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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - M14-430 (Ext.); BRIEF: A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohns Disease. ; DRUG USED: Rinvoq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Crohns Disease; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: For Substudy 1: - Participant who achieve clinical response in Study M14-431 or Study M14-433. - Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic. For Substudy 2: - Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic. - Participant who achieved clincal response at the time descibed in the protocol and completes study procedures in the parent study/ substudy. For Substudy 3: - Participant is an ongoing participant in Substudy 2 for at least 12 months. - Participant is in stable remission for at least 6 months defined as: 1. CDAI < 150 2. CRP < 5 mg/L and FCP < 250 mg/kg AND 3. Participant has not been on locally acting (rectal or suppository) or systemic corticosteroids for CD => 90 days prior to the entry of Substudy 3. Exclusion Criteria: For Substudies 1,2 and 3: - Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. - Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigators judgment makes the participant unsuitable for this study. - Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigators assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigators assessment. - Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 or 2 of Study M14-430 (Week 52). For Substudy 3 only: - Total SES-CD >4 and/or subscore >1 in any segment in the Substudy 2 annual ileo-colonoscopy, if performed within 6 months prior to Week 0 of Substudy 3. - Received any new medication or increase of the dose of current concomitant medication for the treatment of CD in the past 3 months. ; PRIMARY OUTCOME: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohns Disease Activity Index (CDAI); SECONDARY OUTCOME 1: Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)[/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 - CLEAN-PCD; BRIEF: To evaluate the safety and efficacy of treatment with VX-371 with and without ivacaftor, and the effect of VX-371 with and without ivacaftor on quality of life (QOL) in subjects with primary ciliary dyskinesia (PCD). ; DRUG USED: VX-371; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bronchiectasis; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Parion Sciences; CRITERIA: Inclusion Criteria: - The subject must have evidence supportive of a PCD diagnosis. - Subjects with percent predicted FEV1 of ≥40 to <90 percentage points - Non-smoker for at least 90 days prior to the Screening Visit and less than a 5 pack-year lifetime history of smoking - Stable regimen of medications and chest physiotherapy for the 28 days prior to Day 1 - If currently using daily inhaled HS, must be able to discontinue its use for the duration of the study. - If taking daily chronic or chronic cycling antibiotics, has been on a consistent regimen for at least 4 months prior to the Screening Visit. - Clinically stable (as deemed by the investigator) for at least 14 days prior to the Screening Visit - Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening Visit. Subjects of childbearing potential and who are sexually active must meet the contraception requirements. Exclusion Criteria: - Diagnosis of CF based on results of sweat chloride or nasal potential difference (NPD) tests or presence of 2 CF-causing mutations in CFTR gene. - History of any organ transplantation or lung resection or chest wall surgery. - Significant congenital heart defects, other than a laterality defect, at the discretion of the investigator - Diagnosis of Cri du chat syndrome (chromosome 5p deletion syndrome). - Inability to withhold short-acting bronchodilator use for 4 hours prior to clinic visit and long-acting bronchodilator use the night before the first and last clinic visit of each treatment period. - Use of diuretics (including amiloride) or renin-angiotensin antihypertensive drugs - Symptoms of acute upper or lower respiratory tract infection, acute pulmonary exacerbation, or treatment or was treated with systemic antibiotics for ear or sinus disease within 28 days before Day 1 (topical otic antibiotics allowed). - History of significant intolerance to inhaled HS - Pregnant and/or nursing females - Any clinically significant laboratory abnormalities - History of chronic B. cepacia complex or M. abscessus or M. avium - Surgery that required general anesthesia and hospitalization within 3 months of Day 1 Additional Exclusion Criteria for Part B: - In addition to the exclusion criteria above, subjects who participate in Part B and meet any of the following exclusion criteria will not be eligible to continue into Part B - Unable to swallow tablets. - Concomitant use of strong or moderate inhibitors or inducers of cytochrome P450 (CYP) 3A, including consumption of certain herbal medications (e.g., St. Johns Wort), and grapefruit/grapefruit juice. - Known hypersensitivity to ivacaftor. ; PRIMARY OUTCOME: Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs; SECONDARY OUTCOME 1: Part A: Change From Study Baseline in Quality of Life-Primary Ciliary Dyskinesia (QOL-PCD) (Adult Version) Lower Respiratory Symptoms Domain Score at Day 29[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ia - Study 001; BRIEF: The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in healthy volunteers. Additional endpoints include characterization of the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in healthy volunteers. ; DRUG USED: Lpathomab; DRUG CLASS: Biologic; INDICATION: Neuropathic Pain; TARGET: Lysophosphatidic acid receptor 1 (LPAR1); THERAPY: Monotherapy; LEAD SPONSOR: Lpath, Inc.; CRITERIA: Key Inclusion Criteria: - Healthy male or female subject ≥ 18 years old between 50 and 145 kg - Laboratory values and ECG during Screening period within normal range or evaluated as not clinically significant (NCS) - Female subjects must be not of child-bearing potential or using double-barrier method of contraception - Male subjects must use double-barrier contraception during the study period - Subject is able to read, understand, and sign the informed consent form (ICF) and HIPAA release Key Exclusion Criteria: - Subjects with diabetes mellitus (glycated hemoglobin [HbA1c]≥6.5%) or pre-diabetes mellitus (HbA1c between 5.7 and 6.4%). - Male subjects with corrected Q-T interval (QTc)> 450 msec or a QRS interval>120 msec and female subjects with QTc> 470 or a QRS interval>120 msec. - Subjects blood pressure (BP) during screening period exceeds 140/90 mm Hg - Subject is positive for HIV, hep B and/or hep C at screening - Subject has significant psychiatric co-morbidity including but not limited to major depression-severe, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or active suicidal ideation in 6 months prior to screen. - Subject has any significant or advanced systemic illness, unstable or severe medical condition(s) or end stage disease that could put them at risk during the study, interfere with outcome measures, or affect compliance with the protocol procedures and requirements. - Subject has history of cancer stability/remission for less than 5 years, with the exception of non-metastatic basal and/or squamous cell carcinomas of the skin and cervical cancer in situ. ; PRIMARY OUTCOME: Proportion of patients with local or systemic Adverse Events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 01.202 (Ext.); BRIEF: The purpose of this study is to enable continued access to zilucoplan (RA101495) for patients with paroxysmal nocturnal hemoglobinuria (PNH) after they complete a zilucoplan clinical study. ; DRUG USED: Zilucoplan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Ra Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Completion of a qualifying Ra Pharmaceuticals sponsored zilucoplan (RA101495) PNH study - Evidence of ongoing clinical benefit in the opinion of the Investigator Exclusion criteria: - History of meningococcal disease - Current systemic infection or suspicion of active bacterial infection ; PRIMARY OUTCOME: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Number of Participants With Anti-drug Antibodies (ADA)[/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 - CLINGLIO (EU and Israel); BRIEF: The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy. ; DRUG USED: Minerval; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Sphingomyelin Synthase; THERAPY: Combination; LEAD SPONSOR: Laminar Pharmaceuticals; CRITERIA: Inclusion criteria: 1. Written informed consent, signed and dated 2. Subjects who are able to understand and follow instructions during the trial 3. Age ≥18 and ≤75 4. Subjects with newly histologically confirmed intracranial malignant glioma (glioblastoma WHO Grade IV) that is IDH1 wildtype (local assessment) and who are scheduled to receive chemo-radiotherapy with temozolomide 5. Ability to swallow and retain oral medication 6. Centrally obtained MGMT promoter methylation status 7. Subjects who underwent total or partial / incomplete resection and with the appropriate quantity of tumour tissue releasable for eligibility 8. Karnofsky Performance Score (KPS) > 50 % 9. Female subjects with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male subjects admitted in the study must use a reliable method of contraception, for female subjects during the study period up until 32 days after last study treatment and for male subjects up until 92 days after last study administration. Women must be: - Either of NOT childbearing potential: postmenopausal (≥ 60 years of age, or < 60 years of age and amenorrhoea for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with follicle-stimulating hormone (FSH) above 40 U/L and oestradiol below 30 ng/L, or if taking tamoxifen or toremifene, and age < 60 years, then FSH and oestradiol in the postmenopausal range), permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), or otherwise incapable of pregnancy - Or of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; male partner sterilization (the vasectomized partner should be the sole partner for that subject). 10. A man who is sexually active and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom or partner with occlusive cap (diaphragm or cervical/vault caps). 11. Adequate bone marrow function including: Absolute neutrophil count (ANC) ≥1,500/mm^3 or ≥1.5 x 10^9/L; Platelets ≥ 100,000/mm3 or ≥100 x10^9/L; Haemoglobin ≥ 9 g/dL (may have been transfused). 12. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal range (ULN), an aspartate aminotransferase (AST), level ≤ 2.5 × ULN, and an alanine aminotransferase (ALT) level ≤ 2.5 × ULN or, for subjects with documented metastatic disease to the liver, AST and ALT levels ≤ 5 × ULN. Subjects with documented Gilbert disease are allowed if total bilirubin ≤ 3 x ULN 13. Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula Exclusion Criteria: 1. Known hypersensitivity to any component of the investigational product. 2. Any other investigational drug within the preceding 30 days. Prior, concomitant, or planned concomitant treatment with anti-neoplastic aim including (but not limited) to NovoTumor Treatment Fields (Novo TTF), bevacizumab, intratumoural or intracavitary anti-neoplastic therapy (e.g Gliadel wafers), or other experimental therapeutics intended to treat the tumour. 3. Subjects who underwent only biopsy resection 4. Anticancer therapy within 4 weeks of study entry (6 weeks for mitomycin and nitrosoureas) 5. Other major surgery within the preceding 30 days 6. Allergy, hypersensitivity or other intolerability to temozolomide and its excipients, patients with hypersensitivity to dacarbazine and patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 7. Unable to undergo MRI 8. Presenting with diffuse midline gliomas or multifocal GBM (distant from the flare or contralateral) or rapid progression between early post-surgery MRI and pre-radiotherapy MRI 9. Uncontrolled or significant cardiovascular disease 10. A history of uncontrolled hyperlipidaemia and/or the need for concurrent lipid lowering therapy 11. Need for warfarin, phenytoin or sulphonylureas (glibenclamide, glimepiride, glipizide, glyburide or nateglanide) 12. Past medical history of uncontrolled clinically significant active or chronic gastrointestinal disorders (for example, Crohns disease, celiac disease, untreated stomach ulcers, etc) and gastro-inflammatory pathologies 13. Uncontrolled diabetes mellitus, with glycated haemoglobin (HbA1c) levels at the screening visit of ≥7.5% 14. Cardiac disease, defined specifically as either 1. Mean resting corrected QT interval (QTc) > 470 msec (for women) and > 450 ms (for men) obtained from 3 consecutive ECGs 2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (example, complete left bundle branch block, third degree heart block) 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age 15. Previous malignancies within the last three years other than ndGBM, except successfully treated squamous cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix. ; PRIMARY OUTCOME: To evaluate the efficacy of LAM561 in combination with the standard of care (SoC) treatment of radiotherapy (RT) and TMZ.; SECONDARY OUTCOME 1: To evaluate measures of clinical response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GEMINI; BRIEF: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD). ; DRUG USED: AXS-05; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine Reuptake, Nicotinic Acetylcholine Receptors (nAChR) , NMDA Glutamate Receptor, Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Receptors - Unspecified, Sigma-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Axsome Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Age 18 - 65 - Currently meets DSM-5 criteria for MDD - Body Mass Index between 18 and 40 kg/m^2, inclusive Key Exclusion Criteria: - Suicide risk - History of treatment resistance in current depressive episode - History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study ; PRIMARY OUTCOME: Change in MADRS Total Score From Baseline to Week 6; 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 - enliGHten; BRIEF: A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia. ; DRUG USED: Skytrofa; DRUG CLASS: Biologic; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth hormone receptor (GHR); THERAPY: Monotherapy; LEAD SPONSOR: Ascendis Pharma A/S; CRITERIA: Inclusion Criteria: 1. Children who have completed a prior phase 3 TransCon hGH trial 2. Children who have not permanently discontinued study drug in the prior trial 3. Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC Exclusion Criteria: 1. Poorly-controlled diabetes mellitus (HbA1c ≥ 8.0%) or diabetic complications 2. Evidence of closed epiphyses, defined as bone age > 14.0 years for females or > 16.0 years for males 3. Major medical conditions unless approved by Medical Expert 4. Known hypersensitivity to the components of the trial medication 5. Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver) 6. Pregnancy 7. Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability]; SECONDARY OUTCOME 1: Annualized height velocity (HV) with long-term dosing of weekly TransCon hGH treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase 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 II - Japan; BRIEF: The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), FMS-like tyrosine kinase 3 (FLT-3) , Hepatocyte growth factor receptor (c-Met, HGFR), KIT/c-KIT, RET, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Male or female Japanese participants 20 years of age or older on the day of consent. - Documented histological or cytological diagnosis of renal cell carcinoma (RCC) with a clear-cell component. - Measurable disease per RECIST 1.1 as determined by the investigator. - Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib). - For the most recently received VEGFR-targeting TKI the following criteria must apply: - Must have radiographically progressed during treatment, or been treated for at least 4 weeks and radiographically progressed within 6 months after the last dose. Radiographic progression is defined as unequivocal progression of existing tumor lesions or developing new tumor lesions as assessed by the investigator on computerized tomography (CT) or magnetic resonance imaging (MRI) scans. - The last dose must have been within 6 months before the first day of study drug administration (Week 1 Day 1). - Recovery to baseline or ≤Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. - Karnofsky Performance Status (KPS) score of ≥70%. - Adequate organ and marrow function at Screening. Exclusion Criteria: - Prior treatment with everolimus, or any other specific or selective target of rapamycin complex 1/phosphoinositide 3-kinase/AKT inhibitor (eg, temsirolimus), or cabozantinib. - Receipt of any type of small-molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before Week 1 Day 1. - Receipt of any type of anticancer antibody (including investigational antibody) within 28 days before Week 1 Day 1. - Radiation therapy for bone metastasis within 14 days, and/or any other external radiation therapy within 28 days before Week 1 Day 1. Systemic treatment with radionuclides within 42 days before Week 1 Day 1. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible. ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Clinical Benefit Rate (CBR)[/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 - Two-Stage; BRIEF: This study seeks to use Cabozantinib to treat those with Metastatic Colorectal Cancer who have not previously responded to treatment. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), FMS-like tyrosine kinase 3 (FLT-3) , Hepatocyte growth factor receptor (c-Met, HGFR), KIT/c-KIT, RET, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Academic Thoracic Oncology Medical Investigators Consortium; CRITERIA: Inclusion Criteria: 1. The subject has a histologic or cytologic diagnosis of colorectal adenocarcinoma that is metastatic or unresectable and is refractory to or progressed (or relapsed) following a fluoropyrimidine, irinotecan, oxaliplatin, and bevacizumab; prior epidermal growth factor inhibitor therapy is required for patients with left-sided, RAS wild-type tumors; prior FDA-approved PD-1 inhibitor therapy is required for patients with MSI-H colorectal cancer. Prior regorafenib or TAS-102 treatment is not required. 2. Measurable disease per RECIST 1.1 as determined by the investigator. 3. The subject has had an assessment of all known disease sites e.g., by computerized tomography (CT) scan and/or magnetic resonance imaging (MRI) within 28 days before the first dose of cabozantinib. 4. The subject is ≥ 18 years old on the day of consent. 5. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Recovery to baseline or ≤ Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. 7. Adequate archival frozen or fixed tissue available from primary or metastatic site for genotypic analysis (at least 15 unstained slides and/or tumor block). 8. The subject has organ and marrow function and laboratory values as follows within 7 days before the first dose of cabozantinib: 1. ANC ≥ 1500/mm3 without colony stimulating factor support; 2. Platelets ≥ 100,000/mm3; 3. Hemoglobin ≥ 9 g/dL; 4. Bilirubin ≤ 1.5 x ULN. For subjects with known Gilberts disease, bilirubin ≤ 3.0 mg/dL; 5. Serum albumin ≥ 2.8 g/dl; 6. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used: - Male: CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72); - Female: Multiply above result by 0.85; 7. ALT and AST ≤ 3.0 x ULN; 8. Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis; 9. UPCR ≤ 1; 10. Serum phosphorus, calcium, magnesium and potassium ≥ LLN. 9. The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document. 10. Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control or practice abstinence during the study and for 4 months after the last dose of study drug(s). Exclusion Criteria: 1. The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment; 2. Prior treatment with cabozantinib; 3. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible; 4. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment. Note: Subjects with prostate cancer currently receiving LHRH or GnRH agonists may be maintained on these agents; 5. The subject has received any other type of investigational agent within 28 days before the first dose of study treatment; 6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment; 7. The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 7 days before the first dose of study treatment; 8. Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel); Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 12 weeks before randomization, and who have had no complications from a thromboembolic event or the anticoagulation regimen. ; 9. The subject has experienced any of the following: 1. clinically-significant GI bleeding within 6 months before the first dose of study treatment; 2. hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment; 3. any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment. 10. The subject has radiographic evidence of cavitating pulmonary lesion(s); 11. The subject has tumor invading or encasing any major blood vessels; 12. The subject has evidence of clinically significant bleeding from tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib; 13. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: a. Cardiovascular disorders including: i. Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening; ii. Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment; iii. Any history of congenital long QT syndrome; iv. Any of the following within 6 months before the first dose of study treatment: - unstable angina pectoris; - clinically-significant cardiac arrhythmias; - stroke (including transient ischemic attack (TIA), or other ischemic event); - myocardial infarction; - thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (eg, vena cava filter) are not eligible for this study). b. GI disorders particularly those associated with a high risk of perforation or fistula formation including: i. Active peptic ulcer disease, inflammatory bowel disease (eg, Crohns disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction ii. Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before randomization, Note: Complete healing of an intra-abdominal abscess must be confirmed prior to randomization c. Other clinically significant disorders that would preclude safe study participation; 14. Major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible; 15. QTcF > 500 msec within 1 month before the first dose of study treatment: a. Three ECGs must be performed for eligibility determination. If the average of these three consecutive results for QTcF is ≤ 500 msec, the subject meets eligibility in this regard. 16. Pregnant or lactating females; 17. Inability to swallow intact tablets; 18. Previously identified allergy or hypersensitivity to components of the study treatment formulations; 19. Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy; ; PRIMARY OUTCOME: 12-Week Progression Free Survival; SECONDARY OUTCOME 1: 12-Week Progression-Free Survival by RAS Mutation Status[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Dose Escalating; BRIEF: A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age). Study Objectives: Primary: - To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations. Secondary: - To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations - To confirm the dose sparing and value added effects of the aluminum phosphate adjuvant ; DRUG USED: ResVax; DRUG CLASS: Vaccine; INDICATION: Respiratory Syncytial Virus (RSV) Prevention; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Combination; LEAD SPONSOR: Novavax; CRITERIA: Inclusion Criteria: - Male or female aged 18 to 49 years inclusive - Ability to provide written informed consent to participate - Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline - Females are required to fulfill one of the following criteria: - At least 1 year post-menopausal - Surgically sterile - Willing to use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after each vaccination - Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the Investigator (eg, intrauterine device, female condom, and diaphragm with spermicide, cervical cap, use of condom by the sexual partner, or a sterile sexual partner) for study duration and until 28 days after vaccination - All female subjects must have a negative urine pregnancy test within 48 hours preceding receipt of each vaccination. - Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and be contacted by telephone throughout the follow-up period Exclusion Criteria: - Presence of significant uncontrolled medical or psychiatric illness (acute or chronic). This includes institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day 1 prior to vaccination - Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies - Pregnant or lactating female - Females who plan to become pregnant or plan to discontinue contraceptive precautions within 30 days prior to first vaccination and 28 days after each vaccination - Cancer, or treatment for cancer, within 3 years, excluding basal cell carcinoma or squamous cell carcinoma, which is allowed - Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus - Receipt (or history of receipt), during the preceding 3-month period, of any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids will be allowed. - Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination or during the study. If a nonstudy vaccine has been administered, administration of study vaccine injection can be delayed and given as soon as allowable within the 30-day window, provided the nonstudy vaccine is not administered within 2 weeks prior to study enrollment. Immunization with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) vaccine, on an emergency basis, up to 8 days before or at least 8 days after a dose of study vaccine will be allowed. - History of illicit drug or alcohol abuse within the previous 1 year or positive drug or alcohol screen - History of anaphylactic type reaction to injected vaccines - Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or current enrollment in any investigational drug study or intent to enroll in such a study within the ensuing study period - Receipt or donation of blood or blood products 8 weeks prior to vaccination or planned receipt or donation during the study period - Acute disease, defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever, or an oral temperature of ≥38ºC, within 72 hours prior to vaccination. Study vaccine can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory tract infection with or without low-grade fever. Vaccination can be delayed until the subject has recovered. - Any condition that, in the opinion of the Investigator, would interfere with the primary study objectives ; PRIMARY OUTCOME: To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations.; SECONDARY OUTCOME 1: To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations[/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 - OLIVE; BRIEF: The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids. ; DRUG USED: AZD1981; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Chemoattractant Receptor-Homologous Molecule (CRTH2); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Six months history of asthma - Daily use of inhaled glucocorticosteroids - FEV1 40-85% of predicted normal - Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator Exclusion Criteria: - Other clinically relevant disease or disorders - History of smoking of more than 10 pack years - Respiratory infection within 30 days ; PRIMARY OUTCOME: Morning Peak Expiratory Flow (mPEF); SECONDARY OUTCOME 1: Evening Peak Expiratory Flow (ePEF)[/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 - Onc-002; BRIEF: This Phase 2a study will investigate the efficacy, safety and tolerability of ASONEP™ (sonepcizumab/LT1009) when administered intravenously once a week, every 4 weeks (or cycle), to subjects with refractory renal cell carcinoma (RCC) until the disease progresses. Subjects who have failed 3 prior treatments for RCC including vascular endothelial growth factor (VEGF) and/or mammalian target of rapamycin (mTOR) inhibitors or who have tumors that cannot be surgically removed will be eligible for screening. ; DRUG USED: Asonep; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Lpath, Inc.; CRITERIA: Inclusion Criteria: - Unresectable, locally advanced recurrent or metastatic RCC - Histological or cytological confirmation of clear cell RCC - core tissue biopsy of either primary tumor or metastatic lesion with paraffin-embedded tissue specimens if no prior nephrectomy - Measurable disease by RECIST 1.1 - Had one prior therapy for unresectable RCC with a VEGF/VEGFR targeted therapy (sunitinib, sorafenib, other VEGFR TKI or bevacizumab) - One prior treatment with an mTOR inhibitor (everolimus, temsirolimus or sirolimus) for unresectable disease permitted-Prior immunotherapy (immunomodulators such as cytokines, interleukins, vaccines, etc.) such as IL-2 also permitted - Male or non-pregnant, non-nursing female - Life expectancy ≥3 months - ECOG performance status of 0, 1 or 2 - Must not be receiving any concurrent anticancer therapy - Baseline CT or MRI scans of measurable disease sites by RECIST 1.1 performed within 2 weeks of Day 0 - For subjects with bone metastases, baseline bone scan performed within 4 weeks of study entry - Adequate organ and immune function (within 7 days of Day 0): Hemoglobin >9 g/dL-Absolute neutrophil count >1500 cells/uL without growth factors-Platelet count ≥100x10^9/L without transfusion-Serum creatinine <2.0x ULN or creatinine clearance >40 mL/min-Total bilirubin <1.5x ULN-AST/ALT <2.5x ULN (or <5.0x ULN if liver metastases present)-INR and aPTT <1.5x ULN - Subject lesions for arterial spin labeling (ASL) MRI ≥2.5cm by CT imaging - Must understand, be able and willing to fully comply with study procedures Exclusion Criteria: - Prior treatment with >3 VEGF pathway and/or mTOR inhibitors for RC cancer - History of other CNS disease (spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis) - Major surgery within 4 weeks of Day 0 - Radiation therapy within 4 weeks of baseline/infusion. Prior palliative radiation to metastatic lesions is acceptable if there is at least one measurable, non-radiated lesion - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 0 - Known or suspected intolerance or hypersensitivity to study materials or any excipients - Evidence of bowel obstruction because of theoretical possibility of GI perforation with an anti-angiogenesis agent - Severe hemorrhage within 4 weeks of screening - History of GI perforation - History of non-healing wounds including ulcer or delayed bone fractures - Prolonged QTc interval on baseline ECG (>450 msec for males or >470 msec for females), cardiac dysrhythmias including atrial fibrillation, torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG - Secondary malignancy within the last 5 years, except for adequately-treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer - Previously enrolled in an sonepcizumab study or into this study and subsequently withdrawn - History of alcohol or other substance abuse within the last year - Use of corticosteroids or other immunosuppression (if taking systemic steroids [vs. topical], at least 4 weeks must have passed since the last dose) - Growth factors within 1 week of screening - Serious medical conditions that might be aggravated by treatment or limit compliance - Cerebrovascular accident or transient ischemic attack, or pulmonary embolism within 6 months prior to screening - Participation in another clinical trial - Other severe or intercurrent acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration ; PRIMARY OUTCOME: Progression-Free Survival; SECONDARY OUTCOME 1: Safety and Tolerability - Incidence and frequency of adverse events and serious adverse events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD (Germany); BRIEF: This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single ascending dose sequential group study in healthy male subjects. The objectives are to study the safety, tolerability, pharmacokinetics and effects on glucose homeostasis (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid receptor modulator (SGRM). The study will also assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high doses of AZD9567 and placebo. ; DRUG USED: AZD9567; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures. - Healthy male subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture. - Have a body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. - Normal OGTT at screening (<7.8 mmol/L). - Serum cortisol levels within normal limits at screening (collected as part of the clinical chemistry panel). - Able to understand, read and speak the German language. Exclusion Criteria: - History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subjects ability to participate in the study. - History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. - History of or active or latent tuberculosis (TB), or at risk for having acquired TB (social workers or prison staff in countries with endemic rates of TB, having lived with patients with known TB). - History suggesting abnormal immune function, as judged by the investigator. - Any contraindications to be treated with prednisolone (allergy to any ingredient, systemic fungal infection, certain type of malaria, inflammation of the optic nerve, or herpes infection of the eye, scheduled to have a live or attenuated live vaccination or taking mifepristone). - History of severe affective disorder including depressive or manic-depressive illness them self or first degree relatives. - History of previous steroid psychosis - Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP. - Any latent or chronic infections (e.g., recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection), or history of skin abscesses within 90 days prior to the first administration of IMP. - Any clinically important laboratory abnormalities (clinical chemistry, hematology, coagulation or urinalysis results), as judged by the investigator. In particular a subject with an abnormal value in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), creatinine, thyroid-stimulating hormone (TSH), fasting glucose, International Normalised Ratio (INR), haemoglobin (Hb), white blood cell (WBC), absolute neutrophil or platelet count will be excluded. - Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV). - Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: Systolic BP (SBP) < 90mmHg or ≥ 140 mmHg, Diastolic BP (DBP) < 50mmHg or ≥ 90 mmHg, Pulse < 45 or > 85 beats per minute (bpm). - Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy. - Prolonged QTcF > 450 ms or family history of long QT syndrome. - PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation). - PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block, or AV dissociation ; PRIMARY OUTCOME: Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Secondary Outcome: Relative Change From Baseline of AUC0-4h for Plasma Glucose to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])[/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 - 101; BRIEF: AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the signal transduction pathway of EGFR and inhibit the function of ras/raf/MAPK downstream, thus block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010MA Maleate Capsules has three characters: 1. Irreversible binding to EGFR; 2. Effectively suppresses the tumor cell with EGFR mutant while has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with EGFR T790M drug-resistant mutation. ; DRUG USED: Abivertinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), T790M EGFR, Tyrosine Kinases; THERAPY: Monotherapy; LEAD SPONSOR: ACEA Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Is male or female, aged 18 years or older at the time of consent; preferably non-Asian. 2. Has histologically or cytologically confirmed metastatic, or unresectable locally advanced, recurrent NSCLC. 3. Has at least one measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI), according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. 4. Has documented evidence of an activating EGFR mutation in the tumor tissue determined by either sequencing or PCR-based technique (Part 1). 5. For Part 1 only: subjects with a positive T790M mutation are preferred, but not required. Confirmation of T790M mutation status will be determined from an archived tumor tissue sample or fresh tumor tissue sample obtained via biopsy if archived tissue is not available. In Part 2, subjects must have a confirmed, positive T790M EGFR mutation (acquired T790M EGFR mutation or de novo T790M EGFR mutation). 6. Has a life expectancy of at least 3 months. 7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Has adequate hematological and physiological functions. 9. Has documented disease progression while receiving at least 30 days of treatment with a currently approved EGFR tyrosine kinase inhibitor (TKI) (e.g., erlotinib, gefitinib or afatinib) with intervening treatment after most recent EGFR TKI therapy (not required for de novo T790M EGFR mutation). 10. Signed and dated written informed consent obtained prior to any study-specific evaluation. Exclusion Criteria: 1. Has a history of interstitial lung disease related to prior EGFR inhibitor therapy. 2. Has an EGFR TKI- related toxicity that has NOT resolved to Grade 1 or less. 3. Is test positive for hepatitis C virus (HCV), hepatitis B virus (HBV) or human immunodeficiency virus (HIV) antibody. 4. Has received the prohibited therapy (e.g., concurrent anti-cancer therapy including but not limited to: chemotherapy, radiation, hormonal, or immunotherapy) ≤14 days prior to first planned dose of AC0010MA. 5. Received prior treatment with AZD9291 (osimertinib) or CO1686 (rociletinib) and experienced disease progression. 6. Is a female subject who is pregnant or breastfeeding. 7. Female subjects (if of child bearing potential) and male subjects (with a partner of child bearing potential) must use medically acceptable methods of birth control before study entry, for the duration of the study, and for at least 6 months after the last intake of study drug. 8. Has a serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled psychiatric condition, uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism). 9. Has any other reason(s) for the investigator to consider that the subject should not participate in the study. 10. Is receiving treatment with medication(s) that are known to be strong inhibitors or inducers of CYP3A4/5. ; PRIMARY OUTCOME: Safety and tolerability, and the maximum tolerated dose (MTD) of AC0010MA determined by incidence of dose limiting toxicity (DLT); SECONDARY OUTCOME 1: Evaluation of tumor response and duration of response of AC0010MA ((objective response rate, ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1218.64 (Mod-Severe Renal Impairment); BRIEF: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride). ; DRUG USED: Tradjenta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Type 2 diabetes mellitus 2. GFR<60 ml/min 3. HbA1c >=7.0% to <= 10% 4. Age >= 18 years 5. BMI <=45 kg/m2 6. Signed and dated written informed consent Exclusion criteria: 1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent 2. Renal impairment requiring dialysis 3. Bariatric surgery 4. Impaired hepatic function 5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors 6. Treatment with anti-obesity drugs 7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent ; PRIMARY OUTCOME: HbA1c Change From Baseline to Week 12; SECONDARY OUTCOME 1: HbA1c Change From Baseline Over Time[/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 - V934-002 AM 4; BRIEF: This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors. ; DRUG USED: V934/V935; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Immune System, Telomerase; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria Part A - Participant has one of the selected solid tumors with no distant metastases, and is more than 8 weeks from completion of definitive therapy with intention to cure. Selected Solid Tumors: Stage I to III non-small cell lung carcinoma (NSCLC); Stage III breast cancer; Stage IIB or III melanoma; Stage II or III upper gastrointestinal tract carcinoma (e.g., esophagus, stomach, gallbladder, pancreas); Stage III colon carcinoma; Stage II, III, or IV (M0 only) renal cell carcinoma; Stage II, III, or IV (M0 only) bladder carcinoma; clinically-localized prostate carcinoma - Participant has adequate organ function. - Female participant of childbearing potential has a negative serum pregnancy test within 3 days of study enrollment. Exclusion Criteria Part A - Participant has known hypersensitivity to any component of study vaccine. - Participant has a history of clinically significant cardiac conditions, including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or New York Heart Association (NYHA) Class III or IV congestive heart failure. Participant must have no clinically significant electrocardiogram (ECG) abnormalities and not have a pacemaker or cardioverter/defibrillator implanted. - Participant has undergone splenectomy or has any history of autoimmune disorder. - Participant has received immunosuppressive treatment within 1 month prior to enrollment. - Participant has known acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections. - Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of study entry. - Participant is pregnant or breastfeeding, or expecting to conceive at any time during the study or within 1 year after receiving the last vaccination. - Participant is known to be Human Immunodeficiency Virus (HIV)-seropositive. - Participant has known history of Hepatitis B or C or active Hepatitis A. - Participant has been vaccinated for any disease or for prophylaxis within 1 month prior to the first vaccination. - The participant has been diagnosed with Systemic Lupus Erythematosus (SLE) Inclusion Criteria Part B - Participant must have completed their respective vaccination Treatment Group regimen for Part A of this study. - Participant must have completed a ≥12 week safety observation period prior to receiving their first V934-EP boost. Exclusion Criteria Part B - Participant has new or metastatic tumor lesions since enrollment in Part A. - Participant has developed any significant cardiac conditions since enrollment in Part A including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or NYHA Class III or IV congestive heart failure. - Participant has undergone a splenectomy, or has developed any autoimmune disorders, since enrollment in Part A. - Participant has received immunosuppressive treatment within 1 month prior to enrollment in Part B - Participant has developed any acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections - Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of entry to Part B. ; PRIMARY OUTCOME: Number of Participants With Dose-Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CARDEA; BRIEF: Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2 will consist of a randomized, double blind, placebo-controlled (RCT) study that will evaluate efficacy, safety, and the pharmacokinetic profile of Auxora in patients with severe COVID-19 pneumonia. The number of patients with an imputed PaO2/FiO2 >200 randomized into the study will be capped at 26. 320 patients with a PaO2/FiO2 ≤200 will be enrolled. Patients with an estimated PaO2/FiO2 of 75-200 will be stratified to ensure balanced randomization between the Auxora and placebo arms. Subgroup analyses will be performed to explore how time to recovery is influenced by baseline variables and to evaluate the treatment effect at different levels of each of these variables. The dose of Auxora will be 2.0 mg/kg (1.25 mL/kg) administered at 0 hour, and then 1.6 mg/kg (1 mL/kg) at 24 hours and 1.6 mg/kg (1 mL/kg) at 48 hours from the SFISD. The dose of placebo will be 1.25 mL/kg administered at 0 hour and then 1 mL/kg at 24 hours and 1 mL/kg at 48 hours from the SFISD. Remdesivir, corticosteroids and convalescent plasma will be allowed. The infusion of Auxora will start within 12 hours from the time the patient or LAR provides informed consent. Efficacy analyses will be presented by treatment group (Auxora vs Placebo) based on the Efficacy Analysis Set of the imputed PaO2/FiO2 ≤200 subgroup, except where it is specified otherwise. The statistical analysis approach will be designed to assess the significance of the primary and first secondary endpoint using the Benjamini and Hochberg method to control the overall trial level alpha level. ; DRUG USED: Auxora; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Calcium Channel, IL-2 (Interleukin-2), Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Combination; LEAD SPONSOR: CalciMedica, Inc.; CRITERIA: Inclusion Criteria: 1. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either of the following: - PCR positive in sample collected < 72 hours prior to randomization; - PCR positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing SARS-CoV-2 infection; 2. At least 1 of the following symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. At least 1 of the following signs at Screening or noted in the 24 hours before Screening: - PaO2/FiO2 ≤200 when receiving supplemental oxygen. The PaO2/FiO2 may be estimated from pulse oximetry (Appendix 1) or determined by arterial blood gas; - If SpO2 ≥97%, must be receiving 10L or more of supplemental oxygen; 4. The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest X-ray or computerized tomography scan of the lungs; 5. The patient is ≥ 18 years of age; 6. A female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of CM4620-IE; 7. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of CM4620-IE. A male patient must not donate sperm for 39 months; 8. The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol. Exclusion Criteria: 1. Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days. 2. Do Not Intubate order; 3. Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing; 4. PaO2/FiO2 ≤75 at the time of Screening. The PaO2/FiO2 may be estimated from pulse oximetry (Appendix 1) or determined by arterial blood gas; 5. Noninvasive positive pressure ventilation; 6. Invasive mechanical ventilation via endotracheal intubation or tracheostomy; 7. Extracorporeal membrane oxygenation (ECMO); 8. Shock defined by the use of vasopressors; 9. Multiple organ dysfunction or failure; 10. Positive Influenza A or B testing if tested as local standard of care; 11. The patient has a history of: 1. Organ or hematologic transplant; 2. HIV; 3. Active hepatitis B, or hepatitis C infection; 12. Current treatment with: 1. Chemotherapy; 2. Immunosuppressive medications or immunotherapy (Section 5.3 for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent; 3. Hemodialysis or Peritoneal Dialysis; 13. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 12 weeks prior to screening or have a history of recurrent (> 1) VTE; 14. The patient is known to be pregnant or is nursing; 15. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent; 16. Allergy to eggs or any of the excipients in study drug. ; PRIMARY OUTCOME: Number of days from the Start of the First Infusion of Study Drug (SFISD) to recovery; SECONDARY OUTCOME 1: Proportion of patients who have died at day 60 (mortality)[/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 - 003; BRIEF: The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants. ; DRUG USED: Biosimilar Pegfilgrastim (Fresenius Kabi); DRUG CLASS: Biosimilar; INDICATION: Neutropenia / Leukopenia; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: Fresenius Kabi SwissBioSim GmbH; CRITERIA: Inclusion Criteria: - Participants who provide signed and dated written informed consent. - Participants with laboratory test results within predefined ranges. - Other protocol defined inclusion criteria could apply. Exclusion Criteria: - Participants with known hypersensitivity to any component of US-Neulasta or MSB11455. - Other protocol defined exclusion criteria could apply. ; PRIMARY OUTCOME: To Assess the Immunogenicity of MSB11455 Compared to Neulasta; SECONDARY OUTCOME 1: Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)[/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 - FREEDOM Ext.; BRIEF: The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively. ; DRUG USED: Prolia (Osteoporosis); DRUG CLASS: Biologic; INDICATION: Osteoporosis / Osteopenia; TARGET: RANK Ligand (RANKL); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Postmenopausal women who have attended the 20030216 (NCT00089791) study month 36 visit will be eligible to participate if they meet the inclusion and exclusion criteria given below. Inclusion Criteria - Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60 mg subcutaneous injection every 6 months - Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit - Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24. Exclusion Criteria - Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc. is permitted) - Missed 2 or more investigational product doses during the 20030216 study - Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures - Developed sensitivity to mammalian cell derived drug products during the 20030216 study - Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits) - Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study - Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium, or tibolone - For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs); SECONDARY OUTCOME 1: Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SPI-EOQ-13-305; BRIEF: This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT. In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2. Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio. Arm 1 : One dose of Apaziquone. Arm 2 : Two Doses of Apaziquone. Arm 3 : Placebo. Primary endpoint was to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 milligram (mg) apaziquone relative to placebo instillation following TURBT in a participant with NMIBC who received TURBT. ; DRUG USED: Qapzola; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: 1. Participant must have had a diagnosis with urothelial carcinoma of the bladder with clinically apparent tumor Ta, G1-G2. 2. Participant had ≤4 tumors, none of which exceeded 3.5 cm in diameter. 3. Participant must have been willing to give written informed consent, able to adhere to dosing and visit schedules, and meet all study requirements. 4. Participant was at least 18 years of age at randomization. 5. Participant must have been willing to practice two forms of contraception, one of which must have been a barrier method, from study entry until at least 35 days after the last dose of the study drug. 6. Female participant of childbearing potential must have had a negative pregnancy test within 30 days prior to randomization. Female participant who was postmenopausal for at least 1 year (defined as more than 12 months since last menses) or were surgically sterilized did not require this test. Exclusion Criteria: 1. Participant had an active concurrent malignancy/life-threatening disease. If there was a history of prior malignancies/life-threatening diseases, the participant was to be disease-free for at least 5 years. Participant with other prior malignancies less than 5 years before study entry could have still been enrolled if they had received treatment resulting in complete resolution of the cancer and currently had no clinical, radiologic, or laboratory evidence of active or recurrent disease. 2. Participant had positive urine cytology for malignancy at Screening. 3. Participant had an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive protocol treatment. 4. Participant had used any investigational drugs, biologics, or devices within 30 days prior to study treatment or planned to use any of these during the course of the study. 5. Participant had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone. 6. Participant had or has ever had - Upper tract Transitional Cell Carcinoma (TCC). - Urethral tumor (prostatic urethra included). - Any invasive bladder tumor known to be other than tumor Ta, G1-G2. - Any evidence of lymph node or distant metastasis. - Any bladder tumor with histology other than TCC. - Carcinoma in situ (CIS). 7. Participant had a tumor in a bladder diverticulum. 8. Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy.) 9. Participant had a bleeding disorder or a screening platelet count <100×10^9/L. 10. Participant had screening hemoglobin <10 milligrams per deciliter (mg/dL). 11. Participant had any unstable medical condition that would make it unsafe to undergo TURBT. 12. Participant had a history of interstitial cystitis. 13. Participant had a history of allergy to red color food dye. 14. For a participant with a recurrent tumor, the participant had at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination. 15. Participant was pregnant or breast-feeding. ; PRIMARY OUTCOME: Time to Recurrence; SECONDARY OUTCOME 1: 2-Year Recurrence 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 II - 201; BRIEF: This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye drops for up to 28 days, administered both once and twice daily. In the second portion, up to 180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days. Plasma pharmacokinetics will also be evaluated during the first portion of the study. ; DRUG USED: ATS907; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Altheos, Inc.; CRITERIA: Inclusion Criteria: - 18 years of age or greater - Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes - Unmedicated (post-washout) IOP ≥ 23 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 18 mm Hg at 15:00-17:00 on Day 0 (Stage 1) - Unmedicated (post-washout) IOP criteria after wash out < 32 mm Hg OU at all times points (Stage 1) - Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 21 mm Hg at 9:00-17:00 on Day 0 (Stage 2) - Unmedicated (post-washout) IOP criteria after wash out < 36 mm Hg OU at all times points (Stage 2) - Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200) - Must be willing to discontinue the use of all ocular hypotensive medications in both eyes prior to and during the entire course of the study Exclusion Criteria: - Ophthalmic (in either eye) 1. Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s). Prior laser glaucoma surgery is permitted in the non study eye 2. Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) 3. Cataract surgery and or other intraocular surgery within three months prior to Screening in either eye. 4. History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis. 5. Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented. 6. Contact lens wear during the duration of the study. 7. Clinically significant ocular disease (e.g. diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study. 8. Central corneal thickness < 480 or > 600 μm in the study eye - Systemic 1. Clinically significant abnormalities in laboratory tests at screening. 2. Clinically significant systemic disease (e.g., uncontrolled diabetes, uncontrolled hyper or hypotension, hepatic, renal, endocrine or cardiovascular disorders). Participation in any investigational study within the past 30 days. 3. Changes of systemic medication that could have a substantial effect on IOP and or systemic blood pressure within 7 days prior to Baseline (Day 0). 4. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the Screening visit and a negative urine and serum pregnancy at Baseline (Day 0) and must not intend to become pregnant during the study ; PRIMARY OUTCOME: Mean Change in Intraocular Pressure from Baseline; SECONDARY OUTCOME 1: Observed Intraocular Pressure and % change from Baseline IOP[/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 - IMvigor210 (Cohort 1); BRIEF: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity. ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra) - Representative tumor specimens as specified by the protocol - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy greater than or equal to (>=) 12 weeks - Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end organ function Cohort 1-Specific Inclusion Criteria - No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma - Ineligible for cisplatin-based chemotherapy due to one of the following: Impaired renal function, a hearing loss of 25 decibels (dB) at two contiguous frequencies, Grade 2 or greater peripheral neuropathy, or ECOG performance score of 2 Exclusion Criteria: - Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment - Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments - Leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) - Uncontrolled hypercalcemia (greater than [>] 1.5 millimoles per liter [mmol/L] ionized calcium or Ca > 12 milligrams per deciliter [mg/dL] or corrected serum calcium > upper limits of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab - Malignancies other than urothelial bladder cancer within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome or incidental prostate cancer - Pregnant and lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan - Serum albumin less than (<) 2.5 grams per deciliter (g/dL) - Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis - Severe infections within 4 weeks prior to Cycle 1, Day 1 - Significant cardiovascular disease - Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1 - Prior allogeneic stem cell or solid organ transplant - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies ; PRIMARY OUTCOME: Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1; SECONDARY OUTCOME 1: Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1[/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 - FLUTE; BRIEF: Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE. APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed. ; DRUG USED: APT-1011; DRUG CLASS: Non-NME; INDICATION: Esophagitis; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Adare Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Male or female between ≥18 and ≤75 years of age at the time of informed consent - Signed informed consent - Evidence of EoE defined by ≥15 peak eosinophils per HPF as measured from proximal and distal biopsies - Subject-reported history of ≥3 episodes of dysphagia in the 7 days prior to Screening - 7-day Global EoE Symptom Score >3 at baseline and at screening - Willing and able to adhere to study-related treatment regimens, procedures, and visit schedule Exclusion Criteria: - Have known contraindication, hypersensitivity, or intolerance to corticosteroids; - Have any physical, mental, or social condition or history of illness or laboratory abnormality that in the Investigators judgment might interfere with study procedures or the ability of the subject to adhere to and complete the study; - Presence of oral or esophageal mucosal infection of any type; - Have any mouth or dental condition that prevents normal eating; - Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE; - Use of systemic corticosteroids within 60 days prior to Screening, use of inhaled/swallowed corticosteroids within 30 days prior to Screening, or extended use of high-potency dermal topical corticosteroids within 30 days prior to Screening; - Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF); - Morning serum cortisol level ≤5 μg/dL (138 nmol/L); - Use of biologic immunomodulators in the 24 weeks prior to Screening; - Use of calcineurin inhibitors or purine analogues, or potent cytochrome P450 (CYP) 3A4 inhibitors in the 12 weeks prior to Screening; - Have a contraindication to or factors that substantially increase the risk of EGD or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard 9 mm endoscope; - Have a history of an esophageal stricture requiring dilatation within the previous 12 weeks prior to Screening; - Have initiated, discontinued or changed dosage regimen of PPIs, H2 antagonists, antacids or antihistamines for any condition such as GERD or allergic rhinitis within 4 weeks prior to qualifying endoscopy. These drugs must remain constant throughout the study. - A serum cortisol level <18 μg/dL (497 nmol/L) at 60 minutes with adrenocorticotropic hormone (ACTH) stimulation test using 250 μg cosyntropin (i.e., a positive result on the ACTH stimulation test). ; PRIMARY OUTCOME: Percentage of Subjects With ≤6 Peak Eosinophils/High-power Field (HPF); SECONDARY OUTCOME 1: Percentage of Subjects Who Met the Primary Endpoint at Week 12 and Maintained the Primary Endpoint at Weeks 26 and 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 I - MAD; BRIEF: RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal (Type 1 interferon) that tells the immune system that something is wrong and to kill the cell. RBN-2397 has been shown in animal studies to inhibit tumor growth and also shuts down the dont kill me signal the tumor is sending to evade the immune system. As a PARP7 inhibitor RBN-2397 is different from drugs inhibiting PARP1, PARP2 and PARP3 enzymes which are approved for the treatment of certain ovarian and breast cancers. The primary purpose of this study is to determine the maximum tolerated dose (MTD) of orally administered RBN-2397 in patients with advanced or metastatic solid tumors. This study will also evaluate the safety and tolerability of RBN-2397, examine the pharmacokinetics (PK) (measure how the body absorbs, breaks down and eliminates RBN-2397) and investigate whether it has antitumor activity in solid tumor cancers. ; DRUG USED: RBN-2397; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: Ribon Therapeutics, Inc.; CRITERIA: Inclusion Criteria: Dose Escalation Phase only: Metastatic or advanced-stage solid malignant tumor (which may include solid lymphoma [e.g., mantle cell]) for whom no therapy exists that would be curative or might provide clinical benefit. Dose Expansion Phase Only: Patients with locally advanced or metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have received standard therapy or are intolerant of standard therapy, have progressed following their last prior therapy, and have one of the following tumor types: - SCCL: Histologically confirmed NSCLC of predominantly squamous cell histology and must have received no more than 3 lines of prior systemic therapy including chemotherapy regimens and/or immune checkpoint inhibitor therapy (combination allowed). - HNSCC: Histologically confirmed squamous cell carcinoma of the head and neck (either HPV-positive or -negative) and must have received no more than 3 lines of prior systemic immunotherapy and/or chemotherapeutic treatments in the metastatic setting. Includes primary tumor location of the oral cavity, oropharynx, hypopharynx, larynx, and paranasal sinuses (nasopharyngeal carcinoma, skin squamous cell carcinoma, and salivary gland carcinomas are not eligible). - HR+ breast cancer: Histologically confirmed diagnosis of estrogen receptor (ER) and/or progesterone receptor (PR) positive, HER2-negative adenocarcinoma of breast (as per local laboratory testing) whose disease has failed standard systemic therapy for locally advanced or metastatic disease and must have received no more than 1 prior chemotherapeutic for advanced/metastatic disease. - PARP7 amplified: Tumor with documented PARP7 (or TIPARP) gene copy amplification as determined by a CLIA certified laboratory test (e.g., FoundationOne CDx) that has failed standard systemic therapy for locally advanced or metastatic disease. Must agree to undergo tumor biopsy Normal organ and bone marrow function Patient and his/her partner agree to use adequate contraception during and for 3 months after the last study drug dose Exclusion Criteria: - Unable to swallow oral medications - Major surgery within 4 weeks of starting study - Pregnant or breast-feeding. - Receiving intravenous antibiotics for an active infection - Known human immunodeficiency virus (HIV) or hepatitis B or C infection. - History of a different malignancy unless disease-free for at least 5 years - Some medications are not allowed while on study. Interested participants will need to inform study doctor of all the medications he/she is taking. - Herbal medicines, and grapefruit, grapefruit juice, pomegranate juice, star fruit or orange marmalade (made with Seville oranges) are not allowed to be taken during study. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D); SECONDARY OUTCOME 1: Safety and tolerability[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3940 - BOOST (Africa/Asia/EU); BRIEF: This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes. ; DRUG USED: Ryzodeg 70/30; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject) - Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening - Current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, - Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose - Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days - Insulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days) - HbA1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis - Body mass index (BMI) below or equal to 40.0 kg/m^2 Exclusion Criteria: - Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 12 weeks prior to visit 1 (screening) - Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors - Anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits - Cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty - Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physicians opinion could interfere with the results of the trial - Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period - Known or suspected hypersensitivity to trial products or related products ; PRIMARY OUTCOME: Change From Baseline in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG)[/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 - IN 09 006; BRIEF: This is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo. ; DRUG USED: AP-ZP; DRUG CLASS: Non-NME; INDICATION: Insomnia; TARGET: GABA-A Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Intec Pharma Ltd.; CRITERIA: Inclusion Criteria: - Subjects between the ages of 18 and 65 years of age - Subjects that meet DSM IV diagnostic criteria for Primary Insomnia - Subjects that report a time in bed ≥6.5 and ≤9 hours - Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST ≤6.5 hours - Subjects that report on a one week sleep diary (on at least 3 of 7 nights)Wake time after sleep >1.0 hour - Subjects that report on a one week sleep diary (on at least 3 of 7 nights) ≥30 minutes time to sleep onset - On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes - On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes - On two nights of PSG screening a TST of ≤6.5 hours on each of the two nights - Body mass index of 18 - 34 inclusive - Subjects that report a median habitual bedtime between 9:00pm (21:00 hours) and 12:00am (00:00) on a one week sleep diary (based on 3 or more nights). Exclusion Criteria: - Participation in another drug clinical trial within 1 month prior to first screening diary day (calculated from the previous studys last dosing date). - On screening PSG night 1 an AHI >10 (apnea hypopnea index) - On screening PSG night 1 a PLMAI ≥10 (periodic limb movements with arousal) - Subject has a circadian rhythm disorder including shift work or the need to travel ≥3 time zones during the course of the study - Subject has any other sleep disorder (e.g. Restless Legs Syndrome ) - Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first. - Subject with a history (past year) of alcohol or substance abuse - Subject that needs to smoke during the sleep period time - Subject that reports habitual napping (more than 3 times per week) - Subject has currently or a significant history of seizures, sleep apnea or restless leg syndrome or other sleep disorders which, in the opinion of the investigator responsible, contraindicates his/her participation - Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy which, in the opinion of the investigator responsible, contraindicates his/her participation - Subject with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, intestinal obstruction, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology which, in the opinion of the investigator responsible, contraindicates his/her participation - Subjects suffering from any Axis 1 Psychiatric Disorder that in the opinion of the investigator responsible may interfere with full participation - Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the investigator responsible, contraindicates his/her participation. - The subject has any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator - Subject is taking CNS-active drugs (including herbal products with CNS effects), known to affect the sleep/wake cycle including but not limited to anxiolytic, hypnotics, antidepressants, sedating H1 antihistamines, systemic steroids, anticonvulsants, narcotic analgesics, respiratory stimulants respiratory decongestants, OTC and prescription diet aids, OTC and prescription stimulants, St. Johns Wort, and melatonin. - Females who are pregnant or nursing. ; PRIMARY OUTCOME: To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST); SECONDARY OUTCOME 1: To determine the efficacy of Zaleplon AP on Latency to Persistent Sleep (LPS)[/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 - 013 - w/Lumigan; BRIEF: This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension. ; DRUG USED: AGN-210669; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin E Receptor 2 (PTGER2), Prostaglandin E Receptor 3 (PTGER3), Prostaglandin E Receptor 4 (PTGER4); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye - Requires bilateral treatment with an IOP-lowering medication - Best corrected visual acuity of 20/100 or better in each eye Exclusion Criteria: - Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months - Inability to fast for up to 10 hours - Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy) - Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months - Current or anticipated use of artificial tears or any ocular medications aside from study medications during study - Anticipated wearing of contact lenses during study ; PRIMARY OUTCOME: Change From Baseline in Average Eye IOP; SECONDARY OUTCOME 1: Change From Baseline in Worse Eye IOP[/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 - NASH/NAFLD; BRIEF: A Phase 2 study with 4 treatment groups of two differing doses and matched placebos designed to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of MEDI0382 in obese subjects with non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH). The subjects will have biopsy-confirmed NAFLD/NASH with liver fibrosis stage F1, F2 or F3. Approximately 72 subjects will be randomized ; DRUG USED: Cotadutide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: 1. Provision of informed consent (with the exception of consent for future genetic and non genetic research) prior to performing any study-specific procedures, including screening evaluations. 2. Subjects aged ≥ 18 years at the time of consent. 3. Body mass index ≥ 30 kg/m2 at screening. 4. HbA1c ≤ 9.5% (inclusive) at screening if T2DM present, managed by either diet and/or a stable dose of metformin, sodium-glucose co-transporter 2 (SGLT-2) inhibitors, sulphonylureas or acarbose (ie, no major dose adjustments in prior 3 months to screening). 5. Definitive NAFLD / NASH with NASH activity score (NAS) ≥ 4 with ≥ 1 in each component (i.e. steatosis, lobular inflammation and ballooning), as diagnosed by liver biopsy within 6 months of screening with liver fibrosis stage F1, F2 or F3. The number of subjects with F1 will be capped at 25% in the study. 6. Evidence of hepatic steatosis or liver fat (≥ 10%) by MRI. 7. Women of childbearing potential: 1. Who are sexually active with a non-sterilized male partner must have used at least one highly effective method of contraception from screening, and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. 2. Must have a negative urine pregnancy test within 72 hours prior to the first dose of investigational product; and not be breastfeeding. Exclusion Criteria: 1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subjects ability to participate or affect the interpretation of the results of the study. 2. Liver disease of other etiologies (eg, alcoholic steatohepatitis; drug-induced, viral, or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha 1 antitrypsin deficiency; Wilsons disease) including positive results for hepatitis B surface antigen (HBsAg) or hepatitis C antibody tests (anti-HCV). 3. History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding. 4. Prior or planned liver transplantation. 5. Alcohol consumption > 21 units of alcohol per week for men and > 14 units per week for women on average over a two-year time frame prior to baseline biopsy. 6. Evidence of alcohol dependence as assessed by the Alcohol Use Disorder Identification Test (AUDIT) questionnaire at screening 7. A history of type 1 diabetes mellitus (T1DM), a history of diabetic ketoacidosis or current use of insulin-based therapies. 8. Clinically significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract (including bariatric surgery) which may affect gastric emptying or could affect the interpretation of safety and tolerability data 9. Physician-diagnosed diabetic subjects with clinically significant gastroparesis (as judged by the investigator) or those treated for gastroparesis within 6 months prior to screening 10. History of > 5 kg weight loss in the last 6 months prior to screening or recent (within 3 months of screening) use of drugs approved for weight loss (eg, orlistat, bupropion / naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as those drugs used off-label. 11. Clinically significant cardiovascular or cerebrovascular disease within the past 3 months, including but not limited to, myocardial infarction, acute coronary syndrome or stroke, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening. 12. Severe congestive heart failure (New York Heart Association Class IV). 13. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer. 14. History of substance dependence or a positive screen for drugs of abuse, likely to impact subject safety or compliance with study procedures, at the discretion of the investigator. 15. History of psychosis or bipolar disorder. History of major depressive disorder within the past year with the subject being clinically unstable, or any history of suicide attempt or history of suicidal ideation within the past year. 16. Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (eg, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines). 17. Recent (within 3 months of baseline biopsy) use of obeticholic acid or other therapy under investigation for NASH. 18. High dose vitamin E (> 400 IU) unless on a stable dose for at least 1 year prior to the baseline biopsy, and not initiated after the biopsy was taken. 19. Recent (within 3 months of baseline biopsy) use of GLP-1 receptor agonist or GLP-1 receptor agonist containing therapies. 20. Any subject who has received another investigational product as part of a clinical study within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening. Any prior exposure to MEDI0382 is not permitted. 21. Concurrent participation in another interventional study of any kind or repeat randomization in this study. 22. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients. 23. Contra-indication to MRI: such as subjects with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field; subjects with history of extreme claustrophobia or subject cannot fit inside the MR scanner cavity. 24. History of acute pancreatitis or current chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening, as this can precipitate acute pancreatitis. 25. Abnormal laboratory values including any of the following: 1. AST or ALT > 5 × ULN. 2. Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/minute/1.73 m2 at screening (estimated according to chronic kidney disease epidemiology collaboration [CKD-EPI]). 3. Albumin < 35 g/L. 4. International normalized ratio (INR) > 1.3. 5. Total Bilirubin (TBL) > 25 µmol/L in the absence of known Gilberts disease. 6. Platelets < 140-150,000/mm3 7. Any other clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the investigator. 26. Severely uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mm Hg and/or diastolic blood pressure (DBP) ≥ 110 mm Hg on the average of 2 seated measurements after being at rest for at least 10 minutes at screening or randomization. 27. Basal calcitonin level > 50 ng/L at screening, or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2). 28. Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration < 11.5 g/dL [115 g/L] for male subjects or < 10.5 g/dL [105 g/L] for female subjects) at screening, or any other condition known to interfere with interpretation of HbA1c measurements 29. Any positive results for human immunodeficiency virus (HIV) infection. 30. Any AstraZeneca, MedImmune, contract research organization (CRO), or study site employee, or close relatives of any of the aforementioned employees. 31. Females who are pregnant or lactating. ; PRIMARY OUTCOME: Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE; SECONDARY OUTCOME 1: Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive)[/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 - vs. Refib and Avonex (Russia); BRIEF: This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose administration and multiple estimated therapeutic dose administration of BCD-054. ; DRUG USED: Biosimilar Interferon Beta-1a (BIOCAD); DRUG CLASS: Biosimilar; INDICATION: Multiple Sclerosis (MS); TARGET: Interferon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biocad; CRITERIA: InInclusion Criteria: 1. Written informed consent; 2. Male gender; 3. Age 18 - 45 years inclusive; 4. Body mass index (BMI) (18,5 - 24,99 kg/m2); 5. Healthy condition proven by the volunteers history, global assessment and laboratory analysis results: - Absence in past medical history and at screening of clinically significant dysfunctions of circulatory, respiratory, nervous, hematopoietic, endocrine and digestive systems, liver and kidneys; - No history of cardiovascular diseases and diseases of the thyroid gland - Haematology and biochemistry tests, urinalysis and thyroid hormone analysis results are within normal limits according to standards of the study site. Screening laboratory analyses should be performed not more than 14 days before volunteers inclusion in the study; - Hemodynamic parameters are within normal limits: systolic blood pressure - from 100 to 139 mmHg, diastolic blood pressure - from 60 to 90 mmHg, heart rate - from 50 to 90 bpm; - Absence of history of chronic infection (tuberculosis) and chronic inflammation; - Absence of HIV, hepatitis B and C virus, syphilis; - Absence of acute infections within 4 weeks before inclusion in the study; - Absence of psychiatric disorders and other conditions that can interfere with volunteers ability to follow the study protocol, including depression; - Well-being (in volunteers opinion) within 30 days before participation in the study; 6. Absence of history of systematic alcohol and drug abuse; 7. Ability of the volunteer, in investigators opinion, to follow the study protocol procedures and requirements; 8. Willingness of volunteers and their sexual partners of childbearing potential to use reliable contraception methods starting from 2 weeks before inclusion into the study and until 4 weeks after receiving the last dose of the investigational products. This criterion is not applicable to patients who underwent surgical sterilization. Reliable contraceptive measures include one barrier method in combination with one of the following methods: spermicides, intrauterine device or oral contraceptives used by participants partner; 9. Consent to avoid alcohol intake within 24 hours before and 8 days after each administration of the test or reference drugs; 10. Consent to avoid grapefruit juice (or other products containing grapefruit) intake within 72 hours before and 8 days after each administration of the study or reference drugs. Exclusion Criteria: 1. Previous use of IFN-β1-containing medications at any time before inclusion; 2. History of serious allergic reactions (anaphylaxis or multiple allergy); 3. Known allergy or intolerance to interferons or any other components of study or reference drugs or pegylated proteins; 4. Major surgery within 30 days before screening; 5. Impossibility to install venous catheter for blood sampling (e.g. because of skin disorders at the sites of venipuncture); 6. Diseases or other conditions that can interfere with the investigational drugs pharmacokinetics (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others); 7. History of fever over 40°С 8. History of increase in aminotransferases (ALT, AST) > 2.5 × ULN 9. History of epileptic seizures; 10. Depression and/or suicidal ideas, suicide attempts in history 11. Regular oral or parenteral use of any medications including over-the-counter drugs, vitamins and nutritional additives within less than 2 weeks before inclusion in the study; 12. Intake of medications, including over-the-counter drugs and biologically active additives that can influence hemodynamics, liver function etc. (barbiturates, omeprazole, cimetidine etc.) within less than 30 days before inclusion in the study; 13. Intake of medications that influence immune status (cytokines and their inductors, glucocorticoids etc.) within less than 30 days before inclusion in the study; 14. Vaccination within 4 weeks prior to inclusion 15. Smoking more than 10 cigarettes per day; 16. Subjects who consume more than 10 units of alcohol per week or who have history of alcohol abuse or evidence of drug/chemical abuse (one unit of alcohol equals ½ l [500 ml] of beer, one glass [200 ml] of wine or l shot glass [50 ml] of spirits); 17. Donation of 450 ml and more of blood or plasma within 2 months before inclusion in the study; 18. Participation in other clinical studies within less than 1 month before inclusion in the study or simultaneous participation in another clinical study; 19. Previous participation in this study ; PRIMARY OUTCOME: AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a; 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 - 20090203; BRIEF: The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores. ; DRUG USED: Siliq; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-17 Receptor (IL-17R); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Men or women 18 to 65 years of age - Percent of predicted FEV1 ≥ 50% and ≤ 80% - At least 12% reversibility over pre-bronchodilator FEV1 - Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent - Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points Exclusion Criteria: - Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit - History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma - Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease) ; PRIMARY OUTCOME: Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12; SECONDARY OUTCOME 1: Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)[/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 - Rota-090; BRIEF: The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study. ; DRUG USED: Rotarix; DRUG CLASS: Vaccine; INDICATION: Rotavirus Vaccines; TARGET: Immune System, Rotavirus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol. - Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure. - A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination. - Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days). - Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: - Child in care - Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. - Administration of long-acting immune-modifying drugs at any time during the study period. - Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. - Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS). - History of IS. - Family history of congenital or hereditary immunodeficiency. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Major congenital defects or serious chronic illness. - Previous vaccination against RV. - Previous confirmed occurrence of RVGE. - GE within 7 days preceding the study vaccine administration. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. - Hypersensitivity to latex. - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. ; PRIMARY OUTCOME: Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C); SECONDARY OUTCOME 1: Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - w/Pembrolizumab; BRIEF: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies ; DRUG USED: BI-1206; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Fc receptors; THERAPY: Combination; LEAD SPONSOR: BioInvent International AB; CRITERIA: Inclusion Criteria: - Is willing and able to provide written informed consent for the trial. - Is ≥18 years of age on day of signing informed consent. - Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti- PD-1/L1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb. - Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy. - Has at least 1 measurable disease lesion as defined by Response Evaluation Criteria in Solid Tumors. - Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206. - Has a life expectancy of ≥12 weeks. - Has an ECOG performance status of 0-1. - Has adequate organ function as confirmed by laboratory values listed in the main body of the protocol Expansion Cohort Specific Inclusion Criteria: In addition to the general inclusion criteria above, subjects must also meet the criteria for the specific cohort. Cohort 1 (Non-small cell lung cancer): - For subjects whose tumor has PD-L1 ≥ 50%: Required prior therapies will include anti-PD-1 therapy as monotherapy. Prior standard of care chemotherapy will be allowed but not required. - For tumors with unknown PD-L1 or PD-L1 < 50% , required prior therapies will include anti-PD 1/PD-L1 therapy and SOC chemotherapy either combined with anti PD-1/PD-L1 therapy or given separately. - For subjects with known anaplastic lymphoma kinase, ROS1 or epidermal growth factor receptor (EGFR) sensitizing molecular rearrangements or with BRAF mutations, one line of targeted therapy will be required in addition to anti-PD1/ PD-L1 therapy. Cohort 2 (Metastatic Melanoma): - Required prior therapies will include anti-PD-1 therapy either as monotherapy or as part of a combination regimen. - For subjects with a known BRAF V600-activating mutation combination targeted therapy will be required in addition to anti-PD-1/PD-L1 therapy. Cohort 3 (Other Tumor Types): - All subjects will require prior anti-PD-1/PD-L1 therapy. Exclusion Criteria: - Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids). - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Has known or suspected hypersensitivity to pembrolizumab or BI-1206 or any of their excipients. - Has cardiac or renal amyloid light-chain (AL) amyloidosis. - Has received the following: - Chemotherapy or small molecule products within 4 weeks of first dose of BI 1206. - Radiotherapy within 2 weeks of first dose of BI-1206. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease. Subjects who have previously had radiation pneumonitis are not allowed. - Immunotherapy within 4 weeks prior to the first dose of BI-1206. - Has not recovered from AEs to at least Grade 1 by Common Terminology Criteria for Adverse Events v5.0 due to prior anti-cancer therapies. - Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor treatments . - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Has an active, known or suspected autoimmune disease. - Is a female subject and has the ability to become pregnant (or already pregnant or lactating/ breastfeeding). - Is a male subject with partner(s) of child-bearing potential. - Has had major surgery from which the subject has not yet recovered. - Is at high medical risk because of non-malignant systemic disease including severe active infections on treatment with antibiotics, antifungals or antivirals. - Has presence of chronic graft versus host disease. - Has had an allogenic tissue/solid organ transplant. - Has known human immunodeficiency virus (HIV) and / or history of hepatitis B or C infections, or has a positive test for HIV antibody, hepatitis B antigen / hepatitis B virus DNA or hepatitis C antibody or RNA. - Has a history of active tuberculosis (bacillus tuberculosis). - Has received a live vaccine within 30 days before the first dose of study treatment. - Has uncontrolled or significant cardiovascular disease. - Has a known psychiatric or substance abuse disorder that would interfere with the subjects ability to cooperate with the requirements of the study. - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subjects participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. - Is participating or planning to participate in another interventional clinical trial, or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study drug. Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. Participation in an observational trial is acceptable. - Has a known additional malignancy of another type. - Has a diagnosis of primary or acquired immunodeficiency disorder or taking any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. ; PRIMARY OUTCOME: Documenting AEs and SAEs and determining causality in relation to BI-1206 IV or SC and/or pembrolizumab; SECONDARY OUTCOME 1: Evaluation of PK parameters for BI-1206 IV and SC.[/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 - w/Cyclophosphamide+Dexamethasone (Study 441); BRIEF: This is a multicenter, randomized, open label study designed to compare the efficacy and safety of lenalidomide with low-dose alkylating agents versus high-dose melphalan followed by stem cell support in newly diagnosed symptomatic MM patients who are 65 years of age or younger. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: Fondazione EMN Italy Onlus; CRITERIA: Inclusion Criteria: Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements. - Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. - Patient is 65 years old or younger at the time of signing the informed consent - Women of child-bearing potential must agree to use 2 methods of contraception: 1 effective (for example hormonal or tubal ligation) and 1 barrier (for example latex condom, diaphragm) for at least 4 weeks before starting the therapy, during the Treatment Period, and for 4 weeks after the last dose of lenalidomide - Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy. - Negative serum beta-human chorionic gonadotropin ( beta-HCG) pregnancy test both 24 hours prior to beginning of therapy and then at 4 weeks intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles during study treatment for subjects of childbearing potential - Patient was diagnosed with symptomatic multiple myeloma based on standard criteria (10), and has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan); bone marrow plasma cells >10%. - Patient has a Karnofsky performance status ≥ 60%. - Patient has a life-expectancy > 6 months - Patient has HBV, HCV and HIV negative test. - Patients must have normal ECG and NYHA ≤ 2; an evaluation of ejection fraction by ECHO or MUGA is optional - Patients must normal chest X ray; an evaluation of pulmonary function studies on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) is optional. - Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1): - Platelet count ≥ 75 x 109/L without transfusion support within 7 days before the test. - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without the use of growth factors. - Corrected serum calcium ≤ 14 mg/dL (3.5 mmol/L). - Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN). - Alanine transaminase (ALT): ≤ 2.5 x the ULN. - Total bilirubin: ≤ 1.5 x the ULN. - Calculated or measured creatinine clearance: ≥ 20 mL/minute - Patient has a baseline bone marrow sample available for cytogenetics, that will be processed and eventually centralized. Exclusion Criteria: - Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days). - Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study. - Pregnant or lactating women. A serum β-hCG pregnancy test must be performed at the Screening visit, for female patients of child-bearing potential. If the test is positive, the patient must be excluded from the study. Confirmation that the patient is not pregnant must be established by a negative serum or urinary pregnancy test with the result obtained 1 day prior to the Baseline visit (or the day of the visit if results are available before drug delivery). A pregnancy test is not required for naturally post-menopausal women (who have not had menses at any time in the preceding 24 consecutive months) or surgically sterilised women (hysterectomy, bilateral ovariectomy, bilateral salpingectomy); - Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic finding of prostate cancer (TNM stage of T1a or T1b) - Patients previously diagnosed as bearing deep venous thrombosis or arterial thromboembolic event within the latest 12 months. ; PRIMARY OUTCOME: Progression free survival; SECONDARY OUTCOME 1: Overall survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EPOCH 2 (Herniorrhaphy); BRIEF: This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing unilateral open inguinal herniorrhaphy. ; DRUG USED: Zynrelef; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Heron Therapeutics; CRITERIA: Inclusion Criteria: - Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia. - Has an American Society of Anesthesiologists Physical Status of I, II, or III. - Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives. Exclusion Criteria: - Had any prior inguinal hernia repair. - Has a planned concurrent surgical procedure. - Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. - Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. - Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. - Has taken NSAIDs within 10 days prior to the scheduled surgery. - Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting). - Has been administered bupivacaine within 5 days prior to the scheduled surgery. - Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control. - Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. - Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. - Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C. - Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments. - Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. - Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study. - Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. - Has undergone 3 or more surgeries within 12 months. - Has a body mass index (BMI) >39 kg/m2. ; PRIMARY OUTCOME: Mean Area Under the Curve (AUC) of the Numeric Rating Scale of Pain Intensity Scores With Activity (NRS-A; Windowed Worst Observation Carried Forward) for HTX 011 Compared With Saline Placebo.; SECONDARY OUTCOME 1: Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl.[/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 - Multi-Sensitized Allergic Subjects; BRIEF: The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy. ; DRUG USED: STMC-103H; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: Microbiota (flora, microbiome) excluding the digestive tract; THERAPY: Monotherapy; LEAD SPONSOR: Siolta Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Voluntary informed consent from subject or legally acceptable representative and/or child assent from the subject (as applicable). - For part 1, subjects of 18 years to 40 years of age at the timing of the signature on the informed consent. - For part 2, subjects of 12 years to 17 years of age at the timing of the signature on the informed consent. - For part 3, subjects of 2 years to 11 years of age at the timing of the signature on the informed consent. - Good health and free of significant diseases or clinically significant abnormal findings on physical exam and laboratory evaluations. - No history or presence of gastrointestinal, hepatic, or renal disease/disorder. - History of allergic disease confirmed by 2 or more episodes in past 5 years. - Positive skin prick test to two or more common allergens. - Subjects who are of childbearing potential must agree to remain abstinent from heterosexual activity or agree to use (or have their partner use) acceptable contraception to prevent pregnancy within projected duration of the trial. Exclusion Criteria: - Presence or history of any significant acute or chronic medical illness, except for allergic disease. - BMI > 32 kg/m2 at the time of signing consent. - Current or persistent moderate to sever asthma that requires use of control medication (Step 3 or above, according to Asthma Step Program). - Presence of rhinitis secondary to causes other than allergy. - History of anaphylaxis. - Any known allergies to two or more of the following three antibiotics: Augmentin, tetracycline, or bacitracin. - Inability to be venipunctured and/or tolerate venous access (Parts 1 and 2 only). - Consistent consumption of probiotics ≥ 2 days / week over multiple weeks within the 3 months prior to the study Baseline Visit. - Regular use of any of the following medications: - Intranasal or systemic corticosteroids (in 1 month prior to screening or during study) - Leukotriene modifiers (in 1 month prior to screening or during study) - Intranasal cromolyn (in 2 weeks prior to screening or during study) - Intranasal or systemic decongestants (in 3 days prior to screening or during study) - Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine (in 10 days prior to screening or during study) - Intranasal antihistamines (in 3 days prior to screening or during study) - Other systemic antihistamines (in 3 days prior to screening or during study) - Allergies to excipients in the Investigational Product formulation. - Allergy to soy in any form. - Presently consuming alcohol more than 2 glasses per day or has history of alcohol dependence or alcohol abuse during the past one year prior to screening. - Presently a smoker or ex-smoker with history of smoking (subject must abstain from smoking throughout the study). - History or presence of significant recreational or illicit drug abuse in past 1 year. - Participation in another clinical study within 30 days prior to screening. - Use of any probiotic or prebiotic in the past 3 months prior to screening. ; PRIMARY OUTCOME: Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29.; 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 - PLX3397; BRIEF: This study will assess pexidartinib in adult participants with symptomatic TGCT that is associated with severe morbidity or functional limitations and not amendable to improvement with surgery. ; DRUG USED: Turalio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pigmented Villonodular Synovitis (PVNS); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Macrophage Colony Stimulating Factor 1 (M-CSF1)/M-CSF Receptor/FMS/CD115/CSF-1/CSF1R; THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo Co., Ltd.; CRITERIA: Inclusion Criteria: - Age ≥ 18 years (Age ≥ 20 years in Taiwan). - A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board). - Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist. - Stable prescription of analgesic regimen during the 2 weeks prior to enrollment. - Women of childbearing potential must have a negative serum pregnancy test within the 14-day period prior to enrollment (Where demanded by local regulations, this test may be required within 72 hours of enrollment). - Females of reproductive potential should be advised to use an effective, non-hormonal method of contraception during treatment with pexidartinib and for 1 month after the last dose. Males with female partners of reproductive potential should be advised to use an effective method of contraception during treatment with pexidartinib and for 1 month after the last dose. Female partners of male participants should concurrently use effective contraceptive methods (hormonal or non-hormonal). Women of nonchildbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year. Women who have documentation of at least 12 months of spontaneous amenorrhea and have a follicle stimulating hormone level > 40 mIU/mL will be considered postmenopausal. - Adequate hematologic, hepatic, and renal function, defined by: - Absolute neutrophil count ≥ 1.5 × 109/L - Hemoglobin > 10 g/dL - Platelet count ≥ 100 × 109/L - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.0 × upper limit of normal (ULN) - Total bilirubin and direct bilirubin ≤ 1.0 × ULN - Alkaline phosphatase ≤ 1.0 × ULN - Creatinine clearance (CLcr) > 15 mL/min - Willingness and ability to complete the PROMIS Physical Function Scale. - Willingness and ability to use a diary. - Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements. Exclusion Criteria: - Investigational drug/device use within 28 days of enrolment. - Previous use of pexidartinib or any biologic treatment targeting colony stimulating factor 1 (CSF-1) or the CSF-1 receptor; previous use of oral tyrosine kinase inhibitors are allowed (eg, imatinib or nilotinib). - Active cancer except for tumor for which a participant is enrolled in the study, (either concurrent or within the last year of starting study drug) that requires therapy (eg, surgical, chemotherapy, or radiation therapy), with the exception of adequately treated basal or squamous cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix or breast, or prostate carcinoma with a prostate-specific antigen value < 0.2 ng/mL. - Known metastatic TGCT. - Active or chronic infection with hepatitis C or known positive hepatitis B surface antigen, or known active or chronic infection with human immunodeficiency virus. - Active liver or biliary tract disease - Known active tuberculosis. - Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigators opinion, would likely interfere with a participants study participation or the interpretation of his or her results. - Use of strong Cytochrome P450 (CYP) 3A inducers, including St Johns wort, proton pump inhibitors (PPIs), and other products known to cause hepatotoxicity. - Women who are breastfeeding. - A screening Fridericia corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women). - MRI contraindications. - History of hypersensitivity to any excipients in the investigational product. - Inability to swallow capsules. ; PRIMARY OUTCOME: Overall Response Rate (ORR) of Pexidartinib Based on RECIST 1.1 of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25; SECONDARY OUTCOME 1: Overall Response Rate (ORR) of Pexidartinib Based on TVS of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25[/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 - Polymyalgia Rheumatica; BRIEF: Sirukumab is a human anti-IL-6 monoclonal antibody that selectively binds to the cytokine with high affinity that may have therapeutic benefit in the treatment of polymyalgia rheumatica (PMR) by interrupting multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active PMR. The study will be conducted in 2 parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 52-week extension phase with no study drug administration and a 16-week follow-up phase if applicable. Approximately 150 subjects with a diagnosis of PMR and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study who are in clinical remission will be eligible to enter Part B, the 52-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable for those who have withdrawn prematurely from the study or who have completed Part A but are not eligible for Part B. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Inflammatory Disorders; TARGET: IL-6 (Interleukin-6); THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Age >=50 years - Diagnosis of PMR based on the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2012 provisional PMR classification criteria, that is, at the time of PMR diagnosis, subjects should be aged 50 years or older, presenting with new-onset (<12 weeks of diagnosis) bilateral shoulder pain and abnormal acute-phase response, and are required to score 4 or more on the following criteria for the diagnosis of PMR: Morning stiffness duration >45 minutes (2 points) or Hip pain or limited range of motion (1 point) or Absence of rheumatic factor (RF) or anti-citrullinated protein antibody (ACPA) (2 points) or Absence of other joint involvement (1 point). - Active PMR within 6 weeks of randomization where active disease is defined by an ESR >=30 millimeter (mm)/hour (hr) or CRP >=1 mg/dL within 6 weeks of randomization AND the presence of at least one of the following at screening (within 6 weeks of randomization): Unequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain associated with inflammatory stiffness or Other features judged by the clinician investigator to be consistent with PMR or PMR flares (e.g. fever of unknown origin). - Receiving oral prednisone 0-25 mg once daily (or equivalent) for PMR treatment at screening. Dosage of oral prednisone or equivalent, during the screening period can remain constant or be adjusted within the range of 0-25 mg prednisone equivalent based on investigators discretion. - Willing and able to receive treatment with oral prednisone 20 mg once daily at randomization and undergo a pre-defined blinded prednisone taper. - No evidence of active or latent infection with Mycobacterium tuberculosis (TB) - Be able to read, understand, and complete study questionnaires. - Male and female subjects, where male subjects with female partners of child bearing potential must comply with the contraception requirements and not to donate sperm from the time of first dose of study medication until 4 months after the last dose of study medication. A female subject of child bearing potential must comply with contraception requirements. Exclusion Criteria: - Features consistent with atypical PMR according to the investigators clinical judgment. Investigators are encouraged to discuss with the medical monitor when there are questions regarding excluding subjects with atypical PMR. Atypical features or features that increase the likelihood of a non-PMR diagnosis may include some or all of the following: Age <60 years; Chronic onset (>2 months) at time of diagnosis; Lack of shoulder involvement; lack of inflammatory stiffness; prominent systemic features, weight loss, night pain, neurological signs; features of other rheumatic disease; Normal or extremely high acute-phase response; AND treatment dilemmas such as incomplete, poorly sustained or non-response to GCs, inability to reduce GCs, contraindications to GC therapy, the need for prolonged GC therapy (>2 years). - History or current diagnosis of Giant Cell Arteritis (GCA), or Large Vessel Vasculitis (LVV). If GCA/LVV is suspected, this should be ruled out by ultrasound or other imaging techniques (example. fluorodeoxy-glucose positron emission tomography) prior to entering the study. - Maintained on GCs for 2 years or more prior to Screening. - Other inflammatory rheumatic diseases with the exception of gout controlled on stable suppressive therapy and without flares for at least 2 years prior to screening and expected to remain on this therapy for the duration of the study. - Recent (within the past 12 weeks) or planned major surgery that would impact on study procedures or assessments. - Organ transplantation recipients (except corneas within 3 months prior to randomization visit). - Requires continued or repeated use of systemic GCs for conditions other than PMR. - Evidence of serious concomitant disease, which in the opinion of the investigator makes the subject unsuitable for participation in the study for either safety or efficacy. - Major ischemic event within 12 weeks of screening. - At screening, marked prolongation of corrected QT interval (QTc) > 450 millisecond (msec) [QTc by Bazetts formula (QTcB) or QTc by Fridericias formula (QTcF)] or QTc > 480 msec in subjects with Bundle Branch Block. History of Torsade de Pointes, family history of long QT syndrome, history of second or third degree heart block. - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - History of or current active diverticulitis, inflammatory bowel disease, or other symptomatic gastro intestinal (GI) tract condition that might predispose to bowel perforation. - History of known demyelinating diseases such as multiple sclerosis or optic neuritis. - Active infections, or history of recurrent infections or required management of acute or chronic infections, as follows: currently on any suppressive therapy for a chronic infection and History or suspicion of chronic infection (e.g. joint infection) OR Hospitalization for treatment of infection within 60 days of the randomization visit OR Use of parenteral (intravenous [IV] or intramuscular [IM]) antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic agents) within 60 days of randomization or oral antimicrobials within 30 days of randomization. - Primary or secondary immunodeficiency. - Human immunodeficiency syndrome (HIV) infection, hepatitis C. - Hepatitis B infection - Active malignancy or history of malignancy within previous 5 years. - Any other autoimmune disease. - Uncontrolled thyroid disease. - Uncontrolled psychiatric or emotional disorder. - Current history of suicidal ideation or past history of suicide attempt. - Has received prior treatment with any of the following: Systemic immunosuppressives within 4 weeks of randomization; Systemic GCs for conditions other than PMR within 8 weeks of randomization; Biologic agents targeted at reducing Tumor necrosis factor (TNF) alpha within 4-8 weeks of randomization, depending on the agent; B-cell depleting agents (e.g., rituximab) within 12 months prior to baseline or longer if B cell counts have not returned to the normal range or baseline levels; Any prior use of tocilizumab or other anti-IL-6 agents, Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents, Abatacept and Tofacitinib; Methotrexate use within 2 weeks of randomization; Methylprednisolone > 100 mg/day IV (or equivalent) within 8 weeks of randomization. - Has received, or is expected to receive, any live virus or bacterial vaccination within 3 months of randomization, during the study, or within 4 months after the last administration of study treatment. Have had a Bacille Calmette Guérin (BCG) vaccination within 12 months of screening. - Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before randomization. - History of drug abuse, alcohol abuse within 3 years prior to screening. - History of severe allergic reactions to monoclonal antibodies, human proteins, or excipients. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation - Laboratory abnormalities at screening - A female subject who is pregnant or lactating. ; PRIMARY OUTCOME: Proportion of subjects in sustained; SECONDARY OUTCOME 1: Part A: Cumulative prednisone dose at Week 52[/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 - Acute Mountain Sickness; BRIEF: Acute mountain sickness (AMS) is one of three syndromes of altitude illness. It is very common when people venture over 2500 meters altitude. This illness is mainly induced by acute exposure to low partial pressure of oxygen at high altitude that will cause a pathological effect on humans. T89 capsule is a modernized industrialized traditional Chinese herbal medicine. It is a botanical drug for oral use. In recent years, several literatures and clinical studies have showed that oral administration of T89 may provide substantial benefits in the prevention or alleviation of symptoms associated with acute mountain sickness (AMS), including nausea, vomiting, headache, dizziness, fatigue, and sleep disturbance. Such effect was also observed in a pilot clinical study recently conducted in Tibet in China. This study is a prospective, double-blind, randomized, placebo-controlled phase 2 clinical trial having three arms including T89 low-dose, T89 high-dose and a placebo controlled group. People will be screened against the inclusion/exclusion criteria after informed consent signed. Eligible subjects will be randomly assigned into one of three arms and instructed to use T89 orally twice daily for 14 days (Days 1-14) before ascending, and 5 days after ascending during the observation period (Days 15-19). The primary efficacy parameter is Lake Louise Scoring System (LLSS) which will be evaluated by subject-self and principal investigator in clinic. ; DRUG USED: Dantonic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Emesis; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Tasly Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy volunteers: ages 18 - 55 years old; 2. Primary residence elevation of 1,000 ft or lower; 3. Not ascending to altitude >10,000 ft within 4 months prior to screening; 4. Females of childbearing potential must have a negative pregnancy test, not be breast feeding and established on a method of contraception that in the investigators opinion is acceptable. Females must agree to remain on their established method of contraception from the time of the screening visit and throughout the study period. 5. Willing to participate voluntarily and to sign a written informed consent. Exclusion Criteria: 1. Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma; 2. Subjects with clinically significant respiratory system disease, digestive disease, mental disease, metabolic disease, acute infection or anemia; 3. Total LLSS self-assessment score and clinical assessment score is greater than 1 before ascending (Screening visit and Visit 1); 4. Blood oxygen saturation (SpO2) <95% at sea level; 5. Subjects with abnormal renal or liver function with clinical significance (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2×upper limits of normal(ULN), Creatinine> ULN); 6. Subjects with C reactive protein (CRP) > ULN; 7. Subjects with primary headache; 8. Surgery or blood donation within 3 months prior to screening; 9. On treatment of any medications (including any dietary supplements)except for birth control within 14 days prior to screening and throughout the study period; 10. Contradictive to treatment of Danshen (Radix Salivae Miltiorrhizae, RSM) products; 11. Women in pregnancy or lactation period; 12. Substance abuse. Subjects with a recent history (within the last 2 years) of alcoholism or known drug dependence; 13. Participation in any other clinical trial or on an investigational drug within 30 days prior to screening; 14. A family member or relative of the study site staff; 15. Any other condition that, in the opinion of the investigator, is likely to prevent compliance with the study protocol, interfere with the assessment, or pose a safety concern if the subject participates in the study. ; PRIMARY OUTCOME: The LLSS self- and clinical assessments score on Day 16 morning(next morning of arrival at high altitude) between T89 and Placebo groups.; SECONDARY OUTCOME 1: The area under the curve (AUC) of LLSS self- and clinical assessments score in the mean LLSS score-time profile during rapid ascent (Days 15-19) between T89 and Placebo groups.[/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 - DWP16001201 (Korea); BRIEF: The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus. ; DRUG USED: DWP16001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Daewoong Pharmaceutical Co. LTD.; CRITERIA: Inclusion Criteria: - Patients aged 20 to 80 years - Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before - Body Mass Index (BMI) between 20 and 45 kg/㎡ - Patients with 7% ≤ HbA1c ≤ 10% at screening - Subject who has conducted a stable diet and exercise for at least 8 weeks Exclusion Criteria: - Type 1 diabetes mellitus or secondary diabetes - Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis) - Clinical significantly renal disorders - Creatinine clearance < 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) < 60mL/min/1.73 - Severe gastrointestinal disorder - Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg) - History of Acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (NYHA class III/IV), or heart arrhythmia ; PRIMARY OUTCOME: Change from baseline in HbA1c; SECONDARY OUTCOME 1: Change from baseline in FPG[/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 - MCI (Avraham); BRIEF: The purpose of this study is to determine whether treatment with the investigational drug ladostigil will delay the onset of Alzheimers disease(AD) in patients with Mild Cognitive Impairment (MCI). MCI is now recognized as a precursor to AD and clinical tools are available to assess cognitive performance at this earlier stage. Ladostigil is currently under investigation for the treatment of AD. In this study, the investigators will be examining ladostigil at a lower dose level. At this dose level, ladostigil has been shown to reduce signs of early memory loss in animals. Thus, in this study the investigators are attempting to determine if earlier invention with a lower dose of ladostigil will significantly reduce initial memory loss and delay the subsequent progression to more serious cognitive dysfunction. ; DRUG USED: Ladostigil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mild Cognitive Impairment (MCI); TARGET: Monoamine oxidase A (MAO-A), Monoamine oxidase B (MAO-B); THERAPY: Monotherapy; LEAD SPONSOR: Avraham Pharmaceuticals Ltd; CRITERIA: Inclusion Criteria: - Men and women (non-childbearing potential) with a diagnosis of Mild Cognitive Impairment (MCI) according to consensus criteria as defined by Petersen - Abnormal memory function will be evaluated by Verbal Paired Associates from the Wechsler Memory Scale - Revised. Norm values for healthy adults in two age cohorts are: a) 50-70 years 19.7 (SD=2.9) and b) 75-95 years 18.3 (SD=2.8). Patients that score < or = 23 will be included. - Clinical Dementia Rating (CDR) score of 0.5 (Memory box score 0.5 or 1, no box score > 1) - Mini Mental State Examination (MMSE) > 24 and < or = 30 - General cognition and functional performance is sufficiently preserved such that a diagnosis of AD can be excluded by the site physician at the time of the screening visit. - No significant cerebrovascular disease indicated by Modified Hackinski Ischaemic Score equal to or below 4 - Age 55-85 years based upon correlation of cognition and Scheltens score observed in this age range - Geriatric Depression Scale (GDS) of < or = 5 - An informer who has frequent contact with the subject (e.g. an average of 10 hours per week or more) is available and agrees to monitor administration of study drug, to observe the subject for adverse events and to accompany the subject to clinical visits during the trial, if the presence of the informer is required. - All patients have to undergo an MRI scan after the screening visit, i.e. during the screening visit, irrespective of MRIs having been performed prior to entry into the study. MRI findings have to be consistent with a diagnosis of MCI. - Central rating of medial temporal lobe according to Scheltens scale. The right and left medial temporal structures will be rated separately and an overall estimate will be deduced using the average of the two ratings. An average score > 1 is required to make patients eligible for the study. - Adequate visual and auditory acuity must be demonstrated to allow for neuropsychological testing. - Good general health status acceptable for participation in a 36-month clinical trial, with no additional diseases expected to interfere with the study - ECG without clinically significant abnormalities according to exclusion criteria listed below - Subject is not pregnant, lactating or of childbearing potential (i.e. women must be two years post menopausal or surgically sterile) - Signed informed consent by patient and informer prior to any study specific procedure Exclusion Criteria: - Failure to perform screening or baseline examinations - Any significant neurological disease other than suspected MCI - MRI exclusion criteria which allow for mild concomitant vascular lesions are: - Thromboembolic infarction - Other focal lesions which may be responsible for the cognitive status of the patient such as infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with significant central nervous disease - More than one lacunar infarct defined as a focal lesion of CSF signal intensity with a diameter of < 1.5cm in any dimension - Any lacunar infarct in a strategically important location such as the thalamus, hippocampus of either hemisphere, head of the left caudate - White matter lesions involving more than 25% of the hemispheric white matter - Implants such as pacemakers, insulin pumps, cochlear implants, nerve stimulators, implantable cardioverter defibrillators, and other medical implants that have not been certified for MRI - Ferromagnetic foreign bodies such as shell fragments need to be considered on an individual basis - Metallic implants that can cause artifacts and RF induced heating such as surgical prostheses or aneurysm clips need to be considered on an individual basis - Clinical or laboratory findings consistent with: - Central nervous system diseases such as those resulting from severe head trauma, tumours, subdural haematomas or other space occupying processes, etc - Seizure disorder - Other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc) - History or evidence of schizophrenia or bipolar disorder (DSM IV criteria); active major depression - Clinically significant advanced or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk, such as: - Malignant tumours within the last five years except skin malignancies (other than melanoma) or indolent prostate cancer - Metastases - History of myocardial infarction within one year prior to screening or unstable or severe cardiovascular disease including angina or congestive heart failure with symptoms at rest - Uncontrolled hypertension (systolic pressure > 170mmHg or diastolic pressure > 100mmHg) - Bradycardia (persistent heart beat < 50/min) or tachycardia ( persistent heart beat > 100/min) - AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males > 450msec, females > 470msec) - Clinically significant obstructive pulmonary disease or asthma - Clinically significant laboratory findings that indicate abnormalities in blood biochemistry, blood haematology or urinalysis - Uncontrolled diabetes mellitus defined by HbA1c > 8.5 - Clinically significant liver disease, coagulopathy or vitamin K deficiency within the past two years prior to screening - Renal insufficiency (serum creatinine > mg/dl or creatinine clearance < or = to 45ml/min according to Cockgroft-Gault formula); in case of creatinine clearance < or = 45ml/min, an alternative verification of the renal function must be completed using cystatin C analysis. In case of normal level of cystatin C, the patient can be included in the study. - Any prior use of medications approved by local authorities for the treatment of Alzheimers disease (e.g. tacrine, donepezil, rivastigmine, galantamine, memantine or other newly approved medications) - Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc) - Women who are fertile and of child bearing potential - Chronic daily intake of antidepressants as noted in section 9.5 of the clinical study protocol - Suspected or known drug or alcohol abuse, i.e. more than approximately 60g alcohol (approximately 1 lter of beer or 0.5 liter of wine) per day as indicated by elevated MCV significantly above normal value at screening - Suspected or known allergy to any components of the study treatments - Enrollment in another investigational study or intake of investigational drug within the previous three months - Any condition (e.g. epilepsy) which in the opinion of the investigator makes the patient unsuitable for inclusion ; PRIMARY OUTCOME: Conversion From Mild Cognitive Impairment to Alzheimers Disease Compared to Placebo; SECONDARY OUTCOME 1: Change in Geriatric Depression Scale for Ladostigil Versus Placebo Population[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EVADE; BRIEF: Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa. ; DRUG USED: MEDI3902; DRUG CLASS: Biologic; INDICATION: Pseudomonas-Specific Agents (Antibacterial); TARGET: Pseudomonas aeruginosa; THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. Exclusion Criteria: P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund participants. ; PRIMARY OUTCOME: Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa; SECONDARY OUTCOME 1: Maximum Observed Concentration (Cmax) of MEDI3902[/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 - 103; BRIEF: The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC. ; DRUG USED: VB-111; DRUG CLASS: Biologic; INDICATION: Thyroid Cancer; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Vascular Biogenics Ltd. operating as VBL Therapeutics; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell); 2. Absence of sensitivity to therapeutic radioiodine; 3. Measurable disease, defined as at least one non-bony lesion that can be accurately measured in at least one dimension as confirmed with spiral CT scan 4. Life expectancy >3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%; 5. Subjects with a normal/acceptable hematological profile 6. Subjects with adequate renal function Exclusion Criteria: 1. Presence of any of the following: - Radiotherapy or chemotherapy <4 weeks prior to baseline visit; (Concurrent and/or prior therapy with octreotide will be allowed, provided tumor progression on this therapy has been demonstrated; Concurrent and/or prior therapy with biphosphonates will be allowed) - Radiotherapy to ≥25% of bone marrow; 2. Major surgery <4 weeks prior to baseline visit; 3. Any other ongoing investigational agents within 4 weeks before dosing; 4. Subjects who suffered from an acute cardiac event within the last 12 months, including myocardial infarction, cardiac arrythmia, admission for unstable angina, cardiac angioplasty, or stenting; 5. QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia); 6. Subjects with active vascular disease, either myocardial or peripheral; 7. Subjects with proliferative and/or vascular retinopathy; 8. Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases; 9. Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations >6 months after definitive therapy administered, are eligible); 10. Subjects testing positive to one of the following viruses: HIV, HBV or HCV; 11. Any of the following conditions: - Serious or non-healing wound, ulcer, or bone fracture; - History of abdominal fistula, gastro-intestinal perforation, active diverticulitis, intra-abdominal abscess or gastro-intestinal tract bleeding within 6 months of dosing; - Any history of cerebrovascular accident (CVA) within 6 months of dosing; - Current use of therapeutic warfarin (Note: Low molecular weight heparin and prophylactic low-dose warfarin [INR<1.2 X ULN] are permitted); - History of bleeding disorder, including subjects with hemophilia, disseminated intravascular coagulation (DIC), or any other abnormality of coagulation potentially predisposing subjects to bleeding; - Poorly controlled depression or anxiety disorder, or recent (within the previous 6 months) suicidal ideation; 12. Subjects with an ongoing requirement for immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before dosing; 13. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. ; PRIMARY OUTCOME: Progression Free Survival; 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 IIIa - Ellipse; BRIEF: This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population Exclusion Criteria: - Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigators opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics ; PRIMARY OUTCOME: Change in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG)[/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 - MAPK Pathway Aberrations; BRIEF: This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent, progressive, or refractory melanoma or other solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway. ; DRUG USED: DAY101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Day One Biopharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Signed informed consent by patients ≥ 18 years of age and, assent for patients ≥ 12 up to < 18 years of age - Patients must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1) - Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required - If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging Substudy A-specific inclusion criterion: - Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or agency. Substudy B-specific inclusion criterion: - Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) through a tumor or liquid biopsy as assessed by genomic sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency. Exclusion Criteria: - Known presence of concurrent activating mutation - Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO) Substudy A-specific exclusion criterion: - Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy ; PRIMARY OUTCOME: Phase 1b: Determine the safety of tovorafenib in combination with other therapies; SECONDARY OUTCOME 1: Phase 1b: Assess efficacy of tovorafenib in combination with other therapies[/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 - FIND-CKD; BRIEF: Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA). ; DRUG USED: Injectafer; DRUG CLASS: Non-NME; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Independent; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Vifor Pharma; CRITERIA: Inclusion Criteria: 1. At least 18 years of age. 2. NDD-CKD subjects with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m2 using modification of diet in renal disease 4 (MDRD-4) calculation. 3. NDD-CKD subjects with an eGFR loss ≤12 mL/min/1.73 m2/year and a predicted eGFR of ≥15 mL/min/1.73 m2 in 12 months. 4. Any single Hb between 9 and 11 g/dL within 4 weeks of randomisation. A value taken as part of routine medical care was used. 5. Any single serum ferritin <100 mcg/L or <200 mcg/L with TSAT <20% within 4 weeks of randomisation. Measurements taken as part of routine medical care were used. 6. ESA naïve; no exposure to ESA in last 4 months prior to randomisation. 7. Females of childbearing potential must have had a negative pregnancy test, using any medically acceptable assessment, prior to randomisation. 8. Before any study specific procedure, the appropriate written informed consent must have been obtained. Exclusion Criteria: 1. History of acquired iron overload. 2. Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjects with hypersensitivity to other forms of iron were permitted to participate. 3. Documented history of discontinuing oral iron products due to significant gastrointestinal (GI) distress. 4. Screening TSAT >40%. 5. Known active infection, C-reactive protein >20 mg/L, clinically significant overt bleeding, active malignancy (i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia). 6. History of chronic alcohol abuse (alcohol consumption >40 g/day). 7. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range. 8. Active human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome or active hepatitis B or C virus infection. 9. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with treated Vitamin B12 or folic acid deficiency were permitted. 10. IV iron and/or blood transfusion in previous 30 days prior to screening (or during the screening period). 11. Oral iron therapy at doses >100 mg/day dosing must have been discontinued at least 1 week prior to randomisation. If subject had received this therapy for >3 months (at doses >100 mg/day) then subject was not eligible. Ongoing use of multivitamins containing iron was permitted. 12. Immunosuppressive therapy that may have led to anaemia (e.g., cyclophosphamide, azathioprine, or mycophenolate mofetil). Steroid therapy was permitted. 13. Currently requiring renal dialysis. 14. Anticipated dialysis or transplant during the study. 15. Anticipated need for surgery that may have resulted in significant bleeding (>100 mL). 16. Currently suffering from chronic heart failure New York Heart Association Class IV. 17. Poorly controlled hypertension (>160 mmHg systolic pressure or >100 mmHg diastolic pressure). 18. Acute coronary syndrome or stroke within the 3 months prior to screening. 19. Currently suffering from concomitant, severe psychiatric disorders or other conditions which, in the opinion of the Investigator, would have made participation unacceptable. 20. Subject was not using adequate contraceptive precautions. 21. Subject of childbearing potential was evidently pregnant (e.g., positive human chorionic gonadotropin test) or was breast feeding. 22. Body weight <35 kg. 23. Subject currently was enrolled in or had not yet completed at least 30 days since ending other investigational device or drug studies, or subject was receiving other investigational agent(s). 24. Subject would not be available for follow-up assessment. 25. Subject had any kind of disorder that compromised the ability of the subject to give written informed consent and/or to comply with study procedures. ; PRIMARY OUTCOME: Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger; 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 - Japan; BRIEF: - To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962. - To demonstrate the superiority of SPM 962 to placebo in terms of efficacy. - To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day. ; DRUG USED: Neupro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Subject diagnosed as having Parkinsons disease in accordance with Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995). - Subject is 30 and more and less than 80 years of age at the time of informed consent. - Hoehn & Yahr stage 2-4 (on time). - Total UPDRS Part 3 score is over 10 at screening test (on time). - Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962. - Subject has any of the following problematic symptoms; 1) Wearing off phenomenon (including frozen gait at off time and dystonia at off time) 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Dyskinesia 5) Not well controlled with L-dopa. Exclusion Criteria: - Subject who has previously participated in a clinical trial of SPM962 and taken the investigational product (IP). - Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline. - Subject whose SBP declines by at least 30 mmHg from supine to standing position based on the orthostatic hypotension assessment, or subject who develops orthostatic hypotension at baseline. - Subject has a history of epilepsy, convulsion and other. - Subject who has complications or a history of serious cardiac diseases or arrhythmia (eg, congestive heart failure of class 3 or 4 in the NYHA classification, second or third degree atrioventricular block, complete left bundle branch block, sick sinus syndrome, ventricular fibrillation, myocardial infarction within 12 months prior to the screening test, or a complication of angina pectoris). - Subjects has QTc-interval >450 msec twice at screening. Subject has a the average QTc-interval from two ECGs >450 msec in males and >470 msec in females at baseline. - Subject has congenital long QT syndrome. - Subject whose serum potassium level is < 3.5mEq/L at the screening test. - Subject has a total bilirubin >= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or >= 100 IU/L) at screening test, or suffers complications of active phase of chronic hepatitis or liver cirrhosis. - Subject has BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at screening test. - Subject has a history of allergic reaction to topical agents such as transdermal patch. - Subject has a history of known intolerance/hypersensitivity to ropinirole and/or adverse drug reactions that prevent subject from receiving treatment. - Subject is pregnant or nursing or woman who plans pregnancy during the trial. - Subject is receiving therapy with prohibited drug specified in the study protocol. - Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant. - Subject has dementia, including DLB and PDD (MMSE score <= 24 at screening). - Subject who has a complication or history of malignant neoplastic disease, or received treatment for the disease within 12 months prior to the screening test. - Subject is unable to give consent. - Subject who is unable to properly record information in a diary. - Subject is participating in another trial of IPs or received other IPs within 12 weeks prior to commencement of study treatment. - Investigator judges that subject is inappropriate as a study subject with other reasons. ; PRIMARY OUTCOME: Unified Parkinsons Disease Rating Score (UPDRS) Part 3 Sum Score; SECONDARY OUTCOME 1: UPDRS Part 3 Sum 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 - Peritoneal Dialysis CKD; BRIEF: The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal dialysis chronic kidney disease patients with anemia. ; DRUG USED: Roxadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Female subject must either: Be of non-childbearing potential: - post-menopausal (defined as at least 1 year without any menses) prior to Screening, or - documented surgically sterile Or, if of childbearing potential, - Agree not to try to become pregnant during the study and for 28 days after the final study drug administration - And have a negative pregnancy test at Screening - And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration. - Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration. - Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration. - Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration - Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration - Subjects who have not received Erythropoieses Stimulating Agents (ESAs): - Subjects who have been receiving peritoneal dialysis for more than 4 weeks before the screening assessment - Subjects who have never received ESAs after starting peritoneal dialysis, or subjects who have not received ESAs within 6 weeks before the screening assessment. - Mean of the subjects two most recent Hb values before randomization during the Screening Period must be <10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values - Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period - Subjects who have been receiving ESAs: - Subjects with renal anemia who have been receiving ESA within the doses approved in Japan for more than 8 weeks after starting peritoneal dialysis, before the screening assessment - Mean of the subjects two most recent Hb values before randomization during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL - TSAT ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period Exclusion Criteria: - Subjects who had trouble with continuing peritoneal dialysis due to peritonitis, development of catheter trouble (e.g. tunnel infection) within 4 weeks before the screening assessment - Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment - Concurrent autoimmune disease with inflammation that could impact erythropoiesis - History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastro-paresis - Uncontrolled hypertension - Concurrent congestive heart failure (NYHA Class III or higher) - History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment - Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test - Concurrent other form of anemia than renal anemia - Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin, or Alkaline Phosphatase (ALP) that is greater than the criteria below, or previous or concurrent another serious liver disease at screening assessment - Previous or current malignant tumor (no recurrence for at least 5 years is eligible.) - Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) within 4 weeks before the screening assessment - Having undergone a kidney transplantation - Having a previous history of treatment with ASP1517 - History of serious drug allergy including anaphylactic shock - Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition ; PRIMARY OUTCOME: Hemoglobin (Hb) Response Rate from Week 18 to Week 24; SECONDARY OUTCOME 1: Hb Response rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - HALO; BRIEF: Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover, Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these reasons, questions arise whether ABVD could be still considered the standard treatment in HL patients aged > than 60. Regimens containing other alkylators such as CHOP proved even superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine) proved very active in a pioneer study, reporting the preliminary results of a phase 1 multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For all these reason the investigators decided to test the association of an alkylator with an innovative mechanism of action and a very safe toxicity profile in the elderly such as Bendamustine (Be) with BV in untreated elderly HL patients. The combination of BV and Be, investigated in this study, might represent an innovative treatment alternative for HL patients older than 60 years of age, especially for those of them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable. However, even when ABVD is given as upfront treatment for elderly HL patients, it is associated with substantial dose reduction, treatment delay, toxicity, and treatment-related mortality, with treatment outcomes remaining much inferior to those obtained in younger patients. This drug association is expected to be safe, well-tolerated and to demonstrate higher efficiency compared with ABVD. In this setting, it is expected that this therapy could be offered to the large majority of elderly patients with a full treatment completion reached in up to 80% of these patients. Thus, the aim of this study will be to assess safety and efficacy of the above association. ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Hodgkins Lymphoma; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Centre Antoine Lacassagne; CRITERIA: Inclusion Criteria: 1. Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification. All Hasenclever IPS prognostic groups accepted 2. Stages IIB to IV B 3. Age 60-80 years included 4. Patient not previously treated 5. ECOG ≤ 2 6. Patient with adequate organ function: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Haemoglobin ≥ 9 g/dL - Platelets (PTL) ≥ 100 x 109/L - AST - ALAT ≤ 2.5x ULN - Bilirubin ≤ 1.5 x ULN - Creatinine < 150 µmol/l (or 1.7 mg/dl) 7. Male patients, even if surgically sterilized, (i.e., status post vasectomy) and women of childbearing potential agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse. • Contraception as described above is not a requirement if the female patients postmenopausal status is documented (has had no menstrual period for at least 12 consecutive months) 8. Information delivered to patient and voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 9. Patient affiliated with a health insurance system. Exclusion Criteria: 1. Patients aged less than 60 years. 2. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 3. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML. 4. Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication. 5. Symptomatic sensory or motor peripheral neuropathy. 6. Concurrent use of other investigational agents. In case of previous participation to a Clinical trial, a period of 30 days will be observed after the end of the previous Clinical Trial and before the inclusion in HALO study 7. Chemotherapy, biologics, and/or other treatment with immunotherapy not completed at least 4 weeks prior to first dose of study drug. 8. Patient who had major surgery less than 30 days before start of treatment 9. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose. 10. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of BV. 11. Patient presenting an uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody or HIV or HCV serology positivity. In case of HBc positive serology, a PCR could be performed in order to determine viral load. Patients with viral load defined as negative could be included. o A prophylactic treatment will be strongly recommended (see HALO Study protocol, paragraph 6.2.3, page 36) 12. Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions, or laboratory abnormalities that would interfere, in the judgment of the investigator and/or sponsor, with the ability to comply with the study protocol. 13. Patients with uncompensated diabetes mellitus and fasting glucose levels over 180 mg/dl. 14. Known history of any of the following cardiovascular conditions - Myocardial infarction within 2 years of enrollment - New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 12) - Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 15. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50% 16. People particularly vulnerable including: - Person deprived of liberty - Adult patient entitled to protection of law ; PRIMARY OUTCOME: toxicity analysis; SECONDARY OUTCOME 1: Progression Free Survival[/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 - Non-Cirrhotics; BRIEF: The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis. ; DRUG USED: Solithera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Melinta Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Histologic evidence of NASH based on liver biopsy obtained within 180 days - NAS> or = 5 - Able to swallow capsules intact Exclusion Criteria: - Symptoms of acute liver disease - Cirrhosis on liver biopsy - Positive HIV or Hepatitis tests - Primary Biliary Cirrhosis - Poorly controlled diabetes with HgA1C >8.5% - ALT >4-fold upper limit of normal - QTcF >450 msec - CrCl <40 mL/min ; PRIMARY OUTCOME: To evaluate effects on hepatic histology in patients with NASH; SECONDARY OUTCOME 1: Changes in Steatosis on liver biopsy[/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 - ADU-CL-19; BRIEF: Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN). ; DRUG USED: BION-1301; DRUG CLASS: Biologic; INDICATION: Immunoglobulin A (IgA) Nephropathy (Bergers Disease); TARGET: APRIL, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Chinook Therapeutics, Inc.; CRITERIA: Inclusion Criteria for Healthy Volunteers: 1. Healthy male or female volunteers, 18 to 55 years old 2. Females must be of non-childbearing potential 3. Males must agree to follow the protocol-specified contraception guidance 4. Body mass index (BMI) between 18 and 35 kg/m^2, with a weight of at least 50 kg 5. Non-smoker, defined as an individual who has not smoked previously and/or who has discontinued smoking or the use of nicotine/nicotine-containing products at least 3 months before Screening 6. Able to provide signed informed consent Exclusion Criteria for Healthy Volunteers: 1. Regular consumption of alcohol within 6 months prior to Screening, or use of soft drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine and phencyclidine) within 1 year prior to Screening and/or positive blood or urine test results for drugs of abuse or alcohol at Screening or Admission 2. Donated blood in the 3 months prior to the first dose of study drug, plasma in the 7 days prior to the first dose of study drug, or platelets in the 6 weeks prior to the first dose of study drug 3. History or evidence of a clinically significant disorder, condition, or disease that could pose a risk to subject safety or interfere with the study, or would make the subject unsuitable for participation, eg, respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or psychiatric disease 4. Female who is breastfeeding or who has a positive serum pregnancy test at Screening or a positive urine pregnancy test on Day -1 Inclusion Criteria for Adults with IgAN: 1. Male or female ≥18 years old at Screening 2. Women of child-bearing potential (WOCBP; per CTFG 2014) must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through approximately 6 months after the final dose of study drug) 3. Males must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through approximately 6 months after the final dose of study drug) 4. BMI between 18 and 40 kg/m^2, inclusive, at Screening with a weight of at least 50 kg 5. Diagnosis of IgAN verified by biopsy taken within the past 10 years 6. Urine protein ≥ 0.5 g/24h; OR UPCR ≥ 0.5 g/g (or ≥ 50 mg/mmol) 7. eGFR (per Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or measured GFR ≥ 30 mL/min per 1.73 m^2 8. Stable on an optimized dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin-receptor blockers (ARBs) for at least 3 months prior to Screening or intolerant to ACE/ARB Exclusion Criteria for Adults with IgAN: 1. Known or suspected allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody 2. Donated blood in the 3 months prior to the first dose of study drug; plasma in the 7 days prior to the first dose of study drug; or platelets in the 6 weeks prior to the first dose of study drug 3. Participated in any other study in which receipt of an investigational new drug, or investigational device occurred within 28 days, or 5 half-lives (whichever is longer) of first dose of study drug in the present study 4. Secondary forms of IgAN as defined by the treating physician (eg, Henoch-Schönlein purpura patients and those with associated alcoholic cirrhosis) 5. Received systemic corticosteroid therapy (> 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 3 months prior to the first dose of study drug PART 4 Eligibility Criteria for Re-treatment Due to Evidence of Disease Progression (Option 1) Inclusion Criteria for Re-treatment Due to Evidence of Disease Progression 1. Completed Part 3 of the study through Week 124 and entered the 52-week follow-up period. 2. UPCR ≥ 0.5 g/g AND ≥ 30% increase from EOT (Week 124). Both proteinuria criteria must be met by a 24-hour urine assessment during the 52-week follow-up period. In addition to the scheduled assessments, investigators may order periodic FMV assessments (for example monthly) to follow a patient more closely. Based on an off-schedule FMV result, or other laboratory or clinical evidence, investigators may order an off-schedule 24-urine collection to confirm disease progression. Exclusion Criteria for Re-treatment Due to Evidence of Disease Progression 1. Based on the Investigators judgment, the patient would not benefit from resuming treatment with BION-1301 or there is a safety concern for the individual patient which outweighs the expected benefit from resuming treatment. Eligibility Criteria for Optional Re-treatment (Option 2) Inclusion Criteria for Optional Re-treatment 1. Completed Part 3 of the study through Week 124 and completed of the 52-week follow-up period. Exclusion Criteria for Optional Re-treatment 1. Based on the Investigators judgment, the patient would not benefit from resuming treatment with BION-1301 or there is a safety concern for the individual patient which outweighs the expected benefit from resuming treatment. ; PRIMARY OUTCOME: Incidence of Treatment Emergent Adverse Events (TEAEs) as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE); 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 - CONGO (w/Avastin/FOLFOX); BRIEF: This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to estimate the efficacy of MEGF0444A treatment to disease progression, combined with oxaliplatin + folinic acid + 5-Fluorouracil (mFOLFOX-6) + bevacizumab therapy in participants with metastatic colorectal cancer (CRC). ; DRUG USED: Parsatuzumab; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: EGFL7; THERAPY: Combination; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed CRC not amenable to potentially curative resection with at least one measurable metastatic lesion, as defined by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate hematologic and end organ function - For female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form of contraception and to continue its use for 6 months after the last dose of study treatment - Negative serum pregnancy test within 7 days prior to starting study treatment in premenopausal women and women less than (<) 2 years after the onset of menopause Exclusion Criteria: Disease-specific exclusions - Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before Day 1 of Cycle 1 for treatment of CRC General Medical Exclusions - Malignancies other than CRC within 5 years prior to randomization, except for those with a negligible risk of metastasis or death - Radiotherapy to any site for any reason within 28 days prior to Day 1 of Cycle 1 - Clinically detectable third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to Day 1 of Cycle 1 - Lactating women - Clinically suspected or confirmed central nervous system (CNS) metastases or carcinomatous meningitis - Active infection requiring IV antibiotics - Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or the equivalent of less than or equal to (</=) 10 milligrams per day (mg/day) prednisone - Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis - Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2 Bevacizumab-Specific Exclusions - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of bevacizumab or an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications - Inadequately controlled hypertension - Prior history of hypertensive crisis or hypertensive encephalopathy - New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF) - History of myocardial infarction or unstable angina within 6 months prior to Day 1 - History of stroke or transient ischemic attack (TIA) within 6 months prior to Day 1 - Significant vascular disease within 6 months prior to Day 1 - Evidence of bleeding diathesis or significant coagulopathy - Current or recent (within 10 days of first dose of study treatment) use of aspirin or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol - Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study - Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 - History of abdominal or tracheo-oesophageal fistula or gastrointestinal (GI) perforation within 6 months prior to Day 1 - Clinical signs or symptoms of GI obstruction or a requirement for routine parenteral hydration, parenteral nutrition, or tube feeding - Evidence of abdominal free air not explained by paracentesis or recent surgical procedure - Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture 5-Fluorouracil-Specific Exclusion - Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the participant for 5-fluorouracil toxicity ; PRIMARY OUTCOME: Progression-Free Survival Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 as Determined by the Investigator; SECONDARY OUTCOME 1: Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR] Based on RECIST v 1.1 as Determined by the Investigator[/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 - TERACLES - EFC6058 (RMS); BRIEF: The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: - Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on: - Disease activity as measured by brain Magnetic Resonance Imaging (MRI) - Disability progression - Burden of disease and disease progression as measured by brain MRI - Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy - Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy - Assess associations between variations in genes and clinical outcomes (safety and efficacy) - Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life - Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit) ; DRUG USED: Aubagio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Dihydroorotate Dehydrogenase (DHODH), DNA synthesis; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Patient with relapsing forms of MS treated with IFN-beta - Stable dose of IFN-beta (approved brand) for at least 6 months prior to randomization - Disease activity in the 12 months prior to randomization and after first 3 months of IFN-beta treatment (defined by at least 1 relapse supported by EDSS or equivalent neurological examination, or, at least 1 brain or spinal cord MRI with at least one T1 gadolinium enhancing lesion) Exclusion criteria: - McDonald criteria for MS diagnosis not met at time of screening visit - EDSS score greater than (>) 5.5 at randomization visit - A relapse within 30 days prior randomization - Persistent significant or severe infection - Patients must not have used adrenocorticotrophic hormone or systemic corticosteroids for 2 weeks prior to randomization - Prior or concomitant use of cytokine therapy (except baseline interferons), glatiramer acetate or intravenous immunoglobulins in the 3 months preceding randomization - Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2 times the upper limit of normal range (ULN) - Active hepatitis or hepatobiliary disease or known history of severe hepatitis - Pregnant or breast-feeding women or those who were planning to become pregnant during the study - Significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia - Human Immunodeficiency Virus (HIV) positive - Known history of active tuberculosis not adequately treated - Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone - Prior use within 6 months preceding randomization or concomitant use of natalizumab, or any other immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, mycophenolate, or fingolimod The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Annualized Relapse Rate (ARR) (Poisson Regression Estimates); SECONDARY OUTCOME 1: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)[/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 - Safety/PK; BRIEF: This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed. ; DRUG USED: GB004; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.; CRITERIA: Inclusion Criteria: - Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation. Exclusion Criteria: - Evidence of Crohns disease, indeterminate colitis, or presence of bacterial or parasitic infection. - Patients receiving biologic agents and experimental agents are excluded. ; PRIMARY OUTCOME: Incidence of treatment emergent adverse events; SECONDARY OUTCOME 1: Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004[/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 Males; BRIEF: AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and potentially also asthma (in combination with an inhaled corticosteroid [ICS]). The therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism bronchodilators, with an equivalent or superior safety and tolerability profile. The primary purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A multiple ascending dose (MAD) design has been selected for this study following the first time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in an ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent doses will be decided based on safety, tolerability and pharmacokinetic (PK) data generated in the previous dose. The aim of this study is to also enable further investigations in healthy subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable side-effect profile compared to other inhaled bronchodilators on the market as a treatment for COPD and asthma. ; DRUG USED: AZD8871; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of written informed consent prior to conducting any study-related procedures, including withdrawal of medications. 2. Male subjects aged 18 to 55 years, inclusive at Screening. 3. Body mass index (BMI) calculated as weight in kg/height in m2 from ≥18 to ≤30 kg/m2 and weight ≥50 kg at Screening. 4. Healthy, free from any clinically significant disease/ conditions (including all cardiovascular conditions), as determined by medical history, physical examination, clinical laboratory testing, 12-lead ECG findings at Screening and admission to the unit. 5. Spirometry readings (FEV1 and Forced Vital Capacity [FVC]) to be ≥80% of predicted value calculated using Quanjer 2012 reference equations (Quanjer et al 2012) at Screening. 6. Normal blood pressure (BP) (defined as systolic BP [SBP] ≥90 and ≤140 mmHg, and diastolic BP [DBP] ≥50 and ≤90 mmHg) at Screening and admission to the unit, measured after resting in supine position for at least 10 minutes. 7. Normal heart rate (HR) (defined as HR ≥45 and ≤90) measured after resting in supine position for at least 10 minutes at Screening and admission to the unit. 8. Negative for hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody (IgM), hepatitis C antibody and human immunodeficiency virus (HIV) I and II antibodies at Screening. 9. Negative for drugs of abuse and alcohol tests at Screening and admission to the unit. 10. Normal serum potassium at Screening and at admission to the unit. 11. Willing and able to comply with study specific procedures and restrictions Exclusion Criteria: 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 2. Surgical history clinically relevant for the purpose of the study or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of Screening. 3. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin. 4. Current smokers, or a smoking history during the last 6 months or total smoking history of more than 10 pack-years. Use of electronic cigarettes or other forms of nicotine, current use or use within the last 6 months. 5. Prolonged QTcF interval, >450 ms at Screening, or family history of long QT syndrome. 6. Any clinically significant arrhythmia noted on telemetry recording, prior to randomisation. 7. History of excessive use or abuse of alcohol within the past 2 years. 8. History of drug abuse within the past 2 years. 9. Donation or loss >400 ml of blood and plasma within the previous 3 months prior to Visit 1, Screening. 10. History of presence of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the Investigator or history of hypersensitivity to drugs pharmacologically related to study drug. 11. PR (PQ) interval shortening <120 ms (PR >110 ms but <120 ms is acceptable if there is no evidence of ventricular pre-excitation) at Screening. 12. PR (PQ) interval prolongation (> 240 ms), intermittent second (Wenckebach block while asleep is not exclusive), or third degree atrioventricular block, or atrioventricular dissociation at Screening. 13. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS >110 ms. 14. Subject who does not agree to follow instructions to avoid partner pregnancy. 15. Subject who is not able to adhere to the restrictions on prior and concomitant medications. 16. Used any investigational drug within 3 months prior to Screening or within the equivalent time of 5 half-lives of receiving the last administration, whichever is longer, or on an extended follow-up after receiving an IMP. 17. Subjects unable to communicate reliably with the Investigator. 18. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order. ; PRIMARY OUTCOME: Number of Participants With ≥1 Treatment Emergent Adverse Event in Any Category.; SECONDARY OUTCOME 1: Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Single Dose).[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SCULPTURE (Ext.); BRIEF: CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations. 2. Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307 3. Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator Exclusion Criteria: 1. A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject 2. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study. 3. Subjects expected to be exposed to an undue safety risk if participating in the trial 4. Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial 5. Plans for administration of live vaccines during the study period 6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL). ; PRIMARY OUTCOME: Long-term Safety and Tolerability of Secukinumab; SECONDARY OUTCOME 1: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260[/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 - CLL8/ML17102 - 1st Line; BRIEF: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia. ; DRUG USED: Rituxan; DRUG CLASS: Biologic; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: DISEASE CHARACTERISTICS: - Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria - Meets 1 of the following criteria: - Binet stage C disease - Binet stage B disease AND ≥ 1 of the following signs or symptoms*: - B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers > 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue) - Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count > 50 G/I) - Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia - Massive, progressive or painful splenomegaly or hypersplenism - Massive lymph nodes or lymph node clusters (> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy - Occurrence of symptomatic hyperviscosity problems at leukocyte counts > 200 G/I (symptomatic leukostasis) NOTE: * Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility - No Binet stage A disease - No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richters syndrome, or prolymphocytic leukemia) PATIENT CHARACTERISTICS: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Cumulative Illness Rating Scale (CIRS) score > 6 - Life expectancy > 6 months - Bilirubin ≤ 2 times upper limit of normal (ULN) - Alkaline phosphatase and transaminases ≤ 2 times ULN - Creatinine clearance ≥ 70 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study treatment - No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs - No cerebral dysfunction that precludes chemotherapy - No active bacterial, viral, or fungal infection - No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia - No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery - No medical or psychological condition that would preclude study therapy - No concurrent disease that requires prolonged (> 1 month) therapy involving glucocorticoids PRIOR CONCURRENT THERAPY: - No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Event-free Survival (EFS)[/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 - Mexico; BRIEF: The purpose of this study is to evaluate the efficacy, dose-response and safety of udenafil 25 mg, 50 mg and 75 mg every day (q.d.) for 12 weeks in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH and for the treatment of erectile dysfunction (ED). ; DRUG USED: Udenafil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Erectile Dysfunction (ED); TARGET: Phosphodiesterase 5 (PDE5); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Men ≥ 45 years of age. 2. Sexually active, with a stable female partner with whom the participant expects to have a relationship for the entire duration of the study. 3. The participant has benign prostatic hyperplasia with lower urinary tract symptoms (BPH-LUTS) according to clinical diagnostic criteria, with ≥ 6 months of evolution at the screening visit. 4. Clinical history of erectile dysfunction (ED) (defined as the inability to achieve or maintain the penile erection to achieve a satisfactory sexual relationship) of at least 3 months of evolution. 5. Freely given informed consent at the screening visit (an essential requirement to participate in the study). 6. Bladder obstruction defined by maximal flow rate (Qmax) of 4-15 mI/sec (with a premicturition volume of 150 to 550 mL evaluated by ultrasound, with a minimum micturition volume of 125 mL) at Visit I immediately prior to active treatment initiation. 7. Total score of ≥ 13 points in the InternationaI Prostate Symptom Score (IPSS) questionnaire at Visit 1, immediately prior to active treatment initiation. Exclusion Criteria: 1. Participants that are currently taking nitrates, antiandrogens, estrogens, luteninizing hormone-releasing hormone agonist/antagonist, or anabolic steroids at study entry. Participants that are taking a stable dose level of testosterone are not excluded. 2. Post-void residual (PVR) volume ≥ 300 mL, as assessed by ultrasound at the Visit 1. 3. Prostate-specific antigen (PSA) ≥ 10.0 ng/mL at the Visit 1. 4. PSA of 4.0 - 10.0 ng/ml if free PSA is < 0,25 (25%) at Visit 1. 5. Clinical evidence of prostate cancer. 6. Glycosylated hemoglobin (Hb1Ac) > 10 % at study entry. 7. Patients who have undergone bladder catheterization due to acute urine retention. 8. Medical history or clinical evidence of any pelvic, bladder or urinary tract condition, or urinary retention that, as judged by the urologist, might compromise protocol compliance. 9. Any surgical procedure in the lower urinary tract (including prostate biopsy) within 30 days prior to the Screening Visit. ; PRIMARY OUTCOME: Change from Baseline in Total International Prostate Symptom Score (IPSS); SECONDARY OUTCOME 1: Participants with Adverse Events[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMPALA 2; BRIEF: 160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim or placebo for 48 weeks. Subjects completing the 48 week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 96 weeks. ; DRUG USED: Molgradex; DRUG CLASS: Biologic; INDICATION: Pulmonary Alveolar Proteinosis (PAP); TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116; THERAPY: Monotherapy; LEAD SPONSOR: Savara Inc.; CRITERIA: Inclusion Criteria: 1. Subject must be ≥18 years of age, at the time of signing the informed consent (≥20 in Japan). 2. A serum anti-GM-CSF autoantibody test result confirming autoimmune PAP. 3. History of PAP, based on examination of a lung biopsy, bronchoalveolar lavage (BAL) cytology, or a high-resolution computed tomogram (HRCT) of the chest. 4. DLCO 70% predicted or lower at the screening and baseline visits. 5. Change in % predicted DLCO of <15% points during the screening period. 6. Demonstrated functional impairment in the treadmill exercise test (defined as a peak MET ≤8). 7. Willing and able to come off supplemental oxygen use prior to and during the treadmill exercise test, the DLCO assessment, and the arterial blood gas sampling. 8. Resting SpO2 >85% during 15 minutes without use of supplemental oxygen at the screening visits. 9. Male or female 10. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 1. Male subjects: Males agreeing to use condoms during and until 30 days after last dose of trial treatment, or males having a female partner who is using adequate contraception as described below. 2. Female subjects: Females who have been post-menopausal for >1 year, or females of childbearing potential after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with <1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence*), during and until 30 days after last dose of trial treatment. Females of childbearing potential must have a negative serum pregnancy test at the screening visits, and a negative urine pregnancy test at Baseline visit (Visit 3) and must not be lactating. 11. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified in the protocol as judged by the Investigator. Exclusion Criteria: 1. Diagnosis of hereditary or secondary PAP, or a metabolic disorder of surfactant production. 2. WLL performed within 3 months prior to baseline. 3. Requirement for WLL at screening or baseline. 4. GM-CSF treatment within 6 months prior to baseline. 5. Treatment with rituximab within 6 months prior to baseline. 6. Treatment with plasmapheresis within 6 weeks prior to baseline. 7. Treatment with any investigational medicinal product within 5 half-lives or 3 months (whichever is longer) prior to baseline. 8. Previously randomized in this trial. 9. History of allergic reactions to GM-CSF or any of the excipients in the nebulizer solution. 10. Inflammatory or autoimmune disease of a severity that necessitates significant (e.g. more than 10 mg/day systemic prednisolone) immunosuppression. 11. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product. 12. History of, or present, myeloproliferative disease or leukemia. 13. Apparent pre-existing concurrent pulmonary fibrosis. 14. Acute or unstable cardiac or pulmonary disease that may be aggravated by exercise. 15. Known active infection (viral, bacterial, fungal, or mycobacterial) that may affect the efficacy evaluation in the trial. 16. Physical disability or other condition that precludes safe and adequate exercise testing. 17. Any other serious medical condition which in the opinion of the Investigator would make the subject unsuitable for the trial. 18. Pregnant, planning to become pregnant during the trial, or breastfeeding woman. For France only: including as further defined by French Health Code L-1121-5. 19. For France only: Any subject considered to be vulnerable on account of, e.g., mental or physical disability, socio-economic situation, or subjects deprived of their liberty. For France only: including as further defined by French Health Code L1121-8-1. ; PRIMARY OUTCOME: Change from baseline in percentage (%) predicted diffusing capacity of the lung for carbon monoxide (DLCO) to Week 24; SECONDARY OUTCOME 1: Change from baseline in percentage (%) predicted DLCO to Week 48[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - EVOLVE; BRIEF: This is a multicentre, open-label, Phase I/II study of enadenotucirev in patients with either solid tumour of epithelial origin not responding to standard therapy or for whom no standard treatment exists (Phase I dose escalation stage Single cycle), mCRC not responding to standard therapy (Phase I dose escalation Repeat cycle cohort expansion stage ), mCRC not responding to standard therapy or advanced or metastatic bladder cancer not candidate for chemotherapy (Phase Ib) or mCRC in stable disease or partial response after 3-4 months of first line standard of care chemotherapy (Phase II). ; DRUG USED: Enadenotucirev; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Immune System, Oncolytic Virus Therapy, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: Akamis Bio; CRITERIA: Inclusion Criteria: - Patients must provide written informed consent - Age ≥ 18 years and the patient must be at least the legal age limit to be able to give consent within the jurisdiction the study is taking place. - ECOG performance status 0 or 1 - Predicted life expectancy of 3 months or more - Ability to comply with study procedures in the Investigators opinion - Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies - Adequate renal function - Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ≥ 60 mL/min, or measured creatinine clearance ≥ 60 mL/min, Haematuria: dipstick ≤ 2+ - Proteinuria: dipstick ≤ 2+ - Adequate hepatic function - Serum bilirubin < 1.5 mg/dL - Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3x upper limit of normal (ULN) - Adequate bone marrow function: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 100 x 109/L - Haemoglobin ≥ 100 g/L for UCC and ≥ 90 g/L for other cancers - Adequate coagulation tests: international normalised ratio (INR) ≤ 1.5 x ULN - For females of childbearing potential (defined as <2 years after last menstruation or not surgically sterile), a negative serum pregnancy test must be documented within 14 days prior to first administration of study treatment - For women who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, during the treatment period and for at least 3 months after the last dose of study drug - For men: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug - At least 3 weeks since any dose of IV systemic chemotherapy and at least two weeks since any oral dose of capecitabine at the time of first administration of ColoAd1. Phase I Specific Inclusion Criteria: Dose Escalation Stage only (except Repeat Cycle Cohort): - Solid tumour of epithelial origin not responding to standard therapy or for whom no standard treatment exists Dose Expansion Stage Single Cycle and Dose Escalation Stage Repeat Cycle Cohort: - mCRC not responding to standard therapy - ≤ 3 prior lines of systemic therapy for advanced disease OR ≤ 4 prior lines of systemic therapy for advanced disease if one of the 4 lines was an anti EGFR therapy given as a single agent or combined to a previously administered chemotherapy regimen Phase Ib:mCRC not responding to standard therapy - no more than 3 prior lines of systemic therapy for advanced disease OR no more than 4 prior lines of systemic therapy for advanced disease if one of the 4 lines was an anti EGFR therapy given as a single agent or combined to a previously administered chemotherapy regimen - Advanced or metastatic UCC, who have received a maximum of one chemotherapy-containing regimen and a maximum of one other systemic treatment with biologic agents only. Phase II Specific Inclusion Criteria: - mCRC - Have received 3 - 4 months of first line chemotherapy with either FOLFOX, FOLFIRI or CAPOX, with or without bevacizumab - At least one measurable lesion according to RECIST 1.1 criteria - Documented partial response or stable disease - Eligible to receive chemotherapy with FOLFOX or CAPOX after a short chemotherapy interruption (3 to 4 weeks) Exclusion Criteria for all Patients: - Pregnant or breast feeding females; - Known history or evidence of significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [AIDS]) and/or medication (e.g. systemic corticosteroids, or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks) - Splenectomy - Prior allogeneic or autologous bone marrow or organ transplantation - Active infections requiring antibiotics, physician monitoring, or recurrent fevers >38.0 degrees centigrade associated with a clinical diagnosis of active infection - Active viral disease or known positive serology for HIV, hepatitis B or hepatitis C; - Use of the following anti-viral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to day 1; or pegylated interferon (PEG-IFN) (within 14 days prior to first administration of ColoAd1) - Administration of an investigational drug within 28 days prior to first dose of ColoAd1 - Major surgery within 4 weeks or radiotherapy within 3 weeks prior to first dose of ColoAd1 - Another primary malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ) - Central nervous system (CNS) metastasis that is symptomatic and/or requires treatment - Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the drug - Known allergy to treatment medication or its excipients - Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent Phase II Specific Exclusion Criteria: - Progression on first line therapy - A complete response on first line therapy - Use of first line therapy for longer than 4 months - Use of any first line treatment with a chemotherapy regimen other than FOLFOX, FOLFIRI or CAPOX (each with or without bevacizumab) - More than 6 weeks since the last administration of 5 FU, capecitabine, oxaliplatin or irinotecan ; PRIMARY OUTCOME: Phase 1 - Maximum Tolerated Dose; 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 - ATTENTION (Asia) - w/erlotinib; BRIEF: The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population. ; DRUG USED: Tivantinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Combination; LEAD SPONSOR: Kyowa Kirin Co., Ltd.; CRITERIA: Inclusion Criteria 1. Male or female at least 20 years of age with life expectancy ≥ 3 months 2. Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay 3. Evaluable disease according to RECIST, Version 1.1 4. Received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-based therapy 5. ECOG performance status of 0 or 1 6. Demonstrate adequate bone marrow, liver, and renal functions, defined as: • ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN, ANC ≥1.5 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin ≥9.0 g/dL, and serum creatinine ≤1.5 mg/dL. 7. Voluntary written informed consent form before performance of any study-specific procedures or tests Exclusion Criteria 1. Prior therapy with an EGFR inhibitor and/or tivantinib 2. Any systemic anti-tumor treatment for NSCLC or investigational agents within 4 weeks prior to randomization 3. Palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization 4. Major surgical procedure within 4 weeks prior to randomization 5. History of cardiac disease 6. Known symptomatic brain metastases 7. Need to breastfeed a child during or within 12 weeks of completing the study 8. Significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib 9. History of malignancy other than NSCLC 10. Known infection with HIV, active HBV or HCV 11. Clinically significant interstitial lung diseases detected by CT scan or prior history of such diseases 12. Psychiatric disease that could affect the informed consent process 13. Subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective 14. Positive serum or urine pregnancy test in female subjects of childbearing potential 15. Any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Progression free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SKYLITE (w/SSRI); BRIEF: This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin 30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their background therapy with an SSRI. Participants will be allocated to one of two strata. Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2 visit. Participants in both strata will receive the study drug in addition to their background therapy with an SSRI until Week 16. ; DRUG USED: Bitopertin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obsessive-Compulsive Disorder (OCD); TARGET: Glycine Neurotransmitter Transporter (GlyT-1); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) - On a stable dose of SSRI for at least 8 weeks prior to screening an between screening and Day 1 - An insufficient response to current treatment with an SSRI given at an adequate dose for at least 12 weeks prior to Day 1 - Females who are not postmenopausal or surgically sterile and who have (or may have) male sexual partners must agree to use two adequate methods of contraception as defined by protocol from the start of screening until 90 days after the last dose of study drug Exclusion Criteria: - Primary OCD symptom of hoarding - More than two unsatisfactory trials within the last 2 years with different serotonin reuptake inhibitors (not including the current treatment with an SSRI) given in an adequate dose for at least 12 weeks - Failure of more than three augmentation therapies within the last 2 years - Undergoing acute behavioral therapy or having acute behavioral therapy that was completed less than 4 weeks prior to Day 1 - Any primary DSM-IV-TR Axis I disorder other than OCD - Current or prior history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, or Gilles de la Tourette syndrome if symptoms have persisted into adulthood - Any eating disorder within the last 6 months - History of DSM-IV-TR-defined substance dependence and/or substance abuse in the last 6 months, with the exception of nicotine - Previous treatment with bitopertin or another Glycine transporter 1 inhibitor - Positive urine drug screening for cannabis, amphetamines (including 3,4-methylenedioxymethamphetamine [MDMA]/ecstasy), cocaine, barbiturate, and/or opiates - Prior or current general medical condition that may impair cognition or other neuropsychiatric functioning - Body mass index less than (<) 18.5 kilogram per square meter (kg/m^2) or greater than (>) 40 kg/m^2 - Pregnant or lactating women ; PRIMARY OUTCOME: Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment; SECONDARY OUTCOME 1: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score After 12 Weeks of Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Low HDL; BRIEF: The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects. ; DRUG USED: Apabetalone; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiovascular Disease; TARGET: Apolipoprotein A-I, BET Proteins/Bromodomains, BRD4 (Bromodomain Containing 4); THERAPY: Monotherapy; LEAD SPONSOR: Resverlogix Corp; CRITERIA: Inclusion Criteria: - Subjects who meet the following criteria may be enrolled: 1. Be men or women between 18 and 65 years old, inclusive 2. Weigh between 60 kg and 110 kg, inclusive, and have a BMI ≥25 kg/m2. 3. Healthy volunteers with normal or low HDL 4. If female, non-pregnant (as determined by a negative serum pregnancy test at Screening), non-lactating, and not of childbearing-potential or willing to practice an acceptable form of birth control. If male, be willing to practice an acceptable form of birth control. Exclusion Criteria: - Subjects who meet any of the following criteria will not be enrolled: 1. Have presently, or have a history of, clinically significant disease, including cardiovascular, gastrointestinal, renal, hepatic, pulmonary, endocrine, hematologic, vascular, immunologic, metabolic, neurological, or collagen disease, as judged by the Investigator. 2. Have active cholecystitis or gallbladder symptoms within 60 days prior to Check-in (subjects who have had a cholecystectomy are not excluded from this study). 3. Have had a clinically significant illness, in the opinion of the Investigator, within 30 days prior to Check-in. 4. Have hypertension that is currently being treated, or uncontrolled hypertension 5. Have a serum creatinine >1.5 mg/dL, hemoglobin <11.2 g/dL, or white blood cell count <4000/μL. 6. Have positive test results for HIV, hepatitis A, B, or C. 7. Have a positive result on drug screen testing. ; PRIMARY OUTCOME: Safety, pharmacokinetics and changes in lipid parameters from baseline and 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 III - CR013012; BRIEF: The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures. ; DRUG USED: Comfyde; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: Unknown; THERAPY: Combination; LEAD SPONSOR: SK Life Science, Inc.; CRITERIA: Inclusion Criteria: - Male or Female, 16 year or older - Clinical diagnosis of focal epilepsy for at least 1 year - History of poor response to at least 1 anti-epileptic drug in the past - Current treatment with 1 or 2 anti-epileptic drugs - Should have at least 3 seizures per month Exclusion Criteria: - Generalized epilepsy - Cannot count your seizures - Unstable medical disease, such as a recent heart attack or uncontrolled diabetes - Major psychiatric illness - Recent drug or alcohol abuse - Unable to swallow pills ; PRIMARY OUTCOME: The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.; SECONDARY OUTCOME 1: The key secondary outcome is the change in the Seizure Severity Questionnaire score.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - STOP-HF; BRIEF: This is a randomized, double-blind, placebo controlled Phase II study is designed to assess the safety and efficacy of using JVS-100 to treat heart failure. ; DRUG USED: JVS-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiomyopathy - Ischemic; TARGET: Chemokine (C-X-C motif) Ligand 12 (CXCL12)/Stromal Cell-Derived Factor 1 (SDF-1); THERAPY: Monotherapy; LEAD SPONSOR: Juventas Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Willing and able to sign informed consent - Greater than or equal to 18 years of age - Subjects with impaired 6 minute hall walk distance - Impaired quality of life as measured by Minnesota LWHF questionnaire - Ischemic cardiomyopathy without an acute coronary syndrome within the last 6 months - Residual well-demarcated region of LV systolic dysfunction defined as at least 3 consecutive segments of abnormal wall motion by echocardiography read at the echocardiography core laboratory - LVEF ≤40% measured by echocardiography read at the echocardiography core laboratory - Must meet wall thickness criteria - Subject has an implanted, functional AICD - Subjects with diabetes must have had an ophthalmologist exam within the last year showing no active proliferative retinopathy - Subject receiving stable optimal pharmacological therapy defined as: - ACE inhibitor and/or ARB, and Beta-blocker for 90 days with stable dose for 30 days unless contraindicated - Diuretic in subjects with evidence of fluid retention - ASA unless contraindicated - Statin unless contraindicated - Aldosterone antagonist per physician discretion Exclusion Criteria: - Planned revascularization within 30 days following enrollment - Estimated Glomerular Filtration Rate < 30 ml/min* - Signs of acute heart failure within 24 hours of scheduled injection - History of aortic valve regurgitation classified as moderate or severe - Moderate/Severe aortic stenosis defined as AVA <1.5 cm2 Note: Patient should not be excluded if the patients medical records document that within the last 6 months the patient has either: - no aortic stenosis - mild aortic stenosis - normal aortic valve - normal aortic pressure gradient - aortic pressure gradient < 20 mmHg - Presence of an artificial aortic valve - Subjects with aortic aneurysm >3.8 cm - Mitral regurgitation defined as severe measured by echocardiography at the clinical site. - Patients with planned mitral valve repair or replacement surgery - Any patient with a history of cancer will be excluded unless: - The cancer was limited to curable non-melanoma skin malignancies and/or - The cancer was removed by a successful tumor resection, with or without radiation or chemotherapy treatment, 5 years or more prior to enrollment in this study without recurrence Subjects must have the following results on age appropriate cancer screenings: - Subjects age 50 or older have had a Fecal occult blood test (FOBT) or fecal immunochemical test (FIT) that was negative within the last year - Women age 30 or older have had a PAP test that was negative within the last 3 years - Women age 40 or older have had a mammogram that was negative within the last year - Men above age 45 have had a Prostate-Specific Antigen (PSA) blood test and digital rectal examination (DRE) that was negative within the last year - At the request of the site principal investigator, any subject with a non-negative result thought to be due to a non-cancer-related condition will be evaluated by the medical monitor for enrollment Exclusion Criteria (ctd): - Subjects with persistent or chronic atrial fibrillation will be excluded unless: - A stable, regular heart rate is maintained with a biventricular pacemaker - A stable, regular heart rate is maintained with a univentricular pacemaker pacing less than or equal to 40% of the time - Subjects with Biventricular pacing device implant within the last 3 months OR previously implanted Biventricular pacing device with programming planned to be reoptimized following enrollment in this trial - Previous solid organ transplant - Subjects with greater than 40% univentricular RV Pacing - Subjects with uncontrolled diabetes defined as HbA1c >9.0% - Inability to complete 6 minute walk or treadmill exercise test - Participation in an experimental clinical trial within 30 days prior to enrollment - Any subject who has been enrolled in a gene or stem cell therapy cardiac trial within the last year - Life expectancy of less than 1 year - Positive pregnancy test (serum βHCG) in women of childbearing potential and/or unwillingness to use contraceptives or limit sexual activity as described in Section 8.2.1 below - Unwillingness of men capable of fathering a child to agree to use barrier contraception or limit sexual activity as described in Section 8.2.1 below - Subjects who are breast feeding - Subjects with a positive test results for hepatitis B/C and/or HIV - Total Serum Bilirubin >4.0 mg/dl - Aspartate aminotransferase (AST) > 120 IU/L - Alanine aminotransferase (ALT) > 135 IU/L - Alkaline phosphatase (ALP) >300 IU/L - Clinically significant elevations in PT or PTT relative to laboratory norms - Any subject with a known existing LV thrombus or has an LV thrombus detected during the screening period of this study. - Subjects with Rutherford class 5 or 6 critical limb ischemia - Subject with severe chronic obstructive pulmonary disease (COPD) - Any subject requiring home oxygen use - Subjects with a history of Systemic Lupus Erythematosus (SLE) flare - History of drug or alcohol abuse within the last year - A subject will be excluded if he/she is unfit for the trial based on the discretion of the site Principal Investigator ; PRIMARY OUTCOME: Impact of JVS-100 injection on Six Minute Walk Distance (6MWD) at 4 month follow-up; SECONDARY OUTCOME 1: Impact of JVS-100 Injection on Quality of Life[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CIRRUS; BRIEF: The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease ; DRUG USED: AZD5069; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Chemokine (C-X-C motif) Receptor 2 (CXCR2) / IL-8 receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Clinical diagnosis of COPD with symptoms for more than one year before screening - Body mass index of 18-30 kg/m2 and weight of 50-100kg - Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening - FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening - FEV1/FVC less than 70% post-bronchodilator at screening Exclusion Criteria: - Any clinically significant disease or disorder - Exacerbation of COPD which was not resolved within 30 days of first dosing - Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing - Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant - Disease history suggesting reduced or abnormal immune function other than that related to COPD ; PRIMARY OUTCOME: Patients Who Experienced at Least One Adverse Events(s); SECONDARY OUTCOME 1: Plasma Concentration of AZD5069 After 1 Hour 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 III - CheckMate 602 (w/Elotuzumab); BRIEF: The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either: Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. Enrollment is closed for all groups. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Refractory or relapsed and refractory multiple myeloma - Measurable disease - Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination Exclusion Criteria: - Solitary bone or extramedullary plasmacytoma disease only - Active plasma cell leukemia Other protocol defined inclusion/exclusion criteria apply ; 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 - Extension (IV); BRIEF: The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE). ; DRUG USED: Saphnelo; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Interferon-alpha (IFNa); THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: - Must be willing to use 2 methods of effective contraception - Must have venous access - Must be willing to forego participation in other clinical trials for SLE. Exclusion Criteria: - Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product - Major surgery within 8 weeks before signing informed consent form (ICF) - Elective major surgery planned during the study period - Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day, Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate > 25 mg/week - A live or attenuated vaccine within 4 weeks of signing the ICF - Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF ; PRIMARY OUTCOME: Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs); SECONDARY OUTCOME 1: Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab[/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 - CLEAR (Ext.); BRIEF: This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe. ; DRUG USED: Zurampic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gout; TARGET: URAT1 (urate trans-porter 1, SLC22A12/Solute carrier family 22, member 12); THERAPY: Combination; LEAD SPONSOR: Ardea Biosciences, Inc.; CRITERIA: Inclusion Criteria: - Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. - Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit. - Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth Exclusion Criteria: - Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subjects ability to comply with the protocol requirements, or to complete the study. ; PRIMARY OUTCOME: Proportion of subjects with an sUA level that is < 6.0 mg/dL; SECONDARY OUTCOME 1: Resolution of at least 1 target tophi[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/SoC Treatment; BRIEF: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment. ; DRUG USED: JNJ-3872; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Influenza Virus, Polymerase Basic Protein 2 (PB2), RNA polymerase; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay - Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (for example, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including participants admitted to the Intensive Care Unit (ICU) - Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours after onset of influenza symptoms - Being on invasive mechanical ventilation or having a peripheral capillary oxygen saturation (SpO2) less than (<)94 percent (%) on room air during screening. Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than or equal to (>=)3% from pre-influenza SpO2 during screening - Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4 Exclusion Criteria: - Received more than 3 doses of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one day prior to screening - Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive) - Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome - Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy - Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, any history of a lung transplant) - Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients ; PRIMARY OUTCOME: Number of Participants With Hospital Recovery Scale on Day 6; SECONDARY OUTCOME 1: Time to Hospital Discharge[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TEMPO-1 (Fixed Dose, Early Stage); BRIEF: The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD. ; DRUG USED: Tavapadon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine 1 (D1) Receptor, Dopamine 5 (D5) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Cerevel Therapeutics, LLC; CRITERIA: Key Inclusion Criteria: - Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF) - Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment - Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol - Participants with a diagnosis of PD that is consistent with the UK Parkinsons Disease Society Brain Bank diagnostic criteria - Participants with modified Hoehn and Yahr stage 1, 1.5, or 2 - Participants with disease duration (from time of diagnosis) of less than (<) 3 years and disease progression in the 3 years before signing the ICF - Participants with an MDS-UPDRS Part II score >=2 and Part III score >=10 at the Screening Visit and at the Baseline Visit - Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management - Participants who are treatment naïve or have a history of prior incidental treatment with dopaminergic agents (including Levodopa [L-Dopa] and dopamine receptor agonist medications) for <3 months in total but not within 2 months of the Baseline Visit. Prior and concurrent use of monoamine oxidase B (MAO-B) inhibitors is permitted if use was initiated >90 days before the Baseline Visit and the dosage will remain stable for the duration of the trial (i.e, no change in the MAO-B inhibitor dose is permitted during the trial) - Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial. Key Exclusion Criteria: - Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post stroke parkinsonism). - Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages. - Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5). - Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures. - Participants with a history of psychosis or hallucinations within the previous 12 months. - Participants who answer yes on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer yes on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide. - Participants with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days) - Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial - Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding). - Participants who have a positive result for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies at screening. - Participants with a history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical intervention; second- or third-degree atrioventricular block; sick sinus syndrome; severe or unstable angina; or congestive heart failure within the last 12 months. A recent (less than or equal to [<=] 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control. - Participants with a history of neuroleptic malignant syndrome. - Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration). - Participants with a positive urine drug screen for illicit drugs are excluded and may not be retested or rescreened. Participants with a positive urine drug screen resulting from use of marijuana (any Tetrahydrocannabinol [THC]-containing product), prescription, or over-the-counter medications or products that, in the investigators documented opinion, do not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor - Participants with a Montreal Cognitive Assessment (MoCA) score <26 - Participants with clinically significant orthostatic hypotension (eg, syncope) - Participants with a 12-lead ECG demonstrating a QTcF interval >450 msec - Participants with moderate or severe renal impairment (creatinine clearance as estimated by Cockcroft-Gault formula <30 mL/min or on dialysis) - Participants with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary: - Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >=3 × Upper Limit Normal (ULN). - Total bilirubin >=1.5 × ULN. Participants with a history of Gilberts syndrome may be eligible provided they have a value <ULN for direct bilirubin. - Participants with other abnormal laboratory test results, vital sign results, or ECG findings unless, in the judgment of the investigator, the findings are not medically significant and would not impact the safety of the participants or the interpretation of the trial results. ; PRIMARY OUTCOME: Change From Baseline in the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score; SECONDARY OUTCOME 1: Change From Baseline in the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Parts II Score[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II; BRIEF: The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™ 2 mg in improving total night sleep duration and stabilizing the circadian clock phase in totally blind subjects with non-24 hour sleep-wake disorder. ; DRUG USED: Orlogin; DRUG CLASS: Non-NME; INDICATION: Non-24 Hour Sleep Wake Disorder (Non-24); TARGET: Melatonin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Neurim Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria: - Male or female subjects aged 20-80, having no conscious perception of light. - Meeting the criteria for diagnosing Non-24h cycle in the clinical setting: 1) difficulty initiating sleep or difficulty in awakening, 2) progressive delay of sleep phase with inability to maintain entrainment to 24-hour-day, and 3) presence of the sleep pattern for at least six weeks. - Average total night sleep duration of less than 6 hours per night for at least six weeks. - Ability to ingest oral medication and participate in all scheduled evaluations. - Signing of the Informed Consent approved by the Ethics Committee. The Informed Consent will be written in both Braille and black-and-white forms for blind subject and sighted witness. - Education or a work history sufficient to exclude mental retardation. - Stable medications for non-excluded concurrent medical conditions for four weeks prior to the screening visit. Exclusion Criteria: - Presence of medical disorders other than those related to blindness and medical treatment that may influence melatonin production, sleep or alertness. To be ascertained by medical history, complete physical examination including ECG and general biochemical work-up including complete blood count, serum chemistries, and urine analysis. - Presence of a psychiatric or mental disorder to be assessed by a structured psychiatric interview performed by a trained individual. - History of seizure disorders. - Irregular lifestyle or life pattern (e.g. shift workers and patients unable to keep the study routine). - Presence of a sleep problem revealed that may explain the subjects complaints, such as sleep disordered breathing, restless leg syndrome or periodic limb movement syndrome. - Use of benzodiazepines or other hypnotics during the study and preceding two weeks or 5 half lives whichever is longer. - Known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists - Use of melatonin during preceding two weeks - Use of psychiatric medications during the study and preceding three months. - History of autoimmune diseases - Pharmacological immuno-suppression. - Pregnancy or lactation, child-bearing potential with a lack of adequate contraception. - History of severe pathology likely to recur during or immediately after the study. - Participation in a clinical trial with any investigational agent within two months prior to study enrollment. - Patients incapable of performing the daily call to the study IVRS system and reporting on the questionnaires. ; PRIMARY OUTCOME: Total sleep time; SECONDARY OUTCOME 1: Daily diary records of sleep latency, sleep maintenance , total duration of naps;[/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 - INTEGRIS-IPF; BRIEF: A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis. ; DRUG USED: PLN-74809; DRUG CLASS: New Molecular Entity (NME); INDICATION: Idiopathic Pulmonary Fibrosis (IPF); TARGET: Integrin Alpha-V Family, Integrin beta-1/CD29; THERAPY: Monotherapy; LEAD SPONSOR: Pliant Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C & D) - FVC % of predicted ≥45% - DLco (hemoglobin-adjusted) ≥30% - Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed, if on a stable dose for at least 3 months Exclusion Criteria: - Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA - Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio <0.7 at Screening - Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression - Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening - Smoking of any kind within 3 months of Screening ; PRIMARY OUTCOME: Part A - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0; SECONDARY OUTCOME 1: Part A, B & C - Assessment of PLN-74809 plasma concentrations[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase 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 I/II - M.D. Anderson; BRIEF: This phase I/II trial studies the side effects of avelumab when given in different combinations with utomilumab, anti-OX40 antibody PF-04518600, and radiation therapy in treating patients with malignancies that have spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as avelumab, utomilumab, and anti-OX40 antibody PF-04518600, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy rays to kill tumor cells and shrink tumors. It is not yet known how well avelumab works in combination with these other anti-cancer therapies in patients with advanced malignancies. ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: - Subjects must be refractory to, or intolerant of, established therapy known to provide clinical benefit for their conditions, or where subjects refuse existing therapies. - Subjects must have measurable disease (RECIST v 1.1) or patients may have bone metastatic disease evaluable by Prostate Cancer Working Group 2 (PCWG2) for subjects with metastatic castration-resistant prostate cancer (CRPC) or according to tumor evaluation criteria best suitable and accepted for the tumor type evaluated. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - Platelets >= 100 x 10^9/L (For patients with hepatocellular carcinoma, platelets >= 70 x 10^9/L). - Hemoglobin >= 9 g/dL. - Absolute neutrophil count (ANC) >= 1.5 x 10^9/L. - White blood cell (WBC) >= 3 x 10^9/L. - Alanine transaminase (ALT) =< 2.5 x upper normal limit (ULN) (=< 5 x ULN for subjects with documented metastatic disease to the liver). - Aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with documented metastatic disease to the liver). - Alkaline phosphatase < 4 x ULN. - Total bilirubin =< 1.5 x ULN (In the expansion cohort, subjects with Gilberts syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN). - Albumin >= 3 g/dL. - Serum creatinine =< 2 x upper limit of normal (ULN) or estimated creatinine clearance >= 30 ml/min as calculated using the Cockcroft-Gault formula. - Subject has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v 4.03) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia. The exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria. - Life expectancy of at least 12 weeks. - Negative serum pregnancy test in women of childbearing potential within 7 days of first dose of treatment and patients of child-bearing potential must agree to use effective contraception during and after 90 days post dose. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices. - Subjects must have biopsiable disease. For Arms A, B, and C, subjects must have at least two lesions amenable to biopsy and response evaluation. For Arm D subjects should have at least three lesions amenable to biopsy, response evaluation, and radiation. Tumor lesions used for biopsy should not be lesions used as RECIST target lesions. However, if patients in Arm D do not have three separate lesions, patients will be eligible if there are two lesions, in which one is > 2 centimeters (short axis) and can be used for both biopsy and response evaluation. - Subjects must give informed consent according to the rules and regulations of the individual participating sites. Exclusion Criteria: - Subjects with primary central nervous system (CNS) tumor or CNS tumor involvement. However, subjects with metastatic CNS tumors may participate in this study if the subject is: - > 4 weeks from prior therapy completion (including radiation and/or surgery) - Clinically stable with respect to the CNS tumor at the time of study entry - Not receiving steroid therapy in treating CNS tumor or CNS tumor involvement - Not receiving anti-convulsive medications (that were started for brain metastases). - Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of study drug administration (6 weeks for mitomycin C or nitrosoureas). Palliative radiotherapy to a limited field is allowed after consultation with the medical monitor at any time during study participation, including during screening, unless its clearly indicative of disease progression. - Subjects with prior anti-PD-1, anti-PD-L1 treatment. For Arms A and D, subjects may not have had prior 4-1BB treatment. For Arm B, subjects may not have had prior OX40 treatment. For Arm C, subjects may not have had prior 4-1BB or OX40 treatment. - Diagnosis or recurrence of invasive cancer other than the present cancer within 3 years (except basal or squamous cell carcinoma of the skin that has been definitively treated). - Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association classification class II), or serious cardiac arrhythmia requiring medication. - Active infection requiring systemic therapy. - Treatment with an investigational anti-cancer study drug within 4 weeks prior to study drug administration date. - Concurrent therapy with approved or investigational anticancer therapeutics. - Known prior severe hypersensitivity to investigational product(s) or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 4.03 grade >= 3). - Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent; c. steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication). - Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. - Prior organ transplantation including allogenic stem-cell transplantation. - Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. - Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid (RNA) if anti-HCV antibody screening test positive). - Vaccination (live attenuated virus) within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines. - Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigators judgment are acceptable. - Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. - Medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results. - Pregnancy or lactation. - Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception. Highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 90 days after the end of study treatment. Women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months). - A diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy. - Has had prior radiation therapy within the past 3 months where the high dose area of the prior radiation would overlap with the high dose area of the intended radiation based on the judgement of the treatment oncologist. ; PRIMARY OUTCOME: Incidence of adverse events; SECONDARY OUTCOME 1: Objective response rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PK/PD Study (Healthy Subjects); BRIEF: This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in healthy male and female subjects. It is hypothesized that co-administering DS-1040b with aspirin at steady state will be safe and well tolerated by healthy male and female subjects. ; DRUG USED: DS-1040; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ischemic Stroke; TARGET: Carboxypeptidase U (CPU)/thrombin-activable fibrinolysis inhibitor (TAFI) ; THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo, Inc.; CRITERIA: Inclusion Criteria: - Healthy male and female subjects, aged 18 to 45 years. - A body mass index (BMI, or Quetlet index) in the range of 18.0 to 30.0 kg/m2, and weighing between 50 and 100 kg at screening. - Male subjects have to agree to contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another form of contraception (e.g., an intrauterine device, diaphragm with spermicide, oral contraceptive, injectable, or sub dermal hormonal implant) from the first dose until 16 weeks following the last dose administration. Also, the male subjects must not donate sperm after the study for a period of four months. - All women must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission (Day -1). Women must be of non-childbearing potential either: Surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) or naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with a follicle stimulating hormone (FSH) level at screening of ≥ 40 mIU/mL. - Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire trial. - Willingness to give written consent to participate after reading the ICF, and after having the opportunity to discuss the trial with the Investigator or his delegate. - Willingness to give written consent to have data entered into The Overvolunteering Prevention Scheme. - Willing to abstain from grapefruit/grapefruit juice and Seville oranges from 7 days before the first dose and throughout the study. - Willing to refrain from consuming food or beverages containing caffeine/xanthine starting 24 hours prior to check-in on Day -1. Exclusion Criteria: - Clinically relevant abnormal history, including cardiovascular, haematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic (including previous transient ischemic attack or stroke), and psychiatric diseases, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer. - History of a serious reaction to any medicine. - History of major bleeding, stomach ulcer, Raynauds disease, major trauma, or major surgical procedure of any type within 6 months of dosing. - History of minor bleeding episodes such as epistaxis, rectal bleeding (spots of blood on toilet paper), and gingival bleeding within 3 months before the study treatment. - Familial or documented or suspected coagulopathy and haemoglobinopathy. - Females with a history of dysfunctional uterine bleeding, including history of menorrhagia, metrorrhagia, or polymenorrhea. - History of an operation (e.g. stomach bypass), or a condition that could affect how the body handles or absorbs medicines. - History of gastro-oesophageal reflux disease. - Females who are breastfeeding. - Positive urine or faecal occult blood test at screening or admission (Day -1 or day 1). - Bleeding time > 9.5 minutes at screening). - aPTT, PT, INR, or platelet count outside the limit of normal of the clinical laboratorys reference range at screening. - Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 (based on Modification of Diet in Renal Disease [MDRD] equation). - Positive test for hepatitis B, hepatitis C, HIV1 & HIV2. - QTcF interval duration > 430 msec for males and 450 msec for females, obtained as an average from the 3 ECG measurements on the triplicate screening ECGs. - Abnormal waveform morphology on any of the ECGs at screening at admission that would preclude accurate measurement of the QT interval duration. - Physical trauma, dental extraction, surgery, or a significant illness within 4 weeks before the first dose. - History or presence of keloid, hyperpigmentation, or other adverse reaction to skin injury or surgery. - Use of any prescribed or non-prescribed (over-the-counter [OTC]) systemic medications (including anticoagulants or antiplatelet medications), topical medications, or herbal supplements within 14 days before the first dose (excluding paracetamol ≤ 2 g/day). St. Johns Wort (hypericin) must not have been taken for at least 30 days before the first dose. - Donated or lost > 400 mL of blood or plasma during 3 months before the first dose on Day 1. - Donation of blood, plasma, platelets, or any other blood components during the 3 months before the trial, or unwilling to abstain from doing so during the study and for 3 months after receipt of trial medication. - Participated in a clinical study involving administration of an investigational drug, or a marketed drug within 90 days before administration of the first dose. - Male subjects who consume more than 21 units of alcohol per week or female subjects who consume more than 14 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, a glass of wine, or 1 measure of spirits) or those subjects who have a significant history of alcoholism or drug/chemical abuse within the last 2 years. - Use of tobacco products or nicotine-containing products within 3 months before the first dose. - Positive results on tests for drugs of abuse, carbon monoxide, or alcohol at screening or admission. - Possibility that the volunteer will not cooperate with the requirements of the protocol. - Objection by General Practitioner (GP) to volunteer entering the trial. - Known aspirin allergy or intolerance. ; PRIMARY OUTCOME: bleeding time; SECONDARY OUTCOME 1: change in D-dimer level[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Bendamustine; BRIEF: This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation. ; DRUG USED: Brukinsa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Combination; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation 2. Histologically confirmed diagnosis of MCL 3. No prior systemic treatments for MCL 4. Measurable disease by CT/MRI 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Adequate marrow and organ function Key Exclusion Criteria: 1. Known central nervous system involvement by lymphoma 2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant 3. Clinically significant cardiovascular disease 4. History of severe bleeding disorder 5. Unable to swallow capsules or disease significantly affecting gastrointestinal function 6. Active fungal, bacterial and/or viral infection requiring systemic therapy 7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Progression-free survival (PFS) determined by independent central review; SECONDARY OUTCOME 1: PFS by investigator[/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 - ECOG/NCI; BRIEF: This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog) works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. ; DRUG USED: Halaven; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate - Progressive metastatic disease or stable metastatic disease with rising PSA - Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure - Patients who have not undergone bilateral orchiectomy must continue luteinizing hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist therapy (e.g. abarelix) while receiving study treatment - Patients who did not have an orchiectomy must have a testosterone level < 50 ng/dL to confirm androgen suppression within the past 4 weeks - ECOG performance status 0-2 - Adequate bone marrow function - Bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal - Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min - Fertile patients must use effective contraception - A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression - At least 4 weeks since prior chemotherapy or radiotherapy - At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression - Disease progression after antiandrogen withdrawal must be confirmed by rising PSA after the required 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on antiandrogen therapy) - More than 4 weeks since prior estrogen, estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or any other hormonal therapy (including megestrol, finasteride, ketoconazole, or systemic corticosteroids) - Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided the patient has been receiving the bisphosphonate for >= 4 weeks and there is evidence of disease progression Exclusion Criteria: - Active angina pectoris - Known New York Heart Association class III-IV heart disease - Myocardial infarction within the past 6 months - Evidence of ventricular dysrhythmias or other unstable arrhythmia (rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint) - Peripheral neuropathy > grade 2 - Other prior malignancy (excluding nonmelanomatous skin cancer treated with curative intent) unless the malignancy was treated with curative intent and the patient has been disease free for >= 5 years - Serious concurrent medical illness or active infection that would preclude study treatment - No concurrent strong inhibitors or inducers of CYP3A4 - More than 2 prior chemotherapy regimens for hormone-refractory disease - Other concurrent investigational agents - Other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy - Concurrent palliative radiotherapy - Concurrent estrogen, estrogen-like agents, or any other hormonal therapy - Carcinomatous meningitis or brain metastases - Prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes - Concurrent therapeutic anticoagulation with warfarin (Unfractionated heparin [standard, low-dose, or adjusted dose] or low molecular weight heparin allowed ; PRIMARY OUTCOME: Proportion of Patients With PSA Response; SECONDARY OUTCOME 1: Proportion of Patients With Measurable Disease Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ALLEVIATE A; BRIEF: The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard treatments for patients with SLE. ; DRUG USED: Epratuzumab - SLE; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Cluster of Differentiation 22 (CD22); THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Has SLE by ACR revised criteria (meets <4 criteria); - Has SLE with at least one elevated lupus antibody; - Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic Exclusion Criteria: - Active severe CNS or Renal disease defined by BILAG as Level A - Allergy to murine or human antibodies - Antiphospholid antibodies AND a history of thrombocytopenic events ; PRIMARY OUTCOME: Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.; SECONDARY OUTCOME 1: Proportion of patients with complete response or partial response;[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 72 mcg Dose; BRIEF: The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder. ; DRUG USED: Linzess; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Guanylyl cyclase c Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ironwood Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings - Patient has no clinically significant findings on a physical examination and clinical laboratory tests - Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis - Patient is compliant with daily interactive voice response system (IVRS) calls - Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization. Exclusion Criteria: - Patient has history of loose or watery stools - Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS) - Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility - Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments - Patient has Bristol Stool Form Scale score of 7 during Pretreatment period. ; PRIMARY OUTCOME: Percentage of 12-Week CSBM Overall Responders; SECONDARY OUTCOME 1: Change From Baseline in 12-Week CSBM Frequency Rate[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Study 202; BRIEF: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain. ; DRUG USED: ETX-810; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Palmitoylethanolamide (PEA) Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Eliem Therapeutics (UK) Ltd.; CRITERIA: Inclusion Criteria: - The subject is ≥18 and ≤75 years of age at the time of signing ICF. - The subject has a diagnosis of type 1 or 2 diabetes mellitus. - The subject has diabetic neuropathy of a symmetrical nature in the lower extremities for ≥6 months to ≤10 years - The subject reports at least moderate pain intensity - The subjects onset of neuropathic pain is at least 3 months before the screening visit. - The subject has used a stable regimen of antidiabetic agents for at least 1 month before the baseline visit or has achieved adequate glycemic control through diet and exercise. - The subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant. - Sexually active male subjects with female partners of childbearing potential and sexually active female subjects of childbearing potential must agree to practice effective contraception or to remain abstinent during the study and for 4 weeks after the last dose of investigational product - The subject is capable of giving signed informed consent and agrees to provide authorization for use and release of health records. Exclusion Criteria: - The subject has pain that cannot be clearly differentiated from or that could interfere with the assessment of DPNP. - The subject has neurologic and/or circulatory disorders that are unrelated to diabetic neuropathy - The subject has a history of hypoglycemia that disturbed consciousness or ketoacidosis that required hospitalization within the 3 months before screening. - The subject has clinically significant and/or unstable renal, hepatic, hematologic, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study in the judgment of the investigator. - The subject has any neurological disease that could interfere with participation in the study (eg, Huntingtons disease, Parkinsons disease, Alzheimers disease, multiple sclerosis, seizures, epilepsy, stroke). - The subject has an amputation of a lower extremity. Toe amputation is allowed. - The subject has clinically significant abnormal electrocardiogram (ECG) findings at screening or baseline. - The subject is likely to require major surgery during the study. - The subject is pregnant or lactating. - The subject is unwilling or unable to discontinue current medications for neuropathic pain, including topical agents. - The subject is unable to refrain from using nonsteroidal anti-inflammatory drugs (NSAIDs); antiepileptic drugs, steroids, cannabinoids, or major opioids, muscle relaxants, tramadol, or tapentadol throughout the study. - The subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, etc, within 30 days before baseline/Day 1 or anticipates use of such therapies during the study. ; PRIMARY OUTCOME: Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subjects Responses on the Pain Intensity Numerical Rating Scale (PI-NRS); SECONDARY OUTCOME 1: Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MSB-DR001 (Discogenic Lumbar Back Pain); BRIEF: The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1. All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar discs nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only ; DRUG USED: MPC-06-ID; DRUG CLASS: Biologic; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Mesoblast, Ltd.; CRITERIA: Inclusion Criteria: 1. Male or females at least 18 years of age. 2. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. 3. Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US]. 4. Have chronic low back pain for at least 6 months. 5. Have documented symptomatic diagnosis of DDD of one level from L1-S1 as determined by a change in disc hydration on MRI compared to normal disc with or without an annular fissure or a contained disc herniation. 6. Have failed 3 months of non-operative low back pain management. 7. Disc height loss of <30% compared to a normal adjacent disc based upon radiographic evaluation. 8. Pre-treatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale. 9. Low back pain greater than leg pain. 10. Pre-treatment baseline Oswestry Disability Index Questionnaire score of at least 30 on the 100-point questionnaire. Exclusion Criteria: 1. Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery. 2. Have a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening. 3. Patients with compressive pathology due to stenosis or frankly herniated disc or sequestered discs are not candidates. 4. Intact disc bulge/protrusion or focal herniation at the symptomatic level (s) > 3 mm or presence of disc extrusion or sequestration. 5. Lumbar spondylitis or other undifferentiated spondyloarthropathy. 6. Have undergone a previous surgery at the involved levels. 7. Any lumbar intradiscal injection procedure (e.g., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate). Discography may be performed, but must be done at least 2 weeks or more prior to the MPC injection procedure. 8. Have an acute fracture of the spine at the time of enrollment in the study. 9. Have a history of epidural steroid injections within 1 week prior to study treatment. 10. Have a known history of hypersensitivity or anaphylactic reaction to murine or bovine products or dimethyl sulfoxide (DMSO). 11. Have a positive screen for human immunodeficiency virus (HIV) antibodies. 12. Have a known history of hypersensitivity or anaphylactic reaction to Hyaluronan. 13. Have a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening. 14. Have been a recipient of prior stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc. 15. Are transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program. 16. Currently incarcerated (prisoners). ; PRIMARY OUTCOME: To determine the overall safety of MPCs plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).; SECONDARY OUTCOME 1: To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MPCs.[/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 - AURORA; BRIEF: The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis. ; DRUG USED: Lupkynis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Lupus Nephritis; TARGET: Calcineurin phosphatase ; THERAPY: Monotherapy; LEAD SPONSOR: Aurinia Pharmaceuticals Inc.; CRITERIA: Key Inclusion Criteria: - Subjects with evidence of active nephritis, defined as follows: - Kidney biopsy result within 2 years prior to screening indicating Class III, IV-S, IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater increase of UPCR within the last 6 months to a minimum of ≥1.5 mg/mg for Class III/IV or to a minimum of ≥2 mg/mg for Class V at screening. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility. OR - Kidney biopsy result within 6 months prior to screening indicating Class III, IV-S or IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening. OR - Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of ≥2 mg/mg at screening. - Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. Exclusion Criteria: - Estimated glomerular filtration rate (eGFR) of ≤45 mL/minute at screening. - Current or medical history of: - Congenital or acquired immunodeficiency. - In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening. - Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. - Lymphoproliferative disease or previous total lymphoid irradiation. - Severe viral infection or known HIV infection. - Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid. - Other known clinically significant active medical conditions, such as: - Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary disease or asthma requiring oral steroids or any other overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes. ; PRIMARY OUTCOME: Number of Participants With Adjudicated Renal Response at Week 52; SECONDARY OUTCOME 1: Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - w/MTX (SC); BRIEF: The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo. To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development. ; DRUG USED: Vobarilizumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Combination; LEAD SPONSOR: Ablynx, a Sanofi company; CRITERIA: Inclusion Criteria: - Diagnosis of RA for at least 6 months prior to screening, and American College of Rheumatology (ACR) functional class I-III - Subjects treated with and tolerating MTX - Active RA - Others as defined in the protocol Exclusion Criteria: - Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX. - Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening. - Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs, for RA. - Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time. - Others as defined in the protocol ; PRIMARY OUTCOME: Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12; SECONDARY OUTCOME 1: Number and Percentage of Subjects With ACR20 Response at Week 24[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - REPRIEVE; BRIEF: The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia ; DRUG USED: Fanapt; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Dopamine 4 (D4) Receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor, Serotonin 5-HT6 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vanda Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients must understand and be capable to communicate adequately with the study coordinator and to participate in cognitive testing. - Patients must agree to cooperate with all tests and examinations required by the protocol, be willing to comply fully with treatment and able to ingest oral medication. - Patients must understand the nature of the study and must sign an informed consent document. - Patients will have a clear diagnosis of schizophrenia according to DSM-IV criteria for at least 1 year. - Patients must need of ongoing psychiatric treatment and must have a documented reason why a change in treatment is needed which might lead to a clinical improvement - At screening patients will have a Positive and Negative Syndrome Scale (PANSS) of no more than 100 and a Clinical Global Impression Scale (CGI) of no more than 5 (i.e. must not be severely ill or worse). - Patients must be outpatients at the time of screening and have not been an inpatient to treat schizophrenia for at least 1 week prior to the screening visit. - Patients must have a history of at least 2 prior episodes of relapse or impending relapse in the 2 years preceding the screening visit. Exclusion Criteria:- - Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study. - Patients who meet the DSM-IV criteria for schizophreniform disorder (295.40) and schizoaffective (295.70). - Patients with active symptoms of any other primary psychiatric diagnosis (Axis I) or prominent Axis II disorder which would interfere with compliance to the protocol. - Patients who have a diagnosis or history suggestive of chemical dependence, or drug-induced toxic psychosis in the preceding 6 months; diagnosis or history of abuse (except for nicotine and caffeine) within the past 3 months, or a clinical presentation possibly confounded by the use of recreational drugs or alcohol. - Patients who have a positive urine drug screen (at the screening visit). If opiates are positive at screening and clearly due to the use of pain killing medication, the patient may be re screened after the medication has been discontinued and enrolled in the study if urine drug screen is negative. - Note: Occasional users of recreational drugs other than cocaine, amphetamines, hallucinogens, or parenteral drugs may be recruited. Patients who are dependent on nicotine, caffeine, or theophylline are allowed to enter the study. - Patients who are mentally disabled (moderate to severe). - Patients who have had a history of being in a coma for more than 24 hrs. - Patients who have had thoughts of committing suicide within 6 months prior to screening or at baseline or suicide behaviors within 2 years prior to screening or at baseline. - Patients thought to be of imminent risk of harm to others or in imminent legal difficulty. - Patients under any form of legal compulsion to remain hospitalized or undergo treatment or assessment. - Patients who have any disability that prevent them from completing any of the study requirements. - Patients with a known clinically significant ECG abnormality including PR interval >240 msec, QRS complex >110 msec, QTcF >=450 msec, or congenital long QT syndrome based on central ECG reading results - Treatment naive, first episode patients, - Patients taking iloperidone at the screening visit or with a known hypersensitivity to drugs chemically related to benzioxazoles. - Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the patient or the study results. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Time to Relapse or Impending Relapse; SECONDARY OUTCOME 1: PANSS Total Score, Change From Baseline to Last Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Severe Covid-19 Patients; BRIEF: The purpose of this Phase 2 study is to test safety, efficacy, and tolerability of an oral preparation of VB-201 in patients with severe COVID-19 ; DRUG USED: VB-201; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Cluster of differentiation 14 (CD14), IL-12 (Interleukin-12) and IL-12 receptor, IL-23 (Interleukin-23) , Toll-Like Receptor 2 (TLR2); THERAPY: Combination; LEAD SPONSOR: Vascular Biogenics Ltd. operating as VBL Therapeutics; CRITERIA: Inclusion Criteria: 1. Signed and approved informed consent before initiation of protocol-specified procedures; 2. Male or female subjects, ≥18 to ≤80 years of age with COVID-19 3. SARS-2-CoV-2 infection confirmed by PCR in the last 8 days 4. Hospitalized 5. Symptoms of Severe COVID-19 as demonstrated by one of the following: - Respiratory frequency >30 breaths per minute - SpO2 <94% on room air at sea level - Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mmHg - lung infiltrates >50% 6. For a female subject; either: - subject is of non-childbearing potential, defined as: menopause with amenorrhea >1 years, hysterectomy, or bilateral oopherectomy or - agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; Males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug; 7. In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures. Exclusion Criteria: 1. Evidence of critical COVID-19 based on any of the following - Admission to ICU - Assisted ventilation (invasive or non-invasive) - ECMO or hemofiltration required - ARDS - Shock - Acute Cardiac Failure 2. Dementia 3. Bacterial co-infection 4. Co-infection with other common viral pneumonias (e.g. Influenza) 5. Participation in another interventional clinical trial or intention to participate in another interventional study during the course of this study; 6. In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours 7. Unable to take oral medication 8. History of gastrointestinal illness that may cause nausea and vomiting 9. Subjects with any laboratory test at screening that common medical practice would deem as significantly abnormal. For example: - Alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase >5.0 times the upper limit of normal (ULN) or - Creatinine clearance <30 mL/min 10. The subject has a known allergy or sensitivity to the study treatment or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigators Brochure); 11. Female subject with a positive pregnancy test or nursing, or planning a pregnancy during the course of the study; 12. Unwilling or unable to comply with study requirements ; PRIMARY OUTCOME: Assess the safety and tolerability of VB-201; 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 - Neoplasms; BRIEF: The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection. ; DRUG USED: PLM60; DRUG CLASS: Non-NME; INDICATION: Breast Cancer; TARGET: DNA, DNA synthesis, Topoisomerase II (DNA gyrase); THERAPY: Monotherapy; LEAD SPONSOR: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; CRITERIA: Inclusion criteria: - Patients must compliance with the requirements and restrictions listed in the consent form - Patients with Pathology and / or cytologically proven malignant solid tumor - Patients must be 18-70 years old ,both male and female - Failure of standard chemotherapy - Patients have no better choice and may be benefit from the use of anthracyclines - Patients must have Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2 - Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks - Expected survival time ≥ 3 months - Patients agreed to take effective contraceptive measures during the trial - Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements. Exclusion criteria: - Pregnancy and breast-feeding women - Multiple sclerosis - Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease - Patients with heart disease induced by anthracycline - Patients requiring other antineoplastic treatment - Patients with temperature above 38 degrees or active infection that may effects in clinical tests - Patients are allergic to anthracycline and liposomal drugs - Patients are allergic to eggs,egg products,soybean and soybean products - Patients with uncontrolled primary or metastatic brain tumors ; PRIMARY OUTCOME: To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome; 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 - GS-US-342-3921 (Japan); BRIEF: The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen. ; DRUG USED: Epclusa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Genotype 1 or 2 HCV infection - Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy - Previously treated with a DAA-containing regimen of at least 4 week duration Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Cinacalet (Non-Inferiority); BRIEF: The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis. ; DRUG USED: Parsabiv; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperparathyroidism (Secondary); TARGET: Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments - Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to randomization - Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization - Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization Exclusion Criteria: - Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment - Other criteria may apply ; PRIMARY OUTCOME: Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis; SECONDARY OUTCOME 1: Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase[/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 - 001; BRIEF: This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in patients with anemia of chronic disease (inflammation). ; DRUG USED: Lexaptepid Pegol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Oncology Treatment; TARGET: Hepcidin; THERAPY: Monotherapy; LEAD SPONSOR: TME Pharma AG; CRITERIA: Inclusion Criteria - Male subjects or female subjects of non-childbearing potential (Groups A to E), male subjects (groups F to H) - Age 18-65 years - Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters - Males willing to use 2 means of contraceptive methods for at least 2 months after the final examination Exclusion Criteria: 1. Anemia predominantly caused by other factors than chronic disease. 2. Iron overload or disturbances in utilization of iron. 3. Intravenous iron treatment or blood transfusion within 4 weeks prior to screening visit. 4. Erythropoietin treatment within 4 weeks prior to screening visit. 5. Intake of Intravenous iron, Blood transfusions, Erythropoietin during their trial participation. 6. Resting supine pulse rate < 40 or > 100 beats / min. 7. Resting supine blood pressure: Systolic blood pressure < 90 or > 160 mmHg Diastolic blood pressure < 40 or > 100 mmHg. 8. History or presence of confirmed orthostatic hypotension defined. 9. Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies, HCV antibodies. 10. Participation in another clinical trial during the last 3 months before starting this trial. 11. Positive test for drugs of abuse. 12. Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. 13. Marked repolarization abnormality. 14. Current bronchial asthma, childhood asthma which has been resolved is allowed. 15. Definite or suspected history of drug allergy or hypersensitivity or intolerance to PEG 16. Regular intake of over 14 units of alcohol per week for women and 21 units for men. 17. Not able to abstain from consumption of: - Caffeine containing beverages or food (tea, coffee, cola, chocolate, etc.) - Quinine containing beverages or food (bitter lemon, tonic water) - Grapefruit juice (sweet or sour) - Poppy seeds containing beverages or food 18. Subjects who have donated any blood, plasma or platelets in the month prior to screening 19. History of seizures or at risk 20. Known or suspected of not being able to comply with the trial protocol and/or clinical unit restrictions. 21. History of or presence of clinically significant diseases other than the underlying disease. 22. Surgery or trauma with significant blood loss within the last 2 months before administration of study drug. 28. History of increased bleeding risk. ; PRIMARY OUTCOME: Incidence of adverse events; SECONDARY OUTCOME 1: drug plasma concentrations[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - UPCC 03305; BRIEF: The goal of this study is to determine the activity of sorafenib in patients with advanced (metastatic or recurrent) thyroid cancer. ; DRUG USED: Nexavar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thyroid Cancer; TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Raf kinase, RET, Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: University of Pennsylvania; CRITERIA: Inclusion Criteria: - Patients must have histologically confirmed thyroid cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. - Patients may have received multiple treatments of radioactive iodine, one prior biologic treatment, and at least half of the patients will have had no prior chemotherapy for metastatic disease. At least 3 weeks must have elapsed since prior treatment. - Measurable disease defined as at least one malignant lesion that can be accurately and serially measured in at least one dimension (longest diameter to be recorded), using a caliper (diameter > 10 mm) for superficial cutaneous disease, or using contrast-enhanced CT or spiral CT (diameter > 20 mm) for visceral or nodal/soft tissue disease. - ECOG performance status < 2 (Appendix 1). - Life expectancy greater than 3 months. - Adequate organ function that has been determined within 7 days prior to enrollment, defined as:Leucocyte count > 3,000/uL; Absolute neutrophil count (ANC) > 1,500/mm3, platelets > 100,000/mm3, and hemoglobin > 9 g/dl; Serum creatinine < 1.5 times ULN, or 24-hour creatinine clearance > 75 cc/min. (Note: creatinine clearance need not be determined if the baseline serum creatinine is within normal limits); Serum bilirubin < 1.5 times ULN; serum glutamyloxaloacetic transaminase (SGOT) < 2.5 ULN; alkaline phosphatase < 2.5 times ULN; PT-INR/PTT < 1.5 x upper limit of normal. - Intellectual, emotional, and physical ability to comply with oral medication. - Ability to understand and the willingness to sign a written informed consent - Patients with disease accessible for biopsy will be preferentially selected for participation in the study. Accessible disease includes lymph node metastases. - Female patients of child-bearing potential must have a negative pregnancy test within 14 days before initiation of study drug dosing. Post-menopausal women must be amenorrheic for at least 12 months to be considered non-child-bearing potential. Male and female patients of reproductive potential must agree to use adequate contraception (i.e. hormonal or barrier method of birth control). throughout the study and for 3 months after the study. Exclusion Criteria: - Significant medical disease including: uncontrolled congestive heart failure; active symptoms of coronary artery disease, uncontrolled seizure disorder; active infection; uncontrolled diabetes mellitus; requirement for chronic corticosteroid treatment; requirement for concurrent immunosuppressive drug(s); active autoimmune disease. - Organ allografts. - Known HIV-infection (HIV testing is not required for participation). - Pregnancy or lactation. Women of childbearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment - History of second cancer (except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five or more years). - Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment. - Patients with carcinomatous meningitis are excluded from the study. - Excluded therapies and medications, previous and concomitant:Anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to the first dose of the study drug; Radiotherapy for the treatment of a symptomatic (e.g. bone metastasis) as clinically indicated is allowed as long as it is not evidence of progressive disease (see 4.5.2); -Biological response modifiers, such as G-CSF, within 3 week prior to study entry. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however they may not be substituted for a required dose reduction); Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study; Investigational drug therapy outside of this trial during or within 4 weeks prior the screening assessment; Use of ketoconazole, itraconazole, and ritonavir; Use of carbamazepine, phenytoin, phenobarbital; Previous exposure to a Ras pathway inhibitor (including herceptin, EGFr inhibitors, farnesyl transferase inhibitors or MEK inhibitors); Use of grapefruit juice products; Use of cyclosporin; - Pregnant or breast feeding. ; PRIMARY OUTCOME: To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.; SECONDARY OUTCOME 1: Median Progression Free Survival in Patients Receiving BAY 43-9006 (Sorafenib).[/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 - Advanced Follicular Lymphoma; BRIEF: This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel. ; DRUG USED: Truxima; DRUG CLASS: Biosimilar; INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: Celltrion; CRITERIA: Inclusion Criteria: 1. Patient is male or female older than 18 years. 2. Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review. 3. Patient has at least 1 measurable tumour mass that has not previously been irradiated, and the mass must be: - greater than 1.5 cm in the longest dimension or - between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis 4. Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.) 5. Patient has Ann Arbor stage III or IV disease. Exclusion Criteria: 1. Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine. 2. Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone. 3. Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma. 4. Patient has known central nervous system involvement. 5. Patient has received previous treatment for NHL: - Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy) - All doses of corticoid therapy for treatment of NHL - Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone >20 mg per day for the treatment for any purpose ; PRIMARY OUTCOME: Area Under the Serum Concentration-time Curve at Steady State (AUCtau); SECONDARY OUTCOME 1: B-cell Kinetics (B-cell Depletion and Recovery)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 232 (Pediatric); BRIEF: This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs ; DRUG USED: Fycompa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: AMPA-type glutamate receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion: 1. Have a minimum weight of 10 kg (22 lb) 2. Have had brain imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) prior to Visit 1 that ruled out a progressive cause of epilepsy 3. Have a diagnosis of epilepsy with any type of seizure according to the International League Against Epilepsys (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 6 months prior to Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with epilepsy; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e. clinical history) 4. Have had one or more seizure(s) during the 4 weeks prior to Visit 1 5. Are currently being treated with stable doses of one to a maximum of three AEDs for at least 4 weeks prior to Visit 1 and throughout the study duration (Only one perampanel inducing AED [i.e. carbamazepine, oxcarbazepine, phenytoin] out of the maximum of 3 AEDs is allowed in at least one third of the participants in each age cohort and not to exceed one half of the population of each age cohort. The remaining participants should not be taking any inducer) 6. Have been on their current concomitant AED regimen for 2 months or more with a stable dose for at least 4 weeks prior to Visit 1 7. Must have discontinued all restricted medications at least 2 weeks or five half-lives (whichever is longer) prior to Visit 1 8. Females aged at least 8 years or of child-bearing potential must have a negative serum beta-hCG at Visit 1 and a negative urine pregnancy test prior to titration at Visit 2. Female participants of childbearing potential must agree for the duration of the study and for a period of at least 60 days following administration of the last dose of study drug to be abstinent or commit to the consistent and correct use of a medically acceptable method of birth control (e.g., a double-barrier method [condom + spermicide, condom + diaphragm with spermicide]) Exclusion: 1. Have a history of status epilepticus that required hospitalization during the 6 months prior to Visit 1 2. Have current or a history of pseudo-seizures (psychogenic non-epileptic seizures [PNES]) from birth or within approximately 5 years prior to Visit 1 3. Have seizures due to treatable medical conditions, such as those arising due to metabolic disturbances, toxic exposure, or an active infection 4. Have epilepsy secondary to progressive cerebral disease or any other progressive neurodegenerative disease 5. Have had epilepsy surgery within 1 year prior to Visit 1 6. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented failed epilepsy surgery will be allowed 7. Use of intermittent rescue benzodiazepines (i.e. 1-2 doses over a 24-hour period considered one-time rescue) two or more times in a 30-day period prior to Visit 1 8. If felbamate is used as a concomitant AED, participants must be on felbamate for at least 2 years, with a stable dose for 8 weeks prior to Visit 1. They must not have a history of white blood cell (WBC) count below 2500/L (2.50 x 10^9/L), platelets below 100,000, liver function tests (LFTs) above 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If participants received felbamate in the past, it must have been discontinued 8 weeks prior to Visit 1 9. Have concomitant use of vigabatrin: participants who took vigabatrin in the past must be off vigabatrin for approximately 5 months prior to Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in the visual perimetry test 10. If ketogenic diet is used, participants must be on a stable regimen for at least 4 weeks prior to Visit 1 11. Have previously participated in a clinical trial involving perampanel ; PRIMARY OUTCOME: Apparent Clearance (CL/F) of Perampanel [Core Study]; SECONDARY OUTCOME 1: Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study][/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 15062 (Once-Weekly); BRIEF: The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants involvement in the study is expected to last about 30 weeks. ; DRUG USED: OPK-88003; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: OPKO Health, Inc.; CRITERIA: Inclusion Criteria: - Men or women with diabetes mellitus Type 2 - Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening - Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening Exclusion Criteria: - Women of child bearing potential - Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months - Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year - Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men) ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12; SECONDARY OUTCOME 1: Change From Baseline in HbA1c at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pharyngeal Carriage (U.K.); BRIEF: The purpose of this trial was to evaluate the effect of Novartis Vaccines Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population. ; DRUG USED: Bexsero; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: - Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment; - Subjects who were available for all the visits scheduled in the study; - Subjects who were in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria: - History of any serogroup B meningococcal vaccine administration; - Current or previous, confirmed or suspected disease caused by N. meningitidis; - Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment; - Significant acute or chronic infection within the previous 7 days or fever (defined as oral temperature ≥38ºC) within the previous day; - Antibiotics within 3 days (72 hours) prior to enrollment; - Pregnancy or nursing (breastfeeding) mothers; - Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the 12 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence were considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry; - Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); - Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body were allowed]; use of immunostimulants; - Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; - History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; - Participation in another clinical trial within the last 90 days or planned for during study; - Family members and household members of research staff; - Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives. ; PRIMARY OUTCOME: Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination; SECONDARY OUTCOME 1: Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ 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 Ib - MI4-358 w/Decitabine or Azacitidine (Elderly); BRIEF: This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of venetoclax (ABT-199) in combination with posaconazole. ; DRUG USED: Venclexta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Subjects must have confirmation of Acute Myeloid Leukemia (AML) by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors. - Subject must have received no prior treatment for AML with the exception of hydroxyurea - Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for subjects greater than or equal to 75 years of age, or 0 to 3 for subjects greater than or equal to 60 to 74 years of age - Subject must have adequate kidney and liver function as described in the protocol Exclusion Criteria: - Subject has received treatment with the following hypomethylating agent and/or chemo therapeutic agent for for an antecedent hematologic disorder (AHD) (Subjects may have been treated with other agents for AHD i.e., Myelodysplastic syndrome [MDS]) - Subject has history of Myeloproliferative Neoplasm (MPN). - Subject has favorable risk cytogenetics as categorized by the National Comprehensive Cancer Network Guidelines Version 2, 2014 for AML. - Subject has t(8;21), inv(16), t(16;16) or t(15;17) karyotype abnormalities. - Subject has acute promyelocytic leukemia. - Subject has known active central nervous system involvement with AML. - Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment. - Subject has a history of other malignancies prior to study entry, with the exception of: - Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; - Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. - Subject has a white blood cell count > 25 × 10^9/L. Note: Hydroxyurea is permitted to meet this criterion. ; PRIMARY OUTCOME: Number of Participants Experiencing Adverse Events (AEs); SECONDARY OUTCOME 1: Event Free Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MSC-COV-202; BRIEF: This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / acute respiratory distress syndrome. ; DRUG USED: COVI-MSC; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Allogeneic Chimeric Antigen Receptor T-cells (CAR-T), Immune System, Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Sorrento Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen (can be documented from inpatient medical record) - Hospitalized with at least severe COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention - Requires oxygen supplementation at Screening - Willing to follow contraception guidelines Exclusion Criteria: - Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving - Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg with PEEP ≥ 5cm H2O - A previous stem cell infusion unrelated to this trial - Pregnant or breast feeding or planning for either during the study - Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19) - History of a splenectomy, lung transplant or lung lobectomy - Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) - Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days - Has an existing Do Not Intubate order - Has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing (eg, obstructive sleep apnea) - Has any significant medical condition, laboratory abnormality or psychiatric illness that in the investigators opinion would interfere or prevent the subject from safely participating in the study ; PRIMARY OUTCOME: All-cause mortality rate at Day 28; SECONDARY OUTCOME 1: All-cause mortality rate at Day 60 and 90[/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 - MPOWERED; BRIEF: Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs). ; DRUG USED: Mycapssa; DRUG CLASS: Non-NME; INDICATION: Acromegaly; TARGET: Somatostatin Receptors; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Chiasma, Inc.; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of acromegaly - Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months - Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL) Exclusion Criteria: - Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks. - Pituitary radiotherapy within 5 years - Pituitary surgery within six months - Patients who previously participated in CH-ACM-01 study - Any clinically significant uncontrolled concomitant disease - Symptomatic cholelithiasis - Previous treatment with: - Pegvisomant, within 12 weeks - Dopamine agonists, within 6 weeks - Pasireotide, within 12 weeks ; PRIMARY OUTCOME: Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase; SECONDARY OUTCOME 1: Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase[/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 - PVO-1A-201; BRIEF: Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification (HO) following injury. The purpose of the study is to evaluate whether palovarotene, an RAR gamma agonist, will prevent HO during and following a flare-up in subjects with FOP. ; DRUG USED: Palovarotene; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fibrodysplasia Ossificans Progressiva (FOP); TARGET: Retinoic acid receptor (RARs); THERAPY: Monotherapy; LEAD SPONSOR: Clementia Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - Written, signed, and dated informed subject/parent consent or age-appropriate assent. - Subjects clinically diagnosed with classic Fibrodysplasia Ossificans Progressiva (FOP). - Symptomatic onset of a distinct flare-up within 7 days of Study Day 1 (start of study drug) and defined by the presence of at least two of six of the following symptoms: pain, soft tissue swelling, decreased range of motion, stiffness, redness, and warmth. Flare-up must be confirmed by the physician at the Screening visit. - Flare-up is at an appendicular area (upper or lower extremity), abdomen, or chest; and subject has received, is receiving, or is willing to receive treatment per standard of care, which may or may not include oral prednisone (2 mg/kg PO to a maximum dose of 100 mg daily) for 4 days. - Abstinent or using two highly effective forms of birth control. - Subjects must be accessible for treatment and follow-up. Subjects living at distant locations from the investigational site must be able and willing to travel to a site for the initial and all follow-up visits. Exclusion Criteria: - Weight <20 kg. - Intercurrent non-healed fracture at any location. - Complete immobilization of joint at site of flare-up. - The inability of the subject to undergo imaging assessments using plain radiographs. - If currently using vitamin A or beta carotene, multivitamins containing vitamin A or beta carotene, or herbal preparations, fish oil, and unable or unwilling to discontinue use of these products for the duration of the study. - Exposure to synthetic oral retinoids in the past 30 days prior to Screening (signature of the informed consent). - Concurrent treatment with tetracycline due to the potential increased risk of pseudotumor cerebri. - History of allergy or hypersensitivity to retinoids or lactose. - Concomitant medications that are inhibitors or inducers of CYP450 3A4 activity. - Amylase or lipase >1.5x above the upper limit of normal or with a history of chronic pancreatitis. - Elevated aspartate aminotransferase or alanine aminotransferase >2.5x the upper limit of normal. - Fasting triglycerides >400 mg/dL with or without therapy. ; PRIMARY OUTCOME: Percentage of Responders at Week 6; SECONDARY OUTCOME 1: Percentage of Subjects With New HO at Weeks 6 and 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 303; BRIEF: The main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH. Another aim is to check if they tolerate the repeated SC injections. Participants will receive a SC injection of lanadelumab every two weeks for 26 weeks. The first two doses of lanadelumab will be given at the study clinic. Once a participant (and/or parent/caregiver) has been appropriately trained, lanadelumab can be self-injected. Visits to the study clinic are planned for the first, third and fourth week and then every 4 weeks. ; DRUG USED: Takhzyro; DRUG CLASS: Biologic; INDICATION: Hereditary Angioedema (HAE); TARGET: Kinin-Kallikrein System ; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: The Participant will not be considered eligible for the study without meeting all of the applicable population criteria below. - Males and females, 12 years of age and older for participants with non-histaminergic normal C1-INH angioedema at the time of signing of the informed consent form (ICF). - Documented clinical history of recurrent attacks of angioedema in the absence of wheals/urticaria. - Investigator-confirmed diagnosis of non-histaminergic bradykinin-mediated angioedema with normal C1-INH as documented by a history of angioedema attack(s) at screening and occurrence of attacks during the observation period: - History of recurrent angioedema with at least an average of 1 angioedema attack per 4 weeks prior to screening and this attack rate must be confirmed during the observation period while treated with chronic high-dose antihistamine (cetirizine 40 milligram per day [mg/day] or equivalent high-dose second-generation antihistamine medication). - Diagnostic testing results obtained during screening from a sponsor-approved central laboratory that confirm C1-INH function >= 50 percent (%) of normal and C4 level not below the normal range. With prior sponsor approval, participants may be retested during the observation period if results are incongruent with clinical history. - Clinical history of not responding to high-dose antihistamine treatment (cetirizine 40 mg/day or equivalent high-dose second-generation antihistamine medication), which must be confirmed during the observation period with at least 1 angioedema attack per 4 weeks with chronic high-dose antihistamine treatment and no significant difference (as assessed by the investigator and in consultation with the sponsors medical monitor, as necessary) from the historic attack rate without high-dose antihistamine treatment. - Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures. - Participants >= 18 years of age must be willing to use icatibant as the rescue medication during the observation and treatment period. During the observation period, participants need to be treated with icatibant for at least 2 angioedema attacks or at least 1 moderate or severe attack. In the opinion of the investigator, participants with no response to icatibant for acute angioedema attacks in the past medical history/screening, or no improvement or worsened attack severity 2 hours after icatibant treatment during the observation period (based on totality of assessments), will not be included. Note: For participants 12 to < 18 years of age, standard of care therapy per local protocols should be provided. - Males, or non-pregnant, non-lactating females who are of child-bearing potential and who agree to be abstinent or agree to comply with the applicable contraceptive requirements of this protocol for the duration of the study. Female participants of childbearing potential must have a negative serum pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study. Females of non-childbearing potential are defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months. - The participants (or the participants parent/legal guardian, if applicable) has provided written informed consent approved by the institutional review board/research ethics board/ethics committee (IRB/REB/EC). - If the participants is an adult, be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed. OR - If the participants is a minor (i.e. < 18 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (i.e. permission) for the minor to participate in the study before any study-specific procedures are performed. Assent will be obtained from minor participants. Exclusion Criteria The participant will be excluded from the study if any of the following exclusion criteria are met. - Concomitant diagnosis of Type I or Type II HAE, or recurrent angioedema associated with urticaria. - Dosing with any investigational drug or exposure to an investigational device within 4 weeks prior to screening. - Exposure to angiotensin-converting enzyme (ACE) inhibitors or rituximab within 6 months prior to screening. - Use of any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks prior to screening. - Response to omalizumab (prophylactic) or corticosteroid (acute/prophylactic) or epinephrine (acute) or anti-leukotrienes (prophylactic) treatments in the past. - Use of long-term prophylactic therapy for HAE, e.g. C1-INH, attenuated androgens (e.g. danazol, methyltestosterone, testosterone), or anti-fibrinolytics within 2 weeks prior to entering the observation period as long as the investigator determines that doing so would not place the participant at any undue safety risk, and that the participant is at least 18 years of age. - Any exposure to prophylactic plasma kallikrein inhibitors prior to screening. - Use of short-term prophylaxis for HAE within 7 days prior to entering the observation period. Short-term prophylaxis is defined as C1-INH, attenuated androgens, or anti-fibrinolytics used to avoid angioedema complications from medically indicated procedures. - Have any active infectious illness or fever defined as an oral temperature greater than (>) 38°C (100.4°F), tympanic > 38.5°C (101.3°F), axillary > 38°C (100.4°F), or rectal/core > 38.5°C (101.3°F) within 24 hours prior to the first dose of study drug in the treatment period. - Any of the following liver function test abnormalities: alanine aminotransferase (ALT) > 3x upper limit of normal, or aspartate aminotransferase (AST) > 3x upper limit of normal, or total bilirubin > 2x upper limit of normal (unless the bilirubin elevation is a result of Gilberts syndrome). - Pregnancy or breast feeding. - Participant has a known hypersensitivity to the investigational product or its components. - Have any uncontrolled underlying medical condition which would require treatment adjustment during the study treatment period that, in the opinion of the investigator or sponsor, may confound the results of the safety assessments or may place the participant at risk. Participants with stable treatment for at least 3 months prior to screening and NOT expecting any change to their treatment regimen for 6 months during the study treatment period, will not be excluded. - Have any condition (surgical or medical) that, in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude the successful conduct of the study, or interfere with interpretation of the results (e.g. significant pre-existing illness or other major comorbidities that the investigator considers may confound the interpretation of study results). ; PRIMARY OUTCOME: Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182; SECONDARY OUTCOME 1: Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182[/INST]Yes</s>