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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/IIa - ESPS-001; BRIEF: The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors. ; DRUG USED: ESP-01; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Cell Cycle Checkpoint Kinase 1 (Chk1); THERAPY: Monotherapy; LEAD SPONSOR: Esperas Pharma Inc.; CRITERIA: Inclusion Criteria: - Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale - Have an estimated life expectancy of greater than or equal to (≥)12 weeks - Have adequate organ function - Have received 1-4 prior systemic therapies for locally advanced or metastatic disease - Agree to use medically approved contraceptives during the study and for 3 months following the last study treatment - All females must have a negative serum pregnancy test result, and females of child-bearing potential must have a negative urine pregnancy test result, prior to the first study treatment - Have tumor lesions considered measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Must be, in the judgment of the investigator, an appropriate candidate for experimental therapy, and no standard therapy would confer clinical benefit For Part A - Must have evidence of cancer (solid tumors, excluding glioblastoma and primary brain tumor) that is advanced or metastatic - For the Metabolism Phenotype Arm in Part A, participants must have a Cytochrome P450 (CYP2D6) poor metabolizer phenotype For Part B - Have advanced or metastatic colorectal cancer, triple negative breast cancer (per American Society of Clinical Oncology-College of American Pathology guidelines), epithelial ovarian cancer, endometrial, soft tissue sarcoma, pancreatic cancer - For TNBC: - Recurrent/refractory Triple Negative Breast Cancer (TNBC) defined as any beast cancer that expresses <1% estrogen receptor (ER) and <1% progesterone receptor (PR) and is Her2 negative - For Colorectal (CRC): - Must have histologically confirmed advanced or metastatic colorectal cancer - For Ovarian Cancer: - Must have histologically confirmed advanced or metastatic epithelial ovarian cancer - Must be eligible to receive Gemzar (GEM) and not refractory to GEM/carboplatin - Must have the ability to tolerate GEM - May have received GEM as previous therapy - For Endometrial cancer: - Must have histologically confirmed endometrial cancer that is metastatic or locally advanced - Must have failed at least 1 prior chemotherapy - For STS: - Must have histologically confirmed STS that is metastatic or locally advanced - Patients with gastrointestinal stromal tumors (GIST) must have failed a KIT inhibitor - Must have failed at least 1 prior chemotherapy - For Pancreatic Cancer: - Must have histologically confirmed pancreatic cancer that is metastatic or locally advanced - Must have failed at least 1 prior chemotherapy regimen - For Part C - Participants with high grade serous ovarian cancer (HGSOC) will be screened for specific genetic signatures Exclusion Criteria: - Have received treatment with an investigational drug which has not received regulatory approval within 21 days of first study treatment - Have symptomatic central nervous system (CNS) metastasis - Females who are pregnant or nursing - Have known positive test results of human immunodeficiency virus, or have chronic active hepatitis A, B or C - Have a corrected QT interval (QTcB) greater than (>) 470 milliseconds (msec) (female) or >450 msec (male), or a history of congenital long QT syndrome - Have had a bone marrow transplant - Have participated in this study, or are currently enrolled in another clinical study of an investigational medicinal product - Have had radiation therapy to >25% of bone marrow - For Part B - Have a history of another active cancer within the past year, except cervical cancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of the skin, or another in situ carcinoma that is considered cured ; PRIMARY OUTCOME: Maximum Tolerated Dose(s); SECONDARY OUTCOME 1: Number of dose limiting toxicities (DLTs)[/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 - MC-AMAC; BRIEF: The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug. ; DRUG USED: Mirikizumab; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure) - Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved colon) - Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor - Participants must either: be naive to biologic therapy (eg, tumor necrosis factor [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment Exclusion Criteria: - Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohns Disease - Have had surgery for treatment of UC or are likely to require surgery for UC during the study - Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening ; PRIMARY OUTCOME: Induction Period: Percentage of Participants With Clinical Remission at Week 12; SECONDARY OUTCOME 1: Induction Period: Percentage of Participants With Clinical Response at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PROUD-PV; BRIEF: Phase III study to compare the efficacy and safety of the novel monopegylated interferon alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year treatment of patients with polycythemia vera. Objective is to demonstrate non-inferiority of AOP2014 vs. HU in terms of disease response rate in both HU naïve and currently treated patients, diagnosed with Polycythemia Vera. Response is measured as normalisation of key lab parameters as well as normalized spleen size. ; DRUG USED: Ropeginterferon alfa-2b; DRUG CLASS: Biologic; INDICATION: Polycythemia Vera (PV); TARGET: Interferon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AOP Orphan Pharmaceuticals AG; CRITERIA: Inclusion Criteria: 1. 18 years or older 2. Diagnosis of Polycythemia Vera according to the WHO 2008 criteria (Barbui et al, 2011) with the mandatory presence of JAK2V617F mutation as the major disease criterion. 3. For previously cytoreduction untreated patients - documented need of cytoreductive treatment - leukocytosis (WBC>10G/L for two measurements within one week) 4. For patients currently treated or pre-treated with HU, all of the following criteria: - being non responders (as defined by the response criteria for primary endpoint) - total HU treatment duration shorter than three years - no documented resistance or intolerance as defined by modified Barosi et al, 2009 criteria 5. Hospital Anxiety and Depression Scale (HADS) score 0-7 on both subscales 6. Patients with HADS score of 8-10 inclusive on either or both of the subscales may be eligible following psychiatric assessment that excludes clinical significance of the observed symptoms in the context of potential treatment with an interferon alpha 7. Signed written informed consent Exclusion Criteria: 1. Any systematic cytoreduction for PV prior study entry with exception of HU for shorter than 3 years (see respective inclusion criterion) 2. Any contraindication to any of the IMPs (pegylated interferon or hydroxyurea) or their excipients 3. Any systemic exposure to a non-pegylated or pegylated interferon alpha 4. Documented autoimmune disease at screening or in the medical history 5. Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening 6. Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening 7. Known PV-related thromboembolic complications in the abdominal area (e.g. portal vein thrombosis, Budd-chiari syndrome) and/or splenectomy in the medical history 8. Any investigational drug less than 6 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent 9. History or presence of depression requiring treatment with antidepressant 10. HADS score equal to or above 11 on either or both of the subscales 11. Any risk of suicide at screening or previous suicide attempts 12. Any significant morbidity or abnormality which may interfere with the study participation 13. Pregnancy and breast-feeding females of reproductive potential and males not using effective means of contraception 14. History of active substance or alcohol abuse within the last year 15. Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension) 16. Thyroid dysfunction not adequately controlled 17. Patients tested positively with TgAb and / or TPOAb at screening 18. History of major organ transplantation 19. History of uncontrolled severe seizure disorder 20. Leukocytopenia at the time of screening 21. Thrombocytopenia at the time of screening 22. History of malignant disease, including solid tumours and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years ; PRIMARY OUTCOME: Disease response rate; SECONDARY OUTCOME 1: Disease 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 III - ACES 256; BRIEF: This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participants self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participants medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ. ; DRUG USED: Aripiprazole/Escitalopram; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥ 8 weeks in duration - Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period - Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at the Baseline Visit for the Prospective Treatment Phase. Exclusion Criteria: - Lack of prior treatment with an antidepressant during the current depressive episode - Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode. - Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode - Participants with epilepsy or significant history of seizure disorders - Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder - Participants who have received electroconvulsive therapy (ECT) in the last 10 years. ; PRIMARY OUTCOME: Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14); SECONDARY OUTCOME 1: Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at The End of Phase C (Week 14)[/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 - 01; BRIEF: AZD8233 has not been evaluated in clinical studies previously. This is a first-in-human (FiH) study. This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD8233, following subcutaneous (SC) administration of single ascending dose (SAD) of AZD8233. This study will also investigate the pharmacodynamics (PD) of AZD8233 by investigating the effect of AZD8233 on levels of cholesterol and related biomarkers. ; DRUG USED: AZD8233; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of signed and dated, written informed consent before any study specific procedures. 2. Healthy male subjects aged 18 to 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture. 3. Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 60 kg and no more than 100 kg inclusive at the Screening Visit and Day -1. 4. Have a LDL-C ≥ 100 mg/dL < 190 mg/dL at the Screening Visit and Day -1, test may be repeated once for each visit at the discretion of the Investigator if out of the range. 5. Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol. Exclusion Criteria: 1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subjects ability to participate in the study. 2. History or presence of GI, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs. 3. Any clinically important illness, medical/surgical procedure or trauma within 4weeks of the first administration of IMP. 4. Any laboratory values with the following deviations at the Screening Visit and/or Day -1, test may be repeated once for each visit at the discretion of the Investigator if out of range: 4.1.Alanine aminotransferase (ALT)> upper limit of normal (ULN). 4.2.Aspartate aminotransferase (AST)> ULN. 4.3.Creatinine > ULN. 4.4.White blood cell (WBC)< LLN. 4.5.Hemoglobin< LLN. 4.6.Platelet count ≤150000/μL. 4.7.Activated partial thrombin time greater than ULN and PT greater than ULN. 4.8.Have an eGFR < 60mL/min. 4.9.Have an urinary albumin-to-creatinine ratio(ACR)> 3mg/μmol (30mg/g). 5. Any other clinically important abnormalities in clinical chemistry, hematology or urinalysis results, than those described under exclusion criterion number 4, as judged by the Investigator. 6. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV). 7. Abnormal vital signs, after 10 minutes supine rest, with the following deviations at the Screening Visit and/or Day -1, test may be repeated once for each visit at the discretion of the Investigator if out of range: 7.1.Systolic BP< 90mmHgor> 140mmHg. 7.2.Diastolic BP< 50mmHgor > 90mmHg. 7.3.Heart rate < 45 or > 85 beats per minute(bpm). 8. Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12 Lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy at the Screening Visit or Day -1, test may be repeated once for each visit, at the discretion of the Investigator if out of range. 8.1. Prolonged QTcF > 450 ms. 8.2. Shortened QTcF < 340 ms. 8.3. Family history of long QT syndrome. 8.4. PR (PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation). 8.5. PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block, or AV dissociation. 8.6. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of e.g., ventricular hypertrophy or pre-excitation. 9. Known or suspected history of drug abuse as judged by the Investigator. 10. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months before the Screening Visit. 11. History of alcohol abuse or excessive intake of alcohol as judged by the Investigator. 12. Positive screen for drugs of abuse, alcohol, or cotinine (nicotine) at the Screening Visit or positive screen for drugs of abuse or alcohol, on admission to the Clinical Unit. 13. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8233. 14. Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate,) as judged by the Investigator. 15. Use of drugs with enzyme inducing properties such as St Johns Wort within 3 weeks before the first administration of IMP. 16. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times t he recommended daily dose) and minerals during the 2 weeks before the first administration of IMP or longer if the medication has a long half-life. 17. Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months before the Screening Visit. 18. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous Phase 1 study, are not excluded. 19. Involvement of any Astra Zeneca or study site employee or their close relatives. 20. Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements. 21. Subjects who are vegans or have medical dietary restrictions. 22. Subjects who cannot communicate reliably with the Investigator. 23. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order. In addition, any of the following is regarded as a criterion for exclusion from the genetic research: 24. Previous bone marrow transplant. 25. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection. ; PRIMARY OUTCOME: Number of subjects with adverse events (AEs) due to AZD8233 SC SAD treatment; SECONDARY OUTCOME 1: Plasma PK analysis: Time delay between drug administration and the first observed concentration in plasma (tlag)[/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 - LAC-MD-21; BRIEF: The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma. This study will include a screening visit followed by a 4 month treatment period. ; DRUG USED: Formoterol Fumarate Pressair; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Adrenergic Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusions: - Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as defined in the GINA Guidelines) which is unlikely to exacerbate during the study (e.g., due to seasonal allergen exposure). - Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at least 30 days prior to Visit 1. Patients on a combination of ICS/LABA must discontinue the use of LABA and must be on a stable dose of ICS for 30 days prior to Visit 1. - Qualifying spirometry at Visit 1 demonstrates highest FEV1 is ≤ 85% and ≥ 60% of predicted for age, height, and gender using NHANES III (NHANES 2010) when bronchodilator medications have been withheld the appropriate length of time per the List of Concomitant Medications (Appendix III) - Patient demonstrates reversibility with an increase in FEV1 of 12% and 200 mL after the administration of 360 µg of albuterol. - Highest pre-dose FEV1 at Visits 2, 4, 6, 8, and 10 must be within 25% of the qualifying FEV1 at Visit 1 Exclusions: - Patients with any clinically significant respiratory conditions other than mild to moderate asthma, such as COPD, active tuberculosis, or history of interstitial lung disease - Patients with a severe asthma exacerbation requiring hospitalization in the previous 12 months - Patient is not able to withhold use of inhaled short-acting beta-agonist (SABA) for at least 6 hours prior to visit ; PRIMARY OUTCOME: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14); SECONDARY OUTCOME 1: Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 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 - SAD (Healthy); BRIEF: Safety, Tolerability and Pharmacokinetics of PF-06818883 ; DRUG USED: PF-06818883; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hemorrhagic Stroke / Intracerebral Hemorrhage (ICH); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy female subjects of nonchildbearing potential and/or male subjects - Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). - Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study - Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease - Any condition possibly affecting the placement of an intravenous drug administration line. - A confirmed positive urine drug screen - History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening - Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day - Treatment with an investigational drug within 30 days (or as determined by the local requirement) - Screening supine blood pressure >140 mm Hg (systolic) or <90 mm Hg (diastolic), following at least 5 minutes of supine rest - Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec. - Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing. - History of sensitivity to heparin or heparin-induced thrombocytopenia - History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or hepatitis C antibody (HCVAb). - Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product ; PRIMARY OUTCOME: Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability; SECONDARY OUTCOME 1: Maximum Observed Plasma Concentration (Cmax) after single dose for all periods[/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 - NeoCOAST; BRIEF: Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC). ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: 1. Cytologically and/or histologically-documented NSCLC 1. Stage I (> 2 cm) to IIIA (for participants with N2 disease, only those with 1 single nodal station ≤ 3 cm are eligible) NSCLC according to the 8th edition of American Joint Committee on Cancer staging classification 2. Amenable to complete surgical resection 3. Have not received any other therapy for this condition 2. Predicted forced expiratory volume in one second (FEV1) ≥ 50% 3. Predicted diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50% 4. ECOG 0 or 1 5. Adequate organ function Exclusion Criteria: 1. Participants with small-cell lung cancer or mixed small-cell lung cancer 2. Participants who require or may require pneumonectomy 3. Prior treatment with programmed cell death ligand-1 (PD-L1), PD-L1, or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitors 4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug. 5. Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: 1. Participants with vitiligo or alopecia 2. Participants with hypothyroidism on hormone replacement 3. Any chronic skin condition that does not require systemic therapy 4. Participants without active disease in the last 5 years may be included but only after consultation with the study physician 5. Participants with celiac disease controlled by diet alone 6. Pregnant or breast-feeding female 7. Major surgical procedure within prior 30 days 8. History of active primary immunodeficiency 9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV 10. QTc interval (QTc) ≥ 470 ms 11. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent 12. Receipt of live attenuated vaccination within 30 days prior to study entry 13. History of another primary malignancy except for: 1. Curative-treated malignancy with no known active disease > 2 years before enrollment on the study 2. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ ; PRIMARY OUTCOME: Major Pathological Response Rate; SECONDARY OUTCOME 1: Pathological Complete Response (pCR) Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - BNZ-CT-101; BRIEF: This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family. ; DRUG USED: BNZ-1; DRUG CLASS: Biologic; INDICATION: Cutaneous T-Cell Lymphoma (CTCL) - NHL; TARGET: IL-15 (Interleukin-15)/IL-15 Receptor, IL-2 (Interleukin-2), IL-9 (Interleukin-9); THERAPY: Monotherapy; LEAD SPONSOR: Bioniz Therapeutics; CRITERIA: Inclusion Criteria: - males and non-pregnant, non-lactating females - no ongoing clinically significant medical condition - willing and able to provide informed consent - no use of Rx or OTC medications, other than oral contraceptives Exclusion Criteria: - Recent systemic infections - Clinically-significant abnormal clinical labs, ECG or physical examination - Immunization 30 days prior to study ; PRIMARY OUTCOME: The proportion of subjects with related, treatment-emergent adverse events; SECONDARY OUTCOME 1: PK: Exposure as determined by maximum plasma concentration (Cmax)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - EMBRACE-STEMI; BRIEF: The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of IV administered elamipretide (also known as MTP-131, or Bendavia) on a background of standard-of-care therapy for reduction of reperfusion injury in patients with first time acute, anterior wall ST-segment elevation myocardial infarction (STEMI). ; DRUG USED: Elamipretide (Systemic Delivery); DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Mitochondria, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Stealth BioTherapeutics Inc.; CRITERIA: Inclusion Criteria: - Age ≥18 and <85 years - The patient presents with first-time acute, anterior wall STEMI scheduled to undergo primary PCI and stenting. - The patient has symptoms of cardiac ischemia of ≥10 minutes. - The patient must demonstrate an anterior wall STEMI with >0.1 millivolt (mV) ST-segment elevation in at least two contiguous precordial leads (i.e., V1-V4) or presumed new left bundle branch block. - The time from onset of symptoms of cardiac ischemia to the anticipated time of initial PCI balloon inflation does not exceed four (4) hours and it is anticipated that the door-to-balloon time will be <2 hours. - For female patients of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the follow-up visit. Female patients of childbearing potential must have a negative serum pregnancy test prior to entry into the study. - Female patients not of childbearing potential (i.e. female patients who are postmenopausal since last regular menses, or have been surgically sterilized at least 1 year prior to screening visit) are eligible to enter the study. - For male patients with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the post-study medical. - Written informed consent obtained that strictly adheres to the written guidelines from the local Institutional Review Board (IRB)/ Ethical Committee (EC). Exclusion Criteria - Cardiogenic shock or maximal systolic blood pressure (BP) <80 mm Hg after fluid and/or vasopressor resuscitation on at least two consecutive readings. - Ongoing vasopressor support. - Uncontrolled hypertension defined as a systolic BP >180 mm Hg or a diastolic BP >110 mm Hg on at least two consecutive readings. - Cardiac arrest or arrhythmia requiring prolonged (>5 minutes) chest compressions/ cardiopulmonary resuscitation (CPR). - Prior coronary artery bypass graft surgery (CABG). - Prior myocardial infarction (MI). - Implantable cardioverter-defibrillator (ICD) or permanent pacemaker (PPM) unless known to be MRI safe. The presence of an MRI-compatible pacemaker or other MRI-compatible hardware will not be a contraindication to participation in this trial. - Known left ventricular ejection fraction <30% prior to the qualifying infarct. - History of clinically significant hepatic disturbance or chronic renal impairment at the time of admission. - Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days. - Any known disorder that is associated with immunologic dysfunction (e.g., cancer, lymphoma, a positive serologic test for the human immunodeficiency virus, or hepatitis) more recently than 6 months before presentation or the administration of immunosuppressive drugs within 10 days of the STEMI at doses expected to be associated with immunosuppression including high dose steroids (>2.5 mg/d hydrocortisone or equal potency of synthetic steroids), tumor necrosis factor-alpha (TNF-α) blockers or methotrexate/azathioprine. - Any condition that, in the Investigators opinion, would prevent adherence to the requirements of the protocol including language barrier or current alcohol or drug abuse. - Contraindications (including claustrophobia) to cardiac MRI at study entry. - Participation in an investigational drug or device study within the 30 days prior to enrollment into the EMBRACE-STEMI Trial or anticipated within the next 4 days. - Female patients who are pregnant or breastfeeding during the study or intend to within 30 days of receiving study drug. ; PRIMARY OUTCOME: Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB); SECONDARY OUTCOME 1: AUC of Troponin 1 Enzyme[/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 - C326 (TKA); BRIEF: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 232 adult subjects undergoing primary unilateral TKA under general or spinal anesthesia. ; DRUG USED: Exparel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anesthesia; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Male or female, at least 18 years of age at screening. 2. Scheduled to undergo primary unilateral TKA under general or spinal anesthesia. 3. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3. 4. Female subject must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study. 5. Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch. 6. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments. Exclusion Criteria: 1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. 2. Planned concurrent surgical procedure (e.g., bilateral TKA). 3. Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the knee surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, concurrent or prior contralateral TKA, concurrent foot surgery). 4. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted. 5. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics. 6. Contraindication to any one of the following: bupivacaine, oxycodone, morphine, or hydromorphone. 7. Use of any of the following medications within the times specified before surgery: long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours. 8. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration. 9. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study. 10. Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration. 11. History of impaired kidney function, poorly controlled chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in extremities. 12. Impaired kidney function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L] or blood urea nitrogen level >50 mg/dL [17.9 mmol/L]) or impaired liver function (e.g., serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN] or serum alanine aminotransferase [ALT] level >3 times the ULN.) 13. Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments. 14. Any chronic neuromuscular deficit effecting the peripheral nerves or muscles of the surgical extremity. 15. Any chronic condition or disease that would compromise neurological or vascular assessments. 16. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. 17. Suspected or known history of drug or alcohol abuse within the previous year. 18. Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2. 19. Previous participation in an EXPAREL study. 20. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subjects participation in this study. ; PRIMARY OUTCOME: Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores Through 72 Hours; SECONDARY OUTCOME 1: Total Postsurgical Opioid Consumption Through 72 Hours[/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 - JAB-3312-1001; BRIEF: This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles. ; DRUG USED: JAB-3312; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: KRas, MAPK/ERK (mitogen-activated protein kinases/extracellular signal-regulated kinases; Ras-Raf-MEK-ERK pathway); THERAPY: Monotherapy; LEAD SPONSOR: Jacobio Pharmaceuticals Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. 4. Subjects with life expectancy ≥3 months. 5. Patients must have at least one measurable lesion as defined by RECIST v1.1. 6. Patients who have sufficient baseline organ function. Exclusion Criteria: 1. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent). 2. Known malignant central nervous system disease other than neurologically stable, treated brain metastases. 3. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain. 4. 8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 5. History or evidence of active infections (Grade ≥2). 6. History or evidence of significant inflammatory or vascular eye disorder. 7. History of an allogeneic bone marrow or solid organ transplant. 8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312. 9. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312. 10. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment. 11. Subjects experiencing unresolved Grade >1 toxicity before the start of treatment. ; PRIMARY OUTCOME: Number of participants with dose limiting toxicities; SECONDARY OUTCOME 1: Number of participants with adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - BLAST (Consolidation); BRIEF: This study evaluates the addition of BL-8040 to the standard consolidation therapy with cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants will receive BL-8040 and cytarabine in combination, while the other half will receive placebo and cytarabine. ; DRUG USED: Motixafortide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Combination; LEAD SPONSOR: Dr. Petra Tschanter; CRITERIA: Inclusion Criteria: - Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia) - AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy. - AML subjects younger than 60 years at the time of diagnosis with intermediate or high-risk cytogenetics - ECOG performance status ≤2 - Laboratory values as follows (at time of randomization): WBC < 30.000/μl and > 1000/μl, Platelets count > 70.000/μl, Creatinine < 1.0 mg/dl. If creatinine is between 1.0mg/dl and 1.3mg/dl, creatinine clearance should be > 30ml/min as calculated using the Cockroft-Gault formula - Women of child-bearing potential must practice an acceptable method of birth control until 6 month after the last dose of treatment. Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug. - Male with a female partner of childbearing potential using a barrier method of contraception - Written informed consent - Subject is able and willing to comply with the requirements of the protocol. Exclusion Criteria: - Relapsed or refractory AML - Start of induction cycle > 90 days before randomization. - Subjects who have received >2 cycles of induction chemotherapy for AML therapy. - Subjects younger than 60 years at the time of diagnosis with favorable cytogenetics (t(8;21) or inv(16) or t(16;16) or t(15;17)) or the confirmed presence of the resulting fusion protein AML1-ETO, CBFB-MYH11 or PML-RARA. - Subjects for which allogeneic HSCT is planned in CR1. - Planned further maintenance therapy after the end of the protocol defined consolidation therapy. - Known allergic or hypersensitivity to BL8040- or cytarabine or to any of the test compounds, materials - Use of investigational device or agents within 2 weeks or less than 5 half lifes for each investigational product /device at the time of enrolment. Registry studies are permissible. - Abnormal liver function tests: Serum AST/ GOT or ALT/ GPT > 3x upper limit of normal (ULN), Serum bilirubin: Total bilirubin > 2.0mg/dl, conjugated bilirubin > 0.8mg/dl - O2 saturation < 92% (on room air) - Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk - Another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervical cancer after curative therapy. History of other cancer that according to the Investigator might confound the assessment of the endpoints of the study. - A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications. - History of any or more of the following cardiovascular conditions: cardiac angioplasty (within 6 months) or stenting (within 6 months) and/or myocardial infarction (MI) (within 6 months) or cerebro-vascular event within the past 6 months, unstable angina, vascular disease, class III or IV, congestive heart failure (as defined by the New York Heart Association (NYHA)) - Known central nervous system disease that may jeopardize the subjects study participation according to the investigator judgement - Active, uncontrolled infection. - Prior clinically significant grade 3-4 non-hematological toxicity to high-dose cytarabine or grade ≥ 2 of neurological toxicity - Positive serology for HIV, active Hepatitis C and Hepatitis B (HBsAG pos.) at baseline - Left ventricular ejection fraction (LVEF) of <40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) at baseline - Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol ; PRIMARY OUTCOME: Relapse Free Survival time; 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 - Adults; BRIEF: The purpose of this study is to examine the effects of EPI-743 on tic severity in adults with Tourette syndrome. ; DRUG USED: PTC-743; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rett Syndrome; TARGET: NADPH: Quinone Oxidoreductase-1 (NQO1), Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Yale University; CRITERIA: Inclusion Criteria: - Adult between 18-65 years of age - Meet DSM IV criteria for the diagnosis of Tourettes syndrome - Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline - On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial. - Accepted method of birth control - Willingness to participate in an HMPAO SPECT scan at baseline and after 4 weeks of treatment. Exclusion Criteria: - Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70). - Recent change (less than 4 weeks) in medications that have potential effects on tic severity. Medication change is defined to include dose changes or medication discontinuation. - Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks. - Known hypersensitivity or previous anaphylactoid reaction to EPI-743 or any components in its preparation - Positive pregnancy test or drug screening test - Clinical history of bleeding disorder or abnormal baseline PT/PTT - Hepatic insufficiency with LFTs greater than two times upper limit of normal ; PRIMARY OUTCOME: Yale Global Tic Severity Scale; SECONDARY OUTCOME 1: Premonitory Urge for Tics Scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/INC280; BRIEF: The purpose of this study was to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of nazartinib (EGF816) in combination with capmatinib (INC280) and to estimate the preliminary anti-tumor activity of nazartinib in combination with capmatinib in participants with advanced non-small cell lung cancer (NSCLC) with documented EGFR mutation. ; DRUG USED: EGF816; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion criteria: - Participants in Phase Ib and Phase II Groups 1 to 4: histologically documented, locally advanced or recurrent (stage IIIB who were not eligible for combined modality treatment) or metastatic (Stage IV) NSCLC. Participants in Phase II Group 5: stage IIIB/IIIC (not amenable to curative surgery, chemoradiation or radiation) or stage IV NSCLC - Participants in Phase Ib and Phase II Groups 1 to 4: locally documented EGFR mutation L858R and/or ex19del, or a characterized de novo EGFR T790M mutation (or other rare activating mutations that confer sensitivity to 1st and 2nd generation EGFR inhibitors (e.g. L861Q, G719X, S768I), or a characterized de novo EGFRT790M mutation. - Presence of at least one measurable lesion according to RECIST v.1.1 - ECOG performance status ≤1 - Participants had to be screened for HBV. Participants who were either HBsAg positive or HBV-DNA positive had to be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816. - Participants had to be screened for HCV. Participants had to have negative hepatitis C antibody (HCV Ab) or were HCV Ab positive but with an undetectable level of HCV-RNA. Note: participants with detectable HCV-RNA were not eligible for the study. - Phase Ib only: documented progression of disease according to RECIST v1.1 while on continuous treatment with EGFR TKI (e.g.: erlotinib, gefitinib or afatinib). - Phase II Group 1 (EGFRmut, any T790M, any c-MET, 2/4L antineoplastic, EGFR TKI resistant) only: Participants demonstrated a documented clinical benefit (CR (any duration), PR (any duration), or SD for at least 6 months) on prior EGFR TKI (e.g. erlotinib, gefitinib or afatinib, and subsequently demonstrated progression according to RECIST v1.1. - Phase II Group 2 (EGFRmut, de novo T790M, any c-MET, 1/3L antineoplastic, EGFR TKI naïve) only: Advanced NSCLC participants who were not previously treated with any therapy known to inhibit EGFR and harbor de novo T790M mutation . - Phase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic) only: participants had to harbor an EGFR activating mutation and had to be naïve from any line of systemic antineoplastic therapy in the advanced setting. - Phase II Group 4 (EGFRmut, any T790M, any c-MET, 1L (treatment-naïve), 2//3L antineoplastic): All participants had to harbor an EGFR activating mutation and 2/3L participants had to have failed (defined as intolerance to treatment or documented disease progression) a maximum of 2 prior lines of antineoplastic therapy in the advanced setting - Phase II Group 5 only: Histologically or cytologically confirmed diagnosis of NSCLC (excluding squamous cell carcinoma) with all the following: 1. EGFR mutations known to be associated with EGFR TKI sensitivity. This had to be assessed as part of the participant standard of care by a validated test for EGFR mutations, as per local regulations. Exon 19 del, L858R, either alone or in combination with other EGFR sensitivity mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA) certified USA laboratory or an accredited local laboratory outside the USA had to be documented in the participant source documents before the participant consented for pre-screening for MET amplification status. 2. EGFR T790M negative status for participants who had progressed on first or second generation EGFR TKI, or third generation EGFR TKI other than osimertinib, as per tissue-based result from a CLIA-certified USA laboratory or an accredited local laboratory outside of the USA, by a validated test according to local regulations. 3. MET gene amplification defined as: Gene copy number (GCN) ≥ 5 per tissue-based result from a CLIA-certified USA laboratory or an accredited local laboratory outside of the USA by a test that is validated according to local regulations with results documented in the participant source documents. 4. Histological transformation from NSCLC into small cell lung cancer (SCLC) following previous EGFR TKI treatment were excluded. - Participants had to have progressed on one prior line of therapy either to first/second generation EGFR TKIs, osimertinib or other third generation EGFR TKIs for advanced/metastatic disease (stage IIIB/IIIC [not amenable to curative surgery, chemoradiation or radiation or stage IV NSCLC). - Participants had to have a life expectancy of at least 3 months. Key exclusion Criteria: - Phase Ib: - More than one previous treatment line with erlotinib, gefitinib or afatinib - Previous treatment with any investigational agent known to inhibit EGFR (mutant or wild-type) - Participants who had received more than three prior lines of antineoplastic therapies (including EGFR TKI) in advanced setting. - Phase II Group 1 (EGFRmut, any T790M, any c-MET, 2/4L antineoplastic, EGFR TKI resistant): - More than 3 prior lines of systemic antineoplastic therapies (including EGFR TKI) in the advanced setting - More than 1 previous treatment line with 1st or 2nd generation EGFR TKI (e.g. erlotinib, gefitinib, afatinib) in the advanced setting - Previous treatment with an investigational or marketed 3rd generation EGFR TKI (e.g. AZD9291, CO-1686, ASP8273, EGF816) - Previous treatment with an investigational or marketed agent known to inhibit EGFR (e.g. EGF monoclonal antibody therapy, dual TKI inhibitor). - Phase II Group 2 (EGFRmut, de novo T790M, any c-MET, 1/3L antineoplastic, EGFR TKI naïve): - More than two previous treatment lines of systemic antineoplastic therapies in the advanced setting - Previous treatment with an investigational or marketed agent that inhibits EGFR. EGFR inhibitors include (but not limited to) all generations of EGFR TKI (e.g.erlotinib, gefitinib, afatinib, AZD9291, CO-1686, ASP8273, EGF816) or other anti-EGFR or EGFR monoclonal antibody therapy or dual TKI inhibitors. - Phase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic): - De novo EGFR T790M mutation identified by central assessment - Previous treatment with any systemic antineoplastic therapy in the advanced setting (NSCLC stage IIIB or IV. Participants who received only one cycle of antineoplastic therapy in the advanced setting were allowed). - Phase II Group 4 (EGFRmut, any T790M, any c-MET, 1/3L antineoplastic): - More than 2 prior lines of systemic antineoplastic therapies in the advanced setting - Previous treatment with an investigational or marketed 3rd generation EGFR TKI (e.g. AZD9291, CO-1686, ASP8273, EGF816) - Previous treatment with an investigational or marketed agent known to inhibit EGFR (e.g. EGF monoclonal antibody therapy, dual TKI inhibitor). - Previous treatment with a c-MET inhibitor or HGF-targeting therapy. - Participants with symptomatic brain metastases. - Phase II Group 5: Participants with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms. - Presence or history of another malignancy. Exception: Participants who had been disease-free for 3 years, or participants with a history of adequately treated in-situ carcinoma of the uterine cervix, completely resected basal or squamous cell carcinoma, non-melanomatous cancer of skin, history of stage IA melanoma that had been cured, were eligible. For Phase II Group 5: Presence or history of a malignant disease other than NSCLC that had been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type. - Undergone a bone marrow or solid organ transplant. - Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory). For Group 5: Participants with known history of testing positive for human immunodeficiency virus (HIV) infection, and with a history of Acquired ImmunoDeficiency Syndrome (AIDS) defining opportunistic infections in the last 12 months prior to the first dose of study treatment had to be excluded - Participants receiving concomitant immunosuppressive agents or chronic corticosteroids used at the time of study entry except for control of brain metastases, topical applications, inhaled sprays, eye drops or local injections - Participants with clinically significant, uncontrolled cardiovascular disease - Presence or history of interstitial lung disease or interstitial pneumonitis - Participants who had not recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03) - Participants who had out of range laboratory values - Participants who received live vaccines ; PRIMARY OUTCOME: Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618[/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 - Uganda; BRIEF: The study will recruit up to 290 healthy adult males and non-pregnant females into a two-part clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the Sm-TSP-2 vaccine will be tested: one using Alhydrogel® only, and one using Alhydrogel® plus AP 10-701, each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg. The first part of the study will be a Phase I dose-escalation safety and immunogenicity study followed by a Phase IIb trial in which a larger number of adults will be enrolled to assess the impact of the vaccine on infection with S. mansoni. The impact of the vaccine on infection with S. haematobium will also be assessed although this will be exploratory given that potential cross-protection against this species is only hypothetical at this point. ; DRUG USED: Sm-TSP-2; DRUG CLASS: Vaccine; INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: Schistosoma mansoni Tetraspanin-2 (Sm-TSP-2); THERAPY: Monotherapy; LEAD SPONSOR: Baylor College of Medicine; CRITERIA: Inclusion Criteria: 1. Provide written informed consent prior to any study procedures. 2. Able to understand and comply with planned study procedures and be available for all study visits. 3. Male or non-pregnant female aged 18 to 45, inclusive at the time of enrollment. 4. Are in good health, as determined by vital signs (oral temperature, pulse, and blood pressure), medical history, and brief physical examination at screening. 5. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges. 6. Laboratory tests (alanine aminotransferase [ALT], creatinine, white blood cell count (WBC), hemoglobin, and platelets) are all within protocol-defined reference ranges. 7. Urinalysis with no greater than trace protein and negative for glucose. 8. Female subjects of childbearing potential must agree to practice highly effective contraception for a minimum of 30 days prior to first vaccination and for 30 days after last vaccination. 9. Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccination. 10. Able to correctly answer all questions on the informed consent comprehension questionnaire. Exclusion Criteria: 1. Has the intention to become pregnant within 5 months after enrollment in this study. 2. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after their last study vaccination. 3. Has an acute illness, including a documented oral temperature of 38.0°C or greater, within 72 hours prior to vaccination. 4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies. 5. Is immunosuppressed as a result of an underlying illness or treatment. 6. Using or intends to continue using oral or parenteral steroids, high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs. 7. Positive test for HIV infection. 8. Volunteer has had a history of alcohol or illicit drug abuse during the past 23 months. 9. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination. 10. History of a severe allergic reaction or anaphylaxis to known components of the study vaccines. 11. Has an acute or chronic medical condition that, in the opinion of the investigator, would render participation in this study unsafe or would interfere with the evaluation of responses. 12. History of splenectomy. 13. Is participating or plans to participate in another clinical trial with an interventional agent during the duration of the study. 14. Received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to the first study vaccination. 15. Planned receipt of any vaccine from the first study vaccination through 28 days after the last study vaccination. 16. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. 17. Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. 18. Anti-Sm-TSP-2 IgE antibody level above ELISA reactivity threshold. Part A Only: 19. Positive hepatitis B surface antigen (HBsAg). 20. Positive confirmatory test for hepatitis C virus (HCV) infection. Part B Only: 21. Negative for Schistosoma mansoni eggs, as assessed by the Kato Katz fecal thick smear during screening. ; PRIMARY OUTCOME: Safety and Tolerability: frequency of local and systemic reactogenicity events; SECONDARY OUTCOME 1: Immunogenicity: peak anti-Sm-TSP-2 IgG level[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3587 - BEGIN (ONCE); BRIEF: This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes. ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months - Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days) - Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose - HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis - BMI (Body Mass Index) below or equal to 40.0 kg/m^2 Exclusion Criteria: - Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening) - Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors - Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty - Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigators opinion could interfere with the results of the trial - Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period - Known or suspected hypersensitivity to trial product(s) or related products ; PRIMARY OUTCOME: Change From Baseline in HbA1c (%) (Analysed by Central Laboratory); SECONDARY OUTCOME 1: Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes[/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 102; BRIEF: The purpose of this study is to evaluate the safety and efficacy of exogenous gene transfer in DMD participants by measuring biological and clinical endpoints in three parts: two 48-week randomized, double-blinded, placebo-controlled periods (Part 1 and Part 2), and an open-label follow-up period (Part 3). Participants who are randomized to placebo in Part 1 will have the opportunity for treatment with delandistrogene moxeparvovec in Part 2. In order to provide a uniform approach to monitoring long-term safety and efficacy in participants who received SRP-9001 in a clinical trial, the Sponsor has amended Study Completion for this study to occur at Week 130. Therefore, participants have transitioned and will complete the remainder of the Part 3 follow up visits in a long-term extension study, SRP-9001-305 (NCT05967351). ; DRUG USED: SRP-9001; DRUG CLASS: Biologic; INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Microdystrophin; THERAPY: Monotherapy; LEAD SPONSOR: Sarepta Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Established clinical diagnosis of DMD and documented dystrophin gene mutation of DMD phenotype. - Indication of symptomatic muscular dystrophy by protocol-specified criteria. - Ability to cooperate with motor assessment testing. - Stable dose equivalent of oral corticosteroids for at least 12 weeks. - A frameshift mutation contained between exons 18 and 58 (inclusive). Exclusion Criteria: - Impaired cardiovascular function on echocardiogram. - Prior or ongoing medical condition on physical examination, electrocardiogram, or laboratory findings that could adversely affect participant safety, compromise completion of follow-up, or impair assessment of study results. - Exposure to another investigational drug or exon skipping medication within 6 months of screening. - Exposure to an investigational or commercial gene therapy product. - Abnormal liver or renal function by protocol-specified criteria. Other inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Change From Baseline at Week 12 in Quantity of Delandistrogene Moxeparvovec Dystrophin Protein Expression as Measured by Western Blot Adjusted by Muscle Content; 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 - Study 2005 - Large B-Cell NHL; BRIEF: The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkins lymphoma. ; DRUG USED: Besponsa; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 22 (CD22), DNA; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy - Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1 - Eligible for autologous stem cell transplant (aSCT) Exclusion Criteria: - Prior allogeneic hematopoietic stem cell transplant - Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy - Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection ; PRIMARY OUTCOME: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy; SECONDARY OUTCOME 1: Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy[/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 - AFF006 (Early AD; EU); BRIEF: This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimers disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patients participation will last 1 year. ; DRUG USED: AFFITOPE AD02; DRUG CLASS: Vaccine; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Affiris AG; CRITERIA: Inclusion Criteria: - Informed consent capability - Early AD, based on episodic memory deficit and hippocampal atrophy - Age from 50 to 80, inclusive - MMSE of 20+ - Brain magnetic resonance imaging scan consistent with the diagnosis of AD - Stable doses of medications (cholinesterase inhibitors and memantine allowed) - Caregiver able to attend all visits with patient Exclusion Criteria: - Significant neurological disease other than AD - Major psychiatric illness - Significant systemic illness - Autoimmune disease - Prior treatment with experimental immunotherapeutics for AD including IVIG - Women of childbearing potential without birth control - Contraindication for MRI scan ; PRIMARY OUTCOME: cognitive(ADAS-cog modified) and functional(ADCS-ADL modified); SECONDARY OUTCOME 1: cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)[/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 - INSPIRE-CKD; BRIEF: The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney disease (CKD) stage 3 or 4. Participation in the research study will last up to 21 weeks (about 5 months). ; DRUG USED: Aprocitentan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: Endothelin Receptor Type A (EDNRA), Endothelin Receptor Type B (EDNRB); THERAPY: Monotherapy; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria: - Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic, - Participants with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated Glomerular Filtration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology equation), - Women of childbearing potential are eligible only if the following applies: - Negative pregnancy test at the screening visit and at baseline (i.e., end of run-in period). - Agree to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation. - Agree to use highly-effective methods of contraception up to at least 30 days after study treatment discontinuation. Exclusion Criteria: - Mean sitting systolic blood pressure above 170 mmHg measured by automated office blood pressure measurement (AOBPM), - Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM, - Change in renal function requiring hospitalization, documented eGFR decline of greater than 20% in the 3 months prior to the screening visit, dialysis in the 3 months before the screening visit, - Planned dialysis or kidney transplant during the course of this study, - Nephrotic syndrome defined as urine albumin-to-creatinine ratio above 3000 mg/g, - Known and documented chronic heart failure. ; PRIMARY OUTCOME: Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.; SECONDARY OUTCOME 1: Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement.[/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 - DUPICSU; BRIEF: The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with chronic spontaneous urticaria (CSU) who are symptomatic despite H1-antihistamine treatment. ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Urticaria; TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Charite University, Berlin, Germany; CRITERIA: Inclusion Criteria: Diagnosis: chronic spontaneous urticaria (defined as ongoing disease) 1. Patient is informed about study procedures and medications and has given written informed consent before any assessment. 2. Patient is able to communicate with the investigator, understands and complies with the requirements of the study. 3. Male or Female 4. Patient is 18-75 years of age 5. Patient is diagnosed with moderate to severe CSU and refractory to standard of care treatment at the time of randomization, as defined by the following: 1. The presence of itch and hives for more than 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine 2. Urticaria activity score UAS7 score (range 0-42) equal or more than 16, 7 days prior to randomization (Day 1) 3. CSU diagnosis for 6 months 6. Willing and able to complete a daily symptom diary for the duration of the study and adhere to the study visit schedules. 7. Patients must not have more than one missing diary entry in the 7 days prior to randomization. Re-screening may be considered. 8. Women of childbearing potential have to agree to use an acceptable form of contraception (as determined by the site investigator) and have to continue its use for the duration of the study. Exclusion Criteria: 1. Patients whose urticaria is solely due to inducible urticaria. 2. Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency) 3. Any other active skin disease associated with chronic itching that might confound the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, etc.) 4. Patients who have received concomitant prohibited medication within the last 3 months prior to screening - Anti-IgE therapy (e.g. omalizumab) - Routine (daily or every other day during 5 or more consecutive days) doses of systemic corticosteroids or other immunosuppressants - Intravenous immunoglobulins - Biological therapy - Systemic immunosuppressants - Live/attenuated vaccines - Other investigational drug 5. History of anaphylactic shock 6. Active helminthic parasite infection or treatment of helminthic parasites within 6 months of screening ; PRIMARY OUTCOME: Urticaria activity score over 7 days (UAS7); SECONDARY OUTCOME 1: Itch severity score (ISS7; 0 - no pruritus; 21 - most severe pruritus), hive severity score (HSS7; 0 - no hives; 21 - max. hive severity)[/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/Rituximab; BRIEF: The primary objective of this study is to determine the safety and tolerability of GS-0189 (formerly FSI-189) as monotherapy and in combination with rituximab in participants with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). ; DRUG USED: FSI-189; DRUG CLASS: Biologic; INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Immune System, SIRP-alpha; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) relapsed/refractory (R/R) to at least 2 prior lines of therapy. Prior autologous hematopoietic cell transplantation and individuals with transformed lymphomas are permitted. Individuals must be at least 3 months out from prior autologous hematopoietic cell transplantation. Individuals with indolent lymphomas must be candidates for systemic treatment in the judgment of the treating physician. - In the DLBCL Expansion part: DLBCL that is relapsed or refractory to at least 2 prior lines of therapy. Prior autologous hematopoietic cell transplantation and individuals with transformed lymphomas are permitted. - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2. - For the DLBCL expansion cohort, disease must be measurable for response per Lugano criteria. For all other cohorts, disease must be measurable or assessable for response per Lugano criteria. - Exhibit acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests. Key Exclusion Criteria: - Individuals with active brain metastases (Individuals with stable treated central nervous system (CNS) lesions who are off corticosteroid therapy for at least 3 weeks are not considered active. - Individuals with Burkitts lymphoma. - Prior treatment with a chimeric antigen receptor (CAR) T-cell therapy ≤ 90 days from first dose of study drug. - Prior allogeneic stem cell transplant. - Previous anticancer therapy including chemotherapy, hormonal therapy, and investigational agents within 3 weeks or at least 4 half-lives (up to a maximum of 4 weeks), whichever is longer, prior to first dose of study drug. - Known active or chronic hepatitis B or C infection or human immunodeficiency virus. - Prior treatment with CD47 or signal regulatory protein alpha (SIRPα)-targeting agents. - Hypersensitivity to the active substance, to murine proteins, or to any of the other excipients of rituximab - Significant medical diseases or conditions, as assessed by the Investigator and Sponsor, that would substantially increase the risk:benefit ratio of participating in the study. - Rituximab-containing cohorts only: Receipt of live/attenuated vaccines within 30 days of rituximab dosing - Has persisting toxicity related to prior therapy of Grade > 1 in severity per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants Experiencing Treatment-Emergent Adverse Events; SECONDARY OUTCOME 1: Percentage of Participants Experiencing Laboratory Abnormalities[/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 - NGLU-CL02; BRIEF: Study to evaluate the safety and tolerability of intravenous (IV) administration of SBC-103 in participants with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) with evaluable signs or symptoms of developmental delay. ; DRUG USED: SBC-103; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis IIIB (MPS IIIB; Sanfilippo B Syndrome); TARGET: N-Acetylglucosamine; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: - A participant was greater than or equal to 2 years of age but less than 12 years of age at the time of informed consent. - Definitive diagnosis of MPS IIIB. - Documented developmental delay. Key Exclusion Criteria: - Received treatment with gene therapy at any time. - Previous hematopoietic stem cell or bone marrow transplant. - Had any internal or non-removable external metal items that presented a safety risk for study assessments that utilized magnetic fields, or any other medical condition or circumstance in which magnetic resonance imaging was contraindicated according to local institutional policy. - Known hypersensitivity to eggs. ; PRIMARY OUTCOME: Number Of Participants Who Experienced Severe 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 III - 205.464 - CadenTinA (Japan); BRIEF: The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, and number of adverse events. ; DRUG USED: Spiriva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. All patients including the patients under age (under 20 years old) must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and Good Clinical Practice (GCP) prior to participation in the trial [i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test (PFT) at Visit 1]. Regarding patients under age, a guardian or a legally authorised representative must also sign and date an Informed Consent Form. 2. Male or female outpatients aged at least 18 years but not more than 75 years at Visit 0. 3. All patients must have at least a 12-week history of asthma at the time of enrolment (Visit 0) into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5. 4. The initial diagnosis of asthma must have been made before the patients age of 40. 5. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15-30 minutes after 400 µg salbutamol) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200 mL . 6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (ICS) [alone or in a fixed combination with a Long-acting beta-adrenergic (LABA)] for at least 4 weeks prior to Visit 1. 7. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of at least 1.5. 8. All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1. 9. Patients must be never-smokers or ex-smokers who stopped smoking at least one year (52 weeks) prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years. 10. Patients must be able to use the Respimat inhaler correctly, which is judged at the discretion of the investigator.. 11. Patients must be able to perform all trial related procedures including technically acceptable PFTs and use of electronic diary (eDiary)/peak flow meter, which is judged at the discretion of the investigator. Exclusion criteria: 1. Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patients ability to participate in the trial. 2. Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no 1. 3. Patients with a recent history (i.e. 6 months or less) of myocardial infarction prior to Visit 0. 4. Patients who have been hospitalised for cardiac failure during the past year prior to Visit 0. 5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year prior to Visit 0. 6. Patients with lung diseases other than asthma (e.g. COPD). 7. Patients with known active tuberculosis. 8. Patients with malignancy and/or patients who have undergone resection, radiation therapy or chemotherapy for malignancy within the last 5 years prior to Visit 0. Patients with treated basal cell carcinoma are allowed. 9. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1. 10. Patients with significant alcohol or drug abuse, which is judged at the discretion of the investigator, within the past 2 years prior to Visit 0. 11. Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA), or any other components of the study medication delivery systems. 12. Pregnant or nursing women. 13. Women of childbearing potential not using a highly effective method of birth control. 14. Patients who have taken an investigational drug within 4 weeks prior to Visit 1. 15. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed. 16. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva) within four weeks prior to Visit 1 and/or during the screening period. 17. Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period. 18. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1 and/or during the screening period. 19. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period. 20. Patients who have been treated with other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period. 21. Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 and/or during the screening period. 22. Patients who are currently participating in another trial. 23. Patients with narrow-angle glaucoma and/or micturition disorder due to prostatic hyperplasia. 24. Patients with below 80% of the eDiary completion compliance on Visit 2 (diary compliance of at least 80% is required). ; PRIMARY OUTCOME: Number of Patients With Drug-related Adverse Events; SECONDARY OUTCOME 1: Trough FEV1 Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Different Formulations; BRIEF: The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment. ; DRUG USED: LY3375880; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-33 (Interleukin-33)IL-33 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Are overtly healthy males or females, as determined by medical history and physical examination - Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive - Females who are not of child-bearing potential - Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880 - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Exclusion Criteria: - Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy - Have participated or are currently enrolled in clinical trials with LY3375880 - Have infections or evidence of infections - Are pregnant, lactating or breast feeding ; PRIMARY OUTCOME: Visual Analog Scale (VAS) Pain Score; 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 - w/Chemo; BRIEF: This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease. ; DRUG USED: Uproleselan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Selectins; THERAPY: Combination; LEAD SPONSOR: GlycoMimetics Incorporated; CRITERIA: Inclusion criteria: 1. AML (including secondary AML) diagnosed as per WHO criteria 2. For relapsed/refractory subjects only: - Subjects age ≥ 18 years with relapsed or refractory AML after ≤ 2 prior induction regimens, at least one containing anthracyclines - Medically eligible to receive MEC - Absolute blast count (ABC) ≤ 40,000/mm 3. For treatment-naïve subjects only: - Subjects ≥ 60 years of age with newly diagnosed AML - Medically eligible to receive 7+3 cytarabine/idarubicin - ABC count ≤ 40,000/mm 4. ECOG performance status 0-2 5. Hemodynamically stable and adequate organ function Exclusion criteria: 1. Acute promyelocytic leukemia 2. Acute leukemia of ambiguous lineage (biphenotypic leukemia) 3. Active signs or symptoms of CNS involvement by malignancy 4. No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing 5. Known history or evidence of active hepatitis A, B, or C or HIV 6. Uncontrolled acute life threatening bacterial, viral or fungal infection 7. Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy 8. Hematopoietic stem cell transplantation ≤ 4 months of dosing 9. Clinically significant cardiovascular disease ; PRIMARY OUTCOME: Safety assessed by frequency, severity and relatedness of adverse events; SECONDARY OUTCOME 1: Time versus plasma concentration profile of GMI-1271[/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 - CAN3001 (Long-Term Ext.) ; BRIEF: The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib - Investigators assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks - Agrees to protocol-defined use of effective contraception - Negative blood or urine pregnancy test at screening Exclusion Criteria: - Requires anticoagulation with warfarin or equivalent vitamin K antagonists - Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor - Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteers participation in the study ; PRIMARY OUTCOME: Number of participants affected by an adverse event; SECONDARY OUTCOME 1: Number of participants with change in disease status[/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 - +/- Vinorelbine (HER2+ IBC); BRIEF: The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment. ; DRUG USED: Gilotrif; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3, ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer 2. Locally advanced or metastatic disease 3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1) 4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment 5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer 6. Must have biopsiable disease Exclusion criteria: 1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population) 2. Must not have received prior vinorelbine treatment ; PRIMARY OUTCOME: Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).; SECONDARY OUTCOME 1: Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. PP1M; BRIEF: The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M. ; DRUG USED: Invega Trinza; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator - A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120 - Signed informed consent - Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control - Men must agree to use a double-barrier method of birth control - Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria: - A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis - Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc) - A diagnosis of substance dependence within 6 months before screening - History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia - Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness - Clinically significant findings in biochemistry, hematology, ECG or urinalysis results - Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase; SECONDARY OUTCOME 1: Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 300 (Prevention); BRIEF: The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women. ; DRUG USED: Viviant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoporosis / Osteopenia; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Wyeth is now a wholly owned subsidiary of Pfizer; CRITERIA: Inclusion Criteria: - Generally healthy women 45 years of age or older who are at least 1 year postmenopausal. - Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor. Exclusion Criteria: - One (1) or more osteoporotic vertebral fractures (T4-L4). - Diseases that may affect bone metabolism. - Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. ; PRIMARY OUTCOME: The percent change from baseline in lumbar spine bone mineral density (BMD) after 24 months.; SECONDARY OUTCOME 1: Additional BMD evaluation including total hip, femoral neck and trochanter at months 6, 12, 18 and 24. Serum bone markers at months 3, 6, 9, 12, 18 and 24. Lipid panel at months 3, 6, 12, 18 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 II - Proteinuria; BRIEF: This Phase 2A study is an adaptive design pilot study investigating the efficacy and safety of daily Acthar administration in diabetic patients with nephropathy and proteinuria. Patients with type 1 diabetes mellitus (T1DM) or T2DM who currently take insulin will be enrolled and randomized into 6 study groups and will be treated with either Acthar or Placebo for 36 weeks, followed by a 4 week dose taper, and a 12 week observation period. The study will compare three dose regimens of Acthar (8 U [0.1 mL], 16 U [0.2 mL], and 32 U [0.4 mL]) to equivalent volumes of Placebo to ensure the double-blind nature of the study. Insulin-requiring patients are being enrolled to aid compliance with the daily SC administration of study medication and to allow for ease of blood glucose control by adjustment of current insulin therapy in the event of glycemic excursions. Routine safety measures, including glycemic control, will be monitored throughout the study. The adaptive design component of the study allows for the re-assignment of the high dose group to the mid dose group if unacceptable toxicity is noted as per study protocol in the high dose group. Efficacy will be assessed by monitoring serum creatinine, calculated eGFR, and proteinuria (via urinary protein to creatinine ratio [PCR]). Serum cortisol concentration and additional biomarkers in blood and urine will also be monitored. ; DRUG USED: H.P. Acthar Gel; DRUG CLASS: Non-NME; INDICATION: Diabetic Nephropathy; TARGET: Corticotropin Releasing Factor (CRF) / Corticotropin Releasing Hormone (CRH); THERAPY: Monotherapy; LEAD SPONSOR: Mallinckrodt; CRITERIA: Inclusion Criteria (numbers 2, 3, 4, 5, 6, and 7 per protocol): - Body mass index ≤ 45 kg/m2 at screening. - Diagnosis of T1DM or T2DM, with HbA1c ≤ 9.0% at Visit 1A. Diagnosis of T2DM should have been made at > 30 years of age (if diabetes developed at a younger age, C-peptide level may be obtained to confirmed the diagnosis). - Currently insulin-requiring - Patients on oral hypoglycemic therapy plus insulin are eligible provided that oral hypoglycemic agent(s) administered and the dosing regimen(s) of oral hypoglycemic therapy have been stable for ≥ 12 weeks prior to screening. No changes in oral hypoglycemic therapy should be planned or anticipated during the treatment period. - Renal Target Disease Requirements: - The average of two eGFR values collected during screening (Visits 1 and 1A) must be between 20-60 mL/min/1.73m2 (calculated using the abbreviated Modification of Diet in Renal Disease [MDRD] equation AND - Protein to creatinine ratio (PCR) ≥ 3.0 g/g OR total urine protein ≥ 3.0 g from the 24-hour urine collection returned at Visit 1A. - Antihypertensive Therapy: - Treatment with an ACEI and/or an ARB for at least 6 weeks prior to screening Visit 1A, with stable maintenance dose for ≥ 14 days prior to screening Visit 1A. No change in ACEI or ARB therapy should be planned or anticipated for the period of the study. - If treated with additional antihypertensive therapy(ies), duration of therapy ≥ 30 days prior to screening Visit 1A, with stable maintenance dose for ≥ 14 days prior to screening Visit 1A. - If the patient has documented intolerance to ACEI and/or ARB therapy (e.g. angioedema, hyperkalemia), they may be eligible for study entry, but the Medical Monitor must be consulted in these cases prior to randomization. - Mean systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg on ≥ 3 seated readings taken at least 5 minutes apart during the screening period at Visit 1A. Exclusion Criteria (numbers 2, 3, 4, 5, 7, and 11 per protocol): - Therapies and/or Medications: - History of prior sensitivity to Acthar or other porcine protein products. - Chronic systemic corticosteroid use, defined as ≥ 20 mg of prednisone or equivalent systemic corticosteroid taken for more than 4 consecutive weeks within 6 months prior to randomization. Topical, inhaled, or intra-articular corticosteroids are allowed. - Planned treatment with live or live attenuated vaccines once enrolled in the study. - Previous treatment on a drug being investigated for the treatment of diabetic nephropathy within 6 months prior to randomization. - Contraindication to Acthar per Prescribing Information Section 4: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction. - For the purpose of this study, history of peptic ulcer is defined as ≤ 6 months prior to Visit 1A. - Diabetes Target Disease Exceptions: - Severely uncontrolled diabetes mellitus as judged by the Principal Investigator - HbA1c > 9% at screening Visit 1A. - Fasting serum glucose > 230 mg/dL at BOTH screening Visits 1 and 1A. - History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months of screening. - History of ocular laser photocoagulation therapy within 6 months of screening OR diabetic retinopathy, diabetic macular edema, or cataracts associated with impairment of visual acuity that will affect adherence with the dosing or administration of SC injections. - Patients unwilling to titrate insulin for blood glucose control if adjustment of hypoglycemic therapy is required during the study. - Renal Target Disease Exceptions: - History of clinical or renal biopsy evidence of non-diabetic renal disease - Patients requiring diagnostic or interventional procedure requiring an intravenous contrast agent must delay screening/randomization for at least 14 days - Tuberculosis: Any patient with a positive Interferon-gamma release assay, OR signs and symptoms concerning for active tuberculosis. - Cardiovascular: - History of congestive heart failure (NYHA Functional Class III-IV). - History of dilated cardiomyopathy with ejection fraction < 40%. 1. Exceptions require approval by the Medical Monitor. - Patient has had any of the following within 3 months of screening: 1. Unstable angina 2. Myocardial infarction 3. Coronary artery bypass graft or percutaneous transluminal coronary angioplasty 4. Transient ischemic attack or cerebrovascular accident 5. Unstable arrhythmia ; PRIMARY OUTCOME: Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12; SECONDARY OUTCOME 1: Percent Change in eGFR at Visit 17[/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 - V118-AD; BRIEF: The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimers disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD. ; DRUG USED: UB-311; DRUG CLASS: Vaccine; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: United Biomedical; CRITERIA: Inclusion Criteria: - Diagnosis of mild to moderate Alzheimers Disease - Mini-Mental State Examination (MMSE) 15-25 - Other inclusion criteria apply Exclusion Criteria: - Major psychiatric disorder - Severe systemic disease - Serious adverse reactions to any vaccine - Other exclusion criteria apply ; PRIMARY OUTCOME: To evaluate safety and tolerability of the vaccine (UB 311).; SECONDARY OUTCOME 1: To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).[/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/IIb - OHANA ; BRIEF: This is a two-part randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA). Part 1 is an open-label study to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and efficacy of a selected volixibat dose. ; DRUG USED: Volixibat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Progressive Familial Intrahepatic Cholestasis (PFIC); TARGET: Ileal Bile Acid Transporter (IBAT)/Apical Sodium-dependent Bile Acid Transporter (ASBT); THERAPY: Monotherapy; LEAD SPONSOR: Mirum Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Female aged ≥18 and ≤45 years with a viable pregnancy. 2. Provide signed informed consent as described in the protocol and willing to comply with all study visits and requirements. 3. Diagnosis of ICP. 4. (Part 2 only) Qualified level of pruritus associated with ICP, during screening. Exclusion Criteria: 1. At the time of either the screening or baseline visit, decision has already been made to deliver within the next 7 days, for any indication. 2. Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG or BPP) at or within 7 days before the baseline visit. 3. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life. 4. Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study. ; PRIMARY OUTCOME: Mean change in serum bile acids; SECONDARY OUTCOME 1: Mean change in the weekly average worst daily itch score as measured by the Adult Itch Reported Outcome (ItchRO)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Pembrolizumab; BRIEF: This is an open label, safety and preliminary efficacy study of MRx0518 in combination with pembrolizumab in patients with solid tumours (non small cell lung cancer, renal cell carcinoma, bladder cancer or melanoma). Subjects will be treated with IV pembrolizumab every 3 weeks and 1 capsule twice daily of MRx0518. Treatment will continue as long as clinically relevant, until disease progression, unacceptable AEs or withdrawal of consent up to a maximum of 35 cycles (approx. 2 years). ; DRUG USED: MRx0518; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System; THERAPY: Combination; LEAD SPONSOR: 4D pharma plc; CRITERIA: Inclusion Criteria: - Willing and able to provide written informed consent/assent for the trial. - ≥18 years of age on day of signing informed consent. - Histological or cytological evidence of advanced and/or metastatic or recurrent NSCLC, renal cell carcinoma, bladder cancer or melanoma. - At least one measurable lesion per RECIST v 1.1 criteria. - Failure to respond or intolerance to standard therapy or for whom no appropriate therapies are known to provide clinical benefit (per the judgement of the Investigator). - Subjects must have progressed on treatment with a PD-1/PD-L1 inhibitor administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1/PD-L1 inhibitor treatment progression is defined by meeting all of the following criteria: 1. Has received at least 2 doses of a PD-1/PD-L1 inhibitor. 2. Has demonstrated disease progression after PD-1/PD-L1 therapy as defined by RECIST v1.1, iRECIST or irRECIST. The initial evidence of disease progression (PD) is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression. 3. Progressive disease has been documented within 12 weeks from the last dose of a PD-1/PD-L1 inhibitor. - Have adequate organ function - Be willing to provide archival tissue - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥2 years. - Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication - Male subjects with female partners of childbearing potential should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: - Subjects who failed to show any response to initial treatment with PD-1/PD-L1 inhibitor (i.e. no Response or no Stable Disease). - Has active brain metastases or leptomeningeal disease. Subjects with asymptomatic CNS metastases which have been stable (defined as without evidence of progression by MRI for at least 28 days prior to initiation of therapy and any neurologic symptoms have returned to baseline) following treatment with surgery or radiation therapy are allowed. - Prior solid organ or hematologic transplant. - Treatment-related immune-mediated (or immune related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents, anti-CTLA4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were grade 3 or 4 in severity. - Subjects treated with chemotherapy, immunotherapy, biologic therapy, or other investigational agent within <5 times the half-life of the agent or <21 days (whichever is shorter) of starting study drug. Continuation of hormone replacement therapy is permitted. Stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a GnRH agonist), ovarian, or breast cancer are not exclusionary. - Subjects treated with tyrosine kinase inhibitor therapy or completed palliative radiotherapy <14 days from initiation of therapy. - Comorbidity requiring corticosteroid therapy (>10mg prednisone/day or equivalent) within 7 days of starting experimental therapy. Physiologic replacement doses are allowed if they are ≤10mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder. - Significant cardiac dysfunction, New York Heart Association classification for chronic heart failure III-IV, symptomatic coronary artery disease, significant ventricular arrhythmias; myocardial infarction within 6 months; unstable, poorly controlled angina pectoris - Active, known or suspected autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs), except for replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.). Note: corticosteroids given within 24 hours of an imaging study for purposes of pre-medication in subjects with hypersensitivity to radiologic contrast agents are allowed - Has a serious active infection requiring systemic therapy - Subjects who have completed a course of antibiotics within the two weeks prior to dosing - Has a known psychiatric or substance abuse disorder that would interfere with the subjects ability to cooperate with the requirements of the trial - Receipt of a live-virus vaccination within 28 days of planned treatment start - Known HIV infection, or active infection with hepatitis A, B or C - Has a history of (non-infectious) pneumonitis that required steroids or has current active pneumonitis - Known additional malignancy either progressing r requiring active treatment (except for non-melanoma skin cancer, in situ cervical cancer or prostate intraepithelial neoplasia) within the last 2 years - Female subjects who are breastfeeding - Known intolerance or hypersensitivity to study drugs - Subjects who are allergic to amoxicillin/clavulanic acid, erythromycin and imipenem - History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subjects participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator - Has a known inability for oral intake of capsules ; PRIMARY OUTCOME: Part A: To assess the safety and tolerability of MRx0518 in combination with pembrolizumab through the collection of adverse events; SECONDARY OUTCOME 1: Antitumour effect[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Dose Finding & Expansion; BRIEF: This is a single-arm, open-label, multi-center, Phase 1 study to determine safety and tolerability of an experimental therapy called NKX101 (allogeneic CAR NK cells targeting NKG2D ligands) in patients with relapsed/refractory AML or intermediate, high and very high risk relapsed/refractory MDS. ; DRUG USED: NKX101; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Natural Killer Cells (NK Cells), NKG2D / NKG2D Ligands; THERAPY: Monotherapy; LEAD SPONSOR: Nkarta Inc.; CRITERIA: Inclusion Criteria: - General: - ECOG performance status ≤2 - Disease related: - For AML subjects: - Previously treated relapsed/refractory AML, including subjects with MRD+ disease - Received at most 3 lines of previous anti-leukemia therapy - For subjects with targetable fms-like tyrosine kinase 3 (FLT3)-mutated or isocitrate dehydrogenase (IDH)1/2 mutated disease, subjects must have received at least 1 prior respective targeted therapy and may receive up to 4 lines of prior therapy - White blood cell count of ≤25 × 10^9/L - For groups receiving NKX101 after lymphodepletion with fludarabine/cyclophosphamide +/- decitabine: Disease localized to the bone marrow, as evidenced by ≤ 5% peripheral blasts and no evidence of extramedullary disease - For groups receiving NKX101 after lymphodepletion with fludarabine/ cyclophosphamide +/- decitabine, group receiving NKX101 after lymphodepletion with fludarabine/ara-C: Additional subjects with specifically high-risk genetic mutations may be enrolled. High risk genetic mutation per ELN 2022 should be evaluated as per local assay and discussed with the Sponsor prior to study entry - For groups receiving NKX101 after lymphodepletion with fludarabine/cyclophosphamide +/- decitabine, group receiving NKX101 after lymphodepletion with fludarabine/ara-C: Additional subjects who have relapsed following HCT may be enrolled. - For MDS subjects: - Intermediate-, high-, or very high-risk MDS - Previously treated relapsed/refractory MDS - Received at least 1 and at most 3 lines of previous standard anti-MDS therapy - For groups receiving NKX101 after lymphodepletion with fludarabine/ cyclophosphamide +/- decitabine: Additional subjects with specifically high-risk disease may be enrolled. High-risk genetic mutation should be evaluated as per local assay - For group receiving lymphodepletion with fludarabine/cyclophosphamide +/- decitabine and NKX101: Additional subjects who have relapsed following HCT may be enrolled. - Adequate Organ Function - Platelet count ≥30,000/uL (platelet transfusions acceptable) - Other: - Signed informed consent - Agree to use an effective barrier method of birth control Exclusion Criteria: - Disease related: - Acute promyelocytic leukemia with t(15;17) (q22;q12); or abnormal promyelocytic leukemia/retinoic acid receptor alpha (APML-RARA) and AML arising from chronic myelomonocytic leukemia (CMML) - Evidence of leukemic meningitis or known active central nervous system disease - Peripheral leukocytosis with ≥ 20,000 blasts/μL or other evidence of rapidly progressive disease that would preclude subject from completing at least 1 cycle of treatment - Use of any anti-AML/MDS chemotherapeutic or targeted small molecule drug within protocol specified window prior to the first dose of NKX101 - Presence of residual non-hematologic toxicity from prior therapies that has not resolved to ≤ Grade 1 - Any hematopoietic cell transplantation within 16 weeks - Other comorbid conditions and concomitant medications prohibited as per study protocol - Other: - Pregnant or lactating female ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; SECONDARY OUTCOME 1: Assessment of NKX101 half-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 II - TIVO (Ovarian Cancer); BRIEF: This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. ; DRUG USED: Fotivda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Northwestern University; CRITERIA: Inclusion Criteria: - • Patients must have recurrent or persistent, platinum resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma; platinum-resistant disease is defined as a recurrence within 6 months of completing adjuvant, platinum-based chemotherapy - Patients must have measurable disease or non-measurable (detectable) disease: - Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray; lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI - Non-measurable (detectable) disease in a patient is defined in this protocol as one who does not have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria but does have a cancer antigen 125 (CA-125) greater than or equal to two times the upper normal limit within the last 60 days (confirmatory at baseline) and at least one of the following conditions: - Ascites and/or pleural effusion attributed to tumor - Hypermetabolic lesions on positron emission tomography (PET) scan - Patients with measurable disease must have at least one target lesion to be used to assess response on this protocol as defined by RECIST - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Recovery from effects of recent surgery, radiotherapy, or chemotherapy: - Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) - Any other prior therapy directed at the malignant tumor, including chemotherapy, biological/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to registration - At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy, thoracotomy, video assisted thorascopic surgery (VATS); there is no restriction on minor procedures (e.g., minor: central venous access catheter placement, ureteral stent placement or exchange, paracentesis, thoracentesis) - Patients must have had one prior taxane and platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organo platinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic (biologic/targeted agents, such as bevacizumab) or extended therapy administered after surgical or non-surgical assessment; there is no maximum number of prior regimens; - patients may not have had any prior systemic therapy (including interleukin-2, interferon-alpha, chemotherapy, bevacizumab, investigational or licensed drug that targets vascular endothelial growth factor [VEGF] or VEGF receptors/pathway or are mammalian target of rapamycin [mTOR] inhibitors) for treatment of recurrent ovarian cancer - Patients must have signed an approved informed consent and authorization permitting the release of personal health information - Patients must meet pre-entry requirements - A female is eligible to participate if she is of non-childbearing potential or as documentation of a negative pregnancy test prior to the start of the study treatment; sexually active pre-menopausal female subjects must agree to use adequate, highly effective contraceptive measures, while on study and for 45 days after the last dose of last study drug; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable or injectable contraceptives plus one barrier method; or (c) 2 barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm) Exclusion Criteria: - • Age < 18 years - Patients who have had previous treatment with tivozanib - Hemoglobin < 9.0 g/dL - Absolute neutrophil count (ANC) < 1500 per mm^3 - Platelet count < 100,000 per mm^3 - Total bilirubin > 1.5 × upper limit of normal (ULN) (or > 2.5 x ULN for subjects with asymptomatic Gilberts syndrome) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN (or > 5 × ULN for subjects with liver metastasis) - BOTH total bilirubin > ULN AND AST/ALT > ULN - Alkaline phosphatase > 2.5 × ULN (or > 5 × ULN for subjects with liver or bone metastasis) - Creatinine > 2.0 × ULN - Prothrombin time (PT) such that international normalized ratio (INR) > 1.5 x ULN (unless a patient is on therapeutic warfarin) or a partial thromboplastin time (PTT) > 1.5 x ULN - Proteinuria > 3+ by urinalysis or urine dipstick - Significant cardiovascular disease, including: - Symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or echocardiogram (ECHO) of =< lower limit of institutional normal (LLN) - Uncontrolled hypertension: systolic blood pressure of > 140 mmHg or diastolic blood pressure of > 90 mmHg documented on 2 consecutive measurements taken at least 24 hours apart - Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug - History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) - Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication) - Coronary or peripheral artery bypass graft within 6 months of screening - History of class III or IV congestive heart failure, as defined by the New York Heart Association - Central nervous system metastases; Note: subjects with previously treated (radiotherapy or surgery) brain metastasis that have been stable without steroid treatment for at least 3 months following prior treatment may be enrolled - Non-healing wound, bone fracture, or skin ulcer - Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug - Serious/active infection or infection requiring parenteral antibiotics - Corrected QT interval (QTc) of > 480 msec using Bazetts formula - Radiotherapy or minor surgical procedure within 2 weeks, or major surgical procedure within 4 weeks prior to administration of first dose of study drug; inadequate recovery from prior surgical procedure - Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to: - Deep vein thrombosis - Pulmonary embolism - Cerebrovascular accident (CVA) or transient ischemic attack (TIA) - Peripheral arterial ischemia > grade 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) - Significant bleeding disorders within 6 months prior to administration of first dose of study drug, including but not limited to: - Hematemesis, hematochezia, melena or other gastrointestinal bleeding >= grade 2 (per CTCAE version 4.0) - Hemoptysis or other pulmonary bleeding >= grade 2 (per CTCAE Version 4.0) - Hematuria or other genitourinary bleeding >= grade 2 (per CTCAE Version 4.0) - Currently active second primary malignancy, including hematologic malignancies (leukemia, lymphoma, multiple myeloma, etc.), other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast; subjects are considered to have a currently active malignancy if they have completed anti-cancer therapy and have not been disease free for > 2 years - Pregnant or lactating females - History of genetic or acquired immune suppression disease such as human immunodeficiency virus (HIV); subjects on immune suppressive therapy for organ transplant - Life-threatening illness or organ system dysfunction compromising safety evaluation - Requirement for hemodialysis or peritoneal dialysis - Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure - Known hypersensitivity to drugs chemically related to tivozanib hydrochloride or sunitinib or their excipients - Psychiatric disorder or altered mental status precluding informed consent or protocol-related testing ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Progression Free Survival (PFS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib[/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 - University of Texas; BRIEF: The purpose of this research study is to determine whether a medication called pioglitazone (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain structural changes associated with cocaine use and reduce cocaine craving and drug use in cocaine dependent patients. ; DRUG USED: OMS405; DRUG CLASS: New Molecular Entity (NME); INDICATION: Substance Use Disorder; TARGET: PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: The University of Texas Health Science Center, Houston; CRITERIA: Inclusion Criteria: - DSM-IV criteria for cocaine dependence - At least one cocaine positive urine during screening - Female subjects: a negative pregnancy test - Be in acceptable health on the basis of interview, medical history and physical exam - Be able to understand the consent form and provide written informed consent - Be able to provide the names of at least 2 persons who can generally locate their whereabouts. Exclusion Criteria: - Current Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of any psychoactive substance dependence other than cocaine marijuana, alcohol, or nicotine - Any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk - Significant current suicidal or homicidal ideation - Medical conditions contraindicating pioglitazone pharmacotherapy (e.g., congestive heart failure as determined by Framingham criteria, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer) - Taking medications known to have significant drug interactions with the study medication (CYP2C8 inhibitors or inducers, antihyperglycemic medications) - Currently being treated for substance misuse with medication - Conditions of probation or parole requiring reports of drug use to officers of the court - Impending incarceration - Pregnant or planning to become pregnant during the course of the trial or nursing for female patients - Inability to read, write, or speak English (many of the research instruments in this study only exist in English) - Having plans to leave the immediate geographical area within 3 months - Unwillingness to sign a written informed consent form - Unwillingness to use a barrier method of birth control during the study for female patients - History of pacemaker or metal implants or welding or metal work without protective eyewear (for risk of MRI scans). ; PRIMARY OUTCOME: Craving as Assessed by the Brief Substance Craving Scale (BSCS); SECONDARY OUTCOME 1: Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Small Fiber Neuropathy; BRIEF: This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber neuropathy. ; DRUG USED: VX-150; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuropathic Pain; TARGET: Sodium Channel Nav1.8 (SCN10A); THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg - Diagnosis of small fiber neuropathy, as per European Federation Neurological Societies (EFNS)/American Academy of Neurology (AAN) guidelines, with pain for at least 3 months prior to screening - Reduction below the 5th percentile of sex and age-adjusted normal values in epidermal nerve fiber density on punch skin biopsy at the distal site of the leg performed at screening - Normal nerve conduction studies (NCS), including presence of sural response. - Average NRS score between ≥4 and ≤9 reported in the daily diary on Days -7 through -1 Exclusion Criteria: - History in the past 10 years of malignancy except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ - History of connective tissue disorders, sarcoidosis, Sjögrens syndrome, amyloidosis, Fabrys disease, celiac disease, lyme disease, autoimmune disorders - A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses - Current clinically significant liver or kidney dysfunction - Current uncontrolled thyroid dysfunction - A diagnosis of diabetes, HbA1C ≥8% at screening - History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) - Concomitant severe pain conditions which may impair self-assessment of pain due to small fiber neuropathy Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Change in Weekly Average of Daily Pain Intensity on the 11 Point NRS; SECONDARY OUTCOME 1: Percentage of Participants With Greater Than or Equal to (>=) 30 Percent (%) Reduction in the Weekly Average of Daily Pain Intensity on the 11-Point NRS[/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 - P. falciparum or P. vivax; BRIEF: This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day ; DRUG USED: KAE609; DRUG CLASS: New Molecular Entity (NME); INDICATION: Malaria; TARGET: Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female patients aged 20 to 60 years - Presence of mono-infection of P. falciparum or P. vivax - Weight between 40 kg to 90 kg Exclusion Criteria: - Patients with signs and symptoms of severe/complicated malaria - Mixed Plasmodium infection - Presence of other serious or chronic clinical condition requiring hospitalization. - Severe malnutrition - Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Parasite clearance time; SECONDARY OUTCOME 1: Number of participants with adverse events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 015 - Bacterial Vaginosis; BRIEF: The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV). After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30). ; DRUG USED: VivaGel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Cell Membrane, Viral Capsid; THERAPY: Monotherapy; LEAD SPONSOR: Starpharma Pty Ltd; CRITERIA: Key eligibility criteria: - Post-menarchal females, aged 12 years or more - Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells - Nugent score of at least 4 - Otherwise healthy, as determined by medical history, physical examination - normal Pap smear at or documented within 24 months of screening ; PRIMARY OUTCOME: Number of Women With Clinical Cure at the End of Treatment Visit (EOT); SECONDARY OUTCOME 1: Number of Women With Nugent Cure at the EOT Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Sexual Dysfunction - 318 (US/CA); BRIEF: The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Is a man or a woman aged between 18 and 55 years, inclusive, who is currently being treated with selective serotonin reuptake inhibitor (SSRI) monotherapy (only citalopram, paroxetine, or sertraline allowed) for at least 8 weeks, which was prescribed to treat a major depressive episode (MDE), according to the DSM-IV-TR criteria. 2. Is currently stable; and has a Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score of ≤3. 3. Is currently experiencing treatment-emergent sexual dysfunction (TESD; defined as a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score ≤41 for women and ≤47 for men), considered to be attributable to the current SSRI monotherapy and is suitable for a switch. Exclusion Criteria: 1. Has previously participated in a Lu AA21004 clinical study. 2. Has 1 or more the following: any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; as assessed by the Mini International Neuropsychiatric Interview Version 6.0.0); current or history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR; current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to Screening (subject must also have negative urine drug screen prior to Baseline); presence or history of a clinically significant neurological disorder (including epilepsy); neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc); or any Axis II disorder that might compromise the study. 3. Has sexual dysfunction associated with an etiology other than SSRI treatment or current MDE (e.g., due to a medical condition, such as diabetes or hypertension, a medication, a genital anatomical deformity, or alcohol abuse). 4. Is nonsexually active or anticipates decreasing frequency of sexual activity (ie, sexual activity anticipated to lead to orgasm or that would normally lead to orgasm, which can include sexual intercourse, oral sex, masturbation, sexual fantasies, and/or thinking of sexual activity) during the course of the study below the level at study initiation. 5. Is a male with a history of premature ejaculation in the past year. 6. Has had major relationship changes during the preceding SSRI treatment period or plans to have major relationship changes during the course of the study. 7. Has a sexual partner(s) who plans to initiate treatment for sexual dysfunction during the study. ; PRIMARY OUTCOME: Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8; SECONDARY OUTCOME 1: Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed[/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 - University of Texas; BRIEF: This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A sufficient number of participants will be enrolled to yield 30 (approximately 15 pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3). ; DRUG USED: SST-6007; DRUG CLASS: Non-NME; INDICATION: Female Sexual Arousal Disorder; TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Monotherapy; LEAD SPONSOR: Strategic Science & Technologies, LLC; CRITERIA: Inclusion Criteria: 1. Post-menopausal women (surgically induced or natural) must meet 1 of the following criteria: - Surgical oophorectomy, partial hysterectomy, or full hysterectomy at least 1 year prior to screening (self-report). - No spontaneous menses >1 year (self-report). 2. Post-menopausal participants, who are not on any hormone replacement therapies (HRT), must have a serum follicle-stimulating hormone (FSH) lab result >40mIU/mL. 3. Women of childbearing potential must agree to continue using an appropriate form of birth control from Visit 1 through 7 days following the completion of Visit 3. Acceptable forms of birth control include the use of an IUD or hormonal therapy (oral, patch, etc.). Contraceptive foams/gels or condoms are not considered acceptable methods of birth control in this study. Participants must be on a stable dose for at least 6 months prior to Visit 1. 4. Participant has a body mass index (BMI) from 18 to 30 kg/m², inclusive. 5. Participant is heterosexual. 6. Participant has a normal electrocardiogram at Visit 1. 7. Participant is capable of understanding and complying with the protocol and agrees to sign the informed consent document. 8. Participant must agree to not use vaginal or vulvar lubricants, spermicides, creams or gels, contraceptive foams or vaginal douche products from Visit 1 until the completion of Visit 3 9 Participant agrees to not engage in strenuous, unaccustomed exercise within 6 hours of visit 2 or visit 3. Exclusion Criteria: 1. Participant is nursing or pregnant (based on positive serum pregnancy test), or wishes to become pregnant during the study period. 2. Participant has any disorder or a history of any disorder that may prevent the successful completion of the study in the opinion of the Sub-Investigator. 3. Participant has used any topical hormone replacement therapy (HRT) applied locally to the genitals in the past three months. Oral and patch form of HRT are acceptable, as long as the participant reports being on a stable dose for at least 6 months prior to Visit 1. 4. Participant has a significant cardiovascular, hepatic, metabolic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, genitourinary, or psychiatric disease or other unstable medical condition that would contraindicate administration of study medication, interfere with study evaluation, limit study participation, or confound the interpretation of study results in the opinion of the Sub-Investigator. 5. Participant had an active ulcer or clinically significant bleeding disorder. 6. Participant has a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to Visit 1; or any history of coronary disease causing angina; or congestive heart failure requiring medical intervention. 7. Participant has retinitis pigmentosa or sickle cell anemia or related anemias, even if the participant feels clinically well at the time of Visit 1. Participants with retinitis pigmentosa will be identified by specifically asking whether they have the condition, if there are visual signs and symptoms of the condition (including questioning participants as to whether they have difficulty seeing at night or in low light, and if they have any visual field deficits that indicate a loss of peripheral or central vision), or if there is a family history. 8 Participant has a history of orthostatic hypotension or orthostatic hypotension which is present at Visit 1, defined as a drop in systolic blood pressure ≥ 20 mm Hg, a drop in diastolic blood pressure ≥ 10 mm Hg or experiencing lightheadedness or dizziness at 1 or 3 minutes after the change in position from supine to standing. 9. Participant has primary anorgasmia, vaginismus, or sexual aversion disorder. 10. Participant has dyspareunia. 11. Participant has type 1 or type 2 diabetes. 12. Participant has undergone major pelvic surgery that may have caused nerve damage, including, vulvectomy, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage. 13. Participant has current and/or previous reported diagnoses of DSM-IV-TR axis I disorders including organic mental syndromes and disorders (e.g., schizophrenia, bipolar disorder, depression). 14. Participant has a history of cancer, other than basal cell carcinoma. 15. Participant has any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article in the opinion of the Sub-Investigator. 16. Participant has a history of non-arteritic ischemic optic neuropathy (NAION). 17. Participant has positive findings from the urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates). 18. Participant has positive serologic findings for sexually transmitted infection (syphilis, gonorrhea, chlamydia), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies. 19. Participant has moderate to severe current vaginitis, a vaginal infection including bacterial vaginosis or a yeast infection. The diagnosis of yeast infections should be made by the Sub-Investigator based on the physical and gynecological exams; the objective is to exclude women that are symptomatic. If the woman is not complaining of symptoms but the Sub-Investigator observes discharge, than the vaginal wet mount test should also be performed to confirm a diagnosis of yeast infection. ; PRIMARY OUTCOME: Participant-reported levels of subjective sexual arousal measured continuously by the Arousometer; SECONDARY OUTCOME 1: Adverse events and 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 III - 1966; BRIEF: The control of glucose homeostasis in subjects with type 1 diabetes is fragile since exogenous insulin cannot compensate for changing requirements and is not precise either in terms of the dose or the bio-availability of the insulin injected. Furthermore, in the near total absence of insulin secretion, the physiological post prandial inhibition of glucagon secretion by the α-cell is also probably deficient in all type 1 diabetics. Thus, there is a need for therapies beyond insulin that can further improve glycemic control and reduce fluctuations in glucose in these subjects. The investigators have recently shown that Liraglutide, a glucagon like peptide (GLP)-1 analogue with duration of action of 24 hours, when added to insulin in subjects with well controlled type 1 diabetes reduces mean and standard deviation of blood glucose, HbA1c and insulin requirements. Since C-peptide concentrations did not alter following Liraglutide, it is likely that the suppression of glucagon may have contributed to this effect. The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2 diabetes, however, these have not been studied prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed this study to investigate the central hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect. A major secondary objective of this study is to elucidate the mechanisms responsible for its glucose lowering effects and those involved in reducing the insulin dose. The specific aims of this proposal are: Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c, fasting, postprandial and the overall mean glucose concentrations while decreasing the dose of insulin required. Aim 1.1: To compare the HbA1c, mean fasting, glucose, mean weekly glucose, standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring and the dose of insulin required prior to and following 52 weeks of treatment with 1.8 mg of liraglutide daily. Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 52 weeks of treatment with 1.8 mg of liraglutide daily. Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and postprandial glucagon concentrations and increases basal and postprandial C-peptide concentrations. Aim 2.1: To compare the basal and postprandial glucagon and C-peptide concentrations following a test meal before and after 52 weeks of treatment with 1.8 mg of liraglutide daily. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying. Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and after treatment with 1.8 mg of daily subcutaneous liraglutide. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: University at Buffalo; CRITERIA: Inclusion Criteria: 1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2. Regularly measuring blood sugars four times daily. 3. HbA1c of less than 8.5%. 4. Well versed with carbohydrate counting. 5. Age 18-75 years. 6. BMI 20-40 kg/m2 Exclusion Criteria: 1. Type 1 diabetes for less than 6 months; 2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3. Hepatic disease (transaminase > 3 times normal) or cirrhosis; 4. Renal impairment (serum eGFR < 30ml/min/1.73m2); 5. HIV or Hepatitis B or C positive status; 6. Participation in any other concurrent clinical trial; 7. Any other life-threatening, non-cardiac disease; 8. Use of an investigational agent or therapeutic regimen within 30 days of study. 9. history of pancreatitis 10. pregnancy 11. inability to give informed consent 12. history of gastroparesis 13. history of medullary thyroid carcinoma or MEN 2 syndrome. ; PRIMARY OUTCOME: HbA1c; SECONDARY OUTCOME 1: Mean weekly glucose concentrations.[/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 - ACE-LY-001 (w/ACP-196) (B-cell Malignancies); BRIEF: This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies. ; DRUG USED: ACP-319; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: Unknown; THERAPY: Combination; LEAD SPONSOR: Acerta Pharma BV; CRITERIA: Main Inclusion Criteria: - Diagnosis of a b-cell malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO). - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. - Agreement to use contraception during the study and for 90 days after the last dose of study drugs if sexually active and able to bear or beget children. Exclusion Criteria - A life-threatening illness, medical condition or organ system dysfunction which, in the investigators opinion, could compromise the subjects safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk. - Central nervous system (CNS) involvement by lymphoma/leukemia - Any therapeutic antibody within 4 weeks of first dose of study drugs. - The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drugs is < 5 times the half-life of the previously administered agent(s). - ANC < 0.5 x 10^9/L or platelet count < 50 x 10^9/L unless due to disease involvement in the bone marrow. - Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x ULN (unless due to Gilberts disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN. ; PRIMARY OUTCOME: Best Response and Overall Response Rate; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CRT (EORTC); BRIEF: The aim of this study is to assess the potential benefit of the addition of immunotherapy with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and continued as adjuvant in patients with locally advanced cervical cancer. Safety run-in: To test the safety of CRT combined with immunotherapy with INO-3112. This safety run-in phase will include the first 3 patients treated in each of the two INO-3112 combination arms who are exposed to at least two immunotherapy doses and evaluate whether the combination does not pose undue immediate risks to the patients further enrolled in the trial. Phase II:To demonstrate sufficient activity in the experimental combination arms to warrant a further phase III conclusive trial based on progression free survival (PFS) at 18 months assessed by RECIST by the local investigator. The efficacy will be assessed within each experimental arm while the standard arm will serve as a reference arm to check the reliability of the results. ; DRUG USED: MEDI0457; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cervical Cancer; TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Combination; LEAD SPONSOR: European Organisation for Research and Treatment of Cancer - EORTC; CRITERIA: Main inclusion criteria: Registration step - Age 18 years or older; - Newly diagnosed locally advanced cervical cancer defined as FIGO 2009: stage IB2, IIA&IIB, IIIA&IIIB or IVA disease; - No evidence of distant metastases (Stage IVB); - Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix is accepted. Not accepted are small cell, clear cell and other rare variants of the classical adenocarcinoma; - Availability of HPV 16 and HPV 18 testing; - No HIV seropositive, Hepatitis B or C (unless sustained virologic response achieved by anti-HCV therapy); - Written informed consent must be given according to ICH/GCP, and national/local regulations Randomization step - Positive for HPV 16 and/or HPV 18 as assessed by central lab; - WHO/ECOG performance status 0 - 2 - Adequate hematological, liver and renal functions - ECG with no clinically significant findings as assessed by the investigator performed within 30 days of signing the informed consent form - Absence of current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, who have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study; - No prior history of clinically significant autoimmune disease, Crohns disease, ulcerative colitis; - No history of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Silgard®, Cervarix®, Gardasil®) are not excluded); - No known or suspected hypersensitivity to component(s) of investigational product or cisplatin contraindication (e.g. peripheral neuropathy ≤ grade 2 or ototoxicity ≤ grade 2 as per CTCAE v4); - No previous pelvic RT; - No previous chemotherapy for this tumor; - No patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy; - No receipt of any immunotherapy within 4 weeks of start of protocol treatment; - No prior major surgery within 4 weeks of randomization from which the patient has not recovered. ; PRIMARY OUTCOME: Occurence of Adverse Events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 211; BRIEF: This is a phase 2, randomized, placebo-controlled, 2-period study to evaluate the safety, tolerability, and efficacy of belumosudil in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. ; DRUG USED: Rezurock; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: ROCK (Rho-associated protein kinase); THERAPY: Monotherapy; LEAD SPONSOR: Kadmon Corporation, LLC; CRITERIA: Inclusion Criteria: - Adult subjects between the ages of 18 and 65 years - Able to provide written Informed Consent Form prior to the performance of any study-specific procedures - Diagnosis of moderate to severe chronic plaque psoriasis and a candidate for systemic therapy or phototherapy - PASI of ≥ 12 at screening and prior to the first dose of study drug, confirmed at Week 1 Day 1 (Baseline) - ≥ 10% PASI body surface area involvement at screening and prior to the first dose of study drug, confirmed at Baseline - Willing to avoid tanning devices - Adequate bone marrow function: - Absolute neutrophil count > 1500/mm^3 - Hemoglobin > 9.0 g/dL - Platelets > 100,000/mm^3 - Adequate safety laboratory values: - Serum total bilirubin within normal limits (WNL) - Aspartate aminotransferase (AST) and alalnine aminotransferase (ALT) < 2 × upper limit of normal (ULN) - Serum creatinine < 1.5 × ULN - Female subjects of childbearing potential with a negative pregnancy test at screening. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who had any evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to prior chemotherapy, antiestrogens, or ovarian suppression - Women of childbearing potential (i.e., menstruating women) had to have a negative urine pregnancy test (positive urine tests were to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug - Sexually active women of childbearing potential enrolled in the study had to agree to use 2 forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control included: (a) intrauterine device plus 1 barrier method; (b) on stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method; and (c) 2 barrier methods. Effective barrier methods were male or female condoms, diaphragms, and spermicides (creams or gels that contained a chemical to kill sperm); or (d) a vasectomized partner - For male patients who were sexually active and who were partners of premenopausal women: agreed to use 2 forms of contraception as defined above during the treatment period and for at least 3 months after the last dose of study drug - Willing to complete all study measurements and assessments in compliance with the protocol Exclusion Criteria: - Non-plaque or drug-induced (antimalarials, lithium) psoriasis (If subject was taking angiotensin II receptor blockers or beta blockers doses must have been stable for 6 months prior to study entry) - Used systemic corticosteroids within 12 weeks prior to study entry - Used topical corticosteroids except to the face, groin, or scalp - Used methotrexate, retinoids (such as acitretin), or calcineurin inhibitors (such as cyclosporine) within 4 weeks prior to study entry - Phototherapy within 4 weeks prior to study entry - Biologic therapies, including antibodies to IL-17; anti-tumor necrosis factor-alpha; and anti-IL-12 & IL-23 within 3 months prior to study entry - Current use of an inhibitor or inducer of CYP3A4 - Active viral, fungal, or bacterial skin infection (other than nail fungal infection). - Pregnant or lactating woman - History of gastrointestinal (GI) surgery including any bariatric surgery, or any GI condition that might interfere with drug absorption - Participating in another study with an investigational drug or within 28 days or 5 half-lives of the investigational drug (whichever was longer) of study entry - History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study - Regular and/or excessive use of alcohol within 2 years prior to study entry defined as alcohol intake > 14 drinks per week in a man or > 7 drinks per week in a woman. Approximately 10 g of alcohol equaled one drink unit. One unit equaled 1 ounce of distilled spirits, one 12-ounce beer, or one 4-ounce glass of wine - QT interval data corrected using Fridericias formula (QTcF) > 450 msec (average of 3 readings) during screening - Exposure to belumosudil or known allergy/sensitivity to belumosudil within the last 6 months prior to study entry or any other ROCK-2 inhibitor - History or presence of any of the following: - ALT or AST > 2.0 × ULN at screening - Renal disease and/or serum creatinine > 1.5 × ULN at screening ; PRIMARY OUTCOME: Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed; SECONDARY OUTCOME 1: Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed[/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 - C4161001; BRIEF: To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers. ; DRUG USED: PF-07104091; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy) - Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting - Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received at least 1 systemic anti-cancer therapy containing a platinum analog - Participants with cytological diagnosis of advanced/metastatic SCLC - Participants with or cytological diagnosis of advanced/metastatic NSCLC - Participants with HR-positive HER2-negative advanced or metastatic breast cancer (second line plus setting) (histologically or cytologically proven). - Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated - Performance Status 0 or 1 - Adequate bone marrow, hematological, kidney and liver function - Resolved acute effects of any prior therapy to baseline severity Exclusion Criteria: - Participants with known symptomatic brain metastases requiring steroids - Participants with any other active malignancy within 3 years prior to enrollment - Major surgery within 3 weeks prior to study entry - Radiation therapy within 3 weeks prior to study entry. - Systemic anti cancer therapy within 4 weeks prior to study - Prior irradiation to >25% of the bone marrow - Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, and known HIV or AIDS related illness - Active COVID-19/SARS-CoV2 infection - Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results - Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities, unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo embolic disease. - Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed. - Hypertension that cannot be controlled by medications - Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry. - Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091. - Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. - Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short - Participants with an indwelling catheter that has an external component such as those used for drainage of effusion(s) or central venous catheter that is externally - Previous high dose chemotherapy requiring stem cell rescue - Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable). - Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or UGT1A9 inhibitors or inducers - Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates with narrow therapeutic - Serum pregnancy test positive at screening - Other medical or psychiatric condition ; PRIMARY OUTCOME: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle; SECONDARY OUTCOME 1: Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BRISK-APS (Study 047); BRIEF: The purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy. ; DRUG USED: Brivanib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Fibroblast Growth Factor Receptor (FGFR) , VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Key Inclusion Criteria: - Diagnosis of advanced hepatocellular carcinoma - Asian ethnicity - Patient has failed ≥14 days of sorafenib treatment - Cirrhotic status of Child-Pugh Class A or B with a score of 7 - Eastern Cooperative Oncology Group performance status of 0, 1, or 2 - Life expectancy of at least 8 weeks - Adequate hematologic, hepatic, and renal function Key Exclusion Criteria: - Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy - Previous or concurrent cancer that is distinct in primary site - History of active cardiac disease - Thrombotic or embolic events within the past 6 months - Inability to swallow tablets or untreated malabsorption syndrome - History of HIV infection - Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib) ; PRIMARY OUTCOME: Compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to sorafenib and receive brivanib plus best supportive care (BSC) to those receiving placebo plus BSC; SECONDARY OUTCOME 1: Compare time to progression (TTP) using modified RECIST for HCC[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/IIa - w/FOLFOX; BRIEF: BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase. ; DRUG USED: BOLD-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: GRP78/HSPA5; THERAPY: Combination; LEAD SPONSOR: Bold Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Be 18 years or older. 2. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol (see Table 12. Acceptable Contraceptive Methods.) 3. Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX as SOC per investigators judgement. Participants will have received at least one line of chemotherapy in the metastatic setting. Colorectal cancer: Patients must have received at least 1 prior line of therapy prior to enrollment in this study. Pancreatic cancer: Patients must have received at least 1 prior line of therapy. Gastric cancer: Patients who have not received prior treatment may be included in this study. GEJ (gastroesophageal junction) cancer patients are considered eligible to enter this trial. Cholangiocarcinoma: locally advanced or metastatic biliary tract cancer (intra or extrahepatic cholangiocarcinoma or gallbladder cancer) are eligible to enter this trial. Patients must have received at least 1 prior line of therapy (with gemcitabine-based chemotherapy). Colorectal cancer (ARM VI): Patients must have received at least 2 prior lines of therapy prior to enrollment in this study, one of which was a 5-FU based regimen. 4. Have measurable disease according to RECIST v1.1 (at least one measurable lesion). 5. Have an anticipated survival of at least 16 weeks. 6. Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. 7. Have adequate organ function, defined as: 1. Hematologic: ANC ≥ 1.5 x 109/L, Hgb ≥ 9.0 g/dL and platelet count ≥ 100 x 109/L 2. Hepatic: total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for subjects with Gilberts Syndrome); transaminases ≤ 2.5 x ULN (may be up to ≤ 5x ULN if clearly due to liver metastases) and ALP ≤ 2.5 x ULN (or ≤ 3 x ULN if liver metastases). 3. Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min. c. Urine protein is 0, trace, or +1 on dipstick urinalysis, or < 1.0 gram on 24-hour urine protein analysis 8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion (e.g., non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates, diphenylhydantoin, narcotic analgesics, probenecid). Such drugs should not be initiated while the subject is participating in this study or have been initiated within 30 days beforehand before the start of treatment. Whenever possible, narcotic analgesic doses should be stable within 30 days prior to study entry and during the first cycle of therapy. 9. Resolved acute effects of any prior therapy before the start of treatment to baseline severity or grade ≤1 CTCAE 5.0 except for adverse events not constituting a safety risk by investigator judgment (such as alopecia) 10. Able to take oral medications (for pre-medications and supportive management) 11. Understand and be able, willing, and likely to fully comply with study procedures and restrictions. 12. Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF). Exclusion Criteria: 1. Neuropathy > grade 2 2. Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin 3. Cerebrovascular accident within the past 6 months before the start of treatment. 4. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam. 5. Any serious medical conditions that might be aggravated by treatment or limit compliance. This includes, but is not limited to uncontrolled psychiatric disorders, serious infections, active peptic ulcer disease and bleeding diathesis 6. Any history of serious cardiac illness including (but not confined to): - Previous or active myocardial infarction < 6 months before the start of treatment - Congestive cardiac failure (NYHA III or IV) - History of unstable angina pectoris < 6 months before the start of treatment - Recent coronary artery bypass grafting < 6 months before the start of treatment - Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) - Ventricular arrhythmia < 6 months before the start of treatment - Left ventricular ejection fraction (LVEF) < 50% as measured either by radionuclide angiography or echocardiogram - QTc interval > 470 msec 7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment 8. Any other known malignancy within 3 years before the start of treatment (with the exception of non-melanoma skin cancer that had undergone curative treatment, cervical cancer in situ, or ductal/lobular carcinoma in situ of the breast that has underwent local treatment 9. Active gastrointestinal tract disease with malabsorption syndrome. 10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease. 11. Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment. 12. Recent history of weight loss > 10% of current body weight in past 3 months before the start of treatment. 13. Current (within 1 week of the start of the study) or regular use of any medication (including OTC, herbal or homeopathic preparations) that could affect (improve or worsen) the cancer being studied, or could affect the action or disposition of BOLD-100, or its clinical or laboratory assessment, e.g., Coumadin therapy, due to high competitive protein binding. 14. HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent. 15. Any condition potentially decreasing compliance to study procedures. Concurrent use of another investigational therapy or anti-cancer therapy. 16. Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment. ; PRIMARY OUTCOME: Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0; SECONDARY OUTCOME 1: Progression Free Survival (PFS); Overall Response Rate (ORR); Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ARCHWAY (BPD-201); BRIEF: This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode. ; DRUG USED: SAGE-217; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: 1. Participant had a documented history of hypomanic or manic episode and a diagnosis of bipolar I or bipolar II disorder with a current major depressive episode. Exclusion Criteria: 1. Participant had a history of suicide attempt. 2. Participant had current suicidal ideation with plans. 3. Participant had a history of rapid cycling bipolar disorder. ; PRIMARY OUTCOME: Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Part A: Change From Baseline in the 17-Item HAM-D Total Score at Day 15[/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 - SHINE; BRIEF: The primary objective is to evaluate the long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen. ; DRUG USED: Spinraza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Spinal Muscular Atrophy; TARGET: Survival of Motor Neuron (SMN) Protein; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Signed informed consent of parent or guardian and signed informed assent of participant, if indicated per participants age and institutional guidelines. - Completion of the index study in accordance with the study protocol or as a result of Sponsor decision (e.g., early termination of the index study) within the preceding 16 weeks Key Exclusion Criteria: - Have any condition or worsening condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study - Clinically significant abnormalities in hematology or clinical chemistry parameters or electrocardiogram (ECG), as assessed by the Site Investigator, at the Screening visit that would render the participant unsuitable for participation in the study - Participants parent or legal guardian is not willing or able to meet standard of care guidelines (including vaccinations and respiratory syncytial virus prophylaxis if available), nor provide nutritional and respiratory support throughout the study - Treatment with another investigational agent, biological agent, or device within one month of Screening, or 5 half-lives of study agent, whichever is longer NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Number of participants experiencing Adverse events (AEs) and/or Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Percentage of participants who attained motor milestones as assessed by World Health Organization (WHO) 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 - ESCAPE - w/Platinum/Etoposide; BRIEF: The purpose of the study is to evaluate the safety and potential benefit of combination amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small cell lung cancer (SCLC) subjects. ; DRUG USED: Amuvatinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Tyrosine Kinases; THERAPY: Combination; LEAD SPONSOR: Astex Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female ≥ 18 of age at the time of consent and have histologically or cytologically confirmed SCLC 2. Measurable SCLC per RECIST guideline that meets one of the following: - Disease progression by RECIST at anytime during platinum-etoposide (PE) chemotherapy; - Relapse by RECIST within 90 days after completing PE chemotherapy; - Stable disease by RECIST as best response after at least two (2) ≥ 21-day cycles of PE chemotherapy. The assessment of stable disease should be made at least 2 weeks after the start of the second cycle Subjects who received another second-line therapy are eligible if they still fulfill any one of the above three conditions, and all other eligibility criteria 3. Start treatment with the same last regimen (dose and schedule) of first-line PE chemotherapy that they progressed or relapsed on, including any dose reductions because of toxicity, prior to study entry 4. ECOG performance status 0 to 2 5. Adequate organ function 6. Subjects with screening 12-lead ECG with measurable QTc interval of < 450 msec. If QTc ≥ 450 msec, then confirm the reading by evaluating the mean QTc interval of triplicate ECGs. 7. Sign approved informed consent form Exclusion Criteria: 1. Prior exposure to amuvatinib 2. No longer eligible for first-line PE chemotherapy due to toxicity and the Investigator believes that the risk of retreating with the same PE chemotherapy regimen would outweigh the benefit 3. Ongoing toxicity from prior treatment unless the toxicity has resolved, or in the opinion of the Investigator, is stable and does not compromise the safety of the subject 4. Mixed SCLC and non-small cell lung cancer, or large cell lung cancer 5. Untreated, unstable, or symptomatic brain metastasis 6. Hypersensitivity to amuvatinib, excipients of amuvatinib, or any agent given in association with this trial 7. A life-threatening illness, medical condition or organ system dysfunction which, in the Investigators opinion, could compromise the subjects safety or interfere with study outcomes ; PRIMARY OUTCOME: Overall objective response rate (CR or PR); SECONDARY OUTCOME 1: Progression-free survival and 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 Ib/II - w/Gemcitabine and Nab-paclitaxel; BRIEF: This is a Phase 1b/2 study of batiraxcept (AVB-S6-500) designed to evaluate the safety and efficacy of batiraxcept in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced, recurrent, or metastatic pancreatic adenocarcinoma as first line therapy. The phase 1b portion of the study is open label and patients will receive batiraxcept, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of batiraxcept, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy. ; DRUG USED: AVB-500; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Axl Receptor Tyrosine Kinase; THERAPY: Combination; LEAD SPONSOR: Aravive, Inc.; CRITERIA: Inclusion Criteria: - Age 18 years or older - Histologically or cytologically confirmed pancreatic adenocarcinoma. Must have locally advanced, recurrent, or metastatic disease ineligible for curative intent treatment(s) and eligible for first line systemic treatment. - Must have radiologic imaging with a computed tomography (CT) scan or magnetic resonance imaging (MRI) within 22 days of study entry - Must have at least one measurable lesion according to RECIST 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Adequate gastrointestinal (GI), bone marrow, liver and kidney function - Life expectancy minimum of > 12 weeks - Adequate recovery from surgery to Grade 1 or baseline with at least 28 days from time of major surgery Exclusion Criteria: - Received last dose of chemotherapy (neoadjuvant or adjuvant), surgery, or radiation treatment with curative intent within 6 months prior to study entry - Islet-cell neoplasms - Prior malignancy within the past 3 years except adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, breast or melanoma - Symptomatic uncontrolled central nervous system (CNS) metastasis or brain metastases unless adequately treated and controlled - Evidence of clinically significant third spacing (e.g. pleural effusion, ascites, anasarca, etc.) within 28 days prior to study entry - Serious active infection requiring IV antibiotics and/or hospitalization at study entry - Active human immune deficiency (HIV) syndrome, hepatitis B, hepatitis C, or other active viral illness ; PRIMARY OUTCOME: Incidence of adverse events (AEs); SECONDARY OUTCOME 1: Pharmacokinetics: 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 III - 091; BRIEF: This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up. ; DRUG USED: Durysta; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin F receptor (FP)/PGF2 alpha receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: -Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment. Exclusion Criteria: - Previous enrollment in another Allergan Bimatoprost SR Study. - Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye - Anticipated need for laser eye surgery in either eye within the first 52 weeks of the study duration - History of glaucoma surgery ; PRIMARY OUTCOME: Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2); SECONDARY OUTCOME 1: Change From Baseline in IOP in the Study Eye[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MGD/CLD; BRIEF: SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD). ; DRUG USED: AZR-MD-001; DRUG CLASS: Non-NME; INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Azura Ophthalmics; CRITERIA: Inclusion Criteria: - MGD Patients: - Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit - Reported dry eye signs and symptoms within the past 3 months - TBUT < 10 seconds in both eyes - CLD Patients: - Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit - A history of wearing soft contact lenses for at least 6 months - Wearing of the soft contact lenses for at least 3 weeks before the baseline visit and wore or attempted to wear lenses at least 4 times a week before the baseline visit. - Symptomatic as defined by an answer of No at baseline to the question, Are you able to comfortably wear your lenses as long as you want? - Self-reported history of contact lens dryness/intolerance in the 6 months preceding the baseline visit. - Baseline CLDEQ-8 score >12 - Contact lens may be use during the study as long as they are removed 15 minutes before dosing and not reinserted until at least 15 minutes after dosing. Exclusion Criteria: - Uncontrolled ocular disease (except for MGD or CLD) or uncontrolled systemic disease - Patient has glaucoma or ocular hypertension - Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity - BCVA worse than 20/40 in either eye at the baseline visit ; PRIMARY OUTCOME: Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS).; 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 - PRESIDIO (DM + PM); BRIEF: This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM). Patients were evaluated for eligibility during the Screening Period. Eligible patients were stratified by diagnosis of DM or PM and randomized 1:1 to Arm A or Arm B of the study. During the 32-week treatment period, patients received study drug subcutaneously (SC) once weekly with 2 treatment periods of 16 weeks each. This study was conducted on an outpatient basis. ; DRUG USED: KZR-616; DRUG CLASS: New Molecular Entity (NME); INDICATION: Inflammatory Disorders; TARGET: Proteasome; THERAPY: Monotherapy; LEAD SPONSOR: Kezar Life Sciences, Inc.; CRITERIA: Inclusion Criteria: 1. Adult patients at least 18 years of age 2. Body Mass Index (BMI) of 18 to 40 kg/m^2 3. Diagnosis of probable or definite DM or PM by the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria 4. Must have their data reviewed by an adjudication committee to confirm eligibility unless at least 1 of the following is present: 1. Muscle biopsy with evidence of active myositis within the last 6 months prior to or at Screening 2. Electromyography or magnetic resonance imaging with evidence of active myositis within the last 6 months prior to Screening 3. A creatine kinase (CK) ≥4 × upper limit of normal (ULN). 5. Must have demonstrable muscle weakness as measured by the Manual Muscle Testing-8 muscle Groups (MMT-8) with a score ≥80/150 but ≤136/150 units and any 2 of the following: 1. Physician Global Assessment (MDGA) visual analog scale (VAS) ≥2 cm 2. Patient Global Assessment of Disease Activity (PtGADA) VAS ≥2 cm 3. At least one muscle enzyme laboratory measurement ≥1.3 × ULN 4. Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity VAS ≥1 cm. 6. Documented inadequate response OR have demonstrated documented toxicity or intolerance to prior standard of care therapies 7. Has had age-appropriate cancer screening that is up to date and negative for evidence of malignancy as per local standard of care Exclusion Criteria: 1. Has significant muscle damage or has a muscle damage VAS score ≥5 cm on the MDI 2. Any other form of myositis or myopathy other than PM or DM 3. Any condition that precludes the ability to quantitate muscle strength 4. Has severe interstitial lung disease or has a pulmonary damage VAS score ≥5 cm on the Myositis Damage Index (MDI) 5. Presence of autoinflammatory disease 6. Use of nonpermitted medications or treatments within the specified washout periods prior to screening 7. Patient has had recent serious or ongoing infection, or risk for serious infection 8. Any of the following laboratory values at Screening: 1. Estimated glomerular filtration rate <45 mL/min 2. Hemoglobin <10 g/dL 3. White blood cell (WBC) count <3.0 × 10^9/L 4. Absolute neutrophil count (ANC) <1.5 × 10^9/L (1500/mm^3) 5. Platelet count <100 × 10^9/L 6. Serum AST or serum ALT >2.5 × ULN (unless considered consistent with muscle origin) 7. Serum alkaline phosphatase >2.5 × ULN 8. Total bilirubin >1.5 × ULN (3 × ULN for patients with documented Gilberts syndrome) 9. Thyroid stimulating hormone outside of the central laboratory normal range 10. Immunoglobulin G (IgG) <500 mg/dL. 9. Presence of New York Heart Association Class III or IV heart failure, or uncontrolled blood pressure, or prolonged QT interval 10. Major surgery within 12 weeks before Screening or planned during the study period 11. Clinical evidence of significant unstable or uncontrolled diseases 12. Any active or suspected malignancy, including myeloproliferative or lymphoproliferative disorder, or history of documented malignancy within the last 5 years before Screening or within 3 years of diagnosis of myositis, except appropriately excised and cured cervical carcinoma in situ or basal or squamous cell carcinoma of the skin ; PRIMARY OUTCOME: Mean Change in the Total Improvement Score (TIS) From Start to End of Zetomipzomib (KZR-616) Treatment Period; 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 - w/Metformin IR; BRIEF: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control ; DRUG USED: Kombiglyze XR; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK), Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Subjects with type 2 diabetes mellitus; 2. HbA1c ≥8% but ≤12%; 3.Fasting C-peptide ≥1.0 ng/ml; 4. Subject will be drug naïve; 5. Body mass index ≤40 kg/m2. Exclusion Criteria: 1. Symptoms of poorly controlled diabetes; 2. Chronic or repeated intermittent corticosteroid treatment ; 3. Calculated creatinine clearance <60 ml/min or serum creatinine >132.6 μmol/L (>1.5 mg/dL) for men, >123.8 μmol/L (>1.4 mg/dL) for women; 4. Creatine Kinase ≥3x ULN; 5.Abnormal TSH value at screening will be further evaluated by free T4, subjects with an abnormal free T4 will be excluded; 6. History of administration of any antihyperglycaemic therapy for a total of 28 days or for more than three consecutive days or a total of seven non-consecutive days during the eight weeks prior to screening; 7. Current treatment with a strong CYP3A4/5 inhibitor; 8. Prior treatment with saxagliptin or any DPP-4 inhibitor; 9. Significant or history of cardiovascular disease, renal disease, psychiatric disorders, Immunocompromised individuals, hemoglobinopathies, liver disease, Pancreatitis. ; PRIMARY OUTCOME: Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue; SECONDARY OUTCOME 1: Glycemic Response Defined as HbA1c < 7.0% at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - PIFR; BRIEF: This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate. ; DRUG USED: Yupelri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Mylan Inc.; CRITERIA: Inclusion Criteria: - Subject is a male or female subject 40 years of age or older with a diagnosis of COPD. - Subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years. - Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures. Exclusion Criteria: - Subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug. - Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics. - Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention. ; PRIMARY OUTCOME: Change From Baseline in Trough FEV1 on Day 29; SECONDARY OUTCOME 1: Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29[/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 - Expansion (Solids); BRIEF: The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102. In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors. ; DRUG USED: Onzeald; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: Nektar Therapeutics; CRITERIA: Inclusion: 1. Received prior treatment with NKTR-102 2. Free of disease progression since receiving NKTR-102 3. Adequate bone marrow and organ function 4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102 5. Agree to use adequate contraception Exclusion: 1. Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study 2. A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose < 70 mg/m2 upon entry into this study 3. Pregnancy or lactation ; PRIMARY OUTCOME: Length of Exposure to NKTR-102; 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 III - LOGICS; BRIEF: This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushings Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole. ; DRUG USED: Recorlev; DRUG CLASS: Non-NME; INDICATION: Cushings Syndrome; TARGET: 11-beta-hydroxylase, Cytochrome p450; THERAPY: Monotherapy; LEAD SPONSOR: Cortendo AB; CRITERIA: INCLUSION CRITERIA: SONICS STUDY COMPLETERS: Completed the final SONICS visit (M12) and have demonstrated maintenance of clinical response on a stable Therapeutic Dose of levoketoconazole for at least 12 weeks prior to study entry. ALL OTHERS: - Confirmed newly diagnosed, persistent or recurrent endogenous Cushings syndrome of any etiology, except secondary to malignancy (including pituitary or adrenal carcinoma). - Elevated mean 24-hour Urinary Free Cortisol (UFC) levels at least 1.5X upper limit of the normative range of the studys central laboratory assay and from a minimum of three measurements from adequately collected urine. - Presence of abnormal values from at least one of these two diagnostic tests: - Abnormal Dexamethasone Suppression Test (DST) OR - Elevated late night salivary cortisol concentrations (at least two measurements) each greater than the upper limit of the studys central laboratory normative range - Non-candidates for CS-specific surgery, refuse surgery or surgery will be delayed until after study completion and agree to complete this study prior to surgery. - If post-surgical for CS-specific surgery, then no significant post-operative sequelae remain and the risk of such sequelae is considered negligible. EXCLUSION CRITERIA: Subjects will be excluded from the study if ANY of the following criteria are met (NOTE: exclusion criteria apply to and must be assessed in both cohorts): - Enrolled in SONICS but have not completed SONICS through Visit M12. - Pseudo-Cushings syndrome based on assessment of the Investigator. - Cyclic Cushings syndrome with multi-week periods of apparent spontaneous CS remission. - Non-endogenous source of hypercortisolism, including pharmacological corticosteroids or ACTH. - Radiotherapy of any modality directed against the source of hypercortisolism within the last 5 years. - Treatment with mitotane within 6 months of enrollment. - History of malignancy, including adrenal or pituitary carcinomas (other than low-risk, well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely to require further treatment in the opinion of the treating physician, or squamous cell or basal cell carcinoma of the skin). - Clinical or radiological signs of compression of the optic chiasm. ; PRIMARY OUTCOME: Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.; 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 - ICP-1701-102; BRIEF: The objectives of this study are: Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study. ; DRUG USED: Olinciguat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiovascular Disease; TARGET: Guanylate Cyclase (sGC); THERAPY: Monotherapy; LEAD SPONSOR: Cyclerion Therapeutics; CRITERIA: Inclusion Criteria: - Subject is an ambulatory male or female between 18 and 55 years old at the screening visit - Subjects body mass index score is > 18.5 and < 30.0 kg/m2 at the screening visit - Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study - Subject is in good health and has no clinically significant findings on a physical examination - Other inclusion criteria per protocol Exclusion Criteria: - History of any clinically significant medical conditions - Other exclusion criteria per protocol ; PRIMARY OUTCOME: Treatment Emergent Adverse Event; 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 - APS-201; BRIEF: The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or thrombocytopenia. ; DRUG USED: ALXN1007; DRUG CLASS: Biologic; INDICATION: Inflammatory Disorders; TARGET: C5a Receptor, Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Patients with a persistent and clinically significant aPL profile Patients with at least 1 of the following non-criteria manifestations of APS: 1. aPL-nephropathy (diagnosed by kidney biopsy within 12 months of Screening) confirmed based on the updated APS Classification Criteria recommendations, and urine protein to creatinine ratio > 1.0 at the time of the Screening visit and/or 2. Skin ulcers (non-infected livedoid vasculitis-like skin ulcer and/or large skin ulceration resembling pyoderma gangrenosum) for at least 4 weeks prior to the Screening visit, diagnosed by physical examination, and/or 3. Persistent active thrombocytopenia (diagnosed by platelet counts <100 x 103/μL and ≥20 x 103/μL [SI: <100 x 109/L and ≥ 20 x 109/L]) and confirmed at the time of screening (at least 4 weeks after previous test) based on the updated APS Classification Criteria recommendations Patients and spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least 1 of which must be a barrier method) starting at Screening and continuing through the entire study. Patients with aPL-nephropathy must be receiving or agree to initiate an ACE inhibitor or angiotensin receptor blocker at least 4 weeks prior to initiation of ALXN1007 treatment; unless patient is documented to be intolerant. Patients receiving oral corticosteroids must be on a stable dose of ≤ 10 mg/day of prednisone or equivalent dose of another corticosteroid preparation for at least 4 weeks prior to the first dose of ALXN1007. Patients receiving immunosuppressive medications (including but not limited to methotrexate, hydroxychloroquine, azathioprine, cyclosporine and mycophenolate mofetil) must be on a stable dose for at least 4 weeks prior to the first dose of ALXN1007. Patients receiving oral anticoagulants or antiplatelet agents (including but not limited to aspirin) must be on stable doses for at least 4 weeks prior to first dose of ALXN1007. Patients must be willing and able to give written informed consent and to comply with all study visits and procedures. Exclusion Criteria: Patients meeting the ACR classification criteria for systemic lupus erythematosus, systemic sclerosis or other systemic autoimmune diseases other than Primary APS. Patients experiencing an acute thrombosis or a Major Adverse Vascular Event (MAVE) within 12 weeks prior to first administration of ALXN1007. Patients with skin ulcers from causes other than aPL or who are positive for DVT or venous insufficiency at Screening. Patients with renal function status requiring chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy). Patients with unresolved meningococcal disease or with known active bacterial, viral, fungal, mycobacterial or other infection. Patients that have received IVIg treatment within 4 weeks prior to first dose of ALXN1007. Patients that have received a course of rituximab (RITUXAN®) therapy within 12 months prior to first dose of ALXN1007 or have evidence of persistent depletion of the targeted lymphocyte population. Women who are pregnant or nursing. ; PRIMARY OUTCOME: Safety and Tolerability of Intravenous (IV) ALXN1007 as Measured by Percentage of Patients Reporting Adverse Events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Non-influenza vaccine - Children; BRIEF: The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014). ; DRUG USED: Fluarix Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol. - A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination. - Written informed consent obtained from the parent(s) /LAR(s) of the subject. - Subjects in stable health as determined by medical history and clinical examination before entering into the study. Exclusion Criteria: - Participation in a previous FLU-D-QIV-004 study (115345) cohort. - Child in care. - Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. - Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country. - Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination. - Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period. - Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination. - Any contraindication to intramuscular injection. - Acute disease and/or fever at the time of enrolment. - Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study. - Additional criteria for children ≥ 12 months of age: - Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted. * For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination. - Any history of hepatitis A or varicella diseases. - Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine: - Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted. ; PRIMARY OUTCOME: Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.; SECONDARY OUTCOME 1: Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.[/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 - MINT; BRIEF: To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis. ; DRUG USED: Gimoti; DRUG CLASS: Non-NME; INDICATION: Diabetic Gastroparesis; TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT3 receptor, Serotonin 5-HT4 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Evoke Pharma; CRITERIA: Inclusion Criteria 1. Male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years (inclusive) 2. Willing and able to give written informed consent to participate in the study 3. Ability to read and understand English 4. Diagnosis of Type 1 or Type 2 diabetes 5. Diagnosis of diabetic gastroparesis previously documented 6. A mean daily GCSI-DD score of ≥2 and ≤4 for the 7 days prior to the Randomization Visit (Visit 3, Day 0) 7. Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from Screening through the last dose of study drug: hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm, or cervical cap with spermicide), intrauterine device (IUD), or vasectomized partner (6-months minimum) 8. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results (with the exception of lipid profile, glucose and hemoglobin A1c) during screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results 9. Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all medications specified by the protocol for the duration of the study Exclusion Criteria 1. Gastric bypass and gastric banding, gastric pacemakers, post-surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility such as active gastric ulcer, active duodenal ulcer, active severe gastritis, gastric cancer, amyloidosis, neuromuscular diseases (including Parkinsons disease), collagen vascular diseases, alcoholism, uremia, malnutrition, and untreated hypothyroidism 2. A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia to metoclopramide or any comparable or similar product 3. History of or physical findings suggestive of tardive dyskinesia 4. Currently using and unwilling or unable to stop any medication known to be associated with tardive dyskinesia (See Study Reference Manual) prior to Washout (Visit 2) 5. History of allergy to any of the ingredients in the study drug formulation; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, EDTA, or sorbitol 6. History of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease 7. Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment 8. History of other clinically significant renal, hepatic, neurologic, hematologic, oncologic, pulmonary, psychiatric, cardiovascular or infectious disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results 9. Have renal dysfunction calculated as creatinine clearance (CrCl) < 40 mL/min at Screening (Visit 1) 10. Have a hemoglobin A1c > 12.5% at Screening (Visit 1) 11. Inability or unwillingness to stop using the following agents for 7 days during the Washout Period (Day -7 to Day -1) prior to Randomization (Visit 3, Day 0) and refrain from their use for the 4-week study period; oral and parenteral formulations of metoclopramide, domperidone, tricyclic antidepressants, macrolide antibiotics, prokinetic agents, cholinergic agents, agents with significant anticholinergic effects, narcotic analgesics, orally administered β agonists, spasmolytics, dopamine agonists, monoamine oxidase inhibitors, herbal supplements, fiber or bulking products, and laxatives 12. Use of neurotoxins (e.g., botulinum type A or B) as a treatment for gastroparesis or delayed gastric emptying within 6 months of Screening (Visit 1) 13. Clinically significant abnormal finding or a QTc interval >450 milliseconds (msec) on ECGs obtained at Screening (Visit 1) OR pre- or post-dose at Randomization (Visit 3) 14. Inability or unwillingness to stop using medications associated with Torsades de Pointes or a prolonged QT interval for 30 days prior to the initial symptom assessment and refrain from their use for the 4-week study period (see Study Reference Manual) 15. Female subjects who are trying to conceive, are pregnant, or are lactating 16. Positive serum human chorionic gonadotropin (HCG) pregnancy test at Screening or a positive HCG urine test on Day 0 prior to administration of study drug for women of childbearing potential 17. History of alcohol or drug abuse within the year prior to the Screening Visit, or current known evidence of substance dependence or abuse 18. Participation in a clinical (investigational) trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit (Visit 1) with the exception of domperidone ; PRIMARY OUTCOME: The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.; 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 - Maintenance Treatment (Germany); BRIEF: Investigating the efficacy of maintenance and reinduction treatment or no treatment and watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy. The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be compared with a maintenance treatment with bevacizumab alone or no maintenance treatment. Reinduction treatment will be done in case of progression. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: AIO-Studien-gGmbH; CRITERIA: Inclusion Criteria: - Histologically confirmed and inoperable or irresectable metastatic colorectal cancer (stage IV) - Measurable lesion according to RECIST measured within 4 weeks prior to registration of the subject for the study - Not allowed prior treatments: - Previous chemotherapy for metastatic disease (adjuvant therapy for non-metastasized disease is allowed if terminated more than 6 months ago and without recurrence within 6 months after the end of adjuvant treatment) - Prior radiation of indicator lesion(s), except for documented progression during radiation and termination of radiotherapy at least 4 weeks prior to entry into the study - 18 and over - ECOG 0-2 - Prior and concomitant associated diseases: - No past or current history of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin - in situ carcinoma of the cervix - Other malignant disease without recurrence after at least 5 years of follow-up - No severe internal disease (insufficiently treated or uncontrolled arterial hypertension, haemoptoe, New York Heart Association (NYHA) grade II or greater congestive heart failure, symptomatic coronary heart disease, myocardial infarction (= < 12 months prior to inclusion), serious cardiac arrhythmia requiring medication, peripheral arterial occlusive disease stage II or greater, uncontrolled severe disease) - No history or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumour, seizure not controlled with standard medical therapy, brain metastases or history of stroke). - No pre-existing neuropathy > = grade 1 (NCI CTCAE), except for loss of tendon reflex as the only symptom - No interstitial pneumonia or symptomatic fibrosis of the lung - No allogenic transplantation requiring immuno-suppressive therapy - No severe non-healing wounds, ulcers or bone fractions. - No thrombosis or severe bleeding within 6 months prior to entry into the study (except for bleeding of the tumor before its surgical resection) and no evidence of bleeding diathesis or coagulopathy. - Laboratory requirements - within 7 days prior to enrollment: - Neutrophil count > = 1,500/μl - Platelets > = 100,000/μl - Hb > = 9g/dl dL (may be transfused to maintain or exceed this level) - Serum creatinine clearance > 50ml/min (Cockroft/Gault) - Serum total bilirubin: = < 1.5 x UNL - AST and ALT = < 2.5 x UNL; = < 5 x UNL in subjects with documented liver metastases - Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and aPTT < 1.5 ULN within 7 days prior to registration. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of registration. - Laboratory requirements in fertile women, within 2 days prior to treatment: Negative serum pregnancy test - Other medication: - No concomitant therapy with certain anti-viral medicines (sorivudine and brivudine or analogue compounds). - No continuous medication with ASS > 325 mg or NSAIDs, known to inhibit platelet function. - Other: - No major surgical procedure, open biopsy, nor significant traumatic injury within 28 days prior to study treatment start, nor anticipation of the need for major surgical procedure during the course of the study except for surgery for colorectal cancer with curative intent and central venous line placement for chemotherapy administration, which must be inserted at least 2 days prior to treatment start. - No pregnancy or breastfeeding women. - No women of child-bearing potential with positive or missing pregnancy test at study entry; post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-child-bearing potential. - No sexually active men or women of childbearing potential not willing to use effective means of contraception (intrauterine contraceptive device, implants, injectables, sexual abstinence or vasectomised partner). - No subjects with known allergy to the used study drugs or to any of its excipients. - No known DPD deficiency. - No proteinuria (>1+); if dipstick test of urine exceeds 1+, proteinuria has to be below 1g protein in 24 hours urine. - No concomitant treatment with preparations of St. Johns wort. - No currently or recent (within the 28 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. - No known grade III/IV allergic reaction against monoclonal antibodies. - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial. - Before subject registration, written informed consent must be given according to ICH/GCP, and national/local regulations. The subject must be competent to comprehend, sign, and date an IEC-approved informed consent form. ; PRIMARY OUTCOME: Time to failure of maintenance and reinduction treatment strategy measured from randomization; SECONDARY OUTCOME 1: TFS, Toxicity, QoL, PFS 1, PFS 2, ORR (first induction), ORR (reind. treatm.), Treatment free interval/duration of maintenance therapy, second. Resection rate, Reasons for discontinuation, OS, Translational research.[/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 - Pilot Study; BRIEF: This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score. ; DRUG USED: Autologous Human Platelet Lysate; DRUG CLASS: Biologic; INDICATION: Acne Scars ; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Kasiak Research Pvt. Ltd.; CRITERIA: Inclusion Criteria: - Subjects (male and female), aged 18 to 40 years (both inclusive). - Subject willing to refrain from any other treatment of Acne Scarring during entire study duration. - Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study. - Subjects who are willing to give informed consent and adhere to the study protocol. Exclusion Criteria: - Subjects with active infection or active acne. - Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study. - Subjects with history of connective tissue disease. - Subjects with metabolic or hematopoietic disorders. - Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia. - Subjects who have received prior chemotherapy and radiotherapy - Subjects unwilling to or unable to comply with the study protocol. - Subjects taking concomitant therapy that might interfere with the study results in the investigators opinion or participating in another trial in the past 30days ; PRIMARY OUTCOME: Changes in the Global Acne scarring classification; SECONDARY OUTCOME 1: Photographic Assessment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - w/Daratumumab; BRIEF: This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length. There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose limiting toxicities, and to establish the maximum tolerated dose (MTR)/optimum biological dose (OBD) of RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion phase (Part II) will further characterize the safety, tolerability and activity of RO6870810 as monotherapy or in combination with daratumumab at the defined expansion dose-levels. ; DRUG USED: RG6146; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: BET Proteins/Bromodomains; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Performance status </=2 on the Eastern Cooperative Oncology Group (ECOG) scale - Life expectancy > 3 months - Relapsed or refractory multiple myeloma. Participants with primary refractory myeloma only allowed in dose-escalation phase of the study. - Prior treatment: Treated with at least three prior lines of multiple myeloma therapy including a proteasome inhibitor and an immuno modulatory agent or who are double refractory to a proteasome inhibitor and an immuno modulatory agent. Prior anti-CD38 antibody (e.g., daratumumab, isatuximab) treatment is acceptable only for participants receiving monotherapy treatment. - Prior treatment: Treated with two or more lines of prior therapy, with disease refractory to both a proteasome inhibitor and an immunomodulatory agent, and disease progression (as defined by International Myeloma Working Group (IMWG) criteria) following treatment with an anti-CD38 monoclonal antibody given as monotherapy or in combination therapy. The most recent treatment regimen must have contained an anti-CD38 monoclonal antibody. - Treatment with prior autologous transplant is permitted - Documented diagnosis of symptomatic multiple myeloma, as defined by the IMWG - Measurable disease defined as at least one of the following: serum M-protein >/=1 grams/deciliter (g/dL), urine M-protein >/= 200 milligrams/24 hours (mg/24h), serum free light chain (SFLC) assay: involved SFLCs >/= 10 mg/dL (>/= 100 mg/L) and an abnormal SFLC ratio (<0.26 or >1.65). - Female participants of childbearing potential must have a negative serum pregnancy test within the 7 days prior to the first study drug administration. - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 2 months after the last dose of RO6870810 as monotherapy, or for at least 3 months after the last dose of daratumumab. - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 4 months after the last dose of RO6870810 as monotherapy, or for at least 3 months after the last dose of daratumumab. Exclusion Criteria: - Plasma cell leukemia defined as peripheral plasma cell count > 2000/cubic millimeter (mm^3) - For expansion cohorts only: Primary refractory multiple myeloma defined as disease that is non-responsive in participants who have never achieved a minimal response or better with any therapy - History of other malignancy within 2 years prior to screening, except for ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer (Gleason score </= 7) not requiring treatment or appropriately treated Stage I uterine cancer - POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) - Current or prior disease or treatment that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor - Pregnant or breastfeeding female. - Consumption of agents which strongly inhibit CYP3A4 enzyme, within 7 days prior to the first dose of study treatment and during the study. - Consumption of agents which strongly induce CYP3A4 enzyme, within 14 days prior to the first dose of study treatment and during the study. - Surgery within 21 days prior to study entry. - Prior treatment with small molecule BET family inhibitor or receiving steroids >the equivalent of 10mg prednisone daily - participants who are currently receiving any other investigational agent or have received an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to study entry - Uncontrolled cancer pain - Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy) within 14 days except for alkylating agents (e.g., melphalan) within 28 days. ; PRIMARY OUTCOME: Number of Dose-Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Percentage of Participants with 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 - Israel/Germany; BRIEF: This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele or phenotypically similar nonsense allele. Up to 16 patients will be enrolled in the trial; up 4 patients will be homozygotes to G542X, and the remaining patients will be compound heterozygotes with G542X or phenotypically similar nonsense mutation and any Class 1 or Class 2 mutation. Each patient will receive 5 escalating doses as follows: - 0.3 mg/kg per day SC - 0.75 mg/kg per day SC - 1.5 mg/kg per day SC - An individualized dose, as high as 3.0 mg/kg per day SC, based upon the patients observed safety and tolerability, PK at previous doses and the results of laboratory tests - ELX-02 1.5 mg/kg per day SC plus 150 mg ivacaftor every 12 bid ; DRUG USED: ELX-02; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: RNA; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eloxx Pharmaceuticals, Inc.; CRITERIA: Patients must meet the following criteria to participate in this study: 1. Males and females age 18 years and above in Germany and Israel; in countries where permitted, males and females age 16 years and above 2. A confirmed diagnosis of nmCF with a documented G542X or phenotypically similar nonsense mutation, homozygote, or compound heterozygote with one of the specified mutations. For heterozygotes, one mutation has to be G542X or phenotypically similar nonsense mutation, and the second mutation could be and Class 1 or Class 2 mutation. Patients with one G542X or phenotypically similar nonsense allele and a second allele that is not in the above list may be potentially allowed but only after discussion on a case by case basis with and written approval from the Sponsor. 3. Documented SCC ≥ 60 mEq/L 4. FEV1 ≥ 40% predicted normal for age, gender and height at Screening (Knudson Equation) 5. Body Mass Index (BMI) of 19.0 to 30.0 kg/m2 (inclusive). Patients with any of the following characteristics/conditions will not be included in the study: 1. Participation in clinical study including administration of any investigational drug or device in the last 30 days or 5 half-lives (whichever is longer) prior to investigational product dosing in the current study 2. History of any organ transplantation 3. Major surgery within 180 days (6 months) of Screening 4. Patients without documented prior aminoglycoside exposure who have a mitochondrial mutation that has been shown to increase sensitivity to aminoglycosides 5. Known allergy to any aminoglycoside 6. Patients with any abnormality at ENT screening, that indicates the presence of a vestibular toxicity associated with prior exposure to aminoglycosides. 7. Dizziness Handicap Inventory (DHI)-H score at screening >16 8. Patients receiving CFTR modulators within 2 months of study treatment ; PRIMARY OUTCOME: AEs associated with different dose levels of ELX-02; SECONDARY OUTCOME 1: Changes from baseline in sweat chloride concentration[/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/Veledimex (Grade III); BRIEF: This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the bodys natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of Ad-RTS-hIL-12 given with oral veledimex. ; DRUG USED: Ad-RTS-hIL-12; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: IL-12 (Interleukin-12) and IL-12 receptor; THERAPY: Combination; LEAD SPONSOR: Alaunos Therapeutics; CRITERIA: Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 75 years of age 2. Provision of written informed consent for tumor resection, stereotactic surgery, tumor biopsy, samples collection and treatment with investigational products prior to undergoing any study procedures 3. Histologically confirmed supratentorial glioblastoma or other WHO grade III or IV malignant glioma from archival tissue. 4. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy. 5. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. The washout periods from prior therapies are intended as follows: 1. Nitrosoureas: 6 weeks 2. Other cytotoxic agents: 4 weeks 3. Anti-angiogenic agents including bevacizumab: 4 weeks 4. Targeted agents including small-molecule tyrosine kinase inhibitors: 2 weeks 5. Experimental immunotherapies: 3 months 6. Vaccine based therapy: 3 months 6. Able to undergo standard MRI scans with contrast agent 7. Karnofsky Performance Status ≥ 70 8. Adequate bone marrow reserves and liver and kidney function, as assessed by the following laboratory requirements: 1. Hemoglobin ≥ 9 g/L 2. Lymphocytes > 500/ mm3 3. Absolute Neutrophil Count ≥ 1500/ mm3 4. Platelets ≥ 100,000/ mm3 5. Serum creatinine ≤ 1.5 x ULN 6. AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤ 5 × ULN 7. Total bilirubin < 1.5 x ULN 8. International Normalized Ratio (INR) and activated Partial Thromboplastin Time [PTT] within normal institutional limits 9. Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate less than 5% per year) from the screening visit through 28 days after the last dose of study drug. Women of childbearing potential must have a negative pregnancy test at screening. Exclusion Criteria: 1. Radiotherapy within 4 weeks or less prior to starting first veledimex dose 2. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures. 3. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections 4. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is permitted perioperatively. 5. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug. 6. Other concurrent clinically active malignant disease, requiring treatment, with the exception of non-melanoma cancers of the skin or carcinoma in-situ of the cervix or non-metastatic prostate cancer. 7. Nursing or pregnant females 8. Prior exposure to veledimex 9. Use of medications that induce, inhibit or are substrates of CYP450 3A4 within 7 days prior to the first veledimex dosing 10. Presence of any contra-indication for a neurosurgical procedure 11. Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator or medical monitor, jeopardize the safety of a subject and/or their compliance with the protocol. ; PRIMARY OUTCOME: Safety and tolerability of varying doses of intratumoral Ad-RTS-hIL-12 and oral veledimex doses in subjects with recurrent or progressive glioblastoma or Grade III malignant glioma; SECONDARY OUTCOME 1: Veledimex maximum tolerated dose (MTD) when given with varying doses of intratumoral Ad-RTS-hIL-12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NIMBUS (MM-003); BRIEF: The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or 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; CRITERIA: Inclusion Criteria: - Must be ≥ 18 years of age - Subjects must have documented diagnosis of multiple myeloma and have measurable disease - Subjects must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma therapy - Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy - All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib - All subjects must have failed treatment with both lenalidomide and bortezomib in one of the following ways: 1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or bortezomib, or 2) In case of prior response [≥ partial response (PR)] to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or 3) Subjects who have not had a ≥ minimal response (MR) and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide- and/or bortezomib-containing regimen - Patients must have received adequate prior alkylator therapy - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 - Females of childbearing potential (FCBP) must not become pregnant for 28 days prior to initiation of study drug, during the study, and for 28 days after discontinuation - Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation - Males must agree to use a latex condom during any sexual during the study and for 28 days following discontinuation from this study - Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study Exclusion Criteria: - Any of the following laboratory abnormalities: - Absolute neutrophil count (ANC) < 1,000/μL - Platelet count < 75,000/ μL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells - Creatinine clearance < 45 mL/min - Corrected serum calcium > 14 mg/dL - Hemoglobin ≤ 8 g/dL - Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) or transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN) - Serum total bilirubin > 2.0 mg/dL - Previous therapy with pomalidomide - Hypersensitivity to thalidomide, lenalidomide, or dexamethasone - Resistance to high-dose dexamethasone used in the last line of therapy - Peripheral neuropathy ≥ Grade 2 - Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant - Subjects who are planning for or who are eligible for stem cell transplant - Subjects with any one of the following: 1) Congestive heart failure, 2) Myocardial infarction within 12 months prior to starting study treatment, 3) Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris - Subjects who received any of the following within the last 14 days of initiation of study treatment: 1) Plasmapheresis, 2) Major surgery, 3) Radiation therapy, 4) Use of any anti-myeloma drug therapy - Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment - Subjects with conditions requiring chronic steroid or immunosuppressive treatment - Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study - Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide - Subjects unable or unwilling to undergo antithrombotic prophylactic treatment - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form - Pregnant or breastfeeding females - Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B, or C ; PRIMARY OUTCOME: Progression-free Survival (PFS) - Primary Analysis; SECONDARY OUTCOME 1: Number of Participants With Adverse Events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Castration-Resistant (UK); BRIEF: This is an open-label, randomized, parallel group two-stage phase 1-2 study with an escalation and an expansion component. This study will evaluate an extended-release (ER) formulation of onapristone in patients with prostate cancer in which Progesterone Receptor (PR) may be contributing to tumor progression. A companion diagnostic to select patients whose prostate cancer expresses the activated form of the PR (APR) is under development and will be implemented in this study; it may be used to further enrich the selection of the population based upon ongoing review of the results. Patients will be treated until occurrence of an intolerable safety issue, treatment failure, if patient elects to withdraw, or for non-compliance with either protocol-specified evaluations or onapristone treatment. An additional cohort of patients will be included at the recommended phase 2 dose to gain additional understanding of the onapristone safety profile and potential anti-cancer activity. ; DRUG USED: Apristor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Progesterone Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Arno Therapeutics; CRITERIA: Inclusion criteria: 1. Male patients, 18 years of age or greater; 2. Histologically confirmed adenocarcinoma of the prostate (without neuroendocrine differentiation or small cell features); 3. In Stage 2, a mandatory biopsy is required with confirmed PR or APR in ≥1% tumor cells. For patients recruited to the abiraterone-onapristone combination arm, the biopsy must be performed on abiraterone administered as the most recent treatment and after a minimum of 2 weeks continuous treatment. For other patients, the biopsy must be taken at progression on or after abiraterone or enzalutamide or before screening with no anti-cancer treatment taken in the intervening period and a maximum of six (6) months prior to study start. If archival tissue is also available this should be provided for comparison purposes; a paired biopsy at day 8-28 is optional; 4. Metastatic or recurrent inoperable disease after previous surgery, radiation therapy, and/or chemotherapy; 5. For patients in Stage 1 and for patients in Stage 2 who will receive combination therapy with onapristone and abiraterone: no more than one prior chemotherapy regimen for CRPC (docetaxel rechallenge will be regarded as one line of chemotherapy); for patients in Stage 2 who will receive onapristone monotherapy: no prior chemotherapy is allowed; 6. Disease that has progressed by PSA or radiologically, on abiraterone or enzalutamide. Disease progression for study entry is defined as one or both of: - PSA progression defined by a minimum of two rising PSA levels with an interval of ≥1 week between each determination. - Radiological progression per RECIST 1.1; 7. For patients recruited to the abiraterone-onapristone combination arm, progression on abiraterone as their last line of treatment is required after a prior response to abiraterone; 8. The PSA value at screening and baseline should be ≥ 2 µg/L (2 ng/mL); 9. For onapristone monotherapy, corticosteroid discontinuation >4 weeks or >2 weeks with normal adrenal function confirmed by an ACTH stimulation test. For the combination onapristone - abiraterone arm, prednisolone 5mg BID and no other steroid regimen allowed for 2 weeks prior to treatment initiation; 10. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration); • For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial; 11. Serum testosterone level < 1.7 nmol/L (50 ng/dL); 12. Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks; 13. Evaluable disease per RECIST 1.1 [Eisenhauer 2009] or Prostate Cancer Clinical Trials Working Group 2 (PCWG2) [Scher 2008]; 14. ECOG performance status 0-2; 15. Life expectancy ≥ 3 months; 16. Willing and able to sign written informed consent per ICH-GCP, the local regulatory requirements, and local data protection laws prior to study-specific screening procedures. Exclusion criteria: 1. Serum creatinine >1.5 ULN; 2. On ECG a QTc(F) interval >480 msec or any clinically significant cardiac rhythm abnormalities; 3. Liver function tests documented within the screening period and/or at baseline: 1. Total bilirubin > ULN (except in patients diagnosed with Gilberts disease); 2. Alkaline phosphatase > 2.5 x UNL, unless test for alkaline phosphatase isoenzymes is elevated only for bone isoenzyme; 3. ALT/AST > UNL or > 2.5 x UNL in case of liver metastases; 4. Absolute neutrophil count < 1,500/µL, platelet count < 100,000/µL, and hemoglobin < 5.6 mmol/L (9 g/dL) and no growth factors or blood transfusions within 7 days of these values; 5. Serum albumin < 25 g/L (2.5 g/dL); 6. Known positive virology/serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B (surface antigen), or hepatitis C (testing not required); 7. Chronic inflammatory liver condition. History or clinical evidence of any liver or biliary pathology including cirrhosis, infectious disease, inflammatory conditions, steatosis, or cholangitis (including ascending cholangitis, primary sclerosing cholangitis, obstruction, perforation, fistula of biliary tract, spasm of sphincter of Oddi, biliary cyst or biliary atresia; 8. Patients with any other prior malignancy are not allowed except for: 1. Adequately treated basal cell or squamous cell skin cancer; 2. Adequately treated Stage I or II cancer from which the patient is currently in complete remission; 3. Other cancer from which the patient has been disease-free for 2 years; 9. For Stage 1 only: Chronic adrenal failure or is receiving concurrent long-term corticosteroid therapy. Prior long-term corticosteroids must be stopped ≥4 weeks or >2 weeks if normal adrenal function is confirmed by an ACTH stimulation test prior to start of study drug; 10. History or clinical evidence of any surgical or medical condition which the investigator judges as likely to interfere with the results of the study or pose an additional risk in participating; e.g., active or clinically significant history of disease involving a major organ system-vascular, cardiac, uncontrolled hypertension, pulmonary, gastrointestinal, hematologic, neurologic, neoplastic, renal, endocrine or immunodeficiency, or clinically significant active psychiatric disorders; 11. Used any prescription medication during the prior 2 weeks that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating, specifically inhibitors or inducers of cytochrome P450 (CYP)3A4 (see Appendix 4); 12. Received an investigational product or been treated with an investigational device within 30 days prior to first drug administration, or plans to start any other investigational product or device study within 30 days after last drug administration; 13. Received prior therapies within the following time period prior to receipt of first dose of study drug (Day 1, without withdrawal response and with no plans to initiate any of these during study: 1. Ketoconazole or bicalutamide within 6 weeks; 2. Systemic hormone therapy, chemotherapy, targeted therapies, antibodies within 4 weeks excluding abiraterone in the abiraterone-onapristone combination arm; 3. Fractionated radiotherapy within 3 weeks; 4. Single fraction of radiotherapy within 2 weeks; 5. Radionuclide therapy within 8 weeks; 6. Brachytherapy Pd-103 implant within the last 3 months; 7. Brachytherapy I-125 implants within 12 months. 14. Concurrent use of herbal products that may decrease PSA levels (e.g., saw palmetto); 15. Residual toxicity of prior anticancer treatment > grade 1 except for alopecia; 16. Brain metastases, active epidural disease or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for ≥1 week; 17. Pagets disease of the bone; 18. Structurally unstable bone lesions suggesting impending fracture; 19. Patients with reproductive potential not employing adequate contraception during treatment and for 1 month after completing treatment; 20. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to swallow pills; 21. Mental incapacity or language barriers precluding adequate understanding, co-operation, and compliance with the study requirements; 22. Is, in the judgment of the investigator, unable or unwilling to comply with the requirements of the study. ; PRIMARY OUTCOME: Dose limiting toxicities related to onapristone or the combination of onapristone and abiraterone utilizing a day 57 safety cut off and based on CTCAE v4; SECONDARY OUTCOME 1: Safety and tolerability of extended-release onapristone tablets BID[/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 - DUALIDES (EX-US); BRIEF: The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer. ; DRUG USED: ODM-204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Androgen receptors, Cytochrome p450; THERAPY: Combination; LEAD SPONSOR: Orion Corporation, Orion Pharma; CRITERIA: Inclusion Criteria: - Written informed consent (IC) obtained. - Male aged ≥ 18 years. - Histologically or cytologically confirmed adenocarcinoma of prostate. - Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy. - Progressive metastatic disease - Adequate bone marrow, hepatic, and renal function - Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment - Ability to swallow study treatments Exclusion Criteria: - History of pituitary or adrenal dysfunction. - Known brain metastases. - Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated. - Uncontrolled hypertension - Clinically significant heart disease - Prolonged QTc interval ; PRIMARY OUTCOME: Safety and tolerability assessed by incidence of adverse events; SECONDARY OUTCOME 1: Pharmacokinetic profile assessed by plasma peak concentration (Cmax)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Ipilimumab (Japan); BRIEF: The purpose of this study is to determine if TBI-1401(HF10) in combination with ipilimumab is effective in Japanese patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma. ; DRUG USED: C-REV; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Oncolytic Virus Therapy, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: Takara Bio Inc.; CRITERIA: Inclusion Criteria: - Patients with histologically confirmed Stage IIIB, IIIC or IV unresectable or metastatic melanoma except uveal melanoma, who must have a history of treatment (chemotherapy, molecular targeted therapy, or anti PD-1 antibody therapy). - Patients must have measurable non-visceral lesion(s) that are evaluable by the modified World Health Organization (mWHO) criteria and immune-related response criteria (irRC). - Patients must be ≥ 20 years of age. - Patients must have a life expectancy ≥ 24 weeks. - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. - Patients must have adequate organ function, defined as - Total bilirubin levels ≤ 1.5 x upper limit of normal [ULN] (except for patients with Gilberts Syndrome, who must have a total bilirubin of less than 3.0 mg/dL) - AST/ALT levels ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present. - Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated) ≥ 60 mL/min/1.73 m^2 for patients with creatinine > 1.5 x ULN. - Absolute neutrophil count ≥1,500/µL and - Platelet count ≥ 75,000/ µL - Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 30 days after final study treatment. - Females of childbearing potential must have a negative urine or serum pregnancy test within 1 week prior to start of treatment. - Patients must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: - Patients who were previously treated with ipilimumab by intravenous infusion. - Patients receiving chemotherapy or molecularly targeted drug or anti-PD-1 antibody treatment or radiotherapy or immunotherapy within 4 weeks prior to initiating study treatment. - Patients with a history of Grade 4 adverse events caused by chemotherapy, molecularly targeted drug, anti-PD-1 antibody treatment, radiotherapy or immunotherapy conducted more than 4 weeks prior to TBI-1401(HF10) treatment, or presence of such adverse events of Grade 2 or greater, except alopecia and adverse events controlled by a treatment. - Patients receiving anti-herpes medication within 1 week prior to initiating TBI-1401(HF10) administration, except local treatment such as ointment. - Patients with a history of significant tumor bleeding, or coagulation or bleeding disorders. - Patients with target tumors that could potentially invade a major vascular structure (e.g., innominate artery, carotid artery), based on unequivocal imaging findings. - Patients with Grade 2 or greater neurologic abnormalities (CTCAE version 4.0), including Grade 2 or greater peripheral neuropathy caused by previous treatments. - Patients with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C virus (HCV), or Epstein-Barr virus (EBV) infection. - Patients requiring systemic glucocorticoid (except 10 mg/day/body prednisolone or less) or immunosuppressive therapy because of the presence or history of autoimmune disease (e.g., Crohns disease, ulcerative colitis) or other diseases. - Concurrent use of any other investigational agents within 4 weeks prior to initiating study treatment. - Patients with active CNS metastases or carcinomatous meningitis, except patients with CNS lesions that have been treated and have no evidence of progression in the brain on CT/MRI for ≥ 3 months. - Pregnant or breastfeeding women (excluding the case in which breastfeeding is discontinued and will not resume it); women desiring to become pregnant within the timeframe of the study are also excluded. - 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, as determined by the investigator. ; PRIMARY OUTCOME: Best overall response rate (BORR) by irRC; SECONDARY OUTCOME 1: Best overall response rate (BORR) by mWHO response 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 - Puerto Rico; BRIEF: The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will be assessed. MV-CHIK will be compared to the commercially available MMR vaccine. 80% of the subjects will receive MV-CHIK; 20% will receive MMR vaccine. ; DRUG USED: V184; DRUG CLASS: Vaccine; INDICATION: Antiviral - Miscellaneous Vaccines; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Themis Bioscience GmbH; CRITERIA: Inclusion Criteria: 1. Aged ≥21 to ≤50 years on the day of enrollment. 2. Able to provide informed consent. 3. Available and accessible for the duration of the trial. 4. Able and willing to comply with all requirements of the study. 5. For female subjects, willing to practice a reliable form of contraception as specified in the protocol until five months after the second and final vaccination in accordance with recommendations following MMR vaccination. 6. Medical history and physical examination findings are considered normal or not clinically significant in the opinion of the Investigator. 7. Laboratory values are considered normal or not clinically significant in the opinion of the Investigator. 8. History of previous measles vaccination, either in childhood or as an adult if more than three months before participation in this study. Exclusion Criteria: 1. Taking medication or other treatment for unresolved symptoms attributed to a previous chikungunya virus infection. 2. Prior receipt of any chikungunya or other alphavirus vaccine. 3. Recent infection, including suspected chikungunya (within 1 week prior to Screening Visit). 4. History of an allergic or anaphylactic reaction to any vaccine. 5. An allergic reaction other than allergic contact dermatitis to any component of either vaccine (i.e., neomycin, gelatin), or a current egg allergy. Volunteers with a childhood history of egg allergy who are able to tolerate egg in their diet now will not be excluded on this basis. 6. History of an immunosuppressive disorder (such as human immunodeficiency virus [HIV] infection, common variable immunodeficiency), chronic infection (such as chronic hepatitis B or C), autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus [SLE], autoimmune thyroid disease) or any medical condition that, in the opinion of the Investigator, could lead to an atypical immune response to the vaccine. 7. History of moderate or severe non-traumatic arthritis or arthralgia within 3 months of the Screening Visit. 8. Recent (within 30 days), current or anticipated use of any immunosuppressive or immune modifying medication including corticosteroids (excluding nasal, ophthalmic, and other topical preparations). 9. Other vaccination or planned vaccination within 4 weeks of either study dose (seasonal influenza vaccine excepted). 10. Measles vaccination or booster within the last 3 months or planned during the clinical study. 11. Receipt or planned receipt of blood products including immunoglobulins within 120 days of the Screening Visit. 12. Pregnant or lactating or planning pregnancy during the trial. 13. Known alcohol or other substance abuse that in the opinion of the Investigator affects the ability or willingness of the participant to understand and comply with the study protocol. 14. Participation in another clinical study within the past 30 days in which the subject was exposed to an investigational product (pharmaceutical product or placebo or device) or planned concurrent participation in another clinical study during the study period. 15. Relevant history of any medical condition that, in the opinion of the Investigator, may interfere with the safety of the subject (volunteer) or aims of the study. 16. History of neoplastic disease (excluding successfully treated non-melanoma skin cancer or cervical intraepithelial neoplasia) within the past 5 years or a history of any hematological malignancy. 17. Behavioral or psychiatric disease or cognitive impairment that in the opinion of the Investigator affects the ability or willingness of the participant to understand and comply with the study protocol. 18. Non-consent to storage of blood specimens for future research. 19. Persons in direct relationship with the Sponsor or its contract service provider, the clinical research organization (CRO) or its subcontractors, the Investigator or study site staff. Direct relationship includes first degree relatives or dependents (children, spouse/partner, siblings or parents), as well as employees (site or Sponsor). Employees of the University of Puerto Rico not directly employed by the Clinical & Translational Research Center will not be excluded. 20. Any condition that would, in the opinion of the site Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. ; PRIMARY OUTCOME: Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings; SECONDARY OUTCOME 1: Immunogenicity[/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/IIa - VERTICAL (Pediatric); BRIEF: This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6 months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317. ; DRUG USED: Somavaratan; DRUG CLASS: Biologic; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth hormone receptor (GHR); THERAPY: Monotherapy; LEAD SPONSOR: Versartis Inc.; CRITERIA: Inclusion Criteria: - Chronological Age ≥ 3.0 years and ≤ 11.0 - Diagnosis of GHD as documented by GH stimulation test - Below average height SDS at screening - Appropriate weight for Stature - Decreased IGF-I SDS at screening - Delayed bone age - Normal thyroid function test results at screening visit - Legally authorized representative informed consent. Exclusion Criteria: - Prior treatment with any growth promoting agent - Documented history of, or current, significant disease - Chromosomal aneuploidy, significant gene mutations - Diagnosis of Attention Deficit Hyperactivity Disorder - Daily use of anti-inflammatory doses of glucocorticoid - Prior history of leukemia, lymphoma, sarcoma or cancer - Known allergy to constituents of the study drug formulation - Abnormal ocular findings at screening - Significant abnormality in screening laboratory studies ; PRIMARY OUTCOME: Phase 1b and 2a: Evaluate the safety and tolerability of multiple dosing levels of subcutaneous (SC) VRS-317 in pediatric growth hormone deficient (GHD) patients. Phase 2a: Evaluate the efficacy of multiple dose levels of VRS-317; SECONDARY OUTCOME 1: Evaluate pharmacokinetic measures of VRS-317.[/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 - Multiple Dose; BRIEF: The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a multiple dose administration of FSH-GEX™ in healthy pituitary-suppressed female volunteers, in comparison with two marketed comparator products or placebo. ; DRUG USED: FSH-GEX; DRUG CLASS: Biologic; INDICATION: Reproductive Disorder; TARGET: Follicle-Stimulating Hormone Receptor (FSHR) ; THERAPY: Monotherapy; LEAD SPONSOR: Glycotope GmbH; CRITERIA: Inclusion Criteria: 1. Female subjects from 18-40 years of age at screening. 2. Subjects must be in good health as determined by medical and gynecological history, physical and gynecological examination, vital signs, body measurements, electrocardiogram, and laboratory tests 3. Subjects must be willing to use additional non-hormonal contraception 4. Subjects must have used a combined oral contraceptive, combined contraceptive vaginal ring or combined contraceptive patch 5. Vital signs which are within the following ranges: systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 50-90 mmHg, pulse rate between 40 - 100 bpm 6. Subjects must have a body weight of minimally 50.0 kg with a BMI between 18.0 and 29.9 kg/m2 7. Able to provide written informed consent prior to study participation. 8. Able to communicate well with the investigator and to understand and comply with the requirements of the study. Exclusion Criteria: 1. Smokers of more than 5 cigarettes per day. 2. Average daily intake of more than 3 units of alcohol per day (where 1 unit equals 250 mL of beer, 125 mL of wine or 25 mL of spirits) or an average weekly intake of more than 21 units alcohol. 3. Use of any prescription drug or over-the-counter medication from screening until the end-of-study visit, without prior approval of the investigator. Paracetamol® is acceptable without prior approval. 4. Any drugs that may reduce the effectiveness of combination oral contraceptive (COC) from screening until the end-of-study visit 5. Administration of any investigational product or use of any investigational device within 30 days prior to Screening. 6. Donation or loss of 500 mL or more of blood within 90 days prior to first dosing of FSH-GEX(TM). 7. History of acute or chronic bronchospastic disease 8. History of allergies for drugs, seafood, nuts, eggs, wasp-stings; history of atopic allergy. A known hypersensitivity to any of the study drugs. 9. Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of drugs or which may jeopardize the subject in case of participation in the study. 10. History or presence of any malignancy. 11. Determined or suspected pregnancy. 12. Breast feeding women. 13. History of (or current) endocrine abnormalities 14. Contraindication for the use of oral contraceptives 15. Contraindication for the use of follitropin alfa, follicle-stimulating hormone (FSH) or any of the excipients (hypersensitivity to follitropin alfa, FSH or any of the excipients; tumors of the hypothalamus or the pituitary gland; ovarian enlargement or cyst not due to polycystic ovarian disease; gynecological bleeding of unknown origin; ovarian, uterine, or mammary carcinoma). 16. Porphyria or family history of porphyria. 17. History of ovarian surgery. 18. Any ovarian or abdominal abnormality that would interfere with adequate ultrasound investigation. 19. An abnormal cervical smear 20. History or presence of an immune-compromising disease, or a positive human immunodeficiency virus (HIV) test result in the past or at the screening visit. 21. History of Hepatitis B or C, or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at the screening visit. 22. History of drug or alcohol abuse within the 12 months prior to the screening visit or evidence of such abuse 23. Planned surgery or hospitalization during the period of the study. 24. Concurrent participation or participation within 30 days before screening in another clinical trial, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study or previous participation in the 104676-CS0160 (FSH-GEXTM) study. 25. Injection of one or more doses of any depot contraceptive drug /drug combination ≤10 months prior to screening. ; PRIMARY OUTCOME: safety and tolerability of FSH-GEX™ following multiple dose administration by subcutaneous injection; SECONDARY OUTCOME 1: pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection (part 1)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - AC-058A200; BRIEF: This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis. ; DRUG USED: Ponvory; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Actelion; CRITERIA: Inclusion Criteria: - Adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified. Exclusion Criteria: - Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis. - Systemic or topical treatments for psoriasis other than emollients. - Ongoing bacterial, viral or fungal infections. - History or presence of malignancy. - Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients risk from participating in the study. ; PRIMARY OUTCOME: Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.; SECONDARY OUTCOME 1: Clear - almost clear Physician Global Assessment (PGA) at Week 6 visit.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BID vs. Tiotropium (Smokers, Germany) ; BRIEF: The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment. ; DRUG USED: Tudorza Pressair; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines). - Post-salbutamol (FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%. - Current or ex-smokers of 10 ≥pack-years. Exclusion Criteria: - Patients with no history or current diagnosis of asthma. - No evidence of an exacerbation within 6 weeks prior to the screening visit. - No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities. - No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma. ; PRIMARY OUTCOME: Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment; SECONDARY OUTCOME 1: Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/IIa - w/FOLFIRI; BRIEF: This is a Phase 1b/2a study investigating the safety and efficacy of Sym004, an investigational medicinal product (IMP), in combination with FOLFIRI (chemotherapy) when administered every second week (Q2W). ; DRUG USED: Sym004; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Symphogen A/S; CRITERIA: Main inclusion Criteria: 1. Male or female, at least 18 years of age at the time of informed consent 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 3. Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer (CRC) that is documented to be without Kirsten rat sarcoma (KRAS) or neuroblastoma rat sarcoma (NRAS) gene mutations (i.e., tumors must express the KRAS and NRAS wild type [WT], exon 2, 3 and 4). 4. Failed (defined as radiologic progression) treatment for locally advanced or metastatic disease with first-line combination therapy of oxaliplatin and a fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after the last dose of first-line therapy and within < 3 months of C1/D1. Patients who discontinued first-line therapy due to toxicity may be enrolled provided progression occurred < 6 months after the last dose of the first-line therapy regimen. or Failed (defined as radiologic progression) adjuvant therapy with combination therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months after the last dose of oxaliplatin and within < 6 months of C1/D1. 5. Eligible for FOLFIRI 6. Measurable disease according to RECIST v1.1 Main exclusion Criteria: 1. Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or irinotecan (CPT-11) 2. Any antineoplastic agent (standard or investigational) within 4 weeks prior to C1/D1 3. Significant gastrointestinal abnormalities 4. Patients with a significant cardiovascular disease or condition 5. Abnormal hematologic, renal or hepatic function ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).; 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 - CARE; BRIEF: This single-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 20 subjects aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with moderate COVID-19. Two-arm trial comparing the SOC/supportive care alone to the SOC/supportive care with addition of Silmitasertib (allocation ratio 1:1). ; DRUG USED: Silmitasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Protein kinase CK2/Casein Kinase II; THERAPY: Monotherapy; LEAD SPONSOR: Chris Recknor, MD; CRITERIA: Inclusion Criteria: 1. Male or non-pregnant female adult ≥ 18 years of age 2. Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing 3. Outpatient subjects with moderate illness caused by SARS-CoV-2 infection as defined below, - Symptoms of moderate systemic illness/infection with COVID-19: At least two of the key COVID-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion AND - Clinical signs indicative of moderate systemic illness/infection with COVID-19 At least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute AND - No clinical signs indicative of Severe or Critical Illness Severity required hospitalization (see exclusion criterion #1) 4. Patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 5. Adequate hematopoietic capacity, as defined by the following: 1. Hemoglobin ≥ 9.0 g/dL and not transfusion dependent 2. Platelets ≥ 100,000/mm3 3. Absolute neutrophil count ≥ 1500 cells/mm3 6. Adequate hepatic function, as defined by the following: 1. AST and ALT ≤ 2.5 times upper limit of normal (ULN) 2. Total bilirubin ≤ 1.5 x ULN 3. Albumin ≥ 3.0 g/dL 7. Adequate renal function, as defined by the following: a. Renal: calculated creatinine clearance >45 mL/min for patients with abnormal, increased creatinine levels (Cockcroft-Gault formula). 8. Ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see Section 6.3) throughout study duration. Exclusion Criteria: 1. Any signs indicative of Severe or Critical Illness Severity required hospitalization as defined below: - Severe COVID-19: Shortness of breath in rest, or respiratory distress, respiratory rate (RR) >/= 30 per minute, heart rate (HR) >/=125 bpm, SpO2</=93% on room air at sea level or PaO2/FiO2<300 - Critical COVID-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, ESMO; shock or multi-organ dysfunction/failure 2. Pregnant or nursing women. (NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) 3. Active or uncontrolled infections other than COVID-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment 4. Chronic diarrhea (excess of 2-3 stools/day above normal frequency) 5. Concomitant treatment with another investigational drug from Day 1 through Day 28. 6. Current use or anticipated need for drugs that are known strong inhibitors or inducers of major CYP enzymes. ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) within the CX-4945 Treatment Group assessed by CTCAE v5.0; SECONDARY OUTCOME 1: Clinical Recovery associated with COVID-19 within the CX-4945 Treatment Group[/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 - REALIST; BRIEF: Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive Care Units and is associated with a high mortality and a high morbidity in those who survive. ARDS occurs in approximately 20% case of COVID-19 and respiratory failure is the leading cause of mortality. There is a large economic burden with direct healthcare costs, but also indirectly due to the impact on the carer and patient through the patients inability to return to full time employment. There is little evidence for effective drug (pharmacological) treatment for ARDS. There is increasing information that mesenchymal stem cells (MSCs) might be important in treating ARDS. REALIST will investigate if a single infusion of MSCs will help in the treatment of ARDS. The first step will be to first of all determine what dose of MSCs is safe and then divide patients suffering from ARDS into two groups, one of which will get MSCs and the other a harmless dummy (or placebo) infusion, who will then be followed up to determine if lung function improves. If effective this may lead to further research to determine if MSCs are effective in patients with ARDS. ; DRUG USED: Orbcel; DRUG CLASS: Biologic; INDICATION: Acute Respiratory Failure, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Belfast Health and Social Care Trust; CRITERIA: Inclusion Criteria: 1. ARDS as defined by the Berlin definition. 1. Onset within 1 week of identified insult. 2. Within the same 24-hour time period i. Hypoxic respiratory failure (PaO2/ FiO2 ratio ≤ 27kPa on PEEP ≥ 5 cmH20) ii. Bilateral infiltrates on chest X-ray consistent with pulmonary oedema not explained by another pulmonary pathology iii. Respiratory failure not fully explained by cardiac failure or fluid overload 2. Patient is receiving invasive mechanical ventilation 3. COVID-19 based on clinical diagnosis or PCR result or other causes of ARDS. Exclusion Criteria: 1. More than 72 hours from the onset of ARDS. 2. Age < 16 years. 3. Patient is known to be pregnant 4. Major trauma in the prior 3 days. 5. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year. 6. WHO Class III or IV pulmonary hypertension. 7. Venous thromboembolism currently receiving anti-coagulation or within the past 3 months 8. Currently receiving extracorporeal life support (ECLS). 9. Severe chronic liver disease with Child-Pugh score > 12. 10. DNAR (Do Not Attempt Resuscitation) order (excluding advance directives) in place. 11. Treatment withdrawal imminent within 24 hours. 12. Consent declined. 13. Prisoners. 14. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available. 15. Previously enrolled in the REALIST trial. ; PRIMARY OUTCOME: Oxygenation index (OI); SECONDARY OUTCOME 1: Oxygenation index[/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 - Spasticity of Limb(s) in Cerebral Palsy (Children); BRIEF: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy. ; DRUG USED: Xeomin; DRUG CLASS: Biologic; INDICATION: Neuromuscular Spasm and Spasticity; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Merz Pharmaceuticals GmbH; CRITERIA: Inclusion Criteria: Main clinical inclusion criteria for completers of study MRZ60201_3070_1: - Subject with lower limb [LL] spasticity who completed lead-in study MRZ60201_3070_1 in any of the three dose groups with duration of both injection cycles between 12 and 16 weeks. - Ashworth scale [AS] score ≥2 in plantar flexors (at least unilaterally). For subjects with an AS score of 1, the investigator has to decide on the clinical need for reinjection. - Clinical need for spasticity treatment with NT 201 according to the clinical judgment of the investigator for: Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus and need for additional 8 U/kg BW NT 201 (maximum of 200 U) for treatment of clinical pattern flexed knee or adducted thigh (ipsilateral) or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus on each side. No treatment of other clinical patterns is allowed. Main clinical inclusion criteria for subjects who did not participate in MRZ60201_3070_1: - Female or male subject of 2 to 17 years age (inclusive). - Uni- or bilateral CP with clinical need for BoNT injection to treat limb spasticity. - AS score ≥ 2 in plantar flexors (at least unilaterally). - Clinical need according to the clinical judgment of the investigator in one out of four treatment combinations: 1. For LL(s) treatment only (Gross Motor Function Classification System [GMFCS] levels IV): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus, and 8 U/kg BW NT 201 (maximum of 200 U) into flexed knee or adducted thigh or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into each pes equinus (AS score ≥ 2 on both sides). 2. For combined unilateral UL and unilateral LL, (GMFCS levels I-III): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus, and 8 U/kg BW NT 201 (maximum of 200 U) into flexed knee or adducted thigh plus Unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. 3. For combined unilateral UL and unilateral LL (GMFCS level IV-V): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum 200 U) into pes equinus, and 4 U/kg BW NT201 (maximum 100 U) into flexed knee or adducted thigh plus unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. 4. For combined unilateral UL and bilateral LL (GMFCS levels I-III): Bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into each pes equinus (AS score ≥ 2 on both sides) plus unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. Exclusion Criteria: Exclusion Criteria for subjects who completed MRZ60201_3070_1: - Infection and/or inflammation in the area of the planned injection points. - Pregnancy for female with history of menarche. - Clinically relevant pathological findings indicating active disease of vital organs. Exclusion Criteria for subjects who did not participate in MRZ60201_3070_1: - Fixed contracture defined as severe restriction of the range of joint movement on passive stretch in the target clinical pattern(s) or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s). - Surgery in the pes equinus on side(s) intended to treat with BoNT injections within 12 months prior to Screening Visit (V1), within the screening period or planned for the time of participation in this study. - Hip flexion requiring BoNT injection. - Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30. - Vaccination within 2 weeks prior to Screening Visit (V1) and/or within the screening period. - Non-resolved fractures of the treated limb. - Ventilator dependency. - Severe neurological diagnosis and comorbidity outside the spectrum of cerebral palsy. - Pure dyskinetic CP or mixed CP with predominantly dyskinetic movements. - Treatment with BoNT (other than study drug in this study) for any body region within 14 weeks prior to Screening Visit (V1), within the screening period and/or intended to be administered during the study period. - Treatment with phenol or alcohol of any muscle within 6 months prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period. - Treatment with - drugs acting as peripheral muscle relaxants - intrathecal baclofen, or - oral anticoagulants administered within 2 weeks prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period. ; PRIMARY OUTCOME: Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle; SECONDARY OUTCOME 1: Investigators Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle[/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 - BASIL; BRIEF: This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response. ; DRUG USED: BAY 86-9766; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male or Female age >/= 18 years of age - Life expectancy >/= 12 weeks - Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic - Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period - Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 - Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1 - Adequate bone marrow, liver and renal function Exclusion Criteria: - Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors. - History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension - Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days - Renal failure requiring hemo- or peritoneal dialysis - Known human immunodeficiency virus (HIV) infection - Known history or symptomatic metastatic brain or meningeal tumors - History of organ allograft. - History of interstitial lung disease (ILD). - Excluded previous therapies and medications: - Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy - Radiotherapy within 4 weeks prior to start of study treatment - Any other investigational agents within 4 weeks from the first dose of study treatment - Major surgery within 4 weeks of start of study - Concomitant use of strong inhibitors and strong inducers of CYP3A4 ; PRIMARY OUTCOME: Disease Control Rate (DCR); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Knee Osteoarthritis; BRIEF: The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement. ; DRUG USED: Sustained-Release Dexamethasone; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Mark Figgie; CRITERIA: Inclusion Criteria - Male or female ≥ 40 years of age at time of consent - Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior to screening with confirmation of osteoarthritis according to the American College of Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to screening or during the screening period - Kellgren - Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph performed within 6 months prior to or during screening period - Mean score of ≥ 5 and ≤ 10 on the 24 hour average pain score (0 - 10 Numeric Rating System) during the screening period - Body mass index (BMI) ≤ 40 kg/m2 - Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions - Willingness to stop all pain medications except acetaminophen and paracetamol 14 days prior to implantation Exclusion Criteria: - Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee - History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis - Hemophilia - Achondroplasia - History of infection in the index joint - Intra-articular corticosteroid (investigational or marketed) in any joint within three months of screening - Intra-articular hyaluronic acid (investigational or marketed) in the index knee within three months of screening - Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one month of screening - Prior arthroscopic or open surgery of the index knee within 12 months of screening - Planned / anticipated surgery of the index knee during the study period - Active or history of malignancy within the last five years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ - Insulin dependent diabetes - History of or active Cushings syndrome - Skin breakdown at index knee where procedure would take place - Women of child-bearing potential - Case history related to motor vehicle accident or workers compensation - Presence of hardware in the index knee (e.g. screws, plates) - Immunocompromised patients (TB, HIV, etc.) - Allergic reactions to acetaminophen and paracetamol ; PRIMARY OUTCOME: Incidence of treatment emergent adverse events; SECONDARY OUTCOME 1: Change from baseline in weekly mean of the pain intensity score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - +/- Gemcitabine; BRIEF: This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine. ; DRUG USED: RG7602; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Cell Cycle Checkpoint Kinase 1 (Chk1); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 - Signed Informed Consent Form - Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable - Adequate hematologic and end-organ (liver and kidney) function - For female patients of childbearing potential and male patients with partners of childbearing potential, agreement by the patient that the patient and/or partner will use an effective form of contraception - Patients enrolled in certain phases must be willing to provide fresh and/or archival tumor samples Exclusion Criteria: - History of prior significant toxicity from a same class of agents as GDC-0425 or gemcitabine requiring discontinuation of treatment - Allergy, hypersensitivity or contraindication to the GDC-0425 formulation or gemcitabine - Experimental therapy or anti-cancer therapy within 4 weeks prior to the first dose of study drug treatment - Radiotherapy within 2 weeks prior to first dose of study drug treatment - More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer - History of receiving high-dose chemotherapy requiring bone marrow or stem cell support - History of receiving radiation to more than 25% of bone marrow-bearing areas - Acute drug-related toxicities from previous therapies have not resolved prior to study entry, except for alopecia and mild neuropathy - Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding cancer - Significant heart disease and heart dysfunction including but not limited to uncontrolled severe hypertension, heart failure, and reduced cardiac contractility - Uncontrolled ascites, due to diseases other than cancer - Inability or unwillingness to swallow pills/capsules - History of malabsorption or other condition that would interfere with drug absorption - Any history of active stomach and/or intestine bleeding within the 6 months prior to screening - Known HIV infection - Pregnancy, lactation, or breastfeeding - Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms - Inability to comply with study and follow up procedures ; PRIMARY OUTCOME: Incidence of all adverse events graded according to NCI CTCAE, v4.0; SECONDARY OUTCOME 1: Antitumor activity of GDC-0425 in combination with gemcitabine: determination of tumor response using RECIST v1.1 for patients with measurable disease[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia/Ib - +/-Pembrolizumab; BRIEF: This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers. ; DRUG USED: ONC-392; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: OncoC4, Inc.; CRITERIA: Inclusion Criteria: 1. . Patients must have a histological or cytological diagnosis of NSCLC or any other type of carcinoma or sarcomas, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy. 1. In the Part A Phase I dose escalation study of ONC-392 monotherapy, patients with advanced/metastatic solid tumors of any histology are eligible for participation. Please note: tumor types of primary interest in this study are malignant melanoma, renal cell carcinoma, hepatocellular carcinoma, non-small cell lung cancer, head and neck carcinoma, gastric carcinoma, ovarian carcinoma, colorectal cancer, any type of sarcoma. 2. In Part B dose finding of the ONC-392 plus pembrolizumab combination, patients with advanced/metastatic solid tumors of any histology that Pembrolizumab has been approval as standard of care are eligible for participation. 3. In Part C, patients with pancreatic cancer, triple negative breast cancer, non small cell lung cancer, melanoma, Head and Neck cancer, ovarian cancer, and other solid tumors are eligible. 4. In Part D, patients with recurrent and/or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible. 5. Patients must have RECIST V1.1 Measurable disease: 2. Patient is male or female and >18 years of age on day of signing informed consent. 3. Patient must have a performance status of 0 or 1 on the ECOG Performance Scale 4. Patient must have adequate organ function as indicated by the following laboratory values: Hematological: Absolute neutrophil count (ANC) ≥1,500 /mcL; Plateletsa ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications; Renal: Serum creatinine ≤1.5 X upper limit of normal (ULN); Hepatic: Serum total bilirubin ≤1.5 X ULN; OR Direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 ULN; AST (SGOT) and ALT (SGPT) ≤2.5 X ULN, OR ≤5 X ULN for patients with active liver metastases Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN 5. Patient has voluntarily agreed to participate by giving written informed consent. 6. Female patient of childbearing potential has a negative urine or serum pregnancy test. 7. Female and Male patients must agree to use adequate methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy. Exclusion Criteria: A patient meeting any of the following criteria is not eligible to participate in this study: 1. Patients who have not recovered to CTCAE ≤ 1 from the AE due to cancer therapeutics. The washout period for cancer therapeutic drugs (such as chemotherapy, radioactive, or targeted therapy) is 21 days, and for antibody drug 28 days. 2. Patients who are currently enrolled in a clinical trial of an investigational agent or device. 3. Patients who are on chronic systemic steroid therapy at doses >10 mg/day 4. Patients who have active symptomatic brain metastasis or leptomeningeal metastasis. 5. Patients who have an active infection requiring systemic IV therapy within 14 days of prior to administration of ONC-392 or combined ONC-392 and Pembrolizumab. 6. Patients who have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patients participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator. 7. Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 8. Patients who are pregnant or breastfeeding. 9. For the Part B and Part C Arm D to G, the patients that are deemed to be not suitable for Pembrolizumab. ; PRIMARY OUTCOME: Dose limiting toxicity (DLT) in monotherapy; SECONDARY OUTCOME 1: The serum half life of the study drug, ONC-392, in monotherapy.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - M200; BRIEF: The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of volociximab intravitreous injection in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). ; DRUG USED: Volociximab; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Integrin Alpha-5 beta-1/Fibronectin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ophthotech Corporation; CRITERIA: Inclusion Criteria: - Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominantly classic, minimally classic or occult no classic) as documented by fluorescein angiogram. Exclusion Criteria: - Any prior treatment for AMD or any intravitreal treatment for any indication in the study eye prior to the screening visit, except oral supplements of vitamins and minerals. - Previous or concomitant therapy with intravitreous corticosteroids. - Any of the following underlying diseases including: - Diabetic retinopathy - History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment. - History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation. - Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. Patients with results outside these ranges may be enrolled in consultation with Ophthotech. - Stroke (within 12 months of trial entry). - Any major surgical procedure within one month of trial entry. - Previous therapeutic radiation in the region of the study eye. - Any treatment with an investigational agent in the past 60 days for any condition. - Women who are pregnant or nursing. - Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the volociximab formulation. ; PRIMARY OUTCOME: The primary safety endpoint is the presence of any dose limiting toxicity (DLT); 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 - 200181; BRIEF: This study is the first administration of GSK2881078 to humans. The intention of this study is to provide sufficient confidence in the safety of the molecule to inform progression to further repeat dose and proof of concept studies. This study will include approximately 52 subjects and consist of 2 parts. Part A will consist of two cohorts of 8 subjects to assess the safety, tolerability, and pharmacokinetic (PK) of ascending single oral doses of GSK2881078. Cohorts 1 and 2 will include healthy male subjects. Part B (Cohorts 3, 4 and 5) will include three cohorts of 12 healthy male subjects to examine the safety, tolerability, PK, and pharmacodynamic (PD) of repeated doses of GSK2881078 over 14 days. The total duration of the study including screening and follow-up, is not expected to exceed 70 days. ; DRUG USED: GSK2881078; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cachexia / Weight Loss; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Males between 18 and 50 years of age (inclusive), at the time of signing the informed consent form - Body weight >= 50 kilogram (kg) and Body Mass Index (BMI) within the range 19 - 32 kg/meter square (m^2) (inclusive), where BMI= weight in kg/ height in m^2 - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the Lifestyle Section of the protocol. This criterion must be followed through the completion of the follow-up visit. - Average QTcF <450millisecond (msec); or QTcF <480msec in subjects with Bundle Branch Block. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: - Subjects with a history of clinically significant endocrine, gastrointestinal, hepatic, cardiovascular, neurological, haematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases. - Subjects with a history at any time in the past of coronary artery disease, congestive heart failure, angina, myocardial infarction, any cardiac surgery, valvular heart disease, clinically significant arrhythmia, dyspnea, pulmonary edema, stroke, or transient ischemic attack. ECG exclusion criteria: Heart rate-<40 and >100 beats per minute, PR Interval-<120 and >200msec, QRS duration-<70 and >110msec. - Subjects with a history of malignancy that is not in complete remission for at least 5 years or 1 year for non-melanoma skin carcinoma - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - History of drug or alcohol abuse within 5 years prior to the Screening Period. - History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. - Subjects with a family history of early onset prostate cancer or multiple members with prostate cancer. - A positive pre-study drug or alcohol screen. - Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. - Subjects with values outside the specified ranges for the following Key Clinical Laboratory Tests must be excluded from the study: Liver function tests - Alanine aminotransferase, Direct Bilirubin, or Albumin more than 10% outside the normal reference range (<0.9 x lower limit of normal [LLN] or >1.1 x upper limit of normal [ULN]) Renal function - Creatinine >1.6milligrams (mg)/deciliter (dL) with an age appropriate glomerular filtration rate<=60 (mL/minute/1.73 m^2). Electrolytes - Sodium more than ± 5milliequivalents/Liter outside the normal reference range, Potassium or Calcium more than 10% outside the normal reference range (<0.9 x LLN or >1.1 x ULN) Metabolic - Glucose more than 10% outside the normal reference range (<0.9 x LLN or >1.1 x ULN) and Total Cholesterol > 240mg/dL Muscle - creatine phosphokinase >2.0 x ULN Hematology - Hemoglobin, white blood cells, Neutrophils, or Platelets more than 10% outside the normal reference range (<0.9 x LLN or >1.1 x ULN) Prostate Specific Antigen >2.5nanogram/mL - A positive test for human immuno virus antibody - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day - Unable to refrain from prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and throughout the study, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months (12 weeks), 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56-day period. - Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication ; PRIMARY OUTCOME: Vital sign assessment following single doses as a measure of safety and tolerability; SECONDARY OUTCOME 1: Composite of PK parameters following single doses[/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 - 01; BRIEF: MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1 open-label study of MM-310 in patients with solid tumors. In the first part of the study, MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established. After an MTD of MM-310 as a monotherapy is established, an expansion cohort and MM-310 in combination with other therapies will be assessed. ; DRUG USED: MM-310; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Ephrin Receptor EphA2 , Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Merrimack Pharmaceuticals; CRITERIA: Inclusion Criteria: - Must have one of the following cancers, for which the patient has either received or been intolerant to all therapy known to confer clinical benefit - Urothelial carcinoma - Gastric/gastroesophageal junction/esophageal carcinoma (G/GEJ/E) - Squamous Cell Carcinoma of the Head and neck (SCCHN) - Ovarian cancer - Pancreatic ductal adenocarcinoma (PDAC) - Prostate adenocarcinoma (PAC) - Non-small cell lung cancer (NSCLC) - Small cell lung cancer (SCLC) - Triple negative breast cancer (TNBC) - Endometrial carcinoma - Soft tissue sarcoma subtypes except GIST, desmoid tumors and pleomorphic rhabdomyosarcoma - Able to provide informed consent, or have a legal representative able and willing to do so - ≥ 18 years of age - Availability of a cancerous lesion amenable to biopsy and willing to undergo a pre-treatment biopsy - ECOG Performance Status of 0 or 1 - Adequate bone marrow reserve as evidenced by: - ANC > 1,500/µl (unsupported by growth factors) and - Platelet count > 100,000/µl - Hemoglobin > 9 g/dL - Patients must have adequate coagulation function as evidenced by prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) within normal institutional limits - Adequate hepatic function as evidenced by: - Serum total bilirubin ≤ ULN - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN. - Alkaline phosphatase ≤ 2.5 x ULN, unless the elevated alkaline phosphatase is due to bone metastasis. - In case alkaline phosphatase is >2.5 x ULN patients are eligible for inclusion if aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x ULN - Adequate renal function as evidenced by a serum/plasma creatinine < 1.5 x ULN - Recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy to CTCAE v4.03 grade 1, baseline or less, except for alopecia - Women of childbearing potential or fertile men and their partners must be willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 6 months following the last dose of MM-310. Exclusion Criteria: - Prior treatment with docetaxel within 6 months of study enrollment - Pregnant or lactating - Treatment with systemic anticoagulation (e.g. warfarin, heparin, low molecular weight heparin, anti-Xa inhibitors, etc.) except aspirin - Any evidence of hematemesis, melena, hematochezia, ≥ grade 2 hemoptysis, or gross hematuria - Any history of hereditary bleeding disorders - Presence of an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing, which in the investigators opinion might compromise the patients participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled - Known CNS metastases - Known hypersensitivity to the components of MM-310, or docetaxel - Prior treatment with MM-310 - Received treatment, within 28 days or 5 half-lives, whichever is shorter, prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state and all prior clinically significant treatment related toxicities have resolved to Grade 1 or baseline - Received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (or have not yet recovered from any actual toxicities of the most recent therapy) prior to the first scheduled dose of MM-310 - Received any anti-cancer drug known to have anti-VEGF/VEGFR activity within a period of 5 half-lives of this drug (e.g. 100 days for bevacizumab, 75 days for ramucirumab) prior to the first scheduled dose of MM-310 - Clinically significant cardiac disease, including: NYHA Class III or IV congestive heart failure, unstable angina, acute myocardial infarction within six months of planned first dose, arrhythmia requiring therapy (including torsades de pointes, with the exception of extrasystoles, minor conduction abnormalities, or controlled and well treated chronic atrial fibrillation) - Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator - Patients who received organ or allogeneic bone marrow or peripheral blood stem cell transplants - Chronic use of corticosteroids more than 10mg daily prednisone equivalent during the past 4 weeks prior to planned start of MM-310 - Concomitant use of strong inhibitors of CYP3A - Patients with peripheral neuropathy of grade 2 or higher ; PRIMARY OUTCOME: Maximum tolerated dose (MTD) of MM-310 monotherapy administered once every 3 weeks in patients with metastatic solid tumors.; SECONDARY OUTCOME 1: Serum levels of analytes that comprise MM-310[/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 - RESTORE; BRIEF: The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D ; DRUG USED: ONO-2952; DRUG CLASS: New Molecular Entity (NME); INDICATION: Irritable Bowel Syndrome (IBS); TARGET: Mitochondrial Translocator Protein (TSPO); THERAPY: Monotherapy; LEAD SPONSOR: Ono Pharma USA Inc; CRITERIA: Inclusion Criteria: 1. Female 18-65 years of age (inclusive) 2. Diagnosed with IBS based on the following criteria (Rome III criteria): - Symptom onset at least 6 months prior to diagnosis, and - Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and - Abdominal discomfort or pain associated with two or more of the following at least 25% of the time: - improvement with defecation - onset associated with a change in frequency of stool/defecation - onset associated with a change in form (appearance) of stool 3. Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations Exclusion Criteria: - Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis) - History of Chrons disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms ; PRIMARY OUTCOME: Change in pain intensity rating during rectal distention by using a numeric pain rating scale; SECONDARY OUTCOME 1: Safety assessed through adverse events and clinical laboratory values[/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/IIb - Malaria (Burkina Faso); BRIEF: This is a double blind randomised controlled clinical trial to evaluate the efficacy of R21 adjuvanted with Matrix-M in healthy 5-17 month old children in a malaria endemic area. ; DRUG USED: Matrix-M Vaccine Adjuvant; DRUG CLASS: Vaccine; INDICATION: Vaccines (General); TARGET: Immune System; THERAPY: Combination; LEAD SPONSOR: University of Oxford; CRITERIA: Inclusion Criteria: - Healthy child aged 5-17 months at the time of first study vaccination - Provide written Informed consent of parent/guardian - Child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 2 years following last dose of vaccination Exclusion Criteria: - Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. - Weight-for-age Z score of less than -3 or other clinical signs of malnutrition. - History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. neomycin. - Sickle cell disease. - Clinically significant laboratory abnormality as judged by the study clinician. - Blood transfusion within one month of enrolment. - Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. - Previous vaccination with experimental malaria vaccines. - Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period. - Current participation in another clinical trial, or within 12 weeks of this study. - Known maternal HIV infection (No testing will be done by the study team). - Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed). - Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participants ability to participate in the trial. ; PRIMARY OUTCOME: The protective efficacy (number of cases) against clinical malaria of R21 adjuvanted with Matrix-M in 5-17 month old children living in a malaria-endemic area; SECONDARY OUTCOME 1: Duration of Protective efficacy (number of cases) against clinical malaria[/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 - COMMODORE 3 (China); BRIEF: This study will enrol participants aged 12 years or older with a body weight >= 40 kilograms (kg) diagnosed with PNH who have not been previously treated with complement inhibitor therapy. Approximately 50 participants will be treated with Crovalimab for at least 24 weeks. ; DRUG USED: Crovalimab; DRUG CLASS: Biologic; INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Body weight >= 40 kg at screening. - Willingness and ability to comply with all study visits and procedures. - Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry. - LDH Levels >= 2x the ULN at screening. - Participants who have at least four transfusions during 12 months prior to screening (documented in the medical record). - Presence of one or more of the following PNH-related signs or symptoms within 3 months of screening. - Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years prior to initiation of study treatment (Day 1) - Vaccination against Haemophilius influenzae type B and Streptococcus pneumonia according to national vaccination recommendations. - For participants receiving other therapies (e.g., immunosuppressants, corticosteroids): stable dose for >= 28 days prior to screening and up to the first drug administration. - Adequate hepatic and renal function. - Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 46 weeks (approximately 10.5 months) after the final dose of crovalimab. - Platelet count >=30,000 cubic millimeter (mm^3) at screening - ANC > 500/μl at screening Exclusion Criteria: - Current or previous treatment with a complement inhibitor. - History of allogeneic bone marrow transplantation. - History of Neisseria meningitidis infection within 6 months prior to screening and up to first drug administration. - Known or suspected immune or hereditary complement deficiency. - Known HIV infection with CD4 count < 200 cells per microlitre (cells/µl) within 24 weeks prior to screening. - Infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 28 days prior to screening and up to the first drug administration, or oral antibiotics within 14 days prior to screening and up to the first drug administration. - Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration. - Presence of fever (>= 38˚C) within 7 days before the first drug administration. - Splenectomy < 6 months before screening. - History of malignancy within 5 years prior to screening and up to the first drug administration. - Pregnant or intending to become pregnant during the study or within 46 weeks (10.5 months) after the final dose of study treatment. - Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater. ; PRIMARY OUTCOME: Mean Percentage of Participants With Hemolysis Control; SECONDARY OUTCOME 1: Percentage of Participants With Breakthrough Hemolysis (BTH)[/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 - vs. LY2140023; BRIEF: This study will be comprised of 2 parts, Part A and Part B, both in healthy male participants. Part A of the study will investigate the safety of intravenous (IV) ketamine administration after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be completed before starting Part B. Part B of this study will investigate whether different dose levels of LY2979165 or LY2140023, when administered before ketamine, result in changes to the images on a brain scan seen with ketamine alone. Brain imaging is currently used for a number of reasons including understanding where in the brain medicines have their effects. Ketamine is an anesthetic used in this study to activate particular regions of the brain. The single oral doses of LY2979165 to be used in both parts of the study are 20 and 60 mg with matching dummy drug (placebo) for each dose. The doses for LY2140023 are 10, 40, and 160 mg with matching placebo for each dose. Screening is required within 28 days prior to the start of the study and follow up 7-14 days after the last dose of study drug. The study will last up to 8-weeks for an individual participant. ; DRUG USED: LY2979165; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - are overtly healthy, right-handed, Caucasian (non-Hispanic White by self report) males, as determined by medical history and physical examination - agree to use an effective method of birth control during the study and for a period of 3 months after the final dose of study drug - if female partners are of child-bearing potential, agree to use 2 effective methods of birth control during the study and for a period of 3 months after the final dose of study drug - one (1) of these methods must be a male or female condom used in conjunction with spermicidal gel, foam, cream, film or suppository - the other method can be any of the following: - diaphragm or cervical vault cap used in conjunction with spermicidal gel, foam, cream, film, or suppository - male partner sterilization - true abstinence (which is in line with the participants usual lifestyle choice; withdrawal or calendar methods are not considered acceptable) - placement of an effective intrauterine device (IUD) (Consideration should be given to the type of device or system being used, as there are higher failure rates quoted for certain types) - established use of oral, injected, or implanted hormonal methods of contraception - have a body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive, and weigh 50.0 to 100.0 kg, at the time of screening - have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator - have venous access sufficient to allow for blood sampling and administration of intravenous (IV) ketamine as per the protocol - are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures - have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site Exclusion Criteria: - are currently enrolled in, have completed or discontinued within the last 90 days from, a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - have known allergies to LY2979165, LY2140023, ketamine, related compounds or any components of the formulations - are persons who have previously completed or withdrawn from this study or any other study investigating LY2979165 or LY2140023 - have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or have a PR interval greater than 200 msec, or QTc interval greater than 450 msec - have an abnormal resting, supine blood pressure (BP), defined as systolic blood pressure (BP) greater than 150 mm Hg or diastolic BP greater than 85 mm Hg, or a heart rate (HR) outside the range of 40 to 85 beats per minute (bpm), inclusive - have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data - have a history of or regularly use known drugs of abuse and/or show positive findings on urinary drug screening - show evidence of significant active neuropsychiatric disease, suicidal risk (including suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale [C-SSRS]) or have a first degree relative with a history of psychosis - show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies - show evidence of hepatitis C and/or positive hepatitis C antibody - show evidence of hepatitis B and/or positive hepatitis B surface antigen - have used or intend to use over-the-counter or prescription medication within 7 days prior to dosing. Herbal supplements must be discontinued 28 days prior to the first dose of trial medication. At the discretion of the investigator a shorter drug free or discontinuation period may be acceptable depending on the precise drugs/supplements taken. As an exception, paracetamol or acetaminophen may be used at doses of up to 1 g/day - have donated blood of more than 500 mL within the last month - have an average weekly alcohol intake that exceeds 28 units per week, or are unwilling to stop alcohol consumption for 48 hours prior to dosing until the completion of each study period and restrict consumption to no more than 3 units per day for the duration of the study (1 unit = 190 mL of beer; 87.5 mL of wine; 25 mL of distilled spirits) - use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or unable/unwilling to abide by the clinical research unit (CRU) smoking restrictions from admission to the CRU until discharge for each study period - consume caffeine equivalent to more than 6 cups of coffee per day, on a habitual basis, or are unable to abide by the study restrictions for caffeine/xanthine use (that is, refrain from consuming caffeine/xanthine-containing drinks and foods (such as coffee, tea, cola, and chocolate) from admission to the CRU until discharge for each study period - in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study - Have increased risk of seizures as evidenced by a history of more than 1 seizure (except childhood febrile seizure), history of electroencephalogram (EEG) with epileptiform activity, history of stroke; surgery to the cerebral cortex; or head trauma with loss of consciousness Additional criteria for Part B only: - History of claustrophobia or inability to tolerate mock scanner environment during habituation/screening session - Fulfillment of any of the magnetic resonance imaging (MRI) contraindications on the standard radiography screening questionnaire (for example, history of surgery involving metal implants) ; PRIMARY OUTCOME: Part A: Number of participants with one or more drug related adverse events (AEs) or any serious AEs; SECONDARY OUTCOME 1: Pharmacokinetics: Area under the concentration curve (AUC) of LY2979165, LY2140023, and active metabolites[/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/GSK1120212; BRIEF: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given in combination with the MEK inhibitor GSK1120212 in patients with selected, advanced solid tumors. The focus will be on tumors with RAS/RAF mutations and on triple negative breast cancer. Both study drugs will be administered once daily orally on a continuous schedule, a treatment cycle is defined as 28 days. Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the MTD. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting toxicity (DLT) in more than 33% of the treated patients.. At least 12 patients will be required at MTD and 6 patients at RP2D level to allow the evaluation of the combinations safety and pharmacokinetics or pharmacodynamics. Upon declaration of MTD and/or RP2D, patients will be enrolled to an expansion part of the study, to further assess safety, as well as to learn more about the efficacy of the study drug combination. - Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant advanced NSCLC - Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant ovarian cancer - Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant pancreatic cancer ; DRUG USED: Buparlisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - histologically/ cytologically confirmed, advanced non resectable solid tumors - Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0 Exclusion Criteria: - Patients with primary Central Nervous System (CNS) tumor or CNS tumor involvement. - Clinically manifested diabetes mellitus - Unacceptable ocular/retinal conditions Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D) and schedule of BKM120+GSK1120212; SECONDARY OUTCOME 1: Measure the number of Adverse Event and laboratory values that fall outside of pre-determined ranges as a measure of Safety and tolerability of the oral combination of BKM120 and GSK1120212[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Long-Term Ext. Study; BRIEF: Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and adults with Tourette Syndrome (TS). ; DRUG USED: Ingrezza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tourettes Syndrome; TARGET: Vesicular monamine transporters (VMATs); THERAPY: Monotherapy; LEAD SPONSOR: Neurocrine Biosciences; CRITERIA: Inclusion Criteria: - Have participated in and completed the NBI-98854-1501 (T-Force Green) or NBI-98854-1505 (T-Forward) Phase 2 study - Have a clinical diagnosis of Tourette Syndrome (TS) - If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses - Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study - Adolescent and adult subjects (12 to 64 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen. Subjects who are on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates, or psychostimulants (for subjects with comorbid ADHD) are allowed to participate in the study - Be in good general health Exclusion Criteria: - Have an active, clinically significant unstable medical condition within 1 month prior to screening - Have a known history of long QT syndrome or cardiac arrhythmia - Have a known history of neuroleptic malignant syndrome - Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed) - Have a blood loss ≥250 mL or donated blood within 56 days prior to screening (subjects 6 to 17 years of age); have a blood loss ≥550 mL or donated blood within 30 days prior to screening (subjects 18 to 64 years of age) - Have a known history of substance dependence, substance (drug) or alcohol abuse - Have a significant risk of suicidal or violent behavior - Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study - Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study ; PRIMARY OUTCOME: Frequency of 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 III - NAPOLI 3; BRIEF: The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer. ; DRUG USED: Onivyde; DRUG CLASS: Non-NME; INDICATION: Pancreatic Cancer; TARGET: Topoisomerase I (Topo-I); THERAPY: Combination; LEAD SPONSOR: Ipsen; CRITERIA: Inclusion Criteria: - Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting. - Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to screening. - Subject has one or more metastatic lesions measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Subject has adequate biological parameters as demonstrated by the following blood counts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation. - Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit of normal (ULN) (≤5x ULN is acceptable if liver metastases are present). - Adequate renal function as evidenced by creatinine clearance ≥30 mL/min. - Adequate coagulation studies (obtained ≤14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤1.5xULN ). Exclusion Criteria: - Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy - Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present. - Subject has only localised advanced disease. - Documented serum albumin <3 g/dL - Known history of central nervous system (CNS) metastases. - Clinically significant gastrointestinal disorder - History of any second malignancy in the last 2 years - Concurrent illnesses that would be a relative contraindication to trial participation - Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 - Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma - Known low or absent dihydropyrimidine dehydrogenase (DPD) activity ; PRIMARY OUTCOME: Overall survival (OS); SECONDARY OUTCOME 1: Progression free survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - DESTINY-Breast08; BRIEF: DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer ; DRUG USED: Enhertu; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Key Inclusion Criteria: - Patients must be at least 18 years of age - Male or female patients who have pathologically documented breast cancer that: 1. Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay 2. Is documented as HR+ (either ER and/or PgR positive [ER or PgR ≥1%]) or ER and PgR negative (ER and PgR <1%) per ASCO/CAP guidelines in the metastatic setting - Patient must have adequate tumor sample for biomarker assessment - ECOG Performance Status of 0 or 1 For patients with HR+ disease: Part 1: At least 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors), and at least 1 prior line of chemotherapy for MBC are required. Part 2: Only 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) for MBC is allowed. No prior chemotherapy in the metastatic setting is allowed. Note there are no patients with HR+ disease in Part 2 of Modules 2 and 3. For patients with HR- disease: Part 1: At least 1 prior line of chemotherapy for MBC is required. Note there are no patients with HR- disease in Part 1 of Modules 4 and 5. Part 2: For Module 2, no prior lines of therapy for MBC are allowed, and for Modules 1 and 3, only 1 prior line of chemotherapy for MBC is allowed. Note there are no patients with HR- disease in Part 2 of Modules 4 and 5. Key Exclusion Criteria: - Uncontrolled intercurrent illness - Uncontrolled or siginificant cardiovascular disease - History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. - Lung-specific intercurrent clinically significant illnesses - Has spinal cord compression or clinically active central nervous system metastases - Active primary immunodeficiency - Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals - Prior treatment with ADC that comprises of an exatecan derivative that is a topoisomerase I inhibitor. ; PRIMARY OUTCOME: Occurrence of adverse events (AEs)- Part 1; SECONDARY OUTCOME 1: Objective Response Rate (ORR)- Part 2[/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 - First Progression of Glioblastoma; BRIEF: PQR309 is an oral, dual pan-PI3K (phosphatidylinositol 3-kinase phosphoinositide 3-kinase) and mTOR (mammilian target of rapamycin) inhibitor that penetrates the blood-brain barrier at pharmacodynamically active concentrations. This study plans to evaluate PQR309 in treatment of patients with first progression of glioblastoma. ; DRUG USED: Bimiralisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: PIQUR Therapeutics AG; CRITERIA: Inclusion Criteria: 1. Patients with histologically confirmed glioblastoma at first progression following or during standard temozolomide chemoradiotherapy (TMZ/RTTMZ) 2. older than 18 years of age 3. Radiographic demonstration of disease progression by RANO criteria 4. Only for patients of the surgical cohort: - Eligible for open resection of progressive tumor according to standard practice of the study center - Availability of adequate surgical tissue sample for the evaluation of concentration of PQR309 in the tumor and its PD effect - Patients treated with PQR309 after incomplete surgical resection may still have measurable disease according to RANO criteria and may therefore be evaluable for evaluation of response to treatment with PQR309 according to RANO criteria. The best response in patients treated with PQR309 after complete surgical resection is stable disease. All patients can be assessed for PFS6. 5. Only for patients of the non-surgical cohort: - Presence of at least one lesion of bi-dimensionally measurable disease by MRI with a contrast-enhancing tumor of at least 1 cm (10 mm) in the longest diameter on baseline MRI is required for patients who do not undergo surgery at relapse. For patients who undergo surgery for recurrence but do not participate in the presurgical PQR309 dosing cohort, the same rules regarding response assessment as in the surgical cohort apply. All patients can be assessed for PFS6. 6. Patient must have at least 1 formalin-fixed paraffin-embedded archival tumor tissue block representative of glioblastoma available from the first surgical resection of glioblastoma. 7. One prior systemic therapy regimen: patients must have received at least one dose of TMZ in the first line therapy. More than 6 cycles and alternative dosing regiments of TMZ are allowed. 8. If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids and no more than 8 mg dexamethasone equivalent for ≥ 5 days prior to baseline MRI. 9. Karnofsky Performance Score (KPS) >70%. 10. More than 12 weeks from radiotherapy (RT) 11. More than 4 weeks from last administration of TMZ 12. More than 4 weeks from any investigational agent (at the judgment of the investigator and in agreement with lead investigator and PIQUR) 13. Adequate hematological, liver and renal function defined as follows: Absolute neutrophil count (ANC) ≥1.5x109/l, platelets ≥ 100x109/l, hemoglobin ≥ 100g/L. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN Serum Creatinine ≤ 1.5 times ULN 14. Able and willing to swallow and retain oral medication 15. Female and male patients of reproductive potential must agree to use effective contraception from screening until 90 days after discontinuing study treatment* 16. Willing and able to sign the informed consent and to comply with the protocol for the duration of the study Exclusion Criteria: 1. Second or later glioblastoma relapse 2. Received more than one systemic treatment regimen for glioblastoma 3. Patients receiving enzyme-inducing anti-epileptic drug (EIAED) within 7 days of the first dose of PQR309 4. Patient is taking a drug with known risk to promote QT prolongation and Torsades de Pointes. 5. Patient is currently using herbal preparations or medications. Patient should stop using herbal medications 7 days prior to the first dose of the study drug 6. Patients with glioblastoma known to contain IDH1 or 2 mutation 7. Other concomitant anti-tumor therapy as determined by the study team 8. Prior treatment with intracerebral agents, e.g. prolifeprospan 20 with carmustine wafer 9. Patients unable to undergo contrast-enhanced MRI 10. Fasting glucose > 7.0 mmol/L or HbA1c > 6.4%. 11. Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders. 12. Anxiety ≥CTC AE grade 3 13. Patient has an uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, known HIV infection, chronic liver disease, chronic renal disease, pancreatitis, chronic pulmonary disease, active cardiac disease or cardiac dysfunction, interstitial lung disease, active autoimmune disease, uncontrolled diabetes, neuropsychiatric or social situations that would limit compliance with the study requirements 14. Presence of gastrointestinal disease or any other condition that could interfere significantly with the absorption of the study drug. 15. Concomitant treatment with medicinal products that increase the pH (reduce acidity) of the upper gastrointestinal tract, including, but not limited to, proton-pump inhibitors (e.g. omeprazole), H2-antagonists (e.g. ranitidine) and antacids. Patients may be enrolled in the study after a wash-out period sufficient to terminate their effect (See section 11.2.2.8).Women who are pregnant or breast feeding, 16. Women able to conceive and unwilling to practice an effective method of birth control* from screening until 90 days after discontinuing study treatment (women of childbearing potential** must have a negative urine or serum pregnancy test within 7 days prior to first dose of PQR309 - Adequate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), or double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Male patients must agree to use condoms as contraception method. - Child-bearing potential for the sake of this study is defined as sexually mature women who have not undergone a hysterectomy, have not been naturally postmenopausal for at least 12 consecutive months or have a serum FSH < 40 mIU/ml. ; PRIMARY OUTCOME: Progression-free survival rate at 6 months (PFS6) based on RANO criteria [30]glioblastoma, using progression-free survival rate at 6 months (PFS6) based on RANO criteria [30]; SECONDARY OUTCOME 1: Number of Adverse Events and Serious Adverse Events as related to the study medication[/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/ Durvalumab; BRIEF: This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a response with anti-PD-1/PD-L1 based regimens ; DRUG USED: Vactosertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: Transforming Growth Factor-beta (TGF-beta) Receptor; THERAPY: Combination; LEAD SPONSOR: MedPacto, Inc.; CRITERIA: Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment 2. Histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra. 3. Prior anti-PD-(L)1 treatment. 4. Measurable disease per RECIST 1.1 assessed by computed tomography (CT) scan or MRI. 5. Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy. 6. Adequate organ and marrow function as defined 7. Must have a life expectancy of at least 12 weeks. 8. Body weight > 30 kg Exclusion Criteria: 1. History of allogeneic organ transplantation. 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure . 4. History of another primary malignancy 5. History of leptomeningeal carcinomatosis. 6. History of active primary immunodeficiency. 7. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus . 8. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria ; PRIMARY OUTCOME: Overall Response Rate; SECONDARY OUTCOME 1: Time to Tumor Response[/INST]No</s>