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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 III - PIONEER 6 (Cardiovascular Safety); BRIEF: This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes. ; DRUG USED: Rybelsus; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female diagnosed with type 2 diabetes - Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor Exclusion Criteria: - Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide - Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC) - History of pancreatitis (acute or chronic) - History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) - Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening - Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m^2) - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ) ; PRIMARY OUTCOME: Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; SECONDARY OUTCOME 1: Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - NCI - w/Anastrozole (Triple Negative); BRIEF: This phase II trial is studying how well giving entinostat and anastrozole together works in treating postmenopausal women with triple-negative breast cancer that can be removed by surgery. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving entinostat together with anastrozole may be an effective treatment for breast cancer. ; DRUG USED: Entinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Histone Deacetylase (HDAC); THERAPY: Combination; LEAD SPONSOR: University of Maryland, Baltimore; CRITERIA: Inclusion Criteria - Female greater than or equal to 18 years. - Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix A). - Histologically confirmed adenocarcinoma of the breast. - Evidence of hormone insensitivity (ER and PR negative) of primary tumor tissue. ER negative is define as ER 0 or < 1% staining by immunohistochemistry. PR negativity is defined as PR < 1% staining by immunohistochemistry. - HER2 negative in the primary tumor tissue as defined by: - Immunohistochemistry (IHC) Grade 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within ≤10% of the invasive tumor cell - IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within >10% of the invasive tumor cell - IHC Grade 2+ staining intensity by means of IHC analysis with no gene amplification below. - No gene amplification on ISH based on - Single-probe average HER2 copy number <4.0 signals/cell - Dual-probe HER2/CEP17 ratio <2.0 with an average HER2 copy number <4.0 signals/cell - Ability to understand and the willingness to sign a written informed consent document. - Patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least one month prior to baseline study biopsy. - Women of childbearing potential must have negative (serum or urine) pregnancy test within 7 days prior to registration. - Patients must have adequate tumor tissue sample prior to the enrolment available for correlative studies as defined below: - Core needle biopsy or incisional biopsy samples that can provide ≥ 3 unstained sections of 5 micron thickness. Fine needle aspiration (FNA) sample alone is not sufficient except in the second cohort. - Additional core needle biopsy needs to be performed in the patients who agree to participate in this study and do not have adequate tumor tissue sample. - Patients must have adequate organ and marrow function as defined below: - Hemoglobin ≥ 9.0 g/dL - Leukocytes >2,500/mcL - Absolute neutrophil count >1,100/mcL - Platelets >100,000/mcL - Total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) <2.5 x institutional upper limit of normal - Creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal Additional Inclusion Criteria for the First cohort: - Unresected operable breast cancer that meets the following clinical stages (see Appendix B): - T1b, T1c, or T2 - N0 or N1 - M0 (No distant metastasis) Additional Inclusion Criteria for the Second cohort: - Unresectable, inoperable, recurrent local-regional breast cancer or - Metastatic (stage IV) breast cancer - Patients must have measurable or evaluable disease (i.e. ascites or pleural/pericardial effusion). Patients with bone metastatic only will be excluded. - Patients must not have rapidly progressive disease, extensive visceral involvement, or any high risk characteristics that are not appropriate for this treatment as per investigators discretion. - Patients must receive at least one prior line of chemotherapy but not more 2 prior chemotherapy regimens for stage IV breast cancer. Prior chemotherapy in the adjuvant and /or neoadjuvant setting is permitted. However, patients must have finished chemotherapy at least 2 weeks prior to enrollment. - Patients must have an accessible tumor lesion from which a fine needle aspirate or preferably a core biopsy specimen can be obtained. Patients with FNA only samples are allowed in this cohort. Ascites or pleural/pericardial effusion alone is not sufficient. - Patients must be willing to provide consents for 2 research biopsies. However, the pretreatment biopsy can be omitted in patients who have recent biopsy but have not been started on breast cancer treatment within 12 weeks prior to the registration and there is adequate tumor tissue sample Exclusion Criteria - Patients may not be receiving any other investigational agents. - Prior exposure to other HDAC inhibitors. However, prior valproic acid exposure is allowed providing ≥ 30 days wash-out period. - History of allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition to entinostat, benzamide, anastrozole, or tamoxifen. - Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy. Examples: HIV, unstable angina, uncontrolled heart failure or hypertension, uncontrolled hyperlipidemia, uncontrolled diabetes mellitus, uncontrolled systemic infection. - Previous or current systemic malignancy within the past 3 years other than breast cancer or adequately treated cervical carcinoma in situ or basal/squamous carcinoma of the skin. Inclusion of Minorities - Women of all races and ethnic groups are eligible for this trial. ; PRIMARY OUTCOME: Recommended Phase II Dose of Entinostat in Combination With Anastrozole (Pilot); SECONDARY OUTCOME 1: Clinical Response to Entinostat and Anastrozole[/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 - V118_18 (<u>></u> 65 Years of Age); BRIEF: A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age. ; DRUG USED: Fluad Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Seqirus; CRITERIA: Inclusion Criteria: 1. Males and females ≥ 65 years old who are healthy or have co-morbidities 2. Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Ability to attend all scheduled visits and to comply with study procedures Exclusion Criteria: 1. Hypersensitivity, including allergy to any component of vaccines foreseen in this study 2. Abnormal function of the immune system. 3. Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study. 4. Additional eligibility criteria may be discussed by contacting the site ; PRIMARY OUTCOME: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition.; SECONDARY OUTCOME 1: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition.[/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 - Dose-ranging; BRIEF: This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone in patients with Type 2 Diabetes Mellitus. ; DRUG USED: BGP-15; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: N-Gene Research Laboratories, Inc.; CRITERIA: Inclusion criteria Patients meeting all of the following criteria will be eligible for enrollment: 1. Male and female patients with T2DM at time of diagnosis as defined by the American Diabetes Association (ADA) criteria; 2. Age between 30 and 70 years (inclusive); 3. HbA1c ≥7.5% - ≤12.0% at Screening, Visit 1; 4. FPG ≤270 mg/dL (15.0 mmol/L); 5. Body mass index (BMI) >27 and ≤40 kg/m2; 6. Current treatment with either metformin alone or in combination with SU. The dose of the current treatment must be stable for at least 8 weeks prior to randomization. Patients being treated with metformin must be at their optimal or near-optimal dose (≥1500 mg/day ± 500 mg/day for a range of 1000 to 2000 mg/day), and patients being treated with SU must be receiving at least one half of the maximum approved SU dose; 7. Women may be enrolled if all three of the following criteria are met: 1. They have a negative serum pregnancy test at Screening; 2. They are not breast feeding; and, 3. They do not plan to become pregnant during the study AND if one of the following three criteria is met: i. They have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form; ii. They have been postmenopausal for at least 1 year; or, iii. They are of childbearing potential and will practice one of the following methods of birth control throughout the study: injectable or implantable hormonal contraception or intrauterine device; or two of the following methods of birth control throughout the study: oral or patch contraception plus a barrier contraceptive (eg, diaphragm plus spermicide, male or female condom plus spermicide, or vasectomized male partner). Abstinence, partners use of condoms, and vasectomy are NOT acceptable methods of contraception; 8. Willingness to sign an informed consent document; and, 9. No conditions that hinder participation in the trial, as determined by the Investigator and Sponsor. Exclusion criteria Patients meeting any of the following criteria will be ineligible for enrollment: 1. Treatment with peroxisome proliferator-activated receptor (PPAR) agonists (including fibrates) within the last 3 months; 2. Treatment with dipeptidyl peptidase 4 (DPP-4) inhibitors, acarbose, or incretins within the last 3 months; 3. Chronic use of insulin injections within the last 1 month; 4. Hypoglycemia requiring third party assistance within the last 3 months; 5. Impaired hepatic function measured as alanine aminotransferase (ALAT) >2X the upper reference limit; 6. Impaired renal function measured as serum creatinine >150 umol/L (1.7 mg/dL); 7. Decompensated heart failure (New York Heart Association [NYHA] class III and IV); 8. Unstable angina pectoris or myocardial infarction within the last 12 months; 9. Clinically significant ECG abnormalities at screening including QTc interval (Bazetts) ≥450 msec or AV block >1st degree; 10. Uncontrolled, treated or untreated hypertension (systolic blood pressure [BP] ≥160 mmHg and/or diastolic BP ≥100 mmHg); 11. Any condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of the results eg, drug abuse or serious disease such as acquired immunodeficiency syndrome/human immunodeficiency syndrome (AIDS/HIV) antibodies, Hepatitis B, or Hepatitis C; 12. Pregnancy or breastfeeding, the intention to become pregnant, or judged to be using inadequate contraceptive measures; 13. History of alcohol and/or drug dependence within the last 2 years; 14. Receipt of any investigational drug or medical device within 3 months prior to this trial; 15. Fasting triglycerides >700 mg/dL at screening; or, 16. Diagnosis or treatment of cancer within the past 5 years except for excision of basal cell or squamous cell skin lesions. ; PRIMARY OUTCOME: Change from Baseline in Glycosylated Hemoglobin at Week 13; SECONDARY OUTCOME 1: Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13[/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 - VENTURE-AF (Catheter Ablation); BRIEF: The purpose of this exploratory study is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stroke Prevention in Atrial Fibrillation (SPAF); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Scientific Affairs, LLC; CRITERIA: Inclusion Criteria: - Be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation (NVAF); - Have a documented history of paroxysmal (lasting <1 week) or persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent (>=1 year) NVAF; - Be suitable for anticoagulant therapy and catheter ablation as per the judgment of the investigator; - Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active; - Women of childbearing potential must have a negative serum pregnancy test at screening; - Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol; - Have a life expectancy of at least 6 months Exclusion Criteria: - Has a history of a prior stroke, transient ischemic attack (TIA) or non-convulsive status epilepticus within 6 months of the screening visit; - Has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure; - Has had major surgery (requiring general anesthesia), within 6 months before screening or planned surgery during the time the subject is expected to participate in the study; - Has NVAF due to electrolyte imbalance, hyperthyroidism, or other reversible or noncardiac cause of NVAF; - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: Number of Participants With Incidence of Post-Procedure Major Bleeding Events; SECONDARY OUTCOME 1: Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death[/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 - Female Pts w/Functional Constipation; BRIEF: This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with functional constipation. ; DRUG USED: Elobixibat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Ileal Bile Acid Transporter (IBAT)/Apical Sodium-dependent Bile Acid Transporter (ASBT); THERAPY: Monotherapy; LEAD SPONSOR: Michael Camilleri, MD; CRITERIA: INCLUSION CRITERIA 1. Females aged 18 to 65 years old inclusive 2. A diagnosis of functional constipation as defined by two or more of the following: 1. fewer than three spontaneous complete bowel movements per week 2. hard or lumpy stools more than 25 % of the time 3. straining during a bowel movement more than 25 % of the time 3. A normal rectal exam result on file within the past 2 years or performed at screen to exclude the possibility of an evacuation disorder. Examination must exclude findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent and spasm, tenderness or paradoxical contraction of the puborectalis muscles. 4. Females of child-bearing potential (those who have not experienced a bilateral tubal ligation, hysterectomy or menopause) must use an acceptable method of contraception during the study. Acceptable methods are surgical sterilization, hormonal methods such as oral contraceptives, Norplant and Depo-Provera, double barrier method such as a condom and spermicide, and an IUD. Abstinent females may participate if they agree to use the double barrier method should they become sexually active during the study. 5. Able to provide written informed consent prior to any study procedures being performed EXCLUSION CRITERIA 1. Female patients who are pregnant or breast feeding 2. Structural or metabolic diseases/conditions that affect the gastrointestinal system or functional gastrointestinal disorders other than constipation. The long version BDQ will be used to confirm patients have constipation. 3. Unable to withdraw all medications 48 hours prior to Visit 1; any medication that alters GI transit including but not limited to laxatives, magnesium or aluminum-containing antacids. prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants and SNRIs; analgesic drugs including opiates, NSAIDs, and COX-2 inhibitors (Note: Tylenol is permitted), GABAergic agents and benzodiazepines. Note: All other concomitant medications will be reviewed on a case by case basis by the study physicians. 4. Clinical evidence (including but not limited to a clinically significant abnormal physical exam, ECG or laboratory test result in the past medical record) or current clinically significant abnormal physical exam or laboratory test result that could indicate significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that interfere with the objectives of the study. If a laboratory test result is abnormal and clinically significant, it may be repeated once at the discretion of the PI. If the laboratory test result remains abnormal and clinically significant, the patient will be discontinued from the study and referred to a primary care physician for further evaluation. 5. Patients who are considered by the PI to be alcoholics not in remission or known substance abusers. 6. Patients who have participated in another clinical study in the past 30 days. ; PRIMARY OUTCOME: Colonic Transit at 24 Hours; SECONDARY OUTCOME 1: Colonic Filling[/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/Nivolumab; BRIEF: The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC). ; DRUG USED: Epacadostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: IDO (Indoleamine 2,3-dioxygenase); THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy). - No prior treatment with systemic anti-cancer therapy for Stage IV disease. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1. - Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1. - Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization. - Other protocol inclusion criteria may apply Exclusion Criteria: - Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy. - Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy. - Untreated central nervous system (CNS) metastases. - Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory. - Carcinomatous meningitis. - Active, known or suspected autoimmune disease. - Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1 targeted agent, or any other antibody or drug targeting T cell co-stimulation or checkpoint pathways. - History of allergy or hypersensitivity to platinum-containing compounds or study drug components. - Physical and laboratory test findings outside the protocol-defined range. - Other protocol exclusion criteria may apply. ; PRIMARY OUTCOME: Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B); SECONDARY OUTCOME 1: Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)[/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 - Concomitant Radiation, Cisplatin, and Tirapazamine Vs Concomitant Radiation and Cisplatin; BRIEF: The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation. ; DRUG USED: Tirapazamine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: Hypoxia/Tumor Hypoxic Environment; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. - Stage III or IV disease (excluding T1N1, and T2N1). - ECOG performance status less than or equal to 2. - Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X 10^9/L, and hemoglobin > 9g/dL. - Serum bilirubin < 1.25 times ULN and AST/ALT < 2.5 times ULN. - Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min. Exclusion Criteria: - Metastatic Disease ; PRIMARY OUTCOME: Overall survival.; SECONDARY OUTCOME 1: Time to locoregional failure.[/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 - Long-Term Study (MCD2002); BRIEF: The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castlemans disease (MCD). ; DRUG USED: Sylvant; DRUG CLASS: Biologic; INDICATION: Castlemans Disease; TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Has multicentric Castlemans disease - Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm) - Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose - Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible - Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study Exclusion Criteria: - Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study - Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study - Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies, to murine, chimeric, human proteins or their excipients ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs); SECONDARY OUTCOME 1: Percentage of Previously Responding Participants Who Maintained Disease Control[/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 - US; BRIEF: The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of subjects with erectile dysfunction (ED). ; DRUG USED: Udenafil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Erectile Dysfunction (ED); TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Monotherapy; LEAD SPONSOR: Dong-A PharmTech Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Is male and at least 19 years of age. 2. Has a stable monogamous relationship for at least 6 months with a consenting female partner (vaginal intercourse is a required study activity). 3. Provides written informed consent. 4. The subjects female partner provides written informed consent. 5. Has a history of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration. The investigator will record the etiology of the ED (organic, psychogenic or mixed). 6. Has scored between 6-25 for the Erectile Function domain score (Questions Number 1-5, 15) at both Visits 1 & 2. 7. Completes least four diary entries by Visit 2, showing at least 4 attempts at sexual intercourse with a 50% or greater failure rate in achieving or in maintaining an erection sufficient to complete intercourse (defined as answering no to SEP questions #2 or #3). 8. The subjects partner is not pregnant or lactating and both subject and partner agree to the use of a medically acceptable form of birth control. Exceptions would be subjects with a vasectomy or partners that are post menopausal, and partners that have had a tubal ligation or hysterectomy. Exclusion Criteria: 1. Has a history of stroke, myocardial infarction, or coronary artery disease within the past 6 months. 2. Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months. 3. Is taking nitrate medication in any form(Appendix 7) 4. Is taking alpha blockers. 5. Has a clinically significant abnormal laboratory value as determined by the principal investigator. 6. Has a history of uncontrolled diabetes (HbA1c>9%). 7. Has a history of proliferative diabetic retinopathy. 8. Has a history of spinal cord injury or a radical prostatectomy or radical pelvic surgery. 9. Has a supine blood pressure lower than 90/50mmHg or uncontrolled hypertension higher than 170/100mmHg. 10. Has a anatomical deformity of the penis such as severe penile fibrosis or Peyronies disease. 11. Has a thyroid stimulating hormone (TSH) level lower than 30% of LLN. 12. Has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (<300 ng/dl). 13. Has hepatic impairment (GOT, GPT levels > 3 x ULN). 14. Has renal impairment (serum creatinine ≥ 2.5mg/dl). 15. Has a history of hematological disorder such as bleeding disorder or a risk of GI bleeding such as peptic ulceration. 16. Has a history of retinitis pigmentosa. 17. Has a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism. 18. Has a history of significant psychiatric disorder. 19. Has a history of central nervous system disorders such as stroke, transient ischemic attacks, or spinal cord injury. 20. Has a history of drug abuse (alcohol, marijuana, cocaine, or opiates). 21. Has a known sensitivity to drugs especially to phosphodiesterase type 5 inhibitors such as Viagra, Cialis or Levitra. 22. Has used other erectile dysfunction therapies including nutraceutical and herbal products within 14 days prior to entering into this study. 23. Is using concomitant medications that are known or suspected to interact with PDE 5 inhibitors such as the following: 1. Antibacterial: erythromycin 2. Antifungals: itraconazole, ketoconazole 3. Antivirals: ritonavir, saquinavir, amprenavir, indinavir, nelfinavir 4. H2 receptor antagonist: cimetidine 5. Anticoagulants, androgens, trazodone 24. Have other sexual disorders such as hypoactive sexual desire. 25. Have previously failed to respond to PDE-5 inhibitors such as Viagra, Cialis or Levitra. 26. Have a major illness that in the opinion of the investigator would interfere with the conduct of the study. 27. Has not participated in a clinical drug study within the last 30 days prior to entering this study. ; PRIMARY OUTCOME: The primary efficacy end points are:; SECONDARY OUTCOME 1: The study has several secondary efficacy measurements including:[/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 - HARRIER (vs. Aflibercept (Study 2)); BRIEF: The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye. ; DRUG USED: Beovu; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Key Inclusion Criteria: - Provide written informed consent; - Active CNV lesions secondary to AMD that affected the central subfield in the study eye at Screening; - Total area of CNV > 50% of the total lesion area in the study eye at Screening; - Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening; - Best corrected visual acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. Key Exclusion Criteria: - Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline; - Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis ≥ 50% of the total lesion in the study eye at Screening; - Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at Screening; - Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time; - Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline; - Pregnant or nursing women; women of child-bearing potential; - Stroke or myocardial infarction in the 6-month period prior to Baseline. ; PRIMARY OUTCOME: Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye; SECONDARY OUTCOME 1: Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - 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/III - MDS, CMML, AML Study; BRIEF: Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months. ; DRUG USED: ASTX030 ; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Cytidine Deaminase, DNA Methyltransferase (DNMT); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Astex Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Confirmed MDS, CMML, MDS/MPN, or AML who are candidates to receive and benefit from single agent azacitidine as follows and as applicable according to local country approvals and/or local institution standard practice: 1. French-American-British myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), or MDS with intermediate-2 or high risk MDS according to the International Prognostic Scoring System (IPSS). MDS/MPN patients including CMML according to the World Health Organization (WHO) 2016 classification are also eligible if they are candidates to receive single agent azacitidine per local institution standards; or 2. Previously untreated AML with 20% to 30% blasts present in bone marrow and multi-lineage dysplasia (Phase 2 and 3 only); or 3. Previously untreated AML with >30% blasts present in bone marrow, who are not eligible for stem cell transplant and unfit for intensive chemotherapy induction (Phase 2 and 3 only). 2. Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 3. Participants with adequate organ function defined as: 1. Hepatic: Total or direct bilirubin ≤2 × upper limit of normal (ULN); aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤2.5 × ULN. 2. Renal: Calculated creatinine clearance >50 mL/min/1.73 m^2 by Cockcroft-Gault formula or other medically acceptable formulas. 4. For participants with prior allogeneic stem cell transplant, no evidence of graft-versus-host disease (GVHD) and must be ≥2 weeks off systemic immunosuppressive therapy before start of study treatment. 5. Participants with no major surgery within 2 weeks before first study treatment. 6. Participants with no cytotoxic chemotherapy within 4 weeks before first study treatment. 7. Able to swallow the number of tablets/capsules required for the treatment assignment within a 10-minute period and tolerate 4 hours of fasting. 8. Participants with projected life expectancy of at least 12 weeks. 9. Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Exclusion Criteria: 1. Active uncontrolled gastric or duodenal ulcer. 2. Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled bacterial, viral, or fungal infections. 3. Life-threatening illness (e.g., uncontrolled bleeding and patients at risk for or are experiencing leukostasis [AML]), uncontrolled medical condition or organ system dysfunction, or other reasons, which, in the investigators opinion, could compromise the participants safety, interfere with the absorption or metabolism of oral cedazuridine + azacitidine or compromise the integrity of the study outcomes. 4. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer or breast cancer under control with hormone therapy, or other cancer from which the participant has been disease free for at least 2 years. 5. Participants with MDS/MPN who have clinical extramedullary disease including clinically palpable hepatomegaly or splenomegaly. 6. Previous treatment with more than 1 cycles of decitabine, azacitidine, or guadecitabine (Phases 2 and 3 only). 7. Treated with any investigational drug or therapy within 2 weeks, or 5 half lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant adverse events from previous treatment with investigational drug or therapy. 8. Known or suspected hypersensitivity to cedazuridine or azacitidine, or any of their excipients. ; PRIMARY OUTCOME: Total cycle area under the curve (AUC)0-24 exposures; SECONDARY OUTCOME 1: Safety: Number of TEAEs[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ASTRONAUT; BRIEF: This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure. ; DRUG USED: Tekturna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Renin; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female. - Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization. - LVEF < 40% (measured within the last 6 months). - Hospitalization for ADHF and remain stabilized for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization. - Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml). - Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV). Exclusion Criteria: - Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization. - Concomitant use of ACEI and ARB at randomization. - Right heart failure due to pulmonary disease. - Diagnosis of postpartum cardiomyopathy. - Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months. - Patients with a history of heart transplant or who are on a transplant list. - Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization. Other protocol-defined inclusion/exclusion criteria applied. ; PRIMARY OUTCOME: Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months; SECONDARY OUTCOME 1: Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months[/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 - CYCLONE; BRIEF: RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients with newly diagnosed active multiple myeloma. ; DRUG USED: Kyprolis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: Mayo Clinic; CRITERIA: Inclusion - Creatinine =< 2 mg/dL - Calculated Creatinine Clearance >= 30 mL/min - Total Bilirubin =< 2.0 mg/dL - Alkaline Phosphatase =< 3 x ULN - ALT =< 3 x ULN - Absolute neutrophil count >= 1000/uL - Platelet >= 75000/uL - Hemoglobin >= 8.0 g/dL - Untreated symptomatic myeloma: Prior non-systemic therapy for the treatment of solitary plasmacytoma is permitted, but >= 1 month should have elapsed from the last day of radiation; prior therapy with clarithromycin, DHEA, anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the Principal Investigator - Prior high dose corticosteroid therapy for twelve days (480 mg total dose) or less is permitted for emergent complications from newly diagnosed multiple myeloma - Measurable disease of multiple myeloma, as defined by at least ONE of the following: - Serum monoclonal protein >= 1.0 g by protein electrophoresis - OR > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis - OR serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio; OR monoclonal bone marrow plasmacytosis >= 30% (evaluable disease) - ECOG performance status (PS) 0, 1, 2; ECOG PS of 3 will be allowed if secondary to pain in the opinion of the Investigator - Willingness and able to provide informed written consent - Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only - Willingness to return to Mayo Clinic enrolling institution for follow-up Exclusion - MGUS or smoldering myeloma - Peripheral sensory neuropathy >= Grade 2 as defined by CTEP Active Version of the CTCAE - Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer - Pregnant women or women of reproductive ability who are unwilling to use effective contraception - Nursing women - Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment - Known hypersensitivity, allergy or inability to tolerate any of the agents employed - Active, uncontrolled infection - Severe cardiac comorbidity - New York Heart Association Class III or IV Heart Failure - Recent history of myocardial infarction in the six months prior to registration - Uncontrolled angina or electrocardiographic evidence of acute ischemia - Severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of active conduction system abnormalities - Cardiac amyloidosis with hypotension (systolic BP less than 100 mmHg) - Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment - The following medications are not permitted during the trial: any other investigational treatment; any cytotoxic chemotherapy; any other systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy - Palliative radiation therapy is permitted if clinically indicated and not indicative of progressive disease ; PRIMARY OUTCOME: Maximum Tolerated Dose (Phase I); SECONDARY OUTCOME 1: Progression-free Survival (Phase II)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 006 vs. Prevnar 13; BRIEF: The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants ≥50 years of age in good health. ; DRUG USED: Vaxneuvance; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Good health; any underlying chronic illness must be documented to be in stable condition - Highly unlikely to conceive through 6 weeks after administration of the study vaccine Exclusion Criteria: - Prior administration of any pneumococcal vaccine - History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease - Known hypersensitivity to any vaccine component - Known or suspected impairment of immune function - Received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination - Coagulation disorder contraindicating intramuscular vaccination - Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease - Received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion. - Participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study - Breast feeding - User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence ; PRIMARY OUTCOME: Percentage of Participants With an Adverse Event (AE); SECONDARY OUTCOME 1: Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination[/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 - Short Term Pediatric; BRIEF: The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder ; DRUG USED: Abilify (Oral and IM); DRUG CLASS: New Molecular Entity (NME); INDICATION: Autism Spectrum Disorders (Autism); TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. - Inpatient or outpatient status - Others Exclusion Criteria: - The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Aspergers, Retts Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome. - Patients who fall under a contraindication listed in the ABILIFY package insert - Others ; PRIMARY OUTCOME: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale 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 Ib/II - ANNOUNCE-2; BRIEF: The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body. ; DRUG USED: Lartruvo; DRUG CLASS: Biologic; INDICATION: Sarcoma; TARGET: Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - The participant may have no more than 2 prior lines of systemic therapies (neoadjuvant and adjuvant therapies will not be considered as a prior line of therapy) for advanced or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy. All previous therapies must have completed ≥ 3 weeks (21 days) prior to first dose of study drug. - In the Phase 2 part, prior olaratumab/doxorubicin combination therapy in 1 prior treatment line is allowed. - Prior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label. - Prior olaratumab therapy must have included at least 2 full cycles of olaratumab/doxorubicin (that is, a minimum of 4 doses of olaratumab). - Participants, who completed at least 2 cycles of combination olaratumab/doxorubicin therapy then discontinued doxorubicin due to toxicity or maximum dosing and proceeded to olaratumab monotherapy, are eligible. - The most recent dose of olaratumab must have been received within 180 days of randomization in this study. - Availability of tumor tissue is mandatory for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable). - The participant has adequate hematologic, organ, and coagulation function within 2 weeks (14 days) prior to enrollment (Phase 1b) or randomization (Phase 2). Exclusion Criteria: - The participant is diagnosed with gastrointestinal stromal tumor (GIST) or Kaposi sarcoma. - The participant has active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment (Phase 1b) or randomization (Phase 2). Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment (Phase 1b) /randomization (Phase 2) to rule out brain metastasis. - The participant has received prior treatment with gemcitabine or docetaxel. Note: Participants previously enrolled in the I5B-MC-JGDJ (NCT02451943) or any other blinded study with olaratumab are not eligible to participate in this trial. - The participant has electively planned or will require major surgery during the course of the study. - Females who are pregnant or breastfeeding. - The participant has an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required). ; PRIMARY OUTCOME: Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab[/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 - RADIUS (post-HSCT); BRIEF: To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant, ; DRUG USED: Rydapt; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Protein Kinase C (PKC), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients between 18 and 70 years of age - Patients with ECOG Performance Status of ≤ 2 - Patients with a documented unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic leukemia). - Patients with a documented FLT3 ITD mutation, determined by local laboratory for eligibility (historical tissue will be requested for central analysis confirmation) - Patients who undersent allogeneic HSCT in CR1 from a matched related or matched unrelated donor. All of the following criteria had to be met: HLA typing to include available 8/8 or 7/8 allele HLA matched donor (at A,B,C, DRB1) Single allelic mismatch allowed - Patients who had received a conditioning regimen which included one of the following: Busulfan/Fludarabine (Bu/Flu) Busulfan (16 mg/kg PO or 12.8 mg/kg IV) Fludarabine (120-180 mg/m2) Fludarabine / Melphalan (Flu/Mel) Fludarabine (120-180 mg/m2) Melphalan (≤ 150 mg/m2) Busulfan/Cyclophosphamide (Bu/Cy) Busulfan (16 mg/kg PO or 12.8 mg/kg IV) Cyclophosphamide (120 mg/kg) Cyclophosphamide/Total Body Irradiation (Cy/TBI) Cyclophosphamide (120 mg/kg) TBI (1200-1420 cGy) • Recovery of counts by day 42 and was able to start midostaurin by day 60 post-HSCT (first dose of midostaurin to start no earlier than 28 days post-HSCT); ANC >1000µL, platelets ≥20,000 without platelet transfusion Exclusion Criteria: Patients eligible for this study must not have met any of the following criteria: - Patients who failed prior attempts at allogeneic HSCT - Patients who had received an autologous transplant - Patients with Acute GVHD Grade III-IV - Patients with a known confirmed diagnosis of HIV infection or active viral hepatitis. - Impaired cardiac function including any of the following: - Screening ECG with a QTc > 450 msec. If QTc > 450 and electrolytes were not within normal ranges, electrolytes should be corrected and then the patient rescreened for QTc. - Patients with congenital long QT syndrome - History or presence of sustained ventricular tachycardia - Any history of ventricular fibrillation or torsades de pointes - Bradycardia defined as HR. < 50 bpm - Right bundle branch block + left anterior hemiblock (bifascicular block) - Patients with myocardial infarction or unstable angina < 6 months prior to starting study - Congestive Heart Failure NY Heart Association class III or IV - Patients with an ejection fraction < 45% assessed by MUGA or ---ECHO within 28 days prior to starting study cycle 1 (of midostaurin or control group) - Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolves to ≤ Grade 1 within screening timeframe) - Patient required treatment with strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers other than those required for GVH or infection prophylaxis or treatment Pregnant or nursing (lactating) women, or women of child-bearing potential, must have used highly effective methods of contraception during dosing and for 30 days after treatment completion ; PRIMARY OUTCOME: Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis; SECONDARY OUTCOME 1: Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CheckMate 812; BRIEF: The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Hodgkins Lymphoma; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. - Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following:. i) Autologous stem cell transplant (ASCT) ineligible patients. ii) Patients after failure of ASCT. - Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan. Exclusion Criteria - Known central nervous system lymphoma. - Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL). - Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML). - Other protocol-defined inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Complete Response Rate (CRR):[/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/ Temozolomide/Radiation Therapy; BRIEF: The purpose of this trial is to show proof of concept that by blocking the Transforming Growth Factor-beta signaling pathway in patients with Glioblastoma, there will be clinical benefit. Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with radiochemotherapy with temozolomide for Phase 2 in patients with glioma eligible to receive radiochemotherapy with temozolomide (e.g. newly diagnosed malignant glioma World Health Organization Grade III and IV). Phase 2a: To confirm the tolerability and evaluate the pharmacodynamic effect of LY2157299 in combination with standard radiochemotherapy in patients with newly diagnosed glioblastoma. ; DRUG USED: Galunisertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Transforming Growth Factor-beta (TGF-beta) Receptor; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Patients with histologically proven, newly diagnosed and untreated intracranial glioblastoma including lower grade glioma which evolved into glioblastoma and who have not received any radiochemotherapy or who have World Health Organization Grade III malignant glioma (e.g., Anaplastic Astrocytomas, Anaplastic Oligoastrocytomas, Anaplastic Oligodendroglioma) (Phase 1b only) will be eligible for this protocol - Biopsy or resection must have been performed no more than 6 weeks prior to treatment - An Magnetic Resonance Imaging must be obtained within 72 hours after surgery, preferably within 48 hours - Patient must not have had prior cranial radiation therapy - Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors Patients who received Gliadel wafers at the time of original resection will be excluded - Patients must plan to begin partial brain radiotherapy within 2-6 weeks after surgery. Regular fractionated radiotherapy with photons (in any planning mode and possibly image-guided or stereotactic if deemed necessary) is performed according to the discretion of the investigator - Patients must be willing to forego other cytotoxic and noncytotoxic drug therapy against the tumor while being treated with LY2157299 and temozolomide - All patients must sign an informed consent indicating that they are aware of the investigational nature of this study - Patients must have performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale - Patients must have adequate hematologic, hepatic and renal function - Male and female patients with reproductive potential must use an approved contraceptive method,during and for 6 months after discontinuation of study treatment Women of childbearing potential must have a negative human chorionic gonadotropin pregnancy test documented within 14 days prior to treatment Exclusion Criteria: - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - Have moderate or severe cardiac disease as defined by any of the following: - Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension - Have documented major electrocardiogram (ECG) abnormalities that are symptomatic and are not medically controlled - Have major abnormalities documented by echocardiography with Doppler - Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress - Are unable to swallow tablets or capsules - Are pregnant or breastfeeding - Have any significant medical illnesses that in the investigators opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy - Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years are ineligible - Have active infection that would interfere with the study objectives or influence the study compliance - Stereotactic radiosurgery, such as Gamma-Knife treatment, and brachytherapy are not allowed in this study ; PRIMARY OUTCOME: Phase 1: Recommended dose for Phase 2 portion; SECONDARY OUTCOME 1: Phase 1: Pharmacokinetics - Concentration Maximum[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Islands (Japan); BRIEF: Primary Objectives: - Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with relapsed and refractory multiple myeloma. - Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese patients with relapsed and refractory multiple myeloma. Secondary Objectives: - To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events will be assessed. - To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule. - To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria. - To assess the relationship between baseline CD38 receptor density on multiple myeloma cells and efficacy. ; DRUG USED: Sarclisa; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Cluster of Differentiation 38 (CD38); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Males or females, age 20 years or older. - Patient must have a known diagnosis of symptomatic multiple myeloma. - Patients must have received at least 3 prior lines of therapies OR Patients whose disease is double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI). - Subject must have been responsive (ie, minimal response [MR] or better) to at least one prior line of therapy. - Refractory to the most recently received IMiD or PI included therapy. - Patients with measurable disease defined as at least one of the following: - IgG Type: Serum M-protein ≥1 g/dL (≥10 g/L); - IgA and D Type: Serum M-protein, quantification should be performed; - Urine M-protein ≥200 mg/24 hours. - Patients with a Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Exclusion criteria: - Patients treated with any anti-CD38 agent. - Diagnosed or treated for another malignancy within 5 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. - Prior anticancer therapy (chemotherapy, targeted agents, immunotherapy) within 21 days prior to the first drug infusion unless otherwise specified below: - Alkylating agents (eg, Melphalan) within 28 days prior to the first dose of study treatment. - Steroids treatment (eg, prednisone >10 mg/day orally or equivalent except patients being treated for adrenal insufficiency/replacement therapy or treated for inhalation corticosteroids) within 14 days prior to the first dose of study treatment. - Participated in another clinical trial within 30 days prior to the first dose of study treatment. - Patients treated with systemic radiation therapy within 4 weeks prior to the first dose of study treatment OR Localized radiation therapy within 1 week prior to the first dose of study treatment. - Major surgical procedure within 4 weeks prior to the first dose of study treatment. - Any toxicity Grade ≥2 (excluding alopecia, neutropenia or neuropathy) related to any prior anti-cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. - Neuropathy Grade ≥3 or painful peripheral neuropathy Grade ≥2. - History of significant cardiovascular disease unless the disease within the past 6 months is well-controlled. - Previously received an allogenic stem cell transplant. - Diagnosed Crow-Fukase (POEMS) syndrome OR plasma cell leukemia. - Patients with known or suspected amyloidosis. - Patients with Waldenstroms macroglobulinemia OR Multiple myeloma IgM subtype. - Patients with active infection. - Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection. - Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation. - Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results. - Hypersensitivity or history of intolerance to boron or mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to pre-medication with steroids and H2 blockers or would prohibit further treatment with these agents. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Phase I: Dose Limiting Toxicities (DLT); SECONDARY OUTCOME 1: Number of patients with Treatment-emergent adverse events/serious adverse events (TEAE/SAE)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III (Bangladesh); BRIEF: This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months. ; DRUG USED: ANX-005; DRUG CLASS: Biologic; INDICATION: Guillain-Barré Syndrome; TARGET: Complement Component 1q (C1q), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Annexon, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain-Barré Syndrome. - Onset of GBS-related weakness ≤10 days prior to start of infusion. - GBS-DS score of 3,4, or 5 at screening and at Day 1 prior to infusion. Exclusion Criteria: - Clinically significant findings on the screening electrocardiogram (ECG), laboratory test results, or physical examination that are not specific to GBS that may interfere with the conduct of the study, the interpretation of the data, or increase the participants risk. - Body weight <30 kilograms (kg) or >150 kg at screening. - Unresponsive (inexcitable) nerve conduction study results in all nerves tested during screening. - Previous or intended treatment with either plasma exchange or intravenous immunoglobulin for GBS. - Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaffs encephalitis, and overlap syndromes. - History of prior episode of GBS. - GBS-related weakness that improved since symptom onset, including an improvement between screening and Day 1 (baseline). ; PRIMARY OUTCOME: GBS Disability Score (GBS-DS) at Week 8; SECONDARY OUTCOME 1: Medical Research Council (MRC) Sum Score at Week 8[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - MSC-NTF-002 (Israel); BRIEF: The study will evaluate the safety, tolerability and therapeutic effects of transplantation of escalating doses of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), in patients with amyotrophic lateral sclerosis (ALS). ; DRUG USED: NurOwn; DRUG CLASS: Biologic; INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Brainstorm-Cell Therapeutics; CRITERIA: Inclusion Criteria: 1. Patient must fulfill El Escorial criteria (APPENDIX 2) for definite or probable ALS (sporadic and not familial) 2. Participants, either men or non pregnant women are between 20 and 75 years of age. 3. The patient is mentally intact and psychologically stable 4. Patients will be with an ALS-FRS-R scale (APPENDIX 3) of at least 30 and disease duration of less than 2 years. 5. Patient has sufficiently bulky muscles. 6. Participant understands the nature of the procedure and provides written informed consent prior to any study procedure. Exclusion Criteria: 1. Patient has a positive test for HBV, HCV or HIV. 2. Patient has high protein in the CSF (Protein > 70 mg/ml). 3. Patient has lymphocytosis in the CSF (lymphocytes > 5/ml). 4. Patient is positive for anti-GM1 antibodies. 5. Patient has significant conduction blocks or slow nerve conduction velocities (a reduction of more than 30%) confirmed by nerve conduction velocity - EMG studies. 6. The patient is a respiratory dependent patient. 7. Patients with renal failure (Cr > 2 mg/dl). 8. Patients with impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit). 9. Patients suffering from significant cardiac disease, malignant disease or any other disease that may risk the patient or interfere with the ability to interpret the results 10. Patient with active infections. 11. Participation in another clinical trial within 1 month prior to start of this study. 12. Patient has not been treated previously with any cellular therapy. 13. Subject unwilling or unable to comply with the requirements of the protocol. ; PRIMARY OUTCOME: Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF); SECONDARY OUTCOME 1: Changes in the progression rate of the disease as evidenced by changes in the ALS functional rating scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BR.31; BRIEF: The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer. ; 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; LEAD SPONSOR: Canadian Cancer Trials Group; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung. according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible. - Patients must be classified post-operatively as Stage IB (≥ 4cm in the longest diameter), II or IIIA on the basis of pathologic criteria. Note: Although T3N2M0 tumours have been reclassified to stage IIIB in the 8th edition of the IASLC staging system, these patients remain eligible (as stage IIIA under the 7th edition criteria). - Complete surgical resection of the primary NSCLC is also mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. Resection may be accomplished by open or VATS techniques Note: Patients with synchronous primary tumours will not be eligible due to the potential uncertainty regarding their appropriate PD-L1 status. Prior Systemic Therapy: - Pre-operative (neo-adjuvant) platinum based or other chemotherapy is not permissible. - Patients may have received prior post-operative platinum based chemotherapy as per standard of care. - No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible. Radiation: • Patients with N2 disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible. - The patient must have an ECOG performance status of 0, 1. - Hematology: . Absolute neutrophil count ≥ 1.5 x 109/L or ≥ 1,500/µl Platelets ≥ 100 x 109/L or ≥ 100,000/µl - Biochemistry: Total bilirubin* ≤ institutional upper limit of normal Alkaline phosphatase ≤ 2.5 x institutional upper limit of normal AST(SGOT) and ALT(SGPT) ≤ 2.5 x institutional upper limit of normal Creatinine Clearance ≥ 40 ml/min * excluding Gilberts syndrome Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula: Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in μmol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in μmol/L - Patient able and willing to complete the QoL, economics and other questionnaires. The baseline assessment must already have been completed within required timelines prior to randomization. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible - Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate - Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up - Protocol treatment is to begin within 2 working days of patient randomization Exclusion Criteria: - Patients with a history of other malignancies, except: - adequately treated non-melanoma skin cancer, - curatively treated in-situ cancer, or - other malignancies curatively treated with no evidence of disease for ≥ 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy. - A combination of small cell and non-small cell lung cancer, pulmonary carcinoid tumour or large-cell neuroendocrine carcinoma (LCNEC). - History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegeners granulomatosis, Sjögrens syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Graves disease and/or psoriasis not requiring systemic therapy within the last two years from randomization and patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement are not excluded. - History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy. - Live attenuated vaccination administered within 30 days prior to randomization. - History of hypersensitivity to MEDI4736 or any excipient. - Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, must have a LVEF > 50% within 12 weeks prior to randomization. - Concurrent treatment with other investigational drugs or anti-cancer therapy. - Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to: - known clinical diagnosis of tuberculosis; - known active hepatitis B infection (positive HBV surface antigen (HBsAg)). Patients with a past or resolved hepatitis B infection (defined as presence of hepatitis B core antibody (anti-HBc) and absence of HBSAg) are eligible; - known active hepatitis C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA; - known human immunodeficiency virus infection (positive HIV antibodies). - known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function - Pregnant or lactating women. Women of childbearing potential must have a urine pregnancy test proven negative within 14 days prior to randomization. Men and women of child-bearing potential must agree to use adequate contraception. ; PRIMARY OUTCOME: Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 expression TC ≥ 25% and patients without common activating EGFR mutations or ALK gene rearrangements; SECONDARY OUTCOME 1: Disease-free survival in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK 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 III - PALISADE; BRIEF: The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults. ; DRUG USED: Palforzia; DRUG CLASS: Biologic; INDICATION: Food Allergies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Aimmune Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Age 4 through 55 years - Clinical history of allergy to peanuts or peanut-containing foods - Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control - Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL** guidelines - Not be residing at the same address as another subject in this or any peanut OIT study UniCAP™*: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies PRACTALL**: PRACTical issues in ALLergology Joint United States/European Union Initiative Key Exclusion Criteria: - History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension - History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC - History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen - History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology - History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control - History of steroid medication use - History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema - Developing dose-limiting symptoms in reaction to the placebo part of the Screening DBPCFC - Having the same place of residence as another subject in the study ; PRIMARY OUTCOME: Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC); SECONDARY OUTCOME 1: Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)[/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; BRIEF: Small cell lung cancer (SCLC) is a chemotherapy and radiotherapy sensitive tumor, but with very high rates of relapse and metastasis, resulting in a very poor outcome. Among limited-stage patients, the relapse rate is at least 80% and among extensive-stage patients, the relapse rate is 95-98%. The impetus to develop more effective therapies against novel targets in SCLC is therefore high. Hsp-90 inhibitors are a new class of drugs with important anti-malignant potential in a variety of tumor types because of the reliance of multiple oncoproteins on Hsp90 function. Although small cell neuroendocrine tumors generally carry many mutated oncoproteins, without clearly defined clients for Hsp90 mediating inhibitor effects in these cells, a recent study demonstrated that Hsp90 inhibition causes massive apoptosis by activating the intrinsic apoptotic pathway in a number of SCLC cell lines. SCLC is a particularly attractive target for apoptosis inducing drugs because of high growth rates and evidence of molecular alterations affecting apoptotic mechanisms. STA-9090 is a novel, small-molecule inhibitor of Hsp90. Unlike earlier generations of Hsp90 inhibitors, STA-9090 has been shown to be a potent inducer of apoptosis in a variety of cell lines and has anti-tumor activity in multiple types of human xenografts. As was seen with other Hsp90 inhibitors, STA-9090 also induces apoptosis in a number of SCLC cell lines. Based on the anti-tumor potential seen pre-clinically with Hsp90 inhibition, the potent effects of STA-9090 seen pre-clinically as compared with other inhibitors in the same class, as well as early data suggesting safety and tolerability of this drug in the Phase I setting, we propose to study the single-agent activity of STA-9090 in a Phase II trial of patients with relapsed or refractory small cell lung cancer. ; DRUG USED: ADX-1612; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Heat Shock Protein 90 (HSP90); THERAPY: Monotherapy; LEAD SPONSOR: David M. Jackman, MD; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of small cell lung cancer and confirmed progressive disease by radiographic study - </= 3 prior chemotherapy regimens - Subjects with brain metastases will be allowed if they have been treated with surgery and/or radiation therapy > 21 days prior, are asymptomatic, and are stable for at least 1 week off steroids - Must have measurable disease - >/= 18 years of age - Life expectancy of greater than 12 weeks - EGOG performance status 0 or 1 - Lab values must be within limits outlined in the protocol - Not pregnant or breastfeeding - Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Chemotherapy or radiotherapy within 3 weeks or within 5 half-lives of previous therapy - History of severe allergic or hypersensitivity reactions to taxanes. - Subjects who have not recovered from adverse events or toxicities due to agents administered more than 4 weeks earlier to a grade 1 or less - Not receiving any other study agents - History of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery. - Baseline QTc > 470 msec or previous history of QT prolongation while taking other medications. - Ventricular ejection fraction of < 55%. - History or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block. - ECG with clinically significant ventricular arrhythmias or ischemia - Major surgery within 4 weeks of starting treatment - Poor venous access necessitating use of indwelling catheter for IV therapy - 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 - History of another malignancy unless disease-free for 3 years and deemed to be at low risk for recurrence ; PRIMARY OUTCOME: 8-Week Progression-Free Rate; SECONDARY OUTCOME 1: Overall Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - OLE; BRIEF: Primary Objective: To evaluate the long-term safety and tolerability of fitusiran in male patients with moderate or severe hemophilia A or B Secondary Objectives: - To investigate the long-term efficacy of fitusiran - To characterize the safety and efficacy of concomitantly administered Factor VIII (FVIII), Factor IX (FIX) or bypassing agents (BPA) and fitusiran for treatment of bleeding episodes - To assess changes in health-related quality of life (QOL) over time - To characterize antithrombin (AT) reduction and thrombin generation (TG) increase - To characterize the pharmacokinetics (PK) of fitusiran ; DRUG USED: Fitusiran; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion Criteria: - Completed and tolerated study drug dosing in study TDR14767 (ALN-AT3SC-001) - Male aged ≥18 years - Moderate or severe, clinically stable hemophilia A or B as evidenced by a laboratory FVIII or FIX level ≤5% at screening. Patients with a FVIII or FIX level >5% at screening will be eligible on provision of a historic laboratory report indicating a trough level ≤5% - Willing and able to comply with the study requirements and provide written informed consent Exclusion Criteria: - Clinically significant liver disease - Patients known to be human immunodeficiency virus seropositive and have a CD4 count <200 cells/μL - History of venous thromboembolism - Current serious mental illness that, in the judgment of the Investigator, may compromise patient safety, ability to participate in all study assessments, or study integrity - Clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, renal, neurological, inflammatory, or other diseases that, in the judgment of the Investigator, precludes study participation ; PRIMARY OUTCOME: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation; SECONDARY OUTCOME 1: Annualized bleed rate (ABR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SOLUTION (Anthera); BRIEF: Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI). Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating. ; DRUG USED: Sollpura; DRUG CLASS: Biologic; INDICATION: Exocrine Pancreatic Insufficiency; TARGET: Protein, fat, and/or carbohydrate absorption; THERAPY: Monotherapy; LEAD SPONSOR: Anthera Pharmaceuticals; CRITERIA: Inclusion Criteria: - Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride - Fecal elastase <100 mcg/g stool - Minimum Coefficient of Fat (CFA) at screening while on stable PERT therapy - Good nutritional status Exclusion Criteria: - History or diagnosis of fibrosing colonopathy - Distal intestinal obstruction syndrome in 6 months prior to screening - Receiving enteral tube feedings - Chronic diarrheal illness unrelated to pancreatic insufficiency - Liver abnormalities, or liver or lung transplant, or significant bowel resection - Forced expiratory volume in 1 second (FEV1) <30% ; PRIMARY OUTCOME: Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline; SECONDARY OUTCOME 1: Coefficient of Fat Absorption (CFA)[/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 - JGDG (w/Doxorubicin); BRIEF: The main purpose of this study is to gather information about the use of an investigational drug called olaratumab with a drug for soft tissue sarcoma called doxorubicin. ; DRUG USED: Lartruvo; DRUG CLASS: Biologic; INDICATION: Sarcoma; TARGET: Platelet-derived growth factor receptor (PDGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - The participant has histologically- or cytologically-confirmed malignant soft tissue sarcoma - The participant has advanced soft tissue sarcoma (STS), not amenable to treatment with surgery or radiotherapy - The participants Eastern Cooperative Oncology Group (ECOG) performance status is 0-2 - The participant has available tumor tissue from either the primary or metastatic tumor for determination of PDGFRα expression - The participant has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500 μL, hemoglobin ≥ 9.0 g/dL, and a platelet count of 100,000/μL obtained within 2 weeks prior to study entry - The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN) - The participant has adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the participants creatinine clearance is ≥ 45 mL/min - Because the teratogenicity of Olaratumab is not known, women of childbearing potential (WOCBP) and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation Exclusion Criteria: - The participant has histologically- or cytologically-confirmed Kaposis sarcoma - The participant has untreated central nervous system metastases - The participant received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (ie, mitoxantrone) - The participant received prior radiation therapy to the mediastinal/pericardial area - The participant has a history of another primary cancer, with the exception of a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry - The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent - The participant has an elective or a planned major surgery to be performed during the course of the study - The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry - The participant has known immunodeficiency virus (HIV) infection - The participant, if female, is pregnant or lactating - The participant has a known allergy to any of the treatment components ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Number of Participants With AEs and SAEs for Phase 2 Portion[/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 - PS0018 (Ext.); BRIEF: This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab. ; DRUG USED: Bimekizumab; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma SRL; CRITERIA: Inclusion Criteria: - Subject must have completed all dosing requirements in PS0016 without meeting any withdrawal criteria - Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives) Exclusion Criteria: - Subjects previously participating in this study - Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subjects ability to participate in this study. Note: For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including herpes zoster or hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the subjects entry into PS0018 - Subject has any current sign or symptom that may indicate a medically significant infection - Subject has current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if treatment has been completed. - Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded from participating in the open-label extension study (PS0018) ; PRIMARY OUTCOME: Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment; SECONDARY OUTCOME 1: Plasma Concentration of Bimekizumab During the Study[/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 - TEASE; BRIEF: The purpose of this study is to determine the long term safety and tolerability of ALK-001 (C20-D3-retinyl acetate), and to explore the effects of ALK-001 on the progression of Stargardt disease in patients between the ages of 8 and 70 years old. Funding Source - FDA OOPD ; DRUG USED: ALK-001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stargardt Disease (Ophthalmology); TARGET: Vitamin A; THERAPY: Monotherapy; LEAD SPONSOR: Alkeus Pharmaceuticals, Inc.; CRITERIA: Simplified Inclusion Criteria: - Male or female between 8 and 70 years old (inclusive), with any visual acuity - Has a clinical diagnosis of typical autosomal recessive Stargardt macular dystrophy (STGD1) - Has provided a genetic report indicating at least two ABCA4 disease-causing mutations. When only one ABCA4 disease-causing mutation is reported, sponsors permission will be required. - At least one eye (called the primary study eye) must have at least one well-demarcated area of significantly reduced autofluorescence as imaged by fundus autofluorescence (FAF), have decreased retinal sensitivity as measured by microperimetry, or have maculopathy expected to progress over the duration of the study - Primary study eye must have clear ocular media and adequate pupillary dilation, including no allergy to dilating eyedrops, to permit good quality retinal imaging - Healthy as judged by investigator - Able and willing to comply with study requirements, restrictions and instructions and is likely to complete the 24-month study - Has signed and dated the informed consent forms (or assent where appropriate) to participate - Female of childbearing potential has signed the informed consent about birth defects or attestation on contraception requirements Main Exclusion Criteria: - Has taken disallowed items (supplement containing vitamin A or beta-carotene, liver-based products, or prescription oral retinoid medications) over the past 30 days - Is lactating, pregnant, or has a positive serum or urine pregnancy test at screening or at randomization - Has concurrent medical condition or history, which in the opinion of the investigator, is likely to prevent compliance with the protocol and/or interfere with absorption of ALK-001 or study procedures - Has clinically significant abnormal laboratory result(s) at screening - Has active or historical acute or chronic liver disorder - Has active or historical ocular disorder in the primary study eye that, in the opinion of the investigator, may confound assessment of the retina morphologically or functionally (this could include for example cataract surgery within the past 6 months, choroidal neovascularization (CNV), glaucoma, recurring uveitis, diabetic retinopathy, other retinal disease, etc.) - Has had intraocular surgery or injections in the primary study eye within 90 days of the screening visit - Has a clinically significant abnormal electrocardiogram (ECG), or has a corrected QT interval (QTc) that is 450 ms or greater ; PRIMARY OUTCOME: Safety and tolerability of 24 months of daily dosing of ALK-001 assessed by Incidence and/or clinically significant changes of a combination of ocular and non-ocular adverse events; SECONDARY OUTCOME 1: Effects of ALK-001 on the progression of Stargardt 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 I/II - SCRX001-006; BRIEF: The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors. ; DRUG USED: Rova-T; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Antibody-drug Conjugate (ADC), Delta-like 3 (DLL3), DNA synthesis; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy - Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator. - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Delta-like protein 3 (DLL3)-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Minimum life expectancy of at least 12 weeks - Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only) - Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration - Adequate hematologic and organ function as confirmed by laboratory values - Last dose of any prior therapy administered by the following time intervals before the first dose of study drug: 1. Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks. 2. Immune-checkpoint inhibitors (e.g., anti-programmed death protein 1 [PD-1], anti-programmed death-ligand 1 [PD-L1], or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression). - Females of childbearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Exclusion Criteria: - Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months). - Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug. - Recent or ongoing serious infection, including: 1. Any active grade 3 or higher (per National Cancer Institute Common Terminology Criteria for Adverse Events version [NCI CTCAE] 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted. 2. Known seropositivity for or active infection by human immunodeficiency virus (HIV). 3. Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug. - Women who are pregnant or breastfeeding - Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug - History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on pap smear. - Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol ; PRIMARY OUTCOME: Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups; SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Raised IOP; BRIEF: The purpose of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP). ; DRUG USED: AZD4017; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: 11ß-HSD1 (11 beta-hydroxysteroid dehydrogenase); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open-angle glaucoma (POAG), with IOP >20 mmHg and ≤36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit; OR - Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP ≥22 mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication - Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP - Placebo treatment for duration of the study must not be considered detrimental to the patient Exclusion Criteria: - Have uncontrolled intra-ocular hypertension (>36 mmHg) - Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by >1 dB/yr average loss or vision threatening new defect) - Have had severe eye trauma at any time ; PRIMARY OUTCOME: Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment; SECONDARY OUTCOME 1: Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - FUSCIA; BRIEF: Primary Objective: To assess the efficacy of SAR339658 Secondary Objective: To assess the safety of SAR339658 ; DRUG USED: Vatelizumab; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: Integrin Alpha 2 beta 1/VLA-2; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Male or Female ≥18 and ≤70 years old - History of active ulcerative colitis of at least 3 months duration - Active UC should be confirmed by colonoscopy or flexible sigmoidoscopy during the screening period within 7 days prior to randomization. - Moderate to severe ulcerative colitis at time of screening, confirmed by Mayo score ≥6 to 12 and endoscopy subscore of ≥2 despite treatment with immunosuppressants and/or anti-tumor necrosis factors (TNFs): - Immunosuppressants: Patient must be on concurrent treatment with or have had an inadequate response to (did not respond to or lost response to) or be intolerant to immunosuppressants such as azathioprine, 6-mercaptopurine, or methotrexate. - AND/OR - TNF-alpha antagonists: Patient must have had an inadequate response or lost response or be intolerant to TNF-alpha antagonists - Fecal calprotectin ≥200mg/kg - Patients on corticosteroids must be on a stable dose ≥2 weeks prior to screening - Patients on azathioprine, 6- mercaptopurine or methotrexate must be on treatment for at least 12 weeks prior to screening; and on a stable dose ≥4 weeks prior to screening - Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥4 weeks prior to screening - Patients naïve to anti-TNF alpha or non-responder (primary or secondary) or intolerant to anti-TNF alpha - Signed written informed consent Exclusion criteria: - Patients with Crohns Disease - Diagnosis of indeterminate colitis - Patients with stool sample positive for ova, parasites, or positive culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E. Coli spp. or positive for Clostridium difficile B toxin in stools. - Patients with prior colectomy or anticipated colectomy during their participation in the study - Presence of ileal pouch or ostomy - Fulminant disease or toxic megacolon - Colonic dysplasia except for adenoma - Total Parenteral Nutrition - Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus within 2 months prior to screening - Previous exposure to natalizumab (Tysabri®) or vedolizumab - Antidiarrheals within 2 weeks prior to screening - Prednisone >40 mg/day (or equivalent) - Budesonide >9 mg/day - Received intravenous corticosteroids within 2 weeks prior to screening or during screening - Rectally administered topical 5-aminosalicylate or corticosteroids within 4 weeks prior to screening - Received therapeutic enema or suppository, other than required for colonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or during screening - Antibiotics for ulcerative colitis or gastrointestinal infection within 4 weeks prior to screening - Patient who has previously participated in any clinical trial of GBR500 / SAR339658 - Patient who has taken other investigational medications within 2 months or 5 half lives, (whichever is longer) prior to screening - Use of any biologics for the treatment of ulcerative colitis in the previous 8 weeks before screening - Requirement for concomitant treatment that could bias primary evaluation - Pregnant or breast-feeding women - Women of childbearing potential not protected by highly effective contraceptive method of birth control - Patient with latent or active tuberculosis (TB) defined as: - Any signs or symptoms suggestive of active TB upon medical history or clinical examination - Patients with a positive QuantiFERON TB Gold Test - Chest radiograph within 3 months prior to the inclusion visit consistent with prior tuberculosis infection including, but not limited to, apical scarring, apical fibrosis, or multiple calcified granulomasa. This does not include non-caseating granulomasa - Patients with close contact with a person with active tuberculosis - Patient with a history of listeriosis or tuberculosis (unless it is documented that they were adequately treated) - Administration of any live (attenuated) vaccine within 3 months prior to the screening Visit (eg, varicella-zoster vaccine, oral polio, rabies) - Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit - Prior opportunistic infections within 6 months prior to screening or while receiving anti-TNF treatment - History of a hypersensitivity reaction, other than localized injection site reaction, to any biological molecule - History or any current signs of demyelinating disease or any neurological disease that can by the opinion of Investigator interfere with study safety assessments including assessment for progressive multifocal leukoencephalopathy - Patients with bleeding disorders or known platelet dysfunction The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Proportion of Participants with Clinical Response by Mayo Score; SECONDARY OUTCOME 1: Proportion of Participants with Clinical Remission by Mayo Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SAPHIRA 1; BRIEF: 32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting of three consecutive treatment periods: two 1-week periods followed by one 2-week period, evaluating one dose of GLPG1837 each. After the treatment period, there is a 7-10 days follow-up period. During the course of the study, subjects will be examined for any side effects that may occur (safety and tolerability). Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837 present in the blood (pharmacokinetics) will also be determined. ; DRUG USED: GLPG1837; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Male or female subjects ≥ 18 years of age, with a confirmed diagnosis of cystic fibrosis - Subjects with gating G551D CFTR mutation on at least one allele in the CFTR gene - Subjects currently receiving treatment with ivacaftor on a stable regimen or not on a treatment regimen with ivacaftor, for at least 2 weeks prior to screening - Weight ≥ 40.0 kg - Subjects on stable concomitant treatment regimen for at least 4 weeks prior to baseline (excluding ivacaftor) - Pre- or post-bronchodilator FEV1 ≥ 40% of predicted normal - Subject will have to use highly effective contraceptive methods Exclusion Criteria: - On an ivacaftor-containing treatment regimen and unable or unwilling to discontinue ivacaftor for the washout and treatment periods of the study - Concomitant use of antifungal drugs within 4 weeks of baseline - A history of a clinically meaningful unstable or uncontrolled chronic disease - Liver cirrhosis and portal hypertension - Any significant change in the medical regimen for pulmonary health within 4 weeks of baseline - Unstable pulmonary status or respiratory tract infection or changes in therapy for pulmonary disease within 4 weeks of baseline - Abnormal liver function - Clinically significant abnormalities on ECG - History of malignancy, solid organ/haematological transplantation - Abnormal renal function - Participation in another experimental therapy study within 30 days or 5 times halflife ; PRIMARY OUTCOME: Changes in adverse events; SECONDARY OUTCOME 1: Changes in sweat chloride concentration[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DOUBle (Blepharitis); BRIEF: The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis. ; DRUG USED: AzaSite Plus; DRUG CLASS: Non-NME; INDICATION: Other Ophthalmological Indications (Ophthalmology); TARGET: Bacterial ribosome, Glucocorticoid Receptor (GR), Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Sun Pharmaceutical Industries Limited; CRITERIA: Inclusion Criteria: - Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race. - Signature of the subject or legally authorized representative on the Informed Consent Form. - Are willing and able to follow all instructions and attend all study visits. - Are willing to avoid disallowed medication for the duration of the study. - If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months. - Additional inclusion criteria also apply. Exclusion Criteria: - Have known sensitivity or poor tolerance to any component of the Investigational Drug. - Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye. - Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters. - Have used any non-diagnostic topical ophthalmic solutions in the study eye. - Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test. - Currently suffer from alcohol and/or drug abuse. - Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device. - Have a condition or a situation which, in the Investigators opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subjects study participation. - Additional exclusion criteria also apply. ; PRIMARY OUTCOME: Clinical Resolution; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Oral Metformin; BRIEF: A phase 2, multicenter study to evaluate the efficacy and safety of twelve once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin mono therapy. ; DRUG USED: PB-119; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: PegBio Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Patients in whom T2DM has been diagnosed according to 2018 American Diabetes Association T2DM diagnostic criteria, have made lifestyle modifications (ie, diet and exercise) for at least 3 months prior to Screening, and have been taking metformin for at least 3 months before Screening with a stable dosage for at least 8 weeks (stable dosage is defined as metformin dosage ≥1500 mg/day or maximum tolerated dose). 2. Males and/or females between the ages of ≥18 and ≤70 years at Screening 3. HbA1c ≥7.5% and ≤11% at Screening and at Week -1, Visit 3.1; 4. FPG ≥126 and ≤240 mg/dL (≥7.0 and ≤13.3 mmol/L) at Screening and at Week -1, Visit 3.1; 5. Body mass index (BMI) ≥18.5 and ≤40.0 kg/m2 at Screening, with inclusion of patients with BMIs at the lower end of the range enrolled into the study to enable comparisons across BMI range; Exclusion Criteria: 1. Medical history or current diagnosis of: 1. Type 1 diabetes mellitus, diabetes caused by pancreas injury or by other diseases (like acromegaly or Cushing syndrome); 2. Diabetes acute complication, like ketoacidosis or hyperosmolar coma; 3. Diagnosed proliferative retinopathy; 4. 3 instances of severe hypoglycemia (events during which the patient required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions; episodes may be associated with sufficient neuroglycopenia to have induced seizure or coma) in the 6 months prior to Screening; 5. Significant vascular disease; 2. Current/ongoing diagnosis of any type of malignant tumor or evidence of recurrence in the 6 months prior to Screening (patients who have been stable for ≥6 months or those who have had basal or squamous cell skin cancers removed and have no evidence of recurrence will not be excluded). Patients with a medical history of any other type of cancer in the last 5 years prior to Screening will be excluded; 3. Severe cardiovascular diseases occurring within 6 months prior to Screening (eg, congestive heart disease, myocardial infarction, acute coronary syndrome, apoplexy, transient ischemic attack); ; PRIMARY OUTCOME: The change from baseline value of HbA1c will be compared between treatments; SECONDARY OUTCOME 1: The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AIR-BX2; BRIEF: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days. ; DRUG USED: Cayston; DRUG CLASS: Non-NME; INDICATION: Bronchiectasis; TARGET: Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Male/Female 18 years or older with non-CF bronchiectasis - Chronic sputum production on most days - Positive sputum culture for gram-negative organisms - Must have met lung function requirements Exclusion Criteria: - History of CF - Hospitalized within 14 days prior to joining the study - Previous exposure to AZLI - Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study - Must have met liver and kidney function requirements - Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed) - Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment - Other serious medical conditions. ; PRIMARY OUTCOME: Change in QOL-B Respiratory Symptoms Score at Day 28; SECONDARY OUTCOME 1: Change in QOL-B Respiratory Symptoms Score at Day 84[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Levofloxacin; BRIEF: A double-blind, three-arm study, to evaluate the safety and efficacy of two dosing regimens of zabofloxacin (a fluoroquinolone antibiotic) in community acquired pneumonia. ; DRUG USED: Zabofloxacin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Topoisomerase II (DNA gyrase) and IV; THERAPY: Monotherapy; LEAD SPONSOR: IASO Pharma Inc.; CRITERIA: Inclusion Criteria: - Male or female >/= 18 years old - Documented fever (oral >100°F (37.8°C), tympanic >101°F (38.1°C)must be documented within the time frame of 24 hours prior to first dose through 24 hours after first dose of study drug - Community-acquired pneumonia of moderate severity (defined as PSI Risk Class II or III) requiring administration of antibiotics - Dyspnea and/or tachypnea (>20 breaths/minute) - Clinical diagnosis of pneumonia, as demonstrated by all of the following signs and symptoms: 1. new or increased cough 2. production of purulent sputum or a change in the character of sputum in subjects who normally have purulent sputum 3. auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (e.g., bronchial breath sounds, egophony, or dullness on percussion) - Females must be surgically sterile (e.g., tubal ligation, hysterectomy), post-menopausal at least 2 years, or if of childbearing potential, they must have a negative urine pregnancy test (β-human chorionic gonadotropin [β-hCG]) prior to randomization into the study. Males and females must agree that if they have intercourse that they will use at least two medically accepted methods of birth control (e.g., hormonal contraceptive, intrauterine device, spermicide, or condom) from study entry through 60 days after discontinuation of study drug treatment - Able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Committee and comply with the requirements of the study Exclusion Criteria: Subjects must NOT meet any of the following exclusion criteria: - Received one or more doses of any systemic antibiotic in the last 2 weeks - Diagnosed with any other infection requiring systemic antibacterial therapy - Require long-term (>7 days) antibiotic therapy - Previous diagnosed condition that might mimic or complicate the course and evaluation of the infectious disease process (e.g., septic shock, bronchiectasis, lung abcess or empyema, aspiration pneumonia, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia, etc.) - Hypothermia (oral <96°F [35.6°C}, tympanic <97°F [35.9°C] - Hospitalization (inpatient) in the previous 60 days or infection presumably acquired in the hospital - Resident of a skilled nursing facility anytime in the previous 60 days or infection presumably acquired in a skilled nursing facility - Chronic infection with Hepatitis B - Any evidence of, or is a known carrier of , Hepatitis C antibody - Infection with Clostridium difficile - Immunocompromising illness, including known human immunodeficiency virus (HIV) positivity or AIDS, organ (bone marrow) transplant recipients, and hematological malignancy - Psychotic disease, peripheral neuropathy, and glucose-6-phosphate dehydrogenase deficiency; uncontrolled or poorly controlled diabetes. Diabetic subjects who are stable and on a stable course of antihyperglycemic agents for the past 3 months will be permitted in the trial. - High exposure to sunlight or ultraviolet radiation - Immunosuppressive therapy, including cancer chemotherapy or chronic use of corticosteroids (i.e., >20mg prednisone or equivalent per day for >/= 14 days within the last 6 months - History of renal or hepatic disease as defined by at least one of the following: 1. Calculated creatinine clearance <50 mL/min (any subject on dialysis must be excluded) 2. BUN >/= 30 mg/dL 3. ALT or AST > 3x ULN 4. Total bilirubin > 2x ULN 5. Alkaline phosphatase > 1.25x ULN - History of or current malabsorption conditions (i.e., short bowel syndrome, active Crohns disease, celiac disease, etc.) - Neutropenia as defined by absolute neutrophil count <1000 cells/mm3. Subjects with neutrophil counts as low as 500 cells/mm3 are permitted if the reduction can be documented to be due to the acute infectious process - Platelet count <75,000/mm3. Subjects with platelet counts as low as 50,000/mm3 are permitted if the reduction is historically stable - Coagulation tests >1.5x ULN (PT, PTT, or INR). Subjects on anticoagulants with values > 1.5x ULN can be enrolled, provided these values are historically stable and within the therapeutic range - History of alcohol or drug abuse in the past 2 years - History of seizure or currently receiving anti-seizure medication anytime in the past year, or a seizure in the past year - History of ventricular arrhythmia - History of QTc prolongation (i.e., >450msec) or observed QTc measurement at screening > 450msec, or a history of additional risk factors for Torsade de Pointe, such as heart failure, hypokalemia, or familial history of Long QT syndrome - Require medications that may prolong the QTc interval - Require medications that affect absorption, including but not limited to sucralfate or cimetidine - Require treatment with theophylline, probenecid, vitamin K antagonists (other than warfarin; subjects must be on stable dose of warfarin and within therapeutic range) - Pregnant, planning to become pregnant, or breast feeding - Received any investigational drug or device within 30 days prior to study entry - Previously received zabofloxacin in a clinical trial - History of allergy or intolerability to fluoroquinolones - History of fluoroquinolone tendinopathy - Evidence of immediately life-threatening disease including, but not limited to current or impending respiratory failure, acute heart failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive emergency, acute hepatic failure, active gastrointestinal bleeding, profound metabolic abnormalities (e.g., diabetic ketoacidosis), or acute cerebrovascular events - Current condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data - Unable or unwilling to adhere to sthe study specified procedures and restrictions ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Efficacy of the two dosing regimens of zabofloxacin[/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 - VIOLET; BRIEF: To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment) ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Macular Edema from Retinal Vein Occlusion (RVO) (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: The subjects history of aflibercept treatment met all of the following: - Treatment in the study eye was initiated with five monthly (-1 week /+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed and documented. - Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks (one exception was allowed). - The interval between the last 2 pre-study injections was ≥ 8 weeks, and visual and anatomic outcomes had been stable over this interval. - The subject received the last intravitreal (IVT) injection of aflibercept in the study eye 8 weeks (±10 days) before the first planned treatment /randomization in this study. - Total prior treatment duration with aflibercept (i.e. from first aflibercept treatment ever to enrollment into this study) was 1 year or longer. To be met at initiation of pre-study aflibercept treatment: - Type 1 or 2 diabetes mellitus (DM) - Diagnosis of diabetic macular edema (DME) secondary to DM involving the center of the macula (defined as the area of the center subfield on optical coherence tomography [OCT]) in the study eye - Decrease in vision determined to be primarily the result of DME in the study eye - Best corrected visual acuity (BCVA) in the study eye of Early Treatment Diabetic Retinopathy Study (ETDRS) letter score 73 to 24 Exclusion Criteria: At initiation of pre-study aflibercept treatment: - Previous treatment with anti-angiogenic drugs in study eye (e.g., pegaptanib sodium, bevacizumab, ranibizumab, or aflibercept) within the last 12 weeks before initiation of aflibercept pre-study treatment At initiation of pre-study aflibercept treatment, screening for this study, and baseline for this study: - Prior treatment of the study eye with long acting steroids, either periocular or intraocular, in the preceding 120 days or Iluvien intravitreal implant at any time - Active proliferative diabetic retinopathy, current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye - Cataract surgery or any other intraocular surgery within 90 days of aflibercept treatment in the study eye - Ocular inflammation (including trace or above) or history of uveitis in the study eye - Structural damage to the center of the macula in the study eye that was likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates - Concurrent disease in the study eye, other than DME, that could compromise visual acuity, require medical or surgical intervention during the study period, or could confound interpretation of the results (including advanced glaucoma, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause) - Uncontrolled DM as defined by hemoglobin (Hb) A1c > 12.0% at screening and baseline for this study - Any ocular or periocular infection in the preceding 4 weeks in either eye - History of either cerebral vascular accident and/or myocardial infarction within 180 days before aflibercept treatment ; PRIMARY OUTCOME: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52; SECONDARY OUTCOME 1: Mean Change From Baseline in Central Retinal Thickness (CRT) at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MARS; BRIEF: To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular rosacea. ; DRUG USED: HY01; DRUG CLASS: Non-NME; INDICATION: Rosacea; TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Hovione Scientia Limited; CRITERIA: Inclusion Criteria: - Subjects who had provided written informed consent to participate in the study. - Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of moderate to severe facial rosacea, defined as the presence of: i. At least twelve and not more than forty inflammatory facial lesions (i.e., papules/pustules), AND ii. Subjects with a grade 3 or 4 on the 5-point Investigators Global Assessment (IGA) scale, AND iii. Persistent facial erythema (scored as at least mild on Erythema Severity Scale), AND iv. Facial telangiectasia (scored as at least mild on Telangiectasia Severity Scale. - Subject willing to minimize external factors that might trigger rosacea flare-ups as recommended per protocol and patient instructional guide (e.g., spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds and alcoholic beverages). - Non-nursing, female subjects of child bearing potential, who are using an acceptable form of birth control: total abstinence, oral (birth control pills), intravaginal: (e.g. NuvaRing®), implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD); double-barrier (diaphragm or condom with spermicidal gel or foam); for two months prior to study enrollment or a vasectomized partner. All female subjects of child bearing potential must have undergone an in-office urine pregnancy test, with a negative result, prior to being randomized to receive study drug. In addition, women of childbearing potential must have agreed to a have urine pregnancy test at Day 42 and at the end of the study (Day 84). Females not of childbearing potential due to menopause must have been postmenopausal for at least one year. Male subjects must be willing to not attempt to conceive a child during the participation in the study. Females utilizing oral contraception must be willing to utilize an appropriate secondary form of contraception during the study. - Subjects who use the same brand of soap, make-up, hair products, or shaving lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit and agree not to change these product brand/types during the study, with the exception of using the study approved cleanser and moisturizer with sunscreen provided by the sponsor. - Male subjects who are willing to shave, if applicable, at approximately the same time every day. - Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or excessive exposure to the sun for the duration of the study. Exclusion Criteria: - Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea as determined by the Investigator. - Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea. Patients also must not grow excess facial hair during the study (i.e. they need to be free of excess facial hair for follow-up visits). - History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation, or known reactions to cleansers, including Ponds Cold Cream, and moisturizer with sunscreen. - Subjects using, or planning use of concomitant treatments within 30 days prior to Baseline visit (e.g., facial or chemical peels, dermal fillers, acne surgery, intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray, IPL, laser therapy or UV therapy). - Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoin, acitretin) or therapeutic vitamin A supplements of greater than 10,000 International Units/day (multivitamins are allowed). - Subjects using estrogens or progestin agents (e.g., Gynogen, Valergen, Depo-Testadiol, Depogen, birth control pills), for less than 2 months prior to the Baseline Visit. (Subjects using estrogens for 2 months or more are not excluded unless the subject expected to change dose, drug, or discontinue estrogen use during the study). - Use within 2 month prior to the Baseline Visit of 1) topical retinoids to the face, 2) systemic antibiotics known to have an impact on the severity of facial rosacea (e.g., containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim, metronidazole), or 3) systemic corticosteroids. - Use within 2 months prior to the Baseline Visit of 1) topical corticosteroids, 2) topical antibiotics or 3) topical medications for rosacea (e.g., metronidazole, azelaic acid, erythromycin, ivermectin, sulfur based topical products). - Subjects with rhinophyma, dense telangiectasia, or plaque-like facial edema, more than 5 nodules or sinus tracts. - Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics. - Subjects with underlying diseases or other dermatological conditions, such as; atopic dermatitis, perioral dermatitis, or seborrheic dermatitis, which required the use of interfering topical or systemic therapy or may have interfered with the rosacea diagnosis. - Subjects using an investigational drug or participating in an investigational study within 30 days of the Baseline Visit. Use of an investigational drug and/or participation in another investigational study prohibited during this study. - Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse with in the past year. - Medical history of immunodeficiency or other significant ongoing medical condition or disease as determined by the investigator. ; PRIMARY OUTCOME: Change in Lesion Count; SECONDARY OUTCOME 1: Investigators Global Assessment (IGA) Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMbrave251; BRIEF: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients. - Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease (SD), partial response (PR), or complete response (CR). - At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1. - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization - Child-Pugh class A within 7 days prior to randomization - Adequate hematologic and end-organ function Exclusion Criteria: - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. - History of leptomeningeal disease - History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death ; 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 III - ENDURE (Quiescent Uveitis); BRIEF: This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Uveitis (Ophthalmology); TARGET: IL-17 (Interleukin 17); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with quiescent chronic, non-infectious intermediate uveitis, posterior uveitis or panuveitis as evidenced by <1+ anterior chamber cell grade and <1+ vitreous haze in both eyes for at least 6 weeks prior to screening. - Requirement for either of the following immunosuppressive therapies at any time within the past 3 months for the treatment or prevention of uveitis which must not have been increased within the 6 weeks prior to screening: Prednisone or equivalent ≥10 mg daily. ≥1 periocular injection or ≥1 intravitreal corticosteroid injection (i.e. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening.) Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate as monotherapy or in combination with or without steroids. (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study.) Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator. Exclusion Criteria: Ocular concomitant conditions/disease - Patients with a primary diagnosis of Behcets disease, anterior uveitis or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white dot retino-choroidopathies (i.e. Punctate inner choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR.) - Patients with active, non-infectious intermediate, posterior or panuveitis in one or both eyes (≥1+ anterior chamber cells and /or ≥1+ vitreous haze.) - Patients receiving or that may require corticosteroids (prednisone or equivalent) ≥1 mg/kg/day to maintain quiescence of their intraocular inflammation. Ocular treatments - Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening. - Treatment with fluocinolone acetonide implant (Retisert®) in the study eye within the last 3 years, or dexamethasone intravitreal implant and any other investigational corticosteroid implants in the study eye within the last 6 months. - Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle. Systemic conditions or treatments - Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening. No biologic therapy other than the investigational study treatment will be allowed during the course of the clinical trial. - Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening. - Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster or measles) within 2 months prior to screening. No treatment with live or live-attenuated vaccines will be allowed during the course of the clinical trial. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline; SECONDARY OUTCOME 1: Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Placebo - Young Adults; BRIEF: This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated. ; DRUG USED: Trumenba; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: 1. Male or female subject aged >=18 and <26 years at the time of enrollment. 2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. 3. Negative urine pregnancy test for all female subjects. Exclusion Criteria: 1. Previous vaccination with any meningococcal serogroup B vaccine. 2. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination. 3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 4. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study. 5. Significant neurological disorder or history of seizure (excluding simple febrile seizure). 6. Current chronic use of systemic antibiotics. 7. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination. 8. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. ; PRIMARY OUTCOME: Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1; SECONDARY OUTCOME 1: Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 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 - Dose Finding; BRIEF: The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults. Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times. ; DRUG USED: SHP654; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII; THERAPY: Monotherapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: Inclusion Criteria: - Male, aged 18 to 75 years at the time of screening. - Established severe hemophilia A (FVIII:C <1%, measured following >=5 days without FVIII treatment) and/or documented intron 1 inversion or intron 22 inversion mutation in the F8 gene, consistent with severe hemophilia A , and documented evidence of >=3 hemorrhages over the previous 12 months requiring treatment with exogenous FVIII or use of FVIII prophylaxis because of history of frequent bleeding episodes. - History of greater than (>) 150 exposure days to exogenously administered FVIII concentrates or cryoprecipitate. - Sexually active men must agree to use barrier contraception (combination of a condom and spermicide) or limit sexual intercourse to post-menopausal, surgically sterilized, or contraception-practicing partners for a minimum of 6 months after administration of BAX 888, or until BAX 888 genomes are no longer detected in the semen, whichever is sooner. - Participant is willing and able to comply with the requirements of the protocol, including provision of semen samples, maintenance of a diary of bleeding episodes and FVIII protein use. - Signed informed consent. Exclusion Criteria: - Bleeding disorder(s) other than hemophilia A. - Personal laboratory evidence of having developed inhibitors to FVIII protein at any time (>=0.6 Bethesda units [BU] on any single test). - Documented prior allergic reaction to any FVIII product. - Anti-Adeno-associated virus, serotype 8 (AAV8) neutralizing antibody titer >=1:5. Participants whose laboratory assessments are less than or equal to (<=) 1:10 may be re-tested within the same screening window and, if eligibility criterion is met on retest, may be enrolled after confirmation by the Sponsor Medical Monitor. - Known hypersensitivity to prednisolone or prednisone, or to any of the excipients. - Having a disease in which treatment with prednisolone or prednisone is not tolerated (including but not limited to osteoporosis with vertebral fractures, difficult to control hypertension, and difficult to control diabetes). - Evidence of markers of potential underlying risk for autoimmune mediated hepatic disease: - Anti-smooth muscle antibody assay results >=40 (Inova QUANTA LiteTM Actin IgG enzyme-linked immunosorbent assay [ELISA]); values of 31 to 39 will be flagged as possibly abnormal and the Investigator and Medical Monitor will evaluate the participant for eligibility. - Elevated anti-liver-kidney microsomal antibody type 1 (LKM1) titers. - Total immunoglobulin G (IgG) >1.5*upper limit of normal (ULN). - Antinuclear antibody (ANA) titer >1:320; OR ANA titer >1:80 if demonstrated concurrently with alanine aminotransferase (ALT) that is >ULN. - Active Hepatitis virus (Hepatitis C): As indicated by detectable hepatitis C virus (HCV) ribonucleic acid (RNA) by polymerase chain reaction (PCR). - Hepatitis B: If surface antigen is positive. - Seropositive for Human Immunodeficiency Virus (HIV). - Receiving systemic antiviral and/or interferon therapy within 4 weeks prior to enrollment. - Clinically significant infections (e.g. systemic fungal infections) requiring systemic treatment. - Known immune disorder (including myeloma and lymphoma). - Concurrent chemotherapy or biological therapy for treatment of neoplastic disease or other disorders. - An absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3). - Markers of hepatic inflammation or cirrhosis as evidenced by 1 or more of the following: - Platelet count of <150,000/microliter (mcL). - Serum albumin level is below the central laboratorys lower limit of normal and FibroSURE is >=0.48 (i.e., Metavir staging of F2 or greater). Of note, in participants with a known history of Gilberts syndrome, a Fibrotest cannot be used for fibrosis testing. - Total bilirubin >1.5*ULN and direct bilirubin >=0.5 milligram per deciliter (mg/dL). - ALT or aspartate aminotransferase (AST) >1.0*ULN. - Alkaline phosphatase (AP) >2.0*ULN. - History of liver biopsy indicating moderate or severe fibrosis (Metavir staging of F2 or greater). - History of ascites, varices, variceal hemorrhage, or hepatic encephalopathy. - Any findings on screening ultrasound that would preclude the safe use of AAV gene therapy. - Prothrombin time (PT) international normalized ratio (INR) >=1.4. - Serum creatinine >1.5 mg/dL. - Urine protein >30 mg/dL or >0.5 gram per day (g/day). - Body mass index >38. - Major surgery or an orthopedic surgical procedure planned within 6 months after enrollment. - Acute or chronic disease that, in the opinion of the investigator, would adversely affect participant safety or compliance or interpretation of study results. - Received an AAV vector previously or any other gene transfer agent in the previous 12 months prior to Study Day 0. - Received an investigational intervention or participated in another clinical trial within 4 weeks prior to enrollment or within 5 half-lives of the investigational drug administration, whichever is longer. - Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease). - Recent history of psychiatric illness or cognitive dysfunction (including drug or alcohol abuse) that in the opinion of the investigator, is likely to impair participants ability to comply with protocol mandated procedures. - Participant is a family member or employee of the investigator. ; PRIMARY OUTCOME: Number of Participants With BAX 888-Related Adverse Events (AEs); SECONDARY OUTCOME 1: Change from Baseline in Circulating Plasma FVIII Activity 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 IIa - Mucocutaneous Candidiasis (NIAID); BRIEF: This is an open-label, dose-titration trial to study the efficacy, safety, and pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous candidiasis infections in patients who are refractory or intolerant to standard non intravenous therapies. ; DRUG USED: MAT2203; DRUG CLASS: Non-NME; INDICATION: Fungal Infections - Systemic; TARGET: Cell Membrane, Sterols; THERAPY: Monotherapy; LEAD SPONSOR: Matinas BioPharma Nanotechnologies, Inc.; CRITERIA: Inclusion Criteria: - Patients must have a clinical diagnosis of at least one of the following: - Persistent OPC for greater than 2 weeks documented on at least one occasion by KOH or fungal stain and confirmed by mycological culture to be azole resistant within the previous 6 months and/or intolerance to standard non intravenous therapies. - EC associated with clinical symptoms of retrosternal pain, odynophagia, and/or pain with swallowing and documented by esophageal biopsy or visualization with culture documenting azole resistance within the previous 6 months and/or intolerance to standard non-intravenous therapies. - Persistent VVC for greater than 2 weeks as documented by presence of vaginal symptoms and a positive wet mount showing Candida structures and confirmed by a vaginal culture positive for Candida with azole resistance within the previous 6 months and/or intolerance to standard non intravenous therapies. - Patient is expected to survive for > = 6 months. - Willing to have samples stored for future research. - Agree to use highly effective contraception. - Contraception: Because the effects of CAMB on the developing human fetus are unknown, sexually active patients of childbearing potential must agree to use highly effective contraception as outlined below before study entry and for the duration of study participation. Females of childbearing potential must have a negative pregnancy test result before receiving CAMB. During the course of the study, if a patient becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately. Acceptable forms of contraception are: - Intrauterine device (IUD) or equivalent. - Hormonal contraceptives (eg, consistent, timely and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full efficacy prior to dosing). If the patient uses contraceptive pill, patch, or ring, then a barrier method (eg, male/female condom, cap, or diaphragm plus spermicide) must also be used at the time of potentially reproductive sexual activity. - Be in a stable, long-term monogamous relationship, per PI assessment, with a partner that does not pose any potential pregnancy risk, eg, has undergone a vasectomy at least 6 months prior to first dose of study agent or is of the same sex as the patient. - Have had a hysterectomy and/or a bilateral tubal ligation or both ovaries removed. Exclusion Criteria: - Allergy to any AMB product or any component of CAMB (eg, phosphatidylserine) - Have evidence of systemic fungal infections requiring intravenous antifungal therapy - Pregnant or nursing women, and women intending to become pregnant during the study period - Had a concomitant medical condition that could interfere with study drug evaluation or that is a contraindication to the proposed investigational treatment based upon known agent safety profile or toxicities. - Had any of the following laboratory abnormalities at the screening visit: - Alanine Transaminase (ALT), Aspartate Transaminase (AST) and Alkaline phosphatase (ALP) > 2.5 times the upper limit of normal (ULN). - Total bilirubin level > 2.5 times the ULN - Serum creatinine level > 2 times the ULN - Absolute neutrophil count less than 500 cells/microliter - Potassium level less than or equal to 3.5 mmol/L - Exposure to any investigational agent within 4 weeks prior to Day 0 (Baseline). - Current or recent history (past 12 months) of drug or alcohol abuse. - Use of intravenous AMB products within 1-week of start of study drug administration - Use of non-intravenous AMB products (such as oral AMB swishes) within 72 hours prior to start of study drug administration - Subjects receiving potassium supplements. - Any other condition the investigator believes would interfere with the patient s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk. ; PRIMARY OUTCOME: Symptoms of mucocutaneous candidiasis; SECONDARY OUTCOME 1: Area under the plasma concentration versus time curve (AUC)[/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 - DUNE; BRIEF: This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care. Standard of care will include debridement of the ulcer, standardized dressings and standardized off-loading using a Removable Cast Walker. ; DRUG USED: Nexagon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Foot and Other Ulcers; TARGET: Connexin / Connexon / Hemichannel; THERAPY: Monotherapy; LEAD SPONSOR: OcuNexus Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Diagnosis of diabetes mellitus (Type I or II) 2. HbA1c of less than or equal to 12.0% 3. Diagnosis of neuropathic foot ulcer with partial or complete neuropathy 4. Cutaneous ulcer on the plantar or dorsal aspect of the foot or toe that is greater or equal to 1.0cm2 and less than or equal to 8.0 cm2 in area at the end of the screening period and is full thickness with no exposed ligament, tendon, joint capsule or bone. Surface area will be measured by digital planimetry. 5. The Medical Monitor(or delegate)must confirm that the reference diabetic foot ulcer (RDFU)is suitable for inclusion after reviewing digital photographs 6. Wound bed consisting of completely viable tissue or one where completely viable tissue will be achieved by the end of the screening period. 7. An Ankle Branchial Index (ABI) of greater or equal to 0.80 in concert with a bi- or tri-phasic Doppler flow pattern; or adequate circulation as demonstrated by any of the following methods: peri-wound transcutaneous partial pressure oxygen (TcpO2)greater or equal to 40 mmHg; or a toe pressure of greater or equal to 40 mmHg; or skin perfusion pressure of greater or equal to 40 mmHg. 8. Ulcer present for 4 weeks or more or less than or equal to 12 months. 9. Willing to wear a Removable Cast Walker (RCW) between study visits for the duration of the study. 10. Signed informed consent form. Exclusion Criteria: 1. Any unstable medical condition that would cause the study to be detrimental to the subject. 2. Decrease in RDFU size by more than 40% or increase in the ulcer size by more than 40% during the 14-day screening period as measured by digital planimetry. 3. Ulcers caused primarily by untreated vascular insufficiency or ulcers with an etiology not related to diabetes.4. Ulcers above the ankle. 5. Ulcers that cannot be effectively off-loaded using the cast walker and sole insert provided in this study (ulcers not located on the weight bearing surface of the foot do not require off-loading). 6. Ulcers on the toes not accessible for photography (e.g. in the web space). 7. Presence of other ulcers within 2cm of the perimeter of the RDFU. 8. BMI > 45 9. Cannot tolerate or will not comply with the off-loading method, or non-compliance with standard or care. 10.The RDFU is infected (clinical assessment of infection)and/or biopsy proof of greater than 100,000 organisms per gram of tissue during the screening period. 11. Subjects presenting with the clinical characteristics of cellulitis at the ulcer site. 12. Necrosis, purulence, or sinus tracts that cannot be removed by debridement.13. Definite or suspected osteomyelitis within any wound located anywhere on the subjects body.14. Acute Charcots neuroarthropathy as determined by clinical and/or previous radiographic examination. 15. Severe Charcot deformity or rocker bottom foot with an associated plantar mid-foot or heel ulcer. 16. Revascularization surgery on the leg with the wound to be treated less than or equal to 4 weeks prior to the start of the screening period. 17. Requirement for concurrent topical antimicrobials to treat the RDFU after the end of the screening period. 18. Received dermal substitute or living skin equivalent (e.g. Dermagraft® or Apligraf®) within 14 days prior of the start of the screening period. 19. Severe complications of diabetes that in the opinion of the Investigator could interfere with wound healing or impede the subjects participation. 20. Subjects on concurrent immunosuppressive therapy to include oral corticosteroid therapy equivalent to greater than 5 mg/day of prednisone. 21. Any history of radiation therapy to the foot. 22. Female subjects who are pregnant or lactating. 23. Pre-menopausal women not using effective birth control methods as determined by the Investigator. 24. Life expectancy of < 12 months. 25. Subjects on renal replacement therapy. 26. Cancer within the last 3 years except basal and squamous cell carcinoma. 27. Cancer within the RDFU ; PRIMARY OUTCOME: Incidence of Reference Diabetic Foot Ulcer (RDFU) complete closure determined by Investigator Assessment; SECONDARY OUTCOME 1: Percentage change in RDFU surface area[/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/Avelumab; BRIEF: The study will consist of two parts : In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation. In the phase II part 1, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm of patients with recurrent or metastatic HPV-16 positive advanced malignancies. In the phase II part 2, evaluation of efficacy of the combination of TG4001 and avelumab will be performed in a randomized, open-label controlled study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV-16 positive advanced malignancies. In both phases, tumor response will be evaluated on local assessment using RECIST 1.1. All patients will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first. ; DRUG USED: TG4001; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Combination; LEAD SPONSOR: Transgene; CRITERIA: Inclusion Criteria: - Female or male patients, aged at least 18 years (no upper limit of age) - ECOG PS 0 or 1 - Life expectancy of at least 3 months - Patients with histologically or cytologically documented metastatic or refractory/recurrent HPV-16 + cancer: cervical, vulvar, vaginal, penile and anal. - Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression - Prior therapy: - No more than one prior systemic treatment for recurrent /metastatic disease - Prior treatment for recurrent or metastatic disease is not required for: - Patients with recurrence/progression within 6 months after completion of prior multimodal therapy for localized or locally advanced disease - Patients who are unsuitable for platinum-based therapy - Patients who refuse chemotherapy or other standard therapies for the treatment of metastatic or recurrent disease - Limited hepatic disease for patients with liver metastases at baseline - Availability of tumor tissue from biopsy - At least one measurable lesion by CT scan according to RECIST 1.1. - Adequate hematological, hepatic and renal function - Negative blood pregnancy test at screening for women of childbearing potential - Highly effective contraception for both male and female patients if the risk of conception exists during the study period and for 3 months after the last study treatment administration Exclusion Criteria: - Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints) - Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with the exception of patients with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to ≤ 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed - Patients with CNS metastases except those with brain metastases treated locally and clinically stable during 4 weeks prior to start of study treatment, and those without ongoing neurological symptoms that are related to the brain localization of the disease - Other active malignancy requiring concurrent systemic intervention - Patients with previous malignancies other than the target malignancy to be investigated in this trial (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period - Patient with any organ transplantation, including allogeneic stem cell transplantation - Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTC), any history of anaphylaxis, or uncontrolled asthma - Any known allergy or reaction to eggs, gentamycin or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products - Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients - Patients with known history or any evidence of active interstitial lung disease / pneumonitis - Patients with active, known, or suspected auto-immune disease or immunodeficiency, except type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment - Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication/active intervention, history of myocarditis - History of uncontrolled intercurrent illness including but not limited to: - Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or lower) - Uncontrolled diabetes (e.g., hemoglobin A1c ≥ 8%) - Uncontrolled infection ; PRIMARY OUTCOME: Phase Ib: To evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies; SECONDARY OUTCOME 1: Overall Response Rate (ORR) by using RECIST 1.1 (phase Ib, phase II 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 III - DAHANCA 19; BRIEF: The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck. ; DRUG USED: Zalutumumab; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Danish Head and Neck Cancer Group; CRITERIA: Inclusion Criteria: - Histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx) - Curative intent and no prior treatment - Age > 18 years - WHO performance 0-2 (incl.) - No prior treatment with EGFr-I - Informed consent according to local guidelines and national law - The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up - Fertile women must use contraceptive devices (IUD or oral contraceptives) Exclusion Criteria: - Rhinopharynx or carcinomas of unknown origin - Distal metastases - Other malignant diseases (prior or current) except from planocellular skin cancer ; PRIMARY OUTCOME: Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab; SECONDARY OUTCOME 1: Disease-specific survival and overall control Acute and late toxicity[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Healthy Adults; BRIEF: 2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial. Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2. Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at up to 40 sites across Australia and/or the United States. ; DRUG USED: NVX-CoV2373; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Novavax; CRITERIA: Inclusion Criteria (Part 1): - Healthy adult males or females between 18 and 59 years of age, inclusive, at screening. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. - The participant has a body mass index 17 to 35 kg/m2, inclusive, at screening. - Willing and able to give informed consent prior to study enrollment and comply with study procedures. - Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone (FSH) level ≥40 mIU/mL]) must agree to be heterosexually inactive from at least 21 days prior to enrollment and through 6 months after the last vaccination OR agree to consistently use any of the described methods of contraception from at least 21 days prior to enrollment and through 6 months after the last vaccination. Exclusion Criteria (Part 1): - Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care, inclusive of changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition. - Chronic disease inclusive of: a) hypertension uncontrolled for age according to the Eighth Joint National Committee (JNC 8) guidelines; b) congestive heart failure by New York Heart Association (NYHA) functional classification of greater or equal to II; c) chronic obstructive pulmonary disease by Global Initiative for Obstructive Lung Disease (GOLD) classification of greater or equal to 2; d) recent (within 6 months prior to first study vaccination) exacerbation of coronary artery disease as manifested by cardiac intervention, addition of new cardiac medications for control of symptoms, or unstable angina; e) asthma (diagnosed by spirometry showing reversibility of disease and must meet at least the Step 1 classification with current prescription/use of medications to control symptoms); f) diabetes requiring use of medicine (insulin or oral) or not controlled with diet. - Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. - History of a confirmed diagnosis of SARS or COVID-19 disease (confirmed by a specific test for each disease) or known exposure to a SARS-CoV-2 positive confirmed close contact (eg, family member, housemate, daycare provider, aged parent requiring care), at the discretion of the investigator. - Currently working in an occupation with a high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel). - Currently taking any product (investigational or off-label) for prevention of COVID-19 disease. - Positive rapid test for SARS-CoV-2 (either ELISA IgG or PCR) at screening or prior to first vaccination. Testing may be repeated during the screening period if exposure to SARS-CoV-2 is suspected, at the discretion of the investigator. - Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 4 weeks prior to first study vaccination. - Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital). - Chronic administration (defined as more than 14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 90 days prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. - Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination. - Any acute illness concurrent or within 14 days prior to first study vaccination (medical history and/or physical examination) or documented temperature of >38°C during this period. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (COVID-19) exposure (ie, cough, sore throat, difficulty breathing). - Known disturbance of coagulation (iatrogenic or congenital). - Evidence of Hepatitis B or C or HIV by laboratory testing. - A positive test result for drugs of abuse (except a positive test result associated with prescription medication that has been reviewed and approved by the investigator) or alcohol at screening. - Any neurological disease or history of significant neurological disorder (eg, meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré syndrome [genetic/congenital or acquired]). - Active cancer (malignancy) within 5 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma, at the discretion of the investigator) - Vital sign (blood pressure, pulse, temperature) abnormalities of toxicity grade >1. - Clinical laboratory abnormalities of toxicity grade >1 for selected serum chemistry and hematology parameters - Any known allergies to products contained in the investigational product or latex allergy. - Women who are pregnant, breastfeeding or who plan to become pregnant during the study. - History of alcohol abuse or drug addiction within 1 year prior to the first study vaccination. - Any condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). - Study team member or first-degree relative of any study team member (inclusive of sponsor, PPD, and site personnel involved in the study). Inclusion Criteria (Part 2): - Healthy adult males or females between 18 and 84 years of age, inclusive, at screening who are of legal adult age in their local jurisdiction. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. - The participant has a body mass index 17 to 35 kg/m2, inclusive, at screening. - Willing and able to give informed consent prior to study enrollment and comply with study procedures. - Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma FSH level ≥40 mIU/mL]) must agree to be heterosexually inactive from at least 21 days prior to enrollment and through 6 months after the last vaccination OR agree to consistently use any of the following methods of contraception from at least 21 days prior to enrollment and through 6 months after the last vaccination. Exclusion Criteria (Part 2): - Participants who are having any current workup of undiagnosed illness within the last 8 weeks, which is either participant-reported or has been clinician-assessed, that could lead to a new condition diagnosis. - Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. - History of a confirmed diagnosis of SARS or history of a confirmed diagnosis of COVID-19 disease resulting in medical intervention. - Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 4 weeks prior to first study vaccination. - Have clinically significant chronic cardiovascular, endocrine, gastrointestinal/ hepatic, renal, neurological, respiratory, or other medical disorders not excluded by other exclusion criteria, that are assessed by the Investigator as being clinically unstable within the prior 4 weeks evidenced by: a) hospitalization for the condition, including day surgical interventions, b) new significant organ function deterioration, c) needing addition of new treatments or major dose adjustments of current treatments. - Diabetes mellitus requiring insulin therapy (either type 1 or type 2 diabetes mellitus). - Chronic obstructive pulmonary disease with a history of an acute exacerbation of any severity in the prior year. - Any history of congestive heart failure. - Any history of chronic kidney disease (the presence of impaired or reduced kidney function lasting at least 3 months). Clinical validation of potential cases of chronic kidney disease should be conducted. - Evidence of unstable coronary artery disease as manifested by cardiac intervention, addition of new cardiac medications for control of symptoms, or unstable angina in the past 3 months. - History of chronic neurological disorders that have required prior specialist physician review for diagnosis and management (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinsons disease, degenerative neurological conditions, neuropathy, and epilepsy) or a history of stroke or previous neurological disorder within 12 months with residual symptoms. Participants with a history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not excluded. - Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital). - Chronic administration (defined as more than 14 continuous days) of immunosuppressants, systemic glucocorticosteroids reaching an immunosuppressive dose, or other immune-modifying drugs within 90 days prior to first study vaccination. - Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination. - Known disturbance of coagulation (iatrogenic or congenital). - Active cancer (malignancy) within 5 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma, at the discretion of the investigator). - Any known allergies to products contained in the investigational product or latex allergy. - Women who are breastfeeding or who plan to become pregnant during the study. - History of alcohol abuse or drug addiction within one year prior to the first study vaccination. - Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). - Study team member or first-degree relative of any study team member (inclusive of sponsor, PPD, and site personnel involved in the study). ; PRIMARY OUTCOME: Participants with Solicited Adverse Events (AEs) - Phase 1; SECONDARY OUTCOME 1: Participants with Unsolicited AEs - Phase 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 - LUN2001; BRIEF: The purpose of this study is to evaluate the efficacy and safety of CNTO 136 administered intravenously in patients with active, International Society of Nephrology/Renal Pathology Society Class III and IV Lupus Nephritis (LN). ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Lupus Nephritis; TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Diagnosis of Systemic lupus erythematosus (SLE), and biopsy-proven International Society of Nephrology/Renal Pathology Society Class III or IV lupus glomerulonephritis within approximately 14 months prior to randomization - Persistently active nephritis defined as, proteinuria greater than 0.5g/day as determined by measurement of total urine protein less than 0.5 g/24- hours or a urine Protein/Creatinine (P/C) ratio greater than 0.5 (mg/mg) in a timed collection of 12 or more hours, for 2 months or more prior to the first administration of study medication and observed during at least 2 visits conducted 1 week apart during the screening period - Active Class III or Class IV lupus nephritis determined by recent biopsy within approximately 6 months prior to screening or at least 1 of the following 3 criteria: hematuria (blood in urine), anti-DNA positivity, or low C3 or C4 complement levels - Stable immunosuppression for at least 9 weeks prior to the first administration of study medication consisting of MMF 1-3 g/day (or equivalent dose of MPA) with/without corticosteroids up to prednisone equivalent of 20 mg/day, or azathioprine 1-3 mg/kg/day with/without corticosteroids up to prednisone equivalent of 20 mg/day - Stable dose of angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blocker (ARB) for at least 9 weeks prior to the first administration of study medication - If using oral corticosteroids, must be on a stable dose equivalent to 20 mg/day or less of prednisone for at least 9 weeks prior to the first administration of study medication Exclusion Criteria: - Cyclophosphamide use within 3 months of randomization - B-cell depletion therapy within 6 months of screening, or evidence of persistent B-cell depletion at the time of screening - Greater than 50 percent glomerular sclerosis on renal biopsy - Serum creatinine > 2.5 mg/dL (SI: > 177 µmol/L) - White blood cell count < 3.5 x 10^3 cells/µL (SI: < 3.5 x 10^9 cells/L) or neutrophils < 1.96 x 10^3 cells/µL (SI: < 1.96 x 10^9 cells/L) - Platelets < 140 x 103 cells/ µL (SI: < 140 x 10^9 cells/L) ; PRIMARY OUTCOME: Number of patients with reduction in proteinuria (measurement of total urine protein greater than 0.5 g/24-hours, or a urine protein to creatinine ratio greater than 0.5 mg/mg); SECONDARY OUTCOME 1: Number of patients with a reduction from baseline in proteinuria by at least 50%[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Post Renal Transplant; BRIEF: Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant. ; DRUG USED: Sensipar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperparathyroidism (Secondary); TARGET: Calcium-Sensing Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose - May be the first kidney transplant or a repeat kidney transplant. - Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² (chromic kidney disease stage 3 or better) at Screening. - Men or women ≥ 18 years at the start of Screening (ie, time of informed consent). - Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period. - iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2). Exclusion Criteria: - Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet). - Anticipated parathyroidectomy within 6 to12 months after Randomization. - Ongoing therapy with bisphosphonates or use within 6 months prior to Screening. - Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening. - Ongoing use of calcium supplements or use within 30 days prior to Screening. - Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening. - Ongoing use of a thiazide diuretic. - Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication. - Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy. ; PRIMARY OUTCOME: Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP); SECONDARY OUTCOME 1: Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck[/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 - Acute Hip Fracture; BRIEF: This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment. Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be eligible for participation 3-7 weeks post-injury. ; DRUG USED: VK5211; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoporosis / Osteopenia; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: Viking Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation. Exclusion Criteria: - Pathological fracture (e.g. fracture due to Pagets disease of bone, malignancy, etc.). Fracture due to postmenopausal osteoporosis is not considered pathological for this trial. ; PRIMARY OUTCOME: Efficacy in hip fracture patients confirmed by DXA scan.; 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 - ASAP; BRIEF: To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimers Disease (AD) in subjects with mild to moderate AD. ; DRUG USED: Anatabine Citrate; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: NF-Kappa B (nuclear factor kappa-light-chain-enhancer of activated B cells) ; THERAPY: Monotherapy; LEAD SPONSOR: Rock Creek Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - At least 65 years old. - Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia. - Score 16 or more on the Mini-Mental State Examination (MMSE). - Otherwise stable medical history and general health. - Weigh between 45 kg and 120 kg inclusive. Exclusion Criteria: - Have contra-indications, allergy, or sensitivity to the study products or their components. - Be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab). - Be a current smoker or smokeless tobacco user. ; PRIMARY OUTCOME: Number of subjects experiencing adverse effects when using the supplement; SECONDARY OUTCOME 1: Measured changes in blood markers of AD[/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 - CHANGE2 ; BRIEF: This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment. ; DRUG USED: Erbitux; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of SCCHN - Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment - Presence of at least 1 measurable lesion according to RECIST Version 1.1 - Signed written informed consent before any trial-related activities are carried out - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Other protocol-defined inclusion criteria could apply Exclusion Criteria: - Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease, that was completed within 6 months before randomization - Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before trial entry - Previous treatment with monoclonal antibody or signal transduction inhibitors targeting epidermal growth factor receptor - Nasopharyngeal carcinoma - Known central nervous system metastasis and/or leptomeningeal disease - Medical or psychological condition that would not permit the participant to complete the trial or sign informed consent - Legal incapacity or limited legal capacity - Other protocol-defined exclusion criteria could apply ; PRIMARY OUTCOME: Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC); SECONDARY OUTCOME 1: Progression-free Survival (PFS) Time, as Assessed by the Investigator[/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 - CLOVER I (Adjunctive); BRIEF: The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome. ; DRUG USED: Onfi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dravet Syndrome (Epilepsy); TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - Onset of seizures in the first year of life - History of fever-induced prolonged seizures as determined by the Investigator - These may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures - Multiple seizure types which may include: - generalised tonic-clonic (required for inclusion) - clonic (required for inclusion) - myoclonic jerks/seizures - history of normal development prior to seizure onset followed by development delay or regression after seizure onset - abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks Exclusion Criteria: 1. The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives 2. The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives 3. The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids 4. The patient has received chronic treatment (≥2 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed 5. The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy Other protocol-defined inclusion and exclusion criteria may apply. ; PRIMARY OUTCOME: Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts; SECONDARY OUTCOME 1: Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts during 4 weeks of maintenance[/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 - TAK-491CLD-301; BRIEF: The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe essential hypertension. ; DRUG USED: Edarbyclor; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Angiotensin II Receptor Type 1 (AT1), Na/Cl transporter - Thiazide-sensitive; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. 190 mm Hg on Day -1 or if the participant has not received antihypertensive treatment within 28 days before screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on Day -1. 2. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. 3. Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant. 4. Is willing to discontinue current antihypertensive medications on Day -21 or on Day -28 if is on amlodipine or chlorthalidone. Exclusion Criteria: 1. Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg. 2. Has a baseline 24-hour ambulatory blood pressure monitoring reading of insufficient quality. 3. Works a night (third) shift (from 11 PM [2300] to 7 AM [0700]). 4. Has an upper arm circumference less than 24 cm or greater than 42 cm. 5. Is noncompliant with study medication during the placebo run-in period. 6. Has secondary hypertension of any etiology. 7. Has a recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack. 8. Has a clinically significant cardiac conduction. 9. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. 10. Has severe renal dysfunction or disease. 11. Has a known or suspected unilateral or bilateral renal artery stenosis. 12. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. 13. Has poorly controlled type 1 or type 2 diabetes mellitus. 14. Has hypokalemia or hyperkalemia. 15. Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease or jaundice. 16. Has any other known serious disease or condition that would compromise safety, might affect life expectancy or make it difficult to successfully manage and follow the participant according to the protocol. 17. Has a known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds. 18. Has been randomized in a previous Azilsartan Medoxomil study. 19. Is currently participating in another investigational study or has participated in an investigational study or is receiving or has received any investigational compound within 30 days prior to Randomization. 20. Has a history of drug abuse or a history of alcohol abuse within the past 2 years. ; PRIMARY OUTCOME: Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.; SECONDARY OUTCOME 1: Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure.[/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 - GEMINI 1 ACS; BRIEF: The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]). ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Coagulation Factor X; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation myocardial infarction (STEMI); b) non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, participant who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior myocardial infarction (MI), in addition to the presenting ACS event - Participant must be randomized within the screening window of 10 days after hospital admission for the index ACS event. Participant should have received acute phase treatment for the index ACS, such as intravenous anticoagulant or antiplatelet, and are receiving maintenance dual antiplatelet therapy (DAPT) with either clopidogrel plus acetyl salicylic acid (ASA), or ticagrelor plus ASA, with the intent to continue the treatment with a platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor) after randomization - Participants must agree to provide a pharmacogenomics deoxyribonucleic acid (DNA) sample Exclusion Criteria: - Participant has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk - Participant with a prior stroke of any etiology or transient ischemic attack (TIA) - Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum - Participant has anticipated need for chronic administration of omeprazole or esomeprazole concomitantly with clopidogrel - Participant has known allergy or intolerance to ASA or rivaroxaban ; PRIMARY OUTCOME: Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - vs. Irinotecan/Temozolomide; BRIEF: The purpose of this research study is to evaluate a new investigational drug (TPI 287) for early relapsed neuroblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tumors response to the study drug, TPI 287, in combination with Irinotecan and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study will also evaluate the safety and tolerability of the study drug, TPI 287. ; DRUG USED: TPI-287; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuroendocrine Tumors (NET); TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Giselle Sholler; CRITERIA: Inclusion Criteria: - Subjects must have histologically proven Neuroblastoma and confirmation of primary refractory or recurrent disease with histologic confirmation at diagnosis or at the time of recurrence/progression. Subjects must have primary refractory or have early relapse disease (early relapse disease is defined as having received ≤ one or two relapse therapies). - Subjects must be age >12 months and diagnosed before the age of 21 years - Measurable disease, including at least one of the following: Measurable tumor >10 mm by CT or MRI Positive bone marrow biopsy/aspirate Positive MIBG - Current disease state must be one for which there is currently no known curative therapy - Lansky Play Score or Karnofsky scale must be more than 30 - Subjects without bone marrow metastases must have an ANC > 750/μl and platelet count >50,000/μl - Adequate Renal Function Defined As Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or - A serum creatinine based on age/gender table - Adequate liver function must be demonstrated, defined as: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age SGPT (ALT) < 10 x upper limit of normal (ULN) for age SGOT (AST) < 10x upper limit of normal (ULN) for age - No other significant organ toxicity defined as >Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE V4.0- http://ctep.cancer.gov/forms/CTCAEv4.pdf) - A negative urine pregnancy test is required for female participants of child bearing potential (≥13 years of age or after onset of menses) - Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (the pill), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended. - Informed Consent: All subjects and/or legal guardians must sign written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines - Subjects may have received microtubulin inhibitors during previous therapies. - Subjects may have received any number of prior biological therapies. Exclusion Criteria: - Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (hematological and bone marrow suppression effects), generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas). Subjects may not have received more than 1 cycle of Irinotecan and Temozolomide as previous relapse therapy. - Subjects who have received any myeloablative therapy within the previous 2 months. - Subjects receiving any investigational drug concurrently - Subjects with serious infection or a life-threatening illness (unrelated to tumor) that is > Grade 2 (NCI CTCAE V4.0), or active, serious infections requiring parenteral antibiotic therapy. - Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subjects ability to sign or the legal guardians ability to sign the informed consent, and subjects ability to cooperate and participate in the study - Subjects with known hypersensitivity to any of the components of the drugs to be administered on study. - Subjects who have previously been treated with TPI 287. ; PRIMARY OUTCOME: Number of Participants With Adverse Events as a Measure of Safety and Tolerability; SECONDARY OUTCOME 1: Pharmacokinetics (PK) of TPI 287 in the Phase I Population of This Trial.[/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 - Children 6 to 35 Months; BRIEF: The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteurs Fluzone® Quadrivalent in children 6 to 35 months of age. ; 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 parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, 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 the first vaccination. - Written informed consent obtained from the parent(s)/LAR(s) of the subject. - Subjects in stable health as determined by investigators clinical examination and assessment of subjects medical history. - Subjects are eligible regardless of history of administration of influenza vaccine in a previous season. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted. - Child in care. - Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean a dose equivalent to either > 2 mg/kg/day of body weight, or to ≥ 20 mg/day of prednisone for persons who weigh ≥ 10 kg, when administered for more than 2 weeks. Inhaled and topical steroids are allowed. - Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within six months preceding the first dose of study vaccine, or planned use during the study period. - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. - History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine. - Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥ 38.0°C/100.4°F by any route. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. - Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study. ; PRIMARY OUTCOME: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains; SECONDARY OUTCOME 1: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)[/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 - 115362 - Japan; BRIEF: The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444 Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary Disease (COPD). This is a multi-centre, open-label study evaluating the safety of GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the morning. The target enrolment is approximately 120 subjects at approximately 20 study centres in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a 7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at screening visit (Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of baseline safety evaluations and to obtain baseline measures of COPD status. At Visit 2, eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects will be instructed to administer medication once daily in the morning for the duration of the 52-week treatment period. Each subject should be advised to adhere to this dosing regimen throughout the study. There will be a total of 8 study visits including at screening (Visit 1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by the phone contact approximately 1 week following the completion/withdrawal of treatment period. A subject will be considered to have completed the study upon completion of the last on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed appropriate COPD medication at the investigators discretion. ; DRUG USED: Anoro Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Outpatient. - A signed and dated written informed consent prior to study participation. - Japanese subjects 40 years of age or older at screening. - Male or female subjects (female subjects who have child bearing potential has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods used consistently and correctly). - Diagnosis of COPD. - 10 pack-year or greater history of cigarette smoking. - Post-bronchodilator FEV1/FVC of <0.7. - Predicted FEV1 of <80%. Exclusion Criteria: - Women who are pregnant or lactating or are planning on becoming pregnant during the study. - A current diagnosis of asthma. - Respiratory disorders other than COPD. - Clinically significant non-respiratory diseases or abnormalities that are not adequate controlled. - A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. - A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition. - Hospitalization for COPD or pneumonia within 12 weeks prior to screening. - Subjects with lung volume reduction surgery within the 12 months prior to screening. - Abnormal and clinically significant ECG findings at screening. - Significantly abnormal finding from clinical chemistry or hematology, tests at screening. - Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. - Regular use (prescribed every day, not for as-needed use) of short-acting bronchodilators via nebulized therapy. - Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to screening. - A know or suspected history of alcohol or drug abuse within 2 years prior to screening. - Affiliation with the investigational site. - Previous use of GSK573719, GW642444, the GSK573719/GW642444 combination or the Fluticasone Furoate/GW642444 combination. - Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer). ; PRIMARY OUTCOME: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period; SECONDARY OUTCOME 1: Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD[/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 - ISLE-1; BRIEF: This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c). ; DRUG USED: HDV-L; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Diasome Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Men and women ≥ 18 yrs. of age 2. Clinical diagnosis of Type 1 diabetes mellitus for at least 12 months 3. Body Mass Index (BMI) ≤ 35 Kg/m2 4. Basal insulin includes insulin Glargine or insulin Detemir 5. Patient should be using bolus insulin defined as 2 to 4 doses of regular human insulin or rapid-acting analog at meals 6. HbA1c ≥ 7.0% and ≤ 10.5% 7. Fasting C-peptide ≤ 0.5 pmol/mL 8. Willingness to adhere to protocol and perform all required tests 9. Willing and able to review and sign the Informed Consent Form. 10. If child bearing age, must use acceptable form of birth control (ligation, 2 forms of birth control) 11. Willing to wear CGM devices and complete diaries. Exclusion Criteria: 1. Total daily insulin dose ≥ 1.5 IU/kg/day. 2. History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that effect HbA1c measurements 3. Evidence of serious complications of diabetes (eg, Symptomatic autonomic neuropathy) 4. Patients who are selected to but are unwilling or unable to participate in the MRI evaluation subset. (These patients may still participate in the non-MRI subset). 5. Significant cardiovascular dysfunction or history within 12 months of Screening, eg, congestive heart failure (New York Heart Association Class III or IV), or clinically significant arrhythmia, myocardial infarction, cardiac surgery; history of valvular heart disease including mild or greater aortic insufficiency, or moderate or greater mitral insufficiency; recurrent syncope, transient ischemic attacks, or cerebrovascular accident 6. Impaired liver function with elevated enzymes > 50% above the normal range at Screening. Patients with elevated liver enzymes may have the test repeated only at Visit 2 on a case-by-case basis at the request of the PI. 7. Creatinine level > 2 mg/dL for men, and > 1.8 mg/dL for women at Screening. 8. Patient on low carbohydrate diet, such as Atkins Diet 9. History of Adrenal supplementation within 3 years of Screening. 10. History of unawareness or SEVERE recurrent hypoglycemia, defined as a patient who is unaware of symptoms of hypoglycemia, or due to autonomic dysfunction, has no inherent warnings of hypoglycemia, and therefore requires outside assistance to rectify any episodes of hypoglycemia 11. Patients treated with systemic corticosteroids (Sporadic use of inhaled, intraarticular, and topical corticosteroids is not considered systemic). 12. Patients with triglyceride levels ≥500 mg/dL at Screening. 13. Patients with a history of cancer within the past 5 years, excluding basal or squamous cell carcinoma localized to the skin. 14. Epilepsy or other physical or medical conditions which could result in non-compliance with the study. 15. Participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study 16. Unwilling to discontinue use of an insulin pump for the duration of the study. 17. Women who are pregnant, nursing, or planning to become pregnant during the course of the study. 18. Patients on NPH as their basal insulin. 19. Positive history of hepatitis A (within 12 months of Screening), or a positive history of hepatitis B, hepatitis C, or HIV at Screening. 20. History of drug addiction and/or alcohol abuse within 12 months of Screening. ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: Change in fasting blood glucose glucose levels[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - VADIS (Ductal Carcinoma in Situ); BRIEF: This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a persons white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer. ; DRUG USED: NeuVax; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, HER2/neu or ErbB-2, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Participants must be pre- or post-menopausal - Participants must have a diagnosis of DCIS made by core needle biopsy - Participants must be human leukocyte antigen (HLA)-A2 positive - Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 (Karnofsky >= 60%) - Clinical chemistry less than 2 x normal upper limit of normal range - Platelets >= 100,000/mm^3 - Hemoglobin >= 10 g/dL - Blood urea nitrogen < 2 x upper limit of normal (ULN) - Alkaline phosphatase < 2 x ULN - Lactate dehydrogenase < 2 x ULN - Creatinine < 2 x ULN - Bilirubin < 2 x ULN - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2 x ULN - A normal ejection fraction, as defined by the participants institution; only limited echocardiograms (ECHOs) will be used as cardiac evaluation; no other tests are allowed; ECHO is to be done only in HLA-A2 positive participants; if ECHO has been done within 30 days prior to randomization and results showing a normal ejection fraction have been obtained prior to randomization, an additional ECHO is not needed at baseline - Willingness to comply with all study interventions and follow-up procedures - The ability to understand and willingness to sign a written informed consent document Exclusion Criteria: - Invasive breast cancer; areas of microinvasion or suspicious for microinvasion on the core biopsy is allowed - History of prior breast cancer treated within the past two years; patients completing all breast cancer-specific treatment over two years prior to the current diagnosis are eligible - History of prior ductal carcinoma in situ (DCIS) treated within the past two years; patients completing all treatment for a previous diagnosis of DCIS over two years prior to the current diagnosis are eligible - Prior lobular carcinoma in situ (LCIS) is allowed - Pregnant, unwilling to use adequate contraception during study treatment duration or breastfeeding; the effects of NeuVax on the developing human fetus are unknown; for this reason and because NeuVax may be teratogenic, pregnant women will be excluded; all heterosexually active women who may become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation OR be post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately - Any autoimmune disease or other medical condition that, in the opinion of the investigator, would compromise the subjects safety - Immune deficiency diseases such as immunoglobulin deficiency or immunosuppressive therapy that might interfere with appropriate immune response - Known history of or known active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C - Patients on chronic steroid therapy or other immunosuppressive therapy except for topical or inhaled steroids known to have low systemic absorption - Patients with a known hypersensitivity to GM-CSF, yeast-derived products, or any component of the GM-CSF product (e.g., mannitol) - Concurrent treatment with other investigational agent - History of non-breast malignancy within 5 years prior to randomization, except curatively treated superficial bladder cancer, carcinoma in situ of the cervix (stage 0-1), and basal cell or squamous cell carcinoma of the skin - History of allergic reactions attributed to compounds of similar chemical or biologic composition to NeuVax - 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 - No recent or planned immunotherapy ; PRIMARY OUTCOME: Mean Percent of Nelipepimut-S-specific Cytotoxic T Lymphocyte Response (E75); SECONDARY OUTCOME 1: Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs) Within the Basement Membrane[/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 - MO-Ped; BRIEF: This is a randomized, double-blind, placebo-controlled study comparing the safety and efficacy of 2 dosage regimens of palovarotene versus placebo in preventing disease progression in pediatric subjects with multiple osteochondromas (MO). ; DRUG USED: Palovarotene; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bone Cancer; TARGET: Retinoic acid receptor (RARs); THERAPY: Monotherapy; LEAD SPONSOR: Clementia Pharmaceuticals Inc.; CRITERIA: Key Inclusion Criteria: - Written, signed, and dated informed subject/parent consent and age-appropriate assent (performed according to local regulations). - A clinical diagnosis of MO with disease-causing exostosin 1 or 2 gene mutations. - Male or female from 2 to 14 years of age. - Female subjects must be premenarchal at screening. - A bone age at screening of 14 years or less. - Symptomatic MO, defined as five or more clinically evident osteochondromas and a new or enlarged osteochondroma that occurred in the preceding 12 months, five or more clinically evident osteochondromas and the presence of a painful osteochondroma, a skeletal deformity, a joint limitation, or prior surgery for a MO-related complication. - The ability to undergo whole body MRI with or without sedation/general anesthesia. - Use of two effective methods of birth control during treatment, and for 1 month after treatment discontinuation, unless committed to true abstinence from heterosexual sex. Sexually active females of child-bearing potential must also agree to start effective methods of birth control at screening. Key Exclusion Criteria: - Weight under 10 kg. - Other syndromic conditions such as Langer-Giedion or Potocki-Shaffer. - Any subject with neurologic signs suggestive of spinal cord impingement. - Concomitant medications that are strong inhibitors or inducers of cytochrome P450 3A4 activity. - Amylase or lipase >2 times the above the upper limit of normal (>2×ULN) or with a history of chronic pancreatitis. - Elevated aspartate aminotransferase or alanine aminotransferase above 2.5×ULN. - Any surgical implant that is contraindicated for MRI. ; PRIMARY OUTCOME: Annualized Rate of New Osteochondromas (OCs); SECONDARY OUTCOME 1: Mean Change From Baseline in the Total Volume of New OCs at Month 12[/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 - ABC-108; BRIEF: ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®, opaganib) alone and in combination with hydroxychloroquine sulfate (HCQ) in the treatment of cholangiocarcinoma (CCA). In Part 1 of this clinical study, all participants will be receiving ABC294640 and in Part 2 all participants will be receiving ABC294640 and HCQ to explore the drugs activity signal in CCA. The study drug, ABC294640 is an orally available inhibitor of the enzyme sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and proliferation. ABC294640 also inhibits proliferation and induces apoptosis of cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated clinical activity in CCA patients. HCQ, is an orally available, FDA approved therapy for the treatment of malaria as well as discoid and systemic lupus erythematosus and rheumatoid arthritis. It is also known as an inhibitor of autophagy, a pro-survival mechanism utilized by many cancers. Evidence indicates that inhibition of autophagy can increase the therapeutic activity of ABC294640 in CCA. In Part 1 of this study, ABC294640 will be continuously administrated orally, twice a day, in 28 day cycles. In Part 2, ABC294640 and HCQ will be continuously administrated orally (the safe and tolerable will be determined in the study) in 28 day cycles. Administration of drug/s in both parts of the study will continue until disease progression, unacceptable toxicity or voluntary withdrawal initiated by the participants or physician. ; DRUG USED: Yeliva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Biliary Tract Cancer; TARGET: Sphingosine kinase (SphK); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: RedHill Biopharma Limited; CRITERIA: Inclusion Criteria: 1. Patients with histologically confirmed intrahepatic, perihilar or extra-hepatic CCA. 2. Patients with no more than 2 prior treatments with systemic anti-neoplastic therapy for CCA. 3. The tumor is unresectable and not amenable to curative therapy. 4. One or more tumors measurable on CT scan per RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0- 1. 6. Life expectancy of at least 3 months. 7. Age ≥18 years. 8. Signed, written IRB-approved informed consent. 9. A negative pregnancy test (if female). 10. Acceptable liver and renal function: - Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline) - AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN), - Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline) - Albumin > 3.0 g/dL 11. Acceptable hematologic status: - Absolute neutrophil count ≥1000 cells/mm3 - Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline) - Hemoglobin ≥ 9 g/dL 12. Acceptable blood sugar control: - Fasting glucose value ≤ 160 mg/dL (CTCAE Grade 1 baseline) 13. Urinalysis: No clinically significant abnormalities. 14. Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 X ULN after correction of nutritional deficiencies that may have contributed to prolonged PT/PTT. 15. For men and women of child-producing potential, willingness to use effective contraceptive methods during the study. If female (or female partner of male patient), was either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing one of the following medically acceptable methods of birth control and agreed to continue with the regimen throughout the duration of the study: - Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline/randomization visit. - Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the baseline/randomization visit). - Intrauterine device. - Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream Exclusion Criteria: 1. >2 previous systemic anti-neoplastic regimens for CCA. 2. Previously having received ABC294640 or HCQ (or chloroquine) for the treatment of a malignancy. 3. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG. 4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 5. Pregnant or nursing women. NOTE: If a woman became pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately. 6. Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days prior to study entry. Patients who had received any antineoplastic therapy > 28 days prior to starting treatment with ABC294640 and HCQ must have recovered from the reversible effects of prior antineoplastic therapy (with the exception of alopecia and Grade 1 neuropathy). 7. Unwillingness or inability to comply with procedures required in this protocol. 8. Known infection with human immunodeficiency virus. 9. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor. 10. Patients who were currently receiving any other investigational agent. 11. Patients who were receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that could not have been stopped at least 7 days or 5 half-lives (whichever was longer) before starting treatment with ABC294640, could not have been replaced with another appropriate medication or not given for the duration of the clinical study must be discussed with the Medical Monitor in order to determine eligibility for the study. 12. Patients who are taking warfarin, apixaban, argatroban or rivaroxaban. 13. If the patient is to receive HCQ, pre-existing retinopathy. 14. Known history of G-6-PD Deficiency, porphyria or psoriasis. 15. History of macular degeneration, visual field changes, retinal disease, or cataracts that would interfere with funduscopic eye examinations. 16. History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ. ; PRIMARY OUTCOME: Part1 - Determine Response Rate; SECONDARY OUTCOME 1: Physical exam to include eye exams (the latter only for patients enrolled in Part 2) to measure safety and tolerability of ABC294640 alone and in combination with HCQ[/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 - 001; BRIEF: This research study is being done to compare the safety and effectiveness of GDC 695 (test drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to establish that these two drugs work better than placebo in the treatment of actinic keratosis. ; DRUG USED: GDC 695; DRUG CLASS: Non-NME; INDICATION: Actinic Keratoses; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Balmoral Medical company; CRITERIA: Inclusion Criteria: - Has provided written informed consent. - Immunocompetent male and/or non-pregnant female, 18 years of age or older. - Willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. - Clinical diagnosis of actinic keratosis. - In good general health and free of any disease state or physical condition. - Women, must be post-menopausal, surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1). Exclusion Criteria: - Women who are pregnant, breastfeeding, or are planning to become pregnant or breastfeed during the study. - Is currently enrolled in another investigational drug or device study or has used an investigational drug or investigational device within 30 days prior to the Baseline Visit (Day 1). - Has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study. - Is immunosuppressed (e.g., human immunodeficiency virus [ HIV], systemic malignancy, graft host disease, etc.) or is taking medications that suppress the immune system. - Has experienced an unsuccessful outcome from previous topical diclofenac sodium therapy. - Has a history of sensitivity to any of the ingredients in the test articles or other excipients in the test or reference drug. - Has signs or symptoms consistent with the aspirin (ASA) triad. - Has used topical medications: corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >2%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, aminolevulinic acid (ALA) or prescription retinoids (e.g., tazarotene, adapalene, tretinoin), over-the-counter (OTC) products labeled as scrubs of any kind which are used to smooth the skin (as they contain some form of exfoliant such as nut shells, coffee grounds, polymer particles, etc.) within the selected treatment area (face or bald scalp) within one month prior to the Baseline Visit. - Has had cryodestruction or chemodestruction, curettage, photodynamic therapy (PDT), surgical excision, or other treatments for AK within the selected treatment area (face or bald scalp) within one month prior to the Baseline Visit. - Has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within one month prior to the Baseline Visit. - Has used oral isotretinoin within six months prior to the Baseline Visit. - Has used chemical peels, including but not limited to alphahydroxy acid, betahydroxy acid, bichloroacetic acid, trichloroacetic acid, and phenol within the selected treatment area (face or bald scalp) within six months prior to the Baseline Visit. - Has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, ultraviolet B (UVB) therapy, ALA-PDT, or dermabrasion within the selected treatment area (face or bald scalp) within six months prior to the Baseline Visit. - Has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or bald scalp). - Has active gastrointestinal ulceration or bleeding or has a history of gastrointestinal bleeds due to use of aspirin or other NSAIDs. - Has severe renal or hepatic impairment. - Has any condition which, in the investigators opinion, could interfere with the evaluation of the test drugs or that could make it unsafe or preclude the subjects ability to fully participate in this research study. ; PRIMARY OUTCOME: Number of Subjects With Complete Clearance of AK Lesions; 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 - PC4; BRIEF: This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer. ; DRUG USED: G17DT; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: gastrin1-17 (G17), Immune System, Protein synthesis; THERAPY: Combination; LEAD SPONSOR: Cancer Advances Inc.; CRITERIA: Inclusion criteria: - Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection - Life expectancy of at least 3 months - Functional status by Karnofsky Index of at least 70 Exclusion criteria: - Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy - Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease - Immunodeficiency - Bone marrow transplant within past year - Brain metastasis ; PRIMARY OUTCOME: Survival; SECONDARY OUTCOME 1: Number of Participants with Serious and Non-Serious Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - LAL-CL04 (Adults Extension); BRIEF: This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the study was to evaluate the long-term safety and tolerability of sebelipase alfa in participants with liver dysfunction due to lysosomal acid lipase (LAL) deficiency. ; DRUG USED: Kanuma; DRUG CLASS: Biologic; INDICATION: Lysosomal Acid Lipase Deficiency ; TARGET: Cholesterol/Cholesteryl Ester, Triglycerides; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Participant received all 4 scheduled doses of sebelipase alfa in Study LAL-CL01 with no life-threatening or unmanageable study drug toxicity. Exclusion Criteria: - Clinically significant concurrent disease, serious inter-current illness, concomitant medications or other extenuating circumstances - Clinically significant abnormal values on laboratory screening tests, other than LFTs or lipid panel tests ; PRIMARY OUTCOME: Number Of Participants Reporting TEAEs And IARs; SECONDARY OUTCOME 1: Changes From Baseline In ALT And AST[/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 - VITAL; BRIEF: The goal of this clinical trial is to compare participants with ovarian, fallopian tube or primary peritoneal cancer when treated with investigational product (Vigil) compared to placebo. The main question it aims to answer is Will participants who receive treatment with Vigil have a longer time to disease recurrence versus the participants that were not given Vigil? ; DRUG USED: Vigil EATC; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Furin, Granulocyte-Macrophage CSF (GM-CSF), Immune System, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Gradalis, Inc.; CRITERIA: Inclusion Criteria Subjects will be eligible for tissue procurement for the Vigil manufacturing process if they meet all of the following criteria: 1. Presumptive Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer. 2. No chemotherapy prior or investigational agents prior to tissue acquisition for Vigil manufacture. 3. No other malignancy (excluding surgically cured nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years. 4. Anticipated availability of a cumulative mass of ~30 grams tissue (golf-ball size or approximately 3cm disease on CT scan) at time of diagnostic laparoscopy or primary surgical debulking. Infiltrating lumen (bowel, fallopian tube, urethra) tissue should not be used as Vigil immunotherapy material to minimize risk of bacterial contamination. 5. ECOG performance status (PS) 0-2 prior to diagnostic laparoscopy or debulking laparotomy. 6. No prior history of hypersensitivity reactions (HSR) with taxanes or platinums. 7. No prior history of allergies or sensitivities to gentamicin. 8. Female, 18 years of age or older. 9. Ability to understand and the willingness to sign a written informed consent document for tissue harvest. Subjects will be registered in this study if they meet all of the following inclusion criteria: 1. Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal. 2. Completion of primary surgical debulking including hysterectomy and bilateral salpingo oophorectomy, and at least 5 but no more than 8 cycles of platinum / taxane adjuvant chemotherapy or chemotherapy as per Category 1 recommendations of the NCCN guidelines, including 5-8 cycles adjuvant intraperitoneal + intravenous (IP/IV) chemotherapy, or 5-8 cycles of intravenous chemotherapy divided and administered as neoadjuvant and adjuvant therapy flanking primary debulking surgery. 3. Clinically defined complete response (cCR) following completion of primary surgical debulking and eligible chemotherapy. cCR defined as no evidence of malignancy on chest x-ray (CT scan is acceptable) and CT scan or MRI of the abdomen and pelvis, normal physical examination, CA-125 antigen level ≤ 35 U/ml (assessed ≥ 2 weeks following removal of catheter in subjects receiving intraperitoneal/intravenous chemotherapy) and no findings on physical examination or symptoms suggestive of active cancer. 4. Subjects must have initiated adjuvant chemotherapy no more than 8 weeks following primary debulking surgery. 5. Successful manufacturing of at least 4 doses (vials) of Vigil and placebo. 6. Recovered from all clinically relevant toxicities related to prior therapy (including neuropathy ≤Grade 2). 7. ECOG performance status (PS) 0-1. 8. Normal organ and marrow function as defined below: Absolute granulocyte count ≥ 1,500/mm^3, Absolute lymphocyte count ≥ 500/mm^3, Platelets ≥ 75,000/mm^3, Total bilirubin ≤ 2 mg/dL, AST(SGOT)/ALT(SGPT)≤ 2x institutional upper limit of normal, Creatinine < 1.5 mg/dL 9. Ability to understand and the willingness to sign a written informed protocol specific consent. Exclusion Criteria: Subjects will be excluded from this study if they meet any of the following criteria (at the time of tissue procurement or at randomization): 1. Surgery involving general anesthesia, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to randomization. 2. Histologically confirmed papillary serous adenocarcinoma of the uterus or disease involving myometrium/endometrium. 3. Systemic immunosuppressive therapy within 14 days of randomization. 4. Subjects requiring chronic steroid or immunosuppressive regimens are excluded except inhaled / intranasal steroids and short term systemic steroids <30 days duration and ≤0.25 mg/kg prednisone-equivalent per day are allowed. 5. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months). 6. Psychiatric illness/social situations that would limit compliance with study requirements. 7. Subjects with history of brain metastases. 8. Subjects with known HIV or chronic Hepatitis B or C infection. 9. Prior solid organ or bone marrow transplant. 10. History of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogrens syndrome, scleroderma, myasthenia gravis, Goodpastures syndrome, Addisons disease, Hashimotos thyroiditis, or Graves disease). Persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled. ; PRIMARY OUTCOME: Recurrence Free Survival (RFS); SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BRAVO 2/3; BRIEF: The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented. ; DRUG USED: Angiomax; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiac Valve Surgery; TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: The Medicines Company; CRITERIA: Inclusion Criteria: - Males and females, ≥18 years of age - High risk (Euroscore ≥18, or considered inoperable) for surgical aortic valve replacement - Undergoing TAVR via transfemoral arterial access - Provide written informed consent before initiation of any study related procedures Exclusion Criteria: - Any known contra-indication to the use of bivalirudin (except presence of severe renal impairment [glomerular filtration rate (GFR) <30 milliliters (mL)/minute] since these participants will be included in the trial or UFH - Refusal to receive blood transfusion - Mechanical valve (any location) or mitral bioprosthetic valve - Extensive calcification of the common femoral artery, or minimal luminal diameter <6.5 millimeters (mm) - Use of elective surgical cut-down for transfemoral access - Concurrent performance of percutaneous coronary intervention with TAVR - International normalized ratio (INR) ≥2 on the day of TAVR procedure or known history of bleeding diathesis - History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation - Severe left ventricular dysfunction (left ventricular ejection fraction <15%) - Severe aortic regurgitation or mitral regurgitation (4+) - Hemodynamic instability (for example, requiring inotropic or intra-aortic balloon pump support) within 2 hours of the procedure - Dialysis dependent - Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure - Acute myocardial infarction, major surgery, or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days - Percutaneous coronary intervention within 30 days - Upper gastrointestinal or genitourinary bleed within 30 days - Stroke or transient ischemic attack within 30 days - Any surgery or biopsy within 2 weeks - Administration of: - UFH within 30 minutes of the procedure - Enoxaparin within 8 hours of the procedure - Fondaparinux or other low-molecular-weight heparins (LMWHs) within 24 hours of the procedure - Dabigatran, rivaroxaban, or other oral anti-Xa or antithrombin agent within 48 hours of the procedure - Thrombolytics, glycoprotein IIb/IIIa inhibitor, or warfarin within 72 hours of the procedure - Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast - Contraindications or allergy to aspirin or clopidogrel - Known or suspected pregnant women or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy - Previous enrollment in this study - Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached ; PRIMARY OUTCOME: Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge; SECONDARY OUTCOME 1: NACE at 48 Hours or Before Hospital Discharge[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/TNO155 ; BRIEF: This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors that have a KRAS G12C mutation. ; DRUG USED: Adagrasib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: KRas; THERAPY: Combination; LEAD SPONSOR: Mirati Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 must be either Non-Small Cell Lung Cancer or Colorectal Cancer) - Unresectable or metastatic disease - No available treatment with curative intent - Adequate organ function Exclusion Criteria: - History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow - Other active cancer - Cardiac abnormalities ; PRIMARY OUTCOME: Characterize the safety of MRTX849 and TNO155 in patients having advanced solid tumor malignancies with KRAS G12C mutation.; SECONDARY OUTCOME 1: Establish maximum tolerated dose[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Israel; BRIEF: The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wounds bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative wounds. This study will be a multi-center, assessor blinded, randomized, controlled study intended to demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control treatment in patients with hard to heal wounds. 72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between 5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be enrolled into the study. Patients will undergo a 1 week screening period (2 visits) which will include: record of demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (wound status and quality of life). During this period wounds will be treated by standard treatment per the decision of the physician. During this screening period, subjects whose study wound size (surface area) decreases by more than 20 percent will be excluded. Following completion of the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10 applications or until complete debridement is achieved, whichever occurs first. In stage 2 (24 patients): Treatment will be performed for up to 8 applications or until complete debridement is achieved, whichever occurs first. Following each application the wound will be washed, photographed and assessed for wound size, removal of nonviable tissue and change in granulation tissue (by digital planimetry software), wound status, and safety parameters. Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline gauze (except when successive 24h or 48h treatments are performed, in the second stage). Following completion of the debridement treatment period, patients will be treated according to standard procedures and evaluated (wound assessments) once a week until complete wound closure for up to 12 weeks from last application (up to 12 visits). Only during the first stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits) follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For patients who didnt achieve wound closure only the 3 months FU visit will be conducted. For patients enrolled at the second stage, if wound closure was achieved at the 12 weeks follow-up, additional visit will be performed 2 weeks later to confirm wound closure. ; DRUG USED: EscharEx; DRUG CLASS: Biologic; INDICATION: Wound Healing; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: MediWound Ltd; CRITERIA: Inclusion Criteria - Patients, men or women, are between 18 and 90 years of age. - Patient with venous leg ulcer or diabetic (lower extremity) ulcer or traumatic/post operative wound (determined by medical history and physical examination) - Wound is not healing for at least 4 weeks - The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area (assessed by clinical evaluation) - Wound surface area is in the range of 5- 200 cm2 in the first stage and 3 - 150cm2 in the second stage. - Patient understands the nature of the procedure, able to adhere to the protocol regimen, and provides written informed consent prior to any study procedure - The Wound is classified as a wound involving full skin thickness but not penetrating to cavities or open joint spaces Exclusion Criteria - Evidence of active osteomyelitis of target organ, - Patients with more than one hard to heal wounds wounds which require debridement and with an area greater than or equal to 2cm2, - Presence of purulent discharge, deep-tissue abscess, cellulitis or tissue damage extending >2 cm around the wounds edge, gangrene or signs of systemic infection, - Wound size decreased by > 20% after 1 week of standard-of-care-only period (screening period), - Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by Silver sulfadiazine (SSD) pseudoeschar (e.g. pseudoeschar as a result of SSD treatment), - Ankle-Brachial Index (ABI) ≤ 0.7 or a significant decrease in the blood flow of the extremity as demonstrated by US doppler. - Wound has sinus tracts or tunnels extending under healthy tissue, - Patients undergoing renal or peritoneal dialysis, - Recent history (less than 4 weeks) of myocardial infarction (MI) or concurrent acute injury or disease that might compromise the patients welfare, - Any condition that would preclude safe participation in the study: evidence of significant hematological (severe pre-existing coagulation disorder), cardiovascular, liver or neoplastic disease, or any other immediate life threatening condition, - Patient is currently receiving, or has received at any time within one month prior to enrollment, any medications or treatments known to affect the wound healing processes; these include: chronic systemic steroid intake with topical skin changes (thin, fragile with multiple hematomas and previous laceration history, immuno-suppressive drugs, radiation therapy and chemotherapy. - History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, - Pregnant women (positive pregnancy test) or nursing mothers, - Participation in another investigational drug trial within 30 days prior to enrollment or anticipated participation while enrolled in the study, - Concurrent use of non-approved drugs or alcohol abuse. - Patients with poor nutritional status (albumin < 2.5g/dl), poor diabetic control (HbA1c > 12%), anemia (hemoglobin<8 g/dL), a leukocyte counts < 4,000// μl or >15000/μl, abnormal liver function (AST, ALT>2 x upper limit of normal range), renal failure (Cr > 3 mg/dl); - Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc), - Patients with general skin disorders (Psoriasis, Panniculitis, ect) that might deteriorate as a result of local trauma. - Patients with skin disorders unrelated to the wound that are presented adjacent to the wound - Clinical suspicion of skin cancer associated with the wound (e.g, BCC, SCC), which was not ruled out by biopsy Patients with diagnosed Sepsis during screening phase, - Patients suffering from Idiopathic Pruritus. ; PRIMARY OUTCOME: Incidence of complete debridement (non-viable tissue removal) at the end of the debridement period assessed by the blinded assessor by clinical evaluation.; SECONDARY OUTCOME 1: Rate of complete wound closure[/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. Forteo; BRIEF: The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis. ; DRUG USED: Bonsity; DRUG CLASS: Non-NME; INDICATION: Osteoporosis / Osteopenia; TARGET: Parathyroid Hormone Receptor (PTHR); THERAPY: Monotherapy; LEAD SPONSOR: Pfenex, Inc; CRITERIA: Inclusion Criteria: - If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD value at least 1 standard deviation (SD) below the average of young, healthy women - If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy men - Able to use the pen injection device correctly - Able to understand and sign the written Informed Consent Form (ICF) Exclusion Criteria: - Treatment with oral bisphosphonates (once daily or once weekly) within 6 months of screening - Any current or prior human PTH-derived products (e.g., Forteo, Teribone, Natpara), including for investigational purposes - Immobility due to severe or chronically disabling conditions (e.g., stroke, Parkinsons disease, multiple sclerosis) - History of metabolic bone diseases other than osteoporosis - History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured) - History of Pagets disease of bone - History of prior external beam or implant radiation therapy involving the skeleton - Active urolithiasis or primary hyperparathyroidism ; PRIMARY OUTCOME: Blood levels of anti-drug antibody (ADA) against teriparatide; SECONDARY OUTCOME 1: Mean percentage change in lumbar-spine bone mineral density (BMD)[/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 - Phototherapy Need; BRIEF: This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to sham (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with intention to treat. ; DRUG USED: Stanate; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperbilirubinemia; TARGET: Heme processing; THERAPY: Monotherapy; LEAD SPONSOR: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company; CRITERIA: Patients were enrolled who meet the following criteria: 1. The infants family may be approached at anytime from 6 hours after birth onward to discuss the possibility of enrollment. However, Informed Consent may not be signed until the baby is between 12 and 36 hours of age. 2. Consent may be obtained as soon as possible after 12 hours of age, when the baby enters the well-baby nursery. 3. An infant may be included if the mother has received, or the baby is receiving, antibiotics and the infant is asymptomatic. For example, the baby has no signs of cardiorespiratory distress and is feeding well. Symptomatic infants are excluded (see Exclusions, below). 4. Born at the study hospital site and admitted to the well-baby nursery or admitted to the intensive-care nursery for <12 hours for post delivery observation (delayed transition, temperature or dextrose instability, meconium staining and/or parental concern). 5. All babies on oral feeding with stable cardiorespiratory status and deemed healthy upon clinical examination, with normal perfusion as defined by capillary filling of the fingernail. 6. Term neonate (≥38 weeks of completed gestation), OR 7. Near-term neonate (>36<38 weeks of completed gestation; >2,000g birth weight), OR 8. Near-term neonate (>35<38 weeks of completed gestation; >2,500g birth weight) 9. Care provided (primarily) in the well-baby nursery population; 10. Absence of concurrent cardiorespiratory distress, sepsis, major congenital anomalies or need for care in an intensive care nursery; 11. Not participating in another concurrent unrelated study. Exclusion Criteria The study enrolled patients who did not have any of the following exclusion criteria: 1. Any condition that in the opinion of the investigator would make the subject unsuitable for the study. 2. Infants receiving antibiotics who are also symptomatic are excluded. For example, a baby who is feeding poorly or is in cardiorespiratory distress is excluded. 3. Mother has received phenobarbital in past 30 days. ; PRIMARY OUTCOME: Need for Phototherapy; SECONDARY OUTCOME 1: hyperbilirubinemia[/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 - Long-Term Extension; BRIEF: The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD. ; DRUG USED: Eylea; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participation in Study VGFT-OD-0605 through week 96. - In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment. Exclusion Criteria: - Presence of any condition that would jeopardize the patients participation in this study. - Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study. ; PRIMARY OUTCOME: Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD; SECONDARY OUTCOME 1: Change in BCVA Letter Score (mLOCF)[/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 - C2201; BRIEF: This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma. ; DRUG USED: RTB101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine (Endometrial) Cancer; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Female ≥ 18 years - Histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy - Objective and radiologically confirmed progression of disease after prior first-line treatment - Recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions - At least one measurable lesion as per RECIST - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: - Previous treatment with PI3K and/or mammalian Target Of Rapamycin (mTOR) inhibitors - More than one line of prior treatment for advanced or metastatic disease - Active uncontrolled or symptomatic Central Nervous System (CNS) metastases - Concurrent malignancy or malignancy in the last 3 years prior to start of study treatment - Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this study - Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) < 50%, Q-T interval corrected for heart rate (QTcF) > 480 msec on screening Electrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) - Inadequately controlled hypertension - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 - Drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of CYP3A4, warfarin and coumadin analogues, Luteinizing Hormone-Releasing Hormone (LHRH) agonists - Pregnant or nursing (lactating) woman Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST); SECONDARY OUTCOME 1: evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - CP-Q12VLP-004; BRIEF: A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine administered to healthy adults 18-49 years of age. A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30 subjects to receive one injection of either a low, a medium, or a high dose level of VLP of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80). ; DRUG USED: MT-2271; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Medicago; CRITERIA: Inclusion Criteria: 1. Male and female adults, 18 to 49 years of age, inclusive. 2. Healthy as judged by the Investigator or designee and determined by medical history, complete general history/symptom-directed physical examination, vital signs, screening laboratories, and medical history conducted no more than 30 days prior to study vaccine administration. 3. BMI of ≥18 and ≤32. 4. Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits. 5. Accessible by phone on a consistent basis. 6. Give his/her consent to participate in this study (by signing the ICF). In the opinion of the Investigator, competence and willingness to provide written, informed consent for participation after reading the informed consent form. The subject must have adequate opportunity to discuss the study with an Investigator or qualified designee. 7. If female, have a negative serum pregnancy test result prior to immunization. 8. Female of childbearing potential (except subjects in a same sex relationship), must use an effective birth control for the 28 days prior to immunization and must agree to continue employing adequate birth control measures for at least 60 days post-immunization and must have no plan to become pregnant for at least 60 days post-immunization. Highly effective birth control includes hormonal contraceptives (e.g., injectable, topical [patch], estrogenic vaginal ring, etc.), intra-uterine device (IUD), abstinence (confirmed by Investigator), or male condom plus spermicide. Abstinent subjects should be asked what method(s) they would use, should their circumstances change, and subjects without a well-defined plan should be excluded. Exclusion Criteria: 1. Presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Uncontrolled is defined as: 1. Requiring a new medical or surgical treatment within one month prior to study vaccine administration; 2. Requiring a change in medication dosage in one month prior to study vaccine administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable); 3. Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to study vaccine administration. 2. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigators opinion, would render the subject incompetent to provide informed consent or unable to provide valid safety observations and reporting. 3. Any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection, Hepatitis B or C, or the presence of lymphoproliferative disease. 4. Presence of any febrile illness, oral temperature of >38.0˚C within 24 hours prior to immunization. Such subjects may be re-evaluated for enrolment after resolution of illness. 5. History of autoimmune disease. 6. Administration of any vaccine (including any other influenza vaccine) within 30 days prior to study enrolment or planned administration within the period from the vaccination up to blood sampling at Day 21 or within 30 days prior to blood sampling at Day 201. Immunization on an emergency basis of a tetanus and diphtheria toxoids adsorbed for adult use (Td) will be allowed provided the vaccine is not administered within two weeks prior to study vaccine administration. Receipt of any other emergency immunizations (e.g., rabies) will result in a case-by-case review by the medical monitor of continued participation. 7. Administration of any adjuvanted or investigational influenza vaccine other than a simple seasonal Trivalent influenza vaccine (TIV) or Quadrivalent influenza vaccine (QIV) within 1 year prior to study enrolment or planned administration prior to the end of this trial (Day 201). 8. Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while participating in this study. 9. Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone per day, or equivalent for more than 7 consecutive days or for 10 or more days in total, within one month of study vaccine administration, any other cytotoxic or immunosuppressant drug, or any globulin preparation within 3 months of vaccination. Low doses of nasal or inhaled glucocorticoids are allowed. 10. Use of high dose inhaled steroids or oral and parenteral high dose steroid medications. Nasal steroids are allowed. 11. Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin [≤ 325 mg/day (1 regular adult aspirin) or ≤ 81 mg/day (1 baby aspirin)], and without a clinically apparent bleeding tendency are eligible. 12. History of allergy to any of the constituents of the quadrivalent VLP study vaccine, or to the Phosphate-buffered saline (PBS) (used as placebo). 13. History of severe allergic reactions (including anaphylaxis) to any food, medication or bee sting or previous severe asthma. 14. History of tobacco allergy. 15. Continuous use of anti-histamines in the last 4 weeks prior to immunization or use of anti-histamines 48 hours prior to study immunization. 16. Have a rash, dermatological condition, tattoos, or muscle mass at injection site which may interfere with injection site reaction rating. 17. Have received a blood transfusion within 90 days prior to study vaccination. 18. If female, either known pregnancy or urine beta-human chorionic gonadotropin (β-hCG) test results consistent with pregnancy during the screening period and prior to study vaccine administration on Day 0. 19. Female subjects who are lactating. 20. Any vital sign abnormalities: systolic blood pressure, diastolic blood pressure, resting heart rate not well controlled or according to the Investigators opinion. 21. Cancer or treatment for cancer within 3 years of study vaccine administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible. ; PRIMARY OUTCOME: Rate of solicited and unsolicited adverse events post-vaccination.; SECONDARY OUTCOME 1: Serum HI response induced in subjects against the vaccine strains[/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 - ENESTop; BRIEF: A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study. ; DRUG USED: Tasigna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Myelogenous Leukemia (CML); TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female patients >= 18 years of age 2. ECOG Performance Status of 0, 1, or 2 3. Patient with diagnosis of BCR-ABL positive CML CP 4. Patient has received a minimum of 3 years of tyrosine kinase inhibitor treatment (first with imatinib (> 4 weeks) and then switched to nilotinib) since initial diagnosis 5. Patient has at least 2 years of nilotinib treatment prior to study entry. 6. Patient has achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening 7. Adequate end organ function as defined by: - Direct bilirubin ≤ 1.5 x ULN except for i) patient with documented Gilberts syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range) - SGOT(AST) and SGPT(ALT) < 3 x ULN (upper limit of normal) - Serum lipase ≤ 2 x ULN - Alkaline phosphatase ≤ 2.5 x ULN - Serum creatinine < 1.5 x ULN 8. Patients must have the following electrolyte values ≥ LLN (lower limit of normal) limits or corrected to within normal limits with supplements prior to the first dose of study medication: - Potassium - Magnesium - Total calcium (corrected for serum albumin) 9. Patients must have normal marrow function as defined below: - Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 100 x 109/L - Hemoglobin ≥ 9.0 g/dL 10. Written informed consent obtained prior to any screening procedures Exclusion Criteria: 1. Prior AP, BC or allo-transplant 2. Patient has documented MR4.5 at the time when switched from imatinib to nilotinib 3. Patients with known atypical transcript 4. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past) 5. Dose reductions due to neutropenia or thrombocytopenia in the past 6 months 6. Patient ever attempted to permanently discontinue imatinib or nilotinib treatment 7. Known impaired cardiac function including any one of the following: - Inability to determine the QT interval on ECG - Complete left bundle branch block - Long QT syndrome or a known family history of long QT syndrome - History of or presence of clinically significant ventricular or atrial tachyarrhythmias - Clinically significant resting bradycardia - QTcF > 480 msec - History or clinical signs of myocardial infarction within 1 year prior to study entry - History of unstable angina within 1 year prior to study entry - Other clinically significant heart disease (e.g. uncontrolled congestive heart failure or uncontrolled hypertension) 8. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes (defined as HbA1c > 9%), uncontrolled infection) 9. History of acute pancreatitis within 1 year prior to study entry or past medical history of chronic pancreatitis 10. Known presence of a significant congenital or acquired bleeding disorder unrelated to cancer 11. History of other active malignancy within 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ treated curatively 12. Patients who have not recovered from prior surgery 13. Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks of Day 1 14. Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to study entry. See Appendix 14.1 for a list of these medications. This list may not be comprehensive. 15. Patients actively receiving therapy with herbal medicines that are strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to study entry. These herbal medicines may include Echinacea, (including E. purpurea, E. angustifolia and E. pallida), Piperine, Artemisinin, St. Johns Wort, and Ginkgo. 16. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either safely discontinued or switched to a different medication prior to study entry. (Please see www.azcert.org/medical-pros/drug-lists/printable-drug-list.cfm for a list of agents that prolong the QT interval.) 17. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery) 18. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 19. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test before initiation of study treatment and must also use highly effective methods of contraception while enrolled in the study. The use of highly effective contraception should continue for at least 14 days after the last dose of study treatment or until the last day of TFR/TFR-2, or for the duration of a monthly cycle of oral contraception, whichever is longer. Acceptable forms of highly effective contraception methods include: - Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment - Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should be stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to enrolling. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. If a study patient becomes pregnant or is suspected of being pregnant during the study or within 30 days as part of safety evaluations after the final dose of nilotinib, the Study Doctor needs to be informed immediately and any ongoing study treatment with nilotinib has to be stopped immediately. ; PRIMARY OUTCOME: Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks; SECONDARY OUTCOME 1: Percentage of Patients in Treatment Free Remission (TFR) Within 96, 144, 192, 264 Weeks and Within 6,7,8,9 and 10 Years[/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 - PB-06-007 - Extension; BRIEF: This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor. ; DRUG USED: Elelyso; DRUG CLASS: Biologic; INDICATION: Gauchers Disease; TARGET: Glucocerebroside (glucosylceramide); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003 - The subject signs an informed consent Exclusion Criteria: - Currently taking another investigational drug for any condition. - Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subjects compliance with the requirements of the study. ; PRIMARY OUTCOME: Spleen Volume; SECONDARY OUTCOME 1: Liver Volume[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ACCUTE; BRIEF: The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy. ; DRUG USED: Reltecimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Cluster of Differentiation 28 (CD28) /ICOS and B7RP-1 Pathway, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Atox Bio Ltd; CRITERIA: Inclusion Criteria: 1. Surgical confirmation of NSTI by attending surgeon; 2. mSOFA score ≥3 (in any one or combination of the 5 major components of SOFA score with one organ component having a score of at least 2: cardiovascular, respiratory, renal, coagulation, CNS), measured as close as possible to the first debridement; 3. IV drug administration within 6 hours from the clinical diagnosis and the decision at the study site, to have an urgent surgical exploration and debridement (drug should not be administered until surgical confirmation is established); 4. If a woman is of childbearing potential, she must consistently use an acceptable method of contraception from baseline through Day 28; 5. If a male patients sexual partner is of childbearing potential, the male patient must acknowledge that they will consistently use an acceptable method of contraception (defined above) from baseline through Day 28. 6. Signed and dated informed consent (ICF) as defined by the Institutional Review Board (IRB) and, if applicable, California Bill of Rights. If patient is unable to comprehend or sign the ICF, patients legally acceptable representative may sign the ICF Exclusion Criteria: 1. BMI>51; 2. Patient who has been operated at least once for the current NSTI infection and had a curative deep tissue debridement; 3. Patients with overt peripheral vascular disease in the involved area ; 4. Diabetic patients with peripheral vascular disease who present with below the ankle infection; 5. Removed deep vein thrombosis (DVT) in area of NSTI as an exclusion criteria 6. Patient with burn wounds; 7. Current condition of: (a) Inability to maintain a mean arterial pressure > 50 mmHg and/or systolic blood pressure > 70 mmHg for at least 1 hour prior to screening despite the presence of vasopressors and IV fluids or (b) a patient with respiratory failure such that an SaO2 of 80% cannot be achieved or (c) a patient with refractory coagulopathy (INR >5) or thrombocytopenia (platelet count <20,000) that does not partially correct with administration of appropriate factors or blood products; 8. Chronic neurological impairment that leads to a neuro mSOFA component ≥2; 9. Recent cerebrovascular accident in the last 3 months; 10. Patients with cardiac arrest requiring cardiopulmonary resuscitation within the past 30 days; 11. Patient is not expected to survive throughout 28 days of study due to underlying medical condition, such as poorly controlled neoplasm; 12. Patient or patients family are not committed to aggressive management of the patients condition; 13. Any concurrent medical condition, which in the opinion of the Investigator, may compromise the safety of the patient or the objectives of the study or the patient will not benefit from treatment such as: - Congestive heart failure (CHF){ New York Heart Association (NYHA) class III-IV} - Severe chronic pulmonary obstructive disease (COPD) - Liver dysfunction {Childs-Pugh class C} - Immunosuppression (see Appendix F, Section 15.6 for list of excluded immunosuppressive medications) - Neutropenia < 1,000 cells/mm3not due to the underlying infection - Idiopathic Thrombocytopenia Purpura - Receiving or about to receive chemotherapy or biologic anti-cancer treatment although hormonal manipulation therapies for breast and prostate malignancies are permitted - Hematological and lymphatic malignancies in the last 5 years; 14. Known HIV infection with CD4 (cluster of differentiation 4) count < 200 cells/mm3 or < 14% of all lymphocytes; 15. Patients with known chronic kidney disease (documented pre-illness creatinine value(s) ≥2.0) or patients receiving renal replacement therapy for chronic kidney disease; 16. Patients that are treated with continuous hemofiltration (e.g. Continuous Veno-Venous Hemofiltration) for acute kidney dysfunction, not due to NSTI, starting prior to study drug administration; 17. Pregnant or lactating women; 18. Previous enrollment in a clinical trial involving investigational drug or a medical device within 30 days; 19. Previous enrollment in this protocol, ATB-202 or the Phase 2 trial of AB103, ATB-201. ; PRIMARY OUTCOME: Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE); SECONDARY OUTCOME 1: Number of Patients With One or More 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 IIa - Perio1; BRIEF: A Phase 2a Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor Analog, AMY-101, in Adults with gingivitis. The study is a 3-month randomized, double-blind, split-mouth study of adults with existing chronic periodontal inflammation determined by the level of gingival index and bleeding on probing. The primary endpoint of change in gingival index will be evaluated at 21, 28 and 90 days after initial treatment (baseline treatment). Subjects will also be followed at Day 3, 7, 14, 21, 28 and 90 for safety evaluations. Change in bleeding on probing plaque index, pocket depth, clinical attachment level and GCF levels of pro-inflammatory cytokines and complement factors will be assessed as secondary outcome measures. Composition of subgingival biofilm will be assessed as an exploratory endpoint. Subjects who meet inclusion criteria will be enrolled in the study and sites will be randomized to treatment groups (AMY-101 or placebo) in split mouth design. After clinical assessments and sample collection at baseline, both test and placebo treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14. ; DRUG USED: AMY-101; DRUG CLASS: Biologic; INDICATION: Periodontitis; TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Amyndas Pharmaceuticals S.A.; CRITERIA: Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age 18-65 years old. 4. Equal to or greater than 18 natural teeth present (excluding third molars). 5. Generalized periodontal inflammation determined by modified gingival index and percent bleeding on probing (MGI≥2.0, BOP ≥ 40%). 6. In good general health as evidenced by medical history. 7. For women of reproductive potential, use of licensed hormonal contraception or barrier methods or abstinence for at least 1 month prior to screening and agreement to use such a method during study participation. 8. For men of reproductive potential, agreement to use condoms or other methods to ensure effective contraception with partner. Exclusion Criteria: 1. Presence of orthodontic appliances (including fixed lingual retainer). 2. A soft or hard tissue tumor of the oral cavity. 3. Carious lesions requiring immediate treatment. 4. Participation in any other clinical study within 30 days of screening or during the study. 5. Antibiotic therapy within the last 30 days. 6. Chronic use (≥3 times/week) of anti-inflammatory medications [e.g., non-steroidal anti-inflammatory drugs (NSAIDs), steroids]. Low dose (<325 mg) aspirin is allowed. 7. Immune compromised subjects (e.g., subjects with HIV infection, neutropenia, complement deficiency, etc.). 8. Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as diabetes (irrespective of level of control), rheumatoid arthritis, Crohns disease, nifedipine, phenytoin (Dilantin), anticoagulant medications (e.g., warfarin [Coumadin] etc.), ongoing cancer treatment either with radiation or chemotherapy. 9. Involvement in the planning or conduct of the study. 10. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or interfere with interpretation of the subjects study results. 11. Pregnancy or lactation. 12. Uncontrolled chronic diseases (e.g., kidney disease, COPD, pulmonary fibrosis, Hepatitis C) 13. Autoimmune disorders (Downs Syndrome, Sjogrens Disease, Psoriasis, Chediak-Higashi Syndrome) 14. Conditions requiring antibiotic prophylaxis. 15. Periodontal therapy within the past one year. 16. Gross tooth decay, as determined by the investigator. 17. Periodontal or dental abscesses. 18. Root fragments, pericoronitis, endo-perio lesions. 19. Use of cigarettes or other tobacco products (including e-cigarette or recreational drug use) within 1 year before the screening visit. ; PRIMARY OUTCOME: Change in mean gingival index (MGI); SECONDARY OUTCOME 1: Gingival inflammation[/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 - Sustained and Immediate Release; BRIEF: This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet (ER) formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D. Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a, the cohort will be further expanded by up to 19 more patients to a total of 29 patients to confirm the efficacy and safety profile of onapristone in this selected patient population (Stage 2b). ; DRUG USED: Apristor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine (Endometrial) Cancer; TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Arno Therapeutics; CRITERIA: Inclusion Criteria: 1. Post- menopausal female patients, 18 years of age or greater. 2. In Stage 1, recurrent or metastatic PR-expressing cancer that has the potential to benefit from an anti-progestin treatment including but not limited to endometrial cancer, ovarian, or breast cancer or uterine sarcoma. In Stage 2, recurrent or metastatic PR-expression uterine endometrioid adenocarcinoma that is determined to be APRpos. 3. Patients who have metastatic or recurrent disease after previous surgery, radiation therapy, and/or chemotherapy are eligible. In Stage 1, no restriction is placed on the number of prior therapies. In Stage 2, patients may have 0 or 1 prior chemotherapy treatments for adjuvant or metastatic disease and no prior endocrine therapies. 4. In Stage 1, evaluable disease per RECIST 1.1. In Stage 2, measurable disease. 5. Appropriate archival OR current tissue blocks or biopsy specimens to determine ER/PR and APR status. 6. Signed, written informed consent must be obtained and documented according to ICH-GCP, the local regulatory requirements, and local data protection laws prior to study-specific screening procedures. 7. ECOG performance status 0-1. 8. Health care coverage. Exclusion Criteria: 1. Calculated creatinine clearance of <60 mL/min in Stage 1 and <40 mL/min in Stage 2 2. Patients with any other prior malignancy are not allowed except for the following: - Adequately treated basal cell or squamous cell skin cancer - In situ cervical cancer - Adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 2 years 3. Body mass index (BMI) <18.5 or >35 kg/m2. 4. On ECG a QTc(F) interval >480 msec or any clinically significant cardiac rhythm abnormalities. 5. Liver function tests documented within the screening period and on day -1 of treatment period: - Total bilirubin > ULN (except in patients diagnosed with Gilberts disease). - Alkaline phosphatase > UNL or > 2.5 x UNL in case of liver metastases, or > 5 x UNL in case of bone metastases. - ALT/AST > UNL or > 2.5 x UNL in case of liver metastases. 6. Known positive virology/serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B (surface antigen), or hepatitis C. 7. Chronic inflammatory liver condition. 8. Chronic adrenal failure or is receiving concurrent long-term corticosteroid therapy. 9. 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. 10. Used any prescription medication during the prior 1 month that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating. 11. 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. 12. Received prior systemic anticancer treatment (chemotherapy, targeted therapies including kinase inhibitors, antibodies, etc) less than 5 half-lives before the first dose of study drug or radiotherapy within 30 days; toxicity of the anticancer treatment must have recovered to grade 1 or less. 13. Current progestin-based hormone replacement therapy. 14. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to swallow pills. 15. Has a mental incapacity or language barriers precluding adequate understanding, co-operation, and compliance with the study requirements. 16. Is, in the judgment of the investigator, unable or unwilling to comply with the requirements of the study. 17. Uncontrolled brain metastases or treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1. 18. For Stage 2 only, mixed histology i.e. patients with >10% non-endometrioid malignant cells in provided histopathology samples. ; PRIMARY OUTCOME: Stage 1: RP2D of a single agent extended-release tablet formulation of oral onapristone for future clinical development.; SECONDARY OUTCOME 1: Safety and tolerability of extended-release onapristone tablets BID and of immediate-release onapristone tablets QD[/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 - 15062 (Once-Weekly); BRIEF: The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants involvement in the study is expected to last about 30 weeks. ; DRUG USED: OPK-88003; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: OPKO Health, Inc.; CRITERIA: Inclusion Criteria: - Men or women with diabetes mellitus Type 2 - Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening - Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening Exclusion Criteria: - Women of child bearing potential - Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months - Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year - Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men) ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12; SECONDARY OUTCOME 1: Change From Baseline in HbA1c at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COSMIC-312 (1L HCC); BRIEF: This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), FMS-like tyrosine kinase 3 (FLT-3) , Hepatocyte growth factor receptor (c-Met, HGFR), KIT/c-KIT, RET, VEGF Receptor (VEGFR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Exelixis; CRITERIA: Inclusion Criteria: - Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by CT or MRI per the AASLD 2018 or EASL 2018 guidelines. - The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE). - Measurable disease per RECIST 1.1 as determined by the Investigator. - Barcelona Clinic Liver Cancer (BCLC) stage Category B or C. - Child-Pugh Score of A. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma. - Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and immune checkpoint inhibitors (ICIs). Subjects who have received local intratumoral or arterial chemotherapy are eligible; local anticancer therapy must be completed ≥ 28 days before randomization - Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 8 weeks prior to randomization. - Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization. - Concomitant anticoagulation with oral anticoagulants ; PRIMARY OUTCOME: Duration of Progression Free Survival (PFS) for the experimental arm vs. the control arm; SECONDARY OUTCOME 1: Duration of Progression Free Survival (PFS) for the single-agent arm vs. the control arm[/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 - Renal; BRIEF: This is a Phase 2 clinical trial to collect data on tumor responses produced by folate-hapten conjugate therapy (vaccination with EC90 [KLH-FITC] and GPI-0100 adjuvant followed by treatment with EC17 (folate-FITC) in combination with low-dose cytokines in patients with progressive metastatic renal cell carcinoma. All patients will undergo imaging with the investigational imaging agent 99mTc-EC20 (FolateScan) during the screening period to confirm eligibility for the treatment portion of the clinical trial. ; DRUG USED: EC17; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Folate Receptor (FOLR1), Immune System; THERAPY: Combination; LEAD SPONSOR: Endocyte; CRITERIA: Inclusion Criteria: - Must have a histologically confirmed diagnosis of renal cell carcinoma (clear cell or predominately clear cell component). Papillary histology may also be enrolled (maximum of 6 patients) - Must be diagnosed with relapsed or Stage IV disease that is medically or surgically unresectable and that has progressed after systemic therapy, including at least one agent in the general class of kinase inhibitors (TKI not required for papillary histology) - Must have measurable/evaluable metastatic disease sites that have not previously received radiotherapy and which does not require palliative intervention (at the time of enrollment). Patients with non-measurable/evaluable disease are ineligible - Must have at least one tumor lesion that displays uptake of 99mTc-EC20 - Must be > than or = 18 years of age - Women must either be 1)not of child-bearing potential of 2)have a negative serum pregnancy test within 7 days prior to commencing treatment with investigational agents - Must have completed prior cytotoxic chemotherapy, radiotherapy, immunotherapy or experimental therapy 30 or more days prior to study enrollment, and recovered (or returned to baseline) from associated acute toxicities. This restriction excludes palliative radiotherapy. - Must have an ECOG score less than or equal to 2 - Must have adequate hematologic, renal, and heptic function Exclusion Criteria: - Must not have a history of severe hypersensitivity (grade 3 - 4 allergic reaction) to fluorescein, radiological contrast agent, cytokines, or have received fluorescein within 30 days of the study - Must not have medical conditions that preclude the use of IL-2 or IFN-α. - Must not be pregnant or breast-feeding - Must not be currently undergoing chemotherapy, anticancer hormonal therapy, and/or therapy with immunosuppressant agents - Must not be currently receiving bisphosphonates such as Zometa® (unless started > four weeks prior to treatment with EC90/GPI-0100, in which case they can be continued) - Must not have any concomitant malignancy with the exception of basal cell or squamous cell carcinoma of skin - Must not have radiographically documented evidence of current brain metastases, a history of stem cell transplant, immunodeficiency, and/or a medical or psychiatric illness (that in the investigators opinion, would prevent adequate compliance with study therapy or evaluation of the endpoints) - Must not have been administered another radiopharmaceutical that would interfere with the assessment of 99mTc-EC20 - Must not be unable to tolerate conditions for radionuclide imaging ; PRIMARY OUTCOME: Response Rate - the proportion of subjects with objective response based on RECIST criteria; SECONDARY OUTCOME 1: To assess the safety and tolerability of folate-hapten conjugate therapy[/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/Calcium Folinate; BRIEF: Primary Objective: To determine disease control rate (DCR) of TS-1® in patients with heavily pre-treated metastatic colorectal cancer Secondary Objectives: - To determine objective response rate (ORR) - To determine time to progression (TTP) - To determine overall survival (OS) - To assess incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability] ; DRUG USED: S-1; DRUG CLASS: Non-NME; INDICATION: Colorectal Cancer (CRC); TARGET: Dihydropyrimidine dehydrogenase (DPD) , Thymidylate Synthase; THERAPY: Combination; LEAD SPONSOR: TTY Biopharm; CRITERIA: Inclusion Criteria: 1. histologically or cytologically confirmed colorectal adenocarcinoma; 2. metastatic and unresectable disease; 3. presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of: 1. 10mm by CT scan and MRI (no less than double the slice thickness and a minimum of 10mm); 2. 20mm by conventional techniques; 4. previously treatment to 1. fluoropyrimidine, oxaliplatin and irinotecan; 2. at least one targeted therapy 5. adequate hematopoietic function which is defined as below: 1. hemoglobin ≥ 9 g/dL; 2. absolute neutrophil count (ANC) ≥ 1,500/mm3; 3. platelet count ≥ 100,000/mm3; 6. adequate hepatic function which is defined as below: 1. total bilirubin ≤ 2 times upper limit of normal (ULN); 2. hepatic transaminases (ALT and AST) ≤ 3 x ULN. If there are known liver metastases, ALT or AST must be ≤ 5 x ULN; 7. adequate renal function which is defined as below: a. serum creatinine ≤ 1.5 x ULN; 8. age of 20 years or above; 9. ECOG performance status 0-2; 10. life expectancy of at least 12 weeks; 11. ability to take oral medication; 12. ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. history or known presence of brain metastasis; 2. presence of mental disease or psychotic manifestation; 3. significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigators discretion; 4. presence of diarrhea ≥ grade 2 in common terminology criteria for adverse event version 4.0 (CTCAE v4.0); 5. other malignancy within the past 5 years (different site or histology) except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ; 6. recent (within 30 days prior to study treatment) treatment of another investigational drug; 7. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential should have effective contraception for both the patient and his or her partner during the study. ; PRIMARY OUTCOME: Disease Control Rate (DCR); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - QIV vs TIV - Child/Adolescent/Adult; BRIEF: The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age). Primary Objective: - To describe the safety profile (injection site reactions and systemic events) of each vaccine during the 21 days following vaccination, and serious adverse events (including adverse events of special interest) throughout the study in all adult and child/adolescent participants. Secondary Objectives: - To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine (QIV) induce an equivalent immune response at 21 days post-vaccination in both age groups (lot consistency) - To describe the compliance of the immunogenicity of QIV to the European Medicines Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group. ; DRUG USED: Fluzone Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria: - Aged 9 to 11 years (children), 12 to 17 years (adolescents), or 18 to 60 years (adults) on the day of inclusion - For child/adolescent subjects, informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative (and independent witness, if required by local regulations), and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations). For adult subjects, informed consent form has been signed and dated by the subject (and an independent witness, if required by local regulations). - Subject/subject and parent/legally acceptable representative is/are able to attend all scheduled visits and to comply with all trial procedures - Covered by health insurance, if required by local regulation. Exclusion Criteria: - Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) - Participation at the time of study enrollment or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure - Receipt of any vaccine in the 4 weeks preceding trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination - Previous vaccination against influenza with the 2012 Southern Hemisphere formulation or the 2011-2012 Northern Hemisphere formulation in the previous 6 months with either the trial vaccine or another vaccine - Receipt of immune globulins, blood or blood-derived products in the past 3 months - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances - Self-reported thrombocytopenia, contraindicating intramuscular vaccination based on investigators judgment - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on investigators judgment - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily - Current alcohol abuse or drug addiction (for adolescent and adult subjects) - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided - Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural, or adopted child) of the investigator or employee with direct involvement in the proposed study. ; PRIMARY OUTCOME: Percentage of participants reporting solicited injection site reactions and solicited systemic reactions during the trial; SECONDARY OUTCOME 1: Percentage of participants with seroprotection and seroconversion post vaccination with either the investigational QIV, or TIV or the licensed 2011-2012 TIV[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - C-10-079; BRIEF: The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score. ; DRUG USED: ESBA105; DRUG CLASS: Biologic; INDICATION: Dry Eye (Ophthalmology); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Alcon Research; CRITERIA: Inclusion Criteria: - Ongoing physician diagnosis of dry eye for at least 6 months. - Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis. - Experience persistent ocular discomfort. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Contact lens wearers. - Severe Sjogrens Syndrome. - History of corneal surgery including refractive surgeries. - Intraocular surgery within 6 months of Visit 1. - Intraocular or periocular injection within 6 months of Visit 1. - Lid function abnormalities. - Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1. - Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1. - Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea. - Other protocol-defined exclusion criteria may apply. ; PRIMARY OUTCOME: Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28; 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 - High-Grade Glioma; BRIEF: This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients. ; DRUG USED: ANG1005; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Cluster of Differentiation 91 (CD91) / Low density lipoprotein receptor-related protein 1 (LRP1), Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Angiochem Inc; CRITERIA: Inclusion Criteria: 1. ≥ 18 years old 2. GBM and GBM variants, WHO Grade III anaplastic glioma diagnosis confirmed 3. Radiologically confirmed recurrent and bi-dimensionally measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria 4. Neurologically stable 5. For bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy 6. Karnofsky performance status (KPS) ≥ 80 7. Expected survival of at least 3 months Exclusion Criteria: 1. More than three relapses 2. Previous ANG1005/GRN1005 treatment 3. Radiotherapy within 3 months. 4. Therapy with bevacizumab within 4 weeks prior to Day 1 of treatment for recurrent WHO grade III anaplastic glioma patients (Arm 3) 5. Evidence of significant intracranial hemorrhage 6. Previous taxane treatment 7. Prior therapy with bevacizumab for bevacizumab-naïve patients (Arm 1) 8. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy 9. Inadequate bone marrow reserve 10. Any evidence of severe or uncontrolled diseases 11. Participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis C or B or HIV 12. Known severe hypersensitivity or allergy to paclitaxel or any of its components ; PRIMARY OUTCOME: Objective Response Rate (ORR) (Arms 1 and 3); SECONDARY OUTCOME 1: ORR in Arm 2[/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 - PT044; BRIEF: A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis. ; DRUG USED: Bermekimab; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Written informed consent provided by the patient - Age 18 years or greater - Chronic Atopic Dermatitis present for at least 3 years - Disease is not responsive to topical medications, or for whom topical treatments are not indicated or desired. - Willing and able to comply with all clinic visits and study-related procedures - EASI score ≥16 at screening and baseline visits - IGA score ≥3 at screening and baseline visits - ≥10% body surface area (BSA) of AD involvement at screening and baseline visits - Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable or undesired. Exclusion Criteria: - Treatment with an investigational drug within 8 weeks of baseline visit - Having received the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment: 1. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) 2. Phototherapy for AD - Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit - Initiation of treatment during the screening period with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit) - Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit. - History of severe allergic or anaphylactic reactions to monoclonal antibodies. - Administration of any live (attenuated) vaccine within 4 weeks prior to the baseline. - Any history of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ of the cervix - Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves - Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment - History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening - Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit - Presence of skin comorbidities that may interfere with study assessments - Severe concomitant illness(es) that, in the investigators judgment, would adversely affect the patients participation in the study. Examples include, but are not limited to, patients with short life expectancy, patients with uncontrolled diabetes (HbA1c ≥ 9%), patients with cardiovascular conditions (eg, stage III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, patients on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary or lymphatic diseases. The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, case report forms [CRFs], etc.) - Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study - Where relevant, women unwilling to use adequate birth control ; PRIMARY OUTCOME: Number of Patients With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last 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 IIb - w/Copaxone; BRIEF: This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone injections in all subjects. The primary outcome measure is a reduction in relapses. ; DRUG USED: Trimesta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Combination; LEAD SPONSOR: University of California, Los Angeles; CRITERIA: Inclusion Criteria: - Diagnosis of relapsing remitting multiple sclerosis - At least one relapse in the last two years Exclusion Criteria: - Patients treated in the past with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine, bone marrow transplantation, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or Tysabri - Clinically significant diseases other than multiple sclerosis ; PRIMARY OUTCOME: Confirmed Relapse, Annualized Relapse Rate; SECONDARY OUTCOME 1: Relapse Event, Annualized Relapse Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Coreg; BRIEF: The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet. ; DRUG USED: EG-P042; DRUG CLASS: Non-NME; INDICATION: Hypertension (Systemic); TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Egalet Ltd; CRITERIA: Inclusion Criteria: - Have a diagnosis of mild or moderate primary hypertension - Be able to tolerate a 2 week washout phase followed by a 2 week Placebo run- in phase - Be minimum 18 years of age Exclusion Criteria: - Be intolerant to alfa- or beta-blockers - Have secondary causes of hypertension - Be taking more than two antihypertensive medications ; PRIMARY OUTCOME: The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise; SECONDARY OUTCOME 1: The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - CLARITY-1; BRIEF: This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss. ; DRUG USED: AUT00063; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hearing Loss - General; TARGET: Potassium channels; THERAPY: Monotherapy; LEAD SPONSOR: Autifony Therapeutics Limited; CRITERIA: - Be between ages 50-89 years old - American-English speaking - Have difficulty hearing speech in a noisy environment - No recent history of middle ear disease - No severe insomnia, major depressive disorders, severe anxiety or post-traumatic stress disorder - Not a current or previous user of hearing aids. You are eligible if you were noncompliant and stopped wearing a hearing aid device >6 months earlier for intermittent use or >3 years if you were a full-time consistent user of hearing aid devices - Not be dependent on alcohol or drugs - Have not participated in another research study within 30-days - If female, you must confirm to be non child bearing (post-menopausal for at least 12-months or surgically sterile) - If male, you must confirm to use a barrier method (condom) - Not be a professional musician - No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease deemed clinically significant by the study doctor While you are in the study, you must: - Follow the instructions you are given - Come to the study centre for all visits with the study doctor or study staff - Answer the telephone at the scheduled date and time for the 2 telephone calls - Tell the study doctor or study staff about any changes in your health or the way you feel - Tell the study doctor or study staff if you want to stop being in the study at any time - Bring your Diary to each visit - Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit (Visit 3, Day 1) until the end of the study - Use sun screen if you plan to sunbathe - Not use headphones or headsets at high volume - Not use hearing aids or devices at any time during the study ; PRIMARY OUTCOME: Change in Hearing Loss After 4 Weeks of Treatment; SECONDARY OUTCOME 1: Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - OMC-SXB-26; BRIEF: The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia. ; DRUG USED: Rekinla; DRUG CLASS: Non-NME; INDICATION: Fibromyalgia; TARGET: GABA-B Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria - Sign & date informed consent - Willing & able to complete trial as described in protocol - > 18 years of age - Meet American College of Rheumatology criteria for Fibromyalgia [Widespread pain for at least 3 months, including all of the following: (1) Pain on right & left sides of body; (2) Pain above & below waist; (3) Pain in axial skeleton; 4) Pain on digital palpation with approximately 4kg force in at least 11 of 18 tender point sites] - (Study continuation) Have an average VAS pain score > 4 on a scale of 0 to 10 as recorded in patient diary the last week before Visit 4. - Discontinue all prescription medication taken for fibromyalgia, including opiates, benzodiazepines, anticonvulsants taken for pain, antidepressants, cyclobenzaprine (Flexeril), and/or tramadol (Ultram) until study completion - Continue all pre-existing nutritional and/or exercise regimens and/or behavioral, massage, acupuncture, physical or cognitive therapies on an unchanged, consistent & regular schedule throughout study - Use only acetaminophen or over-the-counter non-steroidal anti-inflammatory drugs as rescue pain medications & to limit dose to the labeled over-the-counter maximum. Aspirin may only be used as a cardiac protectant; formulations with caffeine are excluded. - Forego ingestion of alcohol for duration of study. - Fertile females must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) for duration of trial. Exclusion Criteria 1. Have any of the following medical conditions: - Other rheumatic disease, such as rheumatoid arthritis, osteoarthritis, or systemic lupus erythematosis - Uncontrolled hypo- or hyper-thyroidism of any type - Unstable cardiovascular, endocrine, neoplastic (excluding localized basal cell carcinoma), gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place patient at risk during trial or compromise objectives outlined in protocol - Myocardial infarction within last six months - On their screening PSG (polysomnogram) have an Apnea Index greater than 10 per hour or an Apnea Hypopnea Index greater than 15 per hour. Note: patients with sleep apnea are not excluded if their indices are below these thresholds while sleeping with CPAP (Continuous Positive Airway Pressure) and they are compliant with CPAP therapy. - Problems that, in the investigators opinion, would preclude the patients participation and completion of this trial or compromise reliable representation of subjective symptoms. - If a patient will have to discontinue antidepressant medication taken for depression, the investigator must make an evaluation as to any risks from cessation of anti-depressant therapy. If, in the opinion of the investigator, a reasonable risk of resultant patient harm exists, patient is excluded from study participation - Current or recent history of substance abuse including alcohol abuse - History of seizure disorder, history of head trauma, migraine headaches or intracranial surgery, & are taking anticonvulsants - Succinic semialdehyde dehydrogenase deficiency 2. Have taken any of these therapies: - gamma-hydroxybutyrate (sodium oxybate) in 30 days prior to signing informed consent - any investigational therapy in 30 days prior to signing informed consent - ever taken anticonvulsants to treat epilepsy or any other convulsions 3. Unwilling to stop these therapies during course of trial: - anticonvulsants prescribed solely for pain - all antidepressants - medication for sleep 4. Have any of the following clinical laboratory results: - Serum creatinine > 2.0 mg/dL - TSH (Thyroid Stimulating Hormone) < 0.3 μU/mL OR TSH > 6 μU/mL - abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal) - elevated serum bilirubin (more than 1.5 times the upper limit of normal) - pre-trial ECG with arrhythmia, greater than a first degree AV block - positive pregnancy test at any time during trial 5. Have any of the following socio-economic factors: - Pending workers compensation litigation or related other monetary settlements - Have an occupation that requires variable shift work or routine night shifts ; PRIMARY OUTCOME: The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).; 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 - Without Inhibitors; BRIEF: SIG-001-121 is a first-in-human (FIH), phase 1/2, multi-centre, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SIG-001 in adults with severe or moderately severe haemophilia A without inhibitors. Up to three dose cohorts (3 patients each) are planned. Cohort expansions (up to 3 additional patients) may be triggered to collect additional information about safety and efficacy. ; DRUG USED: SIG-001; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII; THERAPY: Monotherapy; LEAD SPONSOR: Sigilon Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Males aged 18 years or older - Diagnosis of Haemophilia A defined as ≤2% FVIII activity - Greater than 150 exposure days to treatment with FVIII products - Use of reliable barrier contraception if applicable - Normal levels of von Willebrand factor (VWF) antigen - Able and willing to provide informed consent - Willing to withdraw from FVIII prophylaxis during specified periods in the study Exclusion Criteria: - Body mass index (BMI) ≥35 - Current FVIII inhibitors (>0.6 Nijmegen Bethesda Units/mL) or prior Immune Tolerance Induction (ITI) - History of allergic reaction or anaphylaxis to recombinant FVIII products or SIG-001 components - Evidence of any bleeding disorder in addition to haemophilia A - Abnormal laboratory values as defined in the protocol - Active infection with Hepatitis B or Hepatitis C virus or currently managed with antiviral medications for Hepatitis B or C - Uncontrolled HIV infection - Active alcoholism or drug addiction during the 12 months before the screening visit - Active malignancy or history of malignancy in the 5 years prior to study entry - Participation in another investigational medicine or device study - Prior administration of a gene therapy product - Significant underlying disease or comorbidities that are a contraindication for general anaesthesia or laparoscopic procedure ; PRIMARY OUTCOME: Number and proportion of participants with treatment emergent adverse events (TEAEs) overall and by dose/cohort.; SECONDARY OUTCOME 1: Number and proportion of participants with inhibitor titer values assessed by Nijmegen Bethesda Assay overall and by dose/cohort.[/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/Everolimus (One Prior Treatment); BRIEF: Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate [ORR] at 24 weeks [ORR24W]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any greater than or equal to (>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization). ; DRUG USED: Lenvima; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria: - Histological or cytological confirmation of predominant clear cell renal cell carcinoma (RCC) (original tissue diagnosis of RCC is acceptable) - Documented evidence of advanced RCC - One prior disease progression episode on or after vascular endothelial growth factor (VEGF)-targeted treatment (for example, but not limited to, sunitinib, sorafenib, pazopanib, cabozantinib, bevacizumab, axitinib, vatalanib, AV951/tivozanib) administered for the treatment of RCC. Prior programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) treatment in addition to 1 prior VEGF-targeted treatment is allowed. - At least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) meeting the following criteria: - Lymph node (LN) lesion that measures at least 1 dimension as >=1.5 centimeter (cm) in the short axis; - Non-nodal lesion that measures >=1.0 cm in the longest diameter; - The lesion is suitable for repeat measurement using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a target lesion. - Male or female participants age >=18 years (or any age >=18 years if that age is considered to be an adult per the local jurisdiction) at the time of informed consent - Karnofsky Performance Status (KPS) of >=70 - Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to (<=) 150/90 millimeters of mercury (mmHg) at Screening and no change in antihypertensive medications within 1 week before Cycle 1/Day 1 - Adequate renal function defined as calculated creatinine clearance >=30 milliliters per minute (mL/min) per the Cockcroft and Gault formula - Adequate bone marrow function defined by: - Absolute neutrophil count (ANC) >=1500/millimeters cubed (mm^3) (>=1.5*10^9/Liters [L]); - Platelets >=100,000/mm^3 (>=100*10^9/L); - Hemoglobin >=9 grams per deciliter (g/dL) - Adequate blood coagulation function defined by International Normalized Ratio (INR) <=1.5 (except for participants on warfarin therapy where INR must be <=3.0 prior to randomization) - Adequate liver function defined by: - Total bilirubin <=1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilberts syndrome; - Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3* the ULN (in the case of liver metastases <=5* the ULN). Participants with bone metastases with ALP values greater than 3 times can be included. - Participant must voluntarily agree to provide written informed consent - Participant must be willing and able to comply with all aspects of the protocol Exclusion Criteria: - More than 1 prior VEGF-targeted treatment for advanced RCC - Participants with Central Nervous System (CNS) metastases are not eligible, unless they have completed local therapy for at least 4 weeks and have discontinued the use of corticosteroids for this indication or are on a tapering regimen of corticosteroids (defined as <=10 mg prednisolone equivalent) before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. - Active malignancy (except for RCC or definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months - Any anti-cancer treatment (except for radiation therapy) within 21 days, or any investigational agent within 30 days prior to the first dose of study drug; participants should have recovered from any toxicity related to previous anti-cancer treatment to Common Toxicity Criteria (CTC) grade 0 or 1. - Prior radiation therapy within 21 days prior to the start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior to study treatment start - Known intolerance to study drug (or any of the excipients) and/or known hypersensitivity to rapamycins (example, sirolimus, everolimus, temsirolimus) or any of the excipients - Participants with proteinuria greater than (>) 1+ on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein >=1 g/24 hour will be ineligible. - Fasting total cholesterol ˃300 mg/dL (or ˃7.75 millimoles [mmol]/L) and/or fasting triglycerides level ˃2.5* the ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication. - Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication. - Prolongation of QT corrected (QTc) interval to >480 milliseconds (ms) - Participants who have not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy - Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib or everolimus - Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (example, carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy. - Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug - Significant cardiovascular impairment within 6 months prior to the first dose of study drug; history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke, or cardiac arrhythmia associated with significant cardiovascular impairment or left ventricular ejection fraction (LVEF) below the institutional normal range as determined by screening multigated acquisition (MUGA) scan or echocardiogram. - Active infection (any infection requiring systemic treatment) - Any medical or other condition that in the opinion of the investigator(s) would preclude the participants participation in a clinical study - Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of β-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. - Females of childbearing potential who (Note: all females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing].): - do not agree to use a highly effective method of contraception for the entire study period and for up to 8 weeks after study drug discontinuation, that is: - total abstinence (if it is their preferred and usual lifestyle) - an intrauterine device (IUD) or hormone releasing system (IUS) - a contraceptive implant - an oral contraceptive (with additional barrier method) (Note: Participants must be on a stable dose of the same oral hormonal contraceptive product for at least 4 weeks before dosing with study drug and for the duration of the study.) OR - do not have a vasectomized partner with confirmed azoospermia For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double barrier methods of contraception, such as condom plus diaphragm or cervical/vault cap with spermicide. ; PRIMARY OUTCOME: Objective Response Rate at Week 24 (ORR24W); 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 III - BEACON; BRIEF: The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens. The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physicians Choice selected from a list of seven single-agent intravenous therapies. ; DRUG USED: Onzeald; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: Nektar Therapeutics; CRITERIA: Inclusion Criteria (major highlights): - Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated - Patient can have either measurable or non-measurable disease by RECIST. - Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine - Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen. - Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate hematopoietic, liver and kidney functions. Exclusion Criteria (major highlights): - Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization. - Patient with any major surgery within 28 days prior to randomization. - Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s). - Patient with prior treatment for cancer with a camptothecin derivative. - Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization. - Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV. - Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease. - Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization. - Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization. - Patients with significant cardiovascular impairment. ; PRIMARY OUTCOME: Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population; SECONDARY OUTCOME 1: Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CUV029 (Europe); BRIEF: Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is not yet available on the market. The purpose of this study is to look at whether afamelanotide can reduce the number and severity of EPP symptoms when patients are exposed to light. This study will also look at how the drug is tolerated when taken by people with EPP. The study will involve the use of an implant, which comes in the form of a small rod (approximately 2 cm x 0.15 cm) to be administered under the skin. The implant may contain the study drug afamelanotide or a placebo (inactive medication). Over 450 subjects have been treated with afamelanotide to date with no serious safety concerns identified. For this study, afamelanotide has been formulated as a controlled release depot injection (implant). This means that the afamelanotide will be released slowly into the body over a few days. Once inserted, the implant will remain in the body after afamelanotide has been released and will slowly dissolve. This study will help to provide more information about afamelanotide. This information will be used to determine the safety and efficacy (the ability of the drug to produce an effect) of this drug in EPP sufferers. Up to 70 people will participate in this study from study sites across Europe. ; DRUG USED: Scenesse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Porphyria; TARGET: Melanocortin (MC) receptors; THERAPY: Monotherapy; LEAD SPONSOR: Clinuvel Pharmaceuticals Limited; CRITERIA: Inclusion Criteria: - Male or female subjects with a diagnosis of EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes) of sufficient severity that they have requested treatment to alleviate their symptoms. - Aged 18 - 70 years (inclusive) - Written informed consent prior to the performance of any study-specific procedures. Exclusion Criteria: - Any allergy to afamelanotide or the polymer contained in the implant or to lignocaine or other local anaesthetic to be used during the administration of study medication. - EPP patients with significant hepatic involvement. - Personal history of melanoma or dysplastic nevus syndrome. - Current Bowens disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions. - Any other photodermatosis such as PLE, DLE or solar urticaria. - Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations. - Acute history of drug or alcohol abuse (in the last 12 months). - Patient assessed as not suitable for the study in the opinion of the Investigator (e.g. noncompliance history, allergic to local anaesthetics, faints when given injections or giving blood). - Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating. - Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device). - Sexually active men with partners of child bearing potential not using barrier contraception during the trial and for a period of three months thereafter. - Participation in a clinical trial of an investigational agent within 30 days prior to the screening visit. - Prior and concomitant therapy with medications which may interfere with the objectives of the study, including drugs that cause photosensitivity or skin pigmentation. ; PRIMARY OUTCOME: The Duration of Direct Sunlight Exposure Between 10:00 and 15:00 Hours on Days When Patients Did Not Report Phototoxicity-related Pain (Likert Pain Scale Score of 0); SECONDARY OUTCOME 1: Number of Phototoxic Reactions[/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 - 001; BRIEF: The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies. ; DRUG USED: Oprozomib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: INCLUSION CRITERIA: Phase 1b - Histologically confirmed diagnosis of a hematologic malignancy, excluding patients with acute leukemia or MDS. - Relapsed after standard therapy for their malignancy and considered to be an appropriate candidate for a Phase 1 clinical study by their treating physician. Phase 2 - Multiple myeloma with measurable disease - Waldenström macroglobulinemia with symptomatic relapse - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. Ethical/Other - Patients must sign a written informed consent form in accordance with federal, local, and institutional guidelines. - Female patients of childbearing potential must have a negative serum or urine pregnancy test and agree to use effective contraception. Male patients must use an effective barrier method of contraception. EXCLUSION CRITERIA: - Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy intended to treat underlying malignancy, within 3 weeks prior to first dose or 6 weeks for antibody therapy. - Radiation therapy within 3 weeks prior to first dose. Radioimmunotherapy within 8 weeks prior to first dose. Localized radiation therapy within 1 week prior to first dose. - Immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required). - Prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-vs-host disease (GvHD; as defined in Filipovich 2005). - Evidence of central nervous system (CNS) lymphoma. - Prior treatment with carfilzomib unless in the phase 2. - Major surgery within 3 weeks prior to first dose. - Symptomatic Congestive heart failure, ischemia, conduction abnormalities, or myocardial infarction within 6 months. - Acute active infection requiring systemic antibiotics, antivirals, or antifungals. - Known or suspected human immunodeficiency virus (HIV) infection or patients who are HIV seropositive. - Active hepatitis A, B, or C infection. - Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose. - Patients with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis. - History of previous clinically significant GI bleed in the last 6 months prior to first dose. - Female patients who are pregnant or lactating. ; PRIMARY OUTCOME: Determine the MTD (Phase 1) and ORR (Phase 2).; SECONDARY OUTCOME 1: Evaluate the duration of response (DOR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DIONE; BRIEF: A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohns Disease with up to 48 weeks of treatment. ; DRUG USED: TD-1473; DRUG CLASS: New Molecular Entity (NME); INDICATION: Crohns Disease; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Theravance Biopharma; CRITERIA: Inclusion Criteria: - Is at least 18 years of age at screening - Males and females with clinical evidence of Crohns disease for at least 3 months duration at screening - Moderately-to-severely active Crohns Disease at baseline, as defined by a Crohns Disease Activity Index (CDAI) score of 220-450 inclusive - SES-CD score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD] - Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy, anti-IL-12/23 (anti-interleukin), anti-integrin). - Additional inclusion criteria apply Exclusion Criteria: - Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy - Has a current bacterial, parasitic, fungal, or viral infection - Has clinically significant abnormalities in laboratory evaluations - Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy - Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device) - Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23) - Additional exclusion criteria apply ; PRIMARY OUTCOME: Change From Baseline in Crohns Disease Activity Index (CDAI) Score; SECONDARY OUTCOME 1: Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI[/INST]No</s>