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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 II - +/- Vinorelbine (HER2+ IBC); BRIEF: The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment. ; DRUG USED: Gilotrif; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3, ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer 2. Locally advanced or metastatic disease 3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1) 4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment 5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer 6. Must have biopsiable disease Exclusion criteria: 1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population) 2. Must not have received prior vinorelbine treatment ; PRIMARY OUTCOME: Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).; SECONDARY OUTCOME 1: Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 007 (Breast Cancer/DCIS); BRIEF: This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels. ; DRUG USED: Fulvestrant (Atossa); DRUG CLASS: Non-NME; INDICATION: Breast Cancer; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Atossa Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Female 2. 18 years of age or older 3. Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS 4. Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy or lumpectomy 5. Estrogen Receptor-positive pathology 6. ECOG performance scale of 0-1 7. Adequate organ function as defined by the following criteria: - Absolute neutrophil count (ANC) ≥ 1500/μl - Platelets ≥ 100,000/μl - Hemoglobin ≥ 9.0 g/dl - Creatinine ≤ 2 times upper limit of normal - Bilirubin ≤ 2 times upper limit of normal - Transaminases (AST/SGOT and ALT/SGPT) ≤ 2.5 times upper limit of normal 8. Able to sign informed consent 9. Willing to use effective contraception for at least 100 days post study drug administration. Exclusion Criteria: 1. Concurrent treatment with another anti-estrogen 2. Presence of an active infection requiring systemic therapy 3. The following conditions contra-indicating fulvestrant administration: 1. Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use (excluding aspirin and anti-inflammatories) 2. Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate. 3. Severe hepatic impairment. 4. Prior surgery on the ipsilateral breast which interrupts communication of the ductal systems with the nipple 5. Prior radiation to the breast 6. Pregnant or lactating 7. Impaired cardiac function or history of cardiac problems of NYHA Class 111 and IV 8. Poor nutritional state as indicated by a BMI below 20. 9. Presence of serious infection not controlled with systemic therapy 10. History of allergies to Lidocaine or Novocain 11. Concurrent participation in an experimental drug study ; PRIMARY OUTCOME: Safety and Tolerability of Two Delivery Methods; 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 - REVIRAL 1 (Infants); BRIEF: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it. This study will be conducted in 3 parts: In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B. The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo. To participate in this study participants must meet the following criteria: 1. Age 1 month to 36 months 2. Weight ≥ 3.5 kg 3. Diagnosis of LRTI 4. Diagnosis of RSV 5. Hospitalization due to RSV LRTI ; DRUG USED: RV521; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Syncytial Virus (RSV) Treatment; TARGET: RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: 1. Male or female ≥ 1 month and ≤ 36 months of age 2. Weight ≥ 3.5 kg 3. Clinical diagnosis of LRTI 4. A positive RSV diagnostic test 5. Hospitalised because of RSV LRTI 6. Symptoms of LRTI must be present for no more than 1 week (Part B) and no more than 5 days (Part C) before the Screening Visit 7. Expected to remain in hospital for a minimum of 3 days 8. The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate and are able and willing to comply with the study protocol Exclusion Criteria: 1. Premature (gestational age less than 37 weeks) AND <1 year of post-natal age 2. Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug. 3. Any clinically significant ECG abnormalities. 4. Known to be immunocompromised. 5. High risk of having developing asthma. 6. Suspected of having a clinically significant bacterial infection. 7. History of renal failure. 8. Clinical evidence of hepatic decompensation 9. History of epilepsy or seizures, including febrile seizures 10. Allergy to test medication or constituents 11. Has received 1 or more doses of palivizumab at any time before Screening or received treatment with antiviral therapy for RSV (eg, ribavirin or intravenous [IV] immunoglobulin) within 3 months before the Screening Visit. ; PRIMARY OUTCOME: To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing incidence of AEs, TEAEs, SAEs, and withdrawals due to TEAEs.; SECONDARY OUTCOME 1: To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing time to maximum plasma concentration (tmax).[/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 - Dose Finding (Japan); BRIEF: The purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or other lipid-modifying therapies in Japanese patients with hypercholesterolemia treated for 12 weeks. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Patients who have obtained informed consent to all of the observation/examination/evaluation items specified in the protocol - Patients must be on stable statin therapy defined as atorvastatin, pitavastatin, rosuvastatin, pravastatin, simvastatin, or fluvastatin daily[and other lipid-modifying therapies(LMTs) if needed] at least 4 weeks(6 weeks for fibrates) prior to screening and above LDL-C control target. Or Patients for statin intolerant must be on stable LMT(s) at least 4 weeks prior to screening and above LDL-C control target. Statin intolerance defined as an inability to tolerate 1 or more statins due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued or decreased. Patients on the lowest or under the dosage of the approved dose of statin or unable to tolerate any statin at any dose were eligible. Patients could continue taking the lowest or under the dosage of the approved dose of statin therapy or taking other LMTs throughout the study provided that it was stable and well tolerated. - Fasting mean TG level < 400 mg/dL from measurements at screening - Other protocol specific inclusion criteria may apply Exclusion Criteria: - Women who are pregnant or breastfeeding or who have a positive pregnancy test (urine) result at screening or baseline visits - Sexually active male subjects or sexually active female subjects of childbearing potential who do not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after final IMP administration test (urine) result at screening or baseline visits - Patients with homozygous familial hypercholesterolemia (HoFH) - Patients with a history or current symptoms of any of the following clinically significant cardiovascular diseases within 3 months prior to screening or before baseline visit - Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, stroke, transient ischemic attack, symptomatic carotid artery stenosis, symptomatic peripheral arterial disease, or decompensated heart failure - Abdominal aortic aneurysm - Unexplained syncope or long-QT syndrome, family history of long-QT syndrome, or risk factors for Torsade de Pointes, such as persistent hypokalemia or second- or third-degree atrioventricular block (except when controlled by medication, etc) - Uncontrolled hypertension, defined as follows: - Sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening - Patients with uncontrolled and serious hematologic or coagulation disorders or with Hgb of <10.0 g/dL at screening - Patients with type 1 diabetes or uncontrolled type 2 diabetes with hemoglobin A1c (HbA1c) of ≥9% at screening - Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5 × ULN at screening - Patients with liver disease or dysfunction, including: - Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies at screening - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN and/or total bilirubin of ≥2 × ULN - Patients with creatine kinase (CK) elevation( >3 × ULN) at screening - Patients with renal dysfunction or nephritic syndrome or a history of nephritis and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m2 at screening - Other protocol specific inclusion criteria may apply ; PRIMARY OUTCOME: •Percent change from baseline to Week 12 in LDL-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 II - Vasomotor Symptoms; BRIEF: The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females. ; DRUG USED: AR08; DRUG CLASS: New Molecular Entity (NME); INDICATION: Menopause (including Hormone Replacement Therapy [HRT]); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Arbor Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Generally healthy female > 40 years of age with a body mass index (BMI) ≤ 40; 2. Has undergone menopause defined as any of the following: At least 12 months of spontaneous amenorrhea; or At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy); 3. Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week Exclusion Criteria: 1. Resting systolic blood pressure (SBP) <110 mmHg, resting diastolic blood pressure (DBP) <50 mm Hg, or a resting heart rate (HR) <60 beats per minute while awake; 2. Subjects with pre-existing orthostatic hypotension at Screening; 3. Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening; 4. History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications ; PRIMARY OUTCOME: Mean change from Baseline in the frequency and severity of moderate to severe hot flashes; SECONDARY OUTCOME 1: Patient Global Impression - Improvement (PGI-I)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 002A; BRIEF: The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery. ; DRUG USED: Durezol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Sirion Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Unilateral ocular surgery in the day prior to study enrollment. - Anterior chamber cell grade ≥ 2 on the day after surgery (Day 1). - Aged 2 years or older on the day of consent. - Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigators discretion. - Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate. Presurgical Exclusion Criteria: - Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment. - Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug. - Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis. - Any history of glaucoma or ocular hypertension in the study eye. - History or presence of endogenous uveitis. - Any current corneal abrasion or ulceration. - Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease. - Allergy to similar drugs, such as other corticosteroids. - History of steroid-related IOP increase. - Scheduled surgery on the contralateral eye during the treatment period. - Unwilling to discontinue use of contact lenses during the study period. - Pregnancy or lactation. - Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study. - Prior participation in the study described in this protocol. - Unable or unwilling to give signed informed consent prior to participation in any study related procedures. Postsurgical Exclusion Criteria: - Ocular hemorrhage which interferes with evaluation of postsurgery inflammation. - Injection of gas into the vitreous body during surgery. - Presence of IOP ≥24 mm Hg on Day 1 after surgery. ; PRIMARY OUTCOME: Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo).; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - R3500-AD-1798 (+/-Dupilumab); BRIEF: The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis (AD). Secondary Objectives are to: - Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD - Assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD - Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD ; DRUG USED: REGN3500; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-33 (Interleukin-33)IL-33 Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit 2. Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits 3. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits 4. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable Key Exclusion Criteria: 1. Prior participation in an anti-Interleukin (IL)-33 class antibody (including but not limited to REGN3500) or anti-IL-4Rα class antibody (including but not limited to dupilumab) clinical study; past treatment with or current treatment with dupilumab or another anti-IL-4Rα treatment 2. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit 3. 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 4. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening 5. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit 6. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study Note: Other protocol defined Inclusion/Exclusion Criteria apply ; PRIMARY OUTCOME: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16; SECONDARY OUTCOME 1: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16[/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 - SPR.18144; BRIEF: This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication. ; DRUG USED: Mirvaso; DRUG CLASS: Non-NME; INDICATION: Rosacea; TARGET: Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Galderma R&D; CRITERIA: Inclusion Criteria: - Male or female who is at least 18 years of age. - Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. - CEA (clinicians erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline. - PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline. - Presence of 2 or fewer inflammatory facial lesions. Exclusion Criteria: - History of Raynauds Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression. - History of refractive surgery such as photorefractive keratectomy. - The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants. - The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit. ; PRIMARY OUTCOME: Response Rate for Achieving a 2 Grade Improvement on Clinicians Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa; BRIEF: The purpose of this study is to determine the safety, tolerability, and efficacy of VX-765 in subjects with Treatment-resistant Partial Epilepsy ; DRUG USED: VX-765; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: Caspase-1/ICE (IL-1ß-converting enzyme); THERAPY: Monotherapy; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Subjects that are male or female aged 18 to 64 years (inclusive) with a body mass index between 18 and 35 (kg/m2) - Subjects must have a diagnosis and history of treatment resistant partial onset seizures for which they are taking 1 to 4 concomitant antiepileptic drugs (AED). Treatment resistance is defined as failure to achieve seizure freedom despite adequate use of 2 different AEDs. All AED doses must remain stable for 4 weeks prior to the Screening Visit and throughout the entire study - Subjects must have had at least 1 electroencephalogram (EEG) consistent with partial epilepsy and a brain magnetic resource imaging (MRI) or computed tomography (CT) scan within 5 years of Screening Visit negative for other confounding conditions - Subjects must have had at least 6 observable partial seizures in 6 weeks prior to randomization, with at least 1 seizure per week during 3 of the 6 weeks within the Baseline Period - Subjects who are male or female must agree to use acceptable contraceptive methods as defined in the protocol - Subjects who are in otherwise good health Exclusion Criteria: - Subjects with a history of non-epileptic transient alterations in consciousness - Subjects who have a history of status epilepticus in the past 12 months - Subjects whose seizure frequency cannot be quantified - Subjects who have significant medical illness including kidney, liver, pulmonary or gastrointestinal disease; or unstable or poorly controlled conditions - Subjects who have clinically significant psychiatric illness - Subjects with a positive drug screen (excluding any allowed prescribed medications) and history of alcoholism or drug addiction within past 2 years - Males subjects that have a female partner of childbearing potential who do not agree to use medically approved methods of birth control - Male subjects that have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period, or within 90 days of the last dose of study drug - Female subjects who are pregnant or lactating, or who are of reproductive potential who do not agree to use medically approved birth-control methods - Subjects with a current or prior history of illness precluding them from immunomodulatory therapy (e.g. history of recurrent infections) - Subjects with active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) - Subjects who have participated in any other clinical trials involving an investigational product or device and have received the last dose of study drug within 45 days or 5 half-lives of the Screening Visit ; PRIMARY OUTCOME: Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events); SECONDARY OUTCOME 1: Percent reduction in seizure frequency[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - HERT-GBM; BRIEF: This study is for patients that have a type of brain cancer called glioblastoma multiforme (GBM). The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor 2). This antibody sticks to GBM cells because of a substance on the outside of these cells called HER2. Up to 80% of GBMs are positive for HER2. HER2 antibodies have been used to treat people with HER2-positive cancers. For this study, the HER2 antibody has been changed so that instead of floating free in the blood it is now attached to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T cells seem to be able to kill tumors like GBM, but they dont last very long and so their chances of fighting the cancer are limited. Therefore, developing ways to prolong the life of these T cells should help them fight cancer. We found that T cells work better if we also attach a protein called CD28 to the HER2 chimeric receptor (HER2-CAR). In this study we placed this HER2-CAR into T cells that were pre-selected for their ability to recognize Cytomegalovirus (CMV). This virus exists in most people. These CMV-specific cytotoxic T cells (CMV-T cells) will be more active since they will react to the virus as well as to tumor cells. These HER2-CD28 CMV-T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the largest safe dose of HER2-CD28 CMV-T cells, to learn what the side effects are, and to see whether this therapy might help patients with GBM. ; DRUG USED: AU105; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), HER2/neu or ErbB-2, Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Baylor College of Medicine; CRITERIA: INCLUSION CRITERIA: - Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) with recurrent or progressive disease after front line therapy. - HER2 positive GBM - CMV seropositive - Normal ECHO (Left ventricular ejection fraction (LVEF) has to be with in normal, institutional limits) - Life expectancy 6 weeks or greater - Karnofsky/Lansky score 50 or greater - Patient or parent/guardian capable of providing informed consent - Bilirubin 3x or less than normal, AST 5x or less than normal, creatinine 2x normal or less for age and Hgb 9.0 g/dl or more; WBC greater than 2,000/ul; ANC greater than 1,000/ul; platelets greater than 100,000/ul - Pulse oximetry 90% or more on room air - Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom. - Available autologous HER2.CAR-transduced CMV-specific cytotoxic T lymphocytes with 15% or greater expression of HER2.CAR determined by flow-cytometry and killing of HER2-positive targets 20% or more in cytotoxicity assay. - Recovered from the acute toxic effects of all prior chemotherapy at least 4 weeks before entering this study. One exception is Temozolomide(TMZ), an alkylation agent used as a radiosensitizer and adjuvant chemotherapeutic agent for GBM. Due to the extremely short half life of TMZ, patients will be allowed to continue receiving it up to two days prior to cell infusion and cannot restart until six weeks after the infusion. EXCLUSION CRITERIA: - Severe intercurrent infection - Known HIV positivity - Pregnant or lactating - History of hypersensitivity reactions to murine protein-containing products ; PRIMARY OUTCOME: Number of subjects with dose limiting toxicity after CTL infusion; SECONDARY OUTCOME 1: Decrease in tumor after the CTL infusion[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Study 002 (Breast Cancer); BRIEF: Determination of the effect of balugrastim on the duration and severity of severe neutropenia. ; DRUG USED: Balugrastim; DRUG CLASS: Biosimilar; INDICATION: Neutropenia / Leukopenia; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel). Exclusion Criteria: - Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months). ; PRIMARY OUTCOME: Duration of Severe Neutropenia in Cycle 1; SECONDARY OUTCOME 1: Number of Participants With Febrile Neutropenia[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Temozolomide; BRIEF: The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary objectives in the phase I trial include determining the PK of BSI-201 in malignant glioma patients and correlating BSI-201 PK with degree of PARP-1 inhibition. A safety run-in will confirm the safety of BSI-201 added to standard TMZ and radiation therapy and the phase II portion of the study will assess the efficacy and tolerability of the MTD dose of BSI-201 with daily TMZ and radiation therapy followed by adjuvant TMZ in patients with newly diagnosed GBM and assess overall survival as the primary outcome measure. Information on each phase of the study will be listed when each phase opens for enrollment. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing. ; DRUG USED: Iniparib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: 1. Patients must be at least 18 years of age 2. Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others) 3. Patients must have the following hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine < 1.7 mg/dl, total bilirubin ≤ 1.5 mg/dl, transaminases < 4 times above the upper limits of the institutional normal 4. Patients must be able to provide written informed consent 5. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug as well as the standard drug (temozolomide) may be harmful to the developing fetus or nursing infant 6. Patients must have a Mini Mental Status Exam score of > 15 7. Patients must have tumor tissue form completed and signed by a pathologist. See section 9.6 for details Phase I Criteria (Phase I Patients ONLY) 1. Patients must have histologically proven supratentorial malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme) 2. Patients must have received at least 80% of planned temozolomide and radiation therapy with no grade 3 or grade 4 toxicity attributed to the temozolomide 3. Patients must have received planned treatment with radiation therapy and concomitant temozolomide at least 28 days but no more than 49 days prior to starting treatment on this study 4. Patients must have Gadolinium MRI or contrast CT scan within 28 days of starting treatment Exclusion Criteria: 1. Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety 2. Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant 3. Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents) 4. Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for greater than five years are eligible for this study 5. Patients cannot be receiving cytochrome P450-inducing anticonvulsants (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) and must not have taken them for at least 10 days Phase I Ineligibility Criteria (Phase I Patients ONLY) 1. Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ treatment 2. Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment. Patients who have received Gliadel wafers are eligible for this study ; PRIMARY OUTCOME: To determine the Maximum Tolerated Dose (MTD) of BSI-201, administered as an IV infusion in patients with newly diagnosed malignant glioma when given with temozolomide (TMZ) after the completion of standard radiation therapy and concomitant TMZ; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 301 (Ext.); BRIEF: Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged. ; DRUG USED: Sublocade; DRUG CLASS: Non-NME; INDICATION: Substance Use Disorder; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Indivior Inc.; CRITERIA: Inclusion Criteria: 1. Provide written consent to participate in this study. 2. Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014). 3. Be considered eligible in the medical judgment of the Investigator. 4. Females: Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent form (ICF)) must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 6 months after the last dose of investigational medicinal product (IMP). Males: Subjects with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the ICF through at least 6 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP. 5. Subjects must agree not to take any buprenorphine products other than those administered during the current study throughout participation in the study. 6. Subjects must be willing to adhere to study procedures. Exclusion Criteria: 1. Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety. 2. Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 at the end-of-study (EOS) visit, who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study. 3. History of suicidal ideation within 28 days prior to signing the ICF as evidenced by answering yes to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) since last visit assessment (completed in the EOS Visit for Study RB-US-13-0003), screening/baseline assessment for the current study), or history of a suicide attempt (per the C-SSRS) in the 6 months prior to signing the ICF. 4. Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or over the counter (OTC) and/or herbal supplements with the potential to prolong QTc within 28 days of Day 1 unless prior written approval was obtained from the Medical Monitor. ; PRIMARY OUTCOME: Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - Dose-Ranging; BRIEF: Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments. ; DRUG USED: Nemolizumab; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-31/IL-31R (Interleukin-31/Interleukin-31 Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Galderma R&D; CRITERIA: Inclusion Criteria: - Male or female subjects ≥ 18 years (or legal age when higher) - Chronic AD, that has been present for at least 2 years before the visit - Eczema Area and Severity Index (EASI) score ≥12 - Investigator Global Assessment (IGA) score ≥ 3 - AD involvement ≥ 10% of Body Surface Area (BSA) - Severe pruritus on at least 3 of the last 7 days before the visit - Documented recent history (within 6 months before the visit) of inadequate response to topical medications - Female subjects must fulfill one of the criteria below: - Female subjects of non-childbearing potential - Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration Exclusion Criteria: - Body weight < 45 kg - subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value - Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period - Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period - History of intolerance to low or mid potency TCS or for whom TCS is not advisable ; PRIMARY OUTCOME: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24; SECONDARY OUTCOME 1: Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EU/Israel; BRIEF: This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active, sight-threatening, noninfectious intermediate or posterior uveitis. ; DRUG USED: Piclidenoson; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uveitis (Ophthalmology); TARGET: Adenosine A3 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Can-Fite BioPharma; CRITERIA: Inclusion Criteria: 1. Male or female, 18 years of age and over; 2. Diagnosis of active, sight-threatening, noninfectious intermediate or posterior uveitis, as determined by the Standardization of Uveitis Nomenclature (SUN) Working Group Criteria. 3. Vitreous haze in at least 1 eye (the study eye) of ≥Grade 3 on the Miami Scale at the Screening Visit, as confirmed by the Uveitis Photograph Reading Center; , 4. Best corrected visual acuity (BCVA) in the poorer seeing eye of 1.3 logarithm of the minimum angle of resolution (logMAR) or better by Early Treatment Diabetic Retinopathy Study (ETDRS; equivalent to 20/400) at Screening; 5. Requires, in the judgment of the Investigator, systemic therapy to treat uveitis; 6. No plans for elective ocular surgery during the trial duration; 10. Ability to understand and provide written informed consent. Exclusion Criteria: 1. Primary diagnosis of anterior uveitis; 2. Uveitis of infectious etiology; 3. Presence of chorioretinal scars that are highly suspicious for ocular toxoplasmosis; 4. Confirmed or suspected uveitis of traumatic etiology; 5. Clinically suspected or confirmed central nervous system or ocular lymphoma; 6. Presence of any other form of ocular malignancy in the either eye including choroidal melanoma; 7. Corneal or lens opacities or obscured ocular media other than vitreous haze upon enrollment such that reliable clinical evaluations and grading of the posterior segment cannot be performed; 8. Pupillary dilation inadequate for quality fundus photography; 9. Uncontrolled glaucoma or ocular hypertension in either eye, defined as intraocular pressure (IOP) >21 mm Hg while on medical therapy; 10. Chronic hypotony (IOP <6 mm Hg) in either eye; 11. Presence of an ocular implantable steroid-eluting device; 12. Ocular injection of corticosteroid within 3 months prior to Baseline; 13. Use of Retisert within 6 months prior to baseline; 14. Use of the following within 90 days prior to Baseline or anticipated use to either eye during the trial: 1. Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors), or 2. Posterior subtenon steroids; 15. YAG capsulotomy within 30 days prior to Day 1 in the study eye; 16. History of herpetic infection in the study eye or adnexa; 17. Oral corticosteroid dose >20 mg/day prednisone equivalent; 18. Oral corticosteroid dose has been changed within 2 weeks prior to screening, or is expected to change while on study; 19. Systemic immunosuppressive agent dose has been changed within 2 weeks prior to screening; 20. Treatment with systemic monoclonal antibody within the longer of 1 month or 5 serum half-lives, prior to screening; 21. Diagnosis or history of Behçets Disease; 22. Any significant ocular disease that could compromise vision in either eye, including but not limited to: 1. Diabetic retinopathy: proliferative diabetic retinopathy or non-proliferative diabetic retinopathy that compromise vision, 2. Wet age-related macular degeneration, and 3. Myopic degeneration with active subfoveal choroidal neovascularization. ; PRIMARY OUTCOME: Severity of uveitis on standardized photographic assessment; SECONDARY OUTCOME 1: Safety of CF101[/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 - RA-BUILD; BRIEF: The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate response] participants) and who have not received a biologic disease-modifying antirheumatic drug (DMARD). ; DRUG USED: Olumiant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA - Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints - Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥ (greater than or equal to) 1.2 times the upper limit of normal (ULN) - Have had an insufficient response or are intolerant to conventional disease-modifying antirheumatic drugs (cDMARDs) and either: - Have had regular use of a cDMARD for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry - For participants not receiving a cDMARD at the time of entry, the investigator will document in the participants history that the participant had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD Exclusion Criteria: - Are currently receiving corticosteroids at doses > (greater than)10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization - Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization - Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs - Have ever received any biologic DMARD - Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study - Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study - Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization - Have active fibromyalgia that, in the investigators opinion, would make it difficult to appropriately assess RA activity for the purposes of this study - Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis,spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout(participants with secondary Sjogrens syndrome are not excluded.) - Have a diagnosis of Feltys syndrome - Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant - Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure - Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data - Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair - Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2) - Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin >/=1.5 times the ULN - Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years - Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination) - Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection - Have had symptomatic herpes zoster infection within 12 weeks prior to study entry - Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia) - Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study - Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) - Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participants participation in the study - Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participants participation in the study (eg, Fridericias corrected QT interval >500 millisecond [msec] for men and >520 msec for women) - Have symptomatic herpes simplex at the time of study enrollment - Have evidence of active or latent tuberculosis (TB) ; PRIMARY OUTCOME: Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20); SECONDARY OUTCOME 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) 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 - CS21 Extension (CS21A); BRIEF: Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years. ; DRUG USED: Firmagon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ferring Pharmaceuticals; CRITERIA: Inclusion/Exclusion Criteria: - Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. - Signed informed consent - The patients must have completed the FE 200486 CS21 Study. ; PRIMARY OUTCOME: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight; SECONDARY OUTCOME 1: Percentage of Participants With no Prostate-specific Antigen (PSA) Progression[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - w/Rituximab; BRIEF: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab ; DRUG USED: BI-1206; DRUG CLASS: Biologic; INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Fc receptors; THERAPY: Combination; LEAD SPONSOR: BioInvent International AB; CRITERIA: Inclusion Criteria: - Are ≥ 18 years of age by initiation of study treatment. - Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL grade 3B), MCL and marginal zone lymphoma (MZL). - Have measurable nodal disease - Are willing to undergo lymph node biopsies or biopsies of other involved tissue - Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists. - Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen. - Have a life expectancy of at least 12 weeks - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. - Have CD20+ malignancy - Have hematological and biochemical indices within prespecified ranges Exclusion Criteria: - Have had an allogenic bone marrow or stem cell transplant within 12 months - Have presence of active chronic graft versus host disease - Have current leptomeningeal lymphoma or compromise of the central nervous system. - Have transformed lymphoma from a pre-existing indolent lymphoma. - Have Waldenstroms Macroglobulinemia or FL3B, - Need systemic doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication. - Have known or suspected hypersensitivity to rituximab or BI-1206. - Have cardiac or renal amyloid light-chain amyloidosis. - Have received any of the following: - Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206 - Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks - Immunotherapy within 8 weeks - Have ongoing toxic manifestations of previous treatments. - Have the ability to become pregnant (or already pregnant or lactating/breastfeeding). - Have had major surgery from which the subject has not yet recovered. - Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals. - Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). - Have an active, known or suspected autoimmune disease. - Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), - Have current malignancies of other types ; PRIMARY OUTCOME: Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab; SECONDARY OUTCOME 1: Evaluation of PK parameters for BI-1206.[/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 - JR-141-GS31; BRIEF: A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II. ; DRUG USED: JR-141; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis II (MPS II; Hunter Syndrome); TARGET: Sulfated alpha-L-iduronic acid; THERAPY: Monotherapy; LEAD SPONSOR: JCR Pharmaceuticals Co., Ltd.; CRITERIA: Inclusion Criteria: - A patient who voluntarily signs an Institutional Review Board or Independent Ethics Committee-approved written informed consent form. If the patient is aged under 18 years (aged under 16 years in the UK) at the time of enrollment or willingness to participate in the study cannot be confirmed due to MPS II-related intellectual disability, the patients legally acceptable representative (e.g., his/her parents or guardians) may sign the informed consent on behalf of the patient. Written informed assent should be obtained from the patient, wherever possible. - Patients with confirmed diagnosis of MPS II - Naïve patients or patients who are receiving stable enzyme replacement therapy with idursulfase for more than 12 weeks before starting administration of JR-141 or idursulfase for this study. - Patients or patients whose partners are of child-bearing potential agree to use a medically accepted, highly effective method of contraception being use of condoms from the time of informed consent. <Cohort A> - Patients aged 36-42 months old at the time of ICF signing: patients must have a standard score measured by the BSID-III of 85 or less at screening. - Patients aged 43-71 months old at the time of ICF signing: patients must EITHER have (1) A DQ measured by BSID-III of 20 to 85 at screening OR (2) A composite standard score on NVI measured by KABC-II of 85 or less at screening (only who can perform KABC-II) - Patients aged 30-35 months old at the time of randomization and who are judged as having the severe phenotype by the Expert Board. <Cohort B> - Patients 6 years of age or older at the time of ICF signing and whose IQ are 70 and higher. - Enrollment of subjects in Cohort B is contingent on the availability in that country of a validated country-specific version of the test (either WISC-V, WAIS-IV, or T.O.V.A.). - Attenuated patients with 1 SD deficiency in the omission errors or variability domains of the T.O.V.A.. Exclusion Criteria: - A patient with a history of HSCT with successful engraftment. - A patient who has received gene therapy treatment at any point. - Unable to undergo lumbar puncture. - A patient who is enrolled in another clinical study that involves clinical investigations or use of any investigational product (drug or device) within 4 months before obtaining informed consent. - Unable to comply with the protocol as determined by the principal investigator or subinvestigator. - Judged by the principal investigator or subinvestigator to be ineligible to participate in the study due to a history of serious drug allergy or sensitivity including anesthesia or hypersensitivity to any component of JR-141. - A patient who has a known or suspected local or general infection or is at risk of abnormal bleeding due to medical conditions or therapies. - A patient who has documented mutation of other genes, including loci adjacent to the IDS gene that are known to be associated with developmental delay, seizures, or other significant CNS disorders. - A patient who has documented loss of activity of sulfatases other than IDS. - A patient who has had a ventriculoperitoneal shunt placed or any other brain surgery, or has a clinically significant ventriculoperitoneal shunt malfunction within 30 days of screening. - full time employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members. - A patient who otherwise is judged by the principle investigator or sub-investigator to be ineligible to participate in the study. [Only in France] - Persons deprived of their liberty by a judicial or administrative decision, according to article L.1121-6 the Public Health Code (Code de la santé publique), adults who are the subject of a measure of legal protection or unable to express their consent according to article L. 1121-8 of the Code de la santé publique) ; PRIMARY OUTCOME: Change in levels of cerebrospinal fluid heparan sulfate from baseline (Cohort A); SECONDARY OUTCOME 1: Change in the growth scores of cognitive testing measured from baseline (BSID-III) (Cohort A)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - OSPREY; BRIEF: This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B). Cohort B is complete and no longer recruiting subjects. ; DRUG USED: Pylarify; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer - Imaging; TARGET: Prostate-specific Membrane Antigen (PSMA), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Progenics Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. 2. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. Cohort A Only: - At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA >20 ng/mL or Gleason score ≥8). - Scheduled or planned radical prostatectomy with PLND. Cohort B Only: [Enrollment is complete; No longer recruiting subjects] - Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment. - If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed. - Scheduled or planned percutaneous biopsy of at least one amenable lesion. Exclusion Criteria: 1. Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection. 2. Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion. Cohort A Only: - Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention Cohort B Only: [Enrollment is Complete; No longer recruiting subjects] - Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed - Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression. ; PRIMARY OUTCOME: Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A); SECONDARY OUTCOME 1: Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)[/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 - AP-014; BRIEF: This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress. ; DRUG USED: Ampion; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Ampio Pharmaceuticals. Inc.; CRITERIA: Inclusion Criteria: 1. Male or female, ≥ 18 years old. 2. Diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings. 3. Respiratory distress as evidenced by at least two of the following: - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) - Recording of SpO2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an SpO2 ≥ 90% - Requiring supplemental oxygen - Diagnosis of mild, moderate, or severe ARDS by Berlin definition 4. A signed informed consent form from the patient or the patients legal representative must be available. Exclusion Criteria: 1. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. 2. Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place 3. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.). 4. Patient is on chronic immunosuppressive medication. 5. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study. 6. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate). 7. Patient has known pregnancy or is currently breastfeeding. 8. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use). 9. Baseline QT prolongation. ; PRIMARY OUTCOME: Incidence and severity of adverse events; SECONDARY OUTCOME 1: Clinical status using 8-point ordinal 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 - PURE; BRIEF: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke. ; DRUG USED: Xeomin; DRUG CLASS: Biologic; INDICATION: Neuromuscular Spasm and Spasticity; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Merz Pharmaceuticals GmbH; CRITERIA: Inclusion Criteria: - Upper limb spasticity - Time since stroke greater than 3 months - Need for 400 U Botulinum toxin type A Exclusion Criteria: - Body weight below 50kg - Fixed contractures of the upper limb - Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A - Infection at the injection site ; PRIMARY OUTCOME: Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern; SECONDARY OUTCOME 1: Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern[/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 - PHOENIX; BRIEF: This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients will be enrolled in disease specific cohorts within the trial, and effectiveness of bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD. All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks after the end of treatment. ; DRUG USED: Bardoxolone Methyl; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: KEAP1 (Kelch-like ECH-associated protein 1), STAT3 Transcription Factor; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: - Male and female patients 18 ≤ age ≤ 65 upon study consent; - Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 and ≤ 90 mL/min/1.73 m2. The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference ≤ 25%; - Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit; - If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB), patients should be prescribed the maximally tolerated labeled daily dose (MTLDD) for at least 6 weeks prior to the Screen A visit; - For patients enrolling in T1D Cohort: Diagnosis of type 1 diabetes confirmed by fasting C-peptide level. Diagnosis must have been made ≤ 35 years of age; and prescribed stable dose of insulin to maintain adequate glucose control for at least 6 months prior to the Screen A visit; - For patients enrolling in IgAN Cohort: Biopsy-confirmed IgA nephropathy; - For patients enrolling in FSGS Cohort: Biopsy-confirmed FSGS that is not due to known secondary causes including morbid obesity, decreased renal mass, viral infections, drug-induced nephrotoxicity, or prior history of vasculitis; - For patients enrolling in ADPKD Cohort: Genetic confirmation of PKD1 mutation; - Adequate bone marrow reserve and organ function at the Screen A visit as follows: Hematologic: Absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin (Hgb) ≥ 9 g/dL; and Hepatic: Total bilirubin (TBL) ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times ULN. Exclusion Criteria: - Kidney or any other solid organ transplant recipient or a planned transplant during the study; - B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit; - Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening; - Serum albumin < 3 g/dL at Screen A visit; - Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study; - For patients enrolling in IgAN Cohort: Systemic manifestations of Henoch-Schonlein purpura within 1 year prior to Screen A visit; or have used belimumab, eculizumab, or rituximab within 6 months prior to Screen A visit; - For patients enrolling in ADPKD Cohort: Receiving tolvaptan; - Cerebrovascular event (stroke, transient ischemic attack) or aneurysm within 6 months prior to Screen A visit or during Screening; - History of clinically significant left-sided heart disease and/or clinically significant cardiac disease; - Uncontrolled systemic hypertension; - Systolic BP < 90 mm Hg at Screen A visit after a period of rest; - History of malignancy within 2 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas; - Uncontrolled diabetes (HbA1c > 10.0%) at Screen A visit; - Untreated or uncontrolled active bacterial, fungal, or viral infection; - Participation in other interventional clinical studies within 30 days prior to Day 1; - Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested; - Women who are pregnant or breastfeeding. ; PRIMARY OUTCOME: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Rituxan (NCI; Follicular); BRIEF: This phase II trial studies how well lenalidomide and rituximab work in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide together with rituximab may kill more cancer cells. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Previously untreated, histologically confirmed follicular lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass >= 7 cm in any uni-dimensional measurement) stage II - Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable for diagnosis - Failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation - Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression - Low or intermediate risk by Follicular Lymphoma International Prognostic Index (FLIPI): 0-2 risk factors - No prior systemic therapy for NHL, including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy); patients may have received involved-field radiation therapy - No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm is acceptable - Lesions that are considered non-measurable include the following: - Bone lesions (lesions if present should be noted) - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Bone marrow (involvement by NHL should be noted) - No known central nervous system (CNS) involvement by lymphoma - Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following - No evidence of coinfection with hepatitis B or C - CD4+ cell count >= 400/mm^3 - No evidence of resistant strains of HIV - If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL - If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL - No history of acquired immune deficiency syndrome (AIDS)-defining conditions - No evidence of active hepatitis B or C infection (i.e., no positive serology for anti-hepatitis B core [HBc] or anti-hepatitis C virus [HCV] antibodies); hepatitis B virus (HBV) seropositive patients (hepatitis B surface antigen positive [HBsAg +]) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxyribonucleic acid (DNA) testing and receive suppressive therapy with lamivudine or other HBV suppressive therapy until 6 months after the last rituximab dose - Patients with a history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome are not eligible - Patients with uncontrolled seizures are not eligible - Patients with an autoimmune disorder requires active immunosuppression are not eligible - Non-pregnant and non-nursing; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure - No known human anti-chimeric antibody (HACA) positivity - Absolute neutrophil count (ANC) >= 1,000/microliter - Platelet count >= 75,000/microliter - Creatinine clearance >= 30 mL/min unless attributable to NHL; to be calculated by method of Cockcroft-Gault, using actual weight; maximum creatinine clearance (CrCl) 125 mL/min - Total bilirubin =< 2 times upper limit of normal (ULN) unless attributable to NHL or Gilbert disease ; PRIMARY OUTCOME: Number of Participants Who Achieved a Complete Response; SECONDARY OUTCOME 1: Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0[/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 - Single/Multiple Doses (CL-0101); BRIEF: The objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with solid tumors. ; DRUG USED: ASP5878; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed solid tumor. - Participant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator: - Disease progression despite standard therapies - Progressive disease without any standard therapies established - Standard therapies are considered intolerable - Eastern Cooperative Oncology Group performance status 0 or 1. - Predicted life expectancy ≥ 12 weeks in the judgment of the investigator or sub-investigator. Exclusion Criteria: - Participant with ≥ Grade 2 (CTCAE v 4.0-JCOG) persistent symptoms and objective findings due to the toxicity attributable to prior treatment with antitumor effect (except alopecia). - Participant who received a prior treatment intended for antitumor effect (medication, surgery, radiotherapy, etc.) within 4 weeks prior to the planned first day of study drug dosing (or participant who received mitomycin C or Nitrosourea within 6 weeks prior to the planned first day of study drug dosing). - A major surgical procedure within 4 weeks prior to the planned first day of study drug dosing or a surgical procedure is planned during the course of the study. - Participant who were treated with other investigational drug or medical device within 4 weeks prior to the planned first day of study drug dosing. - Participant who has a history of organ transplantation. - Participant with a brain metastasis with symptoms or requiring treatment. ; PRIMARY OUTCOME: Dose-escalation part and Expansion part: Safety assessed by Adverse Events (AEs); SECONDARY OUTCOME 1: Dose-escalation part: Pharmacokinetics (PK) parameter of ASP5878 in plasma: Cmax[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - CASSINI; BRIEF: The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease - Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 - Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2 - Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min) - Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care Exclusion Criteria: - Diagnosis of primary brain tumors - Known history of brain metastases - Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding - Hematologic malignancies with the exception of lymphoma - Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months ; PRIMARY OUTCOME: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components); SECONDARY OUTCOME 1: Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths[/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 - PLX120-01; BRIEF: The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension Cohorts (Phase IIa portion). The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with advanced BRAF-mutated cancers. ; DRUG USED: FORE-8394; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Fore Biotherapeutics; CRITERIA: Inclusion Criteria: - Age ≥ 18 years - Measurable disease by RECIST 1.1 criteria (solid tumors) - ECOG performance status of 0-2 - Life expectancy ≥ 3 months - Adequate hematologic, hepatic, and renal function: 1. Solid Tumors - Absolute neutrophil count ≥ 1.5 × 109/L, Hgb > 9 g/dL, platelet count ≥ 100 × 109/L, AST/ALT ≤ 2.5 × ULN, bilirubin ≤ 2, creatinine ≤ 1.5 × ULN or calculated CrCl >50 mL/min (Cockcroft-Gault formula) 2. Hairy Cell Leukemia - Absolute neutrophil count ≤ 1.0 × 109/L, Hgb ≤ 10.0 g/dL or platelet count ≤ 100 × 109/L; AST/ALT ≤ 2.5 × ULN, bilirubin ≤ 2, creatinine ≤ 1.5 × ULN or calculated CrCl >50 mL/min (Cockcroft-Gault formula) - Women of child-bearing potential must have a negative serum pregnancy test within 14 days of initiating study drug and must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Urine pregnancy testing during the study and in follow-up per country specific requirements. Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 6 months after the last dose of study drug. - Completion of previous chemotherapy, immunotherapy, or radiation therapy at least 2 weeks before study drug initiation, with resolution of all associated toxicity (to ≤ Grade 1 or Baseline) - Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements - Eligibility for medical insurance coverage 1. DOSE-ESCALATION COHORTS - advanced solid tumors that are refractory to standard therapy, have no standard therapy, or are considered by the investigator to be inappropriate for standard therapy 2. EXTENSION COHORTS - Cancers with a BRAF-activating mutation as assessed by a CLIA-certified method a. Melanoma - unresectable Stage IIIC or Stage IV disease (sub-cohort 1a: BRAF/MEK/ERK inhibitor naïve, sub-cohort 1b: BRAF/MEK/ERK inhibitor pre-treated) b. Non-melanoma Solid Tumors - advanced anaplastic thyroid cancer, advanced papillary thyroid cancer, and advanced solid tumors (e.g., colorectal cancer, non-small cell lung cancer, cholangiocarcinoma, etc) that are refractory to standard therapy, relapsed after standard therapy, have no standard therapy, or are considered by the investigator to be inappropriate for standard therapy c. Hairy Cell Leukemia - histologically confirmed classical hairy cell leukemia that failed to achieve CR or PR to initial purine analog-based therapy, relapsed ≤ 2 years after purine analog-based therapy, or a history of intolerance to purine analogs Exclusion Criteria: - Extension Cohorts (except 1b) - Previous treatment with a selective BRAF/MEK/EKR inhibitor - Symptomatic brain metastases. Patients with untreated brain metastasis ≤ 1 cm can be considered eligible if deemed asymptomatic by the investigator upon consultation with the medical monitor and do not require immediate radiation or steroids. Patients with brain metastasis that is treated and stable for 1 month may be considered eligible if they are asymptomatic and on stable dose of steroids or if they do not require steroids following successful local therapy. - Investigational drug use within 28 days (or < 5 half-lives, whichever is shorter) of the first dose of PLX8394 - Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study - Uncontrolled intercurrent illness - Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Patients with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible. - Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption - Baseline mean QTcF ≥ 450 ms (males) or ≥ 470 ms (females) - Women who are breast-feeding or pregnant - Known chronic HIV, HCV, or HBV infection ; PRIMARY OUTCOME: Phase 1 dose escalation: Identification of Recommended Phase 2 Dose Safety of PLX8394; SECONDARY OUTCOME 1: Identification of Recommended Phase 2 dose (RP2D)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DUPICSU; BRIEF: The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with chronic spontaneous urticaria (CSU) who are symptomatic despite H1-antihistamine treatment. ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Urticaria; TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Charite University, Berlin, Germany; CRITERIA: Inclusion Criteria: Diagnosis: chronic spontaneous urticaria (defined as ongoing disease) 1. Patient is informed about study procedures and medications and has given written informed consent before any assessment. 2. Patient is able to communicate with the investigator, understands and complies with the requirements of the study. 3. Male or Female 4. Patient is 18-75 years of age 5. Patient is diagnosed with moderate to severe CSU and refractory to standard of care treatment at the time of randomization, as defined by the following: 1. The presence of itch and hives for more than 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine 2. Urticaria activity score UAS7 score (range 0-42) equal or more than 16, 7 days prior to randomization (Day 1) 3. CSU diagnosis for 6 months 6. Willing and able to complete a daily symptom diary for the duration of the study and adhere to the study visit schedules. 7. Patients must not have more than one missing diary entry in the 7 days prior to randomization. Re-screening may be considered. 8. Women of childbearing potential have to agree to use an acceptable form of contraception (as determined by the site investigator) and have to continue its use for the duration of the study. Exclusion Criteria: 1. Patients whose urticaria is solely due to inducible urticaria. 2. Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency) 3. Any other active skin disease associated with chronic itching that might confound the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, etc.) 4. Patients who have received concomitant prohibited medication within the last 3 months prior to screening - Anti-IgE therapy (e.g. omalizumab) - Routine (daily or every other day during 5 or more consecutive days) doses of systemic corticosteroids or other immunosuppressants - Intravenous immunoglobulins - Biological therapy - Systemic immunosuppressants - Live/attenuated vaccines - Other investigational drug 5. History of anaphylactic shock 6. Active helminthic parasite infection or treatment of helminthic parasites within 6 months of screening ; PRIMARY OUTCOME: Urticaria activity score over 7 days (UAS7); SECONDARY OUTCOME 1: Itch severity score (ISS7; 0 - no pruritus; 21 - most severe pruritus), hive severity score (HSS7; 0 - no hives; 21 - max. hive severity)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Dose-Finding (PC CO201/08); BRIEF: The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology. ; DRUG USED: Lumacan; DRUG CLASS: Non-NME; INDICATION: Colorectal Cancer (CRC) - Imaging; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Photocure; CRITERIA: Inclusion Criteria: - Female and Male subjects with known or strong suspicion iof adenoma or carcinoma of the colon after screening of follow-up colonoscopy - Female and male patients with verified neoplastic lesions Exclusion Criteria: - Known or strong suspected porphyria - Contraindications to colonoscopy ; PRIMARY OUTCOME: Determine the carcinoma- and adenoma lesion true detection rate; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - US Adult (70+); BRIEF: This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine. ; DRUG USED: Prevnar 13; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Wyeth is now a wholly owned subsidiary of Pfizer; CRITERIA: Inclusion Criteria: - Male or Female aged 70 years or older. - Documented vaccination with 1 dose of 23vPS at least 5 years previous. - Healthy. Exclusion Criteria: - Receipt of more than one dose of 23vPS prior to enrollment. - History of severe adverse reaction to a vaccine. - Immunodeficiency. ; PRIMARY OUTCOME: Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0); SECONDARY OUTCOME 1: Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)[/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 - Unresectable GBM; BRIEF: This is a pilot study to determine the efficacy and safety of aldoxorubicin in subjects with glioblastoma who have progressed following surgery and prior treatments. ; DRUG USED: Aldoxorubicin; DRUG CLASS: Non-NME; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: DNA, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: ImmunityBio, Inc.; CRITERIA: Inclusion Criteria: 1. Age 18 years or older; male or female 2. Histologically or cytologically confirmed unresectable GBM. Subjects with recurrent disease whose prior pathology demonstrated GBM will not need to be re-biopsied. Subjects with prior low-grade glioma or anaplastic glioma are eligible if histological assessment demonstrates transformation into GBM. 3. Cancer progression after treatment with the following: surgery, radiation therapy and temozolomide as first line treatment with no other therapy prior to tumor recurrence. 1. Radiographic progression by RANO Working Group Criteria will be confirmed by Imaging Endpoints, a central imaging vendor. 2. By tumor biopsy if conducted within 4 weeks of randomization. 4. An interval of at least 12 weeks after last dose of radiation and temozolomide is required, unless cancer progression is proven by diagnostic tumor biopsy. If temozolomide is being used in a maintenance phase, there must be a 28-day washout period prior to Randomization. 5. Stable or decreasing dose of corticosteroids for at least 7 days prior to randomization. 6. Capable of providing informed consent and complying with trial procedures. 7. Karnofsky Performance Status 70 or above. 8. ECOG performance status 0-2. 9. Life expectancy 8 or more weeks. 10. Measurable tumor lesions according to RANO working Group Criteria. a. In the case that there is non-measurable disease due to a radical surgical resection during screening, the subject still qualifies if Inclusion #3(b) is met. 11. Women must not be able to become pregnant for the duration of the study. 12. Women of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. 13. Geographically accessible to site, i.e. the ability to come to the study site for each scheduled appointment and evaluation. Exclusion Criteria: 1. Prior exposure to the an anthracycline. 2. Any therapeutic regimen for treatment of recurrent tumor after first line treatment with surgery, radiation and temozolomide. 3. Prior treatment with bevacizumab or an experimental anti-angiogenic agent. 4. Palliative surgery and/or radiation treatment less than 4 weeks to randomization. 5. Exposure to any investigational agent within 30 days of Randomization. 6. History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for 3 or more years. 7. Laboratory values: screening serum creatinine > 1.5xULN, ALT > 2.5xULN, total bilirubin > 1.5xULN, ANC < 1500/mm3, platelet concentrations < 100,000/mm3, absolute lymphocyte count < 1000/mm3, hematocrit level < 27% for females or < 30% for males, serum albumin ≤ 2.5 g/dL, PT/INR 1.5xULN or >3xULN on anticoagulant with no evidence of active bleeding. 8. Evidence of CNS hemorrhage CTCAE ≥ grade 2 on baseline MRI. 9. Clinically evident congestive heart failure > class II of the NYHA guidelines. 10. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrythmias classified as Lown III, IV or V. 11. History or signs of active coronary artery disease with or without angina pectoris. 12. Serious myocardial dysfunction defined as ultrasound-determined LVEF < 45% of predicted institutional normal value. 13. Baseline ATc>470 msec and/or previous history of QT prolongation. 14. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals, or anti-fungals. 15. History of HIV infection. 16. Major surgery, except diagnostic tumor biopsy, within 4 weeks of randomization. 17. Any condition that might interfere with the subjects participation in the study or in the evaluation of the study results. 18. Any condition that is unstable and could jeopardize the subjects participation in the study. ; PRIMARY OUTCOME: Objective Response Rate (Complete Response and Partial Response); SECONDARY OUTCOME 1: Safety[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - w/Sevelamer; BRIEF: This three-part study will be performed with participants on chronic hemodialysis. - Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b - Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer carbonate three times a day - Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b tablets when given with sevelamer carbonate After screening, participants should expect the study to last about 21 days for Part A, and 46 days for Parts B and C. ; DRUG USED: DS-2330; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Unknown; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Daiichi Sankyo, Inc.; CRITERIA: Inclusion Criteria: - Has a body mass index (BMI) of 18 kg/m^2 to 40 kg/m^2 (inclusive) - Is on prescribed maintenance hemodialysis (three times a week) for at least 3 months before Screening with adequacy demonstrated by a dialysis clearance within 3 months before the first dose of the investigational medicinal product - Has permanent vascular access [arteriovenous (A-V) fistula or graft] - Is willing to comply with protocol-specified methods for family planning - For Parts B and C only: 1. Has protocol-specified acceptable serum Pi levels at Screening and in serum Pi after up to 3 weeks of washout from all Pi binders 2. Has protocol-specified acceptable serum Ca^2+ level and intact parathyroid hormone (iPTH) level at screening Exclusion Criteria: - Is employed by the clinic or the sponsor - Has family relationship with another study participant - Has any history, current condition, or drug use that per protocol or in the opinion of the investigator might compromise: 1. safety of the participant or their children 2. safety of study staff 3. analysis of study results - For Parts B and C only: 1. Is not able to take sevelamer carbonate 2. Has had partial or total parathyroidectomy within the last six months ; PRIMARY OUTCOME: Part A, Period 1: Maximum concentration (Cmax) of DS-2330a; SECONDARY OUTCOME 1: Parts B and C: Cmax of DS-2330a[/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 - PROSPECT; BRIEF: The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer. ; DRUG USED: Prostvac; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Immune System, Prostate-Specific Antigen (PSA); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bavarian Nordic; CRITERIA: Inclusion Criteria: Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression). 1. Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer. OR 2. PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria). Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated). Exclusion Criteria: Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed). Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F. History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin. 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) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Number of Subjects Alive Without Event at 6 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 - w/Ixazomib + Dexamethasone; BRIEF: ONC201 is a novel dopamine receptor D2 antagonist that is able to activate the integrated stress response pathway. It is active against multiple myeloma cells in vitro, both as a single agent and in combination with corticosteroids and proteasome inhibitors. In order to document superiority over the combination compared to the individual agents of ixazomib and ONC201 in a single arm study, there will initially be a run-in period of weekly ONC201 625 mg with dexamethasone 40 mg such that if there is progression of disease (25% increase) after 4 weeks or less than a minimal response (25% reduction) after 8 weeks then ixazomib will be added. Dexamethasone is dose-reduced to 20 mg at the same schedule for subjects ≥ 75 years old. If patients do achieve single-agent responses with ONC201 (minimal response or better), they will continue with weekly ONC201 and dexamethasone until progression, with response assessments after each 28-day cycle. Patients who have previously been treated on another clinical trial with weekly ONC201 625mg with dexamethasone with progression while receiving treatment do not need to complete the run-in phase of the study. At the time of progression, they will proceed to the 3 drug combination phase of the study. It is at the point of 3 drug initiation, that below phase I DLT principles or phase II disease control rate considerations apply. ; DRUG USED: ONC201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Dopamine 2 (D2) Receptor; THERAPY: Combination; LEAD SPONSOR: Ajai Chari; CRITERIA: Inclusion Criteria: - Signed Written Informed Consent: Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care - Target Population 1. Symptomatic MM having progressed on 2 prior therapies including proteasome inhibitor (i.e. bortezomib, carfilzomib ixazomib), immunomodulatory drug (i.e., thalidomide, lenalidomide, pomalidomide), and daratumumab or other CD38 targeting monoclonal antibody. Proteasome inhibitor refractory patients are eligible. Subjects must not be candidates for treatment regimens known to provide clinical benefit to be eligible for this study. 2. Male or female patients 18 years or older 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 4. Patients must have measurable disease defined by at least 1 of the following 3 measurements: i. Serum M-protein > 0.5 g/dL ii. Urine M-protein > 200 mg/24 hours iii. Serum free light chain assay: involved free light chain level >10 mg/dL (> 100 mg/L) provided the serum free light chain ratio is abnormal Exclusion Criteria: - Medical History and Concurrent Diseases 1. Peripheral neuropathy > Grade 2 or >Grade 1 with pain on clinical examination during the Screening period. 2. Significant cardiac disease as determined by the investigator including: i. Known or suspected cardiac amyloidosis ii. Congestive heart failure of Class III or IV of the NYHA classification iii. Uncontrolled angina, hypertension or arrhythmia iv. Myocardial infarction in the past 6 months v. Any uncontrolled or severe cardiovascular disease vi. QTc > 470 milliseconds (msec) on a 12-lead ECG obtained during the Screening period. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG. c. Known active hepatitis B (defined as most recent serum PCR or hepatitis B surface antigen positive) or active hepatitis C (note, hepatitis C in sustained virologic response defined as negative RNA PCR at least 12 weeks after any therapy is permitted). d. Any medical conditions that, in the investigators opinion, would impose excessive risk to the subject, e.g., any uncontrolled disease, such as pulmonary disease, infection, seizure disorder, uncontrolled hyperglycemia. e. Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent or limit compliance with study requirements. f. Prior or concurrent malignancy, except for the following: i. Adequately treated basal cell or squamous cell skin cancer ii. Cervical carcinoma in situ iii. Adequately treated Stage I or II cancer from which the subject is currently in complete remission. iv. Or any other cancer from which the subject has been disease-free for ≥ 3 years g. Diarrhea > Grade 1, based on the NCI CTCAE grading, in the absence of antidiarrheals. h. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of study drug, including difficulty swallowing. i. Males or females of childbearing potential who do not agree to practice 2 effective methods of contraception, at the same time through 90 days after the last dose of study drug j. Females who are pregnant or breastfeeding. k. Diagnosis of Waldenstroms macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, myeloproliferative syndrome, or primary amyloidosis (with the exception of patients whose amyloidosis has been documented as a complication of MM, who will be evaluated on a case-by-case basis for trial participation). l. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study drug administration. m. Parkinsons disease 4) Physical and Laboratory Test Findings a. Corrected serum calcium ≥ 14 mg/dl within 2 weeks of enrollment (despite appropriate measure such a short course of steroids, bisphosphonates, hydration, and calcitonin). b. Absolute neutrophil count < 1000 cells/mm3. No growth factors allowed within 1 week of enrollment. c. Platelets < 75,000 cell/mm3 (75 x 109/L). Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours prior to study drug administration. d. Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value e. Serum bilirubin ≥ 1.5 x ULN, patients with Gilberts syndrome and a total bilirubin of < 3 times ULN are permitted) f. AST or ALT ≥ 3 x ULN. g. CrCl < 30 ml/min/1.73m2. Creatinine clearance is estimated by the CKD-EPI formula. (Calculator available at https://www.kidney.org/professionals/kdoqi/gfr_calculator.) - Prior Therapy or Surgery 1. Major surgery or radiation therapy within 14 days before study drug administration. 2. Kyphoplasty or vertebroplasty within 1 week of enrollment. 3. Administration of chemotherapy, biological, immunotherapy, or investigational agent (therapeutic or diagnostic) within 3 weeks before enrollment (14 days for non-myelosuppressive therapy). Subjects should be 6 weeks from last dose of nitrosourea, nitrogen mustards or monoclonal antibody, 12 weeks from autologous SCT, and 16 weeks from allogeneic SCT. 4. Corticosteroids use exceeding a cumulative dose of 160 mg of dexamethasone during screening. 5. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GVHD). 6. Treatment with plasmapheresis within 4 weeks before enrollment. 7. NSAIDs, IV contrast, aminoglycosides, or other potentially nephrotoxic drugs within 2 weeks of enrollment. 8. Current use of a non-standard dialysis membrane. 9. Systemic treatment with strong inhibitors or inducers of CYP450 system should not be used on study including but not limited to fluvoxamine, enoxacin, ciprofloxacin, clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole, rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, buproprion, fluoxetine, paroxetine, ticlopidine, or St. Johns wort within 14 days before the first dose of study treatment. Ixazomib has significant drug-drug interactions with strong CYP3A inducers. No drug-drug interactions with the CYP450 screen have been found with ONC201, but the analysis of these studies is not complete, so during the study use of inhibitors or inducers of CYP450 system is excluded. 10. Failure to have fully recovered (i.e., Grade 1 toxicity or less, with the exception of alopecia) from clinically significant effects of prior chemotherapy regardless of interval since last treatment. - Allergies and Adverse Drug Reaction Known hypersensitivity to bortezomib, ixazomib, dexamethasone, ONC201 ; PRIMARY OUTCOME: Recommended phase II dose (RPTD); SECONDARY OUTCOME 1: Disease control 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 IIa - Inadequate Ursodeoxycholic Acid Response; BRIEF: The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA). ; DRUG USED: Elafibranor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Biliary Cholangitis (PBC) and Hepatic Fibrosis; TARGET: PPAR alpha, PPAR delta; THERAPY: Monotherapy; LEAD SPONSOR: Genfit; CRITERIA: Inclusion Criteria: 1. Must have provided written informed consent 2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: - History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit) - Positive Anti-Mitochondrial Antibodies (AMA) titers (> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies - Liver biopsy consistent with PBC 3. ALP >= 1.67x upper limit of normal (ULN) 4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit 5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment. Exclusion Criteria: 1. History or presence of other concomitant liver diseases 2. Screening creatine phosphokinase (CPK) > upper limits of normal (ULN) 3. Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) > 5 ULN 4. Screening total bilirubin > 2 ULN 5. Screening serum creatinine > 1.5 mg/dl 6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate [eGFR] of less than 60 mL/min/1.73 m^2). 7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C) 8. Platelet count <150 X 10^3/microliter 9. Albumin <3.5 g/dL 10. Presence of clinical complications of PBC or clinically significant hepatic decompensation 11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating 12. Known history of human immunodeficiency virus (HIV) infection 13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Pagets disease) ; PRIMARY OUTCOME: Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint); SECONDARY OUTCOME 1: Percentage of Participants With Response Defined by Composite Risk Scores (ALP< 1.67 * Upper Limit of Normal [ULN] at Endpoint, Total Bilirubin [BIL] Within Normal Limits at Endpoint, and Greater Than [>] 15% ALP Reduction From Baseline to Endpoint)[/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 - STRIDE (HR+/HER2-); BRIEF: EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25). ; DRUG USED: Tecemotide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Immune System, Mucin 1 (MUC-1); THERAPY: Combination; LEAD SPONSOR: EMD Serono; CRITERIA: Inclusion Criteria: - Postmenopausal women as defined in the protocol - Estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, histologically or cytologically confirmed primary carcinoma of the breast - Expressing at least one of the following five human leukocyte antigen (HLA) haplotypes, as centrally assessed by HLA genotyping from whole blood: HLA-A2, -A3, -A11, -B7, or -B35 - Locally advanced, recurrent, or metastatic breast cancer (Subject must have at least one lesion not located in bone) - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), and inoperable - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate hematologic, hepatic, and renal function within two weeks prior to initiation of therapy, as defined by the protocol - Other protocol-defined inclusion criteria may apply Exclusion Criteria: Disease Status - PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within 48 months from the initiation of such therapy - Human epidermal growth factor receptor 2-positive (HER2+) breast cancer as defined in the protocol - Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study (Exception will be granted for well-controlled Type I diabetes mellitus) - Recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies - Past or current history of malignant neoplasm other than breast cancer (BRCA), except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least five years - Known active Hepatitis B infection or carrier state and/or Hepatitis C infection, known Human Immunodeficiency Virus infection, or any other infectious process that in the opinion of the investigator could compromise the subjects ability to mount an immune response or could expose her to the likelihood of more and/or severe side effects Pre-therapies - Receipt of immunotherapy (for example [e.g.], interferons; tumor necrosis factor; interleukins; growth factors granulocyte macrophage-colony stimulating factor [GM-CSF], granulocyte-colony stimulating factor [G-CSF], macrophage-colony stimulating factor [M-CSF], or monoclonal antibodies), or chemotherapy, within four weeks (28 days) prior to randomization. Note: Subjects who have received monoclonal antibodies for imaging are eligible - Prior receipt of investigational systemic drugs (including off-label use of approved products) or any kind of systemic treatment (chemotherapy, or immunotherapy), with the exception of hormonal therapy (HT) when given for a period not exceeding 4 weeks (28 days) prior to randomization, for treatment of inoperable, locally advanced, recurrent, or metastatic breast cancer - Prior radiotherapy to the site of cancer, if only one site will be used for evaluation of tumor response Prior use of bisphosphonates or concurrent use while on study treatment is allowed Physiological Function - Central nervous system disease or brain metastases, as documented by computed tomography (CT) or magnetic resonance imaging (MRI) - Medical or psychiatric conditions that would interfere with the ability to provide informed consent, communicate side effects, or comply with protocol requirements - Clinically significant cardiac disease, e.g., cardiac failure of New York Heart Association (NYHA) classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, or myocardial infarction in the previous six months, as confirmed by an electrocardiogram (ECG) - Splenectomy Standard Criteria - Need for concurrent treatment with a non-permitted therapy (e.g., concurrent chemotherapy, radiotherapy, systemic immunosuppressive drugs, use of herbal medicines or botanical formulations intended to treat cancer) while on protocol therapy. Palliative radiation to painful bone lesions is allowed - Participation in another clinical study within 30 days prior to randomization - Known hypersensitivity to the study drugs - Known alcohol or drug abuse - Legal incapacity or limited legal capacity - Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. - Subject who could be regarded as vulnerable according to International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (e.g., the subjects willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate, plus persons kept in detention; persons in nursing homes; subjects in emergency situations; homeless persons; and nomads) - Any other reason that, in the opinion of the investigator, precludes the subject from participating in this study ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS) Time[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - MAD; BRIEF: The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS. Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101). ; DRUG USED: Opicinumab; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: LINGO-1; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Inclusion Criteria: - Give informed consnet - Aged 18 to 60 years - Have relapsing remitting MS or secondary progressive MS - EDSS score of 1 to 6 inclusive - Body mass index of 18 to 30 kg/m2 - Commitment to use effective contraception 6 months after last dose of study drug Treatment with any interferon beta or glatiramer acetate is allowed to continue during the study as long as the initiation of treatment was at least 3 months and the dose is stable. Key Exclusion Criteria: - Primary progressive MS - Any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, allergic or anaphylactic reactions or other major disease - Clinically significant lab value at screening outside of normal range - Clinically significant ECG abnormality - Contraindication to MRI scans or lumbar punctures - Plans to undergo elective surgery during study - An MS relapse that has not resolved within 30 days before screening - History or postive test result for Hepatitis B, C and HIV - Serious infections within 3 months prior to Day -1 - Treatment with MS medication within 12 months prior to Day -1: natalizumab, daclizumab, azathioprine, methotrexate, iV immunoglobulin, plasmapheresis or mycophenolate motefil - Prior treatment with total lymphoid irradiation, T cell or T-cell receptor vaccination, alemtuzumab, mitoxantone, cyclophosphamide, rituximab, fingolimod. ; PRIMARY OUTCOME: Evaluate safety and tolerability profile of two IV infusions of BIIB033 in subjects with MS; SECONDARY OUTCOME 1: Assess the repeat-dose serum PK profile of BIIB033[/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 - 021; BRIEF: This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin-modifying therapy. ; DRUG USED: Anacetrapib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Cholesteryl Ester Transfer Protein (CETP); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - If female, cannot be of reproductive potential - Have been treated with an optimal dose of statin for at least 6 weeks - Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal Exclusion Criteria: - Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor - Homozygous familial hypercholesterolemia - Severe chronic heart failure - Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months - Uncontrolled hypertension - Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins - Active or chronic hepatobiliary, hepatic, or gall bladder disease - History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable - History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption - Human immunodeficiency virus (HIV) positive - History of malignancy ≤5 years - Donated blood products or has had phlebotomy of >300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study - Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St Johns wort) or has discontinued treatment <3 weeks prior - Consumes more than 2 alcoholic drinks per day - Currently participating or has participated in a study with an investigational compound or device within 3 months - Receiving treatment with systemic corticosteroids or taking systemic anabolic agents ; PRIMARY OUTCOME: Percent Change from Baseline in LDL-C (beta-quantification [BQ] method); SECONDARY OUTCOME 1: Percent change from Baseline in non-HDL-C[/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 - INSTAGE; BRIEF: To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment. ; DRUG USED: Ofev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Idiopathic Pulmonary Fibrosis (IPF); TARGET: Fibroblast Growth Factor Receptor (FGFR) , Platelet-derived growth factor receptor (PDGFR), Src Kinase Family, VEGF Receptor (VEGFR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Written informed consent consistent with International Conference on Harmonization-Good Clinical Practice and local laws, signed prior to any study procedures being performed (including any required washout); - Male or female patients aged >= 40 years at visit 1; - A clinical diagnosis of IPF within the last 6 years before visit 1, based upon the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American thoracic Association 2011 guideline [P11-07084]; - Combination of high-resolution computed tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with a diagnosis of IPF as assessed by the investigator based on a HRCT scan performed within 18 months of visit 1; - Carbon Monoxide Diffusion Capacity (corrected for Hb) less or equal to 35% predicted of normal at visit 1. Exclusion criteria: - Previous enrolment in this trial; - Alanine Transaminase, Aspartate Transaminase > 1.5 fold upper limit of normal (ULN) at visit 1; - Total bilirubin > 1.5 fold ULN at visit 1; - Relevant airways obstruction (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity <0.7 at visit 1) - History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of visit 1 - Bleeding Risk: - Known genetic predisposition to bleeding; - Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin, etc.) or high dose antiplatelet therapy; - History of haemorrhagic central nervous system (CNS) event within 12 months prior to visit 1; - History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to visit 1; - International normalised ratio (INR) > 2 at visit 1; - Prothrombin time (PT) and activated partial thromboplastin time (aPTT) > 150% of institutional ULN at visit 1; - Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery; - History of thrombotic event (including stroke and transient ischemic attack) within 12 months of visit 1; - Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault formula at visit 1; - Presence of aortic stenosis (AS) per investigator judgement at visit 1; - Severe chronic heart failure: defined by left ventricular ejection fraction (EF) < 25% per investigator judgement at visit 1; - Presence of idiopathic hypertrophic subaortic stenosis (IHSS) per investigator judgement at visit 1; - Second-degree or third-degree atrioventricular (AV) block on electrocardiogram (ECG) per investigator judgement at visit 1; - Hypotension (systolic blood pressure [SBP] < 100 mm Hg or diastolic blood pressure [DBP] < 50 mm Hg) (symptomatic orthostatic hypotension) at visit 1; - Uncontrolled systemic hypertension (SBP > 180 mmHg; or DBP > 100 mmHg) at visit 1; - Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose to priapism; - Retinitis pigmentosa; - History of vision loss; - History of nonarteritic ischemic optic neuropathy; - Veno-occlusive disease; - History of acute IPF exacerbation or respiratory infection within 8 weeks of visit 2. - Treatment with nitrates, n-acetylcysteine, pirfenidone, azathioprine, cyclophosphamide, cyclosporine, prednisone >15 mg daily or >30 mg every 2 days OR equivalent dose of other oral corticosteroids as well as any investigational drug within 4 weeks of visit 2; - Treatment with prostaglandins (e.g., epoprostenol, treprostinil), endothelin-1 antagonists (e.g., bosentan, sitaxsentan, ambrisentan), phosphodiesterase inhibitors (e.g., sildenafil, tadalafil, vardenafil) or a stimulator of guanylatcyclase (e.g.,riociguat) within 4 weeks of visit 2; - Treatment with potent cytochrome CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir within 4 weeks of visit 2; - Supplementation with L-arginine and concurrent use of grapefruit juice or St Johns wort within 4 weeks of visit 2; - Treatment with the reduced dose of nintedanib (100 mg bid) within 4 weeks of visit 2; 27. Permanent discontinuation of nintedanib in the past due to adverse events considered drug-related; - Known hypersensitivity or intolerance to nintedanib, sildenafil, galactose, peanut or soya or any other components of the study medication; - A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial; - Alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment; - Further exclusion criteria apply. ; PRIMARY OUTCOME: Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total Score at Week 12; SECONDARY OUTCOME 1: Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Moderate-to-Severe UC; BRIEF: The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product. ; DRUG USED: Tralokinumab; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: IL-13 (Interleukin-13); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Diagnosed ulcerative colitis at least 90 days prior randomisation. - Men or women age 18 - 75 years. - Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization. - Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1. - Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception. Exclusion Criteria: - Pregnant or breastfeeding women. - History of colostomy. - Current diagnosis of indeterminate colitis, Crohns disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis). - Hepatitis B, C or HIV. - History of cancer. ; PRIMARY OUTCOME: Clinical Response at Week 8 Based on Mayo Score; SECONDARY OUTCOME 1: Change in Mayo Score From Baseline to 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 II - US; BRIEF: To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation. ; DRUG USED: Stalaris; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Neuropilin 2 (NRP2); THERAPY: Monotherapy; LEAD SPONSOR: aTyr Pharma, Inc.; CRITERIA: Inclusion Criteria: - Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR). - Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following: - Respiratory rate >30 breaths/minute; - Severe respiratory distress, as determined by the Investigator; - Oxygen saturation (SpO2) ≤93% on room air. Exclusion Criteria: - Participant is intubated/mechanically ventilated. - In the opinion of the Investigator, participants progression to death is imminent. - Treatment with immunosuppressant/immunotherapy drugs, including but not limited to interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (TNF-α) inhibitors, anti-IL-1 agents and janus kinase inhibitors within 5 half-lives or 30 days prior to Day 1. - Use of chronic (>30 days) oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day. - Weight >165 kg or <40 kg. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Time to Hospital Discharge[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - OTEMTO 1; BRIEF: The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD. ; DRUG USED: Stiolto Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Diagnosis chronic obstructive pulmonary disease - Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal and post FEV1/ FVC < 70% - Male or female patients, 40 years of age or more - Smoking history more than 10 pack years Exclusion criteria: - Significant diseases other than COPD - History of asthma - COPD exacerbation in previous 3 months - Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program. - Pregnant or nursing women - Patients unable to comply with pulmonary medication restrictions ; PRIMARY OUTCOME: FEV1 AUC0-3h Response; SECONDARY OUTCOME 1: Trough Forced Vital Capacity (FVC) Response (Change From Baseline)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Lidocaine 04; BRIEF: The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel). ; DRUG USED: COL-1077; DRUG CLASS: Non-NME; INDICATION: Dysmenorrhea; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Juniper Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Experiences primary dysmenorrhea requiring pain medication for moderate-to-severe pain (as measured by a 4-point categorical rating scale) by the subjects own report for at least four of the previous six menstrual cycles. 2. Has a history of primary dysmenorrhea with onset within 4 years of menarche. 3. Has regular menstrual cycles (i.e. onset of menses predictable within 1 - 2 days each month) for the 3 month period preceding enrollment. If a subject has had regular cycles for the past 12 months but had a single cycle that was not regular within the 3 month period preceding enrollment, the subject may be enrolled at investigator discretion after consultation with sponsor. 4. Taking the same strength and type of hormonal contraception on a monthly cycle for at least the previous 6 months prior to screening and plans to remain on this hormonal contraception for the duration of participation in the study or is on an acceptable method of birth control including surgical sterilization (i.e. bilateral tubal ligation, partner vasectomy), double-barrier methods, and total abstinence (at the discretion of the investigator in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance). 5. Is a tampon user and/or must be willing to use tampons throughout the study dosing period. 6. Age 18 to 40 years (inclusive). 7. Has a Body Mass Index (BMI) ≤ 35 kg/m2. 8. Able to understand and willing to complete the efficacy evaluations. 9. Able to speak and understand English, and must give written informed consent for the study. Exclusion Criteria: 1. Unable, in the opinion of the Investigator, to comply fully with any of the study requirements. 2. Experiencing pelvic pain other than that thought to be associated with primary dysmenorrhea, such as chronic pelvic pain occurring at times other than exclusively during menses and/or dyspareunia. 3. Experiencing dysmenorrhea symptoms that are effects of or thought to be effects of (at least in part) secondary causes of dysmenorrhea, such as uterine fibroids, endometriosis, and/or currently symptomatic ovarian cysts. 4. Experienced dysmenorrhea that did not require, in the opinion of the subject, the use of analgesic medication during four of the previous six menstrual episodes. 5. Has dysmenorrhea refractory to treatment with commonly used analgesic medications for the treatment of menstrual pain (e.g., ibuprofen or naproxen sodium). 6. Use of any Class I antiarrhythmic drug. 7. Currently using contraceptive injection, implant, or extended cycle OC (hormonal contraceptive cycles consisting of 28 days or more of active hormones). 8. Pregnant or breastfeeding. 9. Participated in a clinical trial in the 30 days from the time of last dosing in the prior study to the time of providing consent for this study. 10. Previously randomized into this study. 11. A history of allergic hypersensitivity or significant intolerance (including angioedema, urticaria, bronchospasm, and rhinitis) related to treatment with any medications used in this study. 12. A history of past or ongoing clinically significant disease, illness, or disorder that, in the opinion of the Investigator, makes the subject unsuitable for study participation including active vaginal, vulvar, and cervical lesions. 13. Laboratory abnormalities that, in the opinion of the Investigator, could contraindicate study participation such as liver function tests > 1.5 times the upper limit of normal (At the Investigators discretion, laboratory tests may be repeated once for verification.) 14. A history of, within the past 4 years, or ongoing significant psychiatric illness that, in the opinion of the Investigator, makes the subject unsuitable for study participation. 15. A history of chronic analgesic or tranquilizer use or drug abuse including alcohol within the 6 months before providing consent for this study. 16. Regular use of any concomitant medications that might confound efficacy and/or safety assessments, in the opinion of the Investigator, including, but not limited to, the following: psychotropic drugs, antidepressants, sedative-hypnotics, sedating antihistamines, or tranquilizers for 24 hours or five half-lives prior to providing informed consent until 24 hours after the final treatment cycle. Selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and St. Johns Wort are permitted for indications other than pain if the subject has been on a stable dose for at least 2 weeks before providing consent for this study and agrees to remain on a stable dose throughout the course of the study. 17. Unwilling to use only those medications that are allowed in the study for the treatment of their dysmenorrhea, i.e., study drug and rescue medication. 18. Any ongoing vaginal infection requiring intravaginal treatment. 19. A history of toxic shock syndrome (TSS). ; PRIMARY OUTCOME: The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.; SECONDARY OUTCOME 1: Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing[/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 - TT420X2101 (TNBC); BRIEF: This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study consists of a dose escalation part followed by a MTD expansion part. ; DRUG USED: TT-00420; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Kinases - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: TransThera Sciences (Nanjing), Inc.; CRITERIA: Inclusion Criteria: 1. Aged 18 years to 75 years at the time of provision of informed consent 2. Dose Escalation Cohorts: Histopathological or cytologically documented locally advanced or metastatic solid tumors who have no available standard therapeutic treatment options Dose Expansion Cohorts: Histopathological or cytologically documented locally advanced or metastatic TNBC or SATs 3. TNBC Dose Expansion Cohort: 1. Histologically proven invasive breast carcinoma with triple negative receptor status per institutional standard and with confirmed negative for ER and PR by IHC (<10% positive tumor nuclei) 2. relapsed/refractory to at least one line of systemic chemotherapy 4. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors 5. ECOG performance status of 0 or 1 6. Adequate organ function confirmed at Screening and within 10 days of initiating treatment, as evidenced by: - Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L - Hemoglobin (Hgb) ≥ 9 g/dl - Platelets (plt) ≥ 100 x 10^9/L - AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present - Total bilirubin ≤ 1.5 x ULN, or direct bilirubin < ULN for patients with total bilirubin levels >1.5 ULN - Serum creatinine ≤ 1.5 x ULN or calculated 24-hour clearance ≥ 50 mL/min - Negative pregnancy test within 72 hours before starting study treatment in all pre-menopausal women and women < 12 months after the onset of menopause 7. Must agree to take sufficient contraceptive methods to avoid pregnancy during the study and until at least 6 months after ceasing study treatment 8. Able to sign informed consent and to comply with the protocol Exclusion Criteria: 1. Women who are pregnant or lactating 2. Women of child-bearing potential (WOCBP) who does not use adequate birth control 3. Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma. 4. Patients with 1. a history of primary central nervous system tumors or 2. carcinomatous meningitis Note: Patients with treated brain metastases that are off corticosteroid and have been clinically stable 28 days are eligible for enrollment 5. Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as result of patients mood assessment questionnaire: - Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia; a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) - ≥ CTCAE grade 3 anxiety - The psychiatric judgment, if available, overrules the mood assessment questionnaire result/investigator judgment 6. Impaired cardiac function or clinically significant cardiac diseases, including but not limited to any of the following: 1. LVEF < 45% as determined by MUGA scan or ECHO 2. Congenital long QT syndrome 3. QTc ≥ 450 msec on screening ECG 4. Unstable angina pectoris ≤ 3 months prior to starting study drug 5. Acute myocardial infarction ≤ 3 months prior to starting study drug 7. Patients with 1. unresolved diarrhea ≥ CTCAE grade 2, or 2. impairment of gastrointestinal (GI) function, or 3. GI disease that may significantly alter the absorption of TT-00420 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 8. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol 9. Patients who have received chemotherapy, targeted therapy or immunotherapy ≤ 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy 10. Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy 11. Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy 12. Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated before enrollment, may be continued 13. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants 14. Patients who have received corticosteroids ≤ 2 weeks prior to starting study drug or who have not recovered from the side effects of such treatment 15. Patients who are currently receiving treatment with medication that has known risk to prolong the QT interval or inducing Torsades de Pointes, and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug 16. Patients who are receiving high to moderate CYP3A inhibitors and inducers as listed in Appendix F 17. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) 18. Known history of active infection with Hepatitis B (e.g., HBsAg reactive), or Hepatitis C (e.g., HCV RNA (qualitative) is detected) 19. Has received a live-virus vaccination within 30 days of planned first dose Note: Seasonal flu vaccines are permitted. 20. Inability to swallow or tolerate oral medication 21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patients participation and compliance in the trial ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) and/or Dose Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Dose Recommended for Dose Expansion (DRDE)[/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 - CP101 (Solid Tumors) (EU); BRIEF: This research study is looking at a new DARPin® drug candidate, called MP0250. There is evidence from preclinical studies that MP0250 may be effective in the treatment of cancer. This is the first study of MP0250 in humans and its main purpose is to test its safety and tolerability in patients with cancer. This study will also examine how the drug is changed by and removed from the body and look for indicators that the drug may be effective against cancer. This study will test several different dose levels of the study drug to determine the safety and tolerability profile of the drug. ; DRUG USED: MP0250; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Molecular Partners AG; CRITERIA: Inclusion Criteria: 1. Male or female ≥ 18 years 2. Histologically confirmed and documented advanced or metastatic solid tumour refractory to at least 1 prior regimen of standard treatment or for which no curative therapy is available and for whom MP0250 is a reasonable option 3. Progressive or stable disease documented radiologically in the 4 weeks prior to screening 4. Presence of a measurable tumour or a tumour evaluable per RECIST v1.1 5. ECOG performance status ≤ 1 6. Life expectancy ≥ 12 weeks 7. Adequate haematological function prior to first dose, defined as: - Absolute neutrophils count ≥ 1500 cells/μL - Haemoglobin ≥ 9 g/dL - Platelet count > 100,000/μL - Prothrombin time or partial thromboplastin time < 1.2 x ULN 8. Adequate renal function prior to first dose, defined as either - Serum creatinine < 1.5 mg/dL or - Serum creatinine clearance ≥ 50 mL/min/m2 (by Cockroft-Gault equation) 9. Adequate hepatic function prior to first dose, defined as - Total bilirubin ≤ 1.5 x ULN - AST/ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if known hepatic metastases - Alkaline phosphatase ≤ 2.5 x ULN, or ≤ 5 x ULN if known hepatic or bone metastases 10. Female patients with a negative pregnancy test result at screening and baseline Exclusion Criteria: 1. Female patients pregnant or breast-feeding 2. Haematological malignancies or other secondary malignancy, that is currently clinically significant or requires active intervention 3. Known untreated or symptomatic brain metastases 4. Predominantly squamous non-small cell lung carcinoma 5. Anti-tumour treatment within 4 weeks of the first infusion of MP0250, such as chemotherapy, experimental or targeted therapy, biologics, hormonal therapy and radiotherapy. The anti-tumour treatments below need longer wash-out periods and must not be given within the indicated weeks of the first infusion of MP0250: i. Nitrosoureas: 6 weeks ii. Monoclonal antibodies: 8 weeks 6. Exceptions: the following anti-tumour treatments are allowed as indicated i. Palliative radiation to bone metastases to relieve bone pain ii. Standard of care treatment such as bone modifying agents (i.e. bisphosphonates), denosumab, maintenance hormonal therapy for metastatic prostate and breast cancers, hormone-replacement therapy, and oral contraceptives 7. Presence of residual toxicities of CTC-AE Grade ≥ 2 after prior anti-tumour therapy at screening. Except meeting other exclusion criteria, grade 1 toxicities related to previous treatments are acceptable at the time of the first infusion of MP0250, as well as Grade 2 alopecia 8. Exclusion criterion removed 9. Major surgical procedures, open biopsy or significant traumatic injury within 4 weeks of first dose or anticipation of major surgical procedure during the course of the study, core biopsy or minor surgical procedures within 1 week of first dose 10. Serious non-healing wound, active ulcer or untreated bone fracture 11. Proteinuria at screening as defined by ≥ 1+ on urinalysis dipstick, confirmed by ≥ 1g in 24h urinalysis 12. Uncontrolled hypertension or any other serious cardiovascular or cardiac condition as judged by the investigator 13. Severe or uncontrolled renal insufficiency ; PRIMARY OUTCOME: Proportion of patients with dose limiting toxicities; SECONDARY OUTCOME 1: Incidence of anti-drug-antibodies[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - w/Eylea; BRIEF: To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy ; DRUG USED: Zimura; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polypoidal Choroidal Vasculopathy (PCV); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Combination; LEAD SPONSOR: Ophthotech Corporation; CRITERIA: Inclusion Criteria: - Diagnosis of IPCV - Patients must have had 3 sequential Eylea injections within the previous 4 months Exclusion Criteria: - Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea - History or evidence of severe cardiac disease - Any major surgical procedure within one month of trial entry - Subjects with a clinically significant laboratory value - Any treatment with an investigational agent in the past 60 days for any condition - Women who are pregnant or nursing - Known serious allergies to the fluorescein dye, ICG dye, iodine, povidone iodine, or to the components or formulation of either Zimura or Eylea ; PRIMARY OUTCOME: Adverse Events (AEs); 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 IIa - OL007 (Serbia); BRIEF: The purpose of this study is to determine whether the Litx™ system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Litx™ is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment. ; DRUG USED: Aptocine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Light Sciences LLC; CRITERIA: Inclusion Criteria: - Patients with metastatic liver lesions from colorectal disease - Biopsy proven evidence of colorectal cancer - Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter - Age greater than or equal to 18 years - Patients must be able to sign informed consent - Life expectancy greater than or equal to 3 months - ECOG performance status 0-2 - Patients with extrahepatic disease in addition to their hepatic metastases may be eligible - Must have recovered from the toxicity from any prior antineoplastic therapy Exclusion Criteria: - Patients who are candidates for complete surgical resection - Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment - Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study - PT or PTT greater than 1.5X control - Platelet count less than 100,000 - WBC less than 2500/mm - Neutrophils less than 2000/mm - Hemoglobin less than 9 g/dL - Liver enzymes (AST, ALT, GGT, alkaline phosphatase) greater than 3 X ULN - Total bilirubin greater than 1.5 X ULN - Serum creatinine greater than 2.5 X ULN - Patients who have been treated with either AVASTIN™ (Bevacizumab) or ERBITUX™ (Cetuximab) within the previous 4 weeks (28 days) ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - AFFiRiS011; BRIEF: Study AFF011 is a randomized controlled parallel Group phase I study to investigate the safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with early Parkinsons disease. In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo group), each consisting of 12 patients. The patients will be randomized to either receive 15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without active component (Placebo). Over a study duration of 52 weeks, the study participants receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 45 to 70 years can participate in the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved. AFF011 is part of a project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999). ; DRUG USED: AFFITOPE PD03A; DRUG CLASS: Vaccine; INDICATION: Parkinsons Disease (PD); TARGET: Alpha-synuclein, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Affiris AG; CRITERIA: Inclusion Criteria: - Individuals with IPS diagnosed for less than 4 years and who present in Hoehn & Yahr Stages I/II and fulfill the United Kingdom Parkinsons Disease Society Brain Bank Criteria - The result of a DAT-SPECT and MRI examination of the patients brain has to be consistent with the diagnosis of PD - Written Informed Consent Form signed and dated by the patient - Age between 45 and 70 - Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method - A potential participant treated with conventional PD therapies must be on stable doses for at least 3 months prior to Visit 0 and during the entire trial period and must be a stable responder - Accepted PD medications include the following: levodopa (alone or in combination with benserazide, carbidopa), Catechol-O-methyltransferase inhibitors (entacapone, tolcapone), amantadine, non-ergot dopamine agonists (pramipexol, ropinirol, rotigotine), monoamine oxidase-B inhibitors (rasagiline, selegiline) and anticholinergic medication - A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except PD therapies, these will be recorded separately) for at least 30 days prior to Visit 0, if considered relevant by the PI - Upon PIs opinion, no visual or auditory impairments that would reduce the patients ability to complete study questionnaires or be unable to receive instructions for these Exclusion Criteria: - Pregnant women - Sexually active women of childbearing potential who are not using a medically accepted birth control method throughout the study - Participation in another clinical trial within 3 months before Visit 0 - History of questionable compliance to visit schedule; patients not expected to complete the clinical trial - Presence or history of allergy to components of the vaccine, if considered relevant by the PI - Contraindication for MRI imaging such as metallic endoprosthesis or stent implantation in the last 6 months or allergy to MRI contrast agent - Contraindication for DAT-SPECT - Contraindication for lumbar puncture such as anticoagulation - Dementia - History and/or presence of autoimmune disease, if considered relevant by the PI - Recent (≤3 years since last specific treatment) history of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia) - Active infectious disease (e.g., Hepatitis B, C) - Presence and/or history of Immunodeficiency (e.g., HIV) - Significant systemic illness (e.g., chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, other deficiencies), if considered relevant by the PI - History of significant psychiatric illness such as schizophrenia, bipolar affective disorder or psychotic depression - Parkinson-like disease secondary to drug therapy side effects (e.g., due to exposure to medications that deplete dopamine [reserpine, tetrabenazine] or block dopamine receptors [neuroleptics, antiemetics] - Parkinson-plus syndromes (e.g. MSA, PSP) - Heredodegenerative disorders - Alcoholism or substance abuse within the past year (alcohol or drug intoxication) - Prior and/or current treatment with experimental immunotherapeutics including intravenous immunoglobulin - Prior and/or current treatment with immunosuppressive drugs - Change in dose of standard treatments for PD within 3 months prior to Visit 0 - Change in dose of previous and current medications which the patient is taking because of consisting illnesses according medical history (except PD therapies, these will be recorded separately) within the last 30 days prior to Visit 0, if clinically relevant - Treatment with deep brain stimulation - Venous status rendering it impossible to place an i.v. access - L-Dopa related motor complications (response fluctuations and/or dyskinesia) - Evidence for genetic forms of PD: leucine-rich repeat kinase 2 and Parkin ; PRIMARY OUTCOME: Number of patients who withdraw due to Adverse Events (AEs); SECONDARY OUTCOME 1: Immunological activity of AFFITOPE® vaccine PD03A[/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 - Zinc-Finger; BRIEF: This research study is being carried out to study a new way to possibly treat HIV. This agent is called a Zinc Finger Nuclease or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain common types of HIV (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used by the body to fight HIV. The most important T-cells are those called CD4 T-cells. Some people are born without CCR5 on their T-cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and their HIV disease is less severe and is slower to cause disease (AIDS). In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral vector. The viral vector used in this study is called an adenoviral vector. The vector is added to the cells at the beginning of the manufacture process and the ZFNs knock out the CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is permanent. The purpose of this research study is to find out whether zinc finger modified T-cells are 1. safe to give to humans and 2. find how zinc finger modified T cell affects HIV This is an experimental study. Laboratory studies have shown that when CD4 T-cells are modified with zinc fingers, HIV is prevented from killing the CD4 T cells. On the basis of these laboratory results, there is the potential that zinc fingers may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer (HIV usually kills T cells it infects). All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study to monitor subjects. Subjects will be followed every 3 months for four years. If the ZFN Modified CD4+T cells are no longer found in the blood after four years, then subjects will be contacted yearly for the next 6 years. If the ZFN Modified CD4+T cells are found in the blood at year four, then the subjects will continue to be seen once a year until the ZFN Modified CD4+T cells are no longer found in the blood for a maximum of 10 years. ; DRUG USED: SB-728-T; DRUG CLASS: Biologic; INDICATION: HIV / AIDS; TARGET: Chemokine Receptor 5 (CCR5), Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: University of Pennsylvania; CRITERIA: Inclusion Criteria: Cohort 1 Only: - Patients who have been on two more HAART regimens and have failed due to resistance or tolerance (no changes to treatment within 4 weeks of study entry), and who have no viable treatment options likely to result in complete viral suppression. - CD4+ T cell count of ≥200 cells/mm3 - HIV-1 RNA ≥2000 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay. - Two HIV-1 RNA levels <150,000 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay. These HIV-1 RNA measurements must be at least 48 hours apart and may include the HIV-1 RNA measurement done at the time of the screening visit. - Ongoing treatment with HIV entry inhibitors such as enfurvitide or maraviroc are excluded Cohort 2 Only: - On a stable antiretroviral medication (no changes to treatment within 4 weeks of study entry) and be willing to continue on current antiretroviral therapy for the duration of the study until undergoing structured treatment interruption. - CD4+ T cell count of ≥450 cells/mm3 at screen; and a documented CD4 nadir of not lower than 300 cells/mm. - HIV-1 RNA undetectable by ultrasensitive HIV PCR assay obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay. Cohort 3 only: - On a stable antiretroviral medication (no changes to treatment within 4 weeks of study entry) and be willing to continue on current antiretroviral therapy for the duration of the study. - CD4+ T cell count that is persistently <500 cells/mm3 despite at least 2 years of stable HAART and >200 cells/mm3 at screen - Subjects must have received at least 2 continuous years of therapy and have had undetectable viral loads by ultrasensitive assay since 6 months of therapy. Subjects who have had a single viral load blip at any point in this time, or who experience intermittent isolated episodes of detectable low-level viremia (detectable but <1000 copies RNA/mL; blips) will remain eligible. - Subjects who are currently taking maraviroc or have received maraviroc within 6 months of study entry are excluded. Inclusion for Cohort 1, Cohort 2, Cohort 3: - HIV-1 infection, as documented by ELISA and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test. - Adequate venous access and no other contraindications for leukapheresis. - Laboratory values obtained at screen. Hemoglobin: ≥ 10.0 (males); ≥ 9.5 (females) g/dL Absolute neutrophil count (ANC): ≥ 1000/mm3 Platelet count: ≥ 100,000/mm3 Serum creatinine: ≤ 1.5 mg/dL (133µ mol/L) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT): ≤ 2.5 times the upper limit of normal (ULN). - Subjects must be willing to comply with study-mandated evaluations; including not changing their antiretroviral regimen (unless medically indicated) for 2 months in step 2 (Cohort 1) or until undergoing structured treatment interruption (Cohort 2). - Karnofsky Performance Score of 70 or higher Exclusion Criteria: - Acute or chronic hepatitis B or hepatitis C infection - Current or prior AIDS diagnosis (Cohort 1 and 2 only) - History of cancer or malignancy, (basal cell or squamous cell carcinoma of the skin allowed) - History or problems with uncontrolled heart disease, bleeding or hemodynamic instability. - Have been previously treated with any HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector. - Use of the following medications within the last 30 days: chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) - Breast-feeding, pregnant, or unwilling to use acceptable methods of birth control. - Use of aspirin, dyprydamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2-week period prior to leukapheresis. - Active drug or alcohol use or dependence that in the opinion of the investigator, would interfere with adherence to study requirements - Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry. - Receipt of a vaccination within 30 days prior to study entry. - Have an allergy or hypersensitivity to study product excipients (human serum albumin, DMSO and Dextran 40). - Currently taking medications called HIV entry inhibitors such as enfuvirtide or maraviroc ; PRIMARY OUTCOME: Safety - Treatment related adverse events; SECONDARY OUTCOME 1: Compare the percent of CD4+ and CD8+ T cells that secrete cytokines as a response to stimulation by HIV-specific antigens after the infusion of αCCR5 ZFN-modified autologous T cells[/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 - MOUNTAINEER (w/Trastuzumab); BRIEF: This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). Metastatic means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab. ; DRUG USED: Tukysa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria - Histologically and/or cytologically documented adenocarcinoma of the colon or rectum that is metastatic and/or unresectable - Unless contraindicated, participants must have received and failed regimens containing the following agents: fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ramucirumab, or ziv-aflibercept), and an anti-PD-(L)1 therapy (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins or is MSI-High. - Have progression of unresectable or metastatic CRC after the last systemic therapy, or be intolerant of last systemic therapy - Have RAS wild-type in primary or metastatic tumor tissue, based on expanded RAS testing - Willing and able to provide the most recently available tissue blocks obtained prior to treatment initiation. If archival tissue is not available, then a newly-obtained baseline biopsy of an accessible tumor - Have confirmed HER2-positive mCRC, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Act (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory, meeting at least one of the following criteria: - HER2+ overexpression (3+ immunohistochemistry [IHC]) by an FDA-approved or Conformité Européene (CE)-marked HER2 ICH test - HER2 2+ IHC is eligible if the tumor is amplified by an FDA-approved or CE-marked HER2 in situ hybridization assay (FISH or chromogenic in situ hybridization [CISH])) - HER2 (ERBB2) amplification by CLIA-certified or ISO-accredited next generation sequencing (NGS) sequencing assay - Have radiographically measurable disease assessable by RECIST 1.1, with at least one site of disease that is measurable and that has not been previously irradiated; or, if the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 - Life expectancy greater than 3 months - Have adequate hematological, hepatic, renal, coagulation, and cardiac function Exclusion Criteria - Previous treatment with anti-HER2 targeting therapy - Previous treatment with any systemic anticancer therapy, non-central nervous system radiation, or experimental agent within 3 weeks of first dose of study treatment - Toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions: - Alopecia and neuropathy, which must have resolved to ≤ Grade 2 - Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence, and must have resolved completely - Anemia, which must have resolved to ≤ Grade 2 - Decreased ANC, which must have resolved to ≤ Grade 2 - Have clinically significant cardiopulmonary disease - Have known myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to first dose of study treatment - Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to enrollment (≤56 days for hepatectomy, open thoracotomy, or major neurosurgery) or anticipation of need for major surgical procedure during the study - Serious, non-healing wound, ulcer, or bone fracture - Known to be positive for hepatitis B by surface antigen expression - Known to have active hepatitis C infection - Exception for participants with a documented sustained virologic response of 12 weeks - Known to be positive for human immunodeficiency virus (HIV) - Subjects who are pregnant, breastfeeding, or planning a pregnancy - Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications - Have used strong CYP2C8 inhibitor within 5 half-lives of the inhibitor, or have used a strong CYP2C8 or CYP3A4 inducer within 5 days prior to first dose of study treatment - History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. - Exceptions are malignancies with a negligible risk of metastasis or death - Subjects with known active CNS metastasis - Irradiated or resected lesions are permitted, provided the lesions are fully treated and inactive, subject is asymptomatic, and no steroids have been administered for at least 30 days ; PRIMARY OUTCOME: Confirmed Objective Response Rate (cORR) Per RECIST 1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B; SECONDARY OUTCOME 1: ORR by 12 Weeks of Treatment Per RECIST 1.1 According to BICR Assessment[/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 - Onset 3 (w/Basal Insulin); BRIEF: This trial is conducted in Asia, Europe, South America, and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes. ; DRUG USED: FIAsp; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1) - Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1) - Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg - HbA1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1) - Body mass index (BMI) equal or less than 40.0 kg/m^2 Exclusion Criteria: - Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1) - Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) ; PRIMARY OUTCOME: Change From Baseline in HbA1c; SECONDARY OUTCOME 1: Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)[/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 - 101; BRIEF: HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors. ; DRUG USED: HTI-1066; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Antibody-drug Conjugate (ADC), Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy; LEAD SPONSOR: Jiangsu HengRui Medicine Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Male or female ≥18 years of age 2. Subject must have an advanced solid tumor 3. ECOG Performance Status of 0 or 1 4. Life expectancy ≥12 weeks 5. Adequate laboratory parameters 6. Female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception. 7. Willing and able to comply with clinic visits and study-related procedures 8. Provide signed informed consent Exclusion Criteria: 1. Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products 2. Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor) 3. Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor) 4. Any other prohibited or restricted medication as described in the study protocol. 5. Investigational therapy administered <5 half-lives before the first dose of HTI-1066 6. Any anticancer therapy administered <5 half-lives before first dose of HTI-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of HTI-1066. 7. Active CNS metastases. 8. Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment. 9. History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful. 10. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis B or C) 11. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subjects rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results 12. Active infection or an unexplained fever >38.5°C during Screening or on the first scheduled day of dosing. 13. Unresolved toxicities from previous anticancer therapy. ; PRIMARY OUTCOME: Adverse events; SECONDARY OUTCOME 1: AUC[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PROTECT-1; BRIEF: The study is being conducted to examine whether KW-3902IV will result in greater improvement in signs and symptoms of heart failure, with less treatment failure than standard therapy, when it is added to IV loop diuretics in subjects with acute heart failure syndrome and renal impairment. ; DRUG USED: KW-3902 - intravenous; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Adenosine A1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Inclusion Criteria: 1. History of heart failure of at least 14 days duration for which diuretic therapy has been prescribed 2. Hospitalized for acute heart failure syndrome requiring IV diuretic therapy. 3. Impaired renal function Exclusion Criteria: 1. Acute contrast induced nephropathy 2. Ongoing or planned IV therapy for heart failure with positive inotropic agents, vasopressors, vasodilators, or mechanical support with the exception of IV nitrates 3. BNP <500pg/mL or NT-pro-BNP <2000 pg/mL 4. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis 5. Severe pulmonary disease 6. Significant stenotic valvular disease 7. Heart transplant recipient or admitted for cardiac transplantation 8. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening 9. Heart failure due to significant arrhythmias 10. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. 11. Known hepatic impairment 12. Non-cardiac pulmonary edema, including suspected sepsis 13. Allergy to soybean oil or eggs 14. History of seizure 15. Stroke within 2 years 16. History of or current brain tumor of any etiology 17. Brain surgery within 2 years 18. Encephalitis/meningitis within 2 years 19. History of penetrating head trauma 20. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years 21. History of, or at risk for, alcohol withdrawal seizures 22. Advanced Alzheimers disease 23. Advanced multiple sclerosis 24. Hgb <8 g/dL, Hct <25%, or the need for a blood transfusion 25. Previous exposure to KW-3902 ; PRIMARY OUTCOME: effect on heart failure signs and symptoms; SECONDARY OUTCOME 1: safety[/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 - ALSYMPCA; BRIEF: ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases. ; DRUG USED: Xofigo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: DNA, Radiopharmaceutical, Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate - Known hormone refractory disease - Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy - No intention to use cytotoxic chemotherapy within the next 6 months - Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain Exclusion Criteria: - Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period - Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available - Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago - Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks - Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer) - History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Time to Total Alkaline Phosphatase (ALP) Progression[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers; BRIEF: The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo. ; DRUG USED: TCN-202; DRUG CLASS: Biologic; INDICATION: Cytomegalovirus (CMV) Infection (Antiviral); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Theraclone Sciences, Inc.; CRITERIA: Inclusion Criteria: - Healthy adult volunteers - Normal lab tests Exclusion Criteria: - Prior treatment with monoclonal antibody ; PRIMARY OUTCOME: Number and severity of adverse events; SECONDARY OUTCOME 1: Peak serum concentration (Cmax) of TCN-202[/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 - INDIGO; BRIEF: Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo. ; DRUG USED: AG-881; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Isocitrate Dehydrogenase (IDH); THERAPY: Monotherapy; LEAD SPONSOR: Institut de Recherches Internationales Servier; CRITERIA: Key Inclusion Criteria: - Be at least 12 years of age and weigh at least 40 kg. - Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria. - Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. - Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory. - Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC. - Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%. Key Exclusion Criteria: - Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc. - Have features assessed as high-risk by the Investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen). ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Time to Next Intervention[/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 - M.D. Anderson/NCI; BRIEF: This phase Ib trial studies the side effects and best dose of ALRN-6924 when given together with paclitaxel in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ALRN-6924 and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. ; DRUG USED: ALRN-6924; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Mdm2, Mdmx/Mdm4; THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. 18 years of age or older 2. Histologically- or cytologically-confirmed solid tumors (excluding lymphomas) that are metastatic or unresectable and that meet the following criteria: 1. Escalation and expansion cohorts: wild type (WT) TP53 status defined as no mutation on a Clinical Laboratory Improvement Amendments (CLIA)-certified next-generation sequencing (NGS) assay that has sequenced the full length TP53 gene. Patients can be enrolled based on tissue testing or liquid biopsies. If enrolled based on liquid biopsies, testing should have detected other somatic mutations. 2. Expansion cohort A only: estrogen receptor (ER) positive (> 1%), human epidermal growth factor 2 (HER2) negative, WT TP53 metastatic or inoperable locally advanced or locally recurrent breast cancer regardless of progresterone receptor (PR) status, HER2 status will be defined according to the ASCO/CAP 2018 recommendationa (Patients can be HER2 0+ or 1+ by immunohistochemistry (IHC), 2+ by IHC and fluorescent in situ hybridization (FISH) non-amplified to be considered HER2 negative). Standard treatment with therapies known to confer a survival benefit does not exist, is no longer effective or tolerated, or the patient declines standard treatment. For the dose expansion cohort only, breast cancer patients with ER+, HER2- status must have received prior endocrine therapy and CDK4/6 inhibitors 3. Expansion cohort B only: advanced or metastatic solid tumors with MDM2 or MDM4 amplifications and WT TP53 metastatic for which standard treatment with therapies known to confer a survival benefit does not exist, is no longer effective or tolerated, or the patient declines standard treatment. 3. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. In the dose escalation stage, patients without measurable disease by RECIST 1.1, but evaluable disease are also eligible. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Section 12, Appendix A). 5. Demonstrate adequate organ function as defined by the parameters listed below: 1. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or ≥ 45 mL/min/1.73m2 by CKD-EPI equation for subjects with creatinine levels > 1.5 x institutional ULN. 2. Total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULN, or unless due to Gilberts Syndrome. 3. Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if hepatic abnormalities are related to underlying liver metastases or liver/biliary primary. 4. Absolute neutrophil count (ANC) ≥1500/mm3(without G-CSF in the 2 weeks prior to treatment start) 5. Platelet count ≥ 100,000/mm3 6. Hemoglobin ≥ 9 g/dL (without blood transfusion in the 2 weeks prior to treatment start) 6. All patients (males and females) of childbearing potential must agree to use medically effective contraception during the study and for 6 months after the last dose of study drugs. A negative urine or serum pregnancy test in women of childbearing potential is required within 72 hours prior to first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 7. Have no concomitant medical condition (including, but not limited to, ongoing or active infection or any psychiatric disorder), that in the judgment of the investigator will interfere with the patients ability to participate in the study or render such participation medically inappropriate. 8. No medical history of another cancer (except basal or squamous cell skin cancer or in situ cervical cancer, or carcinomas in situ or other malignancies with a ≥95% 5-year survival) within 2 years of the start of study treatment. 9. No investigational drug or other anticancer treatments (including chemotherapy or radiation, except palliative radiation) within 21 days or at least 5 half-lives, whichever is shorter, of the start of the study treatment. No palliative radiation within 2 weeks prior to the start of the study treatment. Supportive treatments such as LHRH agonists can be continued for patients with castration-resistant prostate cancer or pre-menopausal breast cancer while on treatment. 10. No major surgery within 1 month of treatment and fully recovered. 11. Willing and able to provide informed consent. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Previous treatment with investigational agents that inhibit MDM2 or MDMX activity. 2. Known active hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV)-positive patients who have a cluster of differentiation 4 (CD4) count < 200. No antiretroviral medications that are CYP3A4 substrates will be allowed. 3. Pre-existing history of or known cardiovascular risk: 1. History of acute coronary syndromes within 6 months prior to the first dose of ALRN-6924 (including myocardial infarction, unstable angina, coronary artery bypass graft, angioplasty, or stenting). 2. Uncontrolled hypertension 3. Pre-existing cardiac failure (New York Heart Association class III-IV) 4. Clinically significant uncontrolled arrhythmias 5. Corrected QTcF interval on screening ECG ≥450 msec for males and ≥470 msec for females (QTcF >480 msec for any patient with a bundle branch block). 4. Clinically significant gastrointestinal bleeding within 6 months prior to the start of study treatment. 5. Females who are pregnant or nursing. 6. Symptomatic central nervous system (CNS) metastases by history, clinical signs or radiologic findings. Patients with previously treated brain metastases are eligible if clinically stable and off steroid treatment for 2 weeks prior to study enrollment. Patients with new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that immediate CNS specific treatment is not required. 7. Known hypersensitivity to any study drug component. 8. The required use of any concomitant medications that are predominantly cleared by hepatobiliary transporters, OATP members OATP1B1 and OATP1B3, on the day of the ALRN-6924 infusion or within 48 hours after an ALRN-6924 infusion. 9. Patients with Grade ≥2 neuropathy will be excluded. 10. Patients with a known Human Papilloma Virus (HPV)-positive malignancy will be excluded from enrollment. This is owing to the fact that HPV-infected tumor cells continue to express the viral E6 protein, which is known to cause degradation of p53, hence rendering the expected ALRN-6924 - mediated dual inhibition of MDM2/MDMX very unlikely to restore p53 function. ; PRIMARY OUTCOME: Maximum tolerated dose (MTD) of combination of ALRN-6924 and paclitaxel, defined as the isotonic estimate of the toxicity rate closest to 0.30; SECONDARY OUTCOME 1: Objective response rate (ORR) defined as the proportion of patients with complete response (CR) or partial response (PR), as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - AMD or DME; BRIEF: The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME). ; DRUG USED: REGN910-3; DRUG CLASS: Biologic; INDICATION: Diabetic Retinopathy (Ophthalmology); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. For patients with AMD: 1. Active subfoveal choroidal neovascularization (CNV) secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA or OCT in the study eye, as determined by the investigator 2. Men or women ≥50 years and older 2. For patients with DME: 1. Patients with clinically significant DME with central involvement (≥300 μm in the central subfield on spectral domain OCT) 2. Men or women ≥18 years and older Key Exclusion Criteria: 1. For patients with neovascular AMD: 1. Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye 2. Evidence of diabetic retinopathy (DR) or DME in either eye 2. For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye 3. Prior IAI in either eye 4. IVT bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of day 1 or an AE with any of these previous treatments that would preclude administration of drug in this study 5. Any prior treatment with angiopoietin inhibitors 6. Any prior systemic (IV) anti-VEGF administration 7. History of vitreoretinal surgery in the study eye 8. Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit 9. Previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening (The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subjects potential participation in this clinical trial). ; PRIMARY OUTCOME: Incidence of treatment-emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Pharmacokinetic (PK) profile[/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 - Safety/Immunogenicity; BRIEF: In this study we are testing a new vaccine against Respiratory Syncytial Virus (RSV). This virus can cause respiratory infections such as bronchiolitis and pneumonia. It affects all ages, but especially infants, adults with a suppressed immune system, and the elderly. RSV only infects humans and occurs in epidemics each winter. It is the single most common cause of severe respiratory illness in children. There is no effective anti-viral medication to treat RSV infections. There is a monoclonal antibody, which can be given to at-risk children given by injection on a monthly basis during winter to provide short term protection against infection, but it is only partially effective and prohibitively expensive. Currently, there is no licensed vaccine to prevent RSV infection and there remains a real need to develop a vaccine as a cost-effective method to save lives and reduce the cost of disease caused by RSV. ; DRUG USED: GSK3389245A; DRUG CLASS: Vaccine; INDICATION: Respiratory Syncytial Virus (RSV) Prevention; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: ReiThera Srl; CRITERIA: Inclusion Criteria: Participants must satisfy all of the following criteria to be considered eligible for the study: - Willing and able to give informed consent for participation in the study - Aged between 18 and 50 years (Groups 1-4) or aged 60-75 years (Groups 5-9) - In good health as determined by - Medical history - Physical examination - Clinical judgment of the investigators - Willing to use effective contraception - Females: The oral contraceptive pill, contraceptive implant or barrier methods from one month prior and for the duration of the study (Groups 1-4 only) - Males: Barrier contraception from V1 until 3 months after the last vaccination - Able to attend the scheduled visits and to comply with all study procedures - Willing to allow his or her General Practitioner and/or Consultant, if appropriate, to be notified of participation in the study - Confirmation from GP that they are aware of the inclusion and exclusion criteria and are satisfied from their knowledge of the volunteer that they are suitable to enroll - Willing to provide their National Insurance/Passport number for the purpose of TOPS registration Exclusion Criteria: The participant may not enter the study if any of the following apply: - History of significant organ/system disease that could interfere with trial conduct or completion. This includes any history of significant disease in the following; - Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death - Respiratory disease such as asthma (excluding childhood asthma not treated in adulthood) and chronic obstructive pulmonary disease - Endocrine disorders such as diabetes mellitus and Addisons disease - Significant renal or bladder disease, including history of renal calculi - Biliary tract disease - Gastro-intestinal disease such as inflammatory bowel disease, abdominal surgery within the last two years, coeliac disease and liver disease - Neurological disease such as seizures and myasthenia gravis - Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency - Psychiatric illness requiring hospitalization or depression whose severity is deemed clinical significant by the Chief Investigator, Consultant or GP - Non-benign cancer, including squamous cell carcinoma, basal cell carcinoma of the skin and cervical carcinoma in situ - Clinically significant contact dermatitis - Have any known or suspected impairment or alteration of immune function, resulting from, for example: - Congenital or acquired immunodeficiency - Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition - Autoimmune disease - Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy - Receipt of immunoglobulin or any blood product transfusion within 3 months of study start - A vaccination history indicative of; - Planning to receive any vaccine other than the study vaccine within 4 weeks following vaccination - A history of anaphylaxis reaction to a vaccine - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. Kathon - Previously having received a recombinant simian or human adenoviral vaccine - Previously having received a recombinant MVA vaccine - Detection of any of the following at screening - IgA deficiency - Anti-HIV antibody - Hepatitis B surface antigen - Anti-HCV antibody - Any other significant abnormalities on screening investigations at the discretion of an Investigator - Known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week) - Nasal septal pathology including - Congenital deformities such as an abnormal septum or polyps - Previous cauterization, rhinoplasty or surgery of any kind - Recurrent epistaxis - Scheduled procedures requiring general anaesthesia during the study - Participation in another research study involving an investigational product in the past 12 weeks, or are planning to do so within the 20 weeks of this study - Inability, in the opinion of the Investigator, to comply with all study requirements - Female participants who are pregnant, lactating or planning pregnancy during the course of the study - Has donated blood within 4 months before starting the trial, or is intending to donate blood during the trial and up to 12 weeks after completing the study - Any other significant disease or disorder which, in the opinion of the Investigator, may - Put the participants at risk because of participation in the study - Influence the result of the study - Impair the participants ability to participate in the study ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Immunogenicity[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Korea; BRIEF: The main objective of this study is to evaluate the safety and tolerability of HM61713. ; DRUG USED: Olmutinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Hanmi Pharmaceutical Company Limited; CRITERIA: Inclusion Criteria: - Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC - Patients with EGFR mutation-positive tumor - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less - Estimated life expectancy of at least 12 weeks - Subjects with adequate bone marrow (WBC ≥4,000/mm3, Platelet ≥100,000/mm3, Hemoglobin≥9.0g/dL, ANC≥1,500/mm3), renal (Creatinine≤1.5 mg/dl) and hepatic [aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)/ alkaline phosphatase (ALP)≤3 x ULN, Total bilirubin ≤2.0 mg/dL] function. No significant heart and lung disease. ※ For subjects with a liver metastases, AST/ALT/ALP≤ 5 x ULN is allowed; and for subjects with bone marrow metastases, ALP≤ 5 x ULN is allowed - Patients with amylase level ≤ 1.5 x ULN - Subjects who have provided voluntary consent to participate in the study, and signed the written consent document <Dose escalation part> - Malignancy that has progressed after at least two prior chemotherapy regimens, including EGFR-TKI <Expansion part 1> - Patients with disease progression despite anticancer therapy with EGFR-TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) - Patients who have provided voluntary consent for collection of tumor tissue taken and archived after the last anticancer therapy or collection of new tissue specimen and signed the written consent document <Expansion part 2> & <Phase 2> - Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study) - T790M mutation-positive confirmed in tissue collected after PD is confirmed during or after the last anticancer therapy - At least one measurable target lesion allowing repeated measurement according to RECIST ver1.1 as of screening <Phase 1 Expansion part 3> - Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study) - T790M mutation-negative confirmed in tissue collected after progressive disease (PD) is confirmed during or after the last anticancer therapy - At least one measurable target lesion allowing repeated measurement according to RECIST ver1.1 as of screening Exclusion Criteria: - Hematologic malignancies - Symptomatic or uncontrolled central nervous system metastases - Interstitial lung disease, including pulmonary fibrosis - LVEF < 40% or NYHA Class III or IV heart failure - History of pancreatitis - History or current evidence, of any psychiatric or congenital disorder, including dementia or epilepsy - Compromised organ function, infection or allergy - Pregnant or breast-feeding women, or women of child-bearing potential who do not use an appropriate method of contraception (male patients should also use an appropriate method of contraception during the study period) - Patients who had received other investigational product within 30 days prior to screening ; PRIMARY OUTCOME: Safety and tolerability; 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 - EGP-437-002 (Dry Eye); BRIEF: The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye. ; DRUG USED: EGP-437; DRUG CLASS: Non-NME; INDICATION: Dry Eye (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Eyegate Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Have a reported history of dry eye in each eye - Be at least 12 years of age - Demonstrate a response when exposed to the Controlled Adverse Environment model Exclusion Criteria: - Have contraindications to the use of the test articles - Have known allergy or sensitivity to the study medication or their components (including corticosteroids) - Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy - Be current contact lens wearers or wear contacts during the study ; PRIMARY OUTCOME: Sign: Corneal fluorescein staining after CAE exposure at Visit 5; SECONDARY OUTCOME 1: Sign: Fluorescein staining at each visit over 3 weeks[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Peanut Allergy; BRIEF: This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen. ; DRUG USED: QGE031; DRUG CLASS: Biologic; INDICATION: Food Allergies; TARGET: Immunoglobulin E (IgE); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Main Inclusion Criteria: - Diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours). - Positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test. Main Exclusion Criteria: - Prior exposure to any monoclonal antibody treatment - Asthma patients on maintenance long acting beta-agonists - Use of systemic corticosteroids - Concomitant use of beta blockers, ACE inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists - Use of immunosuppressants within 6 months of visit 1 Other protocol-defined inclusion/exclusion criteria may appy ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Oral Tamoxifen; BRIEF: This randomized phase II trial is studying 4-hydroxytamoxifen to see how well it works compared with tamoxifen citrate in treating women with newly diagnosed ductal breast carcinoma in situ. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether topical tamoxifen causes less damage to normal tissue than systemic tamoxifen in treating patients with ductal carcinoma in situ. ; DRUG USED: Afimoxifene Gel; DRUG CLASS: Non-NME; INDICATION: Breast Cancer; TARGET: Estrogen; THERAPY: Monotherapy; LEAD SPONSOR: Northwestern University; CRITERIA: Inclusion Criteria: 1. Diagnosis of hormone receptor positive (more than 5% cells staining for ER + and/ or PR +), any grade (using definition of Page and Lagios) ductal carcinoma in situ (DCIS) with or without evidence of microinvasion on diagnostic core needle biopsy within the previous 60 days. 2. Women of age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of 4-hydroxytamoxifen in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable. 3. ECOG performance status ≥1 (Karnofsky ≥70%) 4. Participants must have normal organ and marrow function as defined below: 1. Leukocytes≥3,000/uL 2. Absolute neutrophil count (ANC)≥1,500/uL 3. Platelets≥100,000/uL 4. Total bilirubin within normal institutional limits 5. AST (SGOT)/ALT (SGPT)≤1.5 X institutional ULN 6. Creatinine within normal institutional limits 5. Women of child-bearing potential must agree to practice barrier birth control, abstinence, or use non-hormonal IUDs from the time that the first pregnancy test is performed throughout the duration of the study and for three months after cessation of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. 6. Ability to understand and the willingness to sign a written informed consent document. 7. Ability and willingness to schedule surgical resection of DCIS lesion for 4-10 weeks (28-70 days) following the start of study agent. 8. Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the 4-10 weeks of study agent dosing. Exclusion Criteria: 1. Prior history of, or at high risk to develop, thromboembolic disease will be excluded. 2. Must not have taken exogenous sex hormones since biopsy diagnosing DCIS and must agree not to use exogenous sex hormones while on study. 3. Must not have taken tamoxifen or other selective estrogen receptor modulators (SERMs) within 2 years prior to entering the study. Women who have discontinued SERM therapy because of thromboembolic or uterine toxicity, will be excluded regardless of duration of use. 4. May not be receiving any other investigational agents. 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 4-hydroxytamoxifen or tamoxifen. 6. 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. 7. Pregnant women are excluded from this study because tamoxifen and 4-hydroxytamoxifen has the potential for teratogenic or abortifacient effects. Women are excluded from enrolling within 3 months of the most recent pregnancy. Women must avoid becoming pregnant in the 3 months following the use of study agent. 8. Women must not have breastfed within three months prior to DCNB. Women who are breast feeding are excluded from entry into this trial because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tamoxifen or 4-hydroxytamoxifen. Women must agree to forego breastfeeding for three months following the use of study agent. 9. Must not have any dermatologic conditions resulting in skin breakdown in the area of gel application. 10. Must not have a history of previous ipsilateral radiation to the affected breast. 11. Must not have had a breast reduction or augmentation within the 6 months prior to first dose of study agents. Patients who have had breast implants more than 6 months prior to first dose of study agents will be eligible. ; PRIMARY OUTCOME: Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment; SECONDARY OUTCOME 1: Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery[/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 - TAGS; BRIEF: The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer. ; DRUG USED: Lonsurf; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: DNA synthesis, Thymidine Phosphorylase, Thymidylate Synthase; THERAPY: Monotherapy; LEAD SPONSOR: Taiho Oncology, Inc.; CRITERIA: Inclusion Criteria: 1. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction. 2. Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy. 3. Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 4. Is able to take medications orally (ie, no feeding tube). 5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1. 6. Has adequate organ function as defined by protocol defined labs. 7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control. Exclusion Criteria: 1. Has certain serious illnesses or medical conditions 2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent within the specified time frames prior to study drug administration. 3. Has previously received TAS-102. 4. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies. 5. Is a pregnant or lactating female. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-Free Survival (PFS)[/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 - 301 - Secondary AML; BRIEF: To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival. ; DRUG USED: Vyxeos; DRUG CLASS: Non-NME; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA polymerase, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Inclusion Criteria: - Ability to understand and voluntarily give informed consent - Age 60-75 years at the time of diagnosis of AML - Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) - Confirmation of: - Therapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease - AML with a history of myelodysplasia: MDSAML must have bone marrow documentation of prior MDS - AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of prior CMMoL - De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must have cytogenetics with abnormalities per WHO. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Able to adhere to the study visit schedule and other protocol requirements - Laboratory values fulfilling the following: - Serum creatinine < 2.0 mg/dL - Serum total bilirubin < 2.0 mg/dL, patients with Gilberts Syndrome should contact the medical monitor - Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN Note: If elevated liver enzymes, above the ULN, are related to disease; contact medical monitor to discuss. - Cardiac ejection fraction ≥ 50% by echocardiography or MUGA - Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible. Exclusion Criteria: - Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible. - Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization. - Clinical evidence of active CNS leukemia - Patients with active (uncontrolled, metastatic) second malignancies are excluded. - Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts. For example, a patient with MDS that changes HMA dose and schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine alone (>1g/m2/day) or cytarabine plus an anthracycline as well as prior HSCT are also excluded. - Administration of any therapy for MDS (conventional or investigational) must be completed by 2 weeks prior to of the first dose of study drug; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment. Toxicities associated with prior MDS therapy must have recovered to grade 1 or less prior to start of treatment. - Any major surgery or radiation therapy within four weeks. - Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent). - Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent - Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging) - Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥72 hrs. - Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values) - Hypersensitivity to cytarabine, daunorubicin or liposomal products - History of Wilsons disease or other copper-metabolism disorder ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Proportion of Subjects With a Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Dose and Biomarker; BRIEF: The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients. ; DRUG USED: Alimta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Thymidylate Synthase; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Be at least 18 years of old. - Have been diagnosed with breast cancer - At least one year disease-free interval after initial treatment. - Have pre-study laboratory tests that are within the requirements of this study. - Be able to visit the doctors office weekly during the treatment period. Exclusion Criteria: - To be pregnant or breastfeeding. - To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy. - To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment. - To have another illness that your doctor thinks would make you unable to participate. - To be unable or not willing to take folic acid and vitamin B12. ; PRIMARY OUTCOME: To assess tumor response.; SECONDARY OUTCOME 1: To evaluate the toxicity profile of two doses of pemetrexed in breast cancer patients.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - BrUOG 276; BRIEF: The main purpose of this study is to study the safety and effectiveness of ADXS11-001 when combined with standard chemotherapy and radiation treatment for anal cancer. ADXS11-001 is an investigational agent that is not approved by the FDA to treat anal cancer or any other cancer. ; DRUG USED: Axalimogene Filolisbac; DRUG CLASS: Biologic; INDICATION: Anal Cancer; TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Brown University; CRITERIA: Inclusion Criteria: 3.1.1 Histologically-proven, invasive primary squamous, basaloid, or cloacogenic carcinoma of the anal canal; 3.1.2 AJCC 2009 TN Stage: T1N1-N3, T2(< 4cm)N1-N3, T2(> 4cm)N0,T3N0-3, T4N0-3;based upon the following minimum diagnostic workup: 3.1.2.1 History/physical examination within 14 days prior to registration; 3.1.2.2 Within 42 days prior to registration, the patient must have an anal examination by any of the following: colonoscopy, sigmoidoscopy, or rigid proctoscopy, with documentation of primary anal lesion size, distance from anal verge. 3.1.3 Groin examination within 42 days prior to registration with documentation of any groin adenopathy and lymphadenopathy (location: right vs. left; medial vs. lateral; mobile vs. fixed; and size); 3.1.4 X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior to registration; 3.1.5 CT scan, MRI, or PET/CT of the abdomen and pelvis within 42 days prior to registration; 3.1.6 Zubrod Performance Status 0-1; 3.1.7 Age ≥ 18; 3.1.8 Laboratory data obtained ≤ 14 days prior to registration on study, with adequate bone marrow, hepatic and renal function defined as follows: - Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; - Platelets ≥ 100,000 cells/mm3; - Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); - Serum creatinine ≤ 1.5 mg/dl; - Bilirubin < 1.4mg/dl; - ALT/AST < 3 x ULN; - Negative serum pregnancy test for women of child-bearing potential; 3.1.9 Women of childbearing potential and male participants must agree to use a 2 forms of medically effective means of birth control (such as a condom and spermicide) throughout their participation in the treatment phase of the study and for 90 days post last dose of study drug. 3.1.10 Patients must sign a study-specific informed consent prior to study entry. 3.1.11 Patients with a history of clinically significant pulmonary disease must have PFTs demonstrating a DLCO ≥ 40%. This testing is considered standard of care prior to mitomycin, 5-FU and radiation. 3.1.12 Patients with a history of clinically significant cardiac disease must have a LVEF ≥ 30% by ECHO. (MUGA scan may also be used to determine LVEF) This testing is considered standard of care prior to mitomycin, 5-FU and radiation. 3.1.13 Patients must be able to swallow pills. Exclusion Criteria: 3.2.1 Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years; 3.2.2 Prior systemic chemotherapy for anal cancer; 3.2.3 Prior allergic reaction to the study drugs involved in this protocol. 3.2.4 Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields; 3.2.5 Severe, active co-morbidity, defined as follows: 3.2.5.1 Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris and cardiac arrhythmia are ineligible. Furthermore, patients with unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months are ineligible; 3.2.5.2 Patients with active infection requiring systemic therapy (oral or IV) or those currently receiving antibiotics that cannot discontinue prior to dosing are ineligible. 3.2.5.3 Transmural myocardial infarction within the last 6 months; 3.2.5.4 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.5.5 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; 3.2.5.6 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; 3.2.6 Patients known to be seropositive for HIV and/or active hepatitis, even if liver function studies are in the eligible range. 3.2.7 Other immunocompromised status (e.g., organ transplant or chronic glucocorticoid use).If patient has diagnosis of immunodeficiency, is dependent on or has received systemic steroids therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of ADXS11-001 they are ineligible. Topical corticosteroid or occasional inhaled corticosteroids are allowed. 3.2.8 Women who are pregnant or lactating are ineligible because the treatment involved in this study may be significantly teratogenic and there is the potential for transmission of listeria to the infant. 3.2.9 Patients allergic to or with a sensitivity to penicillin, ampicillin, trimethoprim-sulfa and quinolones (including history of rash or anaphylaxis). 3.2.10 Patients allergic to naproxen. 3.2.11 Patients receiving oral or IV antibiotics 3.2.12 Patients with a prior history of a splenectomy and/or sickle cell trait/disease 3.2.13 Patient has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants and venous access devices (e.g. Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant. Site is required to submit to BrUOG ALL surgical implants patient has ever had in their medical history and ALL surgeries regardless of link to this cancer diagnosis. 3.2.14 Patients who are receiving or may receive future treatment with PI3K or TNFα inhibitors. To be confirmed by treating medical oncologist in writing 3.2.15 Has undergone a major surgery, including surgery for a new artificial implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment. NOTE: if patient underwent surgery > 6 weeks from start of ADSX11-001, all toxicities and/or complications must have recovered to baseline or Grade 1 prior to the initiation of ADXS11-001 study therapy. 3.2.16 Patient not being willing to have new infusion line placed for each infusion of ADXS11-001 as existing or newly placed central venous catheter or infusion ports are not allowed to be used for ADXS11-001 administration. Must be confirmed as discussed with patient and that they agreed. 3.2.17 Patient not willing to comply with requirement of central venous catheter or infusion port must not be used for 72 hours following the completion of the ADXS11-001 infusion and the patient receives the first post-treatment dose of oral antibiotics. Must be confirmed as discussed with patient and that they agreed. 3.2.18 Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed. All recent vaccines (within 30 days) to be listed on conmed log 3.2.19 Patient has a history of listeriosis or prior ADXS11-001 therapy. ; PRIMARY OUTCOME: To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.; SECONDARY OUTCOME 1: To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - Healthy Adolescents (V102_16); BRIEF: Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine. ; DRUG USED: MenABCWY (GSK); DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B, Neisseria meningitidis - Groups A, C, Y, and W-135; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: - Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment. - Female subjects of childbearing potential must have a negative urine pregnancy test. Exclusion Criteria: - Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine. - Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization. ; PRIMARY OUTCOME: Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.; SECONDARY OUTCOME 1: Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second 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 II - NCI; BRIEF: This phase II trial is studying the side effects and how well viral therapy works in treating patients with metastatic melanoma. Viral therapy may be able to kill tumor cells without damaging normal cells. ; DRUG USED: Pelareorep; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Oncolytic Virus Therapy, Ras; THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed malignant melanoma - All melanomas, regardless of origin, are allowed - Metastatic disease - Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as ≥ 10 mm by spiral CT scan - Must have ≥ 1 metastatic lesion that can be safely biopsied - Must have received ≥ 1 prior treatment for metastatic disease - Not a candidate for curative surgery for metastatic disease - No known brain metastases - Eastern Cooperative Oncology Group performance status 0-2 - Life expectancy > 12 weeks - Total White Blood Cell (WBC) ≥ 3,000/mcL - Absolute neutrophil count ≥ 1,500/mcL - Platelet count ≥ 100,000/mcL - Hemoglobin ≥ 9 g/dL - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) - Aspartate Aminotransferase (AST) ≤ 2.5 times ULN - Creatinine ≤ 1.5 times ULN - Troponin-T normal - Left ventricular ejection fraction (LVEF) ≥ 50% by ECHO or MUGA - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Agrees to provide blood and tissue samples for the mandatory translational research component of the study - Must be able to avoid direct contact with pregnant or nursing women, infants, and immuno compromised individuals during study and for ≥ 3 weeks following the last dose of study agent - No concurrent uncontrolled illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris, cardiac arrhythmia, or myocardial infarction within the past year - Psychiatric illness/social situation that would preclude study compliance - No known HIV positivity - Patients with a clinical history suggestive of an immuno compromised status are required to undergo HIV testing - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered - More than 2 weeks since prior radiotherapy, immunotherapy, or treatment with small molecule cell cycle inhibitors - No other concurrent investigational agents - No other concurrent anticancer therapy ; PRIMARY OUTCOME: Tumor Response; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Europe; BRIEF: Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. Core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. This method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. Still this treatment remains highly controversial, since the success rates of the first studies have not been repeated. The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment. Three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004). This is on the basis of these observations that a proprietary population of autologous osteoblastic cells (PREOB®) has been developed. This Phase 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion is superior to core decompression/placebo implantation in relieving hip symptoms and halting (or reverting) radiological progression of the disease. ; DRUG USED: PREOB; DRUG CLASS: Biologic; INDICATION: Osteonecrosis; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Bone Therapeutics S.A; CRITERIA: Inclusion Criteria: - Men or women between 18 and 70 years (inclusive) with a diagnosis of ARCO Stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by central imaging analysis based on X-ray and MRI. - Ability to provide a written, dated, and signed informed consent prior to any study related procedure and to understand and comply with study requirements - Diagnosis of Osteonecrosis: 1. ARCO stage I associated with WOMAC® VA3.1 pain score ≥20 mm and necrotic angle sum ≥190° based on sagittal and coronal MRI views or 2. ARCO stage II associated with WOMAC® VA3.1 pain score ≥20 mm if necrotic angle sum <190° based on sagittal and coronal MRI views or 3. ARCO stage II associated or not with pain if necrotic angle sum is ≥190° based on sagittal and coronal MRI views 4. Associated with corticosteroid and/or with alcohol abuse and/or idiopathic - Normal haematology function, defined as leukocytes ≥3000/mm3, absolute neutrophils count ≥1500/mm3, platelets ≥140,000/mm3, and haemoglobin concentration ≥10g/dl (peripheral blood test) Exclusion Criteria: Current symptoms and/or signs related to the disease under study - Exclusively diaphyseal or metaphyseal osteonecrotic lesion - Traumatic or hyperbaric osteonecrosis, or osteonecrosis associated with hemoglobinopathy or coagulopathy (e.g., thalassemia, sickle cell disease,…), or Gauchers disease - Any other focal or diffuse bone marrow lesion - Osteoarthritis at the target hip defined as Kellgrens stage ≥2, as assessed by the Central Radiologist - Patients suffering from any medical conditions interfering with patients pain evaluation of the hip under evaluation, such as knee arthritis. - Bone fracture or bone infection at hip under evaluation. - Patients who are candidates for any predictable joint replacement on the hip that is evaluated Current or previous diagnoses, signs and/or symptoms - Active hepatitis B (defined as positive HBs Ag and/or positive PCR), or active hepatitis C (defined as positive PCR), positive serology for HIV, or Syphilis, or HTLV-1, and any other tests that may be required by the authorities in case of a new disease outbreak that can affect the safety of the physicians and operators at the time of patient screening. - Presence, or previous history, of risks factors for diseases caused by prions, and recipients of grafts of cornea, sclera, and dura mater - History of blood loss exceeding 450 ml (incl. donations) within 1 month of screening - Renal impairment defined by an estimated creatinine clearance value < 30 ml per min, calculated with the Cockcroft-Gault formula - Hepatic impairment, defined as alanine aminotransferase or aspartate aminotransferase ≥ 3 times the upper limit of normal - Poorly controlled diabetes mellitus, defined as HbA1C > 9% - Global sepsis - Allergy to gentamicin or porcine collagen or any substance or device the patient might be exposed to in the context of the study related interventions (i.e., bone marrow harvesting and implantation), as judged by the Investigator - History of hypersensitivity to human biological material, including blood and blood derived products, documented clinically or by laboratory tests - Current or past history of solid or haematological neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence) - History of bone marrow transplantation - Patients with a life expectancy less than 2 years, as judged by the Investigator Current or previous treatment - Patients having participated in another clinical trial within 3 months of screening - Patients previously treated with PREOB® - Patients treated by core decompression of the hip under evaluation within 6 months of screening - Treatment with doses of prednisolone ≥15 mg per day (or equivalent) within 1 month from screening, and patients with anticipated needs of daily corticoid doses ≥15 mg prednisone (or equivalent) in the 6 -month period following PREOB/Placebo implantation - Illicit drug or alcohol abuse interfering with patients ability to understand and comply with study requirements, as judged by the Investigator Safety aspects concerning female patients of childbearing potential - Pregnancy - Breast-feeding - Women with childbearing potential not willing or able to use reliable contraceptive method for at least 6 weeks prior to screening and during the whole study period. Reliable contraceptive methods include orally administered hormonal contraceptives, surgical intervention (e.g., tubal ligation), and intrauterine device (IUD). Other exclusion criteria: - Body Mass Index (BMI) ≥ 35 kg/m2 - Patients unable to undergo MRI, e.g. patients with pace-maker, intra-ocular or intra-cerebral metallic foreign bodies, and mechanical artificial heart valves - Patients unable to undergo general anaesthesia or surgical intervention ; PRIMARY OUTCOME: Percentage of Treatment Responders; 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 - 010; BRIEF: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema. ; DRUG USED: Ozurdex; DRUG CLASS: Non-NME; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Key Inclusion Criteria: - 18 years of age or older with diabetic macular edema; - Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse); - Visual acuity in other eye no worse than 20/200 Key Exclusion Criteria: - Known anticipated need for ocular surgery within first 12 months of study; - History of glaucoma or current high eye pressure requiring more than 1 medication; - Uncontrolled systemic disease; - Known steroid-responder; - Use of systemic steroids - Use of Warfarin/Heparin ; PRIMARY OUTCOME: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye; SECONDARY OUTCOME 1: Average Change From Baseline in BCVA in the Study Eye[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DAPA-MI; BRIEF: This study will evaluate the effect of dapagliflozin versus placebo, given once daily in addition to Standard of Care (SoC) therapies for patients with myocardial infarction (MI), for hospitalisation for heart failure (HHF), cardiovascular (CV) death, and other cardiometabolic outcomes. ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Participant must be ≥18 at the time of signing the informed consent - Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019), within the preceding 7 days, or 10 days if earlier randomisation is not feasible - Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation (established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) or definitive evidence on ECG of Q wave MI (defined as presence of Q waves in two or more contiguous leads, excluding leads III and aVR, and meeting all the following criteria: at least 1.5 mm in depth; at least 30 ms in duration; and, if R wave present, more than 25% of the size of the subsequent R wave) - Hemodynamically stable at randomization (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours). - Male or female - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol - Provision of signed and dated, written informed consent prior to any mandatory study specific procedures, sampling, and analyses Exclusion Criteria: - Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission. Patients with hyperglycaemia, but without a diagnosis of diabetes mellitus prior to the index event, are eligible at the discretion of the Investigator. Patients who present with signs and symptoms consistent with ketoacidosis, including nausea, vomiting, abdominal pain, malaise and shortness of breath should be assessed for ketoacidosis, and if ketoacidosis is confirmed the patient should not be randomized. - Chronic symptomatic HF with a prior HHF within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization - Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization - Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial - Active malignancy requiring treatment at the time of screening, except for basal cell- or squamous cell carcinoma of the skin, presumed possible to treat successfully - Any non-CV condition, eg malignancy, with a life expectancy of less than two years based on the investigator´s clinical judgement - Currently on treatment, or with an indication for treatment, with a sodium glucose co-transporter 2 inhibitor (SGLT2-inhibitor) ; PRIMARY OUTCOME: The hierarchical composite endpoint of Death (CV death followed by non-CV death), Hosp due to heart failure (adjudicated followed by investigator reported), Non-fatal MI, AF/flutter event, New onset of T2DM, last visit NYHA class, and weight loss ≥5%; SECONDARY OUTCOME 1: The hierarchical composite endpoint of Death (CV death followed by non-CV death), Hospitalisation due to heart failure (adjudicated followed by investigator reported), Non-fatal MI, AF/flutter event, New onset of T2DM, and last visit NYHA class[/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; BRIEF: The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal antibody therapy using 2 regimens for the treatment of advanced melanoma ; DRUG USED: Tremelimumab; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Histologically confirmed: Stage III (AJCC 6th edition)xxl unresectable melanoma, with measurable disease (either locally relapsed unresectable, in-transit lesions or unresectable draining nodes) or Stage IV melanoma, including: - Metastasis to skin, subcutaneous tissues or distant lymph nodes, or - Metastasis to lungs, or - Metastasis to all other visceral sites with either LDH <= ULN (upper limit of normal) or a single site of metastasis - Note: Patients with melanoma of ocular origin will be considered ineligible - Documented progressive disease following adjuvant therapy, localized therapy or other therapy for metastatic disease - Measurable disease defined by at least one target lesion that can be accurately measured and whose size is at least 1.0 cm (by spiral CT) or 2.0 cm (by conventional techniques) in its longest diameter - ECOG performance status of 0 or 1 Life expectancy of > 3 months - Either gender, aged 18 years and above - Adequate bone marrow, hepatic, and renal functions determined within 2 weeks prior to starting therapy, defined as: - Absolute neutrophil count >= 1.5 x 10(9)cells/L - Platelets >= 100 x 10(9)/L - Hemoglobin >= 10 g/dL - Aspartate and alanine aminotransferases (AST, ALT) <= 2.5 x ULN (<= 5 x ULN, if documented liver metastases are present) - Total bilirubin <= 1.5 x ULN - Creatinine <= 1.5 x ULN - Patients must have recovered from all prior treatment related toxicities, to baseline status, or a CTC grade of 0 or 1. Post-surgical pain shall not be considered a basis for exclusion. - Females must either be not of childbearing potential [surgically sterilized, which includes tubal ligation, or at least 2 years postmenopausal; not breastfeeding], or practicing 1 form of approved contraception for at least three months prior to entry into the study with 1 of the following methods: (a) oral contraceptives, (b) intrauterine device, (c) implanted contraceptive (such as Norplant®), (d) injected contraceptives (such as Depo-Provera®), (e) diaphragm, (f) sexual partner must use condom or be surgically sterilized, or (g) sexually inactive. Females of childbearing potential must be instructed to avoid pregnancy during study participation. Negative serum or urine pregnancy test must be documented during screening evaluation. - Must be willing and able to provide written informed consent. Exclusion Criteria: - Received immunotherapy for cancer within one month prior to the start of screening - Patients previously treated on this protocol - History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (e.g. Addisons disease, asthma, celiac disease, multiple sclerosis, Graves Disease, Hashimotos thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc.) - Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history. - History of autoimmune colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin. - Pregnant or lactating women. - Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. - Diagnosed or suspected brain metastases. Patients with past history of brain metastases but with no radiologic evidence within 12 weeks prior to enter into the protocol will be eligible. - Any serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment. - Coexisting malignancies except for basal or squamous cell carcinoma of the skin. - Received any prior CTLA4 inhibiting agent ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Monitor for human anti-human antibodies at the end of 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 IIIb - 2 Vaccination Schedules; BRIEF: Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis. ; DRUG USED: Ixiaro; DRUG CLASS: Vaccine; INDICATION: Japanese Encephalitis; TARGET: Immune System, Japanese Encephalitis Virus ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: 1. Males and females between 18 and 65 years of age (inclusive). 2. Subjects who have given written consent. 3. Individuals in good health as per investigator judgement. Exclusion Criteria: 1. If female, pregnancy or unwillingness to practice acceptable contraception. 2. If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test. 3. Contraindication or precaution against Rabies and Japanese Encephalitis vaccination. 4. Unable to comprehend and to follow all required study procedures for the whole period of the study. 5. Participating in any other clinical trial 30 days prior to first study visit. 6. History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization. 7. Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43. 8. Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines. 9. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. 10. Individuals who are part of study personnel or close family members conducting this study. 11. Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination. 12. Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries. ; PRIMARY OUTCOME: Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination; SECONDARY OUTCOME 1: RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active 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 II - NAV3-20 ; BRIEF: Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. ; DRUG USED: Lymphoseek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anal Cancer; TARGET: Macrophages, Mannose, Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Cardinal Health 414, LLC; CRITERIA: Inclusion Criteria: - Subject has provided written informed consent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization - Has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus) - Has a documented clinical stage using the tumor, lymph node, metastasis staging (TNM) classification system that was established by at least physical exam with manual palpation, digital anorectal examination, high-resolution anoscopy and PET/CT imaging evaluation of the bilateral inguinal area - Is at least 18 years of age at the time of consent - Has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 3 - If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year Exclusion Criteria: - The subject has had radiation therapy, chemotherapy or immunotherapy within the 30 days prior to Lymphoseek administration - Has had previous surgery or node dissection (exclusive of fine needle aspiration) or radiation to node basins that would be involved in the intraoperative lymphatic mapping procedure - Has a known allergy to dextran - Is breast-feeding or pregnant - Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical - Has received an investigational product within the 30 days prior to Lymphoseek administration ; PRIMARY OUTCOME: Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by standard of care methods); SECONDARY OUTCOME 1: Reverse Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by Lymphoseek)[/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 - CS203 w/Latanoprost; BRIEF: This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP). ; DRUG USED: AR-12286; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Rho GTPase/Rho Kinase; THERAPY: Combination; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Inclusion Criteria: - 18 years of age or greater. - Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). - Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1 month at time of study entry (first qualification visit) in study eye(s). - Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm Hg; Combination therapy patients: >= 16 mm Hg. Qualification Visit 2 (post latanoprost run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in study eye(s). (Note: combination therapy may include any combination of topical ocular hypotensive agents). - Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200). - Able and willing to give signed informed consent and follow study instructions Exclusion Criteria: In either eye: - Previously randomized to treatment in a clinical study of AR-12286. - Intraocular pressure > 36 mm Hg. - History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy - Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics, including history of conjunctival hyperemia with topical latanoprost of severity greater than 1 on a 0-3 scale. - Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months. - Contact lens wear within 30 minutes of instillation of study medication. - PG monotherapy patients: Ocular hypotensive medication (other than prostaglandin) within 4 weeks of Visit 0 (Study entry, first qualification visit). Combination therapy patients: Ocular hypotensive medication (other than prostaglandin and current additional agent) within 4 weeks of Visit 0 (Study entry, first qualification visit). - Conjunctival hyperemia of grade 2+ or greater at Visit 1. - Any other ocular medication within 4 weeks of Visit 1 with the exception of lubricating drops for dry eye (which may be used throughout the study). - Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that treatment with only latanoprost for two periods of up to 4 weeks is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss). - Any abnormality preventing reliable applanation tonometry of either eye. In study eye(s): - Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable. - Previous glaucoma intraocular surgery or laser procedures. - Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.). - Central corneal thickness greater than 600 µ. Systemic: - Known bronchial asthma (history or current), severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or overt cardiac failure. - Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood. - Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study. - Participation in any investigational study within the past 30 days. - Changes of systemic medication that could have a substantial effect on IOP 4 weeks prior to screening, or anticipated during the study. - Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. ; PRIMARY OUTCOME: Intraocular pressure; SECONDARY OUTCOME 1: Ocular safety[/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 IIIa - 12 Month Exacerbation (102970); BRIEF: The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD) ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Type of subject: outpatient - Informed consent: Subjects must give their signed and dated written informed consent to participate. - Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<140 pmol/L) is confirmatory. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact): - Complete abstinence from intercourse from screening until the Follow-Up Phone Contact; or - Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or - Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or - Injectable progestogen administered for at least 1 month prior to study medication administration and administered until the Follow-Up Phone Contact; or - Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or - Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or - An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or - Estrogenic vaginal ring; or - Percutaneous contraceptive patches - Age: ≥40 years of age at Screening (Visit 1) - COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences. - Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history. Number of pack years = (number of cigarettes per day/20) x number of years smoked - Severity of Disease: - Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 at Screening (Visit 1) - Subjects with a measured post-albuterol/salbutamol FEV1 <70% of predicted normal values calculated (via centralized vendor equipment) using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1). Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The study provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values. - History of Exacerbations: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable. Exclusion Criteria: Subjects meeting any of the following criteria must not be enrolled in the study: - Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. - Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD) - α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD - Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases - Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1) - Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 6 months prior to Visit 1. For sites in Germany, if a chest X-ray (or CT scan) is not available in the 6 months preceding Screening (Visit 1), the subject will not be eligible for the study. - Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinsons, Myasthenia Gravis, etc). - A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable). - Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least ≥ 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable). - Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. - Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled. - Hypertension: Subjects with clinically significant hypertension that is uncontrolled. - Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis. - Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subjects participation will also be excluded. - Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years - Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit. - Additional medication: Unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications) - Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ≤12 hours per day) is not exclusionary. - Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device. - Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded. - Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits. - Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. - Prior use of study medication/other investigational drugs: Subjects who have previously been randomized to treatment with GW642444 Inhalation Powder in the B2C111045 study, randomized to treatment in the HZC111348 study or have participated in the HZC112207, HZC102871, HZC102970, or HZC110946 studies. Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer. - Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. ; PRIMARY OUTCOME: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean; SECONDARY OUTCOME 1: Time to First Occurrence of Moderate or Severe COPD Exacerbation[/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 - RAP-MD-33 (Relapse Prevention); BRIEF: The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD). ; DRUG USED: Rapastinel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Receptor - Glycine Site; THERAPY: Monotherapy; LEAD SPONSOR: Naurex, Inc, an affiliate of Allergan plc; CRITERIA: Inclusion Criteria: - - Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32 - If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test Exclusion Criteria: - - DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1 - Lifetime history of meeting DSM-5 criteria for: - 1.Schizophrenia spectrum or other psychotic disorder - 2.Bipolar or related disorder - 3.Major neurocognitive disorder - 4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participants ability to consent, follow study directions, or otherwise safely participate in the study - 5.Dissociative disorder - 6.Posttraumatic stress disorder - 7.MDD with psychotic features - Significant suicide risk, as judged by the Investigator ; PRIMARY OUTCOME: Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP); 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 - 12 weeks (Efficacy & Safety); BRIEF: This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7). ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects must give their signed and dated (written) informed consent to participate. Written informed consent must be obtained if a subjects current medication is changed as a result of study participation - Outpatient >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health. Countries with local restrictions prohibiting enrolment of adolescents will only enroll subjects >=18 years of age - Male or an eligible female. Eligible female is defined as having non-childbearing potential or having childbearing potential and using an acceptable method of birth control consistently and correctly. - Best pre-bronchodilator FEV1 of 40% to 80% of their predicted normal value. - Demonstrate >=12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized treatment with albuterol/salbutamol solution) or have documented reversibility testing within the 6 months prior to Visit 1 meeting this measure of reversibility. A spacer device may be used for testing, if required. - If subject have received ICS for at least 12 weeks prior to Visit 1 and their treatment during the 4 weeks immediately prior to Visit 1 consisted of either of the two regimens (a or b).a.) A stable mid-dose or high-dose of ICS alone (e.g., >=FP 250 mcg twice daily) or b.) A stable dose of a mid-dose ICS/LABA combination (e.g., FP/Salmeterol [SALM] 250/50 mcg twice daily) or an equivalent combination via separate inhalers. - Use of ICS/LABA are not permitted with LABA on the day of Visit 1. - Must be able to replace current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, during the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits Exclusion Criteria: - History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years. - Upper or lower respiratory tract, sinus, or middle ear that is: not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the investigator, expected to affect the subjects asthma status or the subjects ability to participate in the study. - Any asthma exacerbation that required oral corticosteroids within the 12 weeks prior to Visit 1 or, resulted in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1. - A subject must not have current evidence of atelectasis (segmental or larger), bronchopulmonary dysplasia, chronic obstructive pulmonary disease, Or any evidence of concurrent respiratory disease other than asthma - A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study - Chronic stable hepatitis B or C are acceptable provided their screening alanine transaminase (ALT) is <2x upper limit of normal (ULN) and the y otherwise meet the entry criteria. Chronic co-infection with both hepatitis B and hepatitis C are not eligible - Clinical visual evidence of candidiasis at Visit 1 - Use of any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½), whichever is longer of the two. - Allergies to drug or milk protein: any adverse reaction, to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or known or suspected sensitivity to the constituents of the NDPI, or history of severe milk protein allergy - Administration of medication that would significantly affect the course of asthma, or interact with study drug - Use of immunosuppressive medications during the study. - Use of potent CYP3A4 inhibitor within 4 weeks of Visit 1. - A subject or his/her parent or legal guardian has any infirmity, disability, disease, or resides in a geographical location which seems likely, in the opinion of the Investigator, to impair compliance with any aspect of this study protocol, including visit schedule, and completion of the daily diaries. - Current smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, or pipe tobacco). - If subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator. - Subject previously randomized to treatment with FF/VI or FF in another Phase III study - Subjects working on night shift a week prior to Visit 1 or during the study period. - Adolescents who are wards of the state or government ; PRIMARY OUTCOME: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period; SECONDARY OUTCOME 1: Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - MAD (IV) (Healthy Adults); BRIEF: This is a single-center, randomized, placebo-controlled, double-blind, multiple-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study. ; DRUG USED: TP-271; DRUG CLASS: New Molecular Entity (NME); INDICATION: Community Acquired Pneumonia (CAP) (Antibacterial); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Tetraphase Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Be within the age range of 18 to 50 years, inclusive, at the time of Screening 2. Voluntarily sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved ICF to participate in the study after all relevant aspects of the study have been explained and discussed with the subject and before undergoing any study-related procedures 3. Have a body mass index (BMI) ≥18.0 and ≤33.0 kg/m2 4. Have a negative history of and negative screening results for human immunodeficiency virus 1 and 2 and hepatitis B and C antibodies 5. Have the ability to communicate with the study unit staff in a manner sufficient to carry out all protocol procedures as described 6. For female subjects, be of non-childbearing potential, either 1 year postmenopausal or surgically sterile (bilateral oophorectomy, bilateral tubal ligation, or complete hysterectomy) 7. For male subjects, be willing and able to use a barrier method of contraception or practice abstinence (including males who had a vasectomy) from dosing through 90 days after administration of the final dose of study drug Exclusion Criteria: 1. History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, psychiatric, or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the PI or Sub-Investigator(s), may either put the subject at risk because of participation in the study, influence the results of the study, or influence the subjects ability to participate in the study 2. Clinical laboratory values that fall outside the eligibility range specified in Appendix D; for laboratory values that are not included in Appendix D, values outside the reference range are exclusionary, with the following exceptions (Table 4. Acceptable Out-of-Range Clinical Laboratory Values 3. Known allergy to tetracycline antibiotics or to any of the excipients in TP-271 4. Clinically significant abnormality on a 12-lead ECG, including the following: - Rhythm other than sinus - Corrected QT interval using Fridericias formula (QTcF) >450 msec - Evidence of second- or third-degree atrioventricular block - Pathological Q-waves (defined as Q-wave >40 msec or depth >0.4 to 0.5 mV) - Evidence of ventricular pre-excitation - Evidence of complete left bundle branch block (BBB), right BBB, or incomplete left BBB - Intraventricular conduction delay with QRS duration >120 msec - ST segment abnormalities, unless judged by the PI or Sub-Investigator(s) to be non pathologic 5. History of seizures 6. History within 3 years of a positive result on a urine screen for drugs of abuse or a positive result at Screening for any of the following drugs of abuse: tetrahydrocannabinols, cocaine, opioids, phencyclidines, amphetamine, benzodiazepine, and barbiturates 7. Use of tobacco, nicotine, or nicotine-replacement products within 3 months prior to administration of the study drug through the last visit 8. Typical weekly alcohol consumption of 7 or more alcoholic drinks, where 1 alcoholic drink is defined as 1 glass of beer (approximately 10 to 12 oz), 1 can (12 oz) of beer, 1 glass of wine (approximately 4 to 5 oz), or distilled spirits (approximately 1 oz or 30 mL of liquor) 9. Alcohol consumption within 48 hours prior to dosing 10. Participation in a clinical study within 10 half-lives of the prior study drug administration or within the previous 3 months if the half-life or dose of the investigational agent is unknown or planned participation in another clinical study concurrent with the current clinical study 11. History of difficulty donating blood or poor venous access 12. Blood donation (1 unit or approximately 350 mL) within 1 month prior to receiving study drug or plans to donate prior to receiving study drug or during the clinical study 13. Use of any prescription or nonprescription medication, including vitamins or herbal medications, vaccination, or immunization within 7 days or 5 half-lives (if known), whichever is longer, prior to dosing of study drug, with the following exceptions: medications used to treat an AE, and the use of acetaminophen, naproxen, and ibuprofen (except for within 24 hours prior to dosing) 14. Male subject donates or plans to donate sperm during the study and for at least 90 days after study drug administration. 15. Unwillingness or inability to follow the procedures outlined in the clinical study protocol ; PRIMARY OUTCOME: Adverse Events; SECONDARY OUTCOME 1: Assess the Pharmacokinetics (PK) of TP-271in Plasma[/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 - Hepatic Insufficiency; BRIEF: The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated. This study will last approximately 3 weeks for each participant, including check-in and follow-up. ; DRUG USED: Verzenio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Female participants must be of non-child-bearing potential - Have a body mass index of 18 to 40 kilograms per square meter (kg/m²) Exclusion Criteria: - No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders - Have known allergies to abemaciclib, related compounds, or any components of the formulation - No human immunodeficiency virus (HIV) infection or antibodies ; PRIMARY OUTCOME: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites; 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 - Stargardt; BRIEF: The purpose of this study is: - To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD Group - When-MA09-hRPE cell transplantation to evaluate the safety of surgical procedures. - In future studies intended to assess the number of transplanted hRPE cells. - In the past, MA09-hRPE cell therapy used in the study was to evaluate the validity of the potential. - Homologous retinal pigment epithelial cells derived from embryonic stem cells, future studies of drugs that are used in representing the potential validity to evaluate the optimal dose. ; DRUG USED: ASP7317; DRUG CLASS: Biologic; INDICATION: Stargardt Disease (Ophthalmology); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: CHABiotech CO., Ltd; CRITERIA: Inclusion Criteria: - Adult male or female over 20 years of age. - Clinical diagnosis of advanced SMD. - The visual acuity of the eye to receive the transplant will be no better than hand movement. - The visual acuity of the eye that is not to receive the transplant will be no better than 24 (20/320) Early Treatment of Diabetic Retinopathy Study (ETDRS) letters. Exclusion Criteria: - History of malignancy. - History of myocardial infarction in previous 12 months. - History of diabetes mellitus. - Any immunodeficiency. - Any current immunosuppressive therapy other than intermittent or low dose cortico steroids. - Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV. - Current participation in any other clinical trial. - Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration. - Any other sight-threatening ocular disease. - Any chronic ocular medications. Any history of retinal vascular disease (compromised blood-retinal barrier). Glaucoma. Uveitis or other intraocular inflammatory disease. Significant lens opacities or other media opacity. Ocular lens removal within previous 3 months ; PRIMARY OUTCOME: safety and tolerance of transplantation; SECONDARY OUTCOME 1: Evidence of successful engraftment[/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 - evolutionRMS 1 (vs. Aubagio); BRIEF: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period. ; DRUG USED: Evobrutinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: - Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018) - Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization - Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years - Participants are neurologically stable for >= 30 days prior to both screening and baseline (Day 1) - Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure - Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure - Participants have given written informed consent prior to any study-related procedure - Other protocol defined inclusion criteria could apply. Exclusion Criteria: - Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b). Participants with secondary progressive MS without evidence of relapse - Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening and Baseline (Day 1) - Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease - Other protocol defined exclusion criteria could apply. ; PRIMARY OUTCOME: DBTP: Annualized Relapse Rate (ARR); SECONDARY OUTCOME 1: DBTP: Time to First Occurrence of 12-Week Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) Progression[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - OXL-201 (Korea); BRIEF: The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II. ; DRUG USED: Oral Paclitaxel; DRUG CLASS: Non-NME; INDICATION: Gastric Cancer; TARGET: Microtubules (Tubulin), P-gp; THERAPY: Monotherapy; LEAD SPONSOR: Hanmi Pharmaceutical Company Limited; CRITERIA: Inclusion Criteria: 1. Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI) 2. Advanced/metastatic/recurred gastric cancer(PhaseII) 3. ECOG performance status ≤ 2 4. Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL *AST/ALT/ALP ≤ 3 X the upper limit of normal but <5 if liver or bone metastasis is present Exclusion Criteria: 1. Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection) 2. Patients who have received bone marrow transplant or are to receive bone marrow transplant. 3. Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months. ; PRIMARY OUTCOME: Toxicity evaluation (safety evaluation); 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 - CTH301 (Safety); BRIEF: An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinsons Disease ; DRUG USED: Kynmobi; DRUG CLASS: Non-NME; INDICATION: Parkinsons Disease (PD); TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Dopamine 4 (D4) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: De Novo Subjects Inclusion Criteria 1. Male or female ≥ 18 years of age. 2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the more than one affected relative criterion) 3. Clinically meaningful response to L-Dopa as determined by the Investigator. 4. Receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4 times per day OR Rytary™ administered at least 3 times per day, for at least 4 weeks before the initial Screening Visit (SV1). Adjunctive PD medication regimens must be maintained at a stable dose for at least 4 weeks prior to the initial Screening Visit (SV1) with the exception that MAO-B inhibitors must be maintained at a stable level for at least 8 weeks prior to the initial Screening Visit (SV1). 5. No planned medication change(s) or surgical intervention anticipated during the course of study. 6. Subject must experience at least one well defined OFF episode per day with a total daily OFF time duration of ≥ 2 hours during the waking day, based on patient self-assessment. 7. Subject and/or caregiver must be trained in performing home dosing diary assessments of the motor state and must be able to recognize ON and OFF states. 8. Stage III or less on the modified Hoehn and Yahr scale in the ON state. 9. MMSE score > 25. 10. If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control: - Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring, injectables, and implants); - Intrauterine contraceptive system; - Surgical sterilization or partner sterile (must have documented proof); AND One of the following effective methods of birth control: - Male/female condom; - Cervical cap with spermicide; - Diaphragm with spermicide; - Contraceptive sponge. 11. Male subjects must be either surgically sterile, agree to be sexually inactive or use a double-barrier method of birth control (eg, condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration. 12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures. 13. Able to understand the consent form, and to provide written informed consent. De Novo Subjects Exclusion Criteria - 1. Atypical or secondary parkinsonism. 2. Previous treatment with any of the following: a neurosurgical procedure for PD; continuous s.c. apomorphine infusion; Duodopa/Duopa; or APL-130277. 3. Treatment with any form of s.c. apomorphine within 7 days prior to the second Screening Visit (SV2). Patients that stopped s.c. apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered. 4. Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN® (notably sodium metabisulfite). 5. Female who is pregnant or lactating. 6. Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1). 7. Receipt of any investigational (ie, unapproved) medication within 30 days prior to the initial Screening Visit (SV1). 8. Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. 9. Drug or alcohol dependency in the past 12 months. 10. Subject has a history of malignancy within 5 years prior to the Screening visit, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded. 11. Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator. 12. Major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult. 13. History of clinically significant hallucinations during the past 6 months. 14. History of clinically significant impulse control disorder(s). 15. Dementia that precludes providing informed consent or would interfere with participation in the study. 16. Current suicidal ideation within one year prior to the second Screening Visit (SV2) as evidenced by answering yes to Questions 4 or 5 on the suicidal ideation portion of the C-SSRS or attempted suicide within the last 5 years. 17. Donation of blood or plasma in the 30 days prior to first dosing. 18. Presence of canker or mouth sores in the 30 days prior to the initial Screening Visit (SV1), or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a patient into the study. Rollover Subjects Inclusion Criteria 1. Completion of any of the following studies: CTH-201, CTH-203, CTH-300, or CTH 302; and, in the opinion of the Investigator, would benefit from continued treatment with APL 130277. 2. No major changes in concomitant PD medications since completion of any of the following studies: CTH-201, CTH-203, CTH-300, or CTH 302. Any change in PD medications since the previous study should be discussed with the Medical Monitor to determine subject eligibility in the current study. 3. If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control: - Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring, injectables, and implants); - Intrauterine contraceptive system; - Surgical sterilization or partner sterile (must have documented proof); AND One of the following effective methods of birth control: - Male/female condom; - Cervical cap with spermicide; - Diaphragm with spermicide; - Contraceptive sponge. 4. Male subjects must be either surgically sterile, agree to be sexually inactive or use a double-barrier method of birth control (eg, condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration. 5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures. 6. Able to understand the consent form, and to provide written informed consent. Rollover Subjects Exclusion Criteria 1. Female who is pregnant or lactating. 2. Presence of any major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis (including clinically significant hallucinations during the past 6 months) or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult. 3. Presence of any clinically significant medical (including but not limited to CNS, cardiovascular, hepatic, pulmonary, metabolic, or renal events), surgical, or laboratory abnormality that would make study participation unsafe or make treatment compliance difficult. Clinical significance to be determined by the Investigator. 4. Receipt of any investigational (ie, unapproved) medication or participation in any clinical trial of an investigational product since completing a previous study using APL 130277. 5. Development of canker or mouth sores within 14 days of completing a previous study using APL-130277. For other clinically significant oral pathology, the Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling such a subject into the study. Clinical significance to be determined by the Investigator. The eligibility of subjects who have experienced AEs related to the oral cavity during the previous study using APL-130277, should be reviewed with the medical monitor and approval obtained. 6. Current suicidal ideation within one year of the screening visit, as evidenced by answering yes to Question 4 or 5 on the suicidal ideation portion of the C SSRS at Screening or attempted suicide within 5 years. CTH-301 Completer Subjects Inclusion Criteria 1. Completion of the CTH-301 study under protocol version 3.00, and in the opinion of the Investigator, would benefit from continued treatment with APL 130277. 2. If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control: - Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring, injectables, and implants); - Intrauterine contraceptive system; - Surgical sterilization or partner sterile (must have documented proof); AND One of the following effective methods of birth control: - Male/female condom; - Cervical cap with spermicide; - Diaphragm with spermicide; - Contraceptive sponge. 3. Male subjects must be either surgically sterile, agree to be sexually inactive or use a double-barrier method of birth control (eg, condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration. 4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures. 5. Able to understand the consent form, and to provide written informed consent. CTH-301 Completer Subjects Exclusion Criteria 1. Female who is pregnant or lactating. 2. Presence of any major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis (including clinically significant hallucinations during the past 6 months) or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation in unsafe or make treatment compliance difficult. 3. Presence of any clinically significant medical (including but not limited to CNS, cardiovascular, hepatic, pulmonary, metabolic, or renal events), surgical, or laboratory abnormality that would make study participation unsafe or make treatment compliance difficult. Clinical significance to be determined by the Investigator. 4. Receipt of any investigational (ie, unapproved) medication or participation in any clinical trial since completing the CTH 301 study. 5. Development of canker or mouth sores since completing the CTH 301 study. For other clinically significant oral pathology, the Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling such a patient into the study. Clinical significance to be determined by the Investigator. 6. Current suicidal ideation as evidenced by answering yes to Question 4 or 5 on the suicidal ideation portion of the C-SSRS at the Screening Visit Phase 2 (SVP2). ; PRIMARY OUTCOME: Evaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phase; SECONDARY OUTCOME 1: The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 24 Visit (LTS V4) of the LTS Phase Based on the Home Dosing Diary Entries.[/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 - BELLE-2 (HER2-/HR+); BRIEF: This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment. ; DRUG USED: Buparlisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Locally advanced or metastatic breast cancer - HER2-negative and hormone receptor-positive status (common breast cancer classification tests) - Postmenopausal woman - A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status) - Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment - Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1 - Adequate bone marrow and organ function defined by laboratory values Key Exclusion Criteria: - Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant - More than one prior chemotherapy line for metastatic disease - Symptomatic brain metastases - Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent - Active heart (cardiac) disease as defined in the protocol - Certain scores on an anxiety and depression mood questionnaires ; PRIMARY OUTCOME: Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort; SECONDARY OUTCOME 1: Overall Survival (OS) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown 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 III - Study 102; BRIEF: The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes. ; DRUG USED: Afrezza; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Mannkind Corporation; CRITERIA: Inclusion Criteria: - Men or women ≥ 18 and ≤ 80 years old - Clinical diagnosis of type 2 diabetes mellitus - HbA1c > 7.0% and ≤ 11.0% - BMI ≤ 40 kg/m2 - Negative smoking status and urine cotinine test - Written informed consent - Receiving sc insulin 2-3 times daily administered as any of the following 3 regimens: self-mix regimen, pre-mix regimen, or long-acting analogue and regular or rapid-acting insulin analogue not to exceed 3 daily injections. Subjects may also have received oral antidiabetic agents including metformin or thiazolidinediones. - No dose adjustments for insulin and oral antidiabetic agents within the preceding 6 weeks. - FEV1 ≥ 70% of NHANES III predicted; TLC) ≥ 80% of predicted (Intermountain Thoracic Society); DLCO uncorrected ≥ 70% of predicted Exclusion Criteria: - Total daily dose of insulin ≥1.4 IU/kg body weight - Treatment with any sulfonylureas and/or meglitinides and/or alpha-glucosidase inhibitors within the preceding 8 weeks - Treatment with pramlintide acetate (Symlin®), and/or any incretins (e.g., exenatide [Byetta®]) within the preceding 8 weeks - Unstable diabetes mellitus control, defined as 2 or more episodes of severe hypoglycemia (requiring third party intervention) and/or any hospitalization or emergency room visit due to poor diabetic control or hyperglycemia requiring hospitalization within the preceding 6 months - Exposure to an inhaled insulin at any time, treatment with an investigational drug within the preceding 3 months, and/or current participation in another clinical trial - Allergy to insulin or to any drugs to be used as part of the clinical trial, or history of hypersensitivity to the investigational drug or to drugs of similar chemical structures - History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes as evidenced by serum aspartate aminotransferase (AST)and/or alanine aminotransferase (ALT) ≥ 3 x Upper Limit of Normal (ULN)(Includes active hepatitis A, positive hepatitis B and/or hepatitis C serology) - Serum creatinine > 1.8 mg/dL in women and > 2.0 mg/dL in men History of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease confirmed by documented history, pulmonary function testing, or radiologic findings - Congestive heart disease graded as class III or class IV according to New York Heart Association criteria and subjects currently being treated pharmacologically for ventricular dysrhythmias using amiodarone - History of myocardial infarction, cardiac surgery, coronary angioplasty, and/or stroke within the preceding 3 months - Symptomatic coronary artery disease, including crescendo angina, unstable angina, and/or unstable or symptomatic cardiac arrhythmias - Poorly controlled arterial hypertension despite pharmacologic treatment, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 110 mm Hg at screening - History of malignancy within the preceding 5 years (other than excised basal cell carcinoma of the skin), any history of lung neoplasm, and/or subjects with current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity - History of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), or positive human immunodeficiency virus (HIV) serology - Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine - Visit 1/Screening (Week -3), but prior to Visit 1 PFTs and before Visit 3/Baseline (Week 0), subject will be scheduled for PFTs after 30 days from resolution of respiratory infection. An additional hemoglobin and urine β-HCG (for women of childbearing potential age only) will be required - Women who are pregnant, lactating or planning to become pregnant - Women of childbearing potential (defined as pre-menopausal and not surgically sterilized or postmenopausal for less than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous and/or transdermal contraceptives; condoms and diaphragms with a spermicide, or intrauterine devices - Current drug and/or alcohol abuse - Subjects who in the opinion of the Investigator will be unable to comply with the requirements of the protocol - Severe complications of diabetes mellitus, in the opinion of the Investigator, including: symptomatic autonomic neuropathy, disabling peripheral neuropathy, active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene;and/or vascular claudication - Any other concurrent medical or major psychiatric condition which, in the opinion of the Investigator, makes the subject unsuitable for the clinical trial, or could limit the validity of the ICF and/or impair the subjects ability to participate in the trial - Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) acceptability and repeatability criteria. ; PRIMARY OUTCOME: Change From Baseline in HbA1c to Week 52; SECONDARY OUTCOME 1: Change From Baseline in Weight to 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 - vs. Avastin; BRIEF: To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated. ; DRUG USED: Inlyta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Advanced non squamous cell, lung cancer - No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12 months prior to enrollment Exclusion Criteria: - Prior therapy for advanced lung cancer - The need for blood-thinners - Coughing up blood ; PRIMARY OUTCOME: Progression Free Survival (PFS); 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 II - Abramson Cancer Center (Penn); BRIEF: This is a randomized, open-label, parallel group study to determine the optimal dose of CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR Zeta and 4-1 BB co-stimulatory domains) of the two dose levels being assessed (1-5x10e8 vs. 1-5x10e7 CART-19 cells). This trial will be conducted in two stages. ; DRUG USED: Kymriah; DRUG CLASS: Biologic; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: University of Pennsylvania; CRITERIA: Inclusion Criteria - Documented CD19+ CLL or SLL - Successful test expansion of T-cells - At least 2 prior chemotherapy regimens, not including single agent monoclonal antibody (rituxan) therapy. Single agent ofatumumab will be counted as a regimen. -Patients with high risk disease manifested by deletion chromosome 17p will be eligible if they fail to achieve a CR to initial therapy or progress within 2 years of 1 prior regimen. - Patients who progress within 2 years after the second or higher line of therapy will be eligible. For instance, patients who had progression < 2 years after second or greater line therapy, but who have responded to their most recent treatment (3rd line or higher) will be eligible. - Subject is not appropriate candidate for a potentially curative allogeneic SCT due to the state of disease, co-morbid illness, lack of an available donor, or patient declines Performance status (ECOG) 0 or 1 - Age >/= 18 years - Adequate organ system function including: 1. Creatinine < 1.6 mg/dl 2. ALT/AST < 3x upper limit of normal 3. Total Bilirubin <2.0 mg/dl - Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy - Patients with relapsed disease after prior allogeneic SCT (myeloablative or nonmyeloablative) will be eligible if they meet all other inclusion criteria and: 1. Have no active GVHD and require no immunosuppression 2. Are more than 6 months from transplant - No contraindications for leukapheresis - Left Ventricular Ejection fraction >40% - Gives voluntary informed consent Retreatment Inclusion Criteria - Performance Status 0-1 - Adequate organ system function including: - Creatinine < 1.6 mg/dl - ALT/AST < 3x upper limit of normal - Total Bilirubin < 2.0 mg/dl - Subject is not an appropriate candidate for a potentially curative allogeneic SCT due to the state of disease, co-morbid illness, lack of an available donor, or patient declines. - Left Ventricular Ejection Fraction > 40% - No contraindications for leukapheresis (if required for retreatment) - Gives voluntary informed consent for retreatment Exclusion Criteria - Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion. - Uncontrolled active infection - Active hepatitis B or hepatitis C infection - Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications. - Any uncontrolled active medical disorder that would preclude participation as outlined - HIV infection - Patients with active CNS involvement with malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment. - Class III/IV cardiovascular disability according to the New York Heart Association Classification Retreatment Exclusion Criteria - Pregnant or lactating women. Female study participants must have a negative serum or urine pregnancy test performed within 48 hours before infusion. - Uncontrolled active infection - Active hepatitis or hepatitis infection - Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. - Any uncontrolled active medical disorder that would preclude participation as outlined. - HIV infection - Patients with active CNS involvement with malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment on the retreatment cohort. - Class III/IV cardiovascular disability according to the New York Heart Association Classification ; PRIMARY OUTCOME: Number of Patients Achieving Complete Response Within 3 Months; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - INSTRIDE 3; BRIEF: The aim of this extension study is to assess the safety and efficacy of Mylans insulin glargine and Lantus® in T1DM patients. ; DRUG USED: Semglee; DRUG CLASS: Biosimilar; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Mylan Inc.; CRITERIA: Inclusion Criteria: 1. Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study. 2. Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures. 3. The patient is able and willing to comply with the requirements of the extension study protocol including the 8-point self-monitoring blood glucose, completion of patient diary records as instructed and following a recommended diet and exercise plan for the entire duration of the extension study. 4. Female patients complying with the following: - Female patients of childbearing potential must be using oral contraception or two other acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the time of randomization throughout the entire study. - Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. - Postmenopausal females must have had no menstrual bleeding for at least 1 year prior to inclusion in MYL-GAI-3001 study. - Female patients who report surgical sterilization must have had the procedure at least 6 months prior to inclusion to MYL-GAI-3001 study. - All female patients of childbearing potential, must have negative pregnancy test results at baseline (week 0) and at each clinic visit as per the SCHEDULE OF ACTIVITIES. - If female patients have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 months prior to inclusion in MYL-GAI-3001 study. Exclusion Criteria: 1. History or presence of a medical condition or disease that in the Investigators opinion would place the patient at an unacceptable risk from trial participation. 2. History of clinically significant (i.e., significant enough to alter the insulin dose requirement, as per the Investigator) acute bacterial, viral or fungal systemic infections in the 4 weeks prior to inclusion / randomization (recorded while collecting patient history) in to the MYL-1501D-3003 extension study 3. Patients scheduled to receive another investigational drug during the extension study period 4. Any major elective surgery requiring hospitalization planned during the extension study period. 5. Moderate insulin resistance, defined as requiring insulin (Basal + Prandial) of ≥1.5 U/kg/day (Lantus® in U/kg/day or Mylans insulin glargine in IU/kg/day). ; PRIMARY OUTCOME: Change in Hemoglobin A1c (HbA1c) From Baseline; SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers; BRIEF: The study is a randomized, double-blind, placebo-controlled clinical study of imatinib (as mesilate) in healthy subjects exposed inhaled lipopolysaccharide. During the study, eight oral doses of imatinib, or placebo, will each be taken 12 hours apart, before subjects are exposed to nebulized lipopolysaccharide (LPS). Four hours after LPS exposure, a bronchoalveolar lavage (BAL) will be undertaken, and BAL fluid (BALF collected. Once study assessments are completed, a follow-up visit will be conducted approximately 7 days after the last dose of imatinib. The primary objective of the study is to investigate the effect of imatinib on LPS-induced pulmonary vascular dysfunction. The primary endpoints of this study are: 1. Change in the number of neutrophils in BALF 6 hours after the LPS challenge in subjects exposed to imatinib compared with placebo. 2. Change in concentration of total protein in BALF 6 hours after the LPS challenge in subjects exposed to imatinib compared with placebo ; DRUG USED: Gleevec; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Respiratory Failure, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS); TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Exvastat Ltd.; CRITERIA: Inclusion Criteria: 1. Are able and willing to provide written informed consent to participate in this clinical study. 2. Healthy males and females, between 18 and 55 years old (both inclusive) at the screening visit. 3. Male subjects must practice an acceptable contraceptive method from the time of first IMP administration until 6 weeks after the follow-up visit. 4. Female subjects must either be: 1. Of non-childbearing potential: 2. Or if of childbearing potential, must practice an acceptable contraceptive method from 4 weeks before the first IMP administration until 6 weeks after the follow-up visit. 5. Good general health as ascertained by detailed medical history and physical examination at the screening visit. 6. Body mass index ≥18.0 and ≤30 kg/m2 at the screening visit. 7. No clinically relevant abnormalities in the 12-lead ECG as per the Investigators judgement at the screening visit 8. No clinically relevant abnormalities in results of clinical laboratory tests as per the Investigators judgement at the screening visit. 9. Normal spirometry (FEV1 ≥ 85% of predicted, FEV1/FVC ratio ≥ 70%) at the screening visit. 10. Non-smokers or no history of smoking (including e-cigarettes and other forms of vaporizing/inhalation) in the last 6 months prior to the screening visit. 11. Subjects must be able to communicate well with the Investigator/designee. Exclusion Criteria: 1. History of hypersensitivity to the IMP or any of the excipients or to medicinal products with similar chemical structures. 2. Presence of any clinically relevant acute or chronic disease which could interfere with the subject safety during the study, expose the subject to undue risk, limit the biological sampling, interfere with the absorption of the investigational product (or interfere with the study objectives. 3. Any history of previous respiratory, hematological or malignant disease, including childhood asthma. 4. Any history of chronic renal, cardiac (previous myocardial infarction, diagnosis of cardiac failure or cardiac rhythm disturbances such as atrial fibrillation) or hepatic impairment. 5. Current evidence of ongoing or acute infection, history of repeated or chronic significant infections, or history of serious infection within 3 months of randomization. Acute infection is defined as a history of febrile illness (> 38°C), or 2 or more of the following symptoms within the last 7 days prior to the screening visit or Day 1: cough, sore throat, runny nose, sneezing, limb/joint pain, headache or vomiting/diarrhea. 6. Any condition that in the opinion of the Investigator will require regular concomitant medication including herbal products, or predicted need of any concomitant medication during the study. 7. Intake of any prescription and over-the-counter medication (except paracetamol, hormonal contraceptives and hormonal replacement therapy) including herbal and dietary supplements (including St Johns Wort), vitamins and minerals, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of IMP. 8. Systolic blood pressure < 90 mmHg or > 140 mmHg, or diastolic blood pressure < 50 mmHg or > 90 mmHg after 5 minutes in the supine position at the screening visit. 9. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV)-1 and/or -2 antibodies at the screening visit. 10. Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) or intake of food or drinks containing xantine (e.g., caffeine) within 24 hours prior to the screening visit or Day 1. 11. Positive urine cotinine test at the screening visit or Day 1, or the inability to stop using nicotine-containing products during the clinical study. 12. History or presence of drug addiction (positive urine drug screen at the screening visit or Day 1). 13. History of regular alcohol consumption within 6 months of the screening visit defined as an average weekly intake of > 21 units (or an average daily intake of > 3 units) for males or an average weekly intake of > 14 units (or an average daily intake > 2 units) for females. 14. Positive urine alcohol test at the screening visit or Day 1, or the inability to refrain from the use of alcohol during the clinical study. 15. Intake of any food or any drinks containing grapefruit, Chinese grapefruit (pomelo), Seville orange (including marmalade) or quinine-containing products (e.g., tonic water, bitter lemon) from 7 days prior to Day 1. 16. Blood component or plasma donation within 3 months prior to the first dose of IMP. 17. Participation in another study with an experimental drug within 3 months before the first dose of IMP. Exclusion period starts from last IMP dosed in previous study to first dose of IMP. 18. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limited the ability of the subject to comply with the protocol requirements. 19. Subject is mentally or legally incapacitated. 20. A pregnant woman or a nursing mother. 21. Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude and improbability of completing the clinical study. 22. Subjects who, in the opinion of the Investigator, are considered unsuitable for any other reason. ; PRIMARY OUTCOME: Change in the number of neutrophils in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo; 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 - GS39684; BRIEF: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria (CSU) already treated with anti-histamines. Participants have the option to enter the Open-Label Extension (OLE) study after completing the 8-week treatment period. ; DRUG USED: RG7845; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urticaria; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Aged 18-75 years, inclusive - Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1 antihistamines at the time of randomization - Willing and able to complete an Urticaria Participant Daily eDiary for the duration of the study - No evidence of active or latent or inadequately treated infection with tuberculosis (TB) - Partcipants with a history of Bacille Calmette-Guérin (BCG) vaccination should be screened using the QuantiFERON-TB-Gold (QFT) test - Only for participants currently receiving proton-pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs): Treatment must be at a stable dose during the 2-week screening period prior to randomization and with a plan to remain at a stable dose for the duration of the study - For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 4 weeks after the last dose of study drug. Women must refrain from donating eggs during this same period. Exclusion Criteria: - Treatment with omalizumab or other monoclonal antibody therapies used to treat CSU within 4 months prior to screening or primary nonresponse to omalizumab - Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to study drug administration on Day 1 (or within 5 half-lives of the investigational product, whichever is greater) - Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior to study drug administration on Day 1 - Previous treatment with GDC-0853 or other Brutons tyrosine kinase (BTK) inhibitors - Participants whose urticaria is solely due to physical urticaria - Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, or leukemia - Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or other skin disease associated with itch such as psoriasis - Routine doses of the following medications within 30 days prior to screening: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide - Prior utilization of intravenous (IV) steroids for treatment of laryngeal angioedema - Intravenous immunoglobulin G (IV IG) or plasmapheresis within 30 days prior to screening - History of anaphylactic shock without clearly identifiable avoidable antigen - Hypersensitivity to GDC-0853 or any component of the formulation - Major surgery within 8 weeks prior to screening or surgery planned prior to end of study (12 weeks after randomization) - Require any prohibited concomitant medications - History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during study drug treatment - Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal (GI) disease that, in the investigators opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participant participation - Current treatment with astemizole, terfenadine, and/or ebastine - Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids ; PRIMARY OUTCOME: Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Day 57; SECONDARY OUTCOME 1: Percentage of Participants Who Are Well-Controlled (UAS7 ≤ 6)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OReO; BRIEF: The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer) ; DRUG USED: Lynparza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria - Provision of informed consent prior to any study specific procedures - Female patients ≥18 years of age, with histologically diagnosed relapsed non-mucinous epithelial ovarian cancer (EOC) (including primary peritoneal and/or fallopian tube cancer) (Non-mucinous EOC includes patients with serous, endometrioid, and transitional cell tumours, and those with mixed histology where one of these subtypes is predominant (>50%). Inclusion of other subtypes should first be discussed with the Medical Monitor). - Documented BRCA1/2 status. - Patients must have received one prior PARPi therapy PARPi therapy includes any agent (including Olaparib) used in a maintenance setting For the BRCA1/2 (+ve) cohort, the duration of first PARPi exposure must have been ≥18 months following a first line of chemotherapy or ≥12 months following a second or subsequent line of chemotherapy For the BRCA1/2 (-ve) cohort, the duration of first PARPi exposure must have been ≥12 months following a first line of chemotherapy or ≥6 months following a second or subsequent line of chemotherapy For the last chemotherapy course immediately prior to randomisation on the study Patients must have received a platinum-based chemotherapy regimen (carboplatin, cisplatin or oxaliplatin) and have received at least 4 cycles of treatment Patients must be, in the opinion of the investigator, in response (partial or complete radiological response) or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy) and no evidence of a rising CA-125, as defined below, following completion of this chemotherapy course Pre-treatment CA-125 measurements must meet criterion specified below - If the first value is within upper limit of normal (ULN) the patient is eligible to be randomised and a second sample is not required - If the first value is greater than ULN a second assessment must be performed at least 7 days after the first. If the second assessment is ≥ 15% more than the first the patient is not eligible. Patients must not have received bevacizumab during this course of treatment. Bevacizumab use as part of an earlier line of chemotherapy is permitted Patients must not have received any investigational agent during this course of treatment Patients must be randomised within 8 weeks of their last dose of chemotherapy (last dose is the day of the last infusion) - Patients must have normal organ and bone marrow function measured within 28 days of randomization. - Eastern Cooperative Oncology Group performance status 0-1 - Patients must have a life expectancy ≥16 weeks. - Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1 - At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment. or No measurable disease following a complete response to most recent chemotherapy (+/- surgery) - A formalin fixed, paraffin embedded (FFPE) tumour sample from the cancer of sufficient quantity and quality (as specified in the Covance Central Laboratory Services Manual) must be available for future central testing of tumour genetic status. - For inclusion in the optional biomarker research, patients must sign an informed consent for biomarker research. Exclusion criteria: - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). - Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation. - Other malignancy within the last 5 years except the ones detailed in the exclusion criteria section of study protocol. - Resting electrocardiogram (ECG) with corrected QT interval (QTc) >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome6. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative radiotherapy) within 3 weeks prior to study treatment. - Concomitant use of known strong cytochrome P450 (CYP) subfamily 3A (CYP3A) inhibitors or moderate CYP3A inhibitors. - Concomitant use of known strong or moderate CYP3A inducers. - Persistent toxicities (Common Terminology Criteria for Adverse Event [CTCAE] grade 2 or higher) caused by previous cancer therapy, excluding alopecia and stable Grade 2 peripheral neuropathy . - Patients with current or previous myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML. - Patients with symptomatic uncontrolled brain metastases. - Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). - Patients with a known hypersensitivity to Olaparib or any of the excipients of the product. - Patients with a known active hepatitis (i.e..Hepatitis B or C). - Patient who have received a whole blood transfusion within 30 days prior to screening tests (packed red blood cells and platelet transfusions are acceptable). ; PRIMARY OUTCOME: Efficacy: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Efficacy: Overall Survival (OS)[/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 - GV29893; BRIEF: This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A. ; DRUG USED: RG7745; DRUG CLASS: Biologic; INDICATION: Influenza (excluding vaccines); TARGET: Influenza hemagglutinin (HA), Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Otherwise healthy participants - Positive test for influenza A infection - No more than 72 hours elapsed between onset of influenza-like illness and start of study drug - Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe respiratory symptom such as cough, sore throat, or rhinorrhea - For women of childbearing potential: negative pregnancy test and agreement to use acceptable contraceptive methods for at least 120 days after study drug administration - For men: agreement to use acceptable contraceptive methods for at least 30 days after study drug administration Exclusion Criteria: - Creatinine clearance less than or equal to (</=) 80 milliliters per minute (mL/min) - Any significant medical conditions or laboratory abnormalities - Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection - Use of antiviral therapy in the period from onset of influenza-like illness and prior to enrollment - Pregnancy at Screening or is currently pregnant or breastfeeding - Investigational therapy within 30 days or 5 half-lives prior to start of study drug, whichever is greater - Prior anti-influenza monoclonal antibody use - Receipt of a nasal influenza A vaccine within 14 days prior to Screening - Positive test for influenza B or influenza A+B within 2 weeks prior to study drug - History of significant tobacco use or drug/alcohol abuse - Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening - Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive medications - History of any chronic respiratory condition - Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count </= 200 cells per milliliter (cells/mL) in the past 12 months - Serious infection requiring oral or IV antibiotics within 14 days prior to Screening ; PRIMARY OUTCOME: Percentage of Participants With Adverse Events (AEs); SECONDARY OUTCOME 1: Percentage of Participants Requiring Hospitalization for Influenza-Related Complications[/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 - NIMBUS (MM-003); BRIEF: The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma. ; DRUG USED: Pomalyst; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Must be ≥ 18 years of age - Subjects must have documented diagnosis of multiple myeloma and have measurable disease - Subjects must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma therapy - Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy - All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib - All subjects must have failed treatment with both lenalidomide and bortezomib in one of the following ways: 1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or bortezomib, or 2) In case of prior response [≥ partial response (PR)] to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or 3) Subjects who have not had a ≥ minimal response (MR) and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide- and/or bortezomib-containing regimen - Patients must have received adequate prior alkylator therapy - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 - Females of childbearing potential (FCBP) must not become pregnant for 28 days prior to initiation of study drug, during the study, and for 28 days after discontinuation - Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation - Males must agree to use a latex condom during any sexual during the study and for 28 days following discontinuation from this study - Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study Exclusion Criteria: - Any of the following laboratory abnormalities: - Absolute neutrophil count (ANC) < 1,000/μL - Platelet count < 75,000/ μL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells - Creatinine clearance < 45 mL/min - Corrected serum calcium > 14 mg/dL - Hemoglobin ≤ 8 g/dL - Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) or transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN) - Serum total bilirubin > 2.0 mg/dL - Previous therapy with pomalidomide - Hypersensitivity to thalidomide, lenalidomide, or dexamethasone - Resistance to high-dose dexamethasone used in the last line of therapy - Peripheral neuropathy ≥ Grade 2 - Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant - Subjects who are planning for or who are eligible for stem cell transplant - Subjects with any one of the following: 1) Congestive heart failure, 2) Myocardial infarction within 12 months prior to starting study treatment, 3) Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris - Subjects who received any of the following within the last 14 days of initiation of study treatment: 1) Plasmapheresis, 2) Major surgery, 3) Radiation therapy, 4) Use of any anti-myeloma drug therapy - Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment - Subjects with conditions requiring chronic steroid or immunosuppressive treatment - Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study - Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide - Subjects unable or unwilling to undergo antithrombotic prophylactic treatment - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form - Pregnant or breastfeeding females - Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B, or C ; PRIMARY OUTCOME: Progression-free Survival (PFS) - Primary Analysis; SECONDARY OUTCOME 1: Number of Participants With Adverse Events (AEs)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 1311.6 (w/Anti-TNF Therapy); BRIEF: This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohns disease. ; DRUG USED: Skyrizi; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion criteria: 1. Men or women 18-75 years at the time of consent. 2. Diagnosis of Crohns disease (CD) at least 3 months prior to screening. 3. Moderate to severe active CD, defined as Crohns Disease Activity Index (CDAI) ≥ 220 and ≤ 450. 4. Presence of mucosal ulcers in at least one segment of the ileum or colon and a Crohns Disease Endoscopic Index of Severity (CDEIS) score ≥ 7 (for patients with isolated ileitis, ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer before randomization 5. Patients who are naive or experienced to 1 or more TNF antagonists (infliximab, adalimumab, or certolizumab pegol) at a dose approved for CD. TNF antagonist experienced patients may have stopped anti-TNF treatment due to primary or secondary non-responsiveness, intolerance or for other reasons. 6. Female patients: Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause), that, if sexually active agree to use one of the appropriate medically accepted methods of birth control in addition to the consistent and correct use of a condom from date of screening until 15 weeks after last administration of study medication. Medically accepted methods of contraception are: ethinyl estradiol containing contraceptives, diaphragm with spermicide substance, and intra-uterine-device, or 1. Surgically sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy, or 2. Postmenopausal women with postmenopausal is defined as permanent cessation = 1 year of previously occurring menses, and 3. Negative serum ß-Human Chorionic Gonadotrophin (ß-HCG) test at screening and urine pregnancy test prior to randomization. Male patients: 1. Who are documented to be sterile, or 2. Who consistently and correctly use effective method of contraception (i.e. condoms) during the study and 15 weeks after last administration of study medication. 7. Have the capacity to understand and sign an informed consent form. 8. Be able to adhere to the study visit schedule and other protocol requirements. Exclusion criteria: 1. Have complications of CD such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 655066. 2. Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to randomization and are not anticipated to require surgery. Patients with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present. 3. Have had any kind of bowel resection or diversion within 6 months or any other intra-abdominal surgery within 3 months prior to screening. Patients with a current ileostomy or colostomy are excluded. 4. Have received treatment with: - Total parenteral nutrition (TPN) within 2 weeks of screening. - Any dose of ustekinumab (Stelara®). - Anti-TNF therapy ≤ 8 weeks prior to the first administration of study medication or any other biologic ≤ 8 weeks prior to the first administration of study drug or within 5 times the half-life of the biologic prior to the first administration of study agent, whichever is longer. - Natalizumab, efalizumab, or agents that deplete B or T cells (e.g., rituximab, alemtuzumab, or visilizumab) within 6 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population. - Any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer. - Regular daily use of opioids for medical reasons within previous 3 months prior to the first administration of study agent. - Rectal 5-aminosalicylic acid (5-ASA) compounds, parenteral or rectal corticosteroids must have been discontinued at least 4 weeks prior to visit 2. - Cannot adhere to the concomitant medication requirements specified in section 4.2.2. 5. Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study, or within 15 weeks after receiving the last dose of study medication. 6. Have used apheresis (e.g., Adacolumn apheresis) ≤ 2 weeks prior to screening. 7. Have received any live bacterial or viral vaccination ≤ 12 weeks prior to Day 1. Patients must agree not to receive a live virus or bacterial vaccination during the study or up to 12 months after the last administration of study drug. 8. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening. Patient must agree not to receive a BCG vaccination during the study or up to 12 months after the last study drug administration. 9. Have signs or symptoms of infection, history of chronic or recurrent infection, have evidence of active herpes zoster infection ≤ 8 weeks of screening, have a stool culture or other examination positive for an enteric pathogen, have a history of latent or active granulomatous infection, infected with human immunodeficiency virus (HIV), hepatitis B (HepB) or hepatitis C (HepC) virus, established nonserious infections 10. Are not eligible according to tuberculosis (TB) screening criteria 11. Have severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral or psychiatric disease or signs and symptoms. 12. Have a transplanted organ 13. Have known history of lymphoproliferative disease 14. Have any malignancy or history of malignancy 15. Have previously undergone allergy immunotherapy 16. Are unable or unwilling to undergo multiple venipunctures 17. Are known to have substance abuse 18. Are currently or intending to participate in any other study 19. Have screening laboratory test results within the protocol stated parameters 20. Have a known hypersensitivity to study drug 21. Have evidence of current or previous clinically significant disease, medical condition other than CD, finding of the medical examination or lab value. ; PRIMARY OUTCOME: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission at Week 12; SECONDARY OUTCOME 1: Percentage of Participants Achieving CDAI Clinical Response at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - I8H-MC-BDCP; BRIEF: The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes. ; DRUG USED: LY3209590; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year - Participants must have been using multiple daily injections without interruption for at least 3 months - Participants must have HbA1c values of 5.6% to 9.5%, inclusive - Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²) Exclusion Criteria: - Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening - Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening - Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke) - Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease - Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m² - Have active or untreated cancer - Are receiving chronic (>14 days) systemic glucocorticoid therapy ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c); SECONDARY OUTCOME 1: Change From Baseline in Fasting Serum Glucose[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - ANX005-GBS-03; BRIEF: This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS. ; 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 ≤14 days prior to infusion - GBS-DS score of 3, 4, or 5 Exclusion Criteria: - Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data - Be at risk of suicide or self-harm - Received previous treatment with plasma exchange for GBS - Any diagnosis of a variant of GBS - Have a history of anaphylaxis or severe systemic response to immunoglobulin - Documented, clinically significant, pre-existing polyneuropathy from another cause - Clinically significant intercurrent illness, medical condition, or medical history - History of chronic use of steroid or immunosuppressant medication - Active alcohol, drug, or substance abuse - Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study ; PRIMARY OUTCOME: Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AEs; SECONDARY OUTCOME 1: Pharmacokinetics of ANX005 when administered in combination with IVIg[/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 - PLX 1204-01; BRIEF: The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Placebo 4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment. The study will be comprised of 5 stages: Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection ; DRUG USED: PLX Cells; DRUG CLASS: Biologic; INDICATION: Peripheral Arterial Disease (PAD); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Pluristem Ltd.; CRITERIA: Inclusion Criteria: - Adult male or female subjects between 45 to 85 years of age (inclusive) at the time of screening visit. - Subjects with a diagnosis of peripheral artery disease, secondary to atherosclerosis, confirmed by one of the following criteria assessed at the screening visit: - Resting ankle-brachial index (ABI) ≤ 0.80 or - Resting ABI ≤ 0.90 and >20% decrease in ABI from rest to exercise when measured within 1 minute after treadmill exercise or - Toe-brachial index (TBI) ≤ 0.60 - Lifestyle-limiting, moderate to severe claudication (symptoms present and stable for > 6 months and not significantly changed within the past 3 months prior to screening). - Evidence of significant (>50%) stenosis infra-inguinal occlusive disease as confirmed by documented results from Duplex, MRA, CTA and/or contrast angiogram completed within 3 months prior to screening. - The longest maximal walking distance (MWD) from the Screening Period exercise treadmill tests (ETT), utilizing a modified Gardner Protocol (Appendix I), must be between 1 and 10 minutes (inclusive). - Subjects who have persistent claudication symptoms despite having been recommended an exercise program if feasible, and or despite having been on a stable dose of Cilostazol, if indicated. Subjects should be Cilostazol free for at least 2 weeks prior to the first ETT. - Subjects should be receiving standard of care drugs for vascular disease including anti-platelet agent(s) and statin medication, as well as anti-hypertensive medication(s) and oral hypoglycemic agents/insulin, if indicated. - Signed written informed consent. Exclusion Criteria: - Ischemic rest pain; ulceration or gangrene (Fontaine class III-IV; Rutherford category 4-6). - Failed lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within the prior one month of screening. - Planned revascularization (surgical or endovascular intervention) within 12 months after screening. - Lower extremity arteries inflow obstruction (defined as a greater than 50% stenosis of aorta, iliac and/or common femoral arteries). - History of Buergers disease. - Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 180 mmHg during screening). - Uncontrolled diabetes defined as glucose control HbA1c > 9% at screening. - Life-threatening ventricular arrhythmia - except in subjects with an implantable cardiac-defibrillator. - Serum Creatinine level>2.5mg/dl. - SGPT (ALT), SGOT (AST) >2.5 x upper limit of normal range. - Hemoglobin < 10 g/dl. - Unstable cardiovascular disease defined as myocardial infarction (STEMI or NSTEMI) within 3 months prior to screening, or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged episodes. - Transient Ischemic Attack (TIA)/Stroke within 3 months prior to screening. - Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage III to IV). - Subjects with Implant of mechanical prosthetic heart valve(s). - Pulmonary disease requiring supplemental oxygen treatment on a daily basis. - Severe, active infection of the involved extremity(ies), including osteomyelitis, fasciitis, or severe/purulent cellulitis. - History of malignancy within 5 years prior screening requiring chemotherapy and/or radiotherapy and/or immunotherapy, excluding basal or squamous cell carcinoma of the skin. - Exercise is limited by any condition other than IC, including but not limited to congestive heart failure, chronic pulmonary disease, angina pectoris, or degenerative joint disease. - Uninterrupted use of warfarin or non-steroidal anti-inflammatory agents (with the exception of ibuprofen at doses up to 1,200 mg/day or Diclofenac at dose of 75mg/day). - Subjects who are on oral anticoagulant therapy (warfarin, dabigatran, apixaban, endoxaban and rivaroxaban). Unless, upon primary care physician and/or Investigators discretion the subjects who are on warfarin treatment can switch to Low Molecular Weight Heparin treatment (such as: Clexane) 5-7 days prior study treatment administration and return to warfarin treatment 24 hours post study treatment administration. - Subjects who are taking immunosuppressive treatment (including high dose steroids). - Known allergies to protein products (Bovine serum, or recombinant trypsin) used in the cell production process. - Known sensitivity to Gentamycin. - Known sensitivity to antihistamine drugs. - History of hospitalization due to allergic/hypersensitivity reaction to any substance (e.g. Food or drug). - Medical history of Human Immunodeficiency Virus (HIV) or syphilis positivity at time of screening. - Known active Hepatitis B, or Hepatitis C infection at the time of screening. - Pregnant or breast-feeding women or women of childbearing age not protected by an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide). - In the opinion of the Investigator, the subject is unsuitable for participating in the study. - Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s). - Subjects that have prior exposure to gene or cell based therapy. - Subjects who are legally detained in an official institute. ; PRIMARY OUTCOME: Log ratio of week 52 maximal walking distance(MWD)to baseline MWD; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IG1102; BRIEF: This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel. ; DRUG USED: Fibrin Sealant; DRUG CLASS: Biologic; INDICATION: Hemostasis; TARGET: Fibrinogen (Coagulation Factor I), Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Instituto Grifols, S.A.; CRITERIA: Inclusion Criteria: - Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure). - Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume). - A target bleeding site can be identified. - Target bleeding site is identified on the cut raw liver surface (resection area). - Target bleeding site has moderate bleeding according to the Investigators judgment. Exclusion Criteria: - Require hepatic resection due to trauma. - Infection in the anatomic surgical area. - History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product. - Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component. - Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure). - Receiving an organ transplant during the same surgical procedure. - Undergone a therapeutic surgical procedure within 30 days from the screening visit. - A target bleeding site cannot be identified. - The target bleeding site has a mild or severe bleeding. - Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure. - Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment. ; PRIMARY OUTCOME: Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start; SECONDARY OUTCOME 1: Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start[/INST]Yes</s>