOME: Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS); SECONDARY OUTCOME 1: Change From Baseline in Total Lesion Counts[/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 - P903-31; BRIEF: This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital. ; DRUG USED: Teflaro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Male or female, 2 months to < 18 years old. - Presence of CABP requiring hospitalization and IV antibacterial therapy Exclusion Criteria: - Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial. - Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone. - Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens. - Non-infectious causes of pulmonary infiltrates. ; PRIMARY OUTCOME: Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization; SECONDARY OUTCOME 1: Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.[/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 - SUPPORT-1; BRIEF: This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored. ; DRUG USED: CMX-2043; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Ischemix, LLC; CRITERIA: Inclusion Criteria: - Subjects who have stable coronary artery disease undergoing elective PCI. - Female subjects not of child-bearing potential. - Absence of ST segment depression >1.0 mm and absence of ST elevation >1.0 mm in any lead on the baseline 12-lead ECG. - subjects with CK-MB and troponin-T levels lower than the upper limit of normal. - Subjects free of acute injuries or illnesses. Exclusion Criteria: - Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease. - Subjects who had had an MI within 14 days prior to the PCI procedure. - Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD). - Subjects with history of TIA/stroke within 90 days or any intracranial bleed. - Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal. - Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements. - Subjects with a history of alcohol or drug abuse. - Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive. - Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct. - Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results. - Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent. ; PRIMARY OUTCOME: Safety as measured by changes in CK-MB; SECONDARY OUTCOME 1: Cardiac biomarkers[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Fludarabine Phosphate; BRIEF: This study will test whether it is possible to introduce new genetic material into a small portion of a tumor and have the product of the new gene not only kill those tumor cells that were infected initially, but also the surrounding tumor cells as well with limited or no harm to the patient. The desired effects of this approach are achieved by focusing potent chemotherapies directly within the tumor itself and, as a result, avoiding injury to the remainder of the body. In this study, we will use two components, the first of which is a virus, known as an adenovirus, that has been crippled (i.e., it cannot make more of itself) and loaded with a bacterial gene called E. coli purine nucleoside phosphorylase (PNP). Adenoviruses are considered to be relatively safe vehicles for gene delivery and are presently being used in numerous human trials and therapies worldwide, including a head and neck cancer therapy approved for use outside the United States. The loaded adenovirus will be used to deliver the PNP gene directly into a tumor in patients. This gene is not expected to have an effect itself. However, the gene produces PNP inside the tumor and this protein will activate the second component of the therapy, a drug called fludarabine phosphate, which is approved by the FDA for certain types of blood-cell cancers, but has not been shown to be effective against most solid tumors. The proposed therapy gives the patient several infusions of fludarabine following the injection of the virus carrying the PNP gene and, as the fludarabine enters the tumor, it will be converted by PNP into a second compound, fluoroadenine. Numerous studies in mice and rats have shown that fluoroadenine is a very potent anti-cancer agent and that it will kill the tumor cells where it is made as well as those in the immediately surrounding area. ; DRUG USED: Gedeptin; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Nucleoside/Nucleotide, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: PNP Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Biopsy confirmed diagnosis of a solid tumor - Failed or exhausted all standard or approved treatment options that would provide substantive palliation - Have at least one measurable primary or metastatic tumor on imaging studies or physical exam whose potential reduction could provide relief of symptoms or benefit - Tumor is accessible for direct intratumoral injection Exclusion Criteria: - Diagnosis of leukemia - Have previously received any gene therapy products or oncolytic viral therapy - Receiving treatment with allopurinol - Received radiation treatment < 4 wks prior to first injection of Ad/PNP - Received chemotherapy < 4 wks prior to first injection of Ad/PNP - Have signs or symptoms of active infection - Receiving chronic systemic corticosteroids or any chronic immunosuppressive medications within 14 days prior to first injection of Ad/PNP. Subjects receiving short courses of corticosteroids are considered eligible. ; PRIMARY OUTCOME: Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment; SECONDARY OUTCOME 1: Treatment Outcome and Percent Change in Tumor Volume[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Levemir; BRIEF: The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes. ; DRUG USED: Bydureon; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive - Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive - Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start Exclusion Criteria: - Have any contraindication for the OAD that they have been using - Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents - Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease) - Have been treated with drugs that promote weight loss, within 3 months of screening - Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors - Have previously completed or withdrawn from this study or any other study investigating exenatide QW - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study ; PRIMARY OUTCOME: Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26); SECONDARY OUTCOME 1: Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (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 III - CompoSIT-R (vs dapagliflozin, mild renal impairment); BRIEF: The purpose of the study is to assess the effect of the addition of sitagliptin to metformin with or without a sulfonylurea compared with the addition of dapagliflozin to metformin with or without a sulfonylurea on hemoglobin A1c (A1C) over 24 weeks of treatment as well as the overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin after 24 weeks of treatment. The primary hypothesis is that the change from baseline in A1C in participants treated with the addition of sitagliptin is non-inferior compared to that in participants treated with the addition of dapagliflozin after 24 weeks of treatment. ; DRUG USED: Januvia; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria - Have T2DM at Screening visit - Be on metformin monotherapy ≥1500 mg/day alone or in combination with an sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) for ≥8 weeks - Is a male or a female not of reproductive potential (defined as one who is postmenopausal or has had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to Screening visit). If participant is a female of reproductive potential, must agree to remain abstinent from heterosexual activity or agrees to use (or have her partner use) acceptable contraception to prevent pregnancy while receiving blinded study drug and for 14 days after the last dose of blinded study drug Exclusion Criteria: - Has a history of type 1 diabetes mellitus or a history of ketoacidosis - Has a history of secondary causes of diabetes - Has a known hypersensitivity or intolerance to any dipeptidyl peptidase IV (DPP-4) inhibitor or sodium-glucose cotransporter 2 (SGLT2) inhibitor - Has been treated with any anti-hyperglycemic agents (AHA) other than metformin and for participants on dual combination therapy, a sulfonylurea within 12 weeks of screening - Intends to initiate weight loss medication during the study period - Has undergone bariatric surgery within 12 months of Screening visit - Has started a weight loss medication or a medication associated with weight changes within the prior 12 weeks. - Has a history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, heart failure within 3 months of Screening visit - Has a history of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer - Has human immunodeficiency virus (HIV) - Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells, or clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - Has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - Is currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks prior to Screening visit - Is on or likely to require treatment for ≥14 consecutive days or repeated courses of corticosteroids - Is on or likely to require treatment for ≥7 consecutive days with non-steroidal anti-inflammatory drugs - Is pregnant or breast-feeding, or is planning to conceive during the study, including 14 days following the last dose of blinded study drug - Is planning to undergo hormonal therapy in preparation to donate eggs during the study, including 14 days following the last dose of blinded study drug - Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or engages in binge drinking - Has donated blood or blood products within 6 weeks of Screening visit or who plans to donate blood or blood products at any time during the study ; PRIMARY OUTCOME: Change From Baseline in A1C at Week 24; SECONDARY OUTCOME 1: Change From Baseline in Incremental 2-hour (2-hr) Postprandial Glucose Excursion (PPGE) 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 Ib - WT29749; BRIEF: This is a Phase Ib, open-label study of single and repeat doses of obinutuzumab administered as intravenous (IV) infusion in adults with end stage renal disease (ESRD). Participants will be enrolled into two cohorts receiving either one (Cohort 1) or two or more (Cohort 2) obinutuzumab infusions. Both cohorts will receive standard pretreatments to reduce the risk of infusion-related reactions (IRRs). Desensitization Period: In Cohort 1, participants will receive single dose obinutuzumab IV infusion on Day 1. Following review of Cohort 1 aggregated safety data up to 4 weeks post dose for the last participant of Cohort 1, Cohort 2 will be allowed to proceed. In Cohort 2, participants will receive obinutuzumab IV infusion on Days 1 and 15. Transplantation Period: Participants who qualify for transplantation and receive a compatible kidney offer after inclusion in Cohort 1 or Cohort 2 will receive two additional infusions (one at the time of transplantation and second at Week 24 post-transplantation) of obinutuzumab. Assessment of the safety and tolerability of the obinutuzumab regimen will be conducted at Week 24 of the desensitization phase and at Week 28 post-transplantation. All participants will be monitored for a minimum of 12 months following the last obinutuzumab infusion. ; DRUG USED: Gazyva; DRUG CLASS: Biologic; INDICATION: End-Stage Renal Disease (ESRD); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - ESRD with a history of sensitizing events - United network for organ sharing (UNOS) listed for a deceased donor kidney transplantation - Estimated high likelihood of receiving an offer in the coming 12-18 months from screening as evidenced by: present on at least one match run for a deceased donor kidney during the past year, or calculated panel reactive antibody (cPRA) greater than or equal to (≥) 98 percent (based on revisions to allocation policy introduced in 2014) - Female participants of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception during the treatment period and for at least 18 months after the last dose of study drug - Male participants: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 12 months after the last dose of study drug Exclusion Criteria: - Incomplete recovery from recent major surgery or less than (<) 12 weeks since major surgery prior to baseline and participants planned surgery within 24 weeks of baseline except for kidney transplantation - Pregnant or lactating women - Positive serum human chorionic gonadotropin (hCG) measured at screening unless considered not clinically significant based on best medical judgement and if reassessment after ≥48 hours shows a less than a 2-fold rise from previous level - Primary or secondary immunodeficiency disease - Seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or seropositivity for Hepatitis C - History of active or latent tuberculosis (TB) or suspicion of active TB - Known active infection of any kind or any major episode of infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks of baseline or completion of oral anti-infective agents within 2 weeks prior to baseline - Currently active alcohol or drug abuse or history of alcohol or drug abuse - Participants with a history of prior kidney transplantation(s) after 6 participants with prior kidney transplants will be enrolled in the study - Participants on peritoneal dialysis with a history of peritoneal infection at any time during the 12 weeks from prior to screening - Participants on peritoneal dialysis with a positive culture or high cell count numbers on peritoneal fluid indicative of confirmed or suspected infection at the time of screening. - Participants for synchronous organ transplant - Recipients of any live attenuated vaccine(s) within 1 month of the screening visit - Abnormal screening laboratory results - Participants with a history of major cardiovascular or pulmonary disease - Use of investigational agents within 12 weeks or five half-lives of randomization - Use of an anti-CD20 therapy within the past 12 months - Known contraindications to obinutuzumab - History of severe allergic or anaphylactic reactions to monoclonal antibodies or components of obinutuzumab infusion ; PRIMARY OUTCOME: Percentage of Participants with Adverse Events; SECONDARY OUTCOME 1: Maximum Serum Concentration (Cmax) of Obinutuzumab During the Entire Study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MANIFEST-2 (w/Ruxolitinib); BRIEF: A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. ; DRUG USED: Pelabresib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: BET Proteins/Bromodomains; THERAPY: Combination; LEAD SPONSOR: Constellation Pharmaceuticals; CRITERIA: Inclusion Criteria: - Aged ≥ 18 years - Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia) - Adequate hematologic, renal, and hepatic function - Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0 - Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system - Spleen volume of ≥ 450 cm^3 - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: - Splenectomy or splenic irradiation in the previous 6 months - Chronic or active conditions and/or concomitant medication use that would prohibit treatment - Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm ; PRIMARY OUTCOME: Splenic response at Week 24; SECONDARY OUTCOME 1: Total Symptom Score response at Week 24[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DAV-CL002; BRIEF: The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney transplant recipients. ; DRUG USED: ASP8597; DRUG CLASS: Biologic; INDICATION: Kidney Transplant Rejection; TARGET: Phosphatidylserine; THERAPY: Monotherapy; LEAD SPONSOR: Alavita Pharmaceuticals Inc; CRITERIA: Inclusion Criteria: - Scheduled to receive a kidney transplant from a deceased expanded criterion donor (ECD) or a donor cardiac death (DCD) donor that was exposed to no more than 36 hr of cold ischemia prior to transplantation, or scheduled to receive a kidney transplant from a standard criterion donor (SCD) that was exposed to 24-36 hr of cold ischemia prior to transplantation - Willing to use adequate contraception for at least 4 weeks after dosing - Willing and able to provide written Informed Consent and to comply with the requirements of the study Exclusion Criteria: - If female, subject is pregnant or lactating - Known bleeding diathesis - INR at Screening > 1.5 - Platelet count at Screening below LLN and judged clinically significant - Use of Plavix, anticoagulants other than aspirin, antithrombotics, and/or blood-thinning agents within 10 days prior to study entry - Previous receipt of an organ transplant - Will receive concurrent transplant of any additional organ(s) - Clinically significant active infection at study entry - Surgery within 2 weeks prior to study entry - Believed to have used an illicit drug and/or abused alcohol within 3 months prior to study entry - Presence of a psychiatric illness that might interfere with study participation - Cancer, other than basal cell or squamous cell cancer of the skin, within 2 years prior to study entry - Scheduled to receive a kidney transplant from a low risk donor - Currently participation, or participated within 30 days prior to study entry, in an investigational drug study - Known allergy to kanamycin - History or presence of any medical condition or disease that could place the subject an unacceptable risk for study participation ; PRIMARY OUTCOME: Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events; SECONDARY OUTCOME 1: Population pharmacokinetics[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - XCITE; BRIEF: The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy. ; DRUG USED: Xilonix; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: 1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with standard approved regimens including, oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype. 2. Subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2. 4. At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics. 5. Age ≥ 18 years, male or female subjects. 6. Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. 7. Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN. 8. Adequate hepatic function 9. Adequate bone marrow function 10. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening. 11. Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed. 12. Patients enrolled must, in the Investigators judgment, be healthy enough to stay on the clinical trial for three months. Exclusion Criteria: 1. Mechanical obstruction that would prevent adequate oral nutritional intake. 2. Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy. 3. Uncontrolled or significant cardiovascular disease, including: 4. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent. 5. Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1; excluding alopecia and grade 2 neuropathy. 6. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV). 7. Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of hepatitis C RNA. 8. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA). 9. Receipt of a live (attenuated) vaccine within 1 month prior to Screening 10. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition of XILONIX™. 11. Women who are pregnant or breastfeeding. 12. WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication. 13. Weight loss >20% in the previous 6 months. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans[/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 - RE-SONATE (Secondary Prevention); BRIEF: The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA). ; DRUG USED: Pradaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study. 2. Written informed consent Exclusion criteria: 1. Younger then 18 years of age 2. Indication for VKA other than DVT and/or PE 3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued 4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN 5. Creatinine clearance < 30 ml/min 6. Acute bacterial endocarditis 7. Active bleeding or high risk for bleeding. 8. Uncontrolled hypertension (investigators judgement) 9. Intake of another experimental drug within the 30 days prior to randomization into the study 10. Life expectancy <6 months 11. Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding ; PRIMARY OUTCOME: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period; SECONDARY OUTCOME 1: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 3-Part Escalating Doses (Healthy + Elderly); BRIEF: This study will test the safety, tolerability and blood concentrations of single and multiple oral doses of PF-06751979 in health subjects and healthy elderly subjects. PF-06751979 is being developed for the treatment of Alzheimers disease. ; DRUG USED: PF-06751979; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy female subjects of non childbearing potential and male subjects. - Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 (32 kg/m2 for healthy elderly); and a total body weight >50 kg (110 lbs) at Screening. - Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study. - Additional criterion for subjects of Japanese descent who may be enrolled in Part B (multiple ascending dose cohorts in healthy subjects): Japanese subjects who have four Japanese grandparents born in Japan. Exclusion Criteria: - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). - Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product. - Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol. - Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study. - Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Part A: Maximum Observed Plasma Concentration (Cmax) of PF-06751979[/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 - FANCOLEN-II (Spain); BRIEF: This is an open-label Phase II clinical trial to evaluate the efficacy of a hematopoietic cell-based gene therapy for pediatric patients with Fanconi Anemia, subtype A (FA-A). Hematopoietic stem cells from mobilized peripheral blood of patients with FA-A will be transduced ex vivo (outside the body) with a lentiviral vector carrying the FANCA gene. After transduction, the corrected stem cells will be infused intravenously back to the patient with the goal of preventing bone marrow failure. ; DRUG USED: RP-L102; DRUG CLASS: Biologic; INDICATION: Fanconi Anemia; TARGET: Fanconi anemia, complementation group A (FAA, FACA, FANCA); THERAPY: Monotherapy; LEAD SPONSOR: Rocket Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Fanconi anemia as diagnosed by chromosomal fragility assay of cultured lymphocytes in the presence of diepoxybutane (DEB) or similar DNA-crosslinking agent 2. Patient of the complementation group FA-A 3. Minimum age: 1 year and minimum weight of 8 kg. 4. Maximum age: 17 years 5. At least 30 CD34+ cells/µL are determined in one BM aspiration within 3 months prior to the CD34+ cell collection. 6. Provide informed consent in accordance with current legislation 7. Women of childbearing age must have a negative urine pregnancy test at the baseline visit, and accept the use of an effective contraception method during participation in the trial Exclusion Criteria: 1. Patients with an available and medically eligible human leukocyte antigen (HLA)-identical sibling donor 2. Evidence of myelodysplastic syndrome or leukemia, or cytogenetic abnormalities other than those predictive of these conditions in bone marrow (BM) aspirate analysis. This assessment should be made by valid studies conducted within the 3 months before the patient enters the clinical trial 3. Patients with somatic mosaicism associated with stable or improved counts in all PB cell lineages (If T-lymphocyte chromosomal fragility analysis indicates potential mosaicism, a medically significant decrease in at least one blood lineage over time must be documented to enable eligibility) 4. Lansky performance index ≤ 60% 5. Any concomitant disease or condition that, in the opinion of the Principal Investigator, deems the patient unfit to participate in the trial 6. Pre-existing sensory or motor impairment >/= grade 2 according to the criteria of the National Cancer Institute (NCI) 7. Pregnant or breastfeeding women 8. Hepatic dysfunction as defined by either: - Bilirubin > 3 x the upper limit of normal (ULN) - Alanine aminotransferase (ALT ) > 5 x ULN - Aspartate aminotransferase (AST) > 5 x ULN For subjects with bilirubin, ALT, or AST above ULN, a workup to identify the etiology of liver abnormality should be conducted prior to confirmation of eligibility as stipulated in exclusion criterion 5, including evaluation of viral hepatitis, iron overload, drug injury or other causes. 9. Renal dysfunction requiring either hemodialysis or peritoneal dialysis 10. Pulmonary dysfunction as defined by either: - Need for supplemental oxygen during the prior 2 weeks (in absence of acute infection) - Oxygen saturation (by pulse oximetry) <90% 11. Evidence of active metastatic or locoregionally advanced malignancy for which survival is anticipated to be less than 3 years 12. Subject is receiving androgens (i.e. danazol, oxymetholone) 13. Subject is receiving other investigational therapy for treatment/prevention of FA-associated bone marrow failure ; PRIMARY OUTCOME: Phenotypic correction of bone marrow colony forming units after infusion of RP-L102; SECONDARY OUTCOME 1: Phenotypic correction of T-lymphocytes in peripheral blood after infusion of RP-L102[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Study 202; BRIEF: The following study is being conducted to explore the safety and effectiveness of a new chemical entity called NXN-188 in subjects with a history of migraine with aura. In this study subjects will treat two attacks of migraine with aura during the aura phase - once with placebo and once with NXN-188. ; DRUG USED: NXN-188; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Nitric Oxide Synthase, Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Danish Headache Center; CRITERIA: Inclusion Criteria: 1. Male or female migraineurs with aura between 18 and 65 years old, inclusive 2. Meets the following criteria for migraine headache with aura: - Diagnosed with a history of migraine with aura - Aura consisting of at least one of the following, but no muscle weakness or paralysis: - Fully reversible visual symptoms (e.g. flickering lights, spots, lines, loss of vision) - Fully reversible sensory symptoms (e.g. pins and needles, numbness) - Fully reversible dysphasia (speech disturbance) - Aura has at least two of the following characteristics: - Visual symptoms affecting just one side of the field of vision and/or sensory symptoms affecting just one side of the body - At least one aura symptom develops gradually over more than 5 minutes and/or different aura symptoms occur one after the other over more than 5 minutes - Each symptom lasts from 5-60 minutes 3. At least one migraine headache with aura every 8-weeks and resulting in moderate to severe pain (on a 4-point categorical scale) within 2 hours of the onset of aura. 4. Migraine pain following aura in at least 75% of occurrences 5. The subject has a body mass index (BMI) within the range of 18 to 32 6. The subject is in general good health as determined by the medical history, physical exam, clinical laboratory tests, vital signs [heart rate (HR) and blood pressure (BP; after a 3-minute sitting period)] and ECG • ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within normal limits 7. The subject must be able to speak, read, and understand Danish sufficiently to understand the nature of the study, to provide written informed consent, and complete all study assessments 8. The subject is willing and able to comply with all testing requirements defined in the protocol 9. All females will avoid pregnancy at least 10 days before Visit 1, during the study and up until 3 months after Visit 2 10. Women of childbearing potential must be using a reliable form of contraception. A reliable form of contraception is defined as follows: - sterilisation (via hysterectomy or bilateral tubal ligation) - sterilisation of partner - IUD, - birth control pills on stable dose for at least three months before Visit 1, and one month after visit 2. - Medroxyprogesterone acetate (Depo-Provera) or etonogestrel (implanon) active for at least three months prior to the study and with continued administration at intervals sufficient to maintain contraceptive efficacy throughout the study period and at least one month after visit 2. Males must use condoms as contraception. Exclusion Criteria: 1. Presence of any clinically significant condition that would preclude study participation, as evaluated by the investigator 2. Are pregnant or lactating 3. History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease 4. Receiving any medication that, in the opinion of the Investigator or designee, may pose a risk of compromising tolerance or compliance 5. Are known to or suspected to be currently abusing alcohol or drugs, or have a history (within the past 12 months) of active alcohol or drug abuse 6. Participation in another drug or biologic study within 30 days preceding randomization into this study or during participation in this study 7. Subjects who are unable or unwilling, in the opinion of the Investigator, to comply with all study procedures and cooperate fully with study center staff ; PRIMARY OUTCOME: The severity of headache measured with a 4 point scale (The Headache Severity Score (HSS)); SECONDARY OUTCOME 1: The occurence of any type(s) of adverse events(s)[/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 - AWARD-2 (vs. Insulin Glargine); BRIEF: The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride. ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea) 1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication 2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications - Accept treatment with metformin and glimepiride throughout the study, as per protocol - Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine. - Stable weight for 3 months prior to screening - Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2) - Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug Exclusion Criteria: - Type 1 Diabetes - HbA1c equal to or less than 6.5 at randomization - Chronic insulin use - Taking drugs to promote weight loss by prescription or over the counter - Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled - History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening - Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility - Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit - Acute or chronic pancreatitis of any form - Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min) - History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer - A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening - Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis - History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years - Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing - Organ transplant except cornea - Have enrolled in another clinical trial within the last 30 days - Have previously signed an informed consent or participated in a LY2189265 study - Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening ; PRIMARY OUTCOME: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c); SECONDARY OUTCOME 1: Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I; BRIEF: This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL). ; DRUG USED: Denintuzumab Mafodotin; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 19 (CD19), Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor. - Eastern Cooperative Oncology Group status of 2 or lower - Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma - Measurable disease Exclusion Criteria: - Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD ; PRIMARY OUTCOME: Incidence of adverse events; SECONDARY OUTCOME 1: Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)[/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 - GALS; BRIEF: GM604 is an endogenous human embryonic stage neural regulatory and signaling peptide that controls the development, monitoring and correction of the human nervous system. Neurological diseases are multisystem, multifactorial, and single target drugs are ineffective. Genervons Master Regulators play a significant role in embryonic/fetal nervous system development and are potent disease modification drug candidates modulating many pathways including inflammation, apoptotic, and hypoxia. The study drug is an regulatory peptide with a sequence identical to one of the active sites of human Motoneuronotrophic Factor and is manufactured by solid phase synthesis. Pre-clinical research indicates it to be a neuro-protective agent in animal models of ALS, motorneuron diseases, PD, other neuro-degenerative diseases and stroke. GM604 controls and modulates over many known and significant ALS genes with positive effects interactively and dynamically through multiple pathways, and up to twenty-two biological processes, including neuro-protection, neurogenesis, neural development, neuronal signaling, neural transport, and other processes. GM6 is not a cocktail of drugs, but one master regulator peptide drug that functions through multiple pathways. Genervon hypothesized that studying the biomarkers of protein expressions of these ALS genes such as superoxide dismutase 1 (SOD1) and the protein expression of substances such as tau, neurofilament - heavy (NF-H), Cystatin C which were indications of degeneration of neuron in the CSF collected from ALS patients will provide information of the possible GM604s mechanisms of action in treating ALS. 1. This pilot trial is designed to test proof of principle, i.e. determine if a 2-week IV bolus treatment with this agent can (1) change ALS protein expression (target biomarkers and efficacy biomarkers) after treatment (2) have preliminary effects measures of ALS disease clinical progression. Study Objectives are: 1. To test the safety and tolerability of GM604 in a population of ALS patients. 2. To test for changes in ALS biomarkers before and after treatment. 3. To determine preliminary effects of injections of GM604 on measures of ALS disease biomarkers and clinical progression ; DRUG USED: GM604; DRUG CLASS: Biologic; INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Genervon Biopharmaceuticals, LLC; CRITERIA: Inclusion Criteria: 1. Patients with ALS: Familial and Sporadic ALS, with symptom onset < or equal to 24 months. 2. At least 18 years of age 3. Subjects meet the El Escorial criteria of definite criteria for a diagnosis of ALS. 4. Subjects can be on a stable dose of riluzole for at least a month or not taking or initiating riluzole for the duration of the trial. 5. Not on any experimental medication for the last 1 month or five times the half-life of experimental medication. 6. At screening, must have a Forced Vital Capacity (FVC) ≥ 65% of predicted capacity for age, height and gender. 7. Have fully completed informed consent form 8. Ability to comply with study procedures 9. Women of child-bearing age must be on birth control. Pregnancy test should be done in women in child bearing age. 10. Medically safe to have lumbar puncture to collect CSF Exclusion Criteria: 1. History of liver disease, severe renal failure, diabetes, coronary heart disease, cancer 2. Clinically significant EKG abnormality at screening 3. Any comorbid condition which would make completion of the trial unlikely 4. FVC < 65% 5. Presence of a bleeding disorder 6. Allergy to local anesthetics 7. Problem with CSF pressure 8. Topical or other skin infection at the lumbar puncture site 9. BMI > 32 kg/m2 10. Medical or surgical conditions in which a lumbar puncture is contraindicated 11. Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin - ; PRIMARY OUTCOME: Efficacy by percent change in biomarker in th CSF at week 12 from baseline; SECONDARY OUTCOME 1: ALSFRS-R (Amyotrophic Laeral Sclerosis Functional Rating Scale - Revised)[/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 - Uncontrolled BP; BRIEF: This study evaluated the effect of ISIS 757456 (IONIS-AGT-LRx) on plasma angiotensinogen (AGT) and systolic blood pressure (SBP) in uncontrolled hypertensive participants who were on two to three antihypertensive medications. ; DRUG USED: IONIS-AGT-LRx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: Angiotensins (I-IV); THERAPY: Monotherapy; LEAD SPONSOR: Ionis Pharmaceuticals, Inc.; CRITERIA: Inclusion criteria: - Males or females aged 18-75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent - Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal - Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), the participant or participants non-pregnant female partner must be using a highly effective contraceptive method - Body mass index (BMI) ≤ 35.0 kg/square meter (m^2) - Participant must have been diagnosed with essential hypertension for a minimum of 3 months prior to screening - At screening, the participant must have been on a stable regimen of 2 to 3 antihypertensive medications for at least 1 month prior to screening and will be required to maintain this regimen throughout the study, using either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), as well as 1 or 2 additional antihypertensive medications in the following categories: beta blocker, acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, pindolol, calcium channel blocker or, non-potassium sparing diuretic Exclusion Criteria: - Clinically significant abnormalities in medical history, screening laboratory results, or physical examination that would render the participant unsuitable for inclusion - History of secondary hypertension (HTN) The use of the following at time of screening and during the course of the study: - Other medications for the treatment of HTN (e.g., clonidine, guanfacine, guanabenz, alpha-methyldopa, hydralazine, minoxidil, diazoxide, renin inhibitors) - Medications that may cause hyperkalemia (e.g., cyclosporine or tacrolimus, pentamidine, trimethoprim-sulfamethoxazole, all heparins) - Oral or SC anticoagulants (e.g., warfarin, rivaroxaban, apixaban, heparin, lovenox) - Organic nitrate preparations (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, or pentaerythritol) - Phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - Potassium-sparing diuretics (e.g., eplerenone, spironolactone, amiloride, triamterene) Unstable/underlying cardiovascular disease defined as: - Any history of congestive heart failure (New York Heart Association [NYHA] class II-IV) - Any history of previous stroke, transient ischemic attack, unstable or stable angina pectoris, or myocardial infarction prior to screening - 12-lead electrocardiogram (ECG) corrected using Fridericias formula (QTcF) > 450 milliseconds (msec) in males and > 470 msec in females at screening, or a history or evidence of long QT syndrome - Any clinically significant active atrial or ventricular arrhythmias - Any history of coronary bypass or percutaneous coronary intervention ; PRIMARY OUTCOME: Percent Change From Baseline in Plasma Angiotensinogen (AGT) at Day 57 Compared to Placebo; SECONDARY OUTCOME 1: Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Nivolumab; BRIEF: The main purpose of this research study is to determine the maximum tolerable dose (MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy treatment without evidence of disease progression. ; DRUG USED: SX-682; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: Chemokine (C-X-C motif) Receptor 1 (CXCR1) / IL8R , Chemokine (C-X-C motif) Receptor 2 (CXCR2) / IL-8 receptor, Chemokine Receptor; THERAPY: Combination; LEAD SPONSOR: University of Rochester; CRITERIA: Inclusion Criteria: 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, study biopsies and other requirements of the study. 3. Subjects (or an acceptable proxy) must provide a signed and dated IRB/IEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines for both the study and exploratory biomarker analysis obtained via paired biopsies. 4. Subjects (or an acceptable proxy) must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization. 5. The ICF and HIPAA authorization must be obtained before conduction and 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: Study Population/Inclusion Criteria 1. Male or female subjects, aged at least 18 years 2. Have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma 3. Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5. Must have measurable disease with at least 1 unidimensional measurable lesion per iRECIST 6. Screening laboratory values within 14 days prior to first dose of study drug: WBC ≥ 3000/µL Neutrophils ≥ 1500/µL Platelets ≥ 100,000>µL Hemoglobin ≥ 9.0 g/dL in the absence of blood transfusion Creatinine ≤ 1.5 mg/dL AST/ALT ≤ 2.5 x ULN for subjects with no liver metastases - 5 x ULN for subjects with liver metastases Bilirubin ≤ 1.5 mg/dL sa≤ 3.0 mg/dL for subjects with Gilberts disease INR or PT ≤ 1.5 x ULN unless receiving anticoagulation therapy aPTT or PTT ≤ 1.5 x ULN unless receiving anticoagulation therapy 7. Life expectancy of ≥ 12 weeks as judged by the treating physician. 8. Patient must consent for baseline and on treatment biopsies 9. Patients must have baseline pulse oximetry ≥ 90% on room air Exclusion Criteria: Target Disease Exceptions: Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI- except where contraindicated, in which case a CT scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. 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 dry administration. Medical History and Concurrent Disease 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. 4. Clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (< 6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >II) or serious cardiac arrhythmia. 5. 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. 6. 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. 7. Subjects with a condition (including organ or bone marrow transplant) requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 8. Use of other investigational drugs (drugs not marketed for any indication) or medications at immunosuppressive doses within 28 days before study drug administration. 9. Patients who received immunotherapy or investigational drug within 4 weeks prior to enrollment. 10. Patients who underwent major surgery within 4 weeks of enrollment (not including diagnostic laparoscopy) 11. History of myelodysplastic syndromes or myeloproliferative neoplasms. 12. History of or medication induced prolonged QT interval. 13. Any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study or provide supportive care. Use of marijuana and its derivatives for treatment of symptoms related to cancer treatment, even if obtained by medical prescription or if its use (even without a medical prescription) has been legalized locally. Physical and Laboratory Test Findings 1. A history of Hepatitis B or C, either acute or chronic, as indicated by HBV surface antigen positivity, HBV core antibody positivity, or positive HCV antibody with reflex to positive HCV RNA. 2. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 3. Active tuberculosis (history of exposure or history of positive tuberculosis test plus presence of clinical symptoms, physical or radiographic findings). 4. EKG demonstrating a QTc interval >470 msec or patients with congenital long QT syndrome. Allergies and Adverse Drug Reaction 1. History of allergy to study drug components (examples: hydroxpropylmethylcellulose phthalate (hypromellose phthalate or HPMCP), microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, and silicon dioxide). 2. History of severe hypersensitivity reaction to any monoclonal antibody (Grade ≥ 3 NCI-CTCAE v5). 3. History of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma. Sex and Reproductive Status/Special Populations 1. Women of childbearing potential (WOCBP) must use method(s) of contraception with a failure rate of less than 1% while on study and for 5 months after the last dose of SX-682 or nivolumab. 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. 2. 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. 3. 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. 4. Women must not be breastfeeding. 5. 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 7 months after the last dose of study drug. 6. Women who are not of childbearing potential and azoospermic men do not require contraception. 7. Individuals who are incarcerated, compulsory detained or otherwise considered a vulnerable population ; PRIMARY OUTCOME: Maximum tolerable dose [Safety and Tolerability]; 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 II - Pro00062677; BRIEF: To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis ; DRUG USED: JKB-121; DRUG CLASS: Non-NME; INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Toll-like receptor 4 (TLR4); THERAPY: Monotherapy; LEAD SPONSOR: Manal Abdelmalek; CRITERIA: Inclusion Criteria: 1. Age ≥ 18 years 2. Provision of written informed consent 3. Biopsy-proven NASH within 12 months or at screening 4. ALT > 40 U/L for women and > 60 U/L for men at screening and at least once in the previous 12 months. 5. HBA1C of ≤ 9.0 Exclusion Criteria: 1. Any chronic liver disease other than NASH 2. Cirrhosis, as assessed clinically or histologically 3. Presence of vascular liver disease 4. BMI ≤ 25 kg/m2 5. Excessive alcohol use (> 20 g/day) within the past 2 years 6. AST or ALT > 250 U/L. 7. Type 1 diabetes mellitus 8. Bariatric surgery in the past 5 years. 9. Weight gain of > 5% in past 6 months or > 10% change in past 12 months. 10. Contraindication to MRI 11. Inadequate venous access 12. HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or Hepatitis C virus (HCV) RNA positive. 13. Receiving an elemental diet or parenteral nutrition 14. Chronic pancreatitis or pancreatic insufficiency 15. Any history of complications of cirrhosis 16. Concurrent conditions: - Inflammatory bowel disease - Significant cardiac disease - chronic infection or immune mediated disease - Any malignant disease - Prior solid organ transplant - Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or the interpretation of the study data. 17. Concurrent medications which may treat NASH 18. HbA1C > 9.0% 19. Pregnancy or breastfeeding. ; PRIMARY OUTCOME: Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population); SECONDARY OUTCOME 1: Analysis of ALT Change From Baseline to Week 24 (Per Protocol 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 - CARRIE; BRIEF: The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1. ; DRUG USED: Istiratumab; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: ErbB3/HER3, IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Combination; LEAD SPONSOR: Merrimack Pharmaceuticals; CRITERIA: Inclusion Criteria: - Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not eligible. - Patient must have received no prior radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. - Blood sample sent for free IGF-1 testing - ECOG performance status (PS) of 0 or 1 Exclusion Criteria: - Patients who only present with localized disease - Patients with CNS malignancies (primary or metastatic) - Clinically significant cardiac disease ; 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 I/IIa - STARTRK-1; BRIEF: Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or more of these targets are present in several different tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer with a detectable molecular alteration in targets of interest may be eligible for enrollment. Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study. ; DRUG USED: Rozlytrek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Anaplastic lymphoma kinase (ALK), ROS kinase, Trk (Tropomyosin Receptor Kinase) Receptors, Tyrosine Kinases; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Key Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a NTRK1, NTRK2, NTRK3, ROS1, or ALK molecular alteration. - Measurable disease according to RECIST version 1.1. - Prior cancer therapy is allowed, including crizotinib, ceritinib, and investigational drugs. - Prior radiotherapy is allowed - Patients with controlled asymptomatic central nervous system involvement are allowed. - Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. - Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2. - Adult patients age 18 years or older. - Life expectancy of at least 3 months. Key Exclusion Criteria: - Current participation in another therapeutic clinical trial. - Prior treatment with entrectinib. - History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds). - History of additional risk factors for torsade de pointes (e.g., family history of long QT syndrome). - Known active infections (bacterial, fungal, viral including HIV positivity). - Gastrointestinal disease (e.g., Crohns disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption. - Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis. - Peripheral neuropathy ≥ Grade 2. ; PRIMARY OUTCOME: Dose-Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Plasma Concentrations of Entrectinib[/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 202-00; BRIEF: The purpose of the clinical study is to evaluate the safety and bacterial impact of study drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental subjects. ; DRUG USED: C16G2; DRUG CLASS: New Molecular Entity (NME); INDICATION: Periodontitis; TARGET: Streptococcus mutans; THERAPY: Monotherapy; LEAD SPONSOR: Armata Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Adolescent Safety Only Cohort: Males and females, 12-17 years of age, inclusive, at the time the Assent and Informed Consent Form is signed. Study Arms 1 & 2: Males and females, 12-75 years of age, inclusive, at the time the Assent and/or Informed Consent Form is signed 2. Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit 3. Male subjects only: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination 4. Healthy, as determined by the Investigator, based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening 5. Have a minimum of six unrestored bicuspids and molars with ≤50% of molars and bicuspids having restorations, crowns, sealants or are missing 6. Demonstrated ability to expectorate ≥2mL of stimulated saliva in 5 minutes 7. Have a salivary S. mutans of 1.0 x 10e5 CFUs/mL or greater at Screening using MSB agar plating 8. Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study 9. Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit 10. Willing and able to comply with oral hygiene and diet instructions 11. Has dentition adequate for custom dental tray gel application 12. Able to understand and sign the Assent and/or Informed Consent Form prior to initiation of study procedures 13. Able to communicate with the Investigator/study center personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times Exclusion Criteria: 1. Advanced periodontal disease 2. Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs); Note: Subjects presenting with insipient, non-cavitated lesion(s) are not excluded 3. Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures 4. Pathologic lesions of the oral cavity 5. Full or partial dentures, or orthodontic appliances, e.g., night guards, permanent retainers 6. Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the Investigator could influence the study outcome, within 30 days prior to Screening 7. Medical history indicating the woman is pregnant, breastfeeding/ lactating or has a positive urine pregnancy test 8. Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration 9. Prior participation in a C16G2 clinical trial and known to have received C16G2 active gel or mouth rinse 10. Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function, interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results ; PRIMARY OUTCOME: Safety of multiple C16G2 Gel administrations as measured by adverse events; SECONDARY OUTCOME 1: Targeted antimicrobial activity of C16G2 Gel applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque[/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 - BP-005; BRIEF: This is an open-label, non-randomized study to evaluate the safety of two planned infusions of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with hematologic malignancies. ; DRUG USED: Rivo-cel; DRUG CLASS: Biologic; INDICATION: Bone Marrow and Stem Cell Transplant - Graft vs. Host Disease (GVHD) Prophylaxis; TARGET: Caspases, Stem Cells/Other Cell Therapies, T-Cell Receptor (TCR); THERAPY: Combination; LEAD SPONSOR: Bellicum Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Signed informed consent 2. Patients with one of the life-threatening hematological malignancies: - Acute lymphocytic leukemia (ALL) in CR1 with high-risk features including adverse cytogenetics such as t(9;22), t(1;19), t(4;11), or MLL gene rearrangements; greater than 1 cycle to achiever remission or with persistent MRD; ALL in second or greater remission with or without MRD. Acute myeloid leukemia (AML) in CR1 with high-risk features defined as: Greater than 1 cycle of induction therapy required to achieve remission; Preceding myelodysplastic syndrome (MDS) or myeloproliferative disease; Presence of FLT3 mutations or internal tandem duplications; FAB M6 or M7 classification; Adverse cytogenetics, -5, del 5q, -7, del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8 [> 3 abnormalities]; - AML in second or greater remission, primary induction failure and patients with relapsed disease; - Advanced chronic myeloid leukemia (CML) who have progressed to blast phase or accelerated phase and are in need of a transplant and do not have an HLA matched donor; - MDS with IPSS intermediate-2 or higher or therapy-related MDS.Hodgkin lymphoma or Non-Hodgkin lymphoma (NHL): relapsed disease where remission duration is less than 1 year, relapse after previous autologous transplant, or failure to achieve CR with chemotherapy. 3. Age ≥ 18 years and ≤ 65 years 4. Deemed eligible for allogeneic stem cell transplantation 5. Lack of suitable conventional donor (i.e. 8/8 related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor 6. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, and DRBl loci - A minimum genotypic identical haplotype match of 4/8 is required - The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1 7. Subjects with adequate organs function as measured by: - Cardiac: Left ventricular ejection fraction at rest must be >45% - Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin); or O2 saturation > 92% on room air - Hepatic: Direct bilirubin ≤ 3 x upper limit of normal (ULN), or AST/ALT ≤ 5 x ULN - Renal: Serum creatinine within normal range for age or creatinine clearance, or with a recommended GFR ≥ 50 mL/min/1.73m2 8. Performance status: Karnofsky ≥ 80% Exclusion Criteria: 1. HLA 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) related or unrelated donor able to donate; 2. Autologous hematopoietic stem cell transplant ≤ 3 months prior to enrollment; 3. Prior allogeneic transplantation; 4. Active CNS involvement by malignant cells (less than 2 months from the conditioning); 5. Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings); the PI is the final arbiter of this criterion; 6. Positive HIV serology or viral RNA (≥ Grade III per CTCAE criteria); 7. Pregnancy (positive serum or urine βHCG test) or breast-feeding; 8. Fertile men or women unwilling to use effective forms of birth control or abstinence for a year after transplantation; 9. Bovine product allergy. 10. Severe obesity (patients weight is >/= 1.5x the donor weight). ; PRIMARY OUTCOME: Adverse events; SECONDARY OUTCOME 1: Adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MM-011 - w/Dex (Japan); BRIEF: The purpose of this study is to evaluate the efficacy and safety of pomalidomide in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma. ; DRUG USED: Pomalyst; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: Celgene Corporation; CRITERIA: Inclusion Criteria: - 1. Must be ≥ 20 years of age at the time of signing the informed consent document. 2. The subject must understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted. 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease. Subjects must have received at least 2 prior therapies. Subjects must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed progressive disease(PD). Subjects must also have documented evidence of progressive disease(PD) during or within 60 days (measured from the end of the last cycle) of completing treatment with the last antimyeloma drug regimen used just prior to study entry (refractory disease). 5. Subjects must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen). 6. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours). 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. 8.Must agree to comply to pomalidomide Pregnancy Prevention Risk Management Plan. Exclusion Criteria: - 1. Pregnant or breastfeeding females 2. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone 3. ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy 4. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this study 5. Any of the following laboratory abnormalities: - Absolute neutrophil count < 1,000/µL - Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/µL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells - Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula Cockcroft-Gault estimation of Creatinine Clearance: - Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L) - Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior Red blood cell transfusion or recombinant human erythropoietin use is permitted) - Serum glutamic oxaloacetic transaminase(SGOT)/aspartate aminitransferase(AST) or serum glutamic pyruvic transaminase(SGPT)/alanine aminotransferase(ALT) > 3.0 x upper limit of normal(ULN) - Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or ≥ 3.0 x upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinemia. 6. Subjects with any one of the following: - Congestive heart failure (New York Heart Association Class III or IV) - Myocardial infarction within 12 months prior to starting study treatment - Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris 7. Peripheral neuropathy ≥ Grade 2. 8. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 5 years. Exceptions include the following: - Basal or Squamous cell carcinoma of the skin - Carcinoma in situ of the cervix or breast - Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b) 9. Known infection with human immunodeficiency virus (HIV) antibody positive, hepatitis B virus surface antigen (HBsAg) positive or hepatitis C virus antibody (HCVAb) positive. If negative for hepatitis B virus surface antigen (HBsAg) but hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) positive status, a hepatitis B virus DNA test will be performed and if positive the subject will be excluded. 10. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide. 11. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 12. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 13. Any condition that confounds the ability to interpret data from the study. 14. Previous therapy with pomalidomide. 15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment. 16. Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis, and lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment. Includes subjects receiving corticosteroids (> 10 mg/day of prednisone or equivalent) within 3 weeks prior to enrollment. 17. Subjects who received any of the following within the last 14 days of initiation of study treatment: - Plasmapheresis - Major surgery (kyphoplasty is not considered major surgery) - Radiation therapy - Use of any antimyeloma drug therapy. 18. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment. 19. Subjects who are planning for or who are eligible for stem cell transplant. ; PRIMARY OUTCOME: Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria; SECONDARY OUTCOME 1: Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) 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 II - Africa; BRIEF: SQ109 was developed with the aim of shortening TB treatment and providing new drugs for resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable safety profile in first-in-man studies. The objective of this study is to evaluate the extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB. ; DRUG USED: SQ109; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tuberculosis; TARGET: Cell wall synthesis, mycobacterial membrane protein, large-3 (MmpL3); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Michael Hoelscher; CRITERIA: Inclusion Criteria: 1. Provide signed written informed consent for study participation, including HIV testing (if HIV serostatus is not known or the last documented negative is more than four weeks prior to enrolment). 2. Be eighteen (18) to 64 (inclusive) years of age. 3. Have a body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive. 4. Have newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB. 5. Have a chest X-ray which, in the opinion of the Investigator, is compatible with TB. 6. Is sputum positive on direct microscopy for acid-fast bacilli (at least 1+ on the IUATLD/WHO scale (Appendix 3). 7. Is able to produce an adequate spot sputum sample, indicating an overnight sputum volume of at least 10 mL. 8. Female patients of childbearing potential must have a negative serum pregnancy test, and consent to practice two effective methods of birth control when not abstaining from sexual intercourse, unless she and her partner(s) are surgically sterile or she is post-menopausal with no menses for the last 12 months. Preferably, contraceptive measures should be continued until completion of TB treatment, but at least until one month after last dose of IMP, unless she and her partner(s) are sterile (that is, women who have had a bilateral oophorectomy or hysterectomy or have been postmenopausal for at least 12 consecutive months). Two of the following methods may be used, but only one may be hormonal: tubal ligation, vaginal diaphragm, intrauterine device, condom, oral contraceptives, contraceptive implant, combined hormonal patch, combined injectable contraceptive or depot-medroxyprogesterone acetate, partner(s) has had a vasectomy. 9. Male participants must agree to use an adequate method of contraception when not abstaining from sexual intercourse throughout participation in the trial and for 12 weeks after last dose, unless he has had bilateral orchidectomy. 10. A Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs, see Appendix 5) Exclusion Criteria: 1. Poor general condition where any delay in treatment cannot be tolerated per discretion of Investigator. 2. Treatment with any drug active against MTB within the 3 months prior to Visit 1 (this includes, but is not limited to INH, EMB, RIF, PZA, amikacin, cycloserine, rifabutin, streptomycin, kanamycin, para-aminosalicylic acid, rifapentine, thioacetazone, capreomycin, fluoroquinolone, thioamides, metronidazole). 3. Sputum isolate is resistant to RIF as detected by rapid assay from native sputum 4. A history of allergy to the IMP or related substances. 5. Clinically significant evidence of extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the investigator. 6. A history of previous TB. 7. Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease. 8. Laboratory parameters done at, or within 14 days prior to, screening: - Serum amino aspartate transferase (AST) and/or serum alanine aminotransferase (ALT) activity >3 times the upper limit of normal - Serum total bilirubin level >2.5 times the upper limit of normal - Serum creatinine level >2 times the upper limit of normal - Complete blood count with hemoglobin level <7.0 g/dL - Platelet count <50,000/mm3 - Serum potassium <3.5 meq/L 9. History, presence, or evidence of a neuropathy or epilepsy. 10. Clinically relevant change s in the ECG such as atrioventricular (AV) block, prolongation of the QRS complex over 120 milliseconds, or of either the QTcF or QTcB interval over 450 milliseconds on the screening ECG. 11. A history of, or current clinically relevant cardiovascular disorder such as myocardial infarction, heart failure, coronary heart disease, hypertension, arrhythmia, or tachyarrhythmia. Family history of sudden death of unknown or cardiac-related cause, or of prolonged QTc interval. Concomitant use of any drug known to prolong QTc interval (including amiodarone, bepridil chloroquine, chlorpromazine, cisapride, cisapride, clarithromycin, disopyramide dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, lumefantrine, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine). 12. Diabetics using insulin. 13. Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied). 14. Any disease or condition in which the use of the standard TB drugs or any of their components is contraindicated, including but not limited to allergy to any TB drug, their components or to the IMPs. 15. Any disease or condition in which any of the medicinal products listed in the section pertaining to prohibited medication (see 4.10.4) is used. 16. Known or suspected, current or history of within the past 2 years, alcohol or drug abuse, that is, in the opinion of the investigator, sufficient to compromise the safety or cooperation of the patient. Opiates prescribed for cough relief are not counted as drug abuse. 17. Prior administration of SQ109. 18. Is pregnant, breast-feeding, or planning to conceive or father a child within one month of cessation of treatment. 19. Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes (including xenobiotics, quinidine, tyramine, ketoconazole, testosterone, quinine, gestodene, metyrapone, phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine, furafylline, cimetidine, dextromethorphan). Exceptions may be made for subjects that have received 3 days or less of one of these drugs or substances, if there has been a wash-out period equivalent to at least 5 half-lives of that drug or substance. 20. Use of any therapeutic agents within 30 days prior to dosing known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine). 21. Use of systemic glucocorticoids within three months prior to dosing. 22. HIV infection with helper/inducer T lymphocyte (CD4 cell) count of 250 10-6/L. 23. Receiving antiretroviral therapy (ART). ; PRIMARY OUTCOME: The extended early bactericidal activity (EBA)of daily 75 mg, 150 mg, and 300 mg SQ109, and of daily 150 mg or 300 mg SQ109 with daily RIF standard dose in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB.; SECONDARY OUTCOME 1: The standard EBA (EBA 0-2) of each treatment group, as determined by the rate of change of log Colony Forming Units (logCFU) in sputum over the period Day 0-2 (linear, bi-linear or non-linear regression of logCFU over time).[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - T790M; BRIEF: Phase 1 - open label, multi-center, non-randomized, safety, pharmacokinetic and pharmacodynamics dose escalation study of PF-06459988 as a single agent in patients with advance EGFRm NSCLC (del 19, L858R, +/- T790M). The resulting PF-06459988 dose selected from the phase 1 portion will undergo a series of sub-studies to fully characterize the impact of food, antacid and CYP3A4 inhibitors/inducers. The PK studies are in addition to the MTD expansion and will be completed prior to the initiation of Phase 2. Phase 2 is an open label, multi-center single-arm study of PF-06459988 for the assessment of antitumor activity in patients with advanced EGFRm (del 19 or L858R) NSCLC with T790M. ; DRUG USED: PF-06459988; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Evidence of histological or cytologically confirmed diagnosis of locally advanced or metastatic EGFRm (del19 or L858R) NSCLC that is resistant to standard therapy. Patients must have progressed on treatment with an EGFR TKI, and may have also received other line of therapy. - Tissue available (formalin fixed paraffin embedded (FFPE) block or 10 unstained sections (5 micron) - Patients must be willing to participate in additional PK studies as required (cohort dependent); patients will be informed of which PK studies are required prior to consenting for study participation - Adequate Bone Marrow Function (Complete Blood Count laboratory test results) - Adequate Liver Function (Laboratory test) Exclusion Criteria: - Previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to the study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks and are neurologically stable - Systemic anti-cancer therapy within 4 weeks of starting study treatment excluding EGFR TKIs. Patients on EGFR TKIs must discontinue the agent for a minimum of 5 days prior to starting study drug - Hypertension that cannot be controlled by medication (150/100 mmHg despite optimal medical therapy). ; PRIMARY OUTCOME: Number of participants with Dose-limiting toxicities (DLT) (phase 1); SECONDARY OUTCOME 1: Number of Participants With Objective Response for those patients with measurable disease (phase 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 - C27002; BRIEF: The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (<50 ng/dL). ; DRUG USED: Orgovyx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria Each participant must meet all of the following inclusion criteria to be enrolled in the study: 1. Male participant 18 years or older. 2. Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. 3. Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer with 1 of the following clinical disease states: 1) advanced localized disease not suitable for primary therapy, 2) evidence of prostate-specific antigen (PSA) biochemical or clinical relapse following primary surgery or radiation therapy of curative intent, or 3) newly diagnosed metastatic disease that is asymptomatic or not threatening to vital organs. 4. Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol. 5. A body mass index (BMI) ≥ 18.0 at screening and/or baseline. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and/or baseline. 7. Male participants, even if surgically sterilized, who agree to practice effective barrier contraception or agree to practice true abstinence. 8. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. 9. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and pharmacodynamic (PD) Sampling. Exclusion Criteria Participants meeting any of the following exclusion criteria are not to be enrolled in the study: 1. In participants with advanced, localized M0N1 or M1 disease, the presence of clinically significant symptoms or threat to vital organs requiring immediate gonadotropin-releasing hormone (GnRH) /combined or complete androgen blockade (CAB) therapy, chemotherapy, or radiotherapy. 2. Previously received androgen deprivation therapy (ADT) for more than 8 months total duration (if ADT was received for 8 months or less, then that ADT must have been completed at least 2 years prior to screening). 3. Visceral metastases (liver or lung). 4. Features of the participants medical condition that may make ADT unnecessary or not indicated. 5. Scheduled for additional surgical or (salvage) radiation therapy within 6 months after baseline evaluations. 6. History of surgical castration. 7. Diagnosis of or treatment for another malignancy within the 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 8. Abnormal screening and/or baseline laboratory values as specified in the protocol. 9. History of any significant cardiac condition within 6 months before receiving the first dose of study drug. 10. Electrocardiogram (ECG) abnormalities as specified in the protocol 11. Congenital long QT syndrome. 12. Current use of Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. 13. Uncontrolled hypertension despite appropriate medical therapy. Participants may be re-screened after referral and further management of hypertension. 14. Known, previously diagnosed human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to prostate cancer, or any serious medical or psychiatric illness that could, in the investigators opinion, potentially interfere with participation in this study. Specific screening for chronic viral illness is at the discretion of the site and/or local institutional review board (IRB). 15. Treatment with any investigational products within 3 months before the first dose of study drug. 16. A primary family member (spouse, parent, child, or sibling of the participant) is involved in the conduct of the study or is a study site employee. 17. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-385, including difficulty swallowing tablets. 18. Use of any medication, or food products listed in the excluded medications and dietary products table within 2 weeks before the first dose of study drug. Participant must have no history of amiodarone use in the 6 months before the first dose of TAK-385. 19. Admission or evidence of alcohol or drug abuse or use of illicit drugs. ; PRIMARY OUTCOME: Percentage of Participants With Effective Castration Rate Over 24 Weeks; SECONDARY OUTCOME 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs[/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 - Intermittent Claudication; BRIEF: NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 taken twice a day (BID) for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication. ; DRUG USED: NT-702; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral Arterial Disease (PAD); TARGET: Phosphodiesterase 3 (PDE3), Thromboxane Synthase ; THERAPY: Monotherapy; LEAD SPONSOR: Nissan Chemical Industries; CRITERIA: Inclusion Criteria: - Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities - Median treadmill peak walking time between 90 and 600 seconds Exclusion Criteria: - Symptoms of limb threatening ischemia (ischemic rest pain, ischemic ulceration and/or gangrene) - Clinically significant pulmonary, neurological or skeletal dysfunction (e.g., lumbar canal stenosis, emphysema, uncontrolled angina, multiple sclerosis, or gait altering amputation) that would directly interfere or limit exercise testing - Subjects who have had, or will require, a peripheral revascularization procedure within 12 weeks prior to or following treatment initiation. - A resting blood pressure greater than 150/100 and other clinically significant results. ; PRIMARY OUTCOME: Improvement in peak walking time at 24 weeks; SECONDARY OUTCOME 1: Improvement in claudication onset time at 24 weeks[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 202; BRIEF: The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis. ; DRUG USED: INCB47986; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Men or women aged 18 to 75 years, inclusive. - Body mass index between 18 and 40 kg/m^2, inclusive. - Subjects must have a diagnosis of rheumatoid arthritis (RA) of at least 6 months duration at the time of screening and must satisfy the ACR/European League Against Rheumatism (EULAR) 2010 Classification Criteria (Appendix B). - Subjects must have active moderate to severe RA as determined by the following: - ≥ 6 tender joints (28 joint count), - ≥ 4 swollen joints (28 joint count), and - CRP level ≥ 6 mg/L. - Subjects must have a negative tuberculosis (TB) test (QuantiFERON®-TB Gold test or purified protein derivative (PPD)) at screening. Exclusion Criteria: - Current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease. - Current or recent history (< 30 days before screening and/or < 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection. - Onset of RA before the age of 16 years. - History of known or currently suspected inflammatory disease other than RA - Current regimen of prednisone or equivalent with an average daily dose of > 10 mg or having been treated with a stable daily dose ≤ 10 mg for < 6 weeks. - Previous treatment with at Janus kinase (JAK) inhibitor. - Significant impairment of bone marrow function present at screening - Receipt of any live vaccine within 2 months before screening or anticipated need for a live vaccine within the 2 months after last dose of study drug. ; PRIMARY OUTCOME: Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations; SECONDARY OUTCOME 1: Percentage of subjects achieving ACR20 at each visit assessed.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 101 - LCA2; BRIEF: The purpose of this study is to determine whether gene transfer will be safe and effective in the treatment of Leber Congenital Amaurosis (LCA). ; DRUG USED: Luxturna; DRUG CLASS: Biologic; INDICATION: Lebers Congenital Amaurosis (Ophthalmology) ; TARGET: RPE65 (Retinal pigment epithelium-specific 65 kDa protein); THERAPY: Monotherapy; LEAD SPONSOR: Spark Therapeutics; CRITERIA: Inclusion Criteria: - Male and female subjects of any ethnic group are eligible for participation in this study, providing they meet the following criteria: 1. Must be willing to adhere to protocol and companion protocol for long-term follow-up as evidenced by written informed consent or parental permission and subject assent. 2. Adults and children diagnosed with LCA. 3. Molecular diagnosis of LCA due to RPE65 mutations (homozygotes or compound heterozygotes) by a CLIA-approved laboratory. 4. Age eight years old or older at the time of administration. 5. Visual acuity ≤ 20/160 or visual field less than 20 degrees in the eye to be injected. Exclusion Criteria: SUBJECTS WILL NOT BE EXCLUDED BASED ON THEIR GENDER, RACE OR ETHNICITY. Subjects who meet any of the following conditions are excluded from the clinical study: 1. Unable or unwilling to meet requirements of the study. 2. Participation in a clinical study with an investigational drug in the past six months. 3. Pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints (for example, glaucoma, corneal or lenticular opacities). 4. Lack of sufficient viable retinal cells as determined by non-invasive means, such as optical coherence tomography (OCT) and/or ophthalmoscopy. Specifically, if indirect ophthalmoscopy reveals less than 1 disc area of retina which is not involved by complete retinal degeneration (indicated by geographic atrophy, thinning with tapetal sheen, or confluent intraretinal pigment migration), these eyes will be excluded. In addition, in eyes where optical coherence tomography (OCT) scans of sufficient quality can be obtained, areas of retina with thickness measurements less than 100 um, or absence of neural retina, will not be targeted for delivery of AAV2-hRPE65v2. 5. Complicating systemic diseases or clinically significant abnormal baseline laboratory values. Complicating systemic diseases would include those in which the disease itself, or the treatment for the disease, can alter ocular function. Examples are malignancies whose treatment could affect central nervous system function (for example, radiation treatment of the orbit; leukemia with CNS/optic nerve involvement). Also excluded would be subjects with immuno-compromising diseases, as there could be susceptibility to opportunistic infection (such as CMV retinitis). Subjects with diabetes or sickle cell disease would be excluded if they had any manifestation of advanced retinopathy (e.g. macular edema or proliferative changes). Subjects with juvenile rheumatoid arthritis could be excluded due to increased infection risk after surgery due to poor wound healing. Subjects who are positive for hepatitis B, C, and HIV will be excluded. 6. Prior ocular surgery within six months. 7. Known sensitivity to medications planned for use in the peri-operative period. 8. Individuals of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study. 9. Any other condition that would not allow the potential subject to complete follow-up examinations during the course of the study and, in the opinion of the investigator, makes the potential subject unsuitable for the study. 10. Subjects will be excluded if immunological studies show presence of neutralizing antibodies to AAV2 above 1:1000. ; PRIMARY OUTCOME: The primary outcome measures are safety and tolerability. Secondary outcome measure(s) include changes in visual function as measured by subjective, psychophysical tests and by objective, physiologic tests.; 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 - Healthy Adults; BRIEF: Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 ; DRUG USED: Breztri Aerosphere; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR), Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Pearl Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed - Male and female subjects 18 to 40 years of age, inclusive - Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation - Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile - Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period - Screening laboratory tests must be within normal range or determined to not be clinically significant by the Investigator. - Demonstrate correct MDI administration technique Key Exclusion Criteria: - For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods - Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study - Subjects who have cancer that has not been in complete remission for at least 5 years - Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening - Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator - History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) within 1 year of screening - History of smoking or the use of nicotine-containing products within 3 months of screening by self-reporting - A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening or at the beginning of each Treatment Period - Treatment with any prescription or non-prescription drugs including vitamins, herbal, and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study drug use - Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening Period - Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration - Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subjects unwillingness to comply with study-related procedures) ; PRIMARY OUTCOME: Maximum Plasma Concentration (Cmax)-Budesonide; SECONDARY OUTCOME 1: Time to Maximum Plasma Concentration (Tmax)-Budesonide[/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 - BOLD fMRI Study; BRIEF: The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain hemodynamics in healthy elderly participants. ; DRUG USED: Actos; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participants legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. The participant is a healthy adult male or female participant between the ages of 55 and 83 years, inclusive, at the time of informed consent and first dose of study medication dose. 4. Female participants of childbearing potential will not be included in the study. Female participants must be post-menopausal (defined as >2 years without menses). 5. The participant is considered to have normal cognitive abilities, as assessed by standard cognitive tests administered at the Screening visit. All participants will undergo a brief neuropsychological assessment which includes the Montreal Cognitive Assessment (MoCA) and Alzheimer Disease Cooperative Study Cognitive Function Screening Instrument to verify general cognitive status. Memory will be assessed with the Consortium to Establish a Registry for Alzheimers Disease (CERAD) Word List Memory Test and Trail Making Part B. Normal performance will be defined as scores within 1 standard deviation (SD) of age and education normative mean. Exclusion Criteria: 1. The participant has received pioglitazone or any thiazolidinedione (TZD) in a previous clinical study or as a therapeutic agent within 1 year of Screening. 2. The participant is an immediate family member, study site employee (defined as study personnel and employees directly supervised by study personnel), or in a dependant relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress. 3. The participant has uncontrolled, clinically significant neurologic (e.g., migraines not well controlled, narcolepsy, previous head injury with loss of consciousness, or seizures), osteoporosis, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results. 4. Participant has a known hypersensitivity or allergies to any component of the formulation of pioglitazone or related compounds. 5. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. Participant is unwilling to agree to abstain from alcohol 24 hours prior to MRI or unwilling to abstain from drugs throughout the study. 6. History or evidence of any other central nervous system disorder that could be interpreted as a cause of dementia. 7. Current diagnosis of significant psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders Forth Edition Text Revision (DSM-IV-TR). Subjects with recent/past psychiatric disorders who are currently in remission/asymptomatic without the use of medication may be eligible as determined by the principal investigator and the medical monitor. 8. Diabetes mellitus where the participant is being treated with insulin and/or peroxisome proliferator-activated receptor-ɣ (PPARɣ) agonist. 9. Participant has a history of cancer that required chemotherapy treatment within the past 2 years prior to Day 1, metastatic cancer in the past 5 years prior to Day 1, or radiation treatment to the brain in their lifetime. Subjects with basal cell or stage I squamous cell carcinoma of the skin will be eligible. Eligibility of subjects with a history of cancer will be determined by the principal investigator and medical monitor.10. History of macular edema, degeneration or any maculopathy. 11. Participant with a glycosylated hemoglobin (HbA1c) ≥6%. 12. Participant with congestive heart failure or significant edema (2+) of the extremities. 13. History of postmenopausal bone fracture (females only). 14. If male, the participant intends to donate sperm during the course of this study or for 30 days after the last dose of study drug. 15. Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]). 16. Participant has a positive test result for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (anti-HCV) at Screening or a known history of human immunodeficiency virus infection (HIV). 17. Participant has a Screening or Check-in (Day 1) abnormal (clinically significant) ECG. (Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by principal investigator. (If principal investigator is not a MD, ECG must be assessed by a qualified investigator). 18. Participant has abnormal Screening or Day 1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) >2x the upper limits of normal (ULN). 19. Participant has a contraindication to having MRI, for example because of ferromagnetic foreign bodies (e.g., unremovable ferromagnetic dental work), medical devices such as aneurysm clips or cardiac pacemakers, or lead-based tattoos. 20. Participant has hematuria (microscopic or macroscopic) at Screening. ; PRIMARY OUTCOME: Change from Baseline in BOLD fMRI Signal Related to Pioglitazone in Regions of the Brain Related to Cognition.; 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 - UK (Healthy); BRIEF: The purpose of this study is to assess the safety, tolerability, efficacy, and immunogenicity of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in healthy volunteers following a dose of influenza A virus. ; DRUG USED: Flunisyn; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Immune Targeting Systems Ltd; CRITERIA: Inclusion Criteria: 1. Male or female aged 18 to 45 years inclusive, with a body mass index of 18.0 to 32.0 kg/m2 inclusive and body weight of 50.0 to 110.0 kg inclusive; 2. Subjects who are able and willing to give written informed consent to participate; 3. Healthy, as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical safety laboratory examinations at screening (Visit 2) and Day C-1 (prior to virus challenge), as determined by the Investigator; 4. Absent or low levels of detectable pre-existing antibodies to the challenge H1N1 virus (HI titre of ≤10) and predicted seasonal H3N2 virus (HI titre of ≤40) prior to vaccination; 5. Subjects who are non-smokers for at least 3 months preceding screening (Visit 2) and able to refrain from smoking until after the completion of Visit 9 [Day C29]); 6. Females of non-childbearing potential or female subjects of childbearing potential who are using 2 medically acceptable methods of contraception; 7. Comprehension of the study requirements, expressed availability for the required study period, and ability to be quarantined for up to 10 days and to attend the scheduled follow-up visits (Day C29 and Day 209); 8. Negative alcohol and urine drug screening tests on screening and prior to entering quarantine (Day C-1); 9. Being willing to adhere to the prohibitions and restrictions specified in this protocol. Exclusion Criteria: 1. Subjects who do not conform to the above inclusion criteria; 2. Receipt of any influenza vaccine after 31 August 2011; 3. Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition such as chronic sinusitis; 4. Abnormal nasal structure including septal deviation and nasal polyps; 5. History of asthma (childhood asthma allowed), bronchiectasis, emphysema, chronic obstructive pulmonary disease or any other chronic lung disease in the last 10 years; 6. Current use or use within the last 7 days from screening day (Visit 2) of intranasal corticosteroids; 7. Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiac/cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders; this includes, but is not limited to, institution of new surgical or medical treatment (for a chronic condition), or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed before first vaccination; 8. Subjects who do not agree to use medically acceptable methods of contraception; 9. Female subjects who are pregnant, trying to become pregnant or are breast feeding; 10. Diastolic blood pressure <50 or >90 mmHg, a systolic blood pressure <100 or >150 mmHg, a pulse <40 or >100 beats per minute (bpm) after resting for 5 minutes; 11. Forced expiratory volume at one second (FEV1) ≤90% of predicted FEV1; 12. Blood haemoglobin A1c >6.0%; 13. Positive serology for human immunodeficiency virus (HIV) 1 or HIV 2, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies; 14. Cancer or treatment for cancer, within 5 years of Visit 2, excluding basal cell carcinoma of the skin, which is allowed; 15. Presence of immunosuppression or any medical condition that may be associated with impaired immune responsiveness, including, but not limited to, diabetes mellitus and inflammatory bowel disease; 16. Presently receiving or a history of receiving during the 3-month period prior to screening, any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon (IFN), immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) azathioprine or mercaptopurine; topical corticosteroids, except intranasal, will be allowed; 17. Anticipated presence of a household contact with documented severe immunosuppression (including but not limited to HIV, anyone who has haematological malignancy or is taking immunosuppressant medication), either as a result of disease and/or therapy within 2 weeks following discharge from the virus challenge quarantine period; 18. Anticipated presence of a household contact age 5 years or younger, within 2 weeks following discharge from the virus challenge quarantine period; 19. Anticipated presence of a household contact age 65 years or older, within 2 weeks following discharge from the virus challenge quarantine period; 20. Anticipated presence of a household contact with diagnosed emphysema, chronic obstructive pulmonary disease, severe lung disease or any organ or bone marrow transplant, within 2 weeks following discharge from the virus challenge quarantine period; 21. Current professional activity as a carer or healthcare worker; 22. Anticipated presence of a pregnant household contact, within 2 weeks following discharge from the virus challenge quarantine period; 23. History of Guillain-Barré syndrome; 24. History of drug or chemical/alcohol abuse in the year before the study (Visit 2); 25. Receipt of any investigational virus product or any investigational product (IMP) within 3 months prior to first vaccination, or currently enrolled in any investigational drug study or intends to enrol in such a study within the ensuing study period; 26. Receipt of blood or blood products 6 months prior to first vaccination or planned administration during the study period; 27. Blood donation in the 3 months prior to screening (Visit 2); 28. Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness with or without fever (as determined by the Investigator through medical history and physical examination), or presence of a fever (>37.7ºC oral temperature); 29. Elevated white cell count >9.5 x 109/L, absolute neutrophil count >6.9 x 109/L or serum C-reactive protein concentration >10.0 mg/L at screening (Visit 2) or Day C-1; 30. Any condition that, in the opinion of the Investigator, might interfere with the primary study objective; 31. Known or suspected intolerance or hypersensitivity to the IMP or closely related compounds, known allergy to egg or egg protein or any of the stated excipients; 32. Known or suspected intolerance or hypersensitivity to Tamiflu or Relenza; 33. Subject with suspected recent (≤6 months) experience of influenza-like illness (fever [>37.7ºC] and cough and/or sore throat >2 days, in the absence of a known cause other than influenza); 34. Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that in the opinion of the Investigator could interfere with evaluation of injection site local reactions, over the deltoid region of both arms as these will be the dose site; 35. Subjects who are vegans or have medical dietary restrictions; 36. Subjects who cannot communicate reliably with the Investigator. Exclusion Criteria for Virus Challenge Randomised subjects who have completed the vaccination phase of the study (Day 1 to Day 36) will be excluded from proceeding to the virus challenge part of the study under the following conditions: - Subjects have not received 2 administrations of Vaccine FP-01.1 or placebo per protocol; - Positive HI titre on Day 29 (defined as HI titre >20 for the H1N1 challenge virus); - Presence of any mild, moderate or severe influenza symptoms or signs as assessed by the subject scoring card or targeted physical examination prior to dosing; - An oral temperature >37.7°C on Day C-1 or Day C1 prior to dosing. Any subjects who meet the criteria listed above must not be challenged. ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Efficacy[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - KEYNOTE-890 (w/Keytruda; mTNBC); BRIEF: This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a single-arm study of intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP) in combination with pembrolizumab therapy. Cohort 2 will be a single-arm study of intratumoral TAVO-EP plus pembrolizumab along with treatment of an approved chemotherapy per standard of care (either nab-paclitaxel (Abraxane®) or gemcitabine (Gemzar®) plus carboplatin (Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or metastatic setting will be enrolled in this study. ; DRUG USED: TAVO; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: IL-12 (Interleukin-12) and IL-12 receptor; THERAPY: Combination; LEAD SPONSOR: OncoSec Medical Incorporated; CRITERIA: Inclusion Criteria: 1. Subjects with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC. 2. The following prior cancer therapy requirements apply to specific cohorts: 1. For Cohort 1 only, subjects must have received at least 1 prior line of systemic chemotherapy or immunotherapy that includes an approved regimen. 2. For Cohort 2 only, subjects has had no prior systemic therapy in the advanced/metastatic setting and must not have progression or recurrence of disease within 6 months after the last dose of systemic neoadjuvant or adjuvant treatment, if applicable. 3. Subjects must have TNBC defined as estrogen (ER) receptor and progesterone (PR) receptor staining <10% and human epidermal growth factor receptor 2 (HER2) - negative defined as immunohistochemistry (IHC) 0 to 1+ 4. For Cohort 2, the participant must meet each of the following criteria: 1. Has baseline PD-L1 negative disease (defined as Dako 22C3 assay CPS<10 [or equivalent, per sponsor agreement]) with results provided prior to start of study drug dosing: Historic results or new local PD-L1 testing from tissue collected within 6 months and without intervening therapy prior to Cycle 1 Day 1 2. Can provide a separate core or punch tumor biopsy collected at screening or archival tissue collected within 6 months (and without intervening therapy) prior to Cycle 1 Day 1 3. Has at least one lesion suitable for biopsy on Cycle 2 Day 1 (preferably same lesion from which the screening sample was collected). 5. Subjects must not have disease that, in the opinion of the Investigator, is considered amenable to potentially curative treatment. 6. Age ≥ 18 years of age of day of signing informed consent. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 8. Life expectancy of at least 6 months. 9. Participant has measurable disease based on RECIST v1.1 and has at least one identified lesion (target or non-target) that is accessible (up to 1.5 cm from the skin surface) and in a safe location for intratumoral injection and electroporation. 10. Demonstrate adequate organ function. All screening laboratories should be performed within 10 days of treatment initiation. 11. Female participant of childbearing potential must have a negative pregnancy test (for serum or urine pregnancy test, within 72 hours or 24 hours, respectively, prior to receiving the first study drug administration). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 12. Female participant of childbearing potential must be willing to use an adequate method of contraception from the first day of study treatment (or 14 days prior to the initiation of study treatment for oral contraception) and through at least 120 days following the last day of study treatment. 13. Male participant is surgically sterile OR agrees to use an adequate method of contraception when having sex with women of childbearing potential and refrains from sperm donation during the study treatment period and at least 120 days following the last day of study treatment. 14. Participant is able and willing to give informed consent and to follow study instructions. Exclusion Criteria: 1. Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 2. Subject has a clinically active brain metastases or leptomeningeal metastases. Participant who has a previously treated brain metastases or untreated asymptomatic brain metastases ≤5 mm may participate provided that they are radiologically stable (ie, without evidence of progression based on imaging during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment. 3. Subject has had an allogenic tissue/solid organ transplant. 4. Subjects with electronic pacemakers or defibrillators. 5. Subject who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 6. Subject has active hepatitis B (defined as HBsAg reactive) or active hepatitis C (defined as HCV RNA [qualitative] is detected). Note: Participant with a history of HBV or HCV controlled by ongoing viral suppression therapy is allowed. 7. Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 8. Subject has an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 9. Subject has received a live-virus or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed. Seasonal flu vaccines and COVID-19 vaccines that do not contain live virus (including attenuated vaccines) are permitted. 10. Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab or other anti-PD-1 monoclonal antibody therapy and/or any of its excipients. 11. For Cohort 2 only, participant has severe hypersensitivity (≥Grade 3) to or expected intolerance of the protocol-specified chemotherapy options. Participant must be able to tolerate at least one of the trial approved chemotherapy options. 12. Subject has received transfusion of blood products (including platelets or red blood cells) or colony stimulating factors (including G-CSF, GM-CSF, or recombinant erythropoietin) within 2 weeks prior to qualifying screening labs. 13. Subject has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. 14. Subject has a history of interstitial lung disease. 15. Subject has an active infection requiring systemic therapy. 16. Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subjects participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. 17. Participant has not recovered (ie, ≤Grade 1 or at baseline) from adverse events (AEs) due to a previously administered agent. 18. Subject has received any systemic anti-cancer agent or other local anti-cancer immunotherapy within 14 days prior to the start of study treatment. 19. Subject has a known psychiatric or substance abuse disorder that would interfere with the participants ability to cooperate with the requirements of the study. 20. Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. ; PRIMARY OUTCOME: Cohort 1: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Duration of Response (DOR)[/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/PF-03709270; BRIEF: The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia. ; DRUG USED: Sulopenem; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Hospitalized male or female patients 18 years of age or older. - Female patients of childbearing potential must not be pregnant. - Must exhibit at least two pre-specified clinical symptoms/signs of pneumonia. - Must require hospitalization for the pneumonia. - Chest Xray must be suggestive of a pneumonia. Exclusion Criteria: - Hospital or ventilator associated pneumonia. - Patients with cystic fibrosis, pneumocystis carinii pneumonia or active tuberculosis. - Previous treatment for the current pneumonia episode received for more than 24 hours. - Allergies to penems or beta lactams. ; PRIMARY OUTCOME: Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit; SECONDARY OUTCOME 1: Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Moderate to Severe UC; BRIEF: The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point. ; DRUG USED: AMG 181; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Diagnosis of ulcerative colitis (UC) established ≥ 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report. - Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score ≥2 prior to baseline - Inadequate response to, loss of response to, or intolerance to at least one of the following treatments: - Immunomodulators - Anti-TNF agents - Corticosteroids (non-US sites only). - Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization Exclusion Criteria: - Disease limited to the rectum (ie, within 10 cm of the anal verge) - Toxic megacolon - Crohns Disease - History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC - Planned bowel surgery within 24 weeks from baseline - Stool positive for C. Difficile toxin at screening - History of gastrointestinal surgery within 8 weeks of baseline - Primary Sclerosing Cholangitis - Any uncontrolled or clinically significant systemic disease - Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion. - Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody or human immunodeficiency virus (HIV) - Underlying condition that predisposes subject to infections (eg, uncontrolled diabetes; history of splenectomy) - Known history of drug or alcohol abuse within 1 year of screening - Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease free state since treatment) - Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate mofetil, within 1 month prior to baseline - Prior exposure to anti tumor necrosis factor (TNF) agents, within 2 months, or 5 times the respective elimination half life (whichever is longer) prior to baseline - Any prior exposure to vedolizumab, rituximab, efalizumab, natalizumab - Use of topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to baseline - Use of intravenous or intramuscular corticosteroids within 2 weeks prior to screening and during screening - Previously treated with AMG 181 - Received any type of live attenuated vaccine < 1 month prior to baseline or is planning to receive any such live attenuated vaccine over the course of the study - Treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals - Abnormal laboratory results at screening - Any other laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) ; PRIMARY OUTCOME: Percentage of Participants With Remission at Week 8; SECONDARY OUTCOME 1: Percentage of Participants With Response at Week 8[/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 - A6012113US; BRIEF: The primary objective is to determine the maximum tolerated dose/recommended phase II dose of the combination regimen of NK012 and 5-fluorouracil in patients with advanced solid tumors. ; DRUG USED: NK-012 ; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: Nippon Kayaku Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no efficacious therapy exists, or for which a camptothecin-based regimen would be appropriate. 2. For the dose expansion at MTD/RD only: 1. The patient must have failed oxaliplatin-based first line therapy for metastatic colorectal cancer. This includes patients who failed oxaliplatin-based therapy with progressive disease, as well as patients who, based on toxicity or MD/patient discretion, are no longer candidates for oxaliplatin. Patients who failed adjuvant therapy with oxaliplatin-based chemotherapy regimens within one year of last dose of oxaliplatin-based chemotherapy will also be considered eligible for this study. 2. Patients must have had no more than one prior chemotherapy regimen in the metastatic setting. Patients who had radiosensitizing chemotherapy during radiation treatment will not have this treatment count as a prior chemotherapy regimen. 3. Patients must have measurable disease by RECIST (version 1.1). 3. Patient must have recovered from all acute adverse effects of prior therapies, excluding alopecia. 4. For patients enrolled in the dose escalation phase, no more than 4 prior cytotoxic regimens in the metastatic setting. 5. Prior irradiation to no more than 25% of the bone marrow. 6. ECOG performance status of 0-1. 7. Life expectancy of at least 12 weeks. 8. Patients are at least 18 years of age. 9. Adequate bone marrow function as defined by ANC ≥ 1500/mm^3 and platelet count ≥ 100,000/mm^3. 10. AST and ALT ≤ 3.0 x ULN (5 x ULN if documented liver metastases) and total bilirubin ≤ 1.5 x ULN. 11. Serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula* for patients with serum creatinine > 1.5 x ULN. *Cockcroft-Gault formula for creatinine clearance (CrCl): Males: CrCl (ml/min) = (140 - age) x wt (kg) / (serum creatinine x 72) Females: Multiply the above result by 0.85 12. Able to understand and show willingness to sign a written informed consent document. Exclusion Criteria: 1. Prior chemotherapy, radiation therapy, or investigational therapy within 4 weeks (exception: 6 weeks for nitrosoureas or mitomycin C); or prior non-cytotoxic therapy within 5 drug half-lives (or 4 weeks, which ever is shorter); or monoclonal antibodies within 4 weeks prior to the first dose of study treatment. 2. Concurrent use of other investigational agent. 3. History of brain metastases or spinal cord compression, unless irradiated or treated a minimum of 4 weeks prior to first study treatment and stable without requirement of corticosteroids for > 1 week. 4. Concurrent serious infections requiring parenteral antibiotic therapy. 5. Pregnant or of childbearing potential and not using methods to avoid pregnancy. A negative pregnancy test must be documented at baseline for women of childbearing potential. Patients may not breast-feed infants while on this study. 6. Significant cardiac disease including heart failure that meets NYHA class III and IV definitions, history of myocardial infarction within 6 months of study entry, uncontrolled dysrhythmias or poorly controlled angina. 7. History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row), QTc ≥ 450 msec for men and 470 msec for women, or LVEF ≤ 40% by MUGA or ECHO. 8. History of allergic reactions attributed to compounds of topoisomerase I inhibitors. 9. Prior treatment with irinotecan. ; PRIMARY OUTCOME: Number of patients with dose-limiting toxicity as determinant of the maximum tolerated dose/recommended dose; SECONDARY OUTCOME 1: Number of patients with adverse events as a measure of safety and tolerability[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LemKids; BRIEF: Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT. Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL). ; DRUG USED: Lemtrada; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 52 (CD52); THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion criteria : - Participants with RRMS aged from 10 years to <18 years at study entry are eligible. Participants must meet the criteria of diagnosis of MS as defined by the International Pediatric MS Study Group (IPMSSG) criteria for pediatric MS and the criteria of MS based on 2010 McDonald criteria. - Signed written informed consent/assent obtained from participant and participants legal representative (parent or guardian) according to local regulations. - Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening. - At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last year during treatment with a beta interferon therapy (IFNB) or glatiramer acetate (GA) after being on that therapy for at least 6 months, and was currently still taking the same therapy. - At least 1 of the following: - >=1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion while on that same prior therapy (IFNB or GA), or - Two or more relapses in the prior year, or - Tried at least 2 MS DMTs. Exclusion criteria: - Any progressive or non-relapsing forms of MS. - Conditions/situations such as: - Impossibility to meet specific protocol requirements. - Current participation in another interventional clinical study. Participants who are treated with a comparator agent approved for screening inclusion (INF or GA) may be considered for this trial. - Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. - Uncooperative participant or any condition that could make the participant potentially non-compliant to the study procedures in the opinion of the Investigator. - Mental condition rendering the participant or parent/guardian unable to understand the nature, scope, and possible consequences of the study. - Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator. - History of drug or alcohol abuse. - History of known human immunodeficiency virus (HIV) positivity. - Pregnant or breast-feeding female participants or those who had planned to become pregnant during the study. - Unwilling to agree to use a highly effective contraceptive method when receiving a course of alemtuzumab treatment and for 4 months following that course of treatment (fertile participants only). - Female participants who have commenced menstruating (i.e., are of childbearing potential) and are unwilling or unable to be tested for pregnancy. - Previous treatment with alemtuzumab. - Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months prior to screening, or determined by the treating physician to had residual immune suppression from these or other MS treatments. - Treatment with teriflunomide in the last 12 months except if the participant underwent the recommended elimination procedure as per Summary of Product Characteristics (SmPC). - Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, ocrelizumab, leflunomide, or any cytotoxic therapy. - Previous treatment with any investigational medication (drug that had not been approved at any dose or for any indication). Use of an investigational medication that is subsequently licensed and nonstandard use of a licensed medication (e.g., using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) was not exclusionary. Prior treatment with herbal medications or nutritional supplements was also permitted. - Intolerance of pulsed corticosteroids, especially a history of steroid psychosis. - History of malignancy. - Prior documented history of thrombocytopenia, or platelet count at screening < lower limits of normal (LLN). - Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS. - Participants with known Type 1 hypersensitivity or anaphylactic reactions to the active substances or any of the excipients, or intolerance of acyclovir or its therapeutic equivalent. - Major systemic disease or other illness that would, in the opinion of the Investigator, compromise participant safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease, or other conditions that might predispose to hemorrhage, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis. - Medical, psychiatric, cognitive, or other conditions that, in the Investigators opinion, compromise the participants ability to understand the participant information, to give informed consent, to comply with the trial protocol, or to complete the study. - Major psychiatric disorder that is not adequately controlled by treatment in the opinion of the Investigator. - Epileptic seizures that are not adequately controlled by treatment. - Magnetic resonance imaging (MRI)-related conditions: conditions that could interfere with MRI acquisition and/or interpretation of MRI results (eg, claustrophobia, orthopedic implants/treatments, orthodontic treatments etc). - Known bleeding disorder (e.g., dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrands disease, disseminated intravascular coagulation, fibrinogen deficiency, clotting factor deficiency). - Prior history of invasive fungal infections. - Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation. - In the Investigators opinion, participant is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection). The above information is not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan; SECONDARY OUTCOME 1: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan[/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 - CEA-Positive Solid Tumors; BRIEF: This study was to determine the maximum-tolerated dose (MTD) and/or the optimal biological dose (OBD) as well as the optimal schedule for intravenous (IV) and subcutaneous (SC) administrations of RO7172508 as monotherapy, with or without obinutuzumab pre-treatment, in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors who have progressed on standard of care (SOC) treatment, are intolerant to SOC, and/or are non-amenable to SOC. This study was conducted in two parts. Part I of the study consisted of an IV single participant cohort/multiple-ascending dose-escalation to evaluate the safety of RO7172508. Part II was a multiple participant cohort/multiple-ascending dose-escalation to define the MTD and/or OBD of RO7172508 administered as single agent, IV and/or SC, in participants with tumors that are expressing high as well as moderate/low-CEA. The study switched from Part I to Part II when the maximum planned dose for Part I was reached or the occurrence of a RO7172508-related Grade >= 2 adverse event (AE) or dose-limiting toxicity (DLT) was observed, whichever comes first. The Sponsor may decide to switch from Part I to Part II in the absence of an observed RO7172508-related Grade >= 2 toxicity or prior to maximum planned dose for Part I. ; DRUG USED: RG6123; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - For Part I: participants with locally advanced and/or metastatic solid tumor with confirmed cytoplasmic and/or membranous high CEA expression in tumor tissue is required. Participants must have progressed on a SOC therapy, be intolerant to SOC, and/or are non-amenable to SOC. - For <12 mg dose cohorts, serum CEA levels below a certain threshold is required as follows: - For dose cohorts 65-159 microgram, a sCEA level of < 22 ng/mL - For dose cohorts 160-399 microgram, a sCEA level of < 28 ng/mL - For dose cohorts 400-799 microgram, a sCEA level of < 44 ng/mL - For dose cohorts 800-1599 microgram, a sCEA level of < 70 ng/mL - For the dose cohort of 1.6-3.1 milligram, a sCEA level of < 123 ng/mL - For the dose cohort of 3.2-6.3 milligram, an sCEA level of < 229 ng/mL. - For the dose cohort of 6.4-11.9 milligram, an sCEA level of < 440 ng/mL. If dose fractionation is implemented, the sCEA threshold for inclusion should correspond to the dose range of the first dose administered. - For Part II, participants with locally advanced and/or metastatic solid tumor expressing cytoplasmic and/or membranous high-CEA or moderate/low-CEA on archival material, who have progressed on a SOC therapy, are intolerant to SOC, and/or are non-amenable to SOC. Participants must have a lesion amenable to biopsy (except participants with NSCLC, which may be enrolled with archival tissue available only). For participants with colorectal cancer (CRC) only, the CEA assessment by immunohistochemistry should be performed but the result is not required to enroll the participant. - Radiologically measurable disease according to RECIST v1.1. - Life expectancy of >= 12 weeks - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. - All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade <= 1 or returned to baseline except alopecia (any grade) and Grade 2 peripheral neuropathy. - Adequate hematological, liver, renal, and lung function - For women: agree to remain abstinent or use two contraceptive methods that result in a failure rate of <1% per year from screening until 2 months after the last dose of RO7172508 and have a negative pregnancy test within one week prior to the first study treatment administration - For men: remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of <1% per year, with partners who are woman of childbearing potential and refrain from donating sperm during the study Exclusion Criteria: - History or clinical evidence of central nervous system (CNS) primary tumors or metastases unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days before screening. - Non-irradiated lesions > 2 cm at critical sites where tumor swelling induced by RO7172508 is expected to lead to significant complications. - Another invasive malignancy in the last 2 years - Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or contraindicate the use of an investigational drug. - Uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia that requires treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia, and history of myocardial infarction within 6 months of enrollment. - Active or uncontrolled infections. - Known hepatitis B or C - Major surgery or significant traumatic injury < 28 days prior to the first RO7172508 administration or anticipation of the need for major surgery during study treatment. Specific Exclusion Criteria if Pre-treatment with Obinutuzumab is Implemented: - Known HIV - Positive test results for HBV infection, HBcAb indicating an active viral infection and positive test results for HCV. - Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). - History of progressive multifocal leukoencephalopathy. - Active TB requiring treatment within 3 years prior to baseline. - Latent TB diagnosed during Screening. - Positive test results for human T-lymphotropic virus 1 ; PRIMARY OUTCOME: Number of Participants With Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Maximum Concentration of RO7172508[/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/IIa; BRIEF: Primary Objective: To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardts Macular Degeneration (SMD). Secondary Objective: To evaluate for possible biological activity of SAR422459. ; DRUG USED: StarGen; DRUG CLASS: Biologic; INDICATION: Stargardt Disease (Ophthalmology); TARGET: ATP-Binding Cassette Transporter 4 (ABCA4); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - Signed and dated written informed consent obtained from the participant and/or the participants legally acceptable representative. - Diagnosis of SMD, with at least one pathogenic mutant ABCA4 allele on each chromosome. - Women of childbearing potential must had a negative pregnancy test at Day -1, and agree to use an effective form of contraception for at least three months, or be surgically sterile or postmenopausal, with the last menstrual period being over two years prior to enrollment. - Males must agree with their partner to use two forms of contraception for at least three months following SAR422459 administration. - Participants must agree to not donate blood, organs, tissues or cells for at least three months following SAR422459 administration. - Participants enrolled in France must be affiliated to or benefit from a social security regimen. Specific Inclusion Criteria Participant Group A: - Participants (18 years or older) with advanced SMD. - Visual acuity less than or equal to (<=) 20/200 in the worst eye. - Severe cone-rod dysfunction with no detectable or severely abnormal full-field electroretinogram responses. Specific Inclusion Criteria Participant Group B: - Participants (18 years or older) with SMD. - Visual Acuity <=20/200 in the worst eye. - Abnormal full-field electroretinogram responses. Specific Inclusion Criteria Participant Group C: - Participants (18 years or older) with SMD. - Visual acuity <=20/100 in the worst eye. - Abnormal full-field electroretinogram responses. Specific Inclusion Criteria Participant Group D: - Symptomatic participants (from 6 years to 26 years old) with early or childhood-onset SMD (age at disease onset [less than] <18 years) with at least one pathogenic mutant ABCA4 allele on each chromosome confirmed by direct sequencing and co-segregation analysis within the participants family. - Visual acuity of greater than or equal to (>=) 20/200 in both eyes at the time of the screening visit. - Participants were anticipated to experience rapid deterioration in visual function and/or retinal structure as determined by an annual progression rate in at least one of the following parameters occurring in at least one eye (assessments recorded up to 2 years prior to the screening visit date might be considered to document evidence of rapid deterioration): - Loss of >=1 line of Snellen visual acuity (equivalent to 5 early treatment diabetic retinopathy study [ETDRS] letters). - Reduction in macular mean sensitivity of >=1.2 decibels (dB) as assessed by microperimetry. - Reduction in macular mean sensitivity of >=5 dB or reduction in hill of vision by greater than (>)14 dB-sr as assessed by static perimetry. - Enlargement in the area of macular retinal pigment epithelial (RPE) atrophy by fundus autofluorescence at a rate of >=0.5 millimeter square(mm^2). - Enlargement in the area of central macular retinal thinning/photoreceptor loss by ocular coherence tomography at a rate of >=0.5 mm^2. - All eligible participants must demonstrate an ability to understand, willingness to cooperate and ability to reliably perform required study procedures as judged and confirmed by the study investigator. Specific inclusion criteria Participant Group E: - Symptomatic participants (between 6 years and 17 years old) with early or childhood-onset SMD with at least one pathogenic mutant ABCA4 allele on each chromosome confirmed by direct sequencing and co-segregation analysis within the participants family. - Visual acuity of >=20/100 in both eyes at the time of screening visit. - Participants were anticipated to experience rapid deterioration in visual function and/or retinal structure as determined by an annual progression rate in at least one of the following parameters occurring in at least one eye (assessments recorded up to 2 years prior to the screening visit date were considered to document evidence of rapid deterioration): - Loss of >=1 line of Snellen visual acuity (equivalent to 5 ETDRS letters). - Reduction in macular mean sensitivity of >=1.2 dB as assessed by microperimetry. - Reduction in macular mean sensitivity of >=5 dB or reduction in hill of vision by >14 dB-sr as assessed by static perimetry. - Enlargement in the area of macular RPE atrophy by fundus autofluorescence at a rate of >=0.5 mm^2. - Enlargement in the area of central macular retinal thinning/photoreceptor loss by ocular coherence tomography at a rate of >=0.5 mm^2. - All eligible participants demonstrated an ability to understand, willingness to cooperate and ability to reliably perform required study procedures as judged and confirmed by the study investigator. Exclusion Criteria: - Pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study outcome measures. - Cataract surgery with intraocular lens implantation within 6 months of enrolment. - Aphakia or prior vitrectomy in the study eye. - Concomitant systemic diseases including those in which the disease itself, or the treatment for the disease, can alter ocular function. - Any intraocular surgery or laser in either eye planned within 6 months of Day 0. - Any contraindication to pupil dilation in either eye. - Any known allergy to any component of the delivery vehicle or diagnostic agents used during the study, or medications planned for use in the perioperative period particularly topical, injected or systemic corticosteroids. - Any injectable intravitreal treatment to the treated eye or intravitreal device in the treated eye within 6 months prior to screening. - Any periocular injections of corticosteroids to the treated eye within 4 months prior to screening. - Laboratory test abnormalities or abnormalities in electrocardiogram, chest X-rays that in the opinion of the Principal Investigator would make the participant unsuitable for participation in the study. - Significant intercurrent illness or infection during the 28 days prior to enrolment. - Pre-menopausal or non-surgically sterile women who were unwilling to use an effective form of contraception such as the contraceptive pill or intrauterine device. - Alcohol or other substance abuse. - Contraindications to use of anesthesia (local or general, as appropriate). - Concurrent anti-retroviral therapy that would inactivate the investigational agent. - History of any investigational agent within 28 days prior to SAR422459 administration. - Participation in a prior ocular gene transfer therapy study. - Enrolment in any other clinical treatment study throughout the duration of the SAR422459 study. - Current or anticipated treatment with anticoagulant therapy or the use of anticoagulation therapy within the four weeks prior to surgery. - A past medical history of human immunodeficiency virus or hepatitis A, B, or C infection. - Women who were pregnant or were breastfeeding. - History or signs consistent with unilateral amblyopia (strabismic, anisometropic, or stimulus deprivation). ; PRIMARY OUTCOME: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - STAR-1 - APL; BRIEF: This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who are intolerant to either drug are eligible for this study. ; DRUG USED: SY-1425; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Promyelocytic Leukemia (APL); TARGET: Retinoic acid receptor (RARs); THERAPY: Monotherapy; LEAD SPONSOR: CytRx; CRITERIA: Patients must meet all of the following criteria for admission into the study: 1. Have a diagnosis of either relapsed and/or refractory APL: - Refractory disease is defined as a confirmed diagnosis of APL and a myeloblast plus promyelocyte count of > 10% in the bone marrow in patients who have failed to respond to induction therapy in the first or second line setting. Induction therapy must have included ATRA- and ATO-based therapy given either sequentially or in combination. - Relapsed disease is defined as a confirmed diagnosis of APL and a myeloblast plus promyelocyte count of > 10% in the bone marrow following a documented complete remission or positive RT-PCR assay for PML/RAR-α in two consecutive tests separated by at least one month, after treatment with ATRA- and ATO-based therapy given either sequentially or in combination. 2. Confirmation of diagnosis and relapsed/refractory APL must be obtained in blood or bone marrow mononuclear cells by at least one of the following methods: - Conventional cytogenetics showing the translocation t(15:17), - Positive RT-PCR assay for PML/RAR-α, or - Fluorescence in situ hybridization (FISH) analysis showing evidence of the PML/RAR-α translocation. 3. Patients must have received and failed therapy with ATRA and ATO either within the same or separate induction/consolidation schedule(s). Treatment must have been administered for a minimum of 28 days for each agent. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who failed to complete a course of induction/consolidation therapy, as specified, due to drug intolerance are eligible for the study. 4. Patients in whom ATO is contraindicated (for example due to congenital long QT syndrome) are eligible for inclusion on study if they have received and failed ATRA therapy as defined in (3). 5. Be able to provide written informed consent prior to enrollment into the study. 6. Be ≥ 18 years old. 7. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. 8. Have an estimated life expectancy of ≥ 12 weeks. 9. Be male or a non-pregnant, non-lactating female. Fertile patients must agree to use an effective barrier method of contraception (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study drug. [In countries where double barrier contraception is required by Regulatory Authorities, patients who are fertile must agree to use 2 forms of barrier method contraception (e.g., latex condom AND a diaphragm or cervical cap) while on therapy and for 90 days following the discontinuation of the study drug.] A non-fertile female is defined as: - Postmenopausal (amenorrheic for ≥ 12 months) - Undergone a complete oophorectomy or hysterectomy. 10. Have a negative serum or urine pregnancy test within 10 days prior to the first dose of study drug (if patient is a female of childbearing potential). 11. Have adequate organ function. Patients who meet any of the following criteria will be excluded from study admission: 1. Extramedullary leukemia. 2. Patients on a vitamin A preparation or patients with hypervitaminosis A. 3. Have received cytotoxic therapy ≤ 2 weeks from the start of therapy. If the patient needs these agents due to urgent medical care within 2 weeks prior to starting tamibarotene, a waiver may be granted by the INNOVIVE Medical Monitor. 4. Have a history of myelodysplastic syndromes (MDS). 5. Have impaired cardiac function or clinically significant heart disease including: - Myocardial infarction within 3 months, unstable angina pectoris, congenital long QT syndrome and clinically significant resting bradycardia (< 50 beats per minute), uncontrolled congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with antihypertensive medication. 6. Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment. 7. Have clinically significant acute or chronic liver or renal disease considered unrelated to leukemia. 8. Have uncontrolled hyperlipidemia. 9. Have uncontrolled or poorly controlled diabetes mellitus. 10. Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection). 11. Are pregnant or lactating. 12. Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. 13. Have not recovered from acute toxicities of all previous therapy prior to enrollment. 14. Have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol. 15. Have a history of another primary malignancy that has been actively treated in the last 24 months. 16. Are unwilling or unable to comply with the protocol. ; PRIMARY OUTCOME: To determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL.; SECONDARY OUTCOME 1: (1) To determine the rates of morphologic leukemia-free state, partial response, cytogenetic complete response, and molecular complete response for tamibarotene therapy in the indicated patient 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 I - w/Tocilizumab; BRIEF: This is a two cohort, open-label, pilot study to describe the efficacy of administration timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events in pediatric patients with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia with high versus low pre-infusion tumor burden following redirected autologous T cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019). ; DRUG USED: Kymriah; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Combination; LEAD SPONSOR: University of Pennsylvania; CRITERIA: Inclusion Criteria: 1. Signed informed consent form must be obtained prior to any study procedure. Labs, marrows or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required windows. 2. Relapsed or refractory B-cell ALL: 1. 2nd or greater marrow relapse OR 2. CNS relapse OR 3. Any relapse after allogeneic hematopoietic stem cell (SCT) transplant and ≥ 4 months from SCT at enrollment OR 4. Any relapse after CAR-modified T cell therapy OR 5. Refractory disease defined as having not achieved an MRD-negative CR after ≥ 2 chemotherapy regimens/cycles (1 cycle for relapsed patients) OR 6. Patients with Ph+ ALL are eligible if they are intolerant to or have failed tyrosine kinase inhibitor therapy OR 7. Ineligible for allogeneic SCT because of: - Comorbid disease - Other contraindications to allogeneic SCT conditioning regimen - Lack of suitable donor - Prior SCT - Declines allogeneic SCT as the therapeutic option after documented discussion, with expected outcomes, about the role of SCT with a bone marrow transplant (BMT) physician not part of the study team 8. Patients with B lymphoblastic lymphoma will be eligible if they meet one of the above criteria OR: - 2nd or greater relapse OR - Refractory disease defined as having not achieved CR with frontline therapy or after 1 cycle of reinduction therapy for relapsed patients 9. Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion, must meet criteria in Section 5.3) 3. Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor tissue by flow cytometry at relapse (or a recent sample in the case of refractory disease). If the patient has received CD19-directed therapy (i.e. blinatumomab), then the flow cytometry should be obtained after this therapy to show CD19 expression. 4. Adequate organ function defined as: 1. A serum creatinine based on age/gender as follows: Maximum Serum Creatinine (mg/dL) Age Male Female - 1 to < 2 years 0.6 0.6 - 2 to < 6 years 0.8 0.8 - 6 to < 10 years 1.0 1.0 - 10 to < 13 years 1.2 1.2 - 13 to < 16 years 1.5 1.4 - ≥ 16 years 1.7 1.4 2. ALT ≤500 U/L 3. Bilirubin ≤2.0 mg/dl 4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea, pulse oximetry > 92% on room air; DLCO ≥ 40% (corrected for anemia) if PFTs are clinically appropriate as determined by the treating investigator 5. Left Ventricular Shortening Fraction (LVSF) ≥ 28% or Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO, or adequate ventricular function documented by a scan or a cardiologist. 5. Evidence of disease by standard morphologic or MRD criteria. A clinical marrow or tissue biopsy showing disease may be performed at enrollment or within 12 weeks of enrollment. Presence of marrow disease not required for CNS disease or lymphoblastic lymphoma patients. 6. Age 1-29 years. Patients ages 24-29 years are eligible if their original leukemia diagnosis was prior to age 21. 7. Adequate performance status (Lansky or Karnofsky score ≥50). 8. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3. Exclusion Criteria: 1. Active hepatitis B or active hepatitis C. 2. HIV Infection. 3. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy. 5. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity. 6. Pregnant or nursing (lactating) women. 8. Uncontrolled active infection. ; PRIMARY OUTCOME: the frequency of grade 4 CRS; SECONDARY OUTCOME 1: tumor 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 - R668-AD-1314; BRIEF: This was a 32-week, randomized, double-blind, placebo-controlled, parallel-group study assessing immunization responses to vaccination in adults with moderate to severe atopic dermatitis who are treated with subcutaneous dupilumab. ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Male or female adults ages 18 to 64 years with Chronic AD (according to the American Academy of Dermatology Consensus Criteria, [Eichenfeld 2004])that has been present for at least 3 years before the screening visit 2. Participants with documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of outpatient treatment with topical AD medication(s), or for whom topical AD therapies are otherwise inadvisable (e.g., because of side effects or safety risks). 3. Eczema Area and Severity Index (EASI) score ≥16 at the screening visit and the baseline visit 4. Investigators Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the screening and baseline visits 5. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits Key Exclusion Criteria: 1. Prior treatment with dupilumab (REGN668/ SAR231893) 2. Patients needing >10 mg of daily prednisone (including equivalent doses of other steroids) or high dose systemic corticosteroids (≥2 mg/kg) for 14 days or longer during the 16 week treatment period of the study 3. History of Guillain-Barre syndrome 4. History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol 5. Patients with a severe reaction to natural rubber latex products (some packaging components of the vaccines contain rubber latex and may cause a reaction in susceptible individuals) 6. Treatment with biologics within 4 months of baseline visit 7. Chronic or acute infection requiring treatment with antibiotics, antivirals, antiparasitics, antifungals within 4 weeks before screening visit or superficial skin infections within 1 week of screening visit The information listed above is not intended to contain all considerations relevant to a patients potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed. ; PRIMARY OUTCOME: Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16; SECONDARY OUTCOME 1: Percentage of Participants With a Positive Response (≥2-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD/MAD (Study 001); BRIEF: This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4- to 10-day follow-up period after discharge. ; DRUG USED: AZD6423; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures. 2. All male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after dose administration. A male subject is considered biologically capable of having children even if his sexual partner is sterile or using contraceptives. 3. Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive. 4. Subjects must be fluent in English. Exclusion Criteria: 1. A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality. 2. A clinically significant abnormality on physical examination, neurological examination, EEG, ECG, vital signs or laboratory evaluations at screen or between screen and dose administration. 3. A history of seizure. 4. A history of head trauma, including closed head injury with loss of consciousness. 5. Any history of suicide attempt or suicidal behavior, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior. 6. Urine drug screen positive for a drug of abuse 7. A family history of schizophrenia, schizoaffective disorder, or psychosis in first degree relatives. ; PRIMARY OUTCOME: Assessment of the safety and tolerability of AZD6423 in healthy subjects via adverse events; SECONDARY OUTCOME 1: Description of the PK profile for AZD6423 in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z), and area under the curve (AUC).[/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 - STELLAR; BRIEF: The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B). ; DRUG USED: CRS-207; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Immune System, Mesothelin; THERAPY: Combination; LEAD SPONSOR: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; CRITERIA: Inclusion Criteria: - Age ≥18 years. - Have histologically- or cytologically-proven adenocarcinoma of the pancreas. Patients with mixed histology will be excluded. - Have metastatic disease. - Have failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer. - Patients with the presence of at least one measurable lesion. - Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator). - ECOG performance status 0 or 1. - Life expectancy of greater than 3 months. - Patients must have adequate organ and marrow function defined by study-specified laboratory tests. - Must use acceptable form of birth control while on study. - Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: - known history or evidence of brain metastases. - Had surgery within the last 28 days - Have received any non-oncology vaccine therapy used for prevention of infectious diseases including seasonal vaccinations within 28 days of study treatment. - Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, GVAX or CRS-207 - Systemic steroids within the last 14 days - Use more than 3 g/day of acetaminophen. - Patients on immunosuppressive agents. - Patients receiving growth factors within the last 14 days - Known allergy to both penicillin and sulfa. - Severe hypersensitivity reaction to any monoclonal antibody. - Have artificial joints or implants that cannot be easily removed - Have any evidence of hepatic cirrhosis or clinical or radiographic ascites. - Have significant and/or malignant pleural effusion - Infection with HIV or hepatitis B or C at screening - Significant heart disease - Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patients ability to comply with study visits and procedures - Unable to avoid intimate contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen. - Are pregnant or breastfeeding. - Have rapidly progressing disease ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II; BRIEF: This is a prospective, randomized (1:1), double-blind, multi-center, Phase II clinical study to test the safety and efficacy of a recombinant chimeric anti-tissue factor antibody (ALT-836) versus placebo in patients with sepsis and acute lung injury/acute respiratory distress syndrome (ALI/ARDS). This study was divided into two parts and the first part of the study has been completed. In the first part of the study, sixty patients were randomized at a 1:1 ratio to receive one dose of the study drug or placebo. In the second part of the study, ninety patients will be randomized at a 1:1 ratio to receive a multi-dose treatment regimen of single doses every 72 hours up to a maximum of 4 doses of the study drug or placebo, provided there are no safety concerns. ; DRUG USED: ALT-836; DRUG CLASS: Biologic; INDICATION: Acute Respiratory Failure, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS); TARGET: Tissue Factor; THERAPY: Monotherapy; LEAD SPONSOR: Altor BioScience; CRITERIA: INCLUSION CRITERIA: 1. Suspected or proven infection 2. Hypoxemia: PaO2/FiO2is ≤300 mm Hg 3. Bilateral infiltrates consistent with pulmonary edema 4. Positive-pressure mechanical ventilation through an endotracheal tube 5. No clinical evidence of left atrial hypertension to explain bilateral infiltrates 6. Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC Criteria 2 and 3 must occur within a 24-hour interval. The 48-hour enrollment time window begins when criteria 2, 3, and 4 are met. EXCLUSION CRITERIA: 1. <18 years 2. Inability to obtain consent 3. Patient, surrogate, or physician not committed to full support 4. Moribund state in which death was perceived to be imminent 5. Morbid obesity 6. Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be >50% 7. Known HIV positive with known end stage processes 8. Prior cardiac arrest requiring CPR without fully demonstrated neurological recovery; or New York Heart Association Class IV 9. Pregnant or nursing 10. ALI/ARDS induced by mechanical or chemical injury directly to the lung (including burns, trauma, and near drowning) 11. >48 hours since all inclusion criteria are met 12. Neuromuscular disease that impairs ability to ventilate without assistance 13. Severe chronic respiratory disease, severe pulmonary hypertension, or ventilator dependency 14. Chest wall deformity resulting in severe exercise restriction, secondary polycythemia, or respirator dependent 15. History of organ transplant (including bone marrow) 16. Severe chronic liver disease, as determined by a Child-Pugh Score >10 17. Hemoglobin persistently < 7.0 g/dL 18. Platelet count <50,000/mm3 19. Prolonged INR >3 20. Bleeding disorders unless corrective surgery has been performed 21. Active internal bleeding 22. Major surgery within 24 hours before study drug infusion, or evidence of active bleeding postoperatively, or plan for any major surgery within 3 days after study drug infusion. 23. Diffuse alveolar hemorrhage from vasculitis 24. Known bleeding diathesis 25. Presence of an epidural catheter or lumbar puncture within 48 hours before study drug infusion or anticipation of receiving an epidural catheter or a lumbar puncture within 48 hours after study drug infusion 26. Stroke within 3 months of study entry 27. Trauma with an increased risk of life-threatening bleeding 28. A history of severe head trauma that required hospitalization, or intracranial surgery within two months of study entry 29. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion 30. Uses of certain medications or treatment regimens such as chemotherapy, unfractionated heparin, low-molecular-weight heparin, Warfarin, antithrombin III, acetylsalicylic acid, glycoprotein IIb/IIIa antagonists, thrombolytic therapy, and activated Protein C are restricted. 31. Participation in another experimental medication study within 30 days of study entry. ; PRIMARY OUTCOME: Safety profile of the study drug; SECONDARY OUTCOME 1: Mortality at Day 7, 14, 21, 28 and 60[/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 - INDUS-2; BRIEF: This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of AUR101 (RORgamma inhibitor) in patients with moderate-to-severe psoriasis. Approximately 90 patients with chronic moderate-to-severe plaque psoriasis will be randomized to the 2 dose groups of AUR101 and one group of Placebo. The patients will receive the treatment for 12 weeks. ; DRUG USED: AUR-101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Retinoic Acid-related Orphan Receptor &amp;gamma;t (ROR&amp;gamma;t); THERAPY: Monotherapy; LEAD SPONSOR: Aurigene Discovery Technologies Limited; CRITERIA: Inclusion Criteria: - 1. Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months before screening 2. Psoriasis of at least moderate severity, defined as PASI≥12 and involved BSA≥10 % at screening and Day 1 3. Adult males or females,≥18 to ≤ 65 years of age. 4. Ability to communicate well with the investigator and to comply with the requirements of the entire study 5. Willingness to give written informed consent (prior to any study related procedures being performed) and ability to adhere to the study restrictions and assessments schedule. Exclusion Criteria: - 1. History of erythrodermic, guttate, or pustular psoriasis within last 12 months 2. Efficacy failure on any biologic (e.g. interleukin (IL) -17 antibodies or anti-TNF agents) for the treatment of psoriasis. 3. Static 5-point IGA mod 2011 scale of 0 to 2 at screening or Day 1. 4. BMI ≥ 35 kg/m2 5. Current treatment or history of treatment for psoriasis with IL-17 or IL-12/23 antagonist biological agents within 6 months prior to study day 1 6. Current treatment or history of treatment for psoriasis with other biological agents within 3 months prior to study day 1. 7. Current treatment or history of treatment for psoriasis with non-biological systemic medications or phototherapy within 4 weeks prior to study day 1. 8. Treatment with medicated topical agents within 2 weeks prior to study day 1. 9. History or presence of any medical or psychiatric disease, or clinically significant laboratory at screening, 10. Evidence of organ dysfunction 11. Any major recent surgery history within 3 months prior to screening 12. Alcohol abuse or drug abuse 13. History of malignancy 14. Positive for HIV, Hepatitis B or Hepatitis C at screening. 15. Patient with known past history of systemic tuberculosis or currently suspected or known to have tuberculosis 16. Patient expected to be started on anti-tubercular therapy either for treatment or prophylaxis of tuberculosis. 17. Suspected tuberculosis infection as evident from a positive QuantiFERON TBGold test (QFT) at screening. Patients with a positive QFT test may participate in the study if further work up as per the opinion of the investigator . 18. History of hypersensitivity or idiosyncratic reaction to any investigational RORgamma inhibitors or any of the excipients of study drug 19. Past gastrointestinal surgery or recent (within 3 months) / current history of gastrointestinal disease. 20. Positive pregnancy test for women of child bearing potential (WOCBP) at the screening or randomization visit 21. Male patients with partners of childbearing potential not willing to use reliable contraception methods. 22. Pregnant or lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods 23. Has received another new chemical entity/investigational drug within 28 days or 5 half-lives of investigational drug prior to study day 1. 24. Use of herbal remedies, mega dose vitamins and minerals during the 2 weeks prior to the first administration of investigational product. 25. Patients who have received live or attenuated vaccine in the 4 weeks prior to study day 1. ; PRIMARY OUTCOME: Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum)); SECONDARY OUTCOME 1: Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))[/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 - Solid Tumors; BRIEF: To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with recurrent or metastatic solid tumors. ; DRUG USED: MEDI6383; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, OX40/CD134 and OX40L; THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: 1. Male and female subjects; age ≥ 18 2. Written informed consent must be obtained 3. Subjects must meet the following criteria: 1. Have recurrent or metastatic solid tumors 2. Must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 5 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies 4. Subjects must have at least 1 lesion 5. Subjects must consent to provide archived tumor specimens and / or tumor biopsy for correlative biomarker studies. 6. Eastern Cooperative Oncology Group performance score of 0 or 1 7. In the opinion of the invesgator likely to complete ≥ 8 weeks of treatment. 8. Adequate organ function as determined by: i. Absolute neutrophil count ≥ 1.5 x 109/L (1,500/mm3) ii.Platelet count ≥ 100 x 109/L (100,000/mm3) iii.Hemoglobin ≥ 9.0 g/dL within first 2 weeks prior to first dose of investigational product iv.Calculated creatinine clearance* (CrCl) or 24 hour urine CrCl > 50 mL/min v.Total bilirubin ≤ 1.5× ULN; for subjects with documented/suspected Gilberts disease, bilirubin ≤ 3× ULN vi.Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5× ULN vii.Serum Electrolytes within normal limits 9. Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of highly effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product; 10) Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through 90 days after receipt of the final dose of investigational product Exclusion Criteria: 1. Prior treatment with TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR) . 2. Subjects who have received prior therapy with regimens containing CTLA-4, PDL-1, or PD-1 antagonists are NOT permitted to enroll unless all of the following apply: - Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy - All AEs while receiving prior immunotherapy must have resolved to ≤ Grade 1 or baseline prior to screening for this study. 3. Must not have experienced a ≥ Grade 3 AE or neurologic or ocular AE of any grade while receiving prior immunotherapy 4. History of severe allergic reactions to any unknown allergens or any components of the study drug formulations 5. Active or prior documented autoimmune disease within the past 2 years. 6. Untreated central nervous system metastatic disease l 7. Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study 8. Receipt of anticancer therapy within 28 days prior to the first dose of Investigational Product 9. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment. 10. Unresolved toxicities from prior anticancer therapy 11. Systemic anticoagulation or daily aspirin dose exceeding 325 mg per day 12. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI6383. ) 13. History of primary immunodeficiency, solid organ transplantation, or tuberculosis 14. True positive test results for human immunodeficiency virus (HIV) or hepatitis B or C 15. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products ) 16. Pregnant or breastfeeding women 17. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of MEDI6383 or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable 18. Other invasive malignancy within 2 years - ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Preliminary Antitumor Activity[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - INSIGhT (Glioblastoma; Investigator Initiated); BRIEF: This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115 - QBS10072S ; DRUG USED: CC-115; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: DNA-PK, Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Patrick Wen, MD; CRITERIA: Inclusion Criteria: - Participants must have histologically confirmed intracranial glioblastoma or gliosarcoma following maximum surgical resection. Tumors primarily localized in the infratentorial compartment will be excluded. - Participants may have had prior surgery for glioblastoma or gliosarcoma but no systemic or radiation therapy. - Age ≥ 18 years. - Karnofsky performance status ≥60 - Participants must have normal organ and marrow function as defined below: - Leukocytes ≥3,000/mL - Absolute neutrophil count ≥1,500/mL - Platelets ≥100,000/mL - Hemoglobin ≥ 9g/dl - Total bilirubin within normal institutional limits (except for participants with Gilberts disease) - AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal - Creatinine ≤ institutional upper limit of normal OR - Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. - Potassium within normal institutional range, or correctable with supplements - Serum amylase ≤ 1.5 x institutional upper limit of normal - Serum lipase ≤ 1.5 x institutional upper limit of normal - INR < 2.0 - PTT ≤ institutional upper limit of normal, unless receiving therapeutic low molecular weight heparin - Must be able to swallow pills. - Participants must plan to begin radiation therapy 14-42 days after surgical resection. - Immunohistochemically negative for IDH1 R132H mutation. - Evidence that the tumor MGMT promoter is unmethylated by standard of care assays. - Genotyping data available or in process (data must be available at time of initial registration if randomization probabilities differ across biomarker subgroups as determined by the DFCI Coordinating Center) to assign biomarker subgroups through whole exome sequencing, whole genome copy number analysis, or a combination as described in Section 9.1. - MRI with gadolinium should be obtained within 21 days prior to beginning treatment. Patients without measurable disease are eligible. Participants must be able to undergo MRIs (CTs are not allowed for response assessment on study). - The effects of the experimental agents used in this study on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (women who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized) 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 unless otherwise specified in sub-study that the participant is randomized to. 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. - For women of child bearing potential (women who are not free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized) a negative serum pregnancy test must be documented prior to initial registration. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Participants will not be eligible if the original diagnosis was a lower grade glioma and a subsequent histologic diagnosis revealed glioblastoma. - Planned major surgery. - Participants who are receiving any other investigational agents. - Participants who have had any prior cranial radiotherapy. - Planned use of Optune™. - History of a different malignancy, unless (a) have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, and/or (b) malignancy was cervical cancer in situ, superficial bladder cancer or basal cell or squamous cell carcinoma of the skin, and malignancy has been treated. Patients who meet the above listed criteria and are only on preventative treatment will be deemed eligible. - History of intratumoral or peritumoral hemorrhage if deemed significant by the treating physician. - Impaired cardiac function or clinically significant cardiac diseases, including any of the following: - Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of ≥2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia. - Known history of congenital QT prolongation or Torsade de pointes (TdP). - Complete left bundle branch or bifascicular block. --QTc interval > 450 ms for men or > 470 ms for women. - Persistent or history of clinically meaningful ventricular arrhythmias or atrial fibrillation. - Unstable pectoris or myocardial infarction ≤ 3 months prior to starting study treatment. - Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg). - Other clinically significant heart disease such as congestive heart failure requiring treatment. - Uncontrolled diabetes mellitus, or subjects with either of the following: - Fasting blood glucose (FBG defined as fasting for at least 8 hours) ≥ 200 mg/dL (7.0 mmol/L), or - HbA1c ≥ 8% - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects must be free of any clinically relevant disease (other than glioma) that would, in the treating investigators opinion, interfere with the conduct of the study or study evaluations. - Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNS [qualitative] is detected). - Known acute or chronic pancreatitis. - Participants with active diarrhea ≥ CTCAE grade 2 despite medical management. - Active infection requiring antibiotics. - Pregnant or breastfeeding. - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection). Participants with unresolved diarrhea ≥ CTCAE grade 2 will be excluded as previously indicated. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the experimental agents or other agents used in study. - Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participant must be off any EIAEDs for at least 7 days prior to planned start of study treatment. A list of EIAED and other inducers of CYP3A4 is provided. Among non-EIAED, caution is recommended with use of valproic acid due to potential for drug interaction. - Participants taking a drug known to be strong inhibitors or inducers of isoenzyme CYP3A. Participant must be off CYP3A inhibitors and inducers for at least 7 days prior to planned start of study treatment. NOTE: participants must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to planned start of study treatment and during the entire study treatment period due to potential CYP3A4 interaction. - Current use of herbal preparations/medications, including but not limited to: St. Johns wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng. Participants should stop using these herbal medications 7 days prior to planned start of study treatment. - Current use of warfarin sodium or any other coumadin-derivative anticoagulant. Participant must be off Coumadin-derivative anticoagulants for at least 7 days prior to planned start of study treatment. Low molecular weight heparin and factor Xa inhibitors are allowed. ; PRIMARY OUTCOME: Overall Survival in Experimental Arms Compared with Standard Therapy; SECONDARY OUTCOME 1: Incidence of 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 I - SAD/MAD (Healthy Adults); BRIEF: This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers. ; DRUG USED: LBS-008; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stargardt Disease (Ophthalmology); TARGET: Retinol binding protein 4 (RBP4); THERAPY: Monotherapy; LEAD SPONSOR: RBP4 Pty Ltd; CRITERIA: Inclusion Criteria: - The subject is male or female, 18 to 65 years of age, inclusive, at screening. - The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures. - The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits. - Female subjects must be of nonchildbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the dose of study drug] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening; FSH level >40 mIU/mL). Female subjects may also be considered of non-childbearing if they have a confirmed medical condition which would deem the subject as infertile. E.g. MRKH Syndrome (Mullerian Agenesis) or another applicable condition. - Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or remain abstinent or agree to use a highly effective form of contraception when sexually active with a female partner for 90 days after study drug administration. Highly effective contraception requires use of a condom and appropriate contraceptive measures for your female partner (i.e. oral, injected or implanted hormonal methods, or placement of an intrauterine device or intrauterine system). This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential. - The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, and weighs 50 to 100 kg (110 to 220 pounds), inclusive, at screening and check-in. - The subject is considered to be in stable health by the investigator. - The subject agrees to comply with all protocol requirements. Exclusion Criteria: - Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease - Vitamin A deficiency. - Any recent viral or bacterial infection. - Participated in any clinical study in last 6 weeks. - History of significant drug allergy - History of significant vision, ocular or retinal disorder. - Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month. - Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations Other protocol-defined inclusion/exclusion criteria could apply. ; PRIMARY OUTCOME: Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t); 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 - THINK (AML/MM/Solids); BRIEF: THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma). ; DRUG USED: CYAD-01; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Immune System, NKG2D / NKG2D Ligands, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Celyad Oncology SA; CRITERIA: Main inclusion criteria are: - Men or women ≥ 18 years old at the time of signing the ICF, - Patient with a CRC, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, TNBC, pancreatic cancer, AML/MDS or MM, - Disease must be measurable according to the corresponding guidelines, - Patient with an ECOG performance status 0 or 1, and AML patients with anemia resulting in an ECOG performance status of 2, - Patient with adequate bone marrow reserve, hepatic and renal functions. - Patients must have sufficient pulmonary functions with a Forced Expiratory Volume in the first second (FEV-1)/Forced Vital Capacity (FVC) ≥ 0.7 with FEV-1 ≥ 50% predicted. Main exclusion criteria are: - Patient with a tumor metastasis in the central nervous system, - Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis (except hydroxyurea for AML patients), - Patients who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first NKR-2 administration (except hydroxyurea for AML patients), - Patient is under systemic immunosuppressive drugs, unless specific cases authorized per protocol, - Patients who have received other cell therapies, - Patients who underwent major surgery within 4 weeks before the planned day for the first NKR-2 administration. - Patient cannot present with history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute exacerbation of chronic obstructive pulmonary disease (COPD). Detailed disease specific criteria exist and can be discussed with contacts listed below. ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NKR-2 infusion; SECONDARY OUTCOME 1: Clinical activity of the treatment in each tumor type[/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 - Exploratory; BRIEF: The primary objectives of this study are to characterize [18F]molecular neuroimaging (MNI)-1020, a positron emission tomography (PET) radioligand for imaging tau pathology, to visually and quantitatively assess and compare brain uptake and pharmacokinetics of [18F]MNI-1020 in participants with probable Alzheimers disease (AD) and compare with age matched healthy participants, to evaluate the safety of a single injection of [18F]MNI-1020 and to compare the distribution of tau (using [18F]MNI-1020) and amyloid beta (using florbetapir) in participants with probable AD. ; DRUG USED: [18F]MNI-1020; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease - Imaging; TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: All Participants - Female participants must be documented by medical records or physicians note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year. Male participants and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male participants for the study duration - Male participants must not donate sperm during the study and for 3 months after completion Healthy Participants - Males and females aged greater than or equal 50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the [18F]molecular neuroimaging (MNI)-1020 imaging visit - Have screening [18F]florbetapir positron emission tomography (PET) imaging demonstrating no significant amyloid binding based on qualitative analysis (visual read) Alzheimer Disease - Have screening [18F]florbetapir or prior amyloid (in the last 12 months) PET imaging demonstrating amyloid binding based on qualitative (visual read) Exclusion Criteria: All Participants - Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 millisievert (mSv), which would be above the acceptable annual limit established by the United States Federal Guidelines - Unsuitable veins for repeated venipuncture - Magnetic resonance imaging exclusion criteria include: evidence of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct greater than 1 centimeter 3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the FLAIR sequence that is greater than or equal to 20 millimeter (mm) in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with central nervous system disease - Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, central nervous system aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in Magnetic Resonance Imaging (MRI) Alzheimer Disease - Has received treatment that targeted amyloid beta or tau within the last 3 months ; PRIMARY OUTCOME: Standardized Uptake Value Ratio (SUVR) of [18F]MNI-1020; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - AL011; BRIEF: study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with PI-ADHD. subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as follows: 1. week 1:1400 mg, week 2:700 mg, week 3:placebo 2. week 1:700 mg,week 2: placebo,week 3:1400 mg 3. week 1: placebo, week2:1400 mg, week 3 700 mg The study will consist of three periods: a screening period of up to one week, a 3-week double-blind treatment period, and a one-week safety follow-up period. ; 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: 1. Adult men and women, 18 to 55 years old 2. Diagnosed with predominantly inattentive ADHD based on DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS V1.2); 3. Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above) 4. TOVA ADHD score of -1.8 or below at Screening /Baseline 5. Women with childbearing potential must agree to use effective contraceptive and have negative urine pregnancy test at screening visit 6. Able to attend the clinic regularly and reliably 7. Able to swallow tablets/capsules 8. Able to understand, read, write and speak Hebrew fluently to complete study related materials 9. Able to understand and sign written informed consent to participate in the study Exclusion Criteria: 1. Subjects with ADHD not otherwise specified (NOS) diagnosis 2. Subjects with combined type or predominantly hyperactive impulsive ADHD diagnoses 3. Subjects with current Axis I diagnosis on SCID 4. Subjects with lifetime bipolar or psychosis 5. Subjects in treatment for Axis I disorders, even if the disorder is remitted 6. Subjects who were non-responders to at least two adequately administered ADHD treatments 7. Subjects with any medical or psychiatric condition common diseases such as hypertension, type 2 diabetes mellitus, hyperlipidemia, etc. are allowed per the Investigators judgment, as long as they are stable and controlled by medical therapy that is constant for at least 8 weeks prior to randomization and throughout the study 8. Any prescription or non-prescription ADHD medications during the 14 days (for stimulants) or 28 days (for non-stimulants and other psychotropics) prior to the screening visit 9. Known or suspected HIV-positive or with advanced diseases such as AIDS, Hepatitis C, Hepatitis B or tuberculosis 10. History of allergy or sensitivity to B complex vitamins 11. History or suspicion of PDD, NLD or other psychotic conditions 12. Use of Vitamin B throughout the study (either alone or in any multi-vitamin) 13. Use of ADHD medications throughout the study 14. Use of any psychotropic medications throughout the study 15. Use of investigational medication/treatment in the past 30 days prior to the screening visit 16. Use of any medication or food supplement unless cleared by the medical monitor during the 14-day period before randomization 17. Current (or history within the last 6 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine). Subjects should also agree to refrain from significantly changing consumption of caffeine during the study. 18. Suicidality, defined as active ideation, intent or plan, or any lifetime attempt (CSSRS) 19. Subjects who cannot complete any study instruments or questionnaires 20. Any relation to the Sponsor, Investigator or study staff 21. Any condition, which in the opinion of the Principal Investigator would place the subject at risk or influence the conduct of the study or interpretation of results, including (but not limited to) abnormally low intellectual capacity. 22. Subjects who cannot fully comprehend the implications of the protocol or comply with its requirements or are capable to follow the study schedule for any reason 23. Women of childbearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (e.g., oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam]; intrauterine devices; partner with vasectomy; or abstinence) during the study. Note that this inclusion criterion applies only to females of childbearing potential. Females of childbearing potential are defined as women not surgically sterilized and between menarche and 2 years post-menopause ; PRIMARY OUTCOME: Change in TOVA ADHD score from Screening/Baseline to 4 hours post-dose;; SECONDARY OUTCOME 1: Change in CANTAB sub-scores from baseline (Visit 2) to 4 hours post-dose;[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - I8H-MC-BDCP; BRIEF: The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes. ; DRUG USED: LY3209590; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year - Participants must have been using multiple daily injections without interruption for at least 3 months - Participants must have HbA1c values of 5.6% to 9.5%, inclusive - Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²) Exclusion Criteria: - Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening - Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening - Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke) - Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease - Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m² - Have active or untreated cancer - Are receiving chronic (>14 days) systemic glucocorticoid therapy ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: Change From Baseline in Fasting Serum Glucose[/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 - CLIMB-SCD-121; BRIEF: This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in subjects with severe sickle cell disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001. ; DRUG USED: CTX001; DRUG CLASS: Biologic; INDICATION: Sickle Cell Anemia; TARGET: BCL11A, CRISPR/CRISPR-Cas9; THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Key Inclusion Criteria: - Diagnosis of severe sickle cell disease as defined by: - Documented severe sickle cell disease genotype - History of at least two severe vaso-occlusive crisis events per year for the previous two years prior to enrollment - Eligible for autologous stem cell transplant as per investigators judgment Key Exclusion Criteria: - An available 10/10 human leukocyte antigen (HLA)-matched related donor - Prior hematopoietic stem cell transplant (HSCT) - Clinically significant and active bacterial, viral, fungal, or parasitic infection Other protocol defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Proportion of subjects who have not experienced any severe vaso-occlusive crisis (VOC) for at least 12 consecutive months (VF12); SECONDARY OUTCOME 1: Proportion of subjects free from inpatient hospitalization for severe VOCs sustained for at least 12 months (HF12)[/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 - NI-AC101 (8% Gel); BRIEF: This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204. ; DRUG USED: SB204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acne; TARGET: Nitric Oxide/ Nitrogen Monoxide; THERAPY: Monotherapy; LEAD SPONSOR: Novan, Inc.; CRITERIA: Inclusion Criteria: - Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders - 18 years of age and older Exclusion Criteria: - Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc. - Subjects who smoke or use tobacco products - Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter. - Subjects with a previous history of methemoglobinemia - Subjects being treated with nitrates or any drug associated with methemoglobinemia - Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens. ; PRIMARY OUTCOME: Pharmacokinetics of nitrate and silicon; SECONDARY OUTCOME 1: 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 I - Healthy Subjects (Hepatic Impairment); BRIEF: This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects. ; DRUG USED: Tozadenant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Adenosine A2a Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biotie Therapies Inc.; CRITERIA: Inclusion Criteria: All subjects must fulfill the following to participate: - Subject has given his/her written informed consent on an IEC or IRB approved consent form. - Subject understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol. - Be either male or female 18 years old - Have a BMI ≥ 18.5 and ≤ 40.0 kg/m2 at screening - Is a continuous non-smoker or a smoker who will consume up to 10 cigarettes/day - Child bearing females should be sexually inactive (abstinent) prior to dosing - Females subjects of non childbearing potential must have undergone one of the following sterilization or be postmenopausal Subjects with mild, moderate, or severe hepatic impairment must: - Have a medical history consistent with a diagnosis of hepatic impairment. - Have a diagnosis of chronic (> 6 months), stable hepatic insufficiency Healthy subjects must be: - Medically healthy with no significant medical history Exclusion Criteria: Subjects must not be enrolled in the study if they: - Previously participated in any study with tozadenant - Has orthostatic hypotension, history or symptoms of cardiovascular disease, or hypertensive crisis. - Currently participating in or has participated in another study and received drug (active or placebo) - Have a known diagnosis of malignant melanoma - Have a current episode of major depression - Has a recent history of suicide attempt - Has any other condition or clinically significant abnormal findings on the physical or neurological examination, psychiatric and medical history - Had surgery or any medical condition within 6 months - Unable to refrain from or anticipates the use of any drugs, vitamins, natural or herbal supplements - Subject is currently lactating or pregnant or planning to become pregnant. - Recent donation of blood, plasma or significant blood loss - Has positive test for ethanol or drugs of abuse or a history of chronic alcohol or drug abuse - Clinically significant medical history - Positive results hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) for Healthy Volunteers only. ; PRIMARY OUTCOME: To evaluate the pharmacokinetics (PK) [area under the time-concentration curve] of a single-dose of tozadenant in subjects with hepatic impairment to healthy subjects.; SECONDARY OUTCOME 1: Subjects with hepatic impairment will be evaluated for safety assessments (adverse events and treatment-related adverse events) by physical examinations.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - w/BAY86-9766; BRIEF: The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following questions: 1. What are the side effects of the combination of Copanlisib and Refametinib (BAY86-9766)when given together at different/increasing dose levels? 2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future clinical research studies? 3. How much Copanlisib is in the blood at specific times after administration and does adding Refametinib (BAY86-9766) have an affect? 4. How much Refametinib (BAY86-9766) is in the blood at specific times after administration and does adding Copanlisib have an affect? 5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on tumors? ; DRUG USED: Aliqopa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Age greater than/equal to 18 years old - ECOG Performance Status of 0 - 1 - Life expectancy of at least 12 weeks - Patients with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy or have no standard therapy available - LVEF (left ventricular ejection fraction) > or = to the lower limit of normal for the institution - Radiographically or clinically evaluable tumor - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose: - Hemoglobin > 9.0 g/dL - Absolute neutrophil count (ANC) > or = 1500/mm3 - Platelet count > or = 100,000 /mm3 - Total bilirubin < or = 1.5 times the upper limit of normal - ALT (alanine aminotransferase) and AST (aspartate aminotransferase) < or = 2.5 x upper limit of normal (< or = 5 x upper limit of normal for patients with liver involvement) - PT-INR (prothrombin-international normalized ratio) and PTT (partial thromboplastin time) < or = 1.5 times the upper limit of normal - Serum creatinine < or = 1.5 times the upper limit of normal Exclusion Criteria: - History of impaired cardiac function or clinically significant cardiac disease (i.e. congestive heart failure (CHF) NYHA (New York Heart Association) Class III or IV); active coronary artery disease, myocardial infarction within 6 months of study entry; new onset or unstable angina within 3 months of study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy - Type 1 or type 2 diabetes mellitus or fasting glucose > 125 mg/dL or HgBA1c > or = 7.0 - Use of systemic corticosteroids within 2 weeks of study entry - History of retinal vein occlusion - Known glucose-6-phosphate dehydrogenase (G6PD) deficiency - Active clinically serious infection - Uncontrolled hypertension - Positive for HIV, or chronic Hepatitis B or C - Subjects undergoing renal dialysis - Known bleeding diathesis - Ongoing substance abuse - Pregnant or breast-feeding women ; PRIMARY OUTCOME: Maximum Tolerated Dose; SECONDARY OUTCOME 1: Tumor Response as measured by RECIST 1.1 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 II - Neoadjuvant (CSCC; Moffitt); BRIEF: The purpose of this research study is to determine how people with weakened immune systems and unresectable (cannot be removed by surgery) locally recurrent and/or metastatic cutaneous squamous cell carcinoma (CSCC) respond to study treatment with Cemiplimab. Cemiplimab is approved for sale in United States by the U.S. Food and Drug Administration (FDA). ; DRUG USED: Libtayo; DRUG CLASS: Biologic; INDICATION: Skin Cancer - Squamous Cell Carcinoma (SCC) ; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: H. Lee Moffitt Cancer Center and Research Institute; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of invasive Cutaneous Squamous Cell Carcinoma (CSCC) - Immunocompromised patients with invasive CSCC. Immunocompromised patients are defined as: (a) History of HIV with CD4 counts >/= 200 and no AIDS-defining illness (b) History of treated or active hematologic malignancies including lymphoma, Hodgkins disease, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative neoplasm. - At least 1 lesion that is measurable by study criteria by RECIST 1.1. Externally visible cutaneous Squamous Cell Cancer (SCC) target lesion(s) greater than >10 mm, bi-dimensional measurements of the external lesion(s) with a color photograph may be used as target lesions. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Laboratory values as defined per protocol - Ability to sign informed consent - Ability and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study-related procedures. - CSCC not amenable to surgery or radiation therapy such as unresectable tumors determined by surgeons, surgical morbidity unacceptable by the patients, inability to deliver radiation safely determined by radiation oncologists, or radiation related toxicities unacceptable by the patients. Note: In lieu of individual consults performed during screening, it will suffice to document the contraindication of surgery and radiation therapy via a clinic note from the investigator indicating that an individualized benefit:risk assessment was performed by a multidisciplinary team (consisting of, at minimum, a radiation oncologist AND EITHER a medical oncologist with expertise in cutaneous malignancies OR a dermato-oncologist, OR a head and neck surgeon) within 60 days prior to enrollment in the proposed study, and the radiation therapy was deemed to be contraindicated. This is not required for patients with distant metastatic disease. Exclusion Criteria: - Prior known allergy to Cemiplimab-rwlc - Prior exposure to PD-1 or PD-L1 inhibitors - Prior exposure to idelalisib - Immunocompromised patients due to solid organ transplant, allogenic bone marrow transplant, and/or autoimmune disease. - Untreated brain metastasis(es) that may be considered active. - Immunosuppresive corticosteroid doses (>10 mg prednisone daily or equivalent for >5 consecutive days) within 4 weeks prior to the first dose of Cemiplimab-rwlc. - Known active infection requiring therapy, including acute infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). However, it is not required to test only to determine the eligibility for the trail. As an exception, known HIV infection is allowed. - History of pneumonitis within the last 5 years. - Grade >/= 3 hypercalcemia at time of enrollment - Patients on any systemic anticancer treatment (chemotherapy, targeted systemic therapy, photodynamic therapy), investigational or standard of care for CSCC within 28 days of the initial administration of Cemiplimab-rwlc are excluded. - Patients on any systemic anticancer treatment (chemotherapy, targeted systemic therapy, photodynamic therapy), investigational or standard of care for non-hematologic malignancy within 28 days of the initial administration of Cemiplimab-rwlc or planned to occur during the study period are excluded. NOTE: (a) Patients receiving bisphosphonates or denosumab are not excluded. (b) Patients receiving maintenance or supportive therapies for their hematological malignancies are not excluded. (c) If the patients have been disease free for >2 years, patients receiving adjuvant hormonal therapies for breast cancer, prostate cancer, or thyroid cancer are not excluded. - Patients who cannot discontinue the concurrent use of other chemopreventive agents such as 5-FU, capecitabine, Efudex, imiquimod, acitretin are not allowed. - Radiation therapy within 7 days of initial administration of Cemiplimab-rwlc or planned to occur during the study period. - Breast feeding - Positive serum pregnancy test (a false positive pregnancy test, if demonstrated by serial measurements and negative ultrasound, will not be exclusionary) - Concurrent non-hematologic malignancy other than cutaneous SCC within 3 years of date of first planned dose of Cemiplimab-rwlc , except for tumors with negligible risk of metastasis or death, such as adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, or low-risk early stage prostate adenocarcinoma (T1-T2a N0 M0 and Gleason score ≤6 and PSA ≤10 ng/mL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of > 12 months for which the management plan is active surveillance. - Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the patient ineligible for participation. - Continued sexual activity in men or women of childbearing potential who are unwilling to practice highly effective contraception during the study and until 6 months after the last dose of study drug. Note: Highly effective contraceptive measures include stable use of oral contraceptives such as combined estrogen and progestogen and progestogen only hormonal contraception or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal ligation; vasectomy, and sexual abstinence. ; PRIMARY OUTCOME: Overall Response Rate; SECONDARY OUTCOME 1: Progression Free Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DELTA; BRIEF: The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety. ; DRUG USED: Zydelig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: p110 delta/PIK3CD, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group [ECOG] performance score of 0, 1, or 2) - Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following: - Follicular lymphoma (FL) - Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration - Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM) - Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal) - Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL - Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy - Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL - Lymphoma that is refractory to rituximab and to an alkylating agent - Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2 - For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods - Willingness and ability to provide written informed consent and to comply with the protocol requirements Key Exclusion Criteria: - Central nervous system or leptomeningeal lymphoma - Known histological transformation from iNHL to diffuse large B-cell lymphoma - History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years - Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment - Pregnancy or breastfeeding - Ongoing alcohol or drug addiction - Known history of drug-induced liver injury, chronic active hepatitis B infection, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation - Ongoing immunosuppressive therapy, including systemic corticosteroids. Participant may be using topical or inhaled corticosteroids. - Prior therapy with idelalisib - Exposure to another investigational drug within 3 weeks prior to start of study treatment - Concurrent participation in another therapeutic treatment trial - Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigators opinion, could affect the safety of the participant, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Overall Response Rate; SECONDARY OUTCOME 1: Duration of Response[/INST]Yes</s>