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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 - ClarIDHy; BRIEF: Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen. ; DRUG USED: Tibsovo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Biliary Tract Cancer; TARGET: Isocitrate Dehydrogenase (IDH); THERAPY: Monotherapy; LEAD SPONSOR: Institut de Recherches Internationales Servier; CRITERIA: Inclusion Criteria: 1. Be ≥18 years of age. 2. Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies. 3. Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested). 4. Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 5. Have an expected survival of ≥3 months. 6. Have at least one evaluable and measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment. 7. Have documented disease progression following at least 1 and no more than 2 prior systemic regimens for advanced disease (nonresectable or metastatic). Participants must have received at least 1 gemcitabine- or 5-FU-containing regimen for advanced cholangiocarcinoma. Participants who have received systemic adjuvant chemotherapy will be permitted provided there is documented disease progression during or within 6 months of completing the therapy. Exclusion criteria: 1. Received a prior IDH inhibitor. 2. Received systemic anticancer therapy or an investigational agent <2 weeks prior to Day 1 (washout from prior immune based anticancer therapy is 4 weeks). In addition, the first dose of study treatment should not occur before a period ≥5 half-lives of the investigational agent has elapsed. 3. Received radiotherapy to metastatic sites of disease <2 weeks prior to Day 1. 4. Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to Day 1. 5. Have known symptomatic brain metastases requiring steroids. Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and have radiographically stable disease for at least 3 months prior to study entry. Note: up to 10 mg per day of prednisone equivalent will be allowed. ; PRIMARY OUTCOME: Progression Free Survival (PFS) as Determined by the Independent Radiology Committee (IRC); SECONDARY OUTCOME 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)[/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 - ORACAL (Treatment); BRIEF: The purpose of this study is to compare the effectiveness and tolerability of two medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases, which are characterized by loss of bone density, which makes the bones weaker. Osteoporosis often occurs in postmenopausal women. Calcitonin is a hormone found in the human body. Together with other substances, it regulates the concentration of calcium in the blood and inhibits the natural resorption of bone. Both medications in this study contain salmon calcitonin (sCT), because this form of calcitonin is more active than human calcitonin when used as a medicine. The calcitonin Nasal Spray used in this study is registered and available to doctors in United States for the treatment of osteoporosis. The medication being tested in this study is an oral tablet form of salmon calcitonin. ; DRUG USED: Tbria; DRUG CLASS: Non-NME; INDICATION: Osteoporosis / Osteopenia; TARGET: Calcitonin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Tarsa Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Female and age 45 or over. - Must have undergone the onset of spontaneous or surgical menopause. Spontaneous menopause is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels >40 milli-international units (mIU)/milliliter (mL) or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy. - Diagnosis of osteoporosis on the basis of an axial lumbar spine, femoral neck or total hip BMD which is below the mean for premenopausal women by a magnitude of at least 2.5 SD or 2.0 SD, if there is a documented history of a vertebral fragility fracture. - Must have at least three contiguous lumbar vertebrae (L1-L4) that are evaluable by DXA for BMD that is, without fracture or significant degenerative disease, as determined by Bio-Imaging Technologies, Inc. - No clinically significant abnormal findings in the medical history, physical exam or nasal exam. - No clinically significant abnormal laboratory values at the screening assessment. Exclusion Criteria: - History of severe allergic disease. - History of metabolic and other bone diseases, including osteogenesis imperfecta, osteomalacia, and Pagets disease. - Vitamin D insufficiency defined as a 25 hydroxyvitamin D level <20 ng/mL. - Use of any intravenous bisphosphonate in the past 24 months, or >2 doses of intravenous bisphosphonate ever. - Use of oral bisphosphonate before randomization, including investigational bisphosphonates, unless: 1) less than 6 months of treatment and off for 6 months, or 2) 6 to 12 months of treatment and off for 2 years, or 3) More than 12 months of treatment and off for 5 years - Use of denosumab, fluoride, or strontium, ever. - Use of parathyroid hormone analogs or other bone metabolic agents within 1 year preceding randomization. - Any condition or disease that may interfere with the ability to have a DXA scan or to evaluate a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or more than 1 lumbar vertebral fracture in L1 through L4. (More than 4 vertebral fractures in T4 through L4; Bilateral hip replacements) - Use of anabolic steroids or androgens within 6 months preceding randomization. - Use of Vitamin D metabolites and analogs, (e.g., calcitriol) within 3 months preceding randomization). Note: Vitamin D supplementation is not exclusionary. - Use of estrogen or estrogen-related drugs, for example, tamoxifen, tibolone, or raloxifene within 3 months preceding randomization. - Use of coumadin within 4 weeks preceding randomization or heparin within 1 week preceding randomization. - Chronic systemic treatment with glucocorticoids, hormone replacement therapy, calcitonin or any other medication within the previous three months which, in the opinion of the Investigator, would interfere with the study. - Clinically relevant abnormal history, physical findings or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the patient. - Presence of acute or chronic illness or history of chronic illness which, in the judgment of the Investigator, makes participation in the study medically inappropriate. - Uncontrolled hypertension, significant gastrointestinal abnormalities, uncontrolled diabetes mellitus, significant coronary heart disease, any psychotic mental illness, chronic allergic rhinitis, asthma, uncorrected endocrine dysfunction, or significantly impaired hepatic, respiratory or renal function. - History of drug or alcohol abuse, or intake of more than 30 units of alcohol weekly. ; PRIMARY OUTCOME: Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine; SECONDARY OUTCOME 1: Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - LOTIS 3 (w/Ibrutinib); BRIEF: The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma. ; DRUG USED: Zynlonta; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 19 (CD19); THERAPY: Combination; LEAD SPONSOR: ADC Therapeutics S.A.; CRITERIA: Inclusion Criteria: 1. Male or female participant aged 18 years or older 2. Pathologic diagnosis of DLBCL or MCL (For Italy Sites Only: MCL patients are excluded.) 3. Participants with DLBCL must have relapsed or refractory disease and have failed or been intolerant to available standard therapy 4. Participants with MCL must have relapsed or refractory disease and have received at least one prior line of therapy (For Italy Sites Only: This exclusion criterion is not applicable) 5. Participants who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy 6. Measurable disease as defined by the 2014 Lugano Classification 7. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available) 8. ECOG performance status 0 to 2 9. Screening laboratory values within the following parameters: 1. Absolute neutrophil count (ANC) ≥1.0 × 103/µL (off growth factors at least 72 hours) 2. Platelet count ≥75 × 103/µL without transfusion in the past 7 days 3. Hemoglobin ≥8 g/dL (4.96 mmol/L), transfusion allowed 4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤2.5 × the ULN 5. Total bilirubin ≤1.5 × ULN (participants with known Gilberts syndrome may have a total bilirubin up to ≤3 × ULN) 6. Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the Cockcroft and Gault equation 10. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drugs on C1D1 for women of childbearing potential 11. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9 months after the last dose of loncastuximab tesirine or 1 month after last dose of ibrutinib, whichever comes last. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the participant receives his last dose of loncastuximab tesirine or 3 months after last dose of ibrutinib, whichever comes last Exclusion Criteria: 1. Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD19 antibody 2. Known history of hypersensitivity to ibrutinib 3. Previous therapy with ibrutinib or other BTK inhibitors 4. Previous therapy with loncastuximab tesirine 5. Requires treatment or prophylaxis with a moderate or strong cytochrome P450 (CYP) 3A inhibitor 6. Allogenic or autologous transplant within 60 days prior to start of study drugs (C1D1) 7. Active graft-versus-host disease 8. Post-transplantation lymphoproliferative disorder 9. Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease 10. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). 11. History of Stevens-Johnson syndrome or toxic epidermal necrolysis 12. Lymphoma with active CNS involvement at the time of screening, including leptomeningeal disease 13. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath) 14. Breastfeeding or pregnant 15. Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥160/100 millimeters of mercury (mmHg) repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes mellitus, or severe chronic pulmonary disease, or tuberculosis infection (tuberculosis screening based on local standards). 16. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drugs (C1D1), except shorter if approved by the Sponsor 17. Use of any other experimental medication within 14 days prior to start of study drugs (C1D1) 18. Planned live vaccine administration after starting study drugs (C1D1) 19. Any condition that could interfere with the absorption or metabolism of ibrutinib including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel 20. Inherited or acquired bleeding disorders 21. Ongoing anticoagulation treatment, except for low-dose heparinisation or equivalent 22. Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening 23. Congenital long QT syndrome or a corrected QTcF interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block) 24. Active second primary malignancy other than non-melanoma skin cancers, non metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsors medical monitor and Investigator agree, and document should not be exclusionary 25. Any other significant medical illness, abnormality, or condition that would, in the Investigators judgement, make the participant inappropriate for study participation or put the participant at risk ; PRIMARY OUTCOME: Phase 1: Number of Adverse Events (AEs); SECONDARY OUTCOME 1: Phase 1: Overall 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 - KALM-1 (U.S.); BRIEF: This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week Double-blind Phase and a 52-week Open-label Extension Phase. ; DRUG USED: Korsuva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pruritus; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Cara Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: To be eligible for inclusion into the Double-blind Phase of the study, a patient must meet the following criteria: - Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening; - Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis days during the 3 months period prior to screening; - Prior to randomization: - Has completed Worst Itching Intensity NRS worksheets up to 8 days prior to 1st dose; - Has a mean baseline Worst Itching Intensity NRS indicative of moderate to severe uremic pruritus. - To be eligible for inclusion into the Open-label Extension Phase of the study, each patient will have to fulfill the additional key following criteria at the time of entry into the Open-label Extension Phase: - Has received at least 30 doses of the planned 36 doses of study drug during the Double-blind Phase of this study; - Continues to meet inclusion criteria. Key Exclusion Criteria: A patient will be excluded from the Double-blind Phase of the study if any of the following criteria are met: - Known noncompliance with dialysis treatment that in the opinion of the investigator would impede completion or validity of the study; - Scheduled to receive a kidney transplant during the study; - New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening; - Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study; - Has pruritus only during the dialysis session (by patient report); - Is receiving ongoing ultraviolet B and anticipates receiving such treatment during the study; - Participated in a previous clinical study with CR845. - A patient will be excluded from the Open-label Extension Phase of the study if any of the additional key following criteria are met at the time of entry into the Open-label Extension Phase: - Completed the Double-blind Phase of this study but exhibited adverse events during the course of the Treatment Period that may preclude continued exposure to the study drug; - Was noncompliant with protocol procedures during the Double-blind Phase of this study which is indicative of an inability to follow protocol procedures. ; PRIMARY OUTCOME: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12; SECONDARY OUTCOME 1: Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Itch Scale Score at the End of Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OPTIMYST (351); BRIEF: Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. ; DRUG USED: Myobloc; DRUG CLASS: Biologic; INDICATION: Neurology - Other; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinsons Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications. - Able to read and provide written informed consent before enrollment into the study, or the subjects caregiver (Legally Authorized Representative) can provide written informed consent. - Male or female, 18 to 85 years of age (inclusive). - Minimum unstimulated salivary flow rate of 0.2 g/min at screening - Minimum Investigators Drooling Frequency and Severity Scale (DFSS) score of 4 at screening. - Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis Exclusion Criteria: - A moderate to high risk of aspiration will exclude participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate. - Respiratory forced vital capacity (FVC) of <20% of predicted - Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening - Subjects should be excluded if, in the Investigators opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subjects participation is complete). - Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function - Prior salivary gland surgery - Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary - Evidence of any clinically significant neurologic disease - Pregnancy or lactation - Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not exclude the subject from continued study participation. - Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within the previous 6 months before screening. - Current infection at the sialorrhea treatment injection site(s) - History of drug or alcohol abuse currently or within the previous 6 months - Participation in another clinical drug, device, or biological agent study within 30 days of screening or while participating in this study ; PRIMARY OUTCOME: Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE); SECONDARY OUTCOME 1: Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ULTRA 3 (Ext.); BRIEF: To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629). ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629) - Subject is judged to be in generally good health as determined by the principal investigator Exclusion Criteria: - Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or M06-827 (NCT00408629) - Subject considered by the investigator, for any reason, to be an unsuitable candidate - Female subject who is pregnant or breast-feeding or considering becoming pregnant ; PRIMARY OUTCOME: Partial Mayo Score: Change From Baseline Over Time; SECONDARY OUTCOME 1: Percentage of Participants With Remission Per Partial Mayo Score 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 Ib/II - w/MEK162 (NRAS); BRIEF: In the phase Ib, the primary purpose is to establish the maximum tolerated dose (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally administered combination. Once the MTD(s)/RP2D have been determined for each tested schedule, additional patients will be enrolled in the phase II portion of the study at the RP2D on the chosen schedule in order to assess the anti-tumor activity of the combination in addition to continued evaluation of safety. ; DRUG USED: Kisqali; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. - Patients enrolled into phase Ib may be enrolled with evaluable disease only. Patients enrolled into the phase II expansion must have at least one measurable lesion as defined by RECIST 1.1 criteria for solid tumors. - Patients must have adequate organ function, as defined by the following parameter 1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L. 2. Hemoglobin (Hgb) ≥ 9 g/dL. 3. Platelets ≥ 75 x 109/L without transfusions within 21 days before 1st treatment. 4. PT/INR and aPTT ≤ 1.5 ULN. 5. Serum creatinine ≤1.5 ULN. 6. Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN). 7. AST and ALT ≤ 3 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN. Exclusion Criteria: - Presence of any brain metastases detected by MRI or CT with i.v. contrast of the brain at screening. - Uncontrolled arterial hypertension despite medical treatment - Impaired cardiac function or clinically significant cardiac diseases, including any of the following: 1. Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO). 2. Congenital long QT syndrome or family history of unexpected sudden cardiac death. 3. QTcF corrected with Fredericas or Bazetts formula QTcB >450 ms for males and >470 ms for females on screening ECG. 4. Angina pectoris ≤ 3 months prior to starting study drug 5. Acute myocardial infarction ≤ 3 months prior to starting study drug 6. Clinically significant resting bradycardia 7. History or presence of ventricular tachyarrhythmia 8. Unstable atrial fibrillation (ventricular response >100 bpm) 9. Complete left bundle branch block 10. Right bundle branch block and left anterior hemi block (bifascicular block) 11. Obligate use of a cardiac pacemaker or implantable cardioverter defibrillator 12. Any other clinically significant heart disease - Patients who are currently receiving treatment with agents that are known to cause QTc prolongation in humans. - Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) or elevated baseline CK levels (≥ Grade 2) - Patients who are currently receiving treatment with agents that are metabolized predominantly through CYP3A4 and that have a narrow therapeutic window. - Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (i.e. uncontrolled diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection). - History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes). Other protocol related inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Number of Dose Limiting Toxicities (Phase Ib); SECONDARY OUTCOME 1: Plasma Concentration-time Profile (AUCtau) of LEE011 (Phase Ib)[/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 - Pilot Study; BRIEF: The primary objective is to determine whether daily dosing with NYX-2925 changes markers of central pain processing in subjects with fibromyalgia by evaluating changes in evoked pain, and visual stimulation, functional magnetic resonance imaging (fMRI), resting state function connectivity magnetic resonance imaging (rs-fcMRI) and proton magnetic resonance spectroscopy (H-MRS) in fibromyalgia subjects on active drug versus placebo. ; DRUG USED: NYX-2925; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fibromyalgia; TARGET: NMDA Glutamate Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Aptinyx; CRITERIA: Inclusion Criteria: 1. Subjects meets the 2010 American College of Rheumatology (ACR) criteria for fibromyalgia. 2. Self-reported clinical pain ≥ 4 and on the Numeric Pain Rating Scale (NPRS) at screening and baseline. 3. Subject receives and agrees to remain on their stable fibromyalgia treatment plan established at least 14 days prior to dosing. 4. Subject agrees to use only non-steroidal anti-inflammatory (NSAID) or acetaminophen treatment as needed for breakthrough pain, and/or, zopiclone, zolpidem, zaleplon, or eszopiclone for sleep (if needed). 5. Right handed. 6. Calculates creatinine clearance ≥ 60 mL/minute. 7. Female subjects of child bearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (e.g., surgical sterilization, oral or parenteral contraceptives, intrauterine device that is considered safe for MRI procedures, barrier [condom with spermicide]) and who do not plan to become pregnant, breastfeed, or donate ova during the course of the study and for 28 days after the final administration of investigational product. 8. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments. Exclusion Criteria: 1. Current or expected use of opioid or narcotic analgesics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, gabapentins, topiramate, anticonvulsants, benzodiazepines, and sedatives, or hypnotics. 2. Unstable doses of allowed antidepressants or muscle relaxants. Use of NSAIDs or acetaminophen 24 hours prior to imaging procedures is prohibited. 3. Pain due to concurrent disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, or other chronic widespread pain condition(s) that may confound fibromyalgia pain. 4. Untreated endocrine disorder that may confound fibromyalgia assessments. 5. Psychiatric or cognitive disorder (e.g., current schizophrenia, severe depression, suicidal ideation, dementia, etc.). 6. Clinically significant alcohol or other substance abuse within the last 2 years. 7. Positive screen for medically inappropriate or illegal use of drugs of abuse. 8. Current treatment with medications such as ketamine, amantadine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone. 9. History of allergy, sensitivity, or intolerance to medications such as ketamine, amantadine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone. 10. Women, who are pregnant, breast feeding, or planning to become pregnant or donate ova during the course of the study and for 28 days after the final administration of investigational product. 11. Huntingtons, Parkinsons, Alzheimers, Multiple Sclerosis, or history of seizures, epilepsy, or strokes. 12. Contraindications to fMRI procedures. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material. 13. Current or habitual use (within the last 12 months) of artificial nails, nails enhancements, or nail extensions that cover any portion of either thumbnail. 14. Abnormal laboratory results, medical history, or concurrent conditions that would preclude safe study participation, or interfere with study procedures/assessments. 15. Impaired liver function. 16. Known history of significant heart condition or high blood pressure. 17. Current evidence of dysplasia or history of cancer malignancy (including lymphoma and leukemia) in the last 5 years. 18. Human immunodeficiency virus (HIV) infection, hepatitis, or other ongoing infectious disease. 19. History of severe kidney or liver impairment. 20. History of migraine. 21. History of lower limb vascular surgery or current lower limb vascular dysfunction. 22. Received an investigational drug or device within 30 days of dosing. 23. Previous treatment with NYX-2925. 24. Resting heart rate < 45 or ≥ 95 beats per minute. ; PRIMARY OUTCOME: Mean (SD) Glx/Total Creatine Levels in Dorsal Anterior Cingulate Cortex (dACC): NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively.; 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 IIIb - IXORA-S; BRIEF: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis. ; DRUG USED: Taltz; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Chronic plaque psoriasis for at least 6 months before baseline - Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy) - Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline - Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment Exclusion Criteria: - Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis - History of drug-induced psoriasis - Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study - Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline - Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent <5 half-lives prior to baseline - Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol - Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists - Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study - Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study - Have a known allergy or hypersensitivity to latex - Have had any major surgery within 8 weeks of baseline or will require such during the study - Have active or history of malignant disease within 5 years prior to baseline - Significant uncontrolled disorder - Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline - Are women who are lactating or breast-feeding ; PRIMARY OUTCOME: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline; SECONDARY OUTCOME 1: Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Prednisone - Chemo-Naive (Asia); BRIEF: The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC). ; DRUG USED: Zytiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Cytochrome P450c17; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease - Prostate cancer progression documented by PSA progression or radiographic progression - Asymptomatic or mildly symptomatic from prostate cancer - Surgically or medically castrated, with testosterone levels of <50 ng/dL - Previous anti-androgen therapy and progression after withdrawal - ECOG performance status score of 0 or 1 - If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1 - If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1 - If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days - Life expectancy of at least 6 months Exclusion Criteria: - Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated - Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily - Pathological finding consistent with small cell carcinoma of the prostate - Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months - Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) - Radiation or radionuclide therapy for treatment of mCRPC - Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment - History of pituitary or adrenal dysfunction ; PRIMARY OUTCOME: Time to prostate specific antigen (PSA) progression (TTPP); SECONDARY OUTCOME 1: Overall 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 - CP001; BRIEF: Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the safety of Cat-PAD administered as increasing single doses. ; DRUG USED: Cat-SPIRE; DRUG CLASS: Vaccine; INDICATION: Allergic Rhinitis; TARGET: Immune System, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Circassia Limited; CRITERIA: Inclusion Criteria: - A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year. - Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response on single arm. Exclusion Criteria: - Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled). - A history of anaphylaxis to cat allergen. - Subjects with a cat specific IgE >100 kU/L. - Subjects with an FEV1 <80% of normal. - Subjects with an acute phase skin response to cat allergen with a weal diameter > 30mm. - Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season. - Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever. - Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria. - Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). - Subjects being treated with beta-blockers ; PRIMARY OUTCOME: Safety and tolerability of Cat-PAD; SECONDARY OUTCOME 1: Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/JNJ-4178 and Simeprevir (Treatment-Naive, GT1); BRIEF: The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection. ; DRUG USED: AL-335; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site; THERAPY: Combination; LEAD SPONSOR: Alios Biopharma Inc.; CRITERIA: Inclusion Criteria: 1. Participant has provided written consent 2. In the Investigators opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned 3. Male or female, 18-70 years of age 4. Body mass index (BMI) 18-35 kilogram per meter square (kg/m^2), inclusive 5. A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening 6. Female participants must either: - not be of childbearing potential defined as: i. Postmenopausal for at least 12 months (that is [i.e.], 2 years of amenorrhea without an alternative medical cause) and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (per reference laboratory), OR ii. Surgically sterile (example [e.g.], underwent total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant, OR - be of childbearing potential AND - not heterosexually active (e.g., abstinent or homosexual) from screening until 6 months after study drug administration (or longer, if dictated by local regulations), OR - if heterosexually active - have a vasectomized partner (confirmed sterile per verbal account of the participant), OR - using an acceptable method of birth control from screening and agree to continue to use the same method of contraception throughout the study and for 6 months after study drug administration (or longer, if dictated by local regulations). Oral hormone based contraceptives are not allowed from 14 days before the planned study drug administration until 6 months after the last dose of treatment due to the potential for drug-drug interactions which might undermine their efficacy. An intrauterine device (IUD), being either hormonal (i.e., Intra-Uterine System [IUS*]) or non-hormonal, is considered highly effective and reliable; therefore participants using an IUD/IUS are not required to use additional contraceptive methods (no double-barrier method is required). Other non-oral hormone-based contraception methods (e.g., injectable, implants, transdermal system, vaginal ring) may be continued, but as the interaction of the study drug with hormone-based contraception is unknown, these methods are not considered to be reliable and therefore participants should use a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide). - An IUS does not rely on systemic plasma concentrations and is therefore not expected to be impacted by a potential drug-drug interaction (DDI) Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction 7. A post-menopausal female who is receiving hormone replacement therapy and is willing to discontinue hormone therapy 30 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation. - Male participants must either: - be surgically sterile (had a vasectomy), or otherwise incapable of fathering a child, OR - not be heterosexually active (e.g., abstinent or homosexual) from enrollment (Day 1) in the study until at least 6 months after study drug administration, OR - if heterosexually active: - have a partner who is postmenopausal (2 years amenorrhea), surgically sterile (e.g., has had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant OR - be practicing an acceptable method of birth control from enrollment in the study (Day 1) and agree to continue to use the same method of contraception throughout the study and for at least 6 months after study drug administration (or longer, if dictated by local regulations). An acceptable method of birth control for male participants is a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide). Note: Male participants with a female partner who uses hormonal contraceptives (oral, injectable, implants) or a hormonal (IUS) or non-hormonal IUD and male participants who are vasectomized or otherwise incapable of fathering a child are not required to use additional contraceptive methods. Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction. NOTE: Contraceptive use by men and women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria 8. Participants must agree to refrain from sperm/egg donation from start of dosing through 6 months after the completion of study drug administration 9. Genotype (GT) 1a or 1b or GT2 or 3 chronic hepatitis C (CHC), depending on cohort, with positive Hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA) at screening including documentation of CHC infection for at least 6 months. Genotype testing must occur at a screening visit. NOTE: GT1 patients are eligible for inclusion even if they cannot be successfully subtyped unless a specific subtype is required for a cohort 10. Screening HCV RNA viral load greater than or equal to (>=) 50,000 International Units per milliliter (IU/mL), except for participants with compensated cirrhosis (Child Pugh Class A) who may have HCV RNA viral load >=10^4 IU/mL 11. No prior treatment for CHC (defined as no prior exposure to any approved or investigational drug including direct-acting antivirals, and interferon-based treatments) 12. Fibroscan, collected within 6 months of baseline visit, with liver stiffness score less than or equal to (<=) 12.5 kilo Pascal (kPa) to be eligible (except for participants with cirrhosis, see below). - participants with compensated cirrhosis must meet the Child-Pugh Class A definition (see Appendix G) and at least one of the following criteria: i. Liver biopsy result indicating the presence of cirrhosis (e.g., Metavir F4; Ishak >5) or ii. Fibroscan evaluation with a liver stiffness score >12.5 kPa 13. Participant is otherwise in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG) 14. Willing to avoid prolonged sun exposure and use of tanning devices while taking Simeprevir (SMV) and through 4 weeks of follow up. Participant should also be advised to use a broad-spectrum sunscreen and lip balm of at least sun protection factor >30 to help protect against potential sunburn Exclusion Criteria: 1. Pregnant, planning on becoming pregnant (during treatment and up to 6 months after the end of treatment [EOT]), or breast-feeding female participant, or male participant whose female partner is pregnant or planning on becoming pregnant (during treatment and up to 6 months after the EOT) 2. Other than CHC with or without compensated cirrhosis, clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsors Medical Monitor 3. History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant ECG abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening 4. Screening echocardiogram ejection fraction <55 percentage (%) or any other echocardiographic finding suggestive of clinically relevant cardiomyopathy 5. Creatinine clearance of <60 mL/min (Cockcroft-Gault) 6. Positive test for Hepatitis A virus immunoglobulin (HAV) Immunoglobulin M (IgM), Hepatitis B surface antigen (HBsAg), or Human Immunodeficiency Virus (HIV) Ab 7. Abnormal screening laboratory results that are considered clinically significant by the investigator 8. History of clinical hepatic decompensation, e.g., variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice (within last year) 9. Any condition that, in the opinion of the investigator, would compromise the studys objectives or the well-being of the participant or prevent the participant from meeting the study requirements 10. Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication 11. Clinically significant abnormal screening ECG findings (e.g., PR >200 msec, QRS interval >120 millisecond (msec) or corrected QT interval (QTc) >450 msec for male participants and >470 msec for female participants), based on an average of triplicate ECGs. Any evidence of heart block or bundle branch block is also exclusionary 12. History or family history of abnormal ECG intervals, for example prolonged QT syndrome (torsade de pointes) or sudden cardiac death 13. The participant has a positive prestudy drug screen, including methadone unless the drug is prescribed by the participants physician. The list of drugs that should be screened for includes amphetamines, barbiturates, cocaine, opiates, phencyclidine (PCP), and benzodiazepines 14. Laboratory abnormalities including: - Hematocrit <0.34 - White blood cell counts <3,500/millimeter (mm)^3 (<1,000/mm^3 for participants with compensated cirrhosis) - Absolute neutrophil count <1,000/mm^3 (<750/mm^3 for participants with compensated cirrhosis) - Platelets <=120,000/mm^3 (platelets ≤90,000/mm^3 for participants with compensated cirrhosis) - Glycosylated hemoglobin (HbA1C) >55 mmol/mol - Prothrombin time >=1.5 * upper limit of normal (ULN) - Albumin <=32 gram per liter (g/L), bilirubin >=1.5 milligram per deciliter (mg/dL) at screening (participants with documented Gilberts disease allowed) - Serum ALT concentration >=5* ULN - CK >1.5* ULN A single repeat laboratory evaluation under appropriate conditions (e.g., fasted, no antecedent exercise) is allowed for eligibility determination 15. Any condition possibly affecting drug absorption (e.g., gastrectomy or other significant gastrointestinal tract surgery, such as gastroenterostomy, small bowel resection, or active enterostomy) 16. Clinically significant blood loss or elective blood donation of significant volume (i.e., >500 mL) within 60 days of first dose of study drug; >1 unit of plasma within 7 days of first dose of study drug 17. Evidence of clinically relevant active infection that would interfere with study conduct or its interpretation 18. History of regular alcohol intake >10 standard drinks per week of alcohol for females and >15 standard drinks per week for males (one unit is defined as 10 g alcohol) within 3 months of the screening visit 19. The use of prohibited medications, including prescription, over the counter (OTC) medications, herbal medications, inducers or inhibitors of Cytochrome P450 (CYP450) enzymes or drug transporters (including P-gp) within 14 days prior to the first dose of study medication is excluded, unless previously approved by the Sponsors Medical Monitor. NOTE: Chronic medication use is permitted so long as they are medically necessary, deemed acceptable by the Principal Investigator and Medical Monitor, and not Prohibited Medications (see Section 5.12) 20. Hypersensitivity to the active substances (including sulfa allergy) or to any of the excipients of AL-335, Odalasvir (ODV) or SMV 21. Evidence on recent (within 6 months) liver ultrasound of hepatic mass or lesion concerning for malignancy (participants with cirrhosis only) ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Event (TEAE); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End 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 III - TENAYA; BRIEF: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD). ; DRUG USED: Faricimab; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Angiopoietins, VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye - Ability to comply with the study protocol, in the investigators judgment - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment - Other protocol-specified inclusion criteria may apply Exclusion Criteria: - Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1 - Pregnancy or breastfeeding, or intention to become pregnant during the study - CNV due to causes other than AMD in the study eye - Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye - Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study - Uncontrolled glaucoma in the study eye - Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye - Prior IVT administration of faricimab in either eye - History of idiopathic or autoimmune-associated uveitis in either eye - Active ocular inflammation or suspected or active ocular or periocular infection in either eye - Other protocol-specified exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48; SECONDARY OUTCOME 1: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60[/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 - P06107; BRIEF: Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 10 and 17 years old, who are either hospitalized or non-hospitalized. In this 3-weeks, double-blind, parallel design trial, eligible participants will be randomized to receive one out of three fixed dose levels of asenapine, or placebo. The study primary hypothesis is that at least one asenapine dose is superior to placebo as measured by the change from baseline to Day 21 in Young Mania Rating Scale (Y-MRS) total score. Trial medication and placebo are provided as identical-looking sublingual tablets; concurrent use of psychotropics is prohibited, except use of short-acting benzodiazepines and psychostimulants approved for the treatment of attention deficit hyperactivity disorder (ADHD). Main treatment effect is measured using Y-MRS and safety is evaluated using the recordings of adverse events, routine blood panels, physical examinations (including vital signs), and electrocardiograms. Participants who complete the double blind trial may be offered to continue (open-label) treatment with asenapine for an extended period of time. Follow-up information on safety parameters will be collected in all participants within 30 days following treatment discontinuation. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion criteria: - Participants who (or whose parent/legal representative) are able to give written informed consent. - Participants must be 10 years of age or older and 17 years of age or younger at the time of treatment assignment (randomization). - Participants must have a diagnosis of bipolar I disorder, confirmed by structured interview at screening. - Participants must not be pregnant or lactating, and those who are sexually active or become sexually active during the trial, and of child-bearing potential, must be using a medically accepted form of birth control. - Participants will be required to have stopped taking certain psycho-active medications prior to baseline. - Participants must have a caregiver, or other responsible person living with them who agrees to provide support to the participant to ensure study and procedure compliance. Exclusion criteria: - Diagnosis of bipolar II disorder, or other form of bipolar or psychotic disorder. - Known or suspected mental retardation. - Substance abuse, or dependence, within the past 6 months. - There is risk of self-harm or harm to others. - There is a history of tardive dyskinesia or dystonia. - Pregnancy or lactation during the study. - History of seizure disorder. - Participation in any other clinical trial at the same time. - A family member who is part of the study staff or is directly involved with the study. - Other medical conditions determined by the study staff to possibly interfere with the study safety and efficacy evaluations. ; PRIMARY OUTCOME: Change From Baseline in Y-MRS Total Score at Day 21; SECONDARY OUTCOME 1: Change From Baseline in Clinical Global Impression Scale for Use in Bipolar Disorder (CGI-BP) Overall Score at Day 21[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - GS-US-380-1474; BRIEF: The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1. ; DRUG USED: Biktarvy; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: Cohort 1: HIV-1 infected adolescents (12 to < 18 years of age and screening weight ≥ 35 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 2: HIV-1 infected children (6 to < 12 years of age and screening weight ≥ 25 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to < 25 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 4 Group 1: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to < 25 kg) who are virologically suppressed for ≥ 6 months prior to screening and unable to swallow tablets. - Documented plasma HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the Screening visit. Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or blip) prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests. - Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen. - Estimated glomerular filtration rate (GFR) ≥ 90 mL/min/1.73 m^2 according to the Schwartz Formula - No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to < 14 kg) who are treatment naive or on ARV treatment for ≥ 1 month prior to screening - Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age) - On a stable ARV regimen for ≥ 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment) - For < 1 year of age, eGFR ≥ the minimum normal values for age according to the information below using the Schwartz Formula - 30 mL/min/1.73 m^2 for age > 2 months to ≤ 95 days - 39 mL/min/1.73 m^2 for age ≥ 96 days to ≤ 6 months - 49 mL/min/1.73 m^2 for age > 6 months to < 12 months - For ≥ 1 year of age, eGFR ≥ 90 mL/min/1.73 m^2 using the Schwartz Formula - No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. - For individuals < 14 kg, M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed. Individuals with HIV-1 RNA > 50 copies/mL should not have FTC, TFV, or INSTI resistance mutations. - Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrollment Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: PK Parameter: AUCtau of Bictegravir; SECONDARY OUTCOME 1: Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm[/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 - FIT-04; BRIEF: The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants. ; DRUG USED: NTRA-2112; DRUG CLASS: Non-NME; INDICATION: Gastroenterologic Disorders; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Nutrinia; CRITERIA: Inclusion Criteria 1. Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound 2. Birth weight ≥ 500g 3. Singleton or twin birth Exclusion Criteria 1. Complete enteral feeding ; PRIMARY OUTCOME: Numbers of days to achieve complete enteral feeding; SECONDARY OUTCOME 1: Number of days to achieve discharge from hospital or readiness to 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 - RELAX-AHF-EU; BRIEF: This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF). ; DRUG USED: Reasanz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Relaxin Family Peptide Receptors 1-4 (RXFP1-4); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Systolic blood pressure ≥ 125 mmHg - Admitted for Acute Heart Failure (AHF) - Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening - eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m^2 Exclusion Criteria: - Dyspnea (non-cardiac causes) - T > 38.5°C - Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment. - Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm^2 or mean gradient >50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis. - AHF due to significant arrhythmias - Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function). ; PRIMARY OUTCOME: Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5; SECONDARY OUTCOME 1: Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NAV5-01; BRIEF: This is a phase 3, open-label, multiple-center, non-randomized single dose study to assess the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor. ; DRUG USED: NAV5001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease - Imaging; TARGET: Dopamine Transporter (DAT); THERAPY: Monotherapy; LEAD SPONSOR: Navidea Biopharmaceuticals; CRITERIA: Inclusion Criteria: - Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation - Age ≥ 40 years - Have had upper extremity tremor for < 3 years duration, regardless of presumed diagnosis or etiology - Have a UPDRS part III score upon entry of ≤ 16 Exclusion Criteria: - Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator - Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke) - Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator - Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator - Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR [American Psychiatric Association, 1994]) - Positive urine drug screen for opiates, cocaine, or amphetamines at screening - Positive pregnancy test before imaging - Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent - Previous scan with any DAT imaging agent (e.g. [123I]NAV5001, Altropane, DaTscan, DOPASCAN) - Any exposure to radiopharmaceuticals within 30 days before the date of informed consent - Breast-feeding - Inability to lie supine for 1 hour - Any thyroid disease other than adequately treated hypothyroidism - Known sensitivity or allergy to iodine or iodine containing products - Treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram. ; PRIMARY OUTCOME: The incidence of Parkinson Syndrome based on the Movement Disorder Specialist Consensus Panel; SECONDARY OUTCOME 1: The incidence of Parkinson Syndrome based on the on-site neurologist assessment at 6 months[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EQUATOR2; BRIEF: This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment. ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriatic Arthritis (PA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Male or female subjects who are ≥18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigators judgment. - Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol. - Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments. Exclusion Criteria: - Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed. - Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigators clinical judgment. - Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues. - Subjects who require immunization with live/live attenuated vaccine. - Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögrens syndrome. - Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634- CL-224 study. - Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study. - Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study. - Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study. ; PRIMARY OUTCOME: Change in the proportion of subjects with adverse events; SECONDARY OUTCOME 1: Proportion of subjects achieving minimal disease activity (MDA)[/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 - VTI-208; BRIEF: The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing additional survival data up to a maximum of 5 years that will be included, as available, through VTI-208 study termination (after the last surviving enrolled subject completes Study Day 91). Secondary objectives are to determine the proportion of survivors at Study Days 28 and 91. Exploratory objectives are to evaluate the ability of ELAD to stabilize liver function, measured using the Model for End Stage Liver Disease (MELD)-based time to progression (TTP) up to Study Day 91, and the proportion of progression-free survivors (PFS) up to Study Days 28 and 91. Progression is defined as death or the first observed increase of at least 5 points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to both End of Study Days 28 and 91 following Randomization. ; DRUG USED: ELAD; DRUG CLASS: Biologic; INDICATION: Liver Failure / Cirrhosis; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Vital Therapies, Inc.; CRITERIA: Inclusion Criteria: - Age ≥ 18 years; - Total bilirubin ≥ 8 mg/dL; - A clinical diagnosis of alcohol-induced liver decompensation (AILD), based upon evidence (by lab test, medical history, or family interview) of a clinical judgment of a temporal (6 weeks or less) and causal relationship between use of alcohol and this onset of symptoms; - Subjects meeting inclusion criteria 1 through 3 will be classified as having either: a. Severe acute alcoholic hepatitis (AAH), with: i. Medical history of alcohol abuse; AND ii. Maddrey score of ≥ 32; AND iii. AAH documented by either: 1. Confirmatory liver biopsy; OR 2. Two or more of the following: 1. Hepatomegaly, 2. AST > ALT, 3. Ascites, 4. Leukocytosis (WBC count above lab normal at site), OR b. Alcohol-induced decompensation of chronic liver disease that is not acute alcoholic hepatitis (as defined above), with: i. MELD score of 18-35; AND ii. Underlying chronic liver disease documented by: 1. Liver biopsy, AND/OR 2. Laboratory findings, AND/OR 3. Medical history; - Not eligible for liver transplant during this hospitalization; - Subject or legally authorized representative must provide Informed Consent; - Subject must be eligible for Standard of Care treatment as defined in the protocol. Exclusion Criteria: - Platelet count < 40,000/mm3; - International Normalization Ratio (INR) > 3.5; - MELD Score > 35; - AST > 500 IU/L; - Evidence of infection unresponsive to antibiotics; - Evidence of reduction in total bilirubin of 20% or more in the previous 72 hours, if available. Bilirubin measurements must be taken at least 12 hours after any procedure known to artificially alter serum bilirubin (e.g., administration of packed red blood cells, plasma exchange); - Evidence of hemodynamic instability as defined by the following: 1. Systolic blood pressure < 90 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR 2. Mean arterial pressure (MAP) < 60 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR 3. Requirement for escalating doses of vasopressor support prior to Screening; OR 4. Subject at maximum vasopressor dose at Screening; - Evidence of active bleeding or of major hemorrhage defined as requiring ≥ 2 units packed red blood cells to maintain stable hemoglobin occurring within 48 hours of Screening; - Clinical evidence of liver size reduction due to cirrhosis (liver size of the craniocaudal diameter (sagittal view) < 10 cm when measured on the mid clavicular line (or equivalent measurement) by ultrasound, or liver volume < 750 cc as determined by CT), unless Investigator interpretation of the clinical evidence indicates liver size of < 10 cm or volume < 750 cc is not considered reduced for the individual subject; - Occlusive portal vein thrombosis impairing hepatopetal flow, or evidence of bile duct obstruction; - Evidence by physical exam, history, or laboratory evaluation, of significant concomitant disease with expected life expectancy of less than 3 months, including, but not limited to: 1. Severe acute or chronic cardiovascular, central nervous system, or pulmonary disease; 2. Cancer that has metastasized or has not yet been treated; - Subject has chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome); - Subject has liver disease related to homozygous hemachromatosis, Wilsons Disease, has non-alcoholic fatty liver disease, or Budd-Chiari Syndrome; - Pregnancy as determined by β-human chorionic gonadotropin (HCG) results, or lactation; - Participation in another investigational drug, biologic, or device study within one month of enrollment, except for observational studies (the observational study setting should not affect safety and/or efficacy of the VTI-208 clinical trial); - Previous liver transplant; - Previous enrollment in the treatment phase of another ELAD trial (e.g. a subject is not disqualified from enrollment in VTI-208 if they were screened for VTI-210 but did not qualify for enrollment in the treatment phase of the study and therefore did not receive ELAD or Control treatment; - Have a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or such local equivalent) or any other Advanced Directive limiting Standard of Care in place (the DNR/DNI criterion is not applicable in the UK); - Refusal to participate in the VTI-208E follow-up study; - Inability to provide an address for home visits. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Number of Survivors at Study Day 91.[/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 - CD16 (Brazil); BRIEF: Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5). Disruption of the C-C chemokine ligand 5 (CCL5)-CCR5 axis via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory leukocytes and dampen pathogenic immune activation in coronavirus disease 2019 (COVID-19). The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation (ECMO). ; DRUG USED: Vyrologix; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Chemokine Receptor 5 (CCR5); THERAPY: Monotherapy; LEAD SPONSOR: Hospital Israelita Albert Einstein; CRITERIA: Inclusion Criteria: 1. Male or females aged ≥ 18 years 2. Critically ill patients with COVID-19 (defined as Ordinal Scale score of 7): Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) for less than 72 hours. 3. Evidence of pneumonia (pulmonary infiltrates) at chest radiography or computed tomography compatible with COVID-19. 4. Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR). 5. Subject (or legally authorized representative) provides written or oral informed consent prior to initiation of any study procedures. 6. Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study. Exclusion Criteria: 1. Subjects who had been on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) for >72 hours prior to the screening. 2. Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible. 3. Inability to provide informed consent (from subject or legally authorized representative) or to comply with test requirements. 4. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk associated with study participation or, in the investigators judgment, make the participant inappropriate for the study. 5. Pregnancy or breast feeding. 6. Subject participating in another study with for an investigational treatment. 7. Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19), that may increase the risk for the study participant based on investigator judgement. 8. Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (e.g., azathioprine, cyclosporine). 9. Patients with estimated discharge or transfer for other hospital in the first 72 hours of study inclusion. 10. Patients with low probability of survival in the first 48 hours of study inclusion. ; PRIMARY OUTCOME: Cumulative proportion of clinical recovery; SECONDARY OUTCOME 1: Proportion of patients clinically recovered[/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 - Parkinson; BRIEF: To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy in subjects with chronic severe pain associated with Parkinsons disease (PD), as assessed by averaged 24 hour pain scores collected for 7 days prior to the clinic visits ; DRUG USED: Targiniq ER; DRUG CLASS: Non-NME; INDICATION: Chronic Low Back Pain (CLBP); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Mundipharma Research GmbH & Co KG; CRITERIA: Inclusion Criteria 1. Males and females, age of 25 years or over 2. Able to provide written informed consent 3. Primary diagnosis of Parkinsons disease Stage II-IV) 4. Graded as having severe pain 5. An average pain score of 6 or above on an 11 point NRS, over the previous 7 days 6. Female subjects willing to use an adequate and highly effective method of contraception throughout the study. 7. Subjects likely to benefit from WHO step III opioid therapy for the duration of the study 8. Subjects must not have received opioid containing medication in the last 6 months on a regular basis 9. Receiving stable treatment for Parkinsons disease for at least 4 weeks prior to randomisation 10. Subject does not have visual or auditory impairments that would reduce their ability to complete study questionnaires or be unable to receive instructions for these 11. Concomitant medication (including co-analgesic) use anticipated to remain stable throughout the Double-Blind Phase of the study 12. Subjects willing and able to participate in all aspects of the study and comply with the use of study medication. Open-Label Extension Inclusion Criteria The aim of the Open-Label Phase is to ensure a safe transfer of all subjects to a subsequent pain treatment after the study. Subjects must: 1. Still meet general inclusion criteria for Double-Blind Phase; subjects do not have to meet inclusion 5, 6, 9 & 12 2. Have completed the Double-Blind Phase or discontinued early but have had at least 8 weeks treatment with study medication. Exclusion Criteria Subjects who are to be excluded from the study are those who meet any of the following criteria: Medical Conditions 1. Cognitive impairment as assessed with the MMSE scoring 24 or less 2. History of psychosis (hallucinations, delusions, etc.) 3. History of drug or alcohol abuse or current compulsive addictive use of drugs or alcohol 4. Parkinsonian-like disease secondary to drug therapy side-effects e.g. due to exposure to medications that deplete dopamine (reserpine, tetrabenazine) or block dopamine receptors (neuroleptics, antiemetics) 5. Parkinson-plus syndromes e.g. progressive supranuclear palsy (PSP) and the multiple system atrophies (MSA) 6. Females who are pregnant (positive β-hCG test) or lactating 7. Any other contraindications to use of the opioid study medication(s) as per the SmPC/IB: - Hypersensitivity to the active substances or to any of the excipients - Any situation where opioids are contraindicated - Severe respiratory depression with hypoxia and/or hypercapnia - Severe chronic obstructive pulmonary disease - Cor pulmonal - Severe bronchial asthma - Non-opioid induced paralytic ileus - Moderate to severe hepatic impairment (see exclusion criterion 16) 8. Any other contraindications to use of the study Double-Blind Phase rescue medication as per the SmPC: - known hypersensitivity to levodopa or benserazide - contra-indicated in narrow-angle glaucoma (it may be used in wide-angle glaucoma provided that the intra-ocular pressure remains under control); severe psychoneuroses or psychoses; severe endocrine, renal, hepatic or cardiac disorders - should not be given in conjunction with, or within 2 weeks of withdrawal of, monoamine oxidase (MAO) inhibitors, except selective MAO-B inhibitors (e.g. selegiline) or selective MAO-A inhibitors (e.g. moclobemide) unless selective MAO inhibitors are given in combination in which case it is contraindicated - not be used in persons who have a history of, or who may be suffering from, a malignant melanoma 9. Subjects with any of the following as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication: - myxoedema - untreated hypothyroidism - Addisons disease - increase of intracranial pressure - uncontrolled seizures or convulsive disorder - evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease (subjects with controlled co-morbidities may be included following agreement with the Medical Monitor) Contraindicated Treatments 10. Treatment with Deep Brain Stimulation 11. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the Investigators opinion, may pose a risk of additional CNS depression with opioids study medication 12. Subjects presently taking, or who have taken, naloxone or naltrexone less than or equal to 30 days prior to the Screening Visit 13. Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Phase) 14. Any current use of an opioid other than the study medication provided 15. Subjects with a positive urine drug test at Screening Visit 1, which indicates unreported illicit drug use or unreported use of a concomitant medication not required to treat the Subjects medical condition(s) Laboratory Exclusions 16. Abnormal parameters as defined: - aspartate aminotransferase (AST; SGOT) > 3 times the upper limit of normal - alanine aminotransferase (ALT; SGPT) > 3 times the upper limit of normal - alkaline phosphatase levels > 3 times the upper limit of normal - gamma glutamyl transpeptidase (GGT or GGTP) > 3 times the upper limit of normal - Abnormal total bilirubin and/or creatinine level(s) > 1.5 times the upper limit of normal. Subjects whose total bilirubin levels or creatinine levels are below the lower limit of normal can participate in the study if they meet the criteria below: ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TV1001-003; BRIEF: In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily. Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications affects on pain following treatment will also be recorded. ; DRUG USED: JAN101; DRUG CLASS: Non-NME; INDICATION: Neuropathic Pain; TARGET: Nitric Oxide/ Nitrogen Monoxide; THERAPY: Monotherapy; LEAD SPONSOR: TheraVasc Inc.; CRITERIA: Inclusion Criteria: - Female subjects must be post-menopausal, sterilized or using suitable birth control - Diagnosis of diabetes (HbA1c > 6.0) - Diagnosis of diabetic peripheral neuropathy pain in feet - Presence of ongoing diabetic neuropathic for at least 3 months - A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at screening - Ability to provide written informed consent Exclusion Criteria: - Patients with fibromyalgia or regional pain caused by lumbar or cervical compression - History or diagnosis of significant neurological disease - History and diagnosis of clinically significant psychiatric diseases - Serious liver disease - Poorly controlled diabetes - Hypersensitivity to sodium nitrite or related compounds - Life expectancy < 6 months - A chronic illness that may increase the risks associated with this study - Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation - Pregnant or nursing women - Current diagnosis of alcohol or other substance abuse - Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors - History of methemoglobinemia, (met-Hb ≥ 15%) - Subject is involved in litigation or receives workers compensation - Inability to speak English ; PRIMARY OUTCOME: Reporting of Adverse Events During 12 Week Study Period; SECONDARY OUTCOME 1: Pharmacokinetics (Blood Levels of Nitrite)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - P06384 ; BRIEF: This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion criteria: - Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception. - Each participant must be willing and able to provide written informed consent. - Each participant must have an identified external contact person or an identified responsible person. - Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR^TM] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview [MINI]) at Screening. - Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode. Exclusion criteria: - Uncontrolled, unstable clinically significant medical condition. - Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening. - Current primary Axis I disorder other than bipolar 1 disorder. - Meets the current DSM-IV-TR^TM criteria for substance abuse or dependence (excluding nicotine). - Imminent risk of self-harm or harm to others. ; PRIMARY OUTCOME: The time (in days) to recurrence of any mood event during the double-blind treatment period; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - UBR-MD-04 (Ext.); BRIEF: This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year. ; DRUG USED: Ubrelvy; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: -Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709). Exclusion Criteria: - Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities - Requirement for a medication during the study that is on the list of prohibited medications. ; PRIMARY OUTCOME: Percentage of Participants With at Least 1 Treatment Emergent Adverse Event; SECONDARY OUTCOME 1: Number of Participants With Clinically Significant Laboratory Values[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Dose Selection; BRIEF: The current understanding of PR104 justifies the evaluation of PR104 in subjects with relapsed/refractory AML and ALL. These include: - Hypoxia. Leukemic bone marrow is likely to demonstrate a level of hypoxia sufficient to activate PR104 to its active metabolites PR104H and PR104M. - Myelotoxicity as the primary toxicity at MTD. In prior clinical studies in subjects with solid tumors PR104 has demonstrated myelotoxicity as the primary toxicity. This observation suggests that PR104 will exert a similar effect on leukemic cells. - AKR1C3. AML has been reported to exhibit high levels of AKR1C3 which should lead to selective activation of PR104 within both hypoxic and oxic leukemic cells. - Preclinical data. PR104 has demonstrated impressive activity in an initial study using primary human ALL in a mouse model. The initial dose finding phase of the study will provide estimates of the activity and toxicity of PR104 in subjects with refractory/relapsed AML, and determine the optimal individualized dose to give each subject based on his/her covariates (prior CR duration, prior number of salvage therapies, age). Once a potentially beneficial dose has been determined, an expanded cohort of subjects with AML or ALL will receive PR104 at a uniform dose. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity and acceptable safety in AML to warrant future phase II or phase III studies in this indication. Primary objectives - Determine the toxicities and recommended dose of PR104 when administered IV to subjects with relapsed/refractory AML and ALL. Secondary objectives - Evaluate the pharmacokinetics (PK) of PR104 and a series of PR104 metabolites - Evaluate any anti-tumor effects of PR104 - Evaluate the expression of AKR1C3 in bone marrow and leukemic cells - Evaluate potential biomarkers of hypoxia ; DRUG USED: PR104; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Proacta, Incorporated; CRITERIA: Inclusion Criteria: - Signed informed consent - Age 18 years or more - Histologically diagnosed acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) by WHO classification - Refractory or relapsed disease (requiring at least 5% leukemic blasts in the bone marrow, regardless of the presence of other features such as new or recurrent dysplastic changes or extramedullary disease) according to the following definitions: AML Relapsed (defined as ≥5% leukemic blasts in the bone marrow) after receiving up to 2 prior induction regimens, (i.e., first or second relapse); Refractory (defined as ≥5% leukemic blasts in the bone marrow) to not more than 1 prior induction regimen (defined as failure to achieve a CR or CRp following induction therapy), (i.e., up to 1 induction failure). ALL Relapsed/refractory (defined as ≥5% leukemic blasts in the bone marrow) after receiving 1 or more prior induction regimens, (i.e., any number of relapses) - ECOG performance status of 0-2 - At least 2 weeks from administration of prior anti-leukemia therapy unless subject has progressed while receiving targeted therapy on a continuous dosing schedule - No remaining clinically significant toxicities from prior chemotherapy of grade 2 or greater - Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier device) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial - Sexually active men must be willing to use an acceptable contraceptive method for the duration of time on study and for 30 days following the last dose of study drug - Clinical laboratory values within the following ranges unless considered due to leukemic organ involvement: Serum creatinine 2.0 mg/dl; Total bilirubin 1.5x the upper limit of normal unless considered due to Gilberts syndrome; Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) 3x the upper limit of normal - Willingness to provide at least one pre-PR104 leukemia sample (e.g., bone marrow or peripheral blood) for analysis of AKR1C3. Exclusion Criteria: - Pregnant and nursing subjects - Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure - Another active concomitant malignancy likely to effect any of the primary or secondary outcome measures in the current study - Subjects receiving any other standard or investigational treatment for their hematologic malignancy (other than hydroxyurea). Subjects with CNS leukemia are eligible and may receive concurrent standard intrathecal chemotherapy. ; PRIMARY OUTCOME: Determine the optimal individualized dose to give each refractory/relapsed AML subject based on his/her covariates (prior CR duration, prior number of salvage therapies, age).; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Scleroderma; BRIEF: The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynauds Phenomenon secondary to Systemic Sclerosis (SSc). ; DRUG USED: RayVa; DRUG CLASS: Non-NME; INDICATION: Raynauds Phenomenon; TARGET: Prostaglandin E Receptor 1 (EP1); THERAPY: Monotherapy; LEAD SPONSOR: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.); CRITERIA: Inclusion Criteria: - Subjects with a diagnosis of SSc by current ACR/EULAR Classification Criteria; - Evidence of ongoing activity of Raynauds Phenomenon as measured by a Raynaud Condition Score of 3 or greater at Screening; - All females of childbearing potential must have a negative serum pregnancy test; a. Females of childbearing potential must abstain from sexual activity that could result in pregnancy, or agree to use an acceptable method of contraception throughout the study period and for 30 days following dosing of the investigational study drug. Acceptable contraception includes: 1. Intrauterine devices 2. Double barrier methods (e.g. condom or diaphragms with spermicidal gel or foam) 3. Condom use is advised for all forms of contraception - Must be willing and able to discontinue ongoing therapy for RP for at least 72 hours prior to each application of study medication; such drugs include calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, short-acting PDE-5i (sildenafil, vardenafil, avanafil), sympatholytics and topical or systemic nitrates; - Must be willing and able to discontinue consumption of caffeine-containing products (e.g., beverages and over-the-counter (OTC) medications) for at least 24 hours prior to each day of study dosing; - Must be willing and able to remove jewelry from the treated hand prior to each day of study dosing; - Must be willing to remove nail polish and/or nail coverings from the treated hand prior to each day of study dosing; - Must not donate blood during the study; - Have adequate finger extension to permit application of study treatments and attachment of physiologic measuring instruments. - Must be willing to comply with all study procedures and study visits; - Must provide written informed consent. Exclusion Criteria: - BMI less than 18.5; - Clinically significant medical abnormality or history or presence of significant neurological, hepatic, renal, endocrine, gastrointestinal, cardiovascular, pulmonary, psychiatric and/or metabolic condition as determined by the Investigator); - Clinical diagnosis of Systemic Sclerosis in association with other rheumatologic diseases including Mixed Connective Tissue Disease; - Clinically significant abnormal laboratory test results at screening as determined by the Investigator; - Raynauds Phenomenon thought to be of non-systemic sclerosis etiology; - Peripheral or central vasculopathy other than Systemic Sclerosis; - History of Scleroderma renal crisis or currently being treated for hypertension, however, subjects with controlled hypertension will not be excluded; - Active digital ulcers or rash on hand intended for study medication; - History in the past (5) five years of autonomic neuropathy or postural hypotension; - Upper extremity sympathectomy at any level in the 12 months prior to study; - Tobacco smoking within six months of screening or unwillingness to avoid smoking throughout the study (e.g., cigarette, pipe, cigar, e-cigarettes) and the use of nicotine-containing products; - Systolic Blood pressure less than 85mm/Hg; - Prostanoid use by any route of administration within the previous six months; - Current use of systemic or topical nitrates, endothelin receptor antagonists (e.g., bosentan) or any long-acting PDE-5 Inhibitors (e.g. tadalafil); - Use of topical corticosteroid to the hand or fingers within 10 days of screening; - Current use of ergot preparations, methysergide, B-adrenergic antagonists, contraceptives containing female steroid hormones, cyclosporine, clonidine, nicotine and cocaine; - Pregnant or lactating female; - Has known exaggerated pharmacological sensitivity or hypersensitivity to any drug similar to Alprostadil or its excipients; - Has known hypersensitivity to nitrile; - Involvement in any investigational drug or device study within 30 days prior to screening; - History of non-compliance with treatment or clinic visit attendance. ; PRIMARY OUTCOME: Pharmacodynamic evaluation: digital perfusion by laser Doppler capillary velocimetry and on digital temperature recovery with thermography.; 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 - 0002; BRIEF: This is a multiple-dose study in non-treatment seeking male and female subjects with moderate to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to block the effects of exogenous opioids. The primary objective of this study was to demonstrate that the Drug Liking visual analog scale (VAS) measured after challenge with 6 mg (Dose 1) and 18 mg (Dose 2) hydromorphone was noninferior to the Drug Liking visual analog scale (VAS) measured after challenge with placebo at Weeks 1-4 post first injection of subcutaneous buprenorphine 300 mg (RBP-6000). ; DRUG USED: Sublocade; DRUG CLASS: Non-NME; INDICATION: Substance Use Disorder; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Indivior Inc.; CRITERIA: Inclusion Criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder at screening and are not seeking opioid use disorder treatment - Body mass index of >= 18.0 to <= 33.0 kg/m^2 - Females - women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of study drug - Male subjects with female partners of child-bearing potential must agree to use medically acceptable contraception from screening through at least 3 months after the last dose of study drug Exclusion Criteria: - Subjects with any current diagnosis requiring chronic opioid treatment - Subjects who currently meet the criteria for diagnosis of moderate or severe substance use disorder by DSM-5 criteria for any substances other than opioids, caffeine, or nicotine. - Subjects who have abused or used buprenorphine within 14 days prior to informed consent. Other protocol-defined criteria may apply. ; PRIMARY OUTCOME: Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question Do You Like the Drug? Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures; SECONDARY OUTCOME 1: Reinforcing Effects (Breakpoint) by Study Week Analyzed by Mixed Model for Repeated Measures[/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 - TRx-237-020 (Ext.); BRIEF: The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM. ; DRUG USED: LMTX; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: TauRx Therapeutics Ltd; CRITERIA: Inclusion Criteria: - Subjects with all cause dementia and probable Alzheimers disease at enrollment and who completed participation in one of the following three TauRx studies (inclusive of the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015. - Subjects with a diagnosis of probable bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52). - Females, if of child-bearing potential, must practice true abstinence or continue to use adequate contraception and agree to maintain this throughout the study - Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and ethics approval is/are able to read, understand, and provide written informed consent - Has an identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug - Able to comply with the study procedures Exclusion Criteria: - History of swallowing difficulties - Pregnant or breastfeeding - Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit - Current participation in, or intent to enroll in, another clinical trial of a drug, biologic, device, or medical food - In Germany, subjects mandated to reside in a continuous care or assisted living facility or those whose willingness to participate in the clinical trial may be unduly influenced ; PRIMARY OUTCOME: Number of Participants With Serious or Non-serious Adverse Events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/TZD; BRIEF: The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone ; DRUG USED: Onglyza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening. - Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5% - Body mass index < = 45kg/m2 - Fasting C-peptide > = 1 ng/mL Exclusion Criteria: - Symptomatic poorly controlled diabetes - Recent cardiac or cerebrovascular event - Serum creatinine > = 2.0 mg/dL ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (A1C) at Week 24; SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - APDS/PASLI (OLE); BRIEF: This study is designed to provide long-term CDZ173 treatment, a selective PI3Kδ inhibitor, to the patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI who participated in the CCDZ173X2201 study or who were treated previously with PI3Kδ inhibitors other than CDZ173. The study is open-label designed to establish the long-term safety, tolerability, efficay and pharmacokinetics of CDZ173 in the target population. ; DRUG USED: CDZ173; DRUG CLASS: New Molecular Entity (NME); INDICATION: Primary Immunodeficiencies; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Pharming Technologies B.V.; CRITERIA: Inclusion Criteria: - Written informed consent must be obtained before any assessment is performed. - Paients must have participated in the study CCDZ173X2201 or were treated previously with PI3Kδ inhibitors other than CDZ173. - Patients who are deemed by the Investigator to benefit from PI3Kδ inhibitor therapy. - Patients or their legal representatives (for patients under the age of 18 years) must be able to communicate well with the Investigator, to understand and comply with the requirements of the study. - Documented APDS/PASLI-associated genetic PI3K delta mutation. Exclusion Criteria: - Any medically significant disease or condition that is unrelated to APDS/PASLI Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: To evaluate the long term safety and tolerability of CDZ173 in patients with APDS/PASLI; SECONDARY OUTCOME 1: To evaluate the long term efficacy of CDZ173 to modify health-related quality of life in patients with APDS/PASLI[/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. Glimepiride (Japan); BRIEF: The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients. ; DRUG USED: Fasiglifam; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GPR40 (FFAR1, free fatty acid receptor 1); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - The participant is an outpatient. - The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: - The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. - The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator. ; PRIMARY OUTCOME: Blood glucose; 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 - FRAMES; BRIEF: Randomized, double-blind, placebo-controlled study on the effects of MIN-102 on Biochemical, Imaging, neurophysiological, and clinical markers in patients with Friedreichs Ataxia ; DRUG USED: Leriglitazone; DRUG CLASS: New Molecular Entity (NME); INDICATION: Friedreichs Ataxia; TARGET: PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Minoryx Therapeutics, S.L.; CRITERIA: Inclusion Criteria: - Male and female subjects aged ≥12 and ≤60 years, inclusive, with a genetically confirmed diagnosis of Friedreichs Ataxia. - Be able to walk >10 meters with support (two special sticks, stroller, or accompanying person). - Total score on the Scale for the Assessment and Rating of Ataxia (SARA) of <25. Exclusion Criteria: - Age of onset of disease ≥25 years. - Higher degree of cardiomyopathy assessed by echocardiogram. - Diabetes. ; PRIMARY OUTCOME: Change from Baseline in spinal cord area cervical segment C2-C3 [mm²]; SECONDARY OUTCOME 1: Change from Baseline in SARA total score at Week 48[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 301 (Infants, 4-12 Months); BRIEF: The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support. ; DRUG USED: Gattex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Short Bowel Syndrome (SBS); TARGET: GLP-2 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Informed consent by the parent or legal guardian. - Male or female infant 4 to 12 months corrected gestational age at screening. - Weight at least 5 kilogram (kg) and weight-for-length Z-score greater than -2 at screening and baseline. - Short bowel syndrome with dependence on parenteral support to provide at least 50% of fluid or caloric needs. - Stable PN requirements for at least 1 month prior to screening, defined as a less than or equal to (<=) 10% change in the weight-normalized PN total fluid and caloric intake, despite attempts to wean PN, not withstanding transient instability for events such as sepsis or interruption of central venous access. - Parent or legal guardian understands and is willing and able to fully adhere to study requirements as defined in this protocol. Exclusion Criteria: - Previous treatment with teduglutide. - Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, etc. - Severe, known dysmotility syndrome, such as pseudo-obstruction or persistent, severe, active gastroschisis-related dysmotility, that is the primary contributing factor to feeding intolerance and inability to reduce PN support, prior to screening. Dysmotility is defined as severe if it is expected to limit the advancement of enteral feeding. - Inability to advance oral or enteral feeding due to lack of access to the gut, such as oral aversion in the absence of a feeding tube. - Intestinal obstruction or clinically significant intestinal stenosis. - Major gastrointestinal surgical intervention, such as serial transverse enteroplasty or major intestinal resection or anastomosis, within 3 months prior to screening or planned during the study period. - Unstable cardiac disease. - Renal dysfunction, defined as estimated glomerular filtration rate less than (<) 50 milliliter per minute (mL/min) per 1.73 square meter (m^2). - Biliary obstruction, stenosis, or malformation. - Clinically significant pancreatic disease. - Severe hepatic dysfunction or portal hypertension, defined by at least 2 of the following parameters: 1. International normalized ratio (INR) greater than (>) 1.5 not corrected with PN vitamin K 2. Platelet count <100×10^3/ microliter (mcL) due to portal hypertension 3. Presence of clinically significant gastric or esophageal varices 4. Documented cirrhosis - Persistent cholestasis defined as conjugated bilirubin >4 milligram per deciliter (mg/dL) (>68 micromoles per liter [mcmol/L]) over a 2 week period. - More than 3 serious complications of intestinal failure (example [e.g.], catheter-associated bloodstream infections, interruption of nutrition due to feeding intolerance, catheter-associated thrombosis, severe fluid or electrolyte disturbances) within 1 month prior to or during screening. - A history of cancer or a known cancer predisposition syndrome, such as juvenile polyposis or Beckwith-Wiedemann syndrome, or first degree relative with early onset of gastrointestinal cancer (including hepatobiliary and pancreatic cancers). - Concurrent treatment with glucagon-like peptide-1 (GLP-1); glucagon-like peptide-2 (GLP-2); insulin-like growth factor-1 (IGF-1); growth hormone, somatostatin, or analogs of these hormones; or glutamine. - Participation in a clinical study using an experimental drug within 3 months or 5.5 half-lives of the experimental drug, whichever is longer. - Known or suspected intolerance or hypersensitivity to the investigational product, closely-related compounds, or any of the stated ingredients. - Any condition, disease, illness, or circumstance that, in the investigators opinion, puts the participant at any undue risk, prevents completion of the study, or interferes with analysis of the study results. ; PRIMARY OUTCOME: Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weight-normalized Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET); SECONDARY OUTCOME 1: Plasma Concentration of Teduglutide at Nominal Time Points (Baseline at Pre-dose, and 1 Hour and 4 Hours Post-dose; 2 Hours Post-dose at Week 7)[/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 - 313-1580; BRIEF: The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options. ; DRUG USED: Zydelig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: p110 delta/PIK3CD, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Histologically confirmed diagnosis of B-cell follicular lymphoma (FL), and grade limited to 1, 2, or 3a based on criteria established by the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissues - Relapsed or refractory FL and have received at least 2 lines of prior therapy for FL and have no other available therapeutic options. Note: Rituximab maintenance is not routinely considered a separate line of therapy when it is given as part of the prior rituximab-containing regimen given over a number of cycles followed by maintenance. Rituximab monotherapy may be considered a separate line of therapy when disease relapse occurs between the initiation of rituximab monotherapy and the preceding line of therapy. If there are any ambiguities about eligibility, the site should consult with the medical monitor. - Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures ≥ 1.5 cm in the longest dimension (LD) and ≥ 1.0 cm in the longest perpendicular dimension (LPD) as assessed by positron emission tomography-computed tomography (PET-CT), computed tomography (CT) or magnetic resonance imaging (MRI) - Required baseline central laboratory data in protocol. - For female individuals of childbearing potential and male individuals of reproductive potential, willingness to use a protocol- recommended method of contraception - Lactating females must agree to discontinue nursing - Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP) Key Exclusion Criteria: - History of lymphoid malignancy other than FL (eg, diffuse large B-cell lymphoma) - Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma. - Known presence of intermediate- or high-grade myelodysplastic syndrome. - Known history of serious allergic reaction including anaphylaxis or Stevens- Johnson syndrome/ toxic epidermal necrolysis - History of a non-lymphoid malignancy except for protocol allowed exceptions - Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment - Known history of drug-induced liver injury, chronic active hepatitis B virus (HBV), chronic active hepatitis C virus (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis - History of or ongoing drug-induced pneumonitis - History of or ongoing inflammatory bowel disease - Known human immunodeficiency virus (HIV) infection - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation - Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia - Concurrent participation in another therapeutic clinical trial - Prior treatment with phosphatidylinositol 3-kinase (PI3K) inhibitors - Cytomegalovirus (CMV): Ongoing infection, treatment, or specifically CMV antiviral prophylaxis within 28 days prior to the screening visits CMV test Note: Other protocol defined Inclusion/ Exclusion criteria may apply. ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Duration of Response (DOR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VISIBLE 1 (SC as Maintenance Therapy); BRIEF: The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy. ; DRUG USED: Entyvio; DRUG CLASS: Biologic; INDICATION: Ulcerative Colitis (UC); TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report. 2. Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with an endoscopic subscore ≥2) 3. Evidence of UC extending proximal to the rectum (≥15 cm of involved colon). 4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor Necrosis Factor-alpha (TNF-α) antagonists Exclusion Criteria: 1. Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit. 2. Extensive colonic resection, subtotal or total colectomy. 3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 4. Prior exposure to investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer). 5. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer). 6. Prior exposure to vedolizumab 7. Surgical intervention for UC required at any time during the study. 8. History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia. 9. Suspected or confirmed diagnosis of Crohns entercolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. 10. Active infections 11. Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection, HIV or tuberculosis (active or latent), identified congenital or acquired immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included. 12. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease. ; PRIMARY OUTCOME: Percentage of Participants Achieving Clinical Remission at Week 52; SECONDARY OUTCOME 1: Percentage of Participants Achieving Mucosal Healing at Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Prophylaxis (EU and US); BRIEF: Primary Objective: To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE Secondary Objective: To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE ; DRUG USED: Ruconest; DRUG CLASS: Biologic; INDICATION: Hereditary Angioedema (HAE); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Pharming Technologies B.V.; CRITERIA: Inclusion Criteria: Patients fulfilling the following criteria at Screening are eligible for participation in the study: 1. Age 13 years or older 2. Laboratory confirmed diagnosis of HAE 3. A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3 consecutive months). 4. Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. 5. Provided written informed consent (and written assent for minors) 6. Willingness and ability to comply with all protocol procedures Exclusion Criteria: Patients who meet any of the following criteria at Screening are to be excluded from study participation: 1. Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH) 2. Diagnosis of acquired angioedema (AAE) 3. Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant 4. Treatment with any investigational drug in the past 30 days 5. Patients with any condition or treatment that, in the opinion of the Investigator, might interfere with the evaluation of study objectives 6. Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors ; PRIMARY OUTCOME: Number of HAE Attacks; SECONDARY OUTCOME 1: Number of Participants With Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - w/Trastuzumab or Cetuximab; BRIEF: The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the preliminary efficacy for each combination regimen. ; DRUG USED: SNK01; DRUG CLASS: Biologic; INDICATION: Cancer; TARGET: Immune System, Natural Killer Cells (NK Cells); THERAPY: Combination; LEAD SPONSOR: NKGen Biotech, Inc.; CRITERIA: Inclusion Criteria: - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol. - Males and females ages 18 to 75 years, inclusive. - Diagnosed with any documented histologically confirmed HER2 or EGFR-positive malignancy whose disease is confirmed to be metastatic and/or unresectable for which all treatment options considered to be standard of care therapy appropriate for the specific tumor type have been received and are no longer effective (i.e., subjects are refractory to standard of care therapies). - One or more tumors measurable per RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - At least 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational). - At least 2 weeks since prior palliative radiotherapy. - Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO). - Adequate organ function as determined by: a. Hematological (without growth factor or transfusion support within 14 days prior to screening): i. Absolute neutrophil count ≥ 1.5 × 109/L (1,500/mm3) ii. Platelet count ≥ 75 × 109/L (75,000/mm3) iii. Hemoglobin ≥ 9.0 g/dL iv. Prothrombin time-international normalized ratio and partial thromboplastin time ≤ 1.5 × upper limit normal (ULN) b. Renal: i. Calculated creatinine clearance (CrCl) or 24 hour urine CrCl > 50 mL/minute (Note: Cockcroft-Gault formula will be used to calculate CrCl) c. Hepatic: i. Total bilirubin ≤ 1.5 × ULN; for subjects with documented/suspected Gilberts disease, bilirubin ≤ 3 × ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (AST/ALT can be up to 5 × ULN in the presence of liver metastasis, but cannot be associated with concurrent elevated bilirubin) d. Serum electrolytes: i. Potassium, sodium, magnesium, and calcium (corrected for serum albumin) ≤ Grade 1 or within the institutional ranges of normal. If clinically appropriate, electrolytes may be corrected and values re-assessed prior to enrollment. - Women of childbearing potential who are not abstinent and intend to be sexually active with a nonsterilized male partner must be willing to use an adequate method of contraception from 28 days prior to the first study drug(s) administration and 120 days following last day of the last administration of last study drug(s) discontinued; acceptable methods include hormonal contraception (oral contraceptives - as long as on stable dose, patch, implant, and injection), intrauterine devices, or double barrier methods (e.g., vaginal diaphragm/vaginal sponge plus condom, or condom plus spermicidal jelly), sexual abstinence or a vasectomized partner. Women may be surgically sterile for at least 1 year after last menstrual period. - Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 28 days prior to the first study drug(s) administration throughout the total duration of the treatment period and 120 days after the last dose of last study drug(s) discontinued. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male subjects should refrain from sperm donation throughout this period. Exclusion Criteria: - Pregnant and/or lactating females. Women of childbearing potential must have negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days prior to receiving the first administration of the study drug(s) and a negative urine pregnancy test on Day 1 before first administration of the study drug(s). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. - Life expectancy of less than three months. - Currently being treated with immunotherapy or received immunotherapy during the treatment regimen immediately prior to participation in this study. - Untreated for HER2- or EGFR-positive metastatic and/or unresectable malignancy OR have refused an available standard of care therapy appropriate for the specific tumor type for any reason other than for a known sensitivity, toxicity, or contraindication. - For EGFR-positive patients, first line cetuximab treatment stopped due to allergic response. - For EGFR-positive patients, superior vena cava syndrome contra-indicating hydration. - Untreated or symptomatic central nervous system (CNS) metastases. Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroid treatment for at least 4 weeks. - No resolution of specific toxicities related to any prior anti-cancer therapy to Grade ≤1 according to the NCI-CTCAE v.5.0 (except lymphopenia and alopecia). - Active peripheral or motor neuropathy of any CTCAE grade and due to any cause. - Known hypersensitivity or allergy or contraindication to at least one of the study drugs. - In case of previous chemotherapy, wash out period of less than 5 half-lives of treatment before study entry. - Clinically significant cardiovascular disease including: 1. Myocardial infarction within 3 months, 2. Congestive heart failure of the New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening LVEF assessment ≥ 45%, 3. Prolonged QT interval defined as screening corrected QT interval (QTc) > 470 ms (Fridericia correction formula), 4. History of clinically significant ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation), 5. History of Mobitz II 2nd degree or 3rd degree heart block without a permanent pacemaker in place, 6. Hypotension (systolic blood pressure [BP] < 86 mmHg) or bradycardia with a heart rate < 50 bpm, 7. Uncontrolled hypertension as indicated by a resting systolic BP > 170 mmHg or diastolic BP > 105 mmHg despite an optimal treatment, - Major surgery within 4 weeks prior first study drug administration or already planned during the study. - Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug(s). (Note: Subjects participating in an observational study are an exception to this criterion and may qualify for the study with Sponsor approval) - Any pulmonary, thyroid, renal, hepatic severe/uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol. - Active uncontrolled viral, fungal or bacterial infection requiring systematic therapy within 14 days of Day 1. - High fever or any active or unresolved infection. - Known history of testing positive for human immunodeficiency virus (HIV), and/or positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hep C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection. - Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy. - A serious nonmalignant disease (e.g., psychiatric, substance abuse, uncontrolled intercurrent illness, etc.) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. - Any other condition that, in the opinion of the Investigator, would prohibit the subject from participating in the study. ; PRIMARY OUTCOME: Phase 1 - To determine recommended Phase 2 dose (RP2D) of SNK01 in combination with trastuzumab in subjects with advanced HER2 cancers.; SECONDARY OUTCOME 1: Phase 2a - To assess the progression-free survival (PFS) of SNK01 in combination with trastuzumab in subjects with advanced HER2 cancers.[/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 - P10-1; BRIEF: Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases. ; DRUG USED: Provenge; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Immune System, Prostatic Acid Phosphatase (PAP), Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Dendreon; CRITERIA: Inclusion Criteria: - Previously randomized in Dendreons P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T - Radiologic evidence of metastasis - Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease - Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration - Adequate hematologic function Exclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status > 2 - Treatment with chemotherapy within 3 months prior to registration - Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration - Treatment with commercial sipuleucel-T (Provenge®) - Current or imminent pathologic long-bone fracture or spinal cord compression - Known malignancies other than prostate cancer likely to require treatment within 6 months following registration - A requirement for systemic immunosuppressive therapy for any reason - A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF - Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration - Any surgery requiring general anesthetic within 28 days prior to registration ; PRIMARY OUTCOME: Number of Study Participants Enrolled and Treated Prior to Study Termination; 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 - COMPARE (vs. Krystexxa); BRIEF: This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study. ; DRUG USED: SEL-212; DRUG CLASS: Biologic; INDICATION: Gout; TARGET: Uric Acid; THERAPY: Combination; LEAD SPONSOR: Selecta Biosciences, Inc.; CRITERIA: Key Inclusion Criteria: 1. History of symptomatic gout defined as: 1. ≥ 3 gout flares within 18 months of Screening or 2. Presence of ≥ 1 tophus or 3. Current diagnosis of gouty arthritis 2. At the Screening Visit: male age 21 - 80 years, inclusive, or female of non-childbearing potential age 21-80 years, inclusive, where non-childbearing potential is defined as: 1. > 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony or 2. Post-menopausal (> 24 months of natural amenorrhea) 3. Has at the Screening Visit SUA ≥ 7 mg/dL, with chronic refractory gout defined as having failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the medically appropriate dose or for whom these drugs are contraindicated; 4. Willing to provide written informed consent prior to the conduct of any study specific procedures; 5. Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits Key Exclusion Criteria: 1. Prior exposure to any experimental or marketed uricase (e.g., pegloticase [Krystexxa®], pegadricase [SEL-037], rasburicase [Elitek, Fasturtec]); 2. History of anaphylaxis or severe allergic reactions to medications; 3. History of any allergy to pegylated products 4. Drugs known to interact with Rapamune cannot be used during the trial; 5. Uncontrolled diabetes; 6. Glucose-6-phosphate dehydrogenase (G6PD) deficiency; 7. Uncontrolled hypertension; 8. Participants whose arrhythmia is unstable on current treatment; 9. History of coronary artery disease, including myocardial infarction or unstable angina, within the last 6 months; 10. Congestive heart failure; 11. History of hematological disorders within 1 year or autoimmune disorders, is immunosuppressed or immunocompromised; 12. Has received an inactivated vaccine in the previous 3 months or has received a live virus vaccine in the previous 6 months; 13. Is planning to receive any vaccination or live virus vaccination during the study; ; PRIMARY OUTCOME: Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time; SECONDARY OUTCOME 1: Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6[/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 - LIRA-RENAL; BRIEF: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment. The trial medication will be add-on to the subjects stable pre-trial OAD and/or insulin regimen. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines - HbA1c 7-10% (both inclusive) - Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit - Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive) Exclusion Criteria: - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator - Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit - History of chronic pancreatitis or idiopathic acute pancreatitis - Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram)) - Heart failure defined as New York Heart Association (NYHA) class IV - A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg - Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator - Use of immunosuppressive treatment within 90 days prior to screening - Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) - Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator ; PRIMARY OUTCOME: Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - ENB-010-10 - Infants/Children; BRIEF: This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of a study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion protein) to see what effects it has on patients 5 years of age or less with HPP. ; DRUG USED: Strensiq; DRUG CLASS: Biologic; INDICATION: Hypophosphatasia; TARGET: Tissue-nonspecific alkaline phosphatase (TNSALP); THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Patients must meet all of the following criteria for enrollment in this study: 1. Parent or legal guardian(s) must provide written informed consent prior to any study procedures being performed and must be willing to comply with all study-required procedures. Where appropriate and required by local regulations, patient assent should also be provided prior to any study procedures being performed. 2. Documented diagnosis of HPP as indicated by: 1. Total serum alkaline phosphatase (ALP) below the lower limit of normal for age NOTE: Historical values for ALP may be used to determine patient eligibility. 2. Plasma pyridoxal-5-phosphate (PLP) above the upper limit of normal (unless patient is receiving pyridoxine for seizures) NOTE: Historical values for PLP may be used to determine patient eligibility. 3. Radiographic evidence of HPP at screening, characterized by: - Flared and frayed metaphyses, and - Severe, generalized osteopenia, and - Widened growth plates, and - Areas of radiolucency or sclerosis 4. Two or more of the following HPP-related findings: - History or presence of: i) Nontraumatic post-natal fracture or ii) Delayed fracture healing - Nephrocalcinosis or history of elevated serum calcium - Functional craniosynostosis - Respiratory compromise or rachitic chest deformity - Vitamin B6-responsive seizures - Failure to thrive 3. Onset of symptoms prior to 6 months of age 4. Chronological age or adjusted age for premature infants born ≤ 37 weeks gestation of ≤ 5 years 5. Otherwise medically stable in the opinion of the Investigator and/or Sponsor Exclusion criteria: Patients will be excluded from enrollment in this study if they meet any of the following exclusion criteria: 1. Clinically significant disease that precludes study participation, in the opinion of the Investigator and/or Sponsor 2. Serum calcium or phosphate levels below the normal range 3. Current evidence of treatable form of rickets 4. Prior treatment with bisphosphonates 5. Treatment with an investigational drug within 1 month prior to the start of asfotase alfa treatment 6. Current enrollment in any other study involving an investigational new drug, device or treatment for HPP (e.g., bone marrow transplantation) 7. Intolerance to the investigational product (IP) or any of its excipients 8. Previous participation in the same study 9. Family relative of the Investigator ; PRIMARY OUTCOME: Effect of Asfotase Alfa Treatment on Skeletal Manifestations of Hypophosphatasia (HPP); SECONDARY OUTCOME 1: Effect of Asfotase Alfa Treatment on Skeletal Manifestations of Hypophosphatasia (HPP)[/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 - C006; BRIEF: This study will evaluate the effect of 150 mg MSDC-0160 taken daily for 90 days compared to the effect of placebo on changes in brain glucose utilization using FDG-PET and cognition in older persons with mild Alzheimers disease. Safety and tolerability of MSDC-0160 in this population will also be studied. These results will be used to design larger studies of MSDC-0160 in persons with mild Alzheimers disease. ; DRUG USED: MSDC-0160; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Mitochondrial Target of Thiazolidinediones (mTOT; mitochondrial pyruvate carrier [Mpc] 1 and 2); THERAPY: Monotherapy; LEAD SPONSOR: Metabolic Solutions Development Company; CRITERIA: Inclusion Criteria: 1. Male or females 55-85 years of age. 2. Females should be either postmenopausal or surgically sterilized. Males with female partners of child-bearing potential must use contraception if engaging in sexual intercourse. 3. Diagnosis of probable Alzheimers disease based on NIA-AA criteria with MMSE scores of 20 or greater. 4. Willing and able to take part in up to six study visits over a 5-month period, with the support of a caregiver as needed. 5. Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study, with the support of a caregiver as needed. Exclusion Criteria: 1. Diagnosis of diabetes, including use of anti-diabetic medications, or fasting plasma glucose >125 mg/dl or Hemoglobin A1c>6.4%. 2. Unable to participate in FDG-PET scanning, including: - Inability to cooperate/claustrophobia (no sedation offered for this protocol). - Inability to lie still on the scanner bed for 40 minutes. - Total radiation dose exposure to the subject in any given year exceeds the limits of annual and total dose commitment of 50 mSv (5 REMs). The two FDG-PET scans will result in an approximate exposure of 10 mSv (1 REM). 3. Diagnosis of significant neurological/psychiatric disease other than AD, including, but not limited to, any of the following: vascular dementia according to NINDS-AIREN criteria, space occupying cerebral lesion, Huntingtons Disease, Parkinsons Disease, normal pressure hydrocephalus, and seizures. 4. History of heart failure (including CHF). 5. Previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 6 months prior to screening. 6. Inability to undergo a clinical (1.5T) MRI of the brain without contrast and lack of a usable (less the 12 months prior to screening) MRI on record. Contraindications to undergoing an MRI of the brain include, but are not limited to, pacemakers; implantable cardioverter defibrillators; cochlear implants; cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; and, other magnetic, electronic or mechanical implants or clinical findings that in the judgment of the investigator would pose a potential hazard in combination with MRI. 7. ALT and/or AST levels that are twice the upper limit of normal; bilirubin levels that exceed 2 mg/dL; serum creatinine >1.5 mg/dL in men or > 1.4 mg/dL in women. 8. Current or history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the subject unlikely to complete the study. 9. Malignancy (other than non-melanoma skin cancer) within the last 5 years. 10. Known history of HIV, hepatitis B, or hepatitis C. 11. Blood pressure greater than 160/100 mmHg. Subjects with elevated BP will be allowed at the discretion of the principal investigator. Individuals with hypertension must have been stabilized to the current treatment regimen for at least 6 weeks prior to screening and not need adjustments to their treatment regimen during the entire study period. 12. Change in other medications to treat Alzheimers disease within 3 months prior to screening. Change in medication to treat other conditions within 6 weeks prior to screening or during the study period. 13. Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds, or any of their stated ingredients. 14. History of alcohol or drug abuse within 6 months of screening. 15. Have participated in an investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration. 16. Single 12-lead ECG demonstrating a QTcB >450 msec or other clinically significant finding at screening. A single repeat ECG may be done at the investigators discretion. 17. Any surgical or medical condition which may significantly alter the absorption of any drug substance including, but not limited to, any of the following: history of major gastrointestinal tract surgery, currently active inflammatory bowel syndrome. 18. Evidence of clinically relevant pathology that in the investigators opinion could interfere with the study results or put the subjects safety at risk. ; PRIMARY OUTCOME: Effects of MSDC-0160 on Cerebral Metabolic Glucose Rate or Placebo Over 12 Weeks in Pre-specified Regions of Interest Analysis Referenced to Cerebellum; SECONDARY OUTCOME 1: Change From Baseline in Global Cognitive Function Tests[/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 - AGATE-I (w/ABT-450, Ritonavir + Ribavirin, GT4); BRIEF: The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis is to assess the safety and to compare the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold [based on SVR rates for HCV genotype 4-infected participants treated with pegylated interferon (pegIFN)/RBV]. ; DRUG USED: Ombitasvir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: For Arms A, B and C: - Participants must meet one of the following: - Treatment-naive: Participant has never received antiviral treatment for hepatitis C infection OR - Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV); For Arm D: - Participant must have prior treatment experience with SOF/pegIFN/RBV or SOF/RBV and meet one of the following categories: - Prior SOF breakthrough/non-responder: HCV RNA detectable at the end of treatment with SOF/pegIFN/RBV or SOF/RBV; - Prior SOF relapser: achieved HCV RNA undetectable at end of a prior treatment course SOF/pegIFN/RBV or SOF/RBV, but HCV RNA was detectable within 52 weeks following completion of therapy. For Arms A, B, C and D: - Chronic HCV genotype 4 infection with cirrhosis. - Participant has plasma HCV RNA level > 1,000 IU/mL at Screening Exclusion Criteria: - Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). - Current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or Nonstructural viral protein (NS) 5A inhibitor, either investigational or commercially available (including previous exposure to paritaprevir or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration. Prior use of any direct-acting antiviral will not be allowed, except for Arm D where prior experience with the nucleoside polymerase inhibitor, sofosbuvir with pegIFN/RBV or SOF with RBV is required. - Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy. - Confirmed presence of hepatocellular carcinoma. - Any cause of liver disease other than chronic HCV infection. - Abnormal laboratory tests. ; PRIMARY OUTCOME: Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - DELIVER (European Market Access); BRIEF: Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments. ; DRUG USED: Vyepti; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The participant has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit - The participant has a migraine onset of ≤50 years of age. - The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit. - The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit. - The participant fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period: - For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days - For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days - The participant has documented evidence of treatment failure (must be supported by medical record or by physicians confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications. - The participant has a history of either previous or active use of triptans for migraine. Exclusion Criteria: - The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway. - The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications. - The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome). - The participant has a diagnosis of acute or active temporomandibular disorder. - The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). - The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded. - The participant has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). Other in- and exclusion criteria may apply ; PRIMARY OUTCOME: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12; SECONDARY OUTCOME 1: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 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 IIb - STOP-HE; BRIEF: The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients. ; DRUG USED: MNK-6105 IV/MNK-6106 Oral; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatic Encephalopathy (HE); TARGET: Ammonia; THERAPY: Monotherapy; LEAD SPONSOR: Ocera Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis - Elevated venous ammonia Exclusion Criteria: - Renal failure with serum creatinine > 3 mg/dL or need for dialysis - Molecular Adsorbent Recirculation System utilized - Pregnancy or breastfeeding ; PRIMARY OUTCOME: Percentage of Participants in Each HE Stage; 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/III - AVICOVID-2; BRIEF: Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines. ; DRUG USED: Zyesami; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Vasoactive Intestinal Peptide (VIP) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: APR Applied Pharma Research s.a.; CRITERIA: Inclusion criteria: 1. Severe COVID-19 , as defined by clinical signs indicative of severe systemic illness with COVID-19, being given oxygenation and meeting ONE of the following: Respiratory rate ≥ 30 per minute Heart rate ≥ 125 per minute SpO2 ≤ 93% on room air at sea level PaO2/FiO2 < 300 mmHg or SpO2/FiO2 < 315 mmHg 2. Positive test by standard RT-PCR assay or equivalent within last 7 days 3. Physician determination that patient is on SOC therapy, and will receive standard of care if patient progresses to Critical COVID-19, patient must be full CODE Exclusion criteria: 1. Evidence of Critical COVID-19 2. Inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications 3. Age <12 years; 4. Mean arterial pressure < 65 mm Hg after initial hospital stabilization, 5. Non-COVID-19 irreversible underlying condition with projected fatal course within 6 months or with high risk of mortality; 6. Immunosuppressive treatment for transplant or other diseases associated with high mortality; 7. Stage IV cancer or cancer on active treatment with chemotherapy immunotherapy or checkpoint inhibitors; acute renal failure or chronic renal insufficiency with GFR less than 30; CHF New York Heart Association class III or IV, new neurologic disorder in the last 3 months or chronic neurologic disorder or other that would impact on assessing the resolution of severe COVID-19 respiratory failure 8. Myocardial Infarction in previous six months or troponin >0.5 9. Recent history of venous thrombotic events (PE / DVT) within the last 3 months. 10. New diagnosis of atrial fibrillation within the last 3 months. Acceptable if greater than 3 months and well controlled in the opinion of the investigator 11. Watery diarrhea requiring replacement of 1 liter or more of iv fluids and electrolytes 12. Pregnancy ; PRIMARY OUTCOME: Progression to Respiratory Failure; SECONDARY OUTCOME 1: Blood oxygenation[/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 - R/R B-Cell; BRIEF: The drug that will be investigated in the study is an antibody, GEN3009. Since this is the first study of GEN3009 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3009 dose to be tested in a larger group of patients and assess preliminary clinical activity of GEN3009. GEN3009 will be studied in a broad group of cancer patients, having different kinds of lymphomas. All patients will get GEN3009 either as a single treatment (monotherapy) or in combination with another antibody-candidate for treatment of cancer in the blood. The study consists of two parts: Part 1 tests increasing doses of GEN3009 (escalation), followed by Part 2 which tests the recommended GEN3009 dose from Part 1 (expansion). ; DRUG USED: GEN3009; DRUG CLASS: Biologic; INDICATION: Hematologic Cancer; TARGET: Cluster of Differentiation 37 (CD37), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Genmab; CRITERIA: Key Inclusion Criteria: 1. Be at least 18 years of age. 2. Must sign an informed consent form prior to any screening procedures. 3. Dose Escalation: Has histologically or cytologically confirmed relapsed and/or refractory B-cell NHL with no available standard therapy or is not a candidate for available standard therapy, and for whom, in the opinion of the investigator, the experimental therapy may be beneficial. All subjects must have received at least two prior lines of systemic therapy. Dose Expansion: Has histologically or cytologically confirmed relapsed or refractory B-cell NHL. All subjects must have received at least 2 prior lines of systemic therapy, and, 1. For FL and DLBCL, at least 1 of the 2 prior lines of treatment must have been a CD20 containing systemic regimen; 2. For CLL, subjects must have received at least one prior line of BTK inhibitor or BCL 2 inhibitor. 4. Has one of the eligible subtypes of B-cell NHL : Dose Escalation: (DLBCL, HGBCL, PMBCL, FL, MCL, MZL, SLL, or CLL). Dose Expansion: (DLBCL, FL, CLL) 5. Has measurable disease for B-cell NHL or has active disease for Chronic Lymphocytic Leukemia (CLL). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. Has adequate hepatic, renal, and bone marrow functions. 8. Before the first dose of GEN3009, during the trial, and for 12 months after the last dose of GEN3009 and/or the combination, a woman must be either not of childbearing potential or of childbearing potential and practicing a highly effective method of birth control, and must have a negative serum beta-human chorionic gonadotropin (beta-hCG) and urine pregnancy test at screening. 9. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control. 10. Subjects must have a life expectancy of at least 3 months. Key Exclusion Criteria: 1. Prior treatment with a CD37-targeting agent. 2. Prior allogeneic Hematopoietic Stem Cell Transplantation (HSCT). 3. Prior treatment with a CD3xCD20 bispecific antibody (Combination Expansion cohort only). 4. Autologous HSCT within 3 months before the first dose of GEN3009. 5. Lymphomas leukemic phase: high absolute lymphocyte count or the presence of abnormal cells in the peripheral blood indicating circulating lymphoma cells. 6. Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or chimeric antigen receptor (CAR) T-cell therapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of GEN3009. Treatment with small molecules such as BTK inhibitors, BCL2 inhibitors, or PI3K inhibitors within 5 half-lives prior to the first dose of GEN3009. 7. Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009. 8. Treatment with an investigational drug or an invasive investigational medical device within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3009, and at any time during the study treatment period. 9. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy. 10. Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of prednisone within the 2-week period before the first dose of GEN3009. 11. Has uncontrolled intercurrent illness. 12. Seizure disorder requiring therapy (such as steroids or anti-epileptics) (Combination Expansion cohort only). 13. Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy. 14. Primary central nervous system (CNS) lymphoma or known CNS involvement at screening. 15. Known past or current malignancy other than inclusion diagnosis. 16. Had allergic reactions to anti-CD20 or anti-CD37 monoclonal antibody treatment or intolerant to GEN3009 or to the combination therapy excipients. 17. Has had major surgery within 4 weeks before screening or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the trial (or within 4 weeks after the last dose of GEN3009 and/or the combination therapy). 18. Known history/positive serology for hepatitis B. 19. Known medical history or ongoing hepatitis C infection that has not been cured. 20. Known history of seropositivity for HIV infection. 21. Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of GEN3009 and/or the combination therapy. 22. Is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of GEN3009 and/or the combination therapy. 23. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Additionally, vulnerable subjects or subjects under guardianship, curatorship, judicial protection or deprived of liberty), are excluded from participation in this trial. 24. Exposed to live/live attenuated vaccine within 4 weeks prior to initiation of GEN3009 treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Part 1 and Part 2B: Dose liming toxicity (DLT); SECONDARY OUTCOME 1: Total body clearance of drug from the plasma (CL)[/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 - SPD489-345 (OLE); BRIEF: To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults ; DRUG USED: Vyvanse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Eating Disorders; TARGET: Dopamine, Norepinephrine (Noradrenaline); THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion criteria: 1. Completion of an antecedent SPD489 BED Double-blind Study 2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED 3. Subject has a body mass index (BMI) of > or =18 and < or =45 Exclusion criteria: 1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. 2. Subject is considered a suicide risk or risk to harm others ; PRIMARY OUTCOME: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety; SECONDARY OUTCOME 1: Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Proof-of-Concept; BRIEF: The study will evaluate the efficacy and safety of the oral Factor D (FD) inhibitor ALXN2050 (ACH-0145228) monotherapy in patients with PNH that are treatment naïve, or patients currently treated with eculizumab who still experience anemia and reticulocytosis, or patients currently treated with ALXN2040 (danicopan) as monotherapy. After signing consent, participants will have periodic visits through Week 12, at which time the primary endpoint and key secondary assessments will be analyzed. Participants will continue on treatment past 12 weeks into a long-term extension portion of the trial. ; DRUG USED: ALXN2050; DRUG CLASS: New Molecular Entity (NME); INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Factor D (alternate complement pathway); THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: 1. Diagnosis of PNH. 2. Male or female, ≥ 18 years of age Eligibility Criteria: Eligibility Criteria Specific for Group 1: 1. PNH Patients who have no history of treatment with any complement inhibitor at any dose. 2. PNH Type III erythrocyte or granulocyte clone size ≥10% 3. Absolute reticulocyte count ≥100×10^9/liter [L]. 4. Anemia (Hgb <10.5 grams/deciliter [g/dL]). 5. LDH ≥1.5× upper limit of normal. 6. Platelet count ≥30,000/microliter (µL) 7. Absolute neutrophil count (ANC) ≥750/ µL. Eligibility Criteria Specific for Group 2: 1. Stable background regimen of at least 24 weeks for eculizumab without change in dose or interval for at least the past 8 weeks 2. Anemia (Hgb <10 g/dL) 3. Absolute reticulocyte count ≥100×10^9/L 4. Platelet count ≥30,000/µL 5. Absolute neurophil count (ANC) ≥750/ µL Eligibility Criteria Specific for Group 3: 1. Patient received danicopan during Study ACH471-103 Key Exclusion Criteria: 1. History of a major organ transplant or hematopoietic stem cell/marrow transplant . 2. Known aplastic anemia or other bone marrow failure that requires HSCT, or if these patients are on immunosuppressive agents for less than 24 weeks. 3. Known underlying bleeding disorders or any other conditions leading to anemia not primarily associated with PNH. 4. Estimated glomerular filtration rate <30 milliliters/minute/1.73 meters squared and/or are on dialysis. ; PRIMARY OUTCOME: Change In HgB Relative To Baseline; SECONDARY OUTCOME 1: Number Of Patients Who Have Transfusion Avoidance[/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 - SAD; BRIEF: The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection ; DRUG USED: Ximency; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides), HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Chronically infected with HCV genotype 1 - Treatment naive or treatment non-responders or treatment intolerant - HCV RNA viral load of ≥10*5* IU/mL - BMI 18 to 35 kg/m² Exclusion Criteria: - Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection - Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug - Co-infection with HIV or HBV ; PRIMARY OUTCOME: Safety Outcome Measures; SECONDARY OUTCOME 1: Pharmacokinetic Measures[/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 - Staph Bacteremia/Endocarditis; BRIEF: This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE). ; DRUG USED: Vibativ; DRUG CLASS: New Molecular Entity (NME); INDICATION: Septicemia or Bacteremia (Antibacterial, including Endocarditis); TARGET: Cell wall synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Cumberland Pharmaceuticals; CRITERIA: Inclusion Criteria: - 18 years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization - At least one of the following signs or symptoms of bacteremia: - Temperature ≥ 38.0°C - White blood cell (WBC) count > 10,000 or < 4,000 cells/µL or > 10% immature neutrophils (bands) - Tachycardia (heart rate > 90 bpm) - Tachypnea (respiratory rate > 20 breaths/min) - Hypotension (systolic blood pressure < 90 mmHg) - Signs or symptoms of localized catheter-related infection - At enrollment, subjects must have either 1) known right-sided infective endocarditis by Modified Dukes criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for complicated bacteremia. Exclusion Criteria: - Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. EXCEPTION: Documented resistance to the prior systemic antibacterial therapy - Presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment - Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator [ICD]), permanent pacemaker, or cardiac valve support ring) - Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria. NOTE: Right-sided infective endocarditis (RIE) is permitted - Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is permitted - Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a Gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against Gram-negative pathogens ; PRIMARY OUTCOME: Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC); SECONDARY OUTCOME 1: Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) 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 - 012; BRIEF: This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second [FEV1]). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; and (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with montelukast over 12 weeks. The primary hypothesis is: MK-1029 is superior to placebo in a dose-related fashion in the average change from baseline in FEV1 over the last 6 weeks of the 12-week active-treatment period. ; DRUG USED: MK-1029; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Chemoattractant Receptor-Homologous Molecule (CRTH2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - not pregnant or breastfeeding, and not planning to become pregnant during the study - history of symptoms of persistent asthma for at least one year - current use of acceptable asthma treatments and willingness to taper or discontinue these treatments; acceptable asthma treatments: - use of inhaled SABAs (e.g., albuterol/salbutamol) only as-needed with no use of asthma controller medications; OR - use of stable doses of low- or medium-dose inhaled corticosteroids (ICS), alone, or in combination with either a long-acting beta-agonist (LABA) or other asthma controller medications (including leukotriene receptor antagonists) and can tolerate tapering or discontinuation - no history of smoking OR no smoking within <1 year with a smoking history of ≤10 pack-years - ability to maintain a constant day/night, awake/sleep cycle - agreement to not change habitual consumption of beverages or food containing caffeine throughout the study - Body Mass Index (BMI) of 15 to 40 kg/m^2 Exclusion Criteria: - myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within past ≤3 months - hospitalization within past ≤4 weeks - major surgical procedure within past ≤4 weeks - participation in a clinical study involving an investigational drug within past ≤4 weeks - current regular use or recent (within past ≤5 years) past abuse of alcohol (>14 drinks/week) or illicit drugs - donation of a unit of blood within past ≤2 weeks or intention to donate a unit of blood during the study - evidence of another clinically significant, active pulmonary disorder such as chronic obstructive pulmonary disease (COPD) - emergency room treatment for asthma within past ≤4 weeks or hospitalization for asthma within past ≤8 weeks - respiratory tract infection requiring antibiotic treatment within past ≤8 weeks - evidence of active, clinically significant sinus disease within past ≤1 week - history of a clinically significant psychiatric disorder, other than stable depression, within past ≤12 weeks - history of HIV - hypersensitivity or intolerance to inhaled beta-agonists, leukotriene antagonists, leukotriene synthesis inhibitors, or any of their ingredients, including lactose and galactose - clinically unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems - current cancer or history (within past ≤5 years) of cancer (except for successfully treated basal and squamous cell carcinomas of the skin); if cancer-free for >5 years, study participation may be allowed - evidence of uncontrolled hypertension ; PRIMARY OUTCOME: Average Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1); SECONDARY OUTCOME 1: Percentage of Asthma Exacerbation Days[/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 - MABc Study (US); BRIEF: The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc) ; DRUG USED: Nuzyra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Tract Infections (Excluding Pneumonia) (Antibacterial); TARGET: Bacterial ribosome, Gram-Negative Bacteria, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Paratek Pharmaceuticals Inc; CRITERIA: Key Inclusion Criteria: - Has a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc - Has at least 2 of the following NTM-infection symptoms present at Screening and Baseline: chronic cough, coughing up blood (hemoptysis), wheezing, chest pain, frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue, fever, night sweats, poor appetite, and/or weight loss. - At least 1 positive pulmonary (sputum) culture for MABc in the 6 months prior to Screening and 1 positive culture at Screening - Radiographic evidence of MABc infection via computed tomography (CT) scan of the chest within 3 months prior to Screening - In the opinion of the investigator, guideline-directed antibiotic therapy for treatment of MABc will not be required within the next 3 months, and a delay, in order for the subject to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable - Additional inclusion criteria as per protocol Key Exclusion Criteria: - Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC - Has received systemic or inhaled antibiotic therapy (other than chronic macrolide therapy) within 4 weeks prior to Screening - Has any of the following medical conditions: - Active pulmonary malignancy, or any type of malignancy requiring chemotherapy or radiation within 1 year prior to Screening - Active allergic bronchopulmonary mycosis, or any other condition requiring chronic treatment with systemic corticosteroids within 90 days prior to Screening - Radiologic evidence of cavitary disease - Known active pulmonary tuberculosis - Cystic fibrosis - History of lung transplantation - Another advanced lung disease with a known percent predicted forced expiratory volume in 1 second < 30%. - Disseminated or extra-pulmonary NTM disease - Has been previously treated with omadacycline - Has a history of hypersensitivity or allergic reaction to tetracyclines - Additional exclusion criteria as per protocol ; PRIMARY OUTCOME: Clinical Response on NTM Symptom Assessment Scale at Day 84; SECONDARY OUTCOME 1: Change from baseline in the total score of the Quality of Life - Bronchiectasis (QOL-B) questionnaire[/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 - HALO EM; BRIEF: The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine ; DRUG USED: Ajovy; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age - Patient signs and dates the informed consent document - Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis - 85% e-diary compliance - Total body weight between 99 and 265 lbs, inclusive - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: - Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator - Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years - History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism - Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection - Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma - Pregnant or nursing females - History of hypersensitivity reactions to injected proteins, including monoclonal antibodies - Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months or 5 half-lives, whichever is longer - Additional criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug; SECONDARY OUTCOME 1: Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug[/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 - IgA Nephropathy (Extension); BRIEF: Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of fostamatinib in approximately 25 subjects. The study will consist of 11 visits over 15 months. ; DRUG USED: Tavalisse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immunoglobulin A (IgA) Nephropathy (Bergers Disease); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: Rigel Pharmaceuticals; CRITERIA: Inclusion Criteria: - Completed Study C-938788-050, including having received a post-treatment renal biopsy, and having had a clinically meaningful response (i.e. decreased proteinuria or improved renal histology) - Able and willing to give written informed consent Exclusion Criteria: - Unresolved Grade 2 or greater toxicity in Study C-935788-050 ; PRIMARY OUTCOME: Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR); 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 - Enthesitis Related Arthritis (Pediatric Subjects); BRIEF: The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA). ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Juvenile Rheumatoid Arthritis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Diagnosis of Enthesitis Related Arthritis (ERA) as defined by International League of Associations for Rheumatology (ILAR); - Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location; - Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate. Exclusion Criteria: - Any ILAR Juvenile Idiopathic Arthritis (JIA) subtype other than ERA; - Psoriasis or a history of psoriasis in the patient or first-degree relative; - Presence of Immunoglobulin M (IgM) rheumatoid factor; - Presence of systemic JIA; - History of inflammatory bowel disease; - previous biologic therapy including anti-tumor necrosis factor (anti-TNF) therapy with a potential impact on pediatric ERA; - Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline. ; PRIMARY OUTCOME: Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12; SECONDARY OUTCOME 1: Number of Sites of Enthesitis: Change From Baseline to Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TRITON2; BRIEF: The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib. ; DRUG USED: Rubraca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: pharmaand GmbH; CRITERIA: Inclusion Criteria: - Be 18 years old at the time the informed consent form is signed - Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate - Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM) - Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease - Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency Exclusion Criteria: - Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer - Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy - Symptomatic and/or untreated central nervous system metastases - Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib ; PRIMARY OUTCOME: Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR); SECONDARY OUTCOME 1: Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)[/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 - PAMPERO (w/ Medium-Dose ICS-LABA) (48 Weeks); BRIEF: The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and male aged from 18 to 75 years, inclusively 3. History of physician-diagnosed asthma requiring treatment with medium dose ICS (>250ug fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1 4. Documented treatment with medium-dose ICS (>250ug and ≤500ug fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 month prior to Visit 1 Exclusion criteria: 1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome) 2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patients ability to complete the entire duration of study 3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete entire duration of the study ; PRIMARY OUTCOME: Asthma Exacerbations Over 48 Weeks Treatment; 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 - METEOR (vs. Everolimus); BRIEF: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor 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: Exelixis; CRITERIA: Select Inclusion Criteria: 1. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component. 2. Measurable disease as determined by the investigator. 3. Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib). 4. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. 5. Adequate organ and marrow function. 6. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment. 7. Female subjects of childbearing potential must not be pregnant at screening. Select Exclusion Criteria: 1. Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib. 2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization. 3. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization. 4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. 5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization. 6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors. 7. Chronic treatment with corticosteroids or other immunosuppressive agents. 8. Serious illness other than cancer. 9. Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization. 10. Pregnant or lactating females. 11. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors. ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PASADENA; BRIEF: This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinsons Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 260 weeks. ; DRUG USED: Prasinezumab; DRUG CLASS: Biologic; INDICATION: Parkinsons Disease (PD); TARGET: Alpha-synuclein; THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor - Body weight range between: >/=45 kg/ 99 pounds (lbs) and less than or equal to (</=) 110 kg/242 lbs - Body mass index (BMI) of 18 to 34 kilograms per meter-squared (kg/m^2) - A diagnosis of PD for 2 years or less at screening - Hoehn and Yahr Stage I or II - A screening brain DaT-SPECT consistent with PD (central reading) - Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline - If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks - For women of childbearing potential: use of highly effective contraceptive methods (that result in a failure rate of <1 percent [%] per year) during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug - For men with female partners of childbearing potential or pregnant female partners, must use a condom during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The female partners should use a contraception method with a failure rate of <1% per year during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug. Use of contraceptive measures is not required for male participants enrolled in Part 3. Exclusion Criteria: - Medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia - Known carriers of certain familial PD genes (as specified in study protocol) - History of PD related freezing episodes or falls - A diagnosis of a significant CNS disease other than Parkinsons disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child - Mini Mental State Examination (MMSE) </=25 - Reside in a nursing home or assisted care facility - History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality - Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participants ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data - Any significant cardiovascular condition - Any significant laboratory abnormality - Lactating women - Prior treatment with dopaminergic medication (for example, levodopa or a dopaminergic agonist) with no clinical treatment response or a clinical treatment response inconsistent with PD (for example, absence of observable response to a sufficiently high-dose of levodopa [i.e., ≥ 600 mg/day]) - Use of any of the following: catechol-O-methyl transferase (COMT) inhibitors (entacapone, tolcapone), amantadine or anticholinergics, or dopaminergic medication (levodopa and both ergot and non-ergot [pramipexole, ropinirole, rotigotine] dopamine agonists) for more than a total of 60 days or within 60 days of baseline - Anti-epileptic medication for non-seizure-related treatment which has not remained stable for at least 60 days prior to baseline - Anti-depressant or anxiolytic use that has not remained stable for at least 90 days prior to baseline. The use of fluoxetine and fluvoxamine is not permitted. For patients treated with a MAO-B inhibitor and an antidepressant (except fluoxetine and fluvoxamine), a 6-month period of stable and tolerated dosing before baseline is required. - Use of any of the following within 90 days prior to baseline: antipsychotics (including clozapine and olanzapine), metoclopramide, alpha methyldopa, clozapine, olanzapine, flunarizine, amoxapine, amphetamine derivatives, reserpine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, and modafinil - Participated in an investigational drug, device, surgical , or stem cell study in PD - Any prior treatment with an investigational PD-related vaccine (including active immunization or passive immunotherapy with monoclonal antibodies). - Prior participation in any RO7046015 or PRX002 study - Receipt of any non-PD investigational product or device, or participation in a non-PD drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline - Receipt of any monoclonal antibody or an investigational immunomodulator within 180 days (or 5 half-lives, whichever is longer) before baseline - Immunomodulating drugs within 30 days prior to baseline - Allergy to any of the components of RO7046015 such as citrate, trehalose and polysorbate (Tween) 20 or a known hypersensitivity or an Infusion-related reaction (IRR) to the administration of any other monoclonal antibody - Any contraindications to obtaining a brain MRI. Patients with a hypersensitivity to iodine may receive an alternative thyroid blocking agent. - For participants consenting to provide optional cerebrospinal fluid (CSF) samples by lumbar puncture (LP): LP will only be performed if the participant does not have any contraindication to undergoing an LP - Donation of blood over 500 milliliters (mL) within three months prior to screening ; PRIMARY OUTCOME: Change From Baseline in Movement Disorder Society-Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52; SECONDARY OUTCOME 1: Change From Baseline in the MDS-UPDRS Part IA, Part IB, Part I Total, Part II Total, Part III Total and Part III Subscores[/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/III - CR107373; BRIEF: The purpose of this study is to evaluate whether treatment with atabecestat slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are asymptomatic at risk for developing Alzheimers dementia. ; DRUG USED: JNJ-54861911; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Beta-secretase (BACE); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participant must have a global Clinical Dementia Rating Scale- (CDR) score of 0 at Screening - Participants 60 to 64 years of age must also have 1 of the following 3 conditions: a) a positive family history for dementia (minimum of 1 first degree relative), b) a previously known apolipoprotein E, ε4 allele (APOE ɛ4) genotype, c) a previously known biomarker status demonstrating elevated amyloid accumulation in cerebrospinal fluid (CSF) or positron emission tomography (PET) - Participant must be able to read and write and must have adequate hearing and visual acuity to complete the psychometric tests. The legally acceptable representative must also be able to read and write - Participants must have evidence of amyloid accumulation by means of either: a) low Cerebrospinal Fluid (CSF) ABeta 1-42 levels at Screening; b) a positive amyloid positron emission tomography (PET) scan at Screening (depending on the sites PET capability) by visual read - Participant must be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening or at Baseline Exclusion Criteria: - Participant is receiving an acetylcholinesterase (AChE) inhibitor and/or memantine at any time during Screening or Day 1 predose - Participant has evidence of any brain diseases, other than potential very early signs of Alzheimers Dementia (AD) (example. mild hippocampal atrophy) or typical age-related changes (e.g. mild white matter hyperintensity on magnetic resonance imaging [MRI]) or any other abnormality (e.g. folic acid/Vitamin B12 deficiency) that could explain a possible cognitive deficit (including, but not limited to vascular encephalopathy or large strokes (as imaged by cerebral MRI) - Participant has any contraindications for MRI (example, prostheses, implants, claustrophobia, pacemaker) - Participant has met criteria for dementia or has a brain disorder that can cause dementia - Participant has evidence of familial autosomal dominant AD (mutation identified in the family and/or participant prior to randomization) ; PRIMARY OUTCOME: Change From Baseline in Preclinical Alzheimer Cognitive Composite (PACC) Score at Endpoint (Month 24); SECONDARY OUTCOME 1: Change From Baseline in Cognitive Function Index (CFI) Score at Endpoint (Month 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 IIa - PELICAN (Orkambi Treated w/Homozygous F5087del Mutation); BRIEF: This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate GLPG2737 administered orally b.i.d. for 28 days to adult male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the F508del CFTR mutation and on stable treatment with Orkambi. ; DRUG USED: GLPG2737; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Combination; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Male or female subject ≥18 years of age on the day of signing the ICF. - A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation. - Stable intake of physician prescribed Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.) for at least 12 weeks prior to the first study drug administration, and planned continuation of Orkambi for the duration of the study. - FEV1 ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator). - Sweat chloride concentration ≥60 mmol/L at screening. Exclusion Criteria: - History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to any component of the study drug. - History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator. - Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks prior to the first study drug administration. - History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices, etc.). - Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or alkaline phosphatase and/or gammaglutamyl transferase (GGT) ≥3 x the upper limit of normal (ULN), and/or total bilirubin ≥1.5 x the ULN at screening. ; PRIMARY OUTCOME: Change from baseline in sweat chloride concentration compared to placebo; SECONDARY OUTCOME 1: Change versus placebo in the proportion of subjects with adverse events.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - RGN-DE-202; BRIEF: Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product that meets a major unmet medical need in patients with dry eye. ; DRUG USED: RGN-259; DRUG CLASS: Biologic; INDICATION: Dry Eye (Ophthalmology); TARGET: Actin Filaments, ATP Synthase, Integrin-linked kinase (ILK); THERAPY: Monotherapy; LEAD SPONSOR: ReGenTree, LLC; CRITERIA: Inclusion Criteria: 1. Have given a written, informed consent. 2. Be able and willing to follow instructions, including participation in study assessments, and be present for the required study visits for the duration of the study. 3. Have a best corrected visual acuity. 4. Have a patient-reported history of dry eye in both eyes. 5. Use and/or desire to use an artificial tear substitute for dry eye symptoms within the past 6 months. 6. A negative urine pregnancy test if female of childbearing potential. 7. Have a corneal fluorescein staining score of ≥ 2 in any corneal surface segment in at least one eye at Visit 1. - Exclusion Criteria: 1. Have contraindications to the use of the study drug. 2. Have known allergy or sensitivity to the study drug or components thereof. 3. Have anterior blepharitis. 4. Be diagnosed with an on-going ocular infection or active ocular inflammation. 5. Use contact lenses within 1 week before Visit 1 or during the course of the study. 6. Have previously had Laser-Assisted in Situ Keratomileusis (LASIK) surgery within 12 months prior to Visit 1. 7. Be currently taking any topical ophthalmic prescription or over-the-counter (OTC) solutions, artificial tears, gels, or scrubs and cannot discontinue these medications for the duration of the trial. 8. Have used topical ocular cyclosporine within 30 days prior to Visit 1. 9. Have had a past or present evidence of malignancy. ; PRIMARY OUTCOME: Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye; SECONDARY OUTCOME 1: Number of Adverse Events as a Measure of Safety and Tolerability[/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 - Primary Focal Segmental Glomerulosclerosis; BRIEF: The primary objectives of this trial are as follows: - to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo - to compare the safety profile of patients treated with fresolimumab versus placebo The secondary objectives are as follows: - To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo - To evaluate fresolimumab dose-dependent reduction in proteinuria - To compare the change in renal function (estimated glomerular filtration rate [eGFR]) in patients treated with fresolimumab versus placebo - To evaluate the multiple-dose pharmacokinetics of fresolimumab ; DRUG USED: GC1008; DRUG CLASS: Biologic; INDICATION: Focal Segmental Glomerulosclerosis (FSGS); TARGET: Transforming Growth Factor-beta (TGF-beta) and Superfamily; THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion Criteria: - The patients renal biopsy is consistent with the diagnosis of primary Focal Segmental Glomerulosclerosis (FSGS) including all histological subtypes. - The patient has an eGFR ≥ 30 mL/min/1.73 m2 - The patient has a urinary total protein:creatinine ratio ≥ 3 mg protein/mg creatinine - In the opinion of the Investigator, the patient has steroid-resistant FSGS. The patient must have been treated for FSGS with a course of high-dose steroid therapy for a minimum of 4 weeks - The patient has been treated with an ACEi (angiotensin converting enzyme inhibitor) and/or ARB (angiotensin receptor blocker) at a stable dose for a minimum of 4 weeks prior to Visit 2 (treatment start) Exclusion Criteria: - The patient has FSGS which in the Investigators opinion is secondary to another condition - The patient has been taking prednisone at a dose > 10 mg/day (or equivalent dose of an alternative glucocorticoid) within 4 weeks prior to Visit 1 (Screening Visit). - The patient has received any other systemically administered immunosuppressive drugs (other than glucocorticoids) within 8 weeks prior to Visit 1. - The patient has received rituximab within 6 months prior to Visit 1. - The patient has a history of organ transplantation. ; PRIMARY OUTCOME: Percentage of patients achieving partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio); SECONDARY OUTCOME 1: Percentage of patients achieving CR in Up/c ratio[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Pembrolizumab; BRIEF: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with daratumumab in participants with relapsed refractory multiple myeloma (rrMM). The primary outcome measure for this study is the assessment of Objective Response Rate (ORR) in participants with rrMM. ; DRUG USED: Darzalex; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Cluster of Differentiation 38 (CD38); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has a confirmed diagnosis of active MM and measurable disease defined as: a.) Serum M-protein levels ≥0.5 g/dL or b.) Urine M-protein levels ≥200 mg/24 hours or c.) For participants without measurable serum and urine M-protein levels, an abnormal serum free light chain ratio (FLC κ/λ) with involved FLC level ≥100 mg/L. - Has undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy and must have failed their last line of treatment defined as lack of response or documented disease progression during or within 60 days of completing their last anti-myeloma therapy. - Prior anti-myeloma treatments must have included an immunomodulatory drug (IMiD; i.e., lenalidomide, thalidomide, or pomalidomide) AND a proteasome inhibitor (PI; i.e., bortezomib, ixazomib, or carfilzomib) alone or in combination and participant must have failed therapy with an IMiD or PI or both. - Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. - Has adequate organ function. - Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. - Female participants must not be pregnant, breastfeeding, and must agree to use (or have their partner use) acceptable contraception during heterosexual activity during the treatment period and for at least 120 days after the last dose of study treatment. Exclusion Criteria: - Has oligo-secretory myeloma, smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenströms macroglobulinemia, or any history of plasma cell leukemia. - Has a history of repeated infections, primary amyloidosis, hyperviscosity, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome - Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy. - Has known meningeal involvement of MM. - Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or daratumumab and any of its excipients. - Has known allergies, hypersensitivity, or intolerance to monoclonal antibodies (mAbs) or human proteins, or their excipients, or known sensitivity to mammalian-derived products. - Has an active autoimmune disease that has required systemic treatment in past 2 years. - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Has either of the following: a.) Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal, or b.) Known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. - Has an active infection requiring systemic therapy. - Has a known history of human immunodeficiency virus (HIV) infection. - Has a known history of hepatitis B or known active hepatitis C. - Has a known history of active tuberculosis (TB). - Has received prior solid organ transplant. - Has clinically significant cardiac disease or electrocardiogram (ECG) abnormalities or any history of clinically significant ventricular arrhythmias. - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. - Has previously received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies. - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK-3475) clinical study. - Has received prior anti-myeloma therapy including but not limited to dexamethasone, IMiDs, PIs, monoclonal antibody, chemotherapy, or radiation therapy within 4 weeks or 5 half-lives (whichever is longer) before first dose of study treatment or not recovered (≤ Grade 1 or at Baseline) from AEs due to previously administered agents. - Has undergone prior allogeneic stem cell transplant (allo-SCT) within the last 5 years. - Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first dose of study treatment or are planning for or are eligible for auto- or allo-SCT. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment. - Has received prior radiotherapy within 2 weeks of start of study treatment. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease. - Has received a live vaccine within 30 days prior to the first dose of study treatment. - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Disease Control Rate (DCR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/PD-L1 Inhibitor; BRIEF: This phase I/II trial studies the side effects of gene-modified immune cells (FH-MCVA2TCR) and to see how well they work in treating patients with Merkel cell cancer that has spread to other parts of the body (metastatic) or that cannot be removed by surgery (unresectable). Placing a gene that has been created in the laboratory into immune cells may improve the bodys ability to fight Merkel cell cancer. ; DRUG USED: Merkel Cell Polyomavirus TCR-Engineered Autologous T Cells; DRUG CLASS: Biologic; INDICATION: Merkel Cell Carcinoma; TARGET: Immune System, T-Cell Receptor (TCR); THERAPY: Combination; LEAD SPONSOR: Fred Hutchinson Cancer Center; CRITERIA: Inclusion Criteria: - EVALUATION: Metastatic or unresectable Merkel cell polyomavirus (MCPyV)-associated Merkel cell carcinoma (VP-MCC) that has progressed on or after prior treatment with a PD-1 axis immune checkpoint inhibitor. - EVALUATION: Individuals that may be consented to undergo evaluation to determine potential eligibility must have a history of metastatic or unresectable Merkel cell carcinoma (MCC) (as documented by medical record). - EVALUATION: Be 18 years of age or older. - EVALUATION: Be capable of understanding and providing informed consent. - Participants must have metastatic or unresectable, histologically confirmed virus-positive MCC. Confirmation of diagnosis must be or have been performed by internal pathology review of initial or subsequent biopsy or other pathologic material at Fred Hutch/Seattle Cancer Care Alliance (SCCA). - Approximately 80% of MCCs are caused by Merkel cell polyomavirus (MCPyV) T Antigens and the treatment is expected to only be effective in this population. Merkel cell polyomavirus positivity may be established through one of two means: positive Merkel cell polyomavirus T antigen serology (preferred) or immunohistochemistry of a primary or metastatic MCC tumor lesion (if T antigen seronegative). - MCPyV T Antigen serology will be performed with the anti-Merkel cell panel (AMERK) assay run through the University of Washington Medical Center Laboratory Medicine Clinical Immunology Laboratory. Positivity will be defined as a Merkel oncoprotein antibody titer (MSCTT) of >= 75 standard titer units (STU) at any time point from initial diagnosis onward. Patients with negative T antigen serology but MCPyV positive tumor by other methodologies will be considered for additional MCPyV testing as clinically appropriate, as the T antigen serology assays are highly specific but incompletely sensitive for MCPyV status. In this case, immunohistochemistry of any tumor lesion will be performed with the CM2B4 Merkel cell polyomavirus T antigen antibody. Expression of MCPyV in at least 10% of tumor cells will be considered positive. CM2B4 staining performed at any point clinically and at any clinical laboratory may be accepted. However, if CM2B4 staining has not been previously performed by a clinical pathology laboratory as part of MCC diagnostic workup, it will be performed in a clinical diagnostic pathology laboratory at University of Washington (UW)/Fred Hutchinson Cancer Research Center (FHCRC)/SCCA as per standard staining protocols. Persons are not required to have both CM2B4 positivity and seropositivity; either will be acceptable confirmation of viral status and if one negative and the other positive the patient will remain eligible provided other criteria are met. - Patients must have been previously treated with at least one dose of a PD-1 axis inhibitor (e.g. PD-1 or PD-L1 inhibiting monoclonal antibody such as pembrolizumab, nivolumab, avelumab, atezolizumab, durvalumab), developed progression of their MCC tumor on or after treatment, or have biopsy confirmed residual disease following treatment. At least four weeks must have passed between the administration of the first dose of PD-1 axis inhibitor and determination of progression or residual disease. If there is significant clinical concern for pseudoprogression (i.e. progression developed rapidly after checkpoint inhibitor therapy), biopsy must be performed to demonstrate true progression. Patients may have received 1 or more prior systemic regimens for MCC. There is no upper limit on prior regimens. Patients may have received prior anti-PD-1/anti-PD-L1 in the neoadjuvant or adjuvant setting. Patients are also eligible if they have a contraindication to PD-1/PD-L1 axis blockade such as a history of an autoimmune disease. - Participants must be HLA-A*02:01 in order for infused transgenic T cells to recognize antigen-MHC complexes. HLA typing for HLA-A2 should be determined through molecular approaches at a clinical laboratory licensed for HLA testing. - Life expectancy must be anticipated to be > 3 months at trial entry. - 18 years of age or older. Fewer than 0.5% of MCC occur in individuals aged 30 years or younger, thus the protocol includes only adult patients. - Capable of understanding and providing a written informed consent. - If fertile, willingness to comply with reproductive requirements. - Karnofsky performance status of >= 60%. - Should there be no tumor tissue that is accessible for biopsy, patients will still be considered for participation, at discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons biopsies may be cancelled or retimed. - At least 3 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, MCC vaccines, intravenous immunoglobulin, expanded polyclonal tumor infiltrating lymphocyte [TIL] or lymphokine-activated killer cell [LAK] therapy), natural killer (NK) therapy, small molecule or chemotherapy cancer treatment, other investigational agents or other systemic agents that target MCC. There is no washout period for radiation. - Serum creatinine < 2.5 or estimated glomerular filtration rate (eGFR) > 30. - Total bilirubin (tBili) < 3.0. Patients with suspected Gilbert syndrome may be included if Tbili > 3 but no other evidence of hepatic dysfunction. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN). - =< grade 1 dyspnea. - Oxygen saturation (SaO2) >= 92% on ambient air. - If pulmonary function tests (PFTs) are performed based on the clinical judgment of the treating physician, patients with forced expiratory volume in one second (FEV1) >= 50% of predicted and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) of >= 40% of predicted will be eligible. - Patients 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 1 year prior to study treatment. LVEF may be established with echocardiogram or multigated acquisition (MUGA) scan, and must be >= 35%. Cardiac evaluation for other patients is at the discretion of the treating physician. - Absolute neutrophil count (ANC) > 1000 cells/mm^3. - Absolute lymphocyte count (ALC) > 200 cells/mm^3. - Hematocrit (HCT) > 30%. - Platelet count > 50K. Exclusion Criteria: - Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the principal investigator (PI). Patients with a history of autoimmune disease that was a contra-indication to PD-1 axis blockade treatment will be eligible, but will not receive PD-1 axis blockade treatment on trial. - Kidney transplant will be considered on a case by case basis requiring discussion with PI. If kidney transplant, patient must have dialysis access, dialysis plan, supportive nephrologist, willingness to stop transplant immunosuppression, and express understanding that rejection is likely. Dialysis or costs related to transplant kidney will not be supported by the study. Participants having had any other solid organ transplants will be excluded, as will those with a history of allogeneic stem cell transplant. - Corticosteroid therapy at a dose equivalent of > 10 mg prednisone per day. - Concurrent use of other investigational agents or MCC directed therapies. - Any medical or psychological condition other than Merkel cell carcinoma that would significantly increase the risk of harm to a subject or interfere with the interpretation of trial endpoints. - Active uncontrolled infection. Human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count > 500 cells/mm^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication. - Uncontrolled concurrent illness. Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Untreated brain metastases. Participants with small asymptomatic brain metastases (< 1 cm) or those with brain metastases previously treated with surgery or radiotherapy will be considered for inclusion at discretion of principal investigator, so long as other eligibility criteria are met. - Grade 3 or higher immune related adverse event (iRAE) to any prior PD-1 axis blocking agent. iRAEs are persistent T cell mediated inflammatory syndromes caused by PD-1 or PD-L1 inhibitors including colitis, nephritis, pneumonitis, myositis, hepatitis, encephalitis. - Participants receiving treatment for prior immune-related adverse event (iRAE) are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of up to 10 mg prednisone per day, unless otherwise approved by PI. - Study participants must not have significant active underlying neurologic disease, unless approved by PI. Mild neuropathy related to diabetes or prior chemotherapy is acceptable. - Other medical, social, or psychiatric factor that interferes with medical appropriateness and/or ability to comply with study, as determined by PI. ; PRIMARY OUTCOME: Incidence of adverse events grade 3 or higher determined to be possibly, probably or definitely secondary to any of the study treatments; 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 IIb - A3921083 (Induction); BRIEF: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohns disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug). ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Crohns Disease; TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands). - Subjects with clinical diagnosis of Crohns disease for at least 6 months prior to screening. - Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohns Disease Activity Index (CDAI) of 220 to 450 at baseline. Exclusion Criteria: - Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC. - Subjects diagnosed with Crohns disease but without previous exposure to treatment (i.e., treatment-naïve). - Subjects receiving the following treatment for Crohns disease: - Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline. - Anti-TNFα therapy within 8 weeks prior to baseline. - Interferon therapy within 8 weeks prior to baseline. - Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline. - Intravenous corticosteroids within 2 weeks prior to baseline. ; PRIMARY OUTCOME: Percentage of Participants in Clinical Remission (as Defined by a Crohns Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8; SECONDARY OUTCOME 1: Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4[/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 - Pediatric; BRIEF: The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517) plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric participants scheduled to receive chemotherapeutic agent(s) associated with moderate or high risk of causing emesis (vomiting), or chemotherapy agent(s) not previously tolerated due to vomiting. The primary hypothesis is that a single dose of fosaprepitant in combination with ondansetron provides superior control of CINV compared to ondansetron alone as measured by the percentage of participants with a Complete Response (no vomiting, no retching, and no use of rescue medications) in the delayed phase (>24 to 120 hours) following initiation of emetogneic chemotherapy in Cycle 1. ; DRUG USED: Emend (IV); DRUG CLASS: Non-NME; INDICATION: Chemotherapy Induced Nausea and Vomiting (CINV); TARGET: Neurokinin Receptor; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Is 0 (at least 37 weeks gestation) to 17 years of age at time of randomization - Has a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky score ≥60 (participants >16 years of age) - Has a predicted life expectancy ≥3 months - Is receiving chemotherapeutic agent(s) associated with moderate or high risk of emetogenicity, or a chemotherapy regimen not previously tolerated due to vomiting - Has a preexisting functional central venous catheter available for study drug administration - Is male OR is female who is not of reproductive potential OR is female who is of reproductive potential and agrees to avoid becoming pregnant in the 28 days prior to receiving study drug, while receiving study drug and for at least 30 days after last dose of study drug Exclusion Criteria: - Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1 - Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting (asymptomatic participants may participate in study) - Will be receiving stem cell rescue therapy in conjunction with study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant/placebo for fosaprepitant - Has received or will receive total body irradiation of radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period (120 hours following initiation of chemotherapy) - Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior to study drug administration, or is expected to receive within 120 hours following initiation of chemotherapy except for single doses of midazolam, temazepam or triazolam - Has started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen - Is currently taking, or has taken within 48 hours of Treatment Day 1 the following drugs with antiemetic properties: 5-hydroxytryptamine 3 (5-HT3) antagonists (e.g., ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapies with potential antiemetic properties, olanzapine, phenothiazines (e.g., prochlorpenzine), scopolamine (this is not an exhaustive list) - Is or has an immediate family member who is investigational site or sponsor staff directly involved with this study - Is currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence - Is mentally incapacitated or has a significant emotional or psychiatric disorder - Is pregnant or breast feeding - Is allergic to fosaprepitant, aprepitant (MK-0869), ondansetron, or any other 5-HT3 antagonist - Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation - Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy - Has ever participated in a previous study of aprepitant or fosaprepitant or has taken an investigational drug with the last 4 weeks. ; PRIMARY OUTCOME: Percentage of Participants Who Experienced a Complete Response During the Delayed Phase (>24 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1; SECONDARY OUTCOME 1: Percentage of Participants Who Experienced a Complete Response During the Acute Phase (0 to 24 Hours Post Initiation of Chemotherapy) in Cycle 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 - HTX-011-215; BRIEF: This is a Phase 2, open-label study 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 except as a child (less than 6 years of age). - Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy). - Has a 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 any NSAIDs within least 10 days prior to the scheduled surgery. - Has taken long-acting opioids within 3 days prior to the scheduled surgery. - Has taken any opioids within 24 hours prior to the scheduled surgery. - Has been administered bupivacaine within 5 days prior to the scheduled surgery. - Has been administered any local anesthetic within 72 hours prior to the scheduled surgery. - Has initiated treatment with study 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. - As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV). - Has uncontrolled anxiety, psychiatric, or neurological disorder. - 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, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study. - Previously participated in an HTX-011 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: Percentage of Subjects Receiving no Opioid Rescue; SECONDARY OUTCOME 1: Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])[/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 - ProstACT; BRIEF: This multinational, multicenter, prospective, randomized, controlled, open label Phase 3 study is designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody, 177Lu DOTA rosopatamab administered together with Standard of Care (SoC), as compared to the best SoC alone. The phase 3 will be conducted in patients with metastatic castration-resistant PC (mCRPC) that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug (NAAD). ; DRUG USED: ATL101; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Prostate-specific Membrane Antigen (PSMA), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Telix International Pty Ltd; CRITERIA: Inclusion Criteria: 1. Be a male, at least 18 years old, with metastatic adenocarcinoma of the prostate defined by histological / pathological confirmation of PC. 2. Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥6 months. 3. Have metastatic disease (≥1 metastatic lesions present on baseline CT, MRI, or bone scan imaging). 4. Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone [LHRH]) and must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). 5. In the mCRPC setting, must have received a minimum of 12 weeks of prior therapy with a NAAD, either enzalutamide or abiraterone plus prednisone. 6. Should have received one line of prior taxane therapy or have refused or be ineligible for taxanes 7. Have a disease that is progressing at study entry, despite a castrate testosterone level (<50 ng/dL or <1.7 nmol/L), by the demonstration of at least one of the following: 1. Rising PSA values done in sequence at least 1 week apart and with a minimal starting value of 2.0 ng/mL. 2. Progressive disease or new lesion(s) in the viscera or lymph nodes as per RECIST1.1 or in bone as per Prostate Cancer Working Group 3 [PCWG3; Scher et al., 2016]). Any ambiguous results are to be confirmed by other imaging modality (e.g., CT or MRI scan). 8. Have disease that is PSMA positive, as demonstrated by a 68Ga-PSMA11 PET/CT scan and confirmed as eligible by the Sponsors central reader (patient must have at least one site of metastatic disease with SUVmax ≥1.5 times the SUV of normal liver). If the disease meets the criteria for PSMA positivity, but there is one or more soft tissue lesion of ≥ 2 cm that is not PSMA positive, then the patient is to be excluded on the grounds that there is substantial disease which might not respond to the therapy. 9. Must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, NAAD, chemotherapy, etc.). 10. Can be receiving a bisphosphonate or denosumab regimen provided that the patient has been receiving and tolerating this treatment for ≥30 days prior to randomization. 11. Have adequate organ function at Screening: a. Bone marrow: i. Platelets ≥150×109/L. ii. Absolute neutrophil count >1.5×109/L. iii. Hemoglobin ≥10g/dL (no red blood cell transfusion in the previous 4 weeks). b. Liver function: i. Total bilirubin < 1.5×the upper limit of normal (ULN). For patients with known Gilberts Syndrome <3×ULN is permitted. ii. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <3×ULN OR <5×ULN for patients with liver metastases. c. Renal function: i. Serum/plasma creatinine <1.5×ULN or creatinine clearance ≥50 mL/min determined using the Cockcroft & Gault formula. 12. Have the capacity to understand the study and be able and willing to comply with all protocol requirements. 13. Patients must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution in order to protect their contacts and the general public, especially if a female partner of the patient is or could be pregnant. 14. Must agree to practice adequate precautions to prevent pregnancy in a partner and to avoid potential problems associated with radiation exposure to the unborn child (Refer to Clinical Trials Facilitation Group, 2020: Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, CTFG, 2020). Exclusion Criteria: 1. Are unable to understand or are unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the Investigator. 2. Have PC associated with pathological findings consistent with small cell or any histology other than adenocarcinoma of the prostate. If there are minor elements of neuroendocrine histology, this is acceptable. 3. Uncontrolled pain. 4. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease-free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, and superficial bladder cancer. 5. Are at increased risk of hemorrhage or bleeding, or with a recent history of a thrombolytic event (e.g., deep vein thrombosis [DVT]/ pulmonary embolism [PE]) and have been administered long-term anti-coagulant or anti-platelet agents. 6. Have received prior treatment with monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy. 7. Have known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients. 8. Have received prior systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, or biological therapy) and/or radiation therapy within 4 weeks of randomization OR if any significant AEs have not resolved to National Cancer Institute (NCI) AE Criteria ≤2; OR are receiving other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 9. Have received prior treatment with radioisotopes, including but not limited to: 89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium, or hemi-body irradiation within 6 months prior to randomization. 10. Have received other investigational therapy within 4 weeks of randomization. 11. Have known brain metastases or hepatic metastases. 12. Have a history of seizure and/or stroke within past 6 months. 13. Have clinical or radiologic findings indicative of impending cord compression or experience symptomatic cord compression. 14. Have a serious active or sub-clinical infection or angina pectoris (New York Heart Association [NYHA] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, which might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment, particularly with enzalutamide. 15. Have received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs. 16. Have a known alteration in breast cancer genes (BRCA) BRCA1, BRCA2, or Ataxia Telangiectasia Mutated Gene (ATM) gene and are eligible to receive Olaparib therapy according to their institutions SoC ; PRIMARY OUTCOME: Comparison of radiographic progression-free survival (rPFS); 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 II - Pemetrexed Maintenance; BRIEF: - Open label - Enrollment in the order of confirmation of eligibility and HPV+ tumor status - Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR) mutation status, performance status and first-line induction chemotherapy outcome; - Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus ADXS11-001 vs. 42 patients receiving pemetrexed alone) - Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy - Control Arm: Pemetrexed only - Positive control: pemetrexed chemotherapy ; DRUG USED: Axalimogene Filolisbac; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Human Papillomavirus (HPV), Immune System; THERAPY: Combination; LEAD SPONSOR: Advaxis, Inc.; CRITERIA: Inclusion Criteria: 1. Male or female patients, ≥ 20 years of age 2. Patients with NSCLC 3. Patients whose disease has either responded or not progressed following 4-6 cycles of first-line induction chemotherapy. 4. Patients with documented/confirmed intra-tumor positivity for HPV 5. Patients with no major existing co-morbidities or medical conditions that will preclude administration of therapy, in the opinion of the Investigator 6. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 7. Patients will use contraception during the study 8. Patients with the ability to understand and give written informed consent for participation in this trial Exclusion Criteria: 1. Women who are pregnant or breast feeding 2. Patients with histologically- or cytologically-confirmed squamous cell-classified NSCLC 3. Patients with disease progression following first-line induction chemotherapy 4. Patients with known active and uncontrolled central nervous system (CNS) or leptomeningeal metastases 5. Patients with an active second primary malignancy or history of another malignancy 6. Patients with inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy, including ≥ Grade 2 neuropathy 7. Patients with inadequate recovery from any previous surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to the start of study treatment 8. Patients with evidence of inadequate organ function as defined in protocol 9. Patients with a known allergy to both of the following antibiotics: ampicillin, trimethoprim-sulfamethoxazole 10. Patients with a known allergy to anti-emetic medications and/or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, celecoxib) 11. Patients with a history of severe hypersensitivity reaction to pemetrexed disodium (Alimta® or equivalent), or any of the excipients used in its formulation 12. Patients with a history of an autoimmune disorder requiring systemic treatment within the past 3 months, or a documented history of a clinically severe autoimmune disease or a syndrome that requires systemic steroid or immunosuppressive agents 13. Patients with a known immunodeficiency including patients: with HIV infection, who have undergone previous organ transplantation and require immunosuppressive therapy or long-term immunosuppressive therapy for any other reason 14. Patients with interstitial lung disease or active, non-infectious pneumonitis, active or prior documented inflammatory bowel diseases (e.g., Crohns disease, ulcerative colitis) 15. Patients with an active infection requiring systemic therapy, prior to dosing with study drug 16. Patients with any other life-threatening illness, uncontrolled medical condition (e.g., elevated troponin or creatinine; uncontrolled diabetes), significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator would either compromise the patients safety or interfere with evaluation of the study treatment 17. Patients with a psychiatric disorder, substance abuse disorder, or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary study-related evaluations 18. Patients with a history of or current evidence of any condition, therapy, or laboratory abnormality that might: confound the results of the trial, interfere with the patients participation in the trial, or suggest that participation in the trial is not in the best interest of the patient, in the opinion of the treating investigator ; PRIMARY OUTCOME: Number of study participants with objective tumor response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST); SECONDARY OUTCOME 1: Distribution of overall response rate (ORR) as assessed by RECIST v1.1 and irRECIST[/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 - 105GM201 - w/Bevacizumab; BRIEF: The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF therapy) ; DRUG USED: TRC105; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Endoglin / Cluster of Differentiation 105 (CD 105); THERAPY: Combination; LEAD SPONSOR: Tracon Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Patients with histologically confirmed glioblastoma, recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy. 2. Patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma. 3. Patients with up to 3 prior recurrences are allowed. 4. Karnofsky performance status ≥ 70%. 5. Age ≥ 18 years old. 6. Normal organ function Exclusion Criteria: - Patients who have had previous treatment with TRC105. - Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury - Patients with cirrhosis, or active viral or nonviral hepatitis. - Patients with active bleeding or pathologic conditions that carry a high risk of bleeding,(i.e. hereditary hemorrhagic telangiectasia). - Patients who are currently receiving anticoagulation treatment - Patients unwilling or unable to comply with the protocol ; PRIMARY OUTCOME: Median Overall Survival (OS); SECONDARY OUTCOME 1: Median Duration That Patients Remained Progression Free on Study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CARE; BRIEF: This single-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 20 subjects aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with moderate COVID-19. Two-arm trial comparing the SOC/supportive care alone to the SOC/supportive care with addition of Silmitasertib (allocation ratio 1:1). ; DRUG USED: Silmitasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Protein kinase CK2/Casein Kinase II; THERAPY: Monotherapy; LEAD SPONSOR: Chris Recknor, MD; CRITERIA: Inclusion Criteria: 1. Male or non-pregnant female adult ≥ 18 years of age 2. Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing 3. Outpatient subjects with moderate illness caused by SARS-CoV-2 infection as defined below, - Symptoms of moderate systemic illness/infection with COVID-19: At least two of the key COVID-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion AND - Clinical signs indicative of moderate systemic illness/infection with COVID-19 At least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute AND - No clinical signs indicative of Severe or Critical Illness Severity required hospitalization (see exclusion criterion #1) 4. Patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 5. Adequate hematopoietic capacity, as defined by the following: 1. Hemoglobin ≥ 9.0 g/dL and not transfusion dependent 2. Platelets ≥ 100,000/mm3 3. Absolute neutrophil count ≥ 1500 cells/mm3 6. Adequate hepatic function, as defined by the following: 1. AST and ALT ≤ 2.5 times upper limit of normal (ULN) 2. Total bilirubin ≤ 1.5 x ULN 3. Albumin ≥ 3.0 g/dL 7. Adequate renal function, as defined by the following: a. Renal: calculated creatinine clearance >45 mL/min for patients with abnormal, increased creatinine levels (Cockcroft-Gault formula). 8. Ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see Section 6.3) throughout study duration. Exclusion Criteria: 1. Any signs indicative of Severe or Critical Illness Severity required hospitalization as defined below: - Severe COVID-19: Shortness of breath in rest, or respiratory distress, respiratory rate (RR) >/= 30 per minute, heart rate (HR) >/=125 bpm, SpO2</=93% on room air at sea level or PaO2/FiO2<300 - Critical COVID-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, ESMO; shock or multi-organ dysfunction/failure 2. Pregnant or nursing women. (NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) 3. Active or uncontrolled infections other than COVID-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment 4. Chronic diarrhea (excess of 2-3 stools/day above normal frequency) 5. Concomitant treatment with another investigational drug from Day 1 through Day 28. 6. Current use or anticipated need for drugs that are known strong inhibitors or inducers of major CYP enzymes. ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) within the CX-4945 Treatment Group assessed by CTCAE v5.0; SECONDARY OUTCOME 1: Clinical Recovery associated with COVID-19 within the CX-4945 Treatment Group[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Human PK Study; BRIEF: This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema ; DRUG USED: Iluvien; DRUG CLASS: Non-NME; INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Alimera Sciences; CRITERIA: Inclusion Criteria: - Age >= 18 years with diabetic macular edema - Diagnosis of diabetes mellitus types 1 or 2 - Best corrected visual acuity of ≥ 19 letters - Retinal thickness > 250 microns by OCT - Investigator is comfortable deferring macular laser treatment for 6 weeks Exclusion Criteria: - Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents - Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy - Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months - Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months - Any ocular surgery within the last 3 months - Retinal laser treatment within the last 3 months - History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy - Any lens opacity which impairs visualization of the posterior pole ; PRIMARY OUTCOME: Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor; SECONDARY OUTCOME 1: Retinal Thickness[/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 - Healthy Male Subjects; BRIEF: Approximately 24 healthy male volunteers between the ages of 18 and 35 years will be enrolled at a single center for a duration of two months for each subject. Subjects who meet the enrollment criteria will be randomized to one of four open-label groups: Control (no treatment) or treatment with F598 at one of three doses. Following F598 administration or assignment to the Control group, subjects must return to the study site for inoculation with N. gonorrhoeae within 2 weeks. Once subjects have been inoculated with N. gonorrhoeae, they will enter the observation phase and will return to the study site daily for up to 5 days. At the end of the observation phase, definitive antibiotic therapy will be administered. A follow-up visit will be conducted 3-5 days after definitive antibiotic and a confirmatory interaction will occur with the subjects 7-10 days after the follow-up to confirm the subjects response. A final visit will occur approximately 8 weeks after inoculation. ; DRUG USED: SAR279356; DRUG CLASS: Biologic; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: poly-N-acetyl glucosamine (PNAG), Staphylococcus; THERAPY: Monotherapy; LEAD SPONSOR: Alopexx Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: 1. Healthy male between the ages of 18 and 35 years 2. Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number) 3. Able and willing to provide written informed consent 4. Able and willing to attend all study visits and follow-up visit during the week after treatment 5. Willing to abstain from masturbation during the 6 days after inoculation 6. Willing to abstain from all sexual activity during the course of the study 7. No clinically significant abnormalities on physical examination 8. No clinically significant abnormalities in serum chemistries, hematology and urinalysis 9. Urine negative for chlamydia, gonorrhea and trichomonas 10. No history of sexually transmitted infections (STIs), including syphilis and hepatitis B (HBV) & hepatitis C (HCV) 11. Negative human immunodeficiency virus (HIV), syphilis and HCV serologies 12. Negative HBV core and surface antibodies or results consistent with immunization (negative HBV core antibody/positive HBV surface antibody) 13. No history of bleeding diathesis 14. No history of seizures (due to reports of seizures with ciprofloxacin) 15. No history of cancer, except basal cell carcinoma of the skin more than 5 years ago 16. No history of drug abuse 17. No history of psychiatric disorders, except depression controlled by medication 18. No history of genitourinary surgery Exclusion Criteria: 1. Student or employee under the direct supervision of any of the study investigators 2. Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection 3. Sickle cell disease 4. Psychiatric disorders that would interfere with the ability of the subject to comply with the requirements of the protocol 5. Unstable depression (defined as receiving either <3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or depression that, in the opinion of the investigator, will compromise the subjects ability to comply with protocol requirements 6. Heart murmur or heart disease 7. Anatomic abnormality of the urinary tract 8. Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days 9. Chemotherapy within the past year 10. Current steroid use, except for topical application 11. Allergy to penicillin, cephalosporins, ciprofloxacin or to lidocaine 12. Treatment with medications that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the single doses given in this study. 1. Medications not permitted with cefixime or ceftriaxone include: - Warfarin - Probenecid - Aspirin - Diuretics such as furosemide - Aminoglycoside antibiotics - Chloramphenicol 2. Medications not permitted with ciprofloxacin include: - Tizanidine - Theophylline - Warfarin - Glyburide - Cyclosporine - Probenecid - Phenytoin - Methotrexate - Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc - Caffeine-containing medications - Sucralfate or didanosine chewable or buffered 13. Major organ dysfunction 14. Any significant pre-existing condition preventing full compliance with the study 15. Infection or any serious underlying medical condition that would impair the ability of the subject to receive protocol treatment ; PRIMARY OUTCOME: Assess the efficacy of F598 in preventing an experimental urethral infection with N. gonorrhoeae; SECONDARY OUTCOME 1: Assess the impact of F598 on urethritis symptoms caused by N. gonorrhoeae infection[/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 - SIRRESTA; BRIEF: Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of 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 GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable. Approximately 204 subjects with a diagnosis of GCA 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 will be eligible to enter Part B, the 104-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 with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Giant Cell Arteritis; TARGET: IL-6 (Interleukin-6); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria: Age >=50 years. History of ESR >=50 millimeter/hour (mm/hour) or CRP >=2.45 milligram/deciliter(mg/dL). Presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal symptoms of polymyalgia rheumatic (PMR). Presence of at least one of the following: Temporal artery biopsy revealing features of GCA; Evidence of large-vessel vasculitis by angiography or cross-sectional imaging. - Active GCA within 6 weeks of Randomization (Baseline) where active disease is defined by an ESR >=30 mm/hr or CRP >=1 mg/dL AND the presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal symptoms of PMR; Other features judged by the clinician investigator to be consistent with GCA or PMR flares. - At screening, receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA. - Clinically stable GCA disease at baseline such that the subject is able to safely participate in the blinded prednisone taper regimen in the opinion of the investigator. - Practicing acceptable methods of birth control if a female of child-bearing potential. - No evidence of active or latent infection with Mycobacterium tuberculosis (TB). Exclusion Criteria: - Are pregnant or breastfeeding. - 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 baseline visit). - Had prior treatment with any of the following: Systemic immunosuppressives) within 4 weeks of baseline; Biologic agents targeted at reducing tumor necrosis factor-alpha (TNF-alpha) within 2-8 weeks of baseline, depending on the agent; Any prior use of tocilizumab or other anti-IL-6 agents; B-cell depleting agents (eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not returned to normal range or baseline levels; Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline; Abatacept within 8 weeks of baseline; Tofacitinib within 4 weeks of baseline; Methotrexate use within 2 weeks of baseline. Methylprednisolone > 100 mg/day intravenous (IV) (or equivalent) within 8 weeks of baseline. - History of severe allergic reactions to monoclonal antibodies, human proteins, or excipients. - Evidence of serious concomitant disease, which in the opinion of the investigator makes them unsuitable for participation in the study. - Major ischemic event, unrelated to GCA, within 12 weeks of screening. - Marked baseline prolongation of corrected QT (QTc) interval >= 450 milliseconds (msec) (QTc by Bazetts formula [QTcB ]or QTc by Fridericias formula [QTcF] ), history of Torsade de Pointes, family history of long QT syndrome, history of second or third degree heart block. - Current liver disease that could interfere with the trial - History of or current active diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal 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 have required management of acute or chronic infections, as follows: Currently on any suppressive therapy for a chronic infection, history or suspicion of chronic infection, hospitalization for treatment of infection within 60 days of the baseline visit, or use of parenteral (IV) or intra-muscular [IM]) antimicrobials within 60 days of baseline or oral antimicrobials within 30 days of baseline - Primary or secondary immunodeficiency or any other autoimmune disease. - Human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B infection - Live virus or bacterial vaccination within 3 months before the first administration of study drug ; PRIMARY OUTCOME: Part A: Number of Participants in Sustained Remission at Week 52; SECONDARY OUTCOME 1: Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change 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 IIb - RESET (Periumbilical Area); BRIEF: Dose Ranging Study ; DRUG USED: LIPO-202; DRUG CLASS: Non-NME; INDICATION: Fat Removal; TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Neothetics, Inc; CRITERIA: Inclusion Criteria: >18 years of age inclusive Subcutaneous fat in the periumbilical area BMI <30 kg/msq Stable diet and exercise and body weight Exclusion Criteria: Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - NSABP FB-10 (w/T-DM1); BRIEF: This study is being done for the following reasons: - The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with T-DM1. - The purpose of the second part of the study (Phase II) is to find out whether the dose of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time. - In order to learn more about study therapy levels in blood and discover genetic and protein changes associated with cancer, the study includes special research tests using samples from blood and from breast tumor. Blood samples will be collected before study treatment, once during treatment, and after study treatment stops. - In the optional part of this study, three biopsies will be performed to obtain fresh tumor samples from an area where your cancer has spread. ; DRUG USED: Nerlynx; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: NSABP Foundation Inc; CRITERIA: Inclusion Criteria: - The ECOG performance status must be less than or equal to 2. - Patients must have the ability to swallow oral medication. - Patients must have histologic or cytologic confirmation of the diagnosis of invasive adenocarcinoma of the breast. - Patients must have had anti-HER2 based therapy with pertuzumab and trastuzumab for neoadjuvant therapy, adjuvant therapy or with first line therapy for metastatic disease (which may include trastuzumab and pertuzumab either sequentially or in combination). - There must be documentation that the patient has evidence of measurable metastatic breast cancer that is accessible to biopsy at study entry. - Patients must have estrogen receptor (ER) analysis performed prior to study entry. If ER analysis is negative, then progesterone receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.) - Breast cancer must be determined by local testing to be human epidermal growth factor receptor 2 (HER2)-positive prior to study entry using American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) HER2 test guidelines. - At the time of study entry, blood counts performed within 4 weeks prior to study entry must meet the following criteria: - absolute neutrophil count (ANC) must be greater than or equal to 1000/mm3; - platelet count must be greater than or equal to 100,000/mm3; and - hemoglobin must be greater than or equal to 9 g/dL. (Note: Patient must have discontinued growth factors greater than or equal to two weeks prior to entry labs.) - The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met: - Total bilirubin must be less than or equal to 1.5 x upper limit of normal (ULN), and - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab or less than or equal to 5 x ULN if liver metastasis. - Serum creatinine performed within 4 weeks prior to study entry must be less than or equal to 1.5 x ULN for the lab. - The left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multi-gated acquisition (MUGA) scan performed within 90 days prior to study entry must be greater than or equal to 50% regardless of the facilitys lower limit of normal (LLN). - Patients with reproductive potential must agree to use an effective non-hormonal method of contraception during therapy, and for at least 7 months after the last dose of study therapy. Exclusion Criteria - Previous therapy with T-DM1 or any HER2 tyrosine kinase inhibitor (TKI) including neratinib for any malignancy. - Symptomatic brain metastases or brain metastases requiring chronic steroids to control symptoms. - Active hepatitis B or hepatitis C with abnormal liver function tests; HIV positive patients receiving antivirals. - Lung disease resulting in dyspnea at rest. - Active infection or chronic infection requiring chronic suppressive antibiotics. - Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function. - Persistent greater than or equal to grade 2 diarrhea regardless of etiology. - Conditions that would prohibit intermittent administration of corticosteroids for T-DM1 premedication. - Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids). - Uncontrolled hypertension defined as a systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well controlled on medication are eligible.) - Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: - Active cardiac disease: symptomatic angina pectoris within the past 90 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis - History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy - Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up. - Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed within 14 days prior to study entry according to institutional standards for women of childbearing potential.) - The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements. - Use of any investigational agent within 4 weeks prior to study entry. ; PRIMARY OUTCOME: Number of Evaluable Patients With Dose Limiting Toxicity Events in Phase 1; SECONDARY OUTCOME 1: Progression-free Survival (PFS) Time From Start of Study Therapy to Disease Progression or Death From Any Cause[/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 - PROSEEK; BRIEF: This study consists of 2 parts. Part 1 of the study is conducted to evaluate the efficacy, safety, and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinsons Disease who are not receiving dopaminergic therapy. Part 2 is an optional long term extension study for subjects who have completed week 40 of Part 1 ; DRUG USED: SCO-088; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: BCR-ABL Fusion Protein; THERAPY: Monotherapy; LEAD SPONSOR: Sun Pharma Advanced Research Company Limited; CRITERIA: Part 1: Inclusion criteria: 1. Males or females aged ≥ 50 years; 2. Body mass index (BMI) greater than 18.5 kg/m2 and less than 45 kg/m2; 3. Diagnosed with Clinically Probable PD according to the MDS clinical diagnostic criteria, with documented diagnosis of PD per treating physicians records within three years of the Screening visit. Disease severity according to modified Hoehn & Yahr stage ≤ 2; 4. Projected to not required to start dopaminergic therapy within 9 months from Baseline; Exclusion criteria: 1. Current, or within 60 days of Screening, use of any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD. Treatment with Monoamine Oxidase B (MAOB) inhibitors will be allowed if the dose is stable for at least 30 days prior to Screening and subjects agree to remain on it for the duration of the study; 2. Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine) for 30 or more days any time in the past; 3. A diagnosis of a significant central or peripheral nervous system disease affecting the subjects cognition or motor function at any time, such as another neurodegenerative disorder, multiple sclerosis or stroke. This does not include transient neurological deficits such as transient ischemic attacks or migraine aura; 4. A diagnosis of a medical condition that could interfere with interpretation of the MDS-UPDRS during the trial (e.g., musculoskeletal disorders); 5. Contraindications to receiving an MRI; 6. Contraindications to receiving a DaT SPECT scan (e.g., hypersensitivity to the active substance, any of the excipients, or iodine) if a new DaT SPECT scan is required for the study; 7. Most recent DaT SPECT scan not compatible with PD (i.e., Scans Without Evidence of Dopaminergic Deficit [SWEDD]) based on a central reading by a study physician; 8. MRI of the brain performed after onset of PD suggestive of secondary Parkinsonism (e.g., subdural hematoma, normal pressure hydrocephalus, or infarcts of the basal ganglia); 9. Severe tremors as defined by a score of severe on any of the MDS-UPDRS Parts 2 or 3 tremor severity (not constancy) items; 10. Montreal cognitive assessment score < 25 11. History of any surgery on the brain itself including deep brain stimulation for PD (note this does not include surgeries on the skull that do not affect the brain, e.g., small meningioma removal); 12. History of hypersensitivity (e.g., bronchospasm, anaphylaxis, serious drug rash) to contents of the study drug or other tyrosine kinase inhibitors; 13. Recent use of medications that can cause Parkinsonism and suspicion of the investigator that it could have worsened the subjects Parkinsonism. This includes neuroleptics (e.g., olanzapine, risperidone, haloperidol), some anti-nausea medications (e.g., prochlorperizine, metoclopramide) and others (e.g., flunarizine, methyldopa) 14. Use of medications that affect the dopaminergic system within 60 days of Screening. This includes stimulants (e.g., methylphenidate, amphetamine derivatives, modafinil) and Monoamine Oxidase A (MAOA) inhibitors (e.g., phenelzine, and tranylcypromine). Note that antidepressants are acceptable as long as the subject has remained on them at a stable dose for over 60 days prior to Screening and plans to remain on them through the study; 15. Any malignant disease (other than basal cell carcinoma of the skin) with evidence of disease within the past 5 years and with the potential for recurrence Part 2: Inclusion criteria: 1. Subject has completed part 1 of the study. 2. Subject projected not to need dopaminergic treatment except for treatment with Monoamine Oxidase B (MAOB) inhibitors. MAOB inhibitors will be allowed if the patient was already taking the same during part 1 of the study. 3. Subject has received K0706/placebo, as appropriate, within 4 weeks prior to end of part 1 of the study. 4. Male subjects enrolled in the study should not father a child and are advised to prevent the passage of semen to their sexual partner during intercourse using an effective method, as judged by the Investigator, for the duration of the study and for 3 months after the last dose of study drug Exclusion criteria: 1. Clinically significant or unstable psychiatric or medical condition, vital sign, or laboratory abnormality that in the opinion of the investigator interferes with participation in the study 2. Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject. 3. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject ; PRIMARY OUTCOME: Change from Baseline in the sum of MDS-UPDRS Parts 2 and 3; SECONDARY OUTCOME 1: Change in the movement disorder society - unified Parkinsons disease rating scale[/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 - CMP-001-007; BRIEF: CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC) The secondary objectives are to: - To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC - To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC - To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached. ; DRUG USED: Vidutolimod; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Immune System, Toll-Like Receptor (TLR) Family, Toll-like receptor 9 (TLR9); THERAPY: Combination; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: - Histologically- or cytologically-confirmed recurrent or metastatic HNSCC considered incurable by local therapies. - No prior systemic therapy in the recurrent or metastatic setting. Systemic therapy as part of multi-modal treatment for locally advanced disease is allowed. - Primary tumor locations of oropharynx, oral cavity, hypopharynx, larynx or paranasal sinus. Participants may not have a primary tumor site of nasopharynx (any histology). - Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable. - Combined Positive Score (CPS) ≥ 1 for PD-L1 on Immunohistochemistry (IHC) of tumor tissue. - Have results of tumor HPV p16 by IHC for oropharyngeal cancer. - Measurable disease as defined by RECIST v1.1, and both of the following: 1. At least 1 lesion amenable to repeated Intratumoral (IT) injection. 2. Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion. - Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study drug on Week 1 Day 1 (W1D1) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening. - Capable of understanding and complying with protocol requirements. - Women of childbearing potential must have negative serum pregnancy test during Screening and be willing to use an adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug. - Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug. - Able and willing to provide written informed consent and to follow study instructions. - Subjects unable to provide written informed consent on their own behalf will not be eligible for the study. Exclusion Criteria: - Disease suitable for local therapy administered with curative intent. - Has PD within 3 months of completion of curatively intent systemic treatment for locoregionally advanced HNSCC. - Radiation therapy (or other non-systemic therapy) within 2 weeks before the first dose of study drug on W1D1. - Received prior therapy with PD-1 or PD-L1 blocking antibody therapy in the recurrent/ metastatic setting. If PD-1 or PD-L1 blocking antibody therapy was given as part of curative intent therapy, it must be at least 1 year since receipt of PD-1 or PD-L1 blocking antibody. - Not fully recovered from adverse events (to Grade 1 or less [per CTCAE v5.0]), with the exception of persistent alopecia, neuropathy, ototoxicity, hypothyroidism, pain, or dysphagia, due to prior treatment. - Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study drug on W1D1. 1. Subjects who are currently receiving steroids at a prednisone-equivalent dose of ≤ 10 mg/day do not need to discontinue steroids prior to enrollment. 2. Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted. - Active pneumonitis, history of noninfectious pneumonitis that required steroids, or history of interstitial lung disease. - Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, implanted or continuous use of a pacemaker or defibrillator. - Known history of immunodeficiency. - Known additional malignancy that is progressing or required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, and thyroid cancer (except anaplastic). - Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment - Untreated, symptomatic, or enlarging central nervous system (CNS) metastases or carcinomatous meningitis. - Prior allogenic tissue/solid organ transplant. - Active infection requiring systemic therapy. - Known or suspected active infection with SARS-CoV-2 virus. - Known or suspected infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus; testing is not required unless suspected. - Received a live virus vaccination within 30 days before the start of study drug dosing on W1D1. - Received blood products (including platelets or red blood cells) or colony stimulating factors [including granulocyte colony-stimulating factor (GCSF), granulocyte-macrophage colony-stimulating factor (GMCSF) (or recombinant erythropoietin)] within 30 days before the start of Screening. - Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial. - Participation in another clinical trial of an investigational anticancer therapy or device within 30 days before the first dose of study drug. - Requires prohibited treatment (ie. non-protocol specified anticancer pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor). - Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator. - Received previous CMP-001 treatment. - Pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, from the time of consent until at least 120 days after the last dose of study drug. ; PRIMARY OUTCOME: The objective response (investigator-assessed) to CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC).; SECONDARY OUTCOME 1: Safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - Healthy/CML; BRIEF: Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML ; DRUG USED: SCO-088; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Myelogenous Leukemia (CML); TARGET: BCR-ABL Fusion Protein; THERAPY: Monotherapy; LEAD SPONSOR: Sun Pharma Advanced Research Company Limited; CRITERIA: Inclusion Criteria: - Willing and able to give written, and dated, informed consent - Male or female aged ≥ 18 years - Willing and able to comply with the scheduled visits - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib (Part C). Exclusion Criteria: - Presence of T315I (PART C) - Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration - Inability to undergo venipuncture and/or tolerate venous access - Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus - Known or suspected history of significant drug abuse as judged by the Investigator - Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration - Subjects who are eligible for potentially curative therapy that is available, including hematopoietic stem cell transplant - Another primary malignancy within the past 3 years or earlier (except for adequately treated non-melanoma skin cancer or cervical cancer in situ ; PRIMARY OUTCOME: To determine the Maximum Tolerated Dose (MTD) as determined by frequency of Dose Limiting Toxicities; SECONDARY OUTCOME 1: Pharmacokinetic profile of K0706 - Cmax [The maximum (peak) observed drug concentration after dose administration][/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AWARD-3 (vs. Metformin); BRIEF: The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes. ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organizations [WHO] Classification of Diabetes). - Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label. - Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin. - Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%. - Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: a) test negative for pregnancy at screening based on a serum pregnancy test, and b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or c) not be breastfeeding. - Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening. - Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2), inclusive. - Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary. Exclusion Criteria: - Have type 1 diabetes mellitus. - Are being or have been treated with any of the following medications: a) chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable, b) glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3 months prior to screening, e) chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or f) illegal drugs. - Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening. - Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery. - Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke. - Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women. - Have a problem with the liver or pancreas. - Have a creatinine clearance result which shows less than 60 milliliters per minute (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or active autoimmune abnormality. - Have a serum calcitonin test which shows greater than or equal to 20 picograms per milliliter (pcg/mL) at the time of screening. - Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B. - Have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years. - Have had an organ transplant except for corneal transplant. - Have received treatment within the last 30 days with a drug which has not been regulatory approved. - Have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 30 days prior to screening. - Have any condition that is a contraindication to or would interfere with medications provided for this study to treat diabetes. - Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab samples. - Have previously participated or signed an informed consent document for this same type of study and study drug. ; PRIMARY OUTCOME: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c); SECONDARY OUTCOME 1: Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Neoadjuvant (Triple Negative); BRIEF: To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression ; DRUG USED: LCL161; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Caspases, IAPs (Inhibitor of apoptosis proteins); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of invasive triple negative breast cancer - Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening - Candidates for mastectomy or breast-conserving surgery - Primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous Amendment #3 was tumor size greater than 10 mm) - Regional nodes N0-N2 - Absence of distant metastatic disease - ECOG performance status 0-1 - Adequate bone marrow function - Adequate liver function and serum transaminases - Adequate renal function Exclusion Criteria: - Bilateral or inflammatory breast cancer (bilateral mammography is required during Screening/baseline); locally recurrent breast cancer - Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months - Uncontrolled cardiac disease - Patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose ≥ 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug - Impaired GI function that may affect the absorption of LCL161 - Pregnant or breast feeding (lactating) women - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment - Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy; SECONDARY OUTCOME 1: Posterior Distribution of Difference of pCR Rates After Treatment With LCL161 + Paclitaxel Between Patients With Gene Expression Positive and Negative Tumors[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - DUART; BRIEF: This is an open label, multi-institutional, single arm study of a phase Ib study, followed by a phase II study of durvalumab with radiation therapy (RT) in patients with urothelial cancer (UC). No randomization or blinding is involved. ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Monika Joshi, MD; CRITERIA: Inclusion Criteria: Phase Ib subjects must meet the following inclusion criteria: - Locally advanced urothelial cancer of bladder with any of the following: 1. T3-4, N0-2 M0, OR Tx N1-2 M0 OR T2 N1-2 M0: Treatment naïve, unresectable, OR medically unfit for surgery, OR cisplatin ineligible. T3 N0 M0 patients can be included if they are cisplatin ineligible. 2. Patients who have T3-4, N0-2 M0 OR Tx N1-2 M0 OR T2 N1-2 M0 post-neoadjuvant chemotherapy who become unresectable OR medically unfit for surgery. Phase II subjects must meet the following inclusion criteria: - Locally advanced urothelial cancer of bladder with any of the following: 1. T3-4, N0-2 M0 OR Tx N1-2 M0 OR T2 N1-2 M0: Treatment naïve, unresectable, OR medically unfit for surgery OR cisplatin ineligible. T3 N0 M0 patients can be included if they are cisplatin ineligible. 2. T3-4, N0-1 M0 OR Tx N1-2 M0 OR T2 N1-2 M0 patients post-neoadjuvant chemotherapy who become unresectable OR medically unfit for surgery. - T2, N0, M0 who are ineligible to get cisplatin based chemotherapy. All subjects: - Written informed consent and HIPAA authorization for personal health information, obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. - Life expectancy of >6 months per treating physician. - Subjects must have archival tissue available from previous TURBT (preferred) or lymph node core biopsy within 8 weeks of treatment or be assessed by the treating urologist to undergo maximal TURBT. The extent of TURBT may vary for each patient and will be determined by the treating urologist. Further, the treating urologist will decide if performing the TURBT is clinically appropriate. If the potential subject does not have tumor amenable to biopsy, there is insufficient tissue for PD-L1 testing or is not clinically appropriate for TURBT, enrollment must be discussed with the sponsor-investigator on a case by case basis. - Histologically proven urothelial carcinoma of bladder with predominant transitional cell component. Adenocarcinoma, squamous cell differentiation, or other atypical histology (such as plasmacytoid or sarcomotoid) of the bladder will be allowed on the study, provided they form <50% of the histology - Females of childbearing potential must have a negative urine and serum pregnancy test within 3 days of study registration. NOTE: Female subjects are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are ≥60 years old and naturally postmenopausal for at least 12 consecutive months. - Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Exclusion Criteria: - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). - Participation in another clinical study with an investigational product within 2 weeks prior to registration. - Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab. - Previous systemic immunotherapy. Previous use of intravesical BCG is acceptable. - History of another primary malignancy except for: 1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence. However adequately treated prostate cancer >3 years ago with no significant change in PSA for past 6 months can be included. Patients with a history of prostate cancer must not have any definitive radiation therapy to prostate area. 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3. Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ. - Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within14 days prior to the first dose of study drug (14 days prior to the first dose of study drug for subjects who have received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C). - Mean QT interval corrected for heart rate (QTc) ≥470 ms on electrocardiogram (ECG) using Frediricias Correction. - Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. - Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy. (Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy). - Any prior Grade ≥3 Immune-mediated adverse event (imAE) while receiving any previous immunotherapy agent, or any unresolved imAE >Grade 1. - Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Graves disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. Patients with h/o completely resolved childhood asthma or atopy will not be excluded. Patients with well-controlled hypothyroidism on thyroxine replacement will be eligible as well. - Active or prior documented inflammatory bowel disease (e.g., Crohns disease, ulcerative colitis). - History of and/or confirmed pneumonitis. - History of primary immunodeficiency. - History of allogeneic organ transplant. - History of hypersensitivity to durvalumab or any excipient. - History of hypersensitivity to the combination or radiation therapy. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent. - Known history of previous clinical diagnosis of tuberculosis. - Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of starting treatment with durvalumab. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. - Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control. For this study male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 90 days after last dose of study drug - Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. - Brain metastases or history of leptomeningeal carcinomatosis. - Subjects with uncontrolled seizures. - Previous definitive radiation to pelvic area. ; PRIMARY OUTCOME: Safety Assessment - Evaluation of DLT (dose limiting toxicity) rate; SECONDARY OUTCOME 1: Complete Remission[/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 - IMEX; BRIEF: This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival. ; DRUG USED: Iressa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Histological confirmation of evidence of squamous cell carcinoma of the head and neck. - Tumors have progressed after primary treatment with radiation or chemoradiation and have failed to respond to at least one course of standard platinum-based chemotherapy. - Tumors have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy. Exclusion Criteria: - Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors. - Isolated recurrent disease that may be amenable to local therapy; e.g., surgical intervention or radiation therapy. - Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of these products. ; PRIMARY OUTCOME: Compare ZD1839 versus methotrexate in overall survival; SECONDARY OUTCOME 1: Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LOTUS (w/Paclitaxel (TNBC)); BRIEF: This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors. ; DRUG USED: Ipatasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization - Measurable disease, according to the RECIST v1.1 - Adequate hematologic and organ function within 14 days before the first study treatment - For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment Exclusion Criteria: - Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent - Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1 - Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer - Previous therapy with Akt, PI3K, and/or mTOR inhibitors - Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study - Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors[/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 - REVIVE (Vulvovaginal Candidiasis); BRIEF: VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections. ; DRUG USED: Oteseconazole; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fungal Infections - Non-Systemic; TARGET: Cytochrome p450; THERAPY: Monotherapy; LEAD SPONSOR: Viamet; CRITERIA: Key Inclusion Criteria: Clinical diagnosis of symptomatic acute VVC 3 or more episodes of acute VVC in the past 12 months Positive KOH Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening Composite vulvovaginal signs and symptoms score of <3 at Baseline Must be able to swallow tablets Key Exclusion Criteria: Evidence of major organ system disease Presence or a history of another vaginal or vulvar condition(s) History of cervical cancer Poorly controlled diabetes mellitus Pregnant Recent use of topical or systemic antifungal drugs Recent use of immunosuppressive or system corticosteroid therapies ; PRIMARY OUTCOME: The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.; 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 - PEGASUS; BRIEF: Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria ; DRUG USED: Empaveli; DRUG CLASS: New Molecular Entity (NME); INDICATION: Paroxysmal Nocturnal Hemoglobinuria (PNH); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Apellis Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - At least 18 years of age - Primary diagnosis of PNH confirmed by high-sensitivity flow cytometry - On treatment with eculizumab. Dose of eculizumab must have been stable for at least 3 months prior to the Screening Visit - Hb <10.5 g/dL at the Screening Visit - Absolute reticulocyte count > 1.0x ULN at the Screening Visit - Platelet count of >50,000/mm3 at the Screening Visit - Absolute neutrophil count >500/mm3 at the Screening Visit - Vaccination against Neisseria meningitides types A, C, W, Y and B, Streptococcus pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day 1 dosing, or within 14 days after starting treatment with APL-2. Unless documented evidence exists that subjects are non-responders to vaccination as evidenced by titers or display titer levels within acceptable local limits - Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening and Day -28 Visit (Run-in Period) and must agree to use protocol defined methods of contraception for the duration of the study and 90 days after their last dose of study drug - Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and 90 days after their last dose of study drug - Willing and able to give informed consent - Willing and able to self-administer APL-2 (administration by caregiver will be allowed) - Have a body mass index (BMI) ≤35.0 kg/m2 Exclusion Criteria: - Active bacterial infection that has not resolved within 14 week of Day -28 (first dose of APL-2) - Receiving iron, folic acid, vitamin B12 and EPO, unless the dose is stable, in the 4 weeks prior to Screening - Hereditary complement deficiency - History of bone marrow transplantation - History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the investigational product or SC administration - Participation in any other investigational drug trial or exposure to other investigational agent within 30 days or 5 half-lives (whichever is longer) - Currently breast-feeding women - Inability to cooperate or any condition that, in the opinion of the investigator, could increase the subjects risk of participating in the study or confound the outcome of the study This study includes cardiac safety evaluations. The following cardiac eligibility criteria are necessary to avoid confounding the cardiac safety outcomes: - History or family history of Long QT Syndrome or torsade de pointes, unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden death - Myocardial infarction, CABG, coronary or cerebral artery stenting and /or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months or greater than Class 2 Angina Pectoris or NYHA Heart Failure Class >2 - QTcF > 470 ms, PR > 280 ms - Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block unless the patient has an implanted pacemaker or implantable cardiac defibrillator (ICD) with backup pacing capabilities - Receiving Class 1 or Class 3 antiarrhythmic agents, or arsenic, methadone, ondansetron or pentamidine at screening - Receiving any other QTc-prolonging drugs (see Appendix 4 in Section 19.4), at a stable dose for less than 3 weeks prior to dosing - Receiving prophylactic ciprofloxacin, erythromycin or azithromycin for less than one week prior to the first dose of study medication (must have a repeat screening ECG after one week of prophylactic antibiotics with QTcF < 470 ms) ; PRIMARY OUTCOME: Least Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCP; SECONDARY OUTCOME 1: Percentage of Subjects Who Did Not Require a Transfusion (Transfusion Avoidance) During the RCP[/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 - AMAG-FER-IDA-302; BRIEF: The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA). ; DRUG USED: Feraheme; DRUG CLASS: Non-NME; INDICATION: Anemia; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: AMAG Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria include: 1. Males and females ≥18 years of age 2. Participants with IDA defined as having: 1. Hemoglobin <10.0 g/deciliter (dL) 2. Transferrin saturation (TSAT) <20% 3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used 4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study Key Exclusion Criteria include: 1. History of allergy to IV iron 2. Allergy to two or more classes of drugs 3. Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute(min)/1.73 square meter (m^2) 4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test 5. Hemoglobin ≤7.0 g/dL 6. Serum ferritin >600 nanogram/mL ; PRIMARY OUTCOME: Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5; SECONDARY OUTCOME 1: Mean Change In Hemoglobin From Baseline To Week 5[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - IGSC 20% (EU); BRIEF: The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for patients with primary immunodeficiency (PID) diseases. ; DRUG USED: Gammagard (Subcutaneous); DRUG CLASS: Biologic; INDICATION: Primary Immunodeficiencies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: Inclusion Criteria: - Subject must have a documented diagnosis of a form of primary humoral immunodeficiency involving antibody formation and requiring gammaglobulin replacement, as defined according to the IUIS Scientific Committee 2009, and by diagnostic criteria according to Conley ME, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Clin Immunol 1999; 93:190-197. The diagnosis must be confirmed by the Medical Director prior to enrollment. - Subject is 2 years or older at the time of screening - Written informed consent is obtained from either the subject or the subjects legally authorized representative prior to any study-related procedures and study product administration - Subject has been receiving a consistent dose of IgG over a period of at least 3 months prior to screening at an average minimum dose over that interval equivalent to 300 mg/kg body weight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks at a dosing frequency as follows: 1. intravenously (IV) at mean intervals of approximately 3 or 4 weeks or 2. subcutaneously (SC) at mean intervals of approximately 1 or 2 weeks - Subject has a serum trough level of IgG > 5 g/L at screening - Subject has not had a serious bacterial infection within the 3 months prior to screening - Subject is willing and able to comply with the requirements of the protocol Exclusion Criteria: - Subject has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2 - Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent): 1. Persistent alanine aminotransferase (ALT) and aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory 2. Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] <= 500 /mm3) - Subject has creatinine clearance (CLcr) value that is < 60% of normal for age and gender - Subject has been diagnosed with or has a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years - Subject is receiving anti-coagulation therapy or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening or a history of thrombophilia - Subject has abnormal protein loss (protein losing enteropathy, nephrotic syndrome) - Subject has anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site - Subject has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or Immune Serum Globulin (ISG) infusions - Subject has immunoglobulin A (IgA) deficiency (IgA less than 0.07g/L) and known anti IgA antibodies - Subject is on preventative (prophylactic) systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and cannot stop these antibiotics at the time of screening - Subject has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening - Subject has a bleeding disorder or a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy - Subject has total protein >9 g/dL or myeloma, or macroglobulinemia (IgM) or paraproteinemia - Women of childbearing potential meeting any one of the following criteria 1. subject presents with a positive pregnancy test 2. subject is breast feeding 3. subject intends to begin nursing during the course of the study 4. subject does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom [for male partner] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study - Subject has participated in another clinical study and has been exposed to an investigational product (IP) or device within 30 days prior to study enrollment (exception: treatment with immunoglobulin pre-study) - Subject is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an IP or device during the course of the study - Subject has severe dermatitis that would preclude adequate sites for safe product administration ; PRIMARY OUTCOME: Acute serious bacterial infection rate defined as the mean number of acute serious bacterial infections per subject per year in the intent-to-treat population; 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 - Fixed-Dose (7-17 yrs); BRIEF: The goal of the current trial is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourettes Disorder. ; DRUG USED: Abilify (Oral and IM); DRUG CLASS: New Molecular Entity (NME); INDICATION: Tourettes Syndrome; TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - 7 to 17 year old with diagnostic and statistical manual of mental disorders, fourth edition -text revision (DSM-IV-TR) diagnostic criteria for Tourettes disorder (TD), confirmed by the kiddie schedule for affective disorders and schizophrenia - present and lifetime version (K-SADS-PL), including the Diagnostic Supplement 5 - Has a total tic score (TTS) ≥20 on the yale global tic severity scale (YGTSS) at Screening and Baseline - Presenting tic symptoms cause impairment in the participants normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships - Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception, and must not be pregnant or lactating. - Written informed consent form (ICF) obtained from a legally acceptable representative & informed assent at Screening as applicable by study centers Institutional review board/independent ethics committee (IRB/IEC) - The participant, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator. Exclusion Criteria: - Clinical presentation and/or history, consistent with another neurologic condition that may have accompanying abnormal movements. - History of schizophrenia, bipolar disorder, or other psychotic disorder. - Participant receiving psychostimulants for treatment of attention-deficit disorder/Attention-deficit hyperactivity disorder (ADD/ADHD) and who have developed and/or had exacerbations of tic disorder after initiation of stimulant treatment. - Currently meets DSM-IV-TR criteria for a primary mood disorder. - Severe obsessive-compulsive disorder (OCD), per childrens yale-brown obsessive compulsive scale (CY-BOCS) score >16. - Taken aripiprazole within 30 days of the Screening visit. - Received any investigational agent in a clinical trial within 30 days prior to Screening or who were randomized into a clinical trial with Once-weekly aripiprazole at any time. - History of neuroleptic malignant syndrome. - Sexually active participants not using 2 approved methods of contraception; breastfeeding or pregnant. - Risk of committing suicide - Bodyweight lower than 16 kg - Taken neuroleptic or antiparkinson drugs <14 days prior to randomization. - Requiring cognitive-behavioral therapy (CBT) for TD during study. - Participant meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months. - Positive drug screen - Participant requires medications not allowed per protocol - Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for duration of study. - Inability to swallow tablets or tolerate oral medication - Abnormal laboratory test results, vital signs and Electrocardiogram (ECG) results ; PRIMARY OUTCOME: Mean Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score; SECONDARY OUTCOME 1: Mean Change From Baseline in Clinical Global Impressions Scale for Tourettes Syndrome (CGI-TS) 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 - vs. Linezolid; BRIEF: The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs). ; DRUG USED: ARV-1801; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Arrevus Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen. - Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections - Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy. - Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature >=100.4 degree F, increased white blood cell count, or bandemia. - Must not have received treatment with another systemic antibiotic for the current ABSSI. Exclusion Criteria: - Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis. - Infections involving burns, human or animal bites, or chronic diabetic foot ulcers. - Suspected polymicrobial infection involving Pseudomonas aeruginosa - Anticipated need for >14 days of antibiotic therapy. - Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis. - Known significant renal, hepatic, or hematologic impairment. - Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen. ; PRIMARY OUTCOME: Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population; SECONDARY OUTCOME 1: Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population[/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 - LUX-Head & Neck 4 (1200.162); BRIEF: This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy. ; DRUG USED: Gilotrif; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB3/HER3, ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb - Unresected tumour prior to chemo-radiotherapy (CRT) - Concomitant CRT completed prior to randomisation - After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations - Eastern cooperative oncology group (ECOG) performance status 0 or 1 Exclusion criteria: - Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil - Cancer of nasopharynx, sinuses, and/or salivary glands - Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC - Known pre-existing Interstitial Lung Disease (ILD) - Any past or present history of areca/betel-nut chewing or its derivatives for a cumulative duration of more than 3 months ; PRIMARY OUTCOME: Disease Free Survival (DFS); SECONDARY OUTCOME 1: Disease Free Survival (DFS) Rate at 2 Years[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CT04 OLEP; BRIEF: The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment. ; DRUG USED: Itanapraced; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Precursor Protein (APP), FOX (Forkhead box), Gamma-secretase, LRRK2 (leucine-rich repeat kinase 2); THERAPY: Monotherapy; LEAD SPONSOR: Chiesi Farmaceutici S.p.A.; CRITERIA: Inclusion Criteria: - Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment. - Mini-Mental State Examination score higher than 24 at screening. - MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences. Exclusion Criteria: - Diagnosis of Alzheimers disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria. - Any medical condition that could explain the patients cognitive deficits. - CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance - MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm). - Geriatric Depression Scale (30-point scale) score > 9 at screening. - History of stroke. - Modified Hachinski ischemic scale score > 4 at screening. - Women of childbearing potential. - Vitamin B12 or folate deficiency. - Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening. - Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease. - Concomitant use of donepezil at doses > 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose. - Concomitant use of memantine at dose > 20 mg/day. - Concomitant use of psychoactive drugs (sedatives, hypnotics, etc). ; PRIMARY OUTCOME: Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment; 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 - ACHIEVE I (UBR-MD-01); BRIEF: This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack. ; DRUG USED: Ubrelvy; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version - Migraine onset before age 50 - History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom - History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months. Exclusion Criteria: - Difficulty distinguishing migraine headache from other headaches - Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months - Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine - Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy - Required hospital treatment of a migraine attack 3 or more times in the previous 6 months - Has a chronic non-headache pain condition requiring daily pain medication - Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded - Has a history of hepatitis within previous 6 months. ; PRIMARY OUTCOME: Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose; SECONDARY OUTCOME 1: Percentage of Participants With Pain Relief at 2 Hours After the Initial 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 IIa - mRNA-1273-P201; BRIEF: This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-COV-2) vaccine in adults 18 years of age or older. ; DRUG USED: mRNA-1273; DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: ModernaTX, Inc.; CRITERIA: Key Inclusion Criteria: Each participant must meet all of the following criteria during the screening period and at Day 1, unless noted otherwise, to be enrolled in this study: 1. Male or female, 18 years of age or older at the time of consent (Screening Visit, Day 0). For Part B, participants must have been previously enrolled in the mRNA-1273 P201 study. 2. Understands and agrees to comply with the study procedures and provides written informed consent. 3. According to the assessment of the investigator, is in good general health and can comply with study procedures. 4. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening (Day 0) without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - Has a negative pregnancy test at Screening (Day 0) and on the day of the first injection (Day 1). - Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1). - Has agreed to continue adequate contraception through 3 months following the second injection (Day 29). - Is not currently breastfeeding. Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example: - Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - Intrauterine device - Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route - Sterilization of a female participants monogamous male partner prior to entry into the study Note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. Adequate contraception for male participants is defined as: - Monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - Use of barrier methods and spermicide - History of surgical sterilization - Male participants with partners who have become pregnant prior to Screening are eligible to participate in the study. Additional Key Inclusion Criteria for Part C 1. Participants must have been previously enrolled in the mRNA-1273-P301 study and must have received 2 doses of mRNA-1273 in Part A, has been unblinded and aware of their actual treatment in Study mRNA-1273-P301, must have been compliant in Study mRNA-1273-P301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in Study mRNA-1273-P301 prior to enrollment in this part. Key Exclusion Criteria: Participants meeting any of the following criteria at the Screening Visit (Day 0) or at Day 1, unless noted otherwise, will be excluded from the study: 1. Pregnant or breastfeeding. 2. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. 3. Current treatment with investigational agents for prophylaxis against COVID-19. 4. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigators judgment. 5. Is a healthcare worker or a member of an emergency response team. 6. Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors). 7. History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit (Day 0). 8. History of illegal substance use or alcohol abuse within the past 2 years. This exclusion does not apply to historical cannabis use that was formerly illegal in the participants state but is legal at the time of Screening. 9. Known history of hypertension, or systolic blood pressure >150 millimeter of mercury (mmHg) in participants in Cohort 1 (≥18 to <55 years old) or systolic blood pressure >160 mmHg in participants in Cohort 2 (≥55 years old) at the Screening Visit (Day 0). 10. Known history of hypotension or systolic blood pressure <85 mmHg at the Screening Visit (Day 0). 11. Diabetes mellitus 12. Diagnosis of chronic pulmonary disease (for example, chronic obstructive pulmonary disease, asthma) 13. Chronic cardiovascular disease 14. Resides in a nursing home 15. Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0) 16. Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition. 17. Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the Screening Visit (Day 0) (for corticosteroids ≥20 milligrams (mg)/day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the Screening Visit (Day 0). 18. Anticipating the need for immunosuppressive treatment at any time during participation in the study. 19. Positive serology for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibodies identified at the Screening Visit (Day 0). 20. History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine. 21. Bleeding disorder considered a contraindication to IM injection or phlebotomy. 22. Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer). 23. Has received or plans to receive a licensed vaccine ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection. Licensed influenza vaccines may be received more than 14 days before or after any study injection. 24. Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study. 25. Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study. 26. Participated in an interventional clinical study (other than mRNA-1273 P301) within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study. 27. Is an immediate family member or household member of study personnel Additional Key Exclusion Criteria for Part C 1. Is SARS-CoV-2 positive by Reverse transcription polymerase chain reaction (RT-PCR) (central or local testing) at baseline or at any time during the mRNA-1273-P301 study regardless of the presence or absence of symptoms consistent with COVID-19. 2. Had any SAE in the mRNA-1273-P301 study. ; PRIMARY OUTCOME: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs); SECONDARY OUTCOME 1: Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)[/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 - Japan; BRIEF: The purpose of this study is to determine whether TAC-101 combined with Transcatheter Arterial Chemoembolization (TACE) is more effective than TACE alone in slowing tumor activity in patients with advanced hepatocellular carcinoma. The study is also looking at the safety of TAC-101 in combination with TACE. ; DRUG USED: TAC-101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Retinoic acid receptor (RARs); THERAPY: Combination; LEAD SPONSOR: Taiho Oncology, Inc.; CRITERIA: Inclusion Criteria: - A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study and before undergoing the first TACE procedure of this study: 1. Has an HCC diagnosis by histology or by the following non-invasive criteria observed either at enrollment or in the past. - One imaging technique (CT scan or magnetic resonance imaging [MRI] both with unenhanced plus hepatic arterial phase and portal venous phases) showing characteristic features in a focal lesion > 20 mm with arterial vascularization. - Two dynamic imaging techniques (CT scan, MRI with unenhanced plus hepatic arterial phase and portal venous phases) showing characteristic features coincidentally in a focal lesion 10-20 mm with arterial vascularization. 2. Is TACE naïve or has received the most recent TACE procedure at least 120 days before signing ICF. 3. Eligible to receive TACE and being scheduled to receive TACE. 4. Must be ≥ 20 years of age. 5. Is not amenable to treatment with curative surgery, transplant, or percutaneous ablation, including RFA, percutaneous ethanol injection therapy (PEIT) and percutaneous microwave coagulation therapy (PMCT). 6. Must have lesions in the liver that are confirmed nodular type with demonstrated substantial hypervascularity by CT scan or MRI both with unenhanced plus hepatic arterial phase and portal venous phases performed prior to first TACE in this study with the following tumor features: - If there are ≥ 4 intrahepatic lesions, all lesions can be < 30 mm. or, regardless of the number of lesions, the longest diameter of at least one intrahepatic lesion is ≥ 30 mm). - No vascular invasion in main trunk and first order branch of portal vein. - No extrahepatic tumor spread. The absence of extrahepatic abdominal tumors must be confirmed. 7. Has adequate organ function as defined by the following criteria: White blood cell (WBC) count > 3,000/mm3; Platelet count > 60,000/mm3; Hemoglobin > 8.0 grams (g)/deciliter (dL); Aspartate transaminase (AST) < 5 x upper limit of normal (ULN); Alanine transaminase (ALT) < 5 x ULN; Total bilirubin < 2.0 mg/dL; Albumin ≥ 2.8 g/dL; Serum creatinine ≤ 1.5 mg/dL; International normalized ratio (INR) ≤ 2.0; Triglyceride ≤ 2.5 x ULN. 8. Must have a Child-Pugh classification of ≤ 8. 9. Must have a Cancer of the Liver Italian Program (CLIP)60 score of 0, 1, 2 or 3 (Appendix B). 10. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 11. Must be willing and able to comply with schedule visits, treatment plans, laboratory tests, and other study procedures. 12. Must provide written informed consent prior to the implementation of any study assessment or procedures. Exclusion Criteria: - Patients will be excluded from participation in the study if any of the following conditions are observed before undergoing the first TACE procedure: 1. Patient has longest diameter of intrahepatic lesion ≥ 100 mm. 2. Patient has only infiltration type of HCC. 3. Patient has extrahepatic metastasis of HCC including regional lymph node metastases (including in lymph nodes and organs). 4. Patient had systemic chemotherapy (eg, sorafenib, doxorubicin), immunotherapy, or biologic therapy or radiotherapy for HCC, or treatment with TAC-101. 5. Patient received treatment with any of the following within the specified time frame: Any major surgical procedure within 28 days prior to signing the ICF; Any transfusion, treatment with blood component preparation, albumin preparation, and granulocyte colony stimulating factor (G-CSF) within 14 days prior to signing the ICF; Any local therapy such as alcohol injection, radiofrequency/ultrasound ablation, intraarterial chemotherapy (transcatheter arterial injection) for HCC performed within 28 days prior to signing the ICF; Any investigational agent within 28 days prior to signing the ICF. 6. Patient has ascites, pleural effusions or pericardial fluid refractory to diuretic therapy. 7. Patient has clinical symptoms of hepatic encephalopathy. 8. Patient has active or uncontrolled clinically serious infection excluding chronic hepatitis. 9. Patient has a history of gastrointestinal (GI) bleeding in last 3 months. 10. Patient has previous or concurrent malignancy except for in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence for at least 3 years prior to the study. 11. Patient has uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain. 12. Patient has any history of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), cerebrovascular accident (CVA), transient ischemic attack (TIA), unstable angina pectoris, or any other significant thromboembolic event (TE) during the last 3 years. 13. Patient has clinically significant electrocardiogram (ECG) abnormality. 14. Patient has GI disease resulting in an inability to take oral medication. 15. Patient has known allergy or hypersensitivity to TAC-101, doxorubicin, epirubicin, other anthracyclines, anthracenediones or any of the components used in the study drug formulations. 16. Patient has known hypersensitivity to iodinated contrast medium. 17. Patient is receiving therapeutic regimens of anticoagulants. However, use of low dose anticoagulants for prophylactic care of indwelling venous access device is permitted. 18. Patient is taking medication known or suspected to predispose patient to an increased risk of VTE (eg, oral contraceptives, hormone replacement therapy, megestrol acetate). 19. Patient is taking azoles or tetracyclines, because of the potential for drug interactions. 20. Women who intend to become pregnant or are pregnant or lactating and men able to procreate that refuse to use a highly effective method of birth control during treatment with study medication and up to 6 months thereafter. ; PRIMARY OUTCOME: Time to Appearance of New Lesions (TTNL); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - A2405 - ENESTcmr; BRIEF: The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over. ; DRUG USED: Tasigna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Myelogenous Leukemia (CML); TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months Persistent disease demonstrated by two PCR positive tests 3 months apart both during the past 6 months. Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No other current or planned anti-leukemia therapies Exclusion Criteria: Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months) Patient has received another investigational agent within last 6 months or tyrosine kinase inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation Impaired cardiac function including any one of the following: Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known family history of long QT syndrome. Clinically significant resting brachycardia (<50 beats per minute) QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension) History of or presence of clinically significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry ; PRIMARY OUTCOME: Rate of Confirmed Best Cumulative Complete Molecular Response (CMR); SECONDARY OUTCOME 1: Rate of Confirmed Best Cumulative CMR[/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 - ZENITH20 (EGFR or HER2 Exon 20 Mut.); BRIEF: This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven patient cohorts for up to 603 previously treated and treatment-naïve NSCLC patients. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7). ; DRUG USED: Poziotinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), ErbB4/HER4, HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Spectrum Pharmaceuticals, Inc; CRITERIA: Key Inclusion Criteria: - Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements - Patient has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent - Prior treatment status: - Cohorts 1 and 2: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC - Cohorts 3 and 4: Patient is treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with poziotinib as determined by the Investigator. Adjuvant/neo-adjuvant therapies (chemotherapy, radiotherapy, or investigational agents) are permissible as long as they end at least 15 days prior to study entry. - Cohort 5: Patients who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed - Cohort 6: Patients with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib - Cohort 7: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC - Specific mutations: - Cohort 1 and 3: Documented EGFR exon 20 insertion mutation - Cohort 2 and 4: Documented HER2 exon 20 insertion mutation - Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations - Cohort 6: Documented acquired EGFR mutation (tested after osimertinib progression) - Cohort 7: Documented EGFR or HER2 activating mutations - Patient has adequate organ function at Baseline Key Exclusion Criteria: - Patient has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible (Cohorts 1 and 2). - Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks or 5 half lives, whichever is longer; local radiation therapy for bone pain may be allowed - Patient has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully-treated and stable, early-stage prostate cancer, or carcinoma in situ of the cervix or breast without need of treatment - Patient is pregnant or breast-feeding ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Disease Control Rate (DCR)[/INST]No</s>