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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 I - PK/PD; BRIEF: The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab, an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor. ; DRUG USED: ASP9801; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: IL-12 (Interleukin-12) and IL-12 receptor, IL-7 (Interleukin-7) and IL-7 receptor (IL-7R), Immune System, Oncolytic Virus Therapy; THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Global Development, Inc.; CRITERIA: Inclusion Criteria: - Subject must have histologically- or cytologically-confirmed diagnosis of advanced or metastatic solid tumor(s). - Subject has measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter. - Subject has had disease progression after, been intolerant to, or has refused all available therapies that are known to confer clinical benefit. Note: There is no limit to the number of prior treatment regimens. - Subject has a predicted life expectancy ≥ 12 weeks. - Subject has at least 2 sites of disease suitable for biopsy and is willing and able to undergo required tumor biopsies according to the treating institutions guidelines at screening and during study treatment. - Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - A female subject is eligible to participate if she is not pregnant as documented by negative pregnancy test within 72 hours prior to treatment and at least 1 of the following conditions applies: - Not a woman of childbearing potential (WOCBP) OR - WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 180 days after the final study investigational product (IP) administration. - Female subject must agree not to breastfeed starting at screening, and throughout the study period and 180 days after the final study IP administration. - Female subject must not donate ova starting at screening, and throughout the study period and for 180 days after the final study IP administration. - Male subject must agree to remain abstinent or use a condom throughout the study period and for 180 days after the final study IP administration. - Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 180 days after the final study IP administration. - Male subject must not donate sperm during the treatment period and for at least 180 days after the final study IP administration. - Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions. - Subject agrees not to participate in another interventional study while receiving study IP. - Subject has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Subject has ongoing toxicity ≥ National Cancer Institutes Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant. - Subject who has had major surgery ≤ 4 weeks of screening. Subjects must have recovered from prior procedures and/or any complications from surgery prior to starting study treatment. - Subject is concurrently participating in another interventional study or has received an investigational product ≤ 30 days or 5 half-lives whichever is shorter, prior to first IP administration. - Subject with symptomatic or untreated central nervous system (CNS) metastases or leptomeningeal disease. Subjects with treated symptomatic brain metastases should be neurologically stable (without evidence of progression by imaging for at least 4 weeks prior to screening and any neurologic symptoms have returned to baseline) and off steroids for at least 2 weeks prior to first IP administration. Subjects with carcinomatous meningitis are excluded regardless of clinical stability. - Subject with active or prior autoimmune or inflammatory disorders requiring systemic therapy within past 2 years (including inflammatory skin conditions or severe eczema, inflammatory bowel disease (e.g., colitis or Crohns disease), diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc. The following are exceptions to this criterion: - Subject with vitiligo or alopecia - Subject with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement - Any chronic skin condition that does not require systemic therapy - Subject with another malignancy that currently requires treatment. - Subject with only tumors encasing major vascular structures such as the carotid artery, tumors adjacent to vital neurovascular structures or tumors in locations that are at high risk for adverse events (AEs) or otherwise not considered appropriate for IT injection. Subjects with such tumors that have other injectable tumors would be eligible. - Subject with inadequate organ and marrow functions meeting any of the below criteria: - Leukocytes < 3000/μL - Absolute neutrophil count < 1500/μL - Platelets < 100,000/μL - Hemoglobin (Hgb) < 9 g/dL (Criteria must be met without packed red blood cell transfusion within the prior 2 weeks. Subjects can be on stable dose of erythropoietin [≥ approximately 3 months]) - International normalized ratio (INR) > 1.5 × ULN and/or activated partial thromboplastin time (aPTT) > 1.5 × institutional normal limits, except for subjects in Group B (Visceral Lesions) escalation and expansion groups where INR and aPTT must be normal - Total Bilirubin (TBL) > 1.5 × institutional normal limits (subjects with known Gilbert syndrome who are excluded if TBL > 3.0 × institutional normal limits or direct bilirubin > 1.5 × institutional normal limits) - Aspartate aminotransferase (AST) and Alanine transaminase (ALT) > 2.5 × institutional normal limits. Subjects with tumors in the liver AST and ALT > 5 × institutional normal limits. - Albumin < 3.0 g/dL - Creatinine > 1.5 × institutional normal limits - Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study IP. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. - Subject has an uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, any form of substance abuse or psychiatric illness/social situations that would limit compliance with study visits or requirements or a condition that could invalidate communication with the investigator. - Subject is positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core immunoglobulin or immunoglobulin G (IgG) antibody or hepatitis C (IgG or ribonucleic acid (RNA) test) indicating acute or chronic infection. - Subject has a history of moderate to severe ascites, clinically significant and/or rapidly accumulating ascites, bleeding esophageal varices, hepatic encephalopathy or pericardial and/or pleural effusions related to liver insufficiency within 6 months of screening. Mild ascites that does not preclude safe IT injection of ASP9801 is allowed. - Subject has a clinically significant abnormal electrocardiogram (ECG) at screening. - Subject has symptomatic cardiovascular disease within the preceding 12 months unless cardiology consultation and clearance has been obtained for study participation, including but not limited to the following: significant coronary artery disease (e.g., requiring angioplasty or stenting), acute myocardial infarction or unstable angina pectoris < 3 months prior to screening, uncontrolled hypertension, clinically significant arrhythmia or congestive heart failure (New York Heart Association grade ≥ 2). - Subject has medical conditions that predispose the subject to untoward medical risk in the event of volume loading (e.g., intravenous fluid bolus infusion), tachycardia or hypotension during or following treatment with ASP9801. - Subject has a known or suspected hypersensitivity to ASP9801 or any components of the formulation used, including prior adverse reaction to vaccinia (e.g., as smallpox vaccine). - Subject has had previous exposure with ASP9801. - Subject has an active infection requiring systemic therapy. - Subject with known history of active Bacillus Tuberculosis. - Subject has received prior therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4, OX 40, CD137) and was discontinued from that treatment due to an immune-related adverse event. - Subject has received prior radiation therapy within 2 weeks of start of study treatment. Subject must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease. - Subject has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guérin and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. - Subject has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients, or history of ≥ grade 2 infusion reactions that were not prevented by adequate premedication. - Subject has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Subject has had an allogeneic tissue/solid organ transplant. ; PRIMARY OUTCOME: Dose Limiting Toxicities (DLT) - dose escalation part; SECONDARY OUTCOME 1: Percent change from baseline in antitumor activity of ASP9801[/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 - ReSPECT ; BRIEF: The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen. ; DRUG USED: Rezafungin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fungal Infections - Systemic; TARGET: Beta (1,3)-D-Glucan, Cell wall; THERAPY: Monotherapy; LEAD SPONSOR: Cidara Therapeutics Inc.; CRITERIA: Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Males or females ≥18 years of age. 3. Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral BMT from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor. 4. Diagnosed with 1 of the following underlying diseases: 1. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission. 2. Acute lymphoblastic leukemia, in first or second complete remission. 3. Acute undifferentiated leukemia in first or second remission. 4. Acute biphenotypic leukemia in first or second complete remission. 5. Chronic myelogenous leukemia in either chronic or accelerated phase. 6. One of the following myelodysplastic syndrome(s) defined by the following: i. Refractory anemia. ii. Refractory anemia with ringed sideroblasts. iii. Refractory cytopenia with multilineage dysplasia. iv. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts. v. Refractory anemia with excess blasts - 1 (5-10% blasts). vi. Refractory anemia with excess blasts - 2 (10-20% blasts). vii. Myelodysplastic syndrome, unclassified. viii. Myelodysplastic syndrome associated with isolated del (5q). g. Lymphoma (including Hodgkins) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related donor transplant. h. Aplastic anemia. i. Primary or secondary myelofibrosis. j. Chronic myelomonocytic leukemia. k. Chronic lymphocytic leukemia. l. Drepanocytosis (sickle cell anemia). m. Red blood cell aplasia. n. Myeloproliferative disorder, unclassified. o. Multiple myeloma (plasma cell myeloma). 5. Receiving myeloablative or reduced-intensity conditioning regimens. 6. Adequate renal and hepatic function prior to initiation of conditioning regimen, therefore between 40 days prior and 10 days prior to BMT, documented as follows: 1. Hepatic: alanine aminotransferase less than or equal to (≤) 2.5 × upper limit of normal (ULN) and total serum bilirubin ≤1.5 × ULN (excluding Gilberts Syndrome). 2. Renal: serum creatinine ≤2 milligrams (mg)/deciliter (dL) and with creatinine clearance (CrCl) greater than or equal to (≥) 30 milliliters (mL)/minute (min) without a history of renal transplant, or undergoing weekly dialysis within 4 weeks of the BMT. 7. Baseline blood samples drawn for Platelia galactomannan enzyme immunoassay (GM EIA) and β-D glucan levels within 14 days before randomization, with results available prior to randomization. 8. Baseline Toxoplasma serologies available within 6 weeks prior to randomization. 9. Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency testing with no evidence of G6PD deficiency performed any time prior to randomization. 10. Female subjects of child-bearing potential <2 years post-menopausal (unless surgically sterile) must agree to and comply with using 1 barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence (only possible if it corresponds to the subjects usual lifestyle) while participating in this study, and for 30 days after the last dose of study drug. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug. Exclusion Criteria: 1. Diagnosis of AML not in morphological remission. 2. Diagnosis of chemotherapy-resistant lymphoma: a first relapse can occur provided that a second complete remission has occurred. 3. Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of screening. 4. Diagnosed symptomatic heart failure with left ventricular ejection fraction (LVEF) at rest ≤50%, or shortening fraction ≤26%. 5. Personal or family history of Long QT interval on electrocardiogram (ECG) (QT) syndrome or a prolonged QT interval corrected for heart rate by Fridericias formula (QTcF) (>470 milliseconds [msec] in males and >480 msec in females); or concurrent administration of terfenadine, cisapride, astemizole, erythromycin, pimozide, quinidine, or halofantrine. 6. Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin) or forced expiratory volume in 1 second (FEV1) ≤70% of predicted value, or O2 saturation ≤82% on room air. 7. Suspected or documented PCP within 2 years of screening. 8. Positive baseline serum Platelia GM EIA (≥ 0.5) and/or β-D glucan assay (Fungitell ≥80 picograms [pg]/mL or Fujifilm Wako >11 pg/mL) within 14 days of transplant. 9. Receipt of previous allogeneic BMT. 10. Planned receipt of cord blood for transplantation. 11. Planned peripheral blood or marrow autograft. 12. Not applicable to protocol Amendment 6. 13. Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy, per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 14. History of severe (Grade ≥3) ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinsons disease or Huntingtons disease). 15. . . 1. Planned or ongoing intake at screening of a known severe neurotoxic medication or with a known moderate neurotoxic medication in a patient with ataxia, tremor, motor neuropathy, or sensory neuropathy of CTCAE version 5.0 Grade 1 or higher. 2. Any contraindication or a medication or supplement known to severely interact with the standard antimicrobial regimen (SAR) as detailed in the US Prescribing Information (USPI) or Summary of Product Characteristics (SmPC) of fluconazole, posaconazole, or TMP/SMX. 16. Known hypersensitivity to Rezafungin for Injection, any echinocandin, fluconazole, posaconazole, other azole antifungal, or to any of their excipients. 17. Known hypersensitivity or inability to receive TMP/SMX or any of its excipients, including but not limited to anaphylaxis, exfoliative skin disorders, or acute porphyria. 18. Recent use of an investigational medicinal product within 28 days or greater to assure more than 5 half-lives have passed to prevent overlapping toxicities when this studys investigational product is dosed, or presence of an investigational device at the time of screening. 19. Known infection with HIV. Subjects with unknown HIV status should be tested for HIV antibodies per standard of care. 20. Pregnant or lactating females. 21. The Principal Investigator (PI) determines that the subject should not participate in the study. 22. Considered unlikely to follow up for 90 days after receipt of the BMT due to logistic concerns (i.e., location relative to transplant center). 23. Known liver cirrhosis, diagnosed according to country or Medical Society specific guidelines and documented in the medical records prior to initiating conditioning regimen. 24. Body weight >130 kilograms (kg) at screening. ; PRIMARY OUTCOME: Noninferior Fungal-Free Survival (US FDA); SECONDARY OUTCOME 1: Compare Discontinuation for Toxicity or Intolerance[/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 - INSPIRE; BRIEF: Efficacy and Safety of imsidolimab in Participants with Ichthyosis ; DRUG USED: Imsidolimab; DRUG CLASS: Biologic; INDICATION: Congenital Ichthyosis; TARGET: IL-36/IL-36R (Interleukin-36/receptor); THERAPY: Monotherapy; LEAD SPONSOR: AnaptysBio, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of Ichthyosis - IASI total score ≥ 18, erythema score ≥ 2 - Participant has been using emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily at the same frequency throughout the study Exclusion Criteria: - A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded. ; PRIMARY OUTCOME: Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16; SECONDARY OUTCOME 1: Percent Change From Baseline in IASI Total Score at Week 16[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PIONEER 10 (vs. Dulaglutide, Japanese Subjects); BRIEF: This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes. ; DRUG USED: Rybelsus; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Japanese male or female, age above or equal to 20 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening - HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive) - OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Any disorder, which in the investigators opinion might jeopardise subjects safety or compliance with the protocol - Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC) - History of pancreatitis (acute or chronic) - History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) - Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack (TIA) within the past 180 days prior to the day of screening and randomisation - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) - Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening - For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening - Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 14 days - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in situ carcinomas) - History of diabetic ketoacidosis ; PRIMARY OUTCOME: Number of Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Change in 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 III - Motion Syros; BRIEF: A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of tradipitant in the treatment of motion sickness. ; DRUG USED: Tradipitant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Emesis; TARGET: Neurokinin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Vanda Pharmaceuticals; CRITERIA: Inclusion Criteria: - History of motion sickness - Age 18-75 Exclusion Criteria: - Nausea-inducing disorder other than motion sickness - BMI>40 - History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists ; PRIMARY OUTCOME: Reduction in the incidence of vomiting as measured by the MSSS; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - MCRPC; BRIEF: This is a Phase I, multicenter, open-label, dose-escalation study of DSTP3086S administered as a single agent by intravenous (IV) infusion to patients with metastatic Castration-Resistant Prostate Cancer (CRPC). ; DRUG USED: RG7450; DRUG CLASS: Biologic; INDICATION: Prostate Cancer; TARGET: Antibody-drug Conjugate (ADC), Microtubules (Tubulin), STEAP1; THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Life expectancy of at least 12 weeks - Histologic documentation of adenocarcinoma of the prostate - Surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone - Metastatic progressive CRPC defined as progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone - For patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting - Evaluable or measurable disease - Documented willingness to use an effective means of contraception Exclusion Criteria: - Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to Day 1, with the following exceptions: maintenance hormonal therapy for metastatic prostate cancer and palliative radiation to bone metastases within 2 weeks prior to Day 1 - Major surgical procedure within 4 weeks prior to Day 1 - Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds) - Ongoing corticosteroid use with > 10 mg of daily prednisone or equivalent - Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible. - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) - Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis - Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and screening CNS radiographic study is >/= 8 weeks since completion of radiotherapy and >/= 4 weeks since the discontinuation of corticosteroids and anticonvulsants - Dose expansion cohort (B): no prior chemotherapy is allowed ; PRIMARY OUTCOME: Incidence and nature of dose-limiting toxicities (DLTs); SECONDARY OUTCOME 1: Area under the concentration-time curve[/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 - MP4001; BRIEF: The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone) ; DRUG USED: Dymista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Allergic Rhinitis; TARGET: Glucocorticoid Receptor (GR), Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Meda Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female subjects 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis - Must be in generally good health - Must meet minimum symptom requirements, as specified in the protocol. - Must be willing and able to provide informed consent and to participate in all study procedures - Positive skin test to a prevalent Texas Mountain Cedar allergen Exclusion Criteria: - On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study. - Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities. - Nasal surgery or sinus surgery within the previous year. - Chronic sinusitis - more than 3 episodes per year - Planned travel outside of the study area during the study period - The use of any investigational drug within 30 days prior to Day screening. No investigational products are permitted for use during the conduct of this study - Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate - Women who are pregnant or nursing - Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception* see section 6.1.1 - Respiratory Tract Infections within 14 days prior to Day screening - Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening - Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment - Significant pulmonary disease including COPD - Clinically significant arrhythmia or symptomatic cardiac conditions - A known history of alcohol or drug abuse within the last 2 years - Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsors medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subjects ability to complete this trial; or their safety in this trial. - Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures ; PRIMARY OUTCOME: Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS); SECONDARY OUTCOME 1: Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)[/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 - 003; BRIEF: The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris. ; DRUG USED: DMT310; DRUG CLASS: Biologic; INDICATION: Acne; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Dermata Therapeutics; CRITERIA: Inclusion Criteria: - Inclusion Criteria: - Patient is male or non-pregnant female at least 12 years of age. - Clinical diagnosis of moderate to severe acne vulgaris as determined by: Investigators Global Assessment (IGA) at Randomization Patient has at least 20 inflammatory lesions on the face Patient has at least 20 noninflammatory lesions on the face - Patient is willing to apply the Investigational Product as directed - Patient is willing and able to comply with the protocol Exclusion Criteria: - Patient is pregnant or planning to become pregnant - Patient is taking a topical therapy on the face which may affect the patients acne ; PRIMARY OUTCOME: Efficacy as measured by lesion counts; SECONDARY OUTCOME 1: Incidence 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 I/II - Nationwide Children; BRIEF: This clinical trial is an open-label one-time injection dose study in which scAAV1.tMCK.NTF3 will be administered by intramuscular injections into muscles in both legs in CMT1A subjects with PMP22 gene duplication. Three subjects ages 18 to 35 years receiving (8.87e11 vg/kg) will be enrolled. ; DRUG USED: NT-3 Gene Therapy; DRUG CLASS: Biologic; INDICATION: Charcot-Marie-Tooth Disease; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Monotherapy; LEAD SPONSOR: Nationwide Childrens Hospital; CRITERIA: Inclusion Criteria: - Subjects 18- 35 years old inclusive with CMT1A will be enrolled - Must exhibit a 1.5 Mb duplication at 17p11.2 inclusive of the peripheral myelin protein 22 (PMP22) gene - Males and females of any ethnic or racial group - Must exhibit weakness of the ankle dorsiflexion muscle (but has full ROM against gravity and is able to stand on heels 3 seconds or greater) - Abnormal nerve conduction velocities - Ability to cooperate for clinical evaluation and repeat nerve conduction studies - Willingness of sexually active subjects to practice a reliable method of contraception during the study Exclusion Criteria: - Active viral infection based on clinical observations or serological evidence of HIV, or Hepatitis B or C infection, herpesvirus or adenovirus - Ongoing immunosuppressive therapy or immunosuppressive therapy within 6 months of starting the trial (e.g., corticosteroids, cyclosporine, tacrolimus, methotrexate, cyclophosphamide, intravenous immunoglobulin) - Persistent leukopenia or leukocytosis (WBC ≤ 3.5 K/µL or ≥ 20.0 K/µL) or an absolute neutrophil count < 1.5K/µL - Subjects with AAV1 binding antibody titers ≥ 1:50 as determined by ELISA immunoassay - Subjects with circulating anti-NT-3 titers ≥ 1:50 as determined by ELISA immunoassay - Treat with any investigational medication within 30 days before the infusion of study drug - Abnormal laboratory values considered clinically significant (GGT > 3XULN, bilirubin ≥ 3.0 mg/dL, creatinine ≥ 1.8 mg/dL, Hgb < 8 or > 18 g/Dl; WBC > 15,000 per cmm) - Any medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subjects ability to comply with the protocol required testing or procedures or compromise the subjects wellbeing, safety, or clinical interpretability - Ankle contractures or surgeries preventing proper muscle strength testing - Pregnancy or lactation (females subjects will be tested for pregnancy) - Limb surgery in the past six months - Severe infection (e.g. pneumonia, pyelonephritis, or meningitis) within 4 weeks before gene transfer visit (enrollment may be postponed) - Anyone unwilling to disclose study participation with primary care physician and other medical providers. - Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer ; PRIMARY OUTCOME: Safety based on number of participants with adverse events.; SECONDARY OUTCOME 1: Efficacy - the ability to halt the decline in functional and sensory abilities[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Dose Escalation; BRIEF: To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose. ; DRUG USED: PF-06263507; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: 5T4 tumor antigen ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available. - Performance Status of 0 or 1. - Adequate bone marrow, kidney, liver, and heart function. Exclusion Criteria: - Brain metastases requiring steroids. - Major surgery or anti-cancer therapy within 4 weeks of study treatment start. - Active bacterial, fungal or viral infection. ; PRIMARY OUTCOME: Number of Participants With Dose-limiting Toxicities (DLT); SECONDARY OUTCOME 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade[/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 - NOVA; BRIEF: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS). ; DRUG USED: Tremfya; DRUG CLASS: Biologic; INDICATION: Hidradenitis Suppurativa; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history - Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold) - Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for treatment of their HS) in the investigators opinion - Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=) 3 at the screening and baseline visit - Must agree to daily use (throughout the entirety of the study) of one of the following over-the-counter treatments to the body areas affected with HS lesions: either soap and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan, or benzoyl peroxide, or a dilute bleach bath Exclusion Criteria: - Any other active skin disease or condition (example, bacterial, fungal or viral infection) that could have interfered with assessment of HS - Has a draining fistula count of greater than (>) 20 at the baseline visit - Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit - Receipt of systemic non-biologic therapies for the treatment of HS less than (<) 4 Weeks prior to the baseline visit - Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 Weeks prior to the baseline visit ; PRIMARY OUTCOME: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16; SECONDARY OUTCOME 1: Change From Baseline in Participants Total Abscess and Inflammatory Nodule (AN) Count at Week 16[/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 - ALTA (Crizotinib-Resistant); BRIEF: The purpose of this study is to evaluate the efficacy and safety of two different dosing regimens of brigatinib (AP26113) in participants with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on therapy with crizotinib. ; DRUG USED: Alunbrig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Anaplastic lymphoma kinase (ALK), EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Ariad Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Have histologically or cytologically confirmed locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) that is anaplastic lymphoma kinase (ALK+). 2. Must meet one of the following two criteria: 1. Have documented ALK rearrangement by a positive result from the Vysis® ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit; or 2. Have documented ALK positivity by a different test and tissue available for the Vysis® FISH test. Tissue should be derived preferably from a biopsy taken after progression with crizotinib. If such a sample is not available, testing may be performed with archived tumor tissue. 3. Had progressive disease while on crizotinib, as assessed by the investigator or treating physician. 4. Have at least 1 measurable lesion per RECIST v1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were: 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection. 5. Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0) grade ≤2. 6. Are a male or female participants ≥18 years old. 7. Have a life expectancy ≥3 months. 8. Have adequate organ and hematologic function, as determined by: 1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN; ≤5 x ULN is acceptable if liver metastases are present) 2. Total serum bilirubin ≤1.5 x ULN (<3.0 x ULN for participants with Gilbert syndrome) 3. Serum creatinine ≤1.5 x ULN 4. Serum lipase/amylase ≤1.5 x ULN 5. Absolute neutrophil count (ANC) ≥1500/µL 6. Platelets ≥75000/µL 7. Hemoglobin ≥10 g/dL 9. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 10. Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤450 ms in males or ≤470 ms in females. 11. For female participants of childbearing potential, a negative pregnancy test must be documented prior to enrollment. 12. Female and male participants who are fertile must agree to use a highly effective form of contraception with their sexual partners throughout study participation. 13. Must provide a signed and dated informed consent indicating that the participants has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating. 14. Have the willingness and ability to comply with scheduled visits and study procedures. Exclusion Criteria: 1. Received any prior ALK-targeted TKI other than crizotinib. 2. Received crizotinib within 3 days of the first dose of brigatinib (Day 1, Cycle 1). 3. Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except SRS or stereotactic body radiosurgery. 4. Received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib (Day 1, Cycle 1). 5. Have been diagnosed with another primary malignancy within the past 3 years (except for adequately treated non-melanoma skin cancer, cervical cancer in situ, or prostate cancer, which are allowed within 3 years). 6. Have symptomatic CNS metastases that are neurologically unstable or require an increasing dose of corticosteroids. 7. Have current spinal cord compression. 8. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: 1. Myocardial infarction (MI) within 6 months prior to the first dose of brigatinib 2. Unstable angina within 6 months prior to first dose 3. Congestive heart failure (CHF) within 6 months prior to first dose 4. History of clinically significant (as determined by the treating physician) atrial arrhythmia 5. Any history of ventricular arrhythmia 6. Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose 9. Have a history or the presence of pulmonary interstitial disease or drug-related pneumonitis. 10. Have an ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection. 11. Have a known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history. 12. Have a history of or active significant gastrointestinal (GI) bleeding within 3 months of the first dose of brigatinib. 13. Have a known or suspected hypersensitivity to brigatinib or its excipients. 14. Have malabsorption syndrome or other GI illness that could affect oral absorption of the study drug. 15. Have any condition or illness that, in the opinion of the investigator, would compromise participants safety or interfere with evaluation of the drug study. 16. Be pregnant or breastfeeding. ; PRIMARY OUTCOME: Confirmed Objective Response Rate (ORR) as Assessed by Investigator; SECONDARY OUTCOME 1: Confirmed Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)[/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 - 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 - Thrive-IVF F/U; BRIEF: The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03. ; DRUG USED: NT100; DRUG CLASS: Biologic; INDICATION: Reproductive Disorder; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: Nora Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - At least one dose of study drug administered in NT-03 - Ongoing clinical pregnancy at Week 10 of gestation - Able and willing to enroll in NT-04 Exclusion Criteria: • None ; PRIMARY OUTCOME: Number of live births; SECONDARY OUTCOME 1: Number of stillbirths[/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 - PoC (Renal Transplantation); BRIEF: The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors. ; DRUG USED: Iscalimab; DRUG CLASS: Biologic; INDICATION: Kidney Transplant Rejection; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Main Inclusion Criteria: - Written informed consent must be obtained before any assessment is performed. - Recipients of a kidney transplant from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor. - Recipients of a kidney with a cold ischemia time (CIT) < 30 hours. Main Exclusion Criteria: - Recipients of an organ from a non-heart beating donor. - ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant. - Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication. - Subjects at high immunological risk for rejection - Subjects at risk for tuberculosis (TB) - Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment. - Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the national labeling information of these products (see local product label). ; PRIMARY OUTCOME: Mean Cmax Pharmacokinetic Parameter- Part I; SECONDARY OUTCOME 1: Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 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 - Tinea Pedis; BRIEF: The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as azole antifungals. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable. ; 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: - Healthy male and non-pregnant female patients ≥18 years and <65 years - Clinical diagnosis of tinea pedis - Positive baseline KOH - Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity) - Patients must be able to swallow capsules intact - Use acceptable birth control methods Key Exclusion Criteria: - Major organ system disease or clinical infection - Poorly controlled diabetes mellitus - Pregnant or lactating - Confluent, diffuse moccasin-type tinea pedis - Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail - Recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot - Recent use of systemic corticosteroids or antifungal therapy - Known(HIV)infection - Known significant hepatic, or hematologic impairment .Requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason. ; PRIMARY OUTCOME: Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis 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 - BOLERO 2 (ER+/HER2-; w/exemestane); BRIEF: There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI. ; DRUG USED: Afinitor; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. - Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer - Postmenopausal women. - Disease refractory to non steroidal aromatase inhibitors (NSAI), - Radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization. - Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above. Exclusion Criteria: - HER2-overexpressing patients - Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.). - Patients who received more than one chemotherapy line for Advanced Breast Cancer. - Previous treatment with exemestane or mTOR inhibitors. - Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin). - Radiotherapy within four weeks prior to randomization - Currently receiving hormone replacement therapy, Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.; SECONDARY OUTCOME 1: Overall Survival (OS) by Number of Deaths[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - HIV-1 Seronegative; BRIEF: To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers. ; DRUG USED: UBI HIV gp120; DRUG CLASS: Vaccine; INDICATION: HIV / AIDS; TARGET: gp120; THERAPY: Combination; LEAD SPONSOR: United Biomedical; CRITERIA: Inclusion Criteria Volunteers must have: - Normal history and physical exam. - HIV negativity. - CD4 count >= 400 cells/mm3. - Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry. - Normal urine dipstick with esterase and nitrite. Exclusion Criteria Co-existing Condition: Volunteers with the following symptoms or conditions are excluded: - Active tuberculosis. - Occupational or other responsibilities that would prevent completion of study. Volunteers with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. - Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study. - History of anaphylaxis or other serious adverse reactions to vaccines. - History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy. - Acute gastroenteritis or gastrointestinal surgery within the past 12 months. Prior Medication: Excluded: - Live or attenuated vaccine within the past 60 days. - Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months. ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SEER-1; BRIEF: The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK. ; DRUG USED: RGN-259; DRUG CLASS: Biologic; INDICATION: Ophthalmic Wound Healing (Ophthalmology); TARGET: Actin Filaments, ATP Synthase, Integrin-linked kinase (ILK); THERAPY: Monotherapy; LEAD SPONSOR: ReGenTree, LLC; CRITERIA: Inclusion Criteria: - Be male or female of any race, at least 18 years of age - Have provided verbal and written informed consent. - Be able and willing to follow instructions, including participation in all study assessments and visits; - Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use an adequate method of birth control throughout the study period. Exclusion Criteria: - Have any clinically significant slit lamp findings at Visit 1 that in the opinion of the investigator may interfere with the study parameters; - Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergy that requires treatment - Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the investigator, is the primary cause of the persistent epithelial defect; - Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g. follicular conjunctivitis) not related to NK - Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the study; - Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior to Visit 1 or anticipates use of contact lenses during the study period; - Have an uncontrolled systemic disease that in the opinion of the investigator may interfere with the study parameters; - Anticipate a change in immunosuppressive therapy during the course of the study; ; PRIMARY OUTCOME: Percentage of Subjects Achieving Complete Healing at Day 29.; SECONDARY OUTCOME 1: Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 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 II - w/Erlotinib (EGFR Wild-Type) (NCI); BRIEF: This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); 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: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Criteria: - Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows: - EGFR mutation testing of tumor has been performed and did not demonstrate an EGFR tyrosine kinase inhibitor sensitizing mutation; at minimum, testing for EGFR exon 19 deletion and exon 21 L858R mutations must have been included; OR - EGFR mutation testing has been attempted and is inconclusive (for example, due to lack of sufficient deoxyribonucleic acid [DNA] yield); OR - EGFR mutation status is unknown but tumor is positive for at least one alternative driver mutation, i.e: Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation, v-raf murine sarcoma viral oncogene homolog B (BRAF) mutation, human epidermal growth factor receptor 2 (HER2) mutation, ret proto-oncogene (RET) rearrangement/fusion, or one not listed following approval by the study chair prior to registration Inclusion Criteria: - INCLUSION CRITERIA STEP 1: - Cytologically or histologically confirmed non-small cell lung carcinoma (NSCLC) - Predominant non-squamous histology (patients with NSCLC not otherwise specified [NOS] are eligible); mixed tumors will be categorized by the predominant cell type; if small cell elements are present the patient is ineligible - Stage IV disease (includes M1a, M1b, or recurrent disease), according to the 7th edition of the lung cancer TNM classification system - Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria; baseline measurements and evaluation of all sites of disease must be obtained within 4 weeks prior to registration - Prior to registration, the investigator/site must confirm that sufficient pathology material representative of patients cancer is available for submission for MET immunohistochemical (IHC) testing - Patients must have received one or two lines of prior chemotherapy (first line platinum-doublet based chemotherapy plus switch maintenance chemotherapy counts as one line of therapy); prior adjuvant chemotherapy for early stage disease does not count as one line of therapy if 12 months or greater elapsed between completion of adjuvant therapy and initiation of first-line systemic therapy; if less than 12 months elapsed, adjuvant chemotherapy counts as one line of therapy - Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the time frames specified in the protocol - Patients must have discontinued treatment with any other type of investigational agent >= 4 weeks prior to registration - Patients must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) - Patients with no known brain metastasis at baseline must have baseline brain imaging within 12 weeks prior to study registration not demonstrating brain metastases; patients with brain metastases at baseline must have baseline brain imagining within 4 weeks prior to study registration and meet all of the specific criteria for brain mets listed in the protocol - Radiation related toxicities must have resolved to =< grade 1 prior to registration - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 - Patients must have an anticipated life expectancy greater than 3 months - Acceptable bone marrow, renal and hepatic function within 2 weeks prior to registration as defined in the protocol - Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration - Patients must be able to swallow tablets - INCLUSION CRITERIA STEP 2: - Patients must have met all eligibility requirements for Step 1 at time of registration to Step 1 to be eligible for Step 2 - Patients must have radiographic progressive disease per RECIST v1.1 criteria after >= 2 courses of therapy on Arm A or Arm B - Patients must be registered to Step 2 within 4 weeks of the last dose of treatment administration from Step 1 - Patients must have an ECOG performance status between 0-2 - Patients must have recovered to baseline (pre-Step 1) or CTCAE version 4.0 <= grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs Exclusion Criteria: - EXCLUSION CRITERIA STEP 1: - Patients without sufficient pathology material representative of the patients cancer (tumor block or 10 unstained slides) - Prior erlotinib, other EGFR tyrosine kinase inhibitor therapy, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor therapy, Met tyrosine kinase inhibitor therapy, or Met monoclonal antibody (MetMAb); prior antibody therapy such as bevacizumab or cetuximab is allowed with a washout period depending on dosing interval and investigational nature - Prior radiation therapy to the thoracic cavity, abdomen, or pelvis within 3 months prior to registration, to bone or brain metastasis within 14 days prior to registration, or to any other site within 28 days prior to registration - History of the following: Clinically-significant gastrointestinal (GI) bleeding within 6 months prior to registration; Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months prior to registration; Any other signs indicative of pulmonary hemorrhage within 3 months prior to registration - Radiographic or other evidence of the following within 28 days prior to registration: • Tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor; Cavitating pulmonary lesion(s); Tumor in contact with, invading or encasing any major blood vessels - Psychiatric illness/social situations that would limit compliance with study requirements - History of major thrombotic events (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 6 months prior to registration - Concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). (low dose aspirin [=< 81 mg/day] and prophylactic LMWH are permitted) - Concomitant treatment of strong cytochrome P450 3A4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. Johns wort) - Cardiovascular disorders including: Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening; - Concurrent uncontrolled hypertension; Any history of congenital long QT syndrome; Any of the following within 6 months prior to registration: - Unstable angina pectoris - Clinically-significant cardiac arrhythmias - Stroke (including transient ischemic attack [TIA], or other ischemic event) - Myocardial infarction - GI disorders particularly those associated with a high risk of perforation or fistula formation specified in the protocol - Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months prior to registration - Uncontrolled, significant, intercurrent or recent illness - Prior malignancy within 2 years prior to registration which required systemic treatment or is currently active - Pregnant or breast-feeding - Patients with known human immunodeficiency virus (HIV) disease taking antiretroviral therapy - Known chronic active hepatitis B - EXCLUSION CRITERIA (STEP 2): - Intervening anticancer treatment or major surgical procedure(s) between Step 1 and Step 2, except palliative radiation to the bone finishing >= 2 weeks prior to registration to Step 2 - Central nervous system (CNS) progression; patients with stable CNS disease are allowed - Intercurrent illness or disease complication that the investigator believes would limit the ability to safely tolerate the combination of erlotinib and cabozantinib ; PRIMARY OUTCOME: Progression-free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb; BRIEF: The purpose of this study is to evaluate the efficacy, safety and tolerability of VX-765 in subjects with treatment-resistant partial epilepsy. ; DRUG USED: VX-765; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: Caspase-1/ICE (IL-1ß-converting enzyme); THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Part A and Part B Inclusion Criteria: - Males or females aged 18 to 64 years with a body mass index between 18 and 35 (kg/m2) - Subjects who have completed the assigned study treatment in Part A may enter Part B if eligible per protocol - Male or female subjects must agree to use acceptable contraceptive methods, as described in the protocol - Must have a diagnosis and history of treatment-resistant partial-onset epilepsy for which they are taking 1 to 4 concomitant AEDs at the time of Screening Period - Have had at least 1 electroencephalogram consistent with partial epilepsy - Must have had at least 6 partial-onset seizures and a seizure-free period of no more than 3 weeks (21 days) during the Baseline Period. - Subjects with stable medical conditions (e.g., cannot have a condition that will interfere with the conduct of the study or cause a known increase in risk of the intervention) as determined by the principal investigator - Must be able and willing to provide written informed consent to participate - Must be able to understand and comply with protocol requirements and instructions Part A and Part B Exclusion Criteria: - Subjects who are male and their female partner (if of childbearing potential) does not agree to use medically approved methods of contraception as described in the protocol for the duration od the study and for 90 days after last dose of study drug - Subjects who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period, or within 90 days of the last dose of study drug. - Subjects who are pregnant or lactating, or who are of reproductive potential who do not agree to use medically approved birth control methods - History of nonepileptic, transient alterations in consciousness - History of status epilepticus in the past 12 months before the screening visit - Subjects whose seizure frequency cannot be quantified (i.e. seizures with no discrete beginning or end, or period between seizures) - Subjects who have a significant medical illness including kidney, liver, pulmonary, or gastrointestinal disease; or unstable or poorly controlled conditions such as hypertension, diabetes, or angina pectoris, as judged by the investigator. - Have a clinically significant psychiatric illness as judged by the investigator - Subjects who have had an active suicidal plan/intent or active suicidal thoughts, or suicide attempt as defined in the protocol - Clinically significant laboratory abnormalities during the Screening Visit/Baseline Period, as judged by the investigator - Subjects who have had serious adverse events (SAEs) thought to be related to study drug that led to discontinuation during Part A may not participate in Part B - Active hepatitis B, hepatitis C, or human immunodeficiency virus - Positive drug screen at screening or during the Baseline Period (excluding any allowed prescribed medications) and/or a history of alcoholism or drug addiction within past 2 years - Subjects on felbamate with fewer than 18 month of continuous felbamate exposure at the time of the Screening Visit or with significant adverse reactions to felbamate - Subjects treated with vigabatrin fewer than 2 years prior to the Screening Visit or who have a prior history of treatment with vigabatrin without a documented stable examination by an ophthalmologist as defined in the protocol - Using prohibited medications or treated with any systemic immunosuppressant - Have experienced a symptomatic viral, fungal, or bacterial infection requiring systemic treatment within 7 days prior to the first dose of study drug - A current or prior history of illness precluding them from immunomodulatory therapy (e.g., history of recurrent infections) - Have donated any blood or have had a significant loss of blood (500 mL) as defined in the protocol - Have participated in any other clinical studies involving an investigational product or device and have received the last dose of the study drug associated with that clinical study within 30 days or 5 half-lives (whichever is longer) of the Screening Visit - Have participated in earlier VX-765 clinical studies and received at least one dose of study drug - Subjects who have no completed the full 13-week Treatment Period in part A may not participate in Part B - Any subject judged by the investigator, sponsor or designee to be inappropriate for the study ; PRIMARY OUTCOME: Percent reduction in weekly seizure frequency during the Part A Late Treatment Period compared to the Part A Baseline Period; SECONDARY OUTCOME 1: Percent of subjects who are seizure-free during the Part A Late Treatment Period[/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 - 160060; BRIEF: Background: Bronchiolitis obliterans syndrome (BOS) is a complication people can experience after hematopoietic stem cell transplant. It usually affects people with chronic graft versus host disease (cGVHD). This occurs when donor stem cells attack the cells of the person who received them. BOS reduces airflow and oxygen levels in the body. It may be caused by neutrophil elastase in the body. Researchers believe the new drug alvelestat (MPH966) may help. Objectives: To test the safety of alvelestat (MPH966) and see what dose best inhibits neutrophil elastase in people with BOS after a stem cell transplant. To study how well the best dose improves lung function in those people. Eligibility: Adults 18 and older who have had a hematopoietic stem cell transplant and have cGVHD and BOS. Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have lung function and heart function tests. They will have computed tomography scans of the chest. Study part 1: Participants will take the starting dose of the study drug by mouth twice a day for 14 days. This is 1 cycle. They will get different doses, for up to 4 cycles. Study part 2: Participants will take the study drug twice a day by mouth at the dose set in part 1, for up to 12 months. Participants will keep medicine diaries. Participants will have several study visits. These may include: Repeats of the screening tests. Bronchoscopy with bronchoalveolar lavage. Sputum samples taken. 6-minute walking test. cGVHD assessment and answer questions. Participants will be contacted after the study for up to 24 months. ; DRUG USED: MPH-966; DRUG CLASS: New Molecular Entity (NME); INDICATION: Graft vs. Host Disease (GVHD) - Treatment; TARGET: Human Neutrophil elastase (hNE); THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: - INCLUSION CRITERIA: - Patients must have undergone hematopoietic stem cell transplantation and have moderate to severe chronic GVHD as defined by the NIH consensus criteria. - Patients must have BOS as defined by either of the two following criteria (A or B): (A) BOS per NIH consensus criteria (2014 updated criteria). To meet the criteria for BOS, all of the following must be present, in addition to at least one distinctive manifestation of cGVHD: - FEV1/vital capacity <0.7 or the fifth percentile of predicted - FEV1 <75% of predicted with greater than or equal to 10% decline over less than 2 years. FEV1 should not correct to >75% with albuterol - Absence of infection in the respiratory tract - One of the 2 supporting features of BOS: 1. Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution CT, or 2. Evidence of air trapping by PFTs: residual volume >120% predicted or residual volume/total lung capacity elevated outside the 90% confidence interval. If a patient carries the diagnosis of cGVHD by virtue of organ involvement elsewhere, then only the first 3 criteria above are necessary. (B) BOS, expanded NIH criteria - FEV1/vital capacity >0.7 - FEV1 <75% of predicted with greater than or equal to 10% decline over less than 2 years. FEV1 should not correct to >75% with albuterol - Absence of infection in the respiratory tract - One of the supporting features of BOS: 1. Evidence of air trapping by expiratory CT 2. Small airway thickening or bronchiectasis by high-resolution CT 3. Evidence of air trapping by PFTs: residual volume >120% predicted or residual volume/total lung capacity elevated outside the 90% confidence interval. - For the Phase 1b study, patients may have had the diagnosis of BOS for any period of time. For the Phase 2 study, patients must be within 5 years from the time of diagnosis. Patients may be at any time interval after SCT as long as the criteria for chronic GVHD and BOS are met. - If patients are taking systemic therapy for cGVHD at the time of enrollment, they must be receiving stable or tapering doses within the previous 4 weeks. Patients are not required to have completed a course of steroids prior to enrollment. - Age greater than or equal to18 years. - Karnofsky greater than or equal to 60% - Patients must have adequate organ and marrow function as defined below: - Leukocytes greater than or equal to 3,000/mcL - Absolute neutrophil count greater than or equal to 1,000/mcL - Platelets greater than or equal to 50,000/mcL - Total bilirubin less than or equal to 3 x institutional upper limit of normal, unless there is a known history of Gilbert s disease - AST(SGOT)/ALT(SGPT) less than or equal to 2 x institutional upper limit of normal - Serum creatinine less than or equal to 1.5 mg/dL OR Creatinine clearance greater than or equal to 60 mL/min as estimated by GFR per DLM standards - Patients will be required to have received prior treatment with a regimen consisting of inhaled steroids and montelukast plus or minus azithromycin for at least 3 months prior to enrollment, unless there is evidence of progression or unsatisfactory response while on this regimen prior to 3 months of treatment, as deemed by the treating or referring physician. Patients who are on azithromycin will need to discontinue for at least 2 weeks prior to enrollment. - Agree to adhere to methods of contraception and other fertility control measures: The effects of alvelestat (MPH966)on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study therapy. Contraception should be used up until 1 week of discontinuing study medication. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, or if a man s partner becomes pregnant or suspects she is pregnant while he is participating in this study, she or he should inform their treating physician immediately. -Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: - FEV1 <30% (based on absolute percent predicted using USA-ITS-NIH equation) on pulmonary function testing - Patients with clinically relevant abnormal ECG findings, including abnormal QTc>500 ms on screening ECG (Note: If a patient has a QTc interval >500 ms on screening ECG, the screening ECG may be repeated twice [at least 24 hours apart] for a total of 3 ECGs). - Patients who are receiving any other investigational agents - Recurrent or progressive malignancy requiring anticancer treatment - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute kidney injury, or psychiatric illness/social situations within the previous 4 weeks that would limit compliance with study requirements. - Pregnant women are excluded from this study because the teratogenic effects of alvelestat (MPH966) are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with alvelestat (MPH966), breastfeeding should be discontinued if the mother is treated with this agent. - Prior use of neutrophil elastase inhibitors - Patients with a history of cirrhosis, esophageal varices, ascites and hepatic encephalopathy - Patients with non-alcoholic fatty liver disease (NAFLD) or use of drugs associated with NAFLD for more than 2 weeks in the year prior to screening - Patients with a history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening. NOTE: Patients must also be willing to refrain from drinking alcohol during study participation, until end of study drug administration ; PRIMARY OUTCOME: Optimal biologic dose (OBD) based on maximal NE inhibition measured in sputum; SECONDARY OUTCOME 1: Phase 1b and 2: Pharmacokinetics of blood and sputum[/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/Docetaxel; BRIEF: This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes. ; DRUG USED: Mekinist; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - At least 18 years old with histologically- or cytologically-confirmed diagnosis of adenocarcinoma Stage IV NSCLC with a positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene. - Documented tumor progression after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC. - Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. - Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. - Life expectancy of at least three months in the opinion of the investigator. - Women of childbearing potential must have a negative serum pregnancy test within 14 days of randomization to study treatment and agree to use effective contraception. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the time of randomization to study medication until at least four weeks after the last dose of study treatment. - Adequate baseline organ function. Exclusion Criteria: - History of another malignancy. - Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subjects safety, obtaining informed consent or compliance to the study procedures. - Treatment with a BRAF or MEK inhibitor or docetaxel as monotherapy or as part of a combination regimen. - Anti-cancer therapy (including chemotherapy and radiation therapy) within the last three weeks. - History or current evidence / risk of retinal vein occlusion or central serous retinopathy. - Any current or history of tumor manifestation in the Central Nervous System. - History or evidence of cardiovascular risk, including QTcB >=480 msec, uncontrolled arrhythmias, acute coronary syndrome, coronary angioplasty, or stenting within 6 months prior to randomization, >=Class II congestive heart failure, treatment refractory hypertension, intra-cardiac defibrillators or permanent pacemakers or cardiac metastases. - Known Human Immunodeficiency Virus, Hepatitis B Virus (HBV), or Hepatitis C Virus (HBC) infection (with the exception of chronic or cleared HBV and HCV infection). ; PRIMARY OUTCOME: Progression-Free Survival (PFS) as Assessed by the Investigator (INV); SECONDARY OUTCOME 1: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SP-02L02; BRIEF: This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma. ; DRUG USED: Zinapar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Peripheral T-Cell Lymphoma (PTCL) - NHL; TARGET: Mitochondria; THERAPY: Monotherapy; LEAD SPONSOR: Solasia Pharma K.K.; CRITERIA: Inclusion Criteria: - Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each country/region - Patients aged ≥20 years on the date of informed consent - Patients with histologically confirmed diagnosis of one of the following: - Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) - Angioimmunoblastic T-cell Lymphoma (AITL) - Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative) - Relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease - Have at least 1 measurable lesion - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 - Patients with a life expectancy of at least 3 months as determined by the investigator ; PRIMARY OUTCOME: Tumor response; SECONDARY OUTCOME 1: Progression-Free Survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - B521MAD (Healthy Volunteers); BRIEF: Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, in healthy adults. ; DRUG USED: PF-06282999; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Myeloperoxidase (MPO); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Women must be of non childbearing potential. - Body Mass Index (BMI) of 27.0 to 35.0 kg/m2 (Part A) or 17.5 to 30.5 kg/m2 (Part B); and a total body weight >50 kg (110 lbs). Exclusion Criteria: - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). - Subject with any contraindication to midazolam according to the country specific labeling or subject with previous intolerance or allergy to benzodiazepines (applicable to Part B of study only). - Subjects who were enrolled in Part A are excluded from participation in Part B of this study. - Subjects who have previously participated in a study with PF-06282999. ; PRIMARY OUTCOME: Maximum Observed Plasma Concentration (Cmax); SECONDARY OUTCOME 1: Diastolic Blood Pressure[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD; BRIEF: Primary Objective: To assess the safety and tolerability of ascending single intraarticular doses of GZ389988 in patients with painful osteoarthritis (OA) of the knee. Secondary Objectives: To assess the pharmacokinetic (PK) parameters of ascending single intraarticular doses of GZ389988 in patients with painful OA of the knee. To obtain preliminary pharmacodynamic evaluation of ascending single intraarticular doses of GZ389988 in patients with painful OA of the knee. ; DRUG USED: GZ389988; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Trk (Tropomyosin Receptor Kinase) Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion criteria : - Men or women 40 to 60 years of age. - Diagnosis of primary knee osteoarthritis, based upon the following: - Fulfilling the American College of Rheumatology Clinical and Radiographic criteria for OA (at least knee pain and osteophytes), - X-ray evidence within the last 6 months for Kellgren and Lawrence classification II to IV. - Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Pain subscore (walking pain) between 50 and 90 using the 100-mm visual analog scale (VAS), corresponding to moderate to severe pain in the index knee, at both screening and baseline assessments at least 48 hours apart. - Symptomatic for more than 6 months (if both symptomatic knees, at least for the most painful knee that will receive the study drug). - Having given written informed consent prior to any procedure related to the study. - Ambulatory with an active lifestyle and in good general health. (Assistive devices were allowed if used throughout a period of 3 months or more prior to screening, on the condition that they continued to be used throughout the study). - A male who is sexually active must use a condom as part of a method of highly effective contraception (eg, condom + spermicide, and an additional contraceptive method used by the partner) during sexual intercourse with a women of childbearing potential for the duration of the study period up to the end-of-study visit and should not father a child in this period. Male patients also have to agree not to donate sperm for the duration of the study until the end-of-study visit. Exclusion criteria: - Women of childbearing potential. - Pregnant or breastfeeding women. - Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Investigator, could potentially put the patient at increased risk. - Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (including diabetic neuropathy), psychiatric, hematological, renal, dermatological disease, or any other medical condition that might interfere with the evaluation of the investigational medicinal product (IMP) according to Investigators medical judgment. - Chondrocalcinosis. - Fibromyalgia. - Major depression. - History or presence of drug or alcohol abuse (alcohol consumption >40 grams per day). - Any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. - Abnormal coagulation parameters: outside the range international normalized ratio (INR) 0.85-1.15, activated partial thromboplastin time >33 seconds, platelets <140 x 10^9/L. - Moderate to severe renal impairment. - Underlying hepatobiliary disease and/or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN). - High sensitivity C-reactive protein (hsCRP) >2 x ULN. - Hemoglobin <10 g/dL, white blood cell count (WBC) <3 x 10^9/L. - Positive result on any of the following tests: hepatitis B surface (HBsAg) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab). - Secondary OA. - Ipsilateral hip OA. - Symptomatic contralateral knee OA with WOMAC A1 pain subscore (walking pain) >30 on 100-mm VAS. - Prior history of osteonecrosis and/or rapidly progressive OA. - Intraarticular injection within 3 months prior to inclusion. - Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol (No non-steroidal non-inflammatory drug [NSAID] use during the 12 weeks of the study; after the end-of-study visit [Day 84 ± 7] patients may be given an NSAID if necessary to provide better control of OA symptoms). - Any IMP within 3 months prior to the study. - Any knee MRI contraindication. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Proportion of patients with adverse events; SECONDARY OUTCOME 1: Maximum plasma concentration (Cmax) of GZ389988 single dose intraarticular (IA)[/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 - PDX-011; BRIEF: The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body). ; DRUG USED: Folotyn; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: Dihydrofolate reductase (DHFR); THERAPY: Monotherapy; LEAD SPONSOR: Acrotech Biopharma Inc.; CRITERIA: Inclusion Criteria: - Histologically confirmed transitional cell carcinoma of the urinary bladder. Fine needle aspirate will not be accepted. - Relapsed or progressed after treatment with a platinum- and/or methotrexate-based systemic chemotherapy regimen. No more than 1 prior regimen is permitted for recurrent/metastatic disease. Patients has had a chemotherapy-free interval of ≥ 12 months from last dose if most recent prior chemotherapy was in neoadjuvant/adjuvant setting and has had ≥ 6-month chemotherapy-free interval in recurrent/metastatic setting. Patient has recovered from the toxic effects of prior therapy. Previous intravesical therapy is allowed. Prior surgical resection is allowed, as long as the patient has recovered. - Measurable disease outside a previously irradiated region, per Response Evaluation Criteria in Solid Tumors (RECIST). - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - At least 18 years of age. - Adequate blood, liver, and kidney function as defined by laboratory results. - Patient has received 1.0-1.25 mg of oral folic acid daily for at least 7 days of enrollment & 1 mg intramuscular vitamin B12 within 10 weeks of enrollment. - Women of childbearing potential have a negative serum pregnancy test within 14 days prior to enrollment and agree to use medically acceptable and effective birth control from enrollment until at least 30 days after the last dose of pralatrexate. - Men who are not surgically sterile and whose partner is of childbearing potential must use medically safe and effective birth control start of pralatrexate until at least 90 days after the last dose of pralatrexate. - Accessible for repeat dosing and follow up. - Give written informed consent. Exclusion Criteria: - Active concurrent primary malignancy or prior malignancies occurring within 5 years (except non-melanoma skin cancer, in situ carcinoma of the cervix, or occult, indolent carcinoma of the prostate). If there is a history of prior malignancies other than those exceptions listed above, the patient must be disease free for ≥ 5 years. Patients with other prior malignancies < 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. In the case of a single extrapelvic metastatic site, irrespective of the patient having a history of previous malignancy, a biopsy proof of the metastatic diseased organ will be necessary. - More than 1 previous regimen for recurrent/metastatic disease. - Evidence of clinically significant active third-space phenomenon - Use of investigational drugs, biologics, or devices within 28 days prior to study enrollment. - Previous exposure to other antifolates, including pralatrexate. Previous methotrexate is allowed, only if it was part of an M-VAC or MCV regimen. - Women who are pregnant or breastfeeding. - Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA) Functional Classification. - Uncontrolled hypertension. - Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of < 100 mm3 or detectable viral load within the past 3 months, and receiving combination anti-retroviral therapy. - Central nervous system metastatic disease. - Major surgery within 2 weeks of study enrollment. - Radiation therapy (RT) within 4 weeks (within 3 months for RT to the pelvis) prior to study enrollment. - Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment. - Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent or limit study compliance. ; PRIMARY OUTCOME: Objective 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 I/II - w/Ionizing Radiation + Pembrolizumab; BRIEF: This study evaluates the effectiveness of adding a single four-day treatment of the fusion protein A-dmDT390-bisFv(UCHT1) - plus single palliative tumor radiation - with standard of care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results will be measured by comparing the combined therapy to historical data of KEYTRUDA alone. ; DRUG USED: Resimmune; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cluster of Differentiation 3 (CD3), Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Angimmune LLC; CRITERIA: Inclusion Criteria: - All patients must have histologically proven stage IV metastatic melanoma consisting of at least two lesions >= 1.5 cm that would not occupy the same radiation field. Patients must be treatment naïve except for treatment with BRAF inhibitors. Patients with melanoma must have an anti-DT titer of <20 μg/ml. Patients with brain metastasis and ocular and mucosal lesions can be enrolled at the discretion of the PI providing that other non-brain and non-ocular metastatic lesions are available as targets for radiation therapy - Patients must have a performance status of < 2 on Eastern Cooperative Oncology Group scale (see Appendix). Patients must have fully recovered from toxicity of prior therapy with BRAF inhibitors. Adequate bone marrow function will be defined as ANC >750 uL, WBC >1000 uL, platelets >60,000 uL and Hb > 9g/dL - Patients must have: - bilirubin < 1.5 mg/dL, - transaminases < 2.5 X ULN, - albumin > 3 gm/dL, - creatinine < 2.0 mg/dL, - adequate pulmonary function by physical exam and pulse oximetry and adequate cardiac reserve (EF > 50% normal). - Patients must have a normal echocardiogram without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis. The Sponsor must be provided with copies of these tests before Sponsor will approve enrollment. In addition, the sponsor must receive a list of current medications taken by the patient before Sponsor will approve enrollment. - Patients must give written informed consent prior to registration (see Informed Consent). - Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion. - Patients of ages 18-80 are eligible provided they have stage IV melanoma and are negative for BRAF or have failed BRAF inhibitor treatment or if they have failed or are intolerant to other established therapy known to provide clinical benefit for their condition or if they have been adequately consented and agreed to forgo FDA approved clinically meaningful therapy. Exclusion Criteria: - Failure to meet any of the criteria set forth in Inclusion Criteria. - Inability to give informed consent because of psychiatric problems, or complicated medical problems. - Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC). - Preexisting cardiovascular disease, the only exception being well controlled essential hypertension with a sitting B.P. of <155 systolic and <90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction > 8 months ago. A past history of the any of the following are exclusions: - Congestive heart failure, - Atrial fibrillation, - Pulmonary hypertension, - Anticoagulant drug therapy, - Thromboembolic events, - Cardiomyopathy or a myocardial infarction within the past 8 months. Referring physicians will be asked to verify that their referred patients do not have these exclusionary histories listed in 3.2 and a copy of this verification must be sent to the Sponsor before the Sponsor will approve of enrollment. Because beta-blockers have been associated with adverse events during anaphylactic reactions and because such reactions can occur with IV infusions of proteins such as the study drug, the sponsor requires that patients receiving beta-blockers for hypertension be converted to another anti-hypertensive reagent 2-3 weeks prior to receiving the study drug. Angiotensin inhibitors, angiotensin receptor blockers and calcium channel blockers are all acceptable. - Pregnant or nursing women will be excluded from study. - History of congestive heart failure. - History of cirrhosis of the liver. - Prior treatment with alemtuzumab (Campath) or similar agents or procedures that depress blood T cell counts to below 50% of the lower limit of normal. ; PRIMARY OUTCOME: Clinical Response primary outcome measure is the change in Progression Free Survival time (PFS).; SECONDARY OUTCOME 1: Changes in Clinical Response Rates[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - w/Rituximab; BRIEF: The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). ; DRUG USED: Dinaciclib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Must have received at least one prior therapy that includes either fludarabine or equivalent nucleoside analogue or an alternative regimen - Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) - Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2 - Women of child-bearing potential who are sexually active, ,including both female subjects and the female sexual partners of male subjects, must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified treatment, and for 12 months after stopping study treatment. - Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study. - Life expectancy ≥12 weeks Exclusion Criteria: - Symptomatic brain metastases or primary central nervous system malignancy - Treatment with any chemotherapy or biologic therapy within 4 weeks prior to enrollment - Non-hematological toxicities from prior therapy - Presence of any serious or uncontrolled infection defined as infection requiring hospital admission and/or parenteral antibiotics - Known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy - Clinically active hepatitis B or C defined as disease that requires therapy - Women who are breast-feeding, pregnant, or intend to become pregnant - Prior allogeneic bone marrow transplant (auto hematopoietic stem cell transplantation [HSCT] is allowed if fully recovered) - Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the subject is considered by his or her physician to have a 2 year survival expectation - Any investigational drugs within 4 weeks prior to the start of treatment - Concurrently receiving treatment in any other clinical study - Previously treated with a cyclin dependent kinase (CDK) inhibitor (e.g., dinaciclib or flavopiridol) - Active autoimmune anemia or idiopathic thrombocytopenic purpura (ITP) unless stable, defined as being responsive to corticosteroids or other standard therapy ; PRIMARY OUTCOME: Number of Participants Experiencing a Dose Limiting Toxicity (DLT); SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy SAD/MAD; BRIEF: RPX7009 (beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014) to treat bacterial infections, including those due to multi-drug resistant bacteria. ; DRUG USED: Vabomere; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company); CRITERIA: Inclusion Criteria: 1. Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening. 2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). 3. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical examination) as deemed by the PI. 4. Non-tobacco/nicotine-containing product users for a minimum of Dose Study 6 months prior to Day 1. 5. Voluntarily consent to participate in the study. 6. Sexually abstinent or agree to use two approved methods of contraception. Exclusion Criteria: 1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. 2. Positive urine drug/alcohol testing at screening or check-in (Day -1). 3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV). 4. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1. 5. Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI. 6. Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1. 7. Plasma donation within 7 days prior to Day 1. 8. Participation in another investigational clinical trial within 30 days prior to Day 1. 9. Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1). ; PRIMARY OUTCOME: Safety from baseline through the end of the study; SECONDARY OUTCOME 1: Composite of PK parameters RPX7009, RPX2014, combination of RPX7009 and RPX2014 & placebo following single and multiple dose administration.[/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 - REDUCE-2; BRIEF: The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen. ; DRUG USED: Duexis; DRUG CLASS: Non-NME; INDICATION: Arthritis Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Histamine H2 Receptor (HRH2); THERAPY: Monotherapy; LEAD SPONSOR: Horizon Pharma Ireland, Ltd., Dublin Ireland; CRITERIA: Inclusion Criteria: - Expected to require daily administration of an NSAID for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain. - Did not use a NSAID within the 30 days prior to study entry Exclusion Criteria: - History of erosive esophagitis - History of any of the following serious gastrointestinal complications: - perforation of ulcers, - gastric outlet obstruction due to ulcers, or - gastrointestinal bleeding. - Active cardiac, renal, and/or hepatic disease - Current Helicobacter pylori (H. pylori) infection - Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry. - Uncontrolled diabetes - Uncontrolled hypertension - Positive pregnancy test at screening - Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. - Currently participating, or participation within 30 days prior to study entry, in an investigational drug study Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria. ; PRIMARY OUTCOME: Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers; SECONDARY OUTCOME 1: Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 17p Deletion, Age > 65 (NHLBI); BRIEF: Background: - Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood cells that hurt the immune system and make it more difficult to fight infections. These cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL are over age 70. Elderly people often do not respond well to standard chemotherapy for CLL/SLL. They may have other health problems that make chemotherapy difficult. In addition, individuals who have a genetic abnormality called 17p deletion also do not respond well to standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug, PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups. Objectives: - To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and people with 17p deletion. Eligibility: - Individuals over 65 years of age who have CLL/SLL. - Individuals at least 18 years of age who have CLL/SLL and 17p deletion. Design: - Participants will be screened with a medical history, physical exam, and imaging studies. Blood and urine samples will be taken. Optional bone marrow and lymph node biopsies may also be taken. - Participants will take PCI-32765 capsules every day for 28 days (one cycle of treatment). Treatment will be monitored with frequent blood tests and clinic visits. - PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug will continue to take it as long as there are no side effects and the disease does not progress. Those who do not benefit will stop treatment and have regular followup exams. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Monotherapy; LEAD SPONSOR: National Heart, Lung, and Blood Institute (NHLBI); CRITERIA: -INCLUSION CRITERIA: 1. Cohort 1: Treated and untreated patients age 65 or older and need for therapy Cohort 2: Treated (maximum accrual n=16) and untreated (n=27, evaluable) patients at least 18 years old with 17p deletion or p53 expression by immunohistochemistry or p53 mutation by sequencing analysis. 2. Men and women with histologically confirmed disease as defined by the following: - B-lymphocytosis greater than 5000 cells/microL (may be less than 5000 cells/microL if lymphadenopathy is present with histologic confirmation of lymph node involvement by SLL) - Immunophenotypic profile read by an expert pathologist as consistent with CLL. This will include CD5, CD19, and CD20 expression by the CLL cells typically also with CD23 expression, but CD23 negative cases may be included if there is no t11;14 translocation present. 3. Active disease as defined by at least one of the following: - Weight loss greater than or equal to 10% within the previous 6 months - Extreme fatigue - Fevers of greater than 100.5 degrees F for greater than or equal to 2 weeks without evidence of infection - Night sweats for more than one month without evidence of infection - Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia - Massive or progressive splenomegaly - Massive nodes or clusters or progressive lymphadenopathy - Progressive lymphocytosis with an increase of greater than 50% over a 2 month period, or an anticipated doubling time of less than 6 months - Compensated autoimmune hemolysis 4. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 5. ANC greater than 500/microL, platelets greater than 30,000/microL 6. Agreement to use contraception during the study and for 90 days after the last dose of study drug if sexually active and able to bear children 7. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty 8. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations) EXCLUSION CRITERIA: 1. Previous radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product fpr CCL treatement in the last 4 weeks (i.e. intravenous immunoglobulin). 2. Transformed CLL 3. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy 4. Impaired hepatic function: Total bilirubin greater than or equal to 1.5 times upper limit of normal unless dute to Gilberts disease, AST/ ALT greater than or equal to 2.5 times institutional upper limit of normal unless due to infiltration of the liver. 5. Impaired renal funtion: Creatinine greater than or equal to 2.0 mg/dL or GFR less than or equal to 50ml/min 6. Life-threatening illness, medical condition or organ system dysfunction which, in the investigators opinion, could compromise the subjects safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk 7. Concomitant immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone > 20 mg/day), or experimental therapy 8. Active Hepatitis B infection 9. HIV infection 10. Female patients: Current pregnancy or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential or currently breastfeeding. Male patients who are unwilling to follow the contraception requirements described in this protocol. 11. Psychiatric illness/social situations that would limit the patient s ability to tolerate and/or comply with study requirements. 12. Unable to understand the investigational nature of the study or give informed consent. 13. Individuals < 18 yrs old 14. Known hypersensitivity to any component of PCI-32765 15. Any prior therapy with PCI 32765 or any other BTK inhibitors. 16. Requires anticoagulation with warfarin. 17. Requires treatment with strong CY3A4/5 and/or CYP2D6 inhibitors (unless no alternative is available). ; PRIMARY OUTCOME: Overall Response Rate at 6 Months; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - RSV-MVA-006; BRIEF: A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo. ; DRUG USED: MVA-BN RSV; DRUG CLASS: Vaccine; INDICATION: Respiratory Syncytial Virus (RSV) Prevention; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: Bavarian Nordic; CRITERIA: Inclusion Criteria: - signed and dated an informed consent form and HIPAA. - Subjects without symptomatic cardiopulmonary and/or metabolic disease. - Body mass index (BMI) ≥ 18.5 and ≤ 34.9. - Negative human immunodeficiency virus antibody test (anti-HIV), HBsAG and HCV virus. - Electrocardiogram (ECG) without clinically significant acute findings. - WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination. Exclusion Criteria: - History of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial - Active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum - pregnant or breast-feeding women. - History or current clinical manifestation of any serious medical condition. - History of or active autoimmune disease. - Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I. - Knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - History of anaphylaxis or severe allergic reaction to any vaccine. - Chronic systemic administration defined as more than 14 days of > 5 mg prednisone per day ; PRIMARY OUTCOME: Occurrence of serious adverse events; SECONDARY OUTCOME 1: RSV-specific humoral immune response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EOC or PPC (2); BRIEF: Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy. ; DRUG USED: Nexavar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Raf kinase, RET, Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment. - Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - All scans used to document complete response must be done within 30 days prior to randomization. - Patients must be able to swallow and retain oral medication. Exclusion Criteria: - Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI). - Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy. - Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell). - Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization. ; PRIMARY OUTCOME: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment; SECONDARY OUTCOME 1: Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CRISTALLO (w/Obinutuzumab); BRIEF: This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B). ; DRUG USED: Venclexta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Ability to comply with the study protocol, in the investigators judgment - Aged 18 years or older - Have previously untreated documented Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria - CLL requiring treatment according to the iwCLL criteria - Cumulative Illness Rating Scale (CIRS) score ≤ 6 and creatinine clearance (CrCl) ≥ 70 mL/min - Hematology values within the following limits, unless cytopenia is caused by the underlying disease (i.e., no evidence of additional bone marrow (BM) dysfunction; e.g., myelodysplastic syndrome, hypoplastic BM): - Absolute neutrophil count ≥ 1.0 x 109/L, unless there is BM involvement - Platelet count ≥ 75 x 109/L and more than 7 days since last transfusion, or ≥ 30 x 109/L if there is BM involvement - Adequate liver function as indicated by a total bilirubin, aspartate aminotransferase, and Alanine transaminase ≤ 2 times the institutional upper limit of normal (ULN) value, unless directly attributable to the participants CLL - Life expectancy >6 months - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm Exclusion Criteria: - Transformation of CLL to aggressive Non-Hodgkins Lymphoma (NHL) - Participants with Small Lymphocyclic Lymphoma (SLL) only - Known central nervous system involvement - Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) - Detected del(17p) or TP53 mutation (valid test within 6-months from screening is required for randomisation) - An individual organ/system impairment score of 4 as assessed by the Cumulative Illness Rating Scale (CIRS) definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system - Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia - History of prior malignancy - Participants with infections requiring IV treatment (Grade 3 or 4) within the last 8 weeks prior to enrollment - Evidence of other clinically significant uncontrolled conditions including but not limited to active or uncontrolled systemic infection (e.g., viral, bacterial, or fungal) - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products - Hypersensitivity to fludarabine, bendamustine, cyclophosphamide, rituximab, obinutuzumab, or venetoclax or to any of the excipients (e.g., trehalose) - Pregnant women and nursing mothers - Vaccination with a live vaccine ≤ 28 days prior to randomization - Prisoners or participants who are institutionalized by regulatory or court order or persons who are in dependence to the Sponsor or an investigator - History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigators judgment - Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) - Positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing) - Participants with known infection with HIV or Human T-Cell Leukemia Virus 1 (HTLV-1) - Any serious medical condition or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the participants safe participation in and completion of the study - Received any of the following agents within 28 days prior to the first dose of study treatment: - Immunotherapy - Radiotherapy - Hormone therapy - Any therapies intended for the treatment of lymphoma/leukemia whether approved or experimental - Participants who have received the following agents: - Strong and moderate CYP3A inhibitors/inducers within 7 days prior to the initiation of study treatment - Steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration - Consumed grapefruit, grapefruit products, Seville oranges(including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration - Inability to swallow a large number of tablets. ; PRIMARY OUTCOME: Minimal Residual Disease (MRD) Response Rate Using Next-generation Sequencing (NGS); SECONDARY OUTCOME 1: Progression-free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - 003; BRIEF: Purpose of this study is to determine the safety and efficacy of topical applications of NB-001 as compared to placebo for the treatment of recurrent herpes labialis. ; DRUG USED: NB-001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Herpes Simplex Virus (HSV) (Antiviral); TARGET: Herpes Simplex Virus (HSV); THERAPY: Monotherapy; LEAD SPONSOR: NanoBio Corporation; CRITERIA: Inclusion Criteria: - 18 to 80 years of age of either gender - Good general health - History of recurrent herpes labialis with at least 3 episodes per year Exclusion Criteria: - Pregnant and/or nursing female - Lesions or irritation on or around the lips that would interfere with recognition of a herpes labialis attack - Treatment with topical steroids, antivirals, or new topical products on or around the lips in the week prior to the onset of an attack - Known allergies to topical creams, ointments or medications. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Time to healing as assessed by the subject.; SECONDARY OUTCOME 1: Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - SAD/MAD (JP); BRIEF: The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to moderate Alzheimers Disease (AD). The secondary objectives of this study are as follows: To evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of Aducanumab on immunogenicity. ; DRUG USED: Aduhelm; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Must be ambulatory - Must have a clinical diagnosis of mild to moderate AD - Must be in good health as determined by the Investigator, based on medical history and Screening assessments - Must have a caregiver who, understands the study and assents to accompany the subject to all study site visits, provide information to the Investigator/study site staff, specifically about cognitive abilities and AEs/SAEs and return for per-protocol follow-up visits and procedures - Must consent to blood sample collection for deoxyribonucleic acid (DNA; genotyping) and ribonucleic acid (RNA; for potential future analysis). Key Exclusion Criteria: - Any medical or neurological condition (other than AD) that in the opinion of the Investigator could be a contributing cause of the subjects dementia - Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening - Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within the 3 months prior to Day 1 - History of unstable angina, myocardial infarction, chronic heart failure - Chronic, uncontrolled hypertension - History of seizure within 3 years prior to Screening - History within the past 6 months or evidence of clinically significant psychiatric illness - History of severe allergic or anaphylactic reactions, or history of hypersensitivity to any of the inactive ingredients in the drug product NOTE: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Incidence and nature of adverse events (AE) / serious adverse events(SAE); SECONDARY OUTCOME 1: Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)[/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 - +/- Rituximab; BRIEF: The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkins lymphomas. ; DRUG USED: CC-99282; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - History of Non-Hodgkins Lymphoma (NHL) with relapsed or refractory disease - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Exclusion Criteria: - Life expectancy ≤ 2 months - Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter - Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD) - Impaired cardiac function or clinically significant cardiac disease Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Incidence of Adverse Events (AEs); SECONDARY OUTCOME 1: Pharmacokinetics - Maximum plasma concentration of drug (Cmax)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - KEYNOTE-164; BRIEF: In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti-vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. The primary hypothesis is that Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor in participants with locally advanced unresectable or metastatic MMR deficient or MSI high CRC is greater than 15%. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion criteria: - Histologically-proven locally advanced unresectable or metastatic colorectal carcinoma - Locally confirmed MMR deficient or MSI-H status - Has been previously treated with standard therapies, which must include, for Cohort A, fluoropyrimidine, oxaliplatin, and irinotecan, and for Cohort B, at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/- anti-VEGF/EGFR monoclonal antibody (mAb). - Eastern Cooperative Oncology Group performance status of 0 or 1 - Life expectancy of greater than 3 months - Provides an archival or newly obtained (≤60 days prior to first dose of study treatment) tumor tissue sample (Cohort B) - At least one measurable lesion - Female participants of childbearing potential should be willing to use acceptable methods of contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment - Male participants should agree to use an adequate method of contraception starting with the first dose of study treatment through 120 days after the last dose of study treatment - Adequate organ function Exclusion criteria: - Currently participating in another study and receiving trial treatment, participated in a study of an investigational agent and received trial treatment within 4 weeks of the first dose of treatment in this study, or used an investigational device within 4 weeks of the first dose of treatment in this study - Active autoimmune disease that has required systemic treatment in past 2 years - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment - Known active central nervous system metastases and/or carcinomatous meningitis - Prior monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events (AEs) due to a previously administered agent - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent - Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. - Received a live vaccine within 30 days of planned start of study treatment - Known history of human immunodeficiency virus (HIV) - Known active Hepatitis B or C - Has known history of, or any evidence of interstitial lung disease or active, noninfectious pneumonitis - Active infection requiring systemic therapy - Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study - 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 ; PRIMARY OUTCOME: Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor; SECONDARY OUTCOME 1: Disease Control Rate (DCR) Per RECIST 1.1 Assessed by Central Imaging Vendor.[/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 - FX2014-04; BRIEF: This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. ; DRUG USED: Amzeeq; DRUG CLASS: Non-NME; INDICATION: Acne; TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Vyne Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Has facial acne vulgaris with: - 20 to 50 inflammatory lesions (papules, pustules, and nodules); - 25 to 100 noninflammatory lesions (open and closed comedones); - no more than 2 nodules on the face; and - IGA score of moderate (3) to severe (4) - Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study Exclusion Criteria: - Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations - Sunburn on the face - Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results. - Abnormal baseline laboratory values that are considered clinically significant - Allergy to tetracycline-class antibiotics or to any ingredient in the study drug - Pseudomembranous colitis or antibiotic-associated colitis ; PRIMARY OUTCOME: Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12; SECONDARY OUTCOME 1: Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DESTINY-CRC01; BRIEF: The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer. ; DRUG USED: Enhertu; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo Co., Ltd.; CRITERIA: Inclusion Criteria: - Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsors notification to the study sites, subject must be a RAS/BRAF wild-type cancer) - Has received at least 2 prior regimens of standard treatment - Has measurable disease assessed by the investigator based on RECIST version 1.1. - Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 Exclusion Criteria: - Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure - Has a medical history of clinically significant lung disease - Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy ; PRIMARY OUTCOME: Number of Participants With Best Objective Response Based on Independent Central Review (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer; SECONDARY OUTCOME 1: Number of Participants With Best Objective Response Based on Investigator (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer[/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 - Safety in Adults w/AMI; BRIEF: The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh. ; DRUG USED: Selatogrel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Adenosine Diphosphate P2Y12 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Main Inclusion Criteria: - Informed consent obtained prior to any study-mandated procedure, - Males aged from 18 to 85 and postmenopausal females aged up to 85 years, - Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to randomization, - Subjects presenting a type I AMI including STEMI or NSTEMI. Main Exclusion Criteria: - Cardiogenic shock or severe hemodynamic instability, - Cardiopulmonary resuscitation, - Loading dose of any oral P2Y12 receptor antagonist prior to randomization, - Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h prior to randomization, - Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand disease). - Active internal bleeding, or bleeding diathesis or conditions associated with high risk of bleeding. - Known clinically important anemia. - Oral anticoagulation therapy within 7 days prior to randomization ; PRIMARY OUTCOME: Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - AML/MDS; BRIEF: The purpose of this study is to determine the safety profile and tolerability of S 055746 in patients with AML, and high or very high risk MDS, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy. ; DRUG USED: BCL201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Apoptosis (Cell Death), B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Monotherapy; LEAD SPONSOR: Institut de Recherches Internationales Servier; CRITERIA: Inclusion Criteria: - Women or men aged >= 18 years - Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML excluding acute promyelocytic leukaemia: - with relapsed or refractory disease or - > or = 65 years not previously treated for AML, who are not candidates for intensive chemotherapy or not candidates for standard chemotherapy - Patients with cytologically confirmed and documented MDS or non proliferative Chronic Myelomonocytic Leukaemia (CMML) in relapse or refractory after previous treatment line including at least one hypomethylating agent therapy: - with high or very high risk MDS and without established alternative therapy - transformed to AML and without established alternative therapy - Ability to swallow oral tablet(s) - World Health Organization (WHO) performance status 0-2 - Circulating white blood cells < or = 30 x 10^9 /L and < or = 13 x10^9 for non proliferative CMML - Adequate renal and hepatic functions - Negative serum pregnancy test within 7 days prior to the first day of study drug administration - Patients must use effective contraception - Written informed consent Exclusion Criteria: - Foreseeable poor compliance to the study procedures - Legally incapacitated person under guardianship or trusteeship - Pregnant or breast-feeding women - Participation in therapeutic interventional study involving investigational drug intake at the same time or within 2 weeks or at least 5 half-lives or patient already enrolled - Previous treatment with a BH3 mimetic - Patients who have not recovered to baseline or CTCAE< or = Grade 1 from toxicity due to all prior therapies received for the studied disease - Any previous anti-leukaemic treatment for the studied disease within at least 5 half-lives or 2 weeks (hydroxycarbamide permitted) - Any radiotherapy within 4 weeks before first intake (except palliative radiotherapy at localized lesions) - Major surgery within 3 weeks before first intake of S 055746 - Allogenic stem cell transplant within 6 months before the first intake of S 055746 and for patients who still need immunosuppressive treatment - Leukaemic leptomeningeal or leukaemic central nervous system involvement - Concomitant uncontrolled infection, organ dysfunction or medical disease likely to interfere with evaluation of S 055746 safety or study outcome - Human immunodeficiency virus (HIV) infection, hepatitis B or active hepatitis C infection - Within 6 months prior to the first intake of S 055746, history of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, and/or stenting, ischemic/haemorrhagic stroke, atrial fibrillation, digestive haemorrhagic risk, deep venous/arterial thromboembolic complication or bleeding diathesis - Decreased Left Ventricular Ejection Fraction (LVEF) - QTcF prolongation - Patients who are receiving QT prolonging drug - Coagulopathies with increased risk of bleeding complications - Other malignancy within 2 years prior to the first intake - Strong or moderate CYP3A4 inhibitors or inducers (treatment, food or drink products) within 7 days prior to the first intake - Treatment highly metabolised by the CYP3A4 or CYP2D6 and/or with a narrow therapeutic index, multi-enzymes and/or OATP and/or P-gp substrates or herbal products within 7 days prior to the first intake. - Patients receiving proton pump inhibitor - Patients having received anticoagulant oral drugs, aspirin > 325 mg/day and antiplatelets within 7 days prior to first S 055746 intake ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Plasma concentration of S 055746[/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 - 001; BRIEF: The purpose of this study is to determine the safety and tolerability of XL765. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. ; DRUG USED: SAR245409; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - The subject has a histologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival. - The subject has disease that is assessable by tumor marker, physical, or radiologic means. - The subject is at least 18 years old. - The subjects weight is at lease 40 kg. - The subject has an Eastern Cooperative Oncology Group performance status of 0 - 2. - The subject has adequate organ and bone marrow function. - The subject has fasting plasma glucose < 120 mg/dL at screening. - for subjects who are to be enrolled into the Expanded MTD Cohort and Lower-Dose Tumor Genetic Alteration Subjects: 1. tumor tissue amenable to serial biopsy; 2. additional informed consent - The subject is capable of understanding the protocol and has signed the informed consent. - Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study. - Female subjects of childbearing potential must have a negative serum pregnancy test at screening. - If the subject has received more than 3 prior regimens of cytotoxic chemotherapy, more than 2 biologic regimens, or more than 3000 cGy to >25% of his or her bone marrow, the sponsor must determine subject suitability before enrollment. - The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥ 2 years ago, and has had no evidence of disease for 2 years prior to screening for this study.) Exclusion Criteria: - The subject has received anticancer treatment (chemotherapy, radiotherapy, cytokines, or hormones) within 30 days (6 weeks for nitrosoureas, mitomycin C, or bicalutamide) before the first dose of XL765. - The subject has received radiation to > 25% of his or her bone marrow. - The subject has not recovered from adverse events, except Grade 2 alopecia, due to other investigational or other agents administered prior to study enrollment. - The subject has received another investigational agent within 30 days or the first dose of XL765 or a small-molecule kinase inhibitor within 14 days or 5 half-lives. - The subject is known to have diabetes - The subject has uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. - The subject has psychiatric illness/social situation that would limit compliance with study requirements. - The subject is pregnant or breast feeding. - The subject is known to be positive for HIV. - The subject has a known allergy or hypersensitivity to components of the XL765 formulation. - The subject has a baseline corrected QT interval > 450 ms. ; PRIMARY OUTCOME: Safety, tolerability, and maximum tolerated dose (MTD) of daily oral administration of XL765 in two treatment schedules; SECONDARY OUTCOME 1: Plasma pharmacokinetics of daily oral administration of XL765 in two treatment schedules[/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 - POLARIS-02; BRIEF: The purpose of this study is to preliminarily evaluate anti-tumor activity of a Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Infusion (JS001) in treating advanced gastric adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and neck squamous cell carcinoma and to determine the recommended phase II dose (RP2D) ; DRUG USED: Toripalimab; DRUG CLASS: Biologic; INDICATION: Nasopharyngeal Cancer; TARGET: Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Shanghai Junshi Bioscience Co., Ltd.; CRITERIA: Inclusion Criteria Subjects may be entered in the study only if they meet all of the following criteria: 1. Fully understand the study and signed the Informed Consent Form (ICF) voluntarily; 2. Subjects with histologically and/or cytologically confirmed advanced and/or metastatic gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma, who meet the following conditions (not applicable to cohort 5, 6, 7, and 8): Subjects with gastric adenocarcinoma must have received at least one line of anti-tumor treatment for advanced gastric adenocarcinoma and have documented tumor progression or be intolerable to the current available chemotherapy regimen. Subjects who have recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant chemotherapy of radical operation are eligible to this study; Subjects with esophageal squamous cell carcinoma must have received at least one line of treatment for advanced esophageal squamous cell carcinoma (including but not limited to anticancer drug treatment or radio-chemotherapy) and have documented tumor progression or be intolerable to the current chemotherapy regimen. Subjects who have recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant therapy (including but not limited to chemotherapy or radio-chemotherapy) of radical operation are eligible to this study; Subjects with nasopharyngeal carcinoma or head and neck squamous cell carcinoma who have received at least one line of treatment for advanced nasopharyngeal carcinoma or head and neck squamous cell carcinoma (including but not limited to anticancer drug treatment or radio-chemotherapy) and have documented tumor progression or be intolerable to other current chemotherapy regimens. Subjects with recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant radio-chemotherapy of radical operation are eligible to this study (only applies for Version 4.1 and the previous ones); while for the working protocol version 5.0, subjects with nasopharyngeal carcinoma can be enrolled only if they meet the following criteria: subjects having received at least two lines of treatment for advanced nasopharyngeal carcinoma (including but not limited to anticancer drug treatment and radio-chemotherapy), who are confirmed to have tumor progression or be intolerable to other current chemotherapy regimens; adjuvant or neoadjuvant radio-chemotherapy after radical surgery can be considered as one line of treatment if tumor recurrence or metastasis occurred within 6 months after the end of the radio-chemotherapy. 3. At least one measurable lesion (according to RECIST 1.1); Note: Any lesion which received radiotherapy treatment previously cannot be regarded as a target lesion, unless that it has definitely progressed after radiotherapy. 4. Agree to provide archived tumor tissue specimens or have biopsy to collect tumor tissues for PD-L1 IHC measurement in the central laboratory; 5. Males or females aged between 18 and 75 years old; 6. ECOG score of 0-1; 7. Life expectancy ≥ 3 months; 8. The results of laboratory tests performed within 7 days prior to enrollment must meet the following criteria: 1. Neutrophils ≥ 1.5×109/L (not applicable to cohort 5, 6, 7, and 8); 2. Platelets ≥ 75×109/L (not applicable to cohort 5, 6, 7, and 8); 3. Hemoglobin ≥ 90 g/L (without receiving infusion of concentrated red blood cells within 2 weeks); 4. Serum creatinine ≤ 1.5× upper limit of normal (ULN), or creatinine clearance > 50 mL/min (not applicable to cohort 5, 6, 7, and 8); 5. Serum total bilirubin ≤ 1.5×ULN (total bilirubin ≤ 3×ULN are acceptable for subjects with Gilbert syndrome); 6. Both AST and ALT ≤ 2.5×ULN; ALT and AST ≤ 5×ULN are acceptable for subjects with liver metastasis; 9. Serum pregnancy test result must be confirmed as negative for women of childbearing potential within 28 days prior to enrollment and the subjects must agree to take effective contraception measures throughout the study treatment period until 60 days after the end of study treatment. Women of childbearing potential are defined as women with sexual maturity, who meet any of the following conditions: 1) no hysterectomy or bilateral oophorectomy; 2) without natural menopause for a consecutive 24 months (patients with menopause after cancer treatment may also have childbearing potential) (i.e. menstruation occurred at any time during the previous consecutive 24 months) (not applicable to cohort 5, 6, 7, and 8). Female partners of childbearing potential of the male subjects should also follow the contraception requirements. Other special inclusion criteria for cohort 5, 6, 7, and 8. 1. Subjects with histologically and/or cytologically confirmed advanced and/or metastatic gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma, who meet any of the following conditions: 1. Subjects who have not received any systematic treatment. 2. Subjects who have received any neoadjuvant chemotherapy, adjuvant chemotherapy for the purpose of curing must experience a period for at least 6 months from the end of the last chemotherapy to tumor progression. 3. Subjects with head and neck squamous cell carcinoma must have received radiotherapy for the purpose of curing, and the period from the end of radiotherapy to tumor progression must be at least 1 year. 4. For subjects with gastric carcinoma, Her2 negative is required. HER2 positive is defined as IHC 3+ or IHC 2+ combined with ISH+, and ISH positive is defined as the ratio of the number of HER2 gene copies to the number of CEP17 signals ≥ 2.0. 2. Results of laboratory test conducted within 7 days before enrollment must meet the following criteria: 1. Neutrophils ≥ 2×109/L; WBC count ≥ 4×109L and < 15×109/L 2. Platelets ≥ 100×109/L; 3. Hemoglobin ≥ 90 g/L (no infusion of concentrated red blood cells within 2 weeks); 4. Creatinine clearance rate > 60 mL/min, based on the predicted value of Cockcroft-Gault glomerular filtration rate: (140 - age) × (weight, kg) × (0.85, if females) 72× (serum creatinine, mg/dL) Or: (140 - age) × (weight, kg) × (0.85, if females) 0.818 × (serum creatinine, μmol/L) 5. Serum total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN are acceptable for subjects with Gilbert syndrome); 6. INR and aPTT ≤ 1.5 × ULN, applies only to subjects who have not received anticoagulation; and for subjects who are receiving anticoagulation, the dose for anticoagulation must be stable. 3. Serum pregnancy test result must be confirmed as negative for women of childbearing potential within 28 days prior to enrollment and the subjects must agree to take effective contraception measures throughout the study treatment period until 6 months after the end of chemotherapy or 60 days after the end of study treatment (whichever comes last). Women of childbearing potential are defined as women with sexual maturities, who meet any of the following conditions: 1) no hysterectomy or bilateral oophorectomy; 2) without natural menopause for a consecutive 24 months (patients with menopause after cancer treatment may also have childbearing potential) (i.e. menstruation occurred at any time during the previous consecutive 24 months) . Female partners of childbearing potential of the male subjects should also follow the contraception requirements. Subjects fulfilling any of the following conditions cannot be enrolled in the study: 1. Known hypersensitivity to citric acid monohydrate, dihydrate sodium citrate, mannitol or polysorbate (components of the investigational drug); 2. Anti-tumor treatment with cytotoxic drugs, biological drugs (e.g. monoclonal antibody), immunotherapy (e.g. interleukin 2 or interferon), or other investigational drugs within 4 weeks prior to enrollment; 3. Tyrosine kinase inhibitor treatment within 2 weeks prior to enrollment; 4. Radiotherapy within 4 weeks prior to enrollment, or radioactive drugs within 8 weeks prior to enrollment. However, patients receiving local palliative radiotherapy for bone metastasis lesions can be included; 5. Subjects with any major surgical operation within 4 weeks prior to enrollment or who have not completely recovered from the prior operation (for the definition of major surgical operation, please refer to the Level 3 and Level 4 operations stipulated in the Management of Clinical Application of Medical Technology enforced on May 1, 2009); 6. Toxicity due to any previous anticancer treatment has not recovered to CTCAE Grade 0-1, excluding the following conditions: 1. Alopecia; 2. Pigmentation; 3. Peripheral nerve toxicity recovered to < CTCAE Grade 2 (not applicable to cohort 5, 6, 7, and 8, subjects are not eligible if peripheral neurotoxicity does not restore to normal); 4. Long-term toxicity related to radiotherapy, which will not fully recover as judged by the investigator. 7. Central nervous system metastasis with clinical symptoms (e.g. brain edema, hormone intervention required, or progression of brain metastasis) and/or carcinomatous meningitis. Subjects with prior treatment for brain or meningeal metastasis can be included if they have remained stable clinically for at least 2 months and systemic hormone treatment (Prednisone at a dose of > 10 mg/day or other equivalent hormone formulations) has been discontinued for more than 4 weeks; 8. Subjects with nasopharyngeal carcinoma or head and neck squamous cell carcinoma, who are found to have necrotic lesions by examination within 4 weeks prior to enrollment, for which there is a potential risk of massive hemorrhage as judged by the investigator; 9. Previous or other concurrent malignant tumors (expect for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors which were effectively controlled without treatment over the past 5 years); 10. Any active autoimmune disease or history of any autoimmune disease (including but are not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism. Patients with vitiligo or asthma (in childhood) which was completely resolved and without need of any intervention in adulthood can be included. However, subjects with asthma which needs bronchodilator for medical intervention cannot be included); 11. Previous treatments with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody which acts on T-cell co-stimulatory or checkpoint pathway); 12. Subjects diagnosed with active tuberculosis (TB), who are receiving anti-tuberculosis therapy or used to have anti-tuberculosis therapy within 1 year prior to screening; 13. Concomitant diseases requiring long-term treatment with immunosuppressive drugs, or corticosteroids at an effective immunosuppressive dose (Prednisone at a dose of > 10 mg/day or other equivalent hormone formulations) for systemic or local treatment purpose; 14. Subjects who have received any anti-infection vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment; 15. Pregnant or lactating women 16. Positive test for HIV; 17. Positive test for HBsAg, with HBV DNA copies detected as positive (quantitative measurements ≥ 1000 cps/mL); 18. Positive test for chronic Hepatitis C in blood screening test (HCV antibody positive); Any other clinical significant disease or condition, which as evaluated by the investigator, may affect the protocol compliance, signing of inform consent form (ICF), or not suitable to participate into this clinical trial. ; PRIMARY OUTCOME: Objective response rate (ORR) evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1); 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 I - Dose Escalation; BRIEF: This study is a first-in-human, multicenter, open-label, nonrandomized, dose-escalation trial to be conducted in 2 sequential parts: - Part A (Dose Escalation) in subjects with advanced malignancies - Part B (Dose Confirmation) in subjects with tumor type(s) to be determined by results of Part A ; DRUG USED: NEV-801; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Hypoxia Inducible Factor-1 alpha (HIF-1a), Topoisomerase I (Topo-I), Topoisomerase II (DNA gyrase), VEGF (Vascular endothelial growth factor), VEGF Receptor (VEGFR), WRN Protein; THERAPY: Monotherapy; LEAD SPONSOR: Neovia Oncology Ltd.; CRITERIA: Inclusion Criteria: 1. Male or female at least 18 years of age 2. Willing and able to provide written informed consent and comply with the requirements of the study 3. Pathologically confirmed advanced malignancy for which standard therapy proven to provide clinical benefit does not exist or is no longer effective 4. Part A only: Evaluable disease, measurable either on physical examination or by imaging according to RECIST v1.1 or by informative tumor marker(s) 5. Part B only: Selected tumor type(s), as determined by results of Part A 6. Part B only: Measurable disease, using RECIST v1.1 7. ECOG performance status of 0 or 1 Exclusion Criteria: 1. Receipt of more than 5 prior regimens of cytotoxic chemotherapy (unless prior approval is granted by the Sponsor) 2. Any chemotherapy, immunomodulatory drug therapy, antineoplastic hormonal therapy, immunosuppressive therapy, corticosteroids > 20 mg/day prednisone or equivalent (unless administered to prevent contrast material reactions during radiographic procedures), or growth factor treatment (e.g., erythropoietin) within 14 days before first NEV801 dose 3. Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to ≤ Grade 1, according to the NCI CTCAE v4.03 4. Radiotherapy within 28 days before the first NEV801 dose 5. Use within 7 days of the first NEV801 dose, or anticipated use, of agents that are strong inhibitors of CYP3A4, CYP1A2 and CYP2D6 enzymes (unless approved by the Sponsor) - see Section 5.6 for a list of strong CYP3A4, CYP1A2 and CYP2D6 inhibitors 6. Use of any investigational agents within 28 days of the first NEV801 dose 7. Major surgery within 28 days before the first NEV801 dose 8. Life expectancy < 12 weeks 9. Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months before the first NEV801 dose 10. History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QT corrected by the Fridericia formula (QTcF) interval to > 450 msec for males or > 470 msec for females 11. Previous malignancy other than non-squamous-cell carcinoma of skin or carcinoma in situ of the uterine cervix (unless the tumor was treated with curative intent more than 2 years before the first NEV801 dose) 12. Active bacterial, viral, or fungal infection requiring systemic therapy. 13. Known HIV infection or AIDS-related illness 14. Known active viral hepatitis 15. Presence of genetic polymorphism of UGT1A1 leading to reduced glucuronidation 16. Pregnant or lactating female 17. Women of childbearing potential, unless they agree to use 2 contraceptive methods which, in the opinion of the Investigator, are effective and adequate for that subjects circumstances while on study drug and for 3 months afterward 18. Men who partner with a woman of childbearing potential, unless they agree to use 2 effective contraceptive methods (i.e., a condom, female partner using oral, injectable, or barrier method) while on study drug and for 3 months afterward 19. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or NEV801 administration; that may interfere with the informed consent process or with compliance with the requirements of the study; or that may interfere with the interpretation of study results and, in the Investigators opinion, would make the subject inappropriate for entry into this study ; PRIMARY OUTCOME: Maximum Tolerated Dose; SECONDARY OUTCOME 1: Observe any antitumor effects of NEV801[/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 - RE-SPECT ESUS; BRIEF: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment). ; DRUG USED: Pradaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Stroke Prevention in Atrial Fibrillation (SPAF); TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is a non-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical.Visualization by CT usually requires delayed imaging >24-48 hours after stroke onset. - The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months before randomization (mRS <=3 at randomization) in selected patients that are >= 60 years plus at least one additional risk factor for recurrent stroke. - Arterial imaging or cervical plus Transcranial Doppler (TCD) ultrasonography does not show extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis in artery supplying the area of acute ischemia. - As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection, there is absence of AF > 6 minutes in duration (within a 20 hour period, either as single episode or cumulative time of multiple episodes). Further inclusion criteria apply. Exclusion criteria: - Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications. - Major risk cardioembolic source of embolism such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent Atrial fibrillation (AF), c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis. - Any indication that requires treatment with an anticoagulant as per Investigators judgment. - History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved). - Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse). - Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gault equation) <30mL/min at screening, or where Investigator expects creatinine clearance is likely to drop below 30mL/min during the course of the study. Further exclusion criteria apply. ; PRIMARY OUTCOME: Adjudicated Recurrent Stroke; SECONDARY OUTCOME 1: Adjudicated Ischaemic Stroke[/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 - NT-003 (w/NEO-PV-01 + Nivolumab); BRIEF: The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma. The study will also investigate an alternative schedule for the administration of the NEO-PV-01 vaccine. Study interventions will be assessed by both clinical and immune responses to treatment. ; DRUG USED: APX005M; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Combination; LEAD SPONSOR: BioNTech US Inc.; CRITERIA: Inclusion Criteria: - Willing and able to give written informed consent. - Age ≥ 18 years. - Have cytologically or histologically confirmed advanced or metastatic melanoma and having received no prior systemic therapy for metastatic disease. - Have at least 1 site of disease measurable by RECIST 1.1 that has not been treated with local therapy within 6 months of study treatment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. - Have at least 1 site of disease accessible to repeat biopsies for tumor sequencing and immunological analysis. This site may be a target lesion as long as it will not become unmeasurable by the biopsy procedure. - Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 with an anticipated life expectancy of > 6 months. - Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities, see below limits for inclusion) or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (e.g., alopecia or vitiligo). - Screening laboratory values must meet the following criteria and should be obtained within 30 days (or 45 days if a biopsy is repeated) prior to study treatment: 1. White blood cell (WBC) count ≥ 3 × 103/µL 2. Platelet count ≥ 100 × 103/µL 3. Hemoglobin > 9 g/dL 4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastases 6. Total bilirubin ≤ 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL). - Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. - Female patients of childbearing potential must be willing to use an adequate method of contraception, as outlined in the protocol, for the course of the study through 120 days after last dose of study medication. - Male patients of childbearing potential must agree to use an adequate method of contraception, as outlined in the protocol, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. Exclusion Criteria - Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of first dose of treatment. - Received any systemic therapy for advanced or metastatic cancer treatment including immunotherapeutic agents such as anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-CD40, or anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA-4) antibody therapy. - Have had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AE due to agents administered more than 4 weeks earlier. - Have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 30 days prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously administered agent. 1. Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study. 2. Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. - Received radiation therapy at the biopsy sites. - Received prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of Cycle 1/Day 1. - Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either magnetic resonance imaging (MRI) or computed tomography (CT) scan] for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability. - Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. - Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. - Received a live vaccination within 30 days of planned treatment start date. - Have an active infection requiring systemic therapy. - Have a history of sensitivity or allergy to mAbs or immunoglobulin G (IgG). - Have a history of allogeneic bone marrow transplantation. - Have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). - Have known active Hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (e.g., hepatitis C virus [HCV] RNA [qualitative] is detected). - Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia. - Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs. - Have a planned major surgery. - Are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. - Nursing women are excluded from this study because there is an unknown but potential risk of AEs in nursing infants secondary to treatment of the mother with nivolumab, personalized neoantigen peptides, adjuvant, ipilimumab, and APX005M. - Have a history of additional invasive metastatic disease (other than melanoma), except for the following: 1. Individuals with a history of invasive metastatic disease are eligible if they have been disease free for at least 2 years and are deemed by the Investigator to be at low risk for recurrence of that metastatic disease; 2. Individuals with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or local papillary thyroid cancer, who have undergone therapy with curative intent. - Have severe hypersensitivity (≥ Grade 3) to nivolumab and/or any of its excipients. - Have mucosal melanoma, uveal melanoma, or acral lentiginous melanoma. ; PRIMARY OUTCOME: The rate of adverse events and severe adverse events leading to treatment discontinuation; SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - Multinational; BRIEF: The purpose of this adaptive trial is to determine the clinical efficacy of Ifenprodil in the treatment of patients infected with COVID-19. This Protocol is largely based on the recommendations of the World Health Organization (WHO) R&D Blueprint Clinical Trials Expert Group COVID-19 Therapeutic Trial Synopsis, and associated Master Protocol. The choice of the primary outcome measure will be determined by a pilot study of the first 150 subjects. Subject clinical status (on a 7-point ordinal scale) at day 15 in treatment versus the control group is the default primary endpoint. ; DRUG USED: NP-120; DRUG CLASS: Non-NME; INDICATION: COVID-19 Treatment; TARGET: NMDA Glutamate Receptor, Sigma-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Algernon Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male and female subjects aged ≥18 years of age 2. Confirmed coronavirus infection 1. Positive real-time fluorescence polymerase chain reaction of the patients respiratory or blood specimens for COVID-19 nucleic acid 2. Viral gene sequences in respiratory or blood specimens that are highly homologous to COVID-19 3. Any other diagnostic test accepted by local regulatory authorities 3. Must be hospitalized and requiring supplemental oxygen, or on non-invasive ventilation or high flow oxygen devices (Score of 4 or 5 on WHO Ordinal Clinical Scale) 4. Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least 1 highly effective method of contraception (e.g. oral contraceptives, intrauterine device, diaphragm plus spermicide) from the time of screening and must agree to continue using such precautions for 90 days after the final dose of study drug(s) 5. Non-sterilized males who are sexually active with a female partner of childbearing potential must use condom plus spermicide from day 1 through 90 days after receipt of the last dose of study drug(s) 6. Subjects (or reasonable legal designate) must have the capacity to understand, sign and date a written, informed consent form and any required authorization prior to initiation of any study procedures Exclusion Criteria: 1. Patients with vasodilatory shock, orthostatic hypotension, hypotension, or tachycardia at screening/baseline 2. Patients experiencing cerebral hemorrhage or cerebral infarction at baseline 3. ALT/AST > 5 times the upper limit of normal; Child-Pugh Score 10 to 15 4. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) 5. Patients on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6. Patients taking droxidopa 7. Pregnant and lactating women and those planning to get pregnant 8. Known or suspected allergy to the trial drug or the relevant drugs given in the trial 9. Presence of other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial 10. Know inability of patient to comply with the protocol for the duration of the study 11. Involvement in a clinical research study within 4 weeks prior to screening and/or prior enrollment in the study or plan to participate in another interventional clinical trial during the study period. Participation in observational registry studies is permitted. ; PRIMARY OUTCOME: Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients:; SECONDARY OUTCOME 1: Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EV-002; BRIEF: The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult subjects ; DRUG USED: Jeuveau; DRUG CLASS: Biosimilar; INDICATION: Wrinkles; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Evolus, Inc.; CRITERIA: Inclusion Criteria: - Subjects is an adult, of at least 18 years of age - Subject is able to provide informed consent and comply with study instructions - Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS - Subject has moderate to severe glabellar lines at maximum frown as assessed by the subject using the GLS - Subject is willing and able to complete the entire course of the study Exclusion Criteria: - Previous treatment with botulinum toxin of any serotype in any area within the last 6 months - Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months - Previous insertion of permanent material in the glabellar area - Planned treatment with botulinum toxin of any serotype in any other body region during the study period - Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow) - Energy-based or cryo-therapy based treatment of facial muscles superior to the lateral canthus - Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine) - Subjects who may not respond to 20 Units of botulinum toxin (e.g., inability to substantially lessen glabellar frown lines even by physically spreading them apart) - Marked facial asymmetry - Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis - History of facial nerve palsy - Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin - Any active infection in the area of the injection sites - Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis) - Evidence of recent alcohol or drug abuse - Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study - Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception - Known allergy or hypersensitivity to botulinum toxin preparation - Participation in another interventional clinical study within the last 30 days ; PRIMARY OUTCOME: Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject; SECONDARY OUTCOME 1: Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject[/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 - PACIFIC; BRIEF: A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer. ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Age at least 18 years. 2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III) 3. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. 4. World Health Organisation (WHO) Performance Status of 0 to 1. 5. Estimated life expectancy of more than 12 weeks. Exclusion Criteria: 1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. 2. Active or prior autoimmune disease or history of immunodeficiency. 3. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. 4. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. 5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy. 6. Active or prior documented inflammatory bowel disease (eg, Crohns disease, ulcerative colitis). ; PRIMARY OUTCOME: Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1); SECONDARY OUTCOME 1: Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Safety; BRIEF: This study is being done to find out the side effects (unwanted effects) that are caused in patients with cancers who are given SGN-2FF. This study will also attempt to find the most suitable dose in the disease or condition being studied and look at other effects of SGN2FF, including its effect on cancer. This study has several different parts. Part A will try to find the highest safe dose. Part B will enroll more patients to be treated at the highest safe dose or a lower dose to better understand how well SGN-2FF is tolerated. Part C will try to find the highest safe dose of SGN-2FF when it is given combined with pembrolizumab. Pembrolizumab is a standard treatment for cancer. Part D will enroll more patients to be treated at the highest safe dose of SGN-2FF combined with pembrolizumab or a lower dose of SGN-2FF to better understand how well SGN-2FF is tolerated when it is given with pembrolizumab. ; DRUG USED: SGN-2FF; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Fucosyltransferase/Fucosylation; THERAPY: Monotherapy; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Patients with histologically or cytologically-confirmed, locally advanced, or metastatic solid malignancy that is relapsed, refractory, or progressing following at least 1 prior systemic therapy (Part A) - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 - Patients in Part B must have histologically or cytologically-confirmed, locally-advanced, or metastatic solid malignancy within the disease indications of Part A - Adequate baseline hematologic, renal, and hepatic function - Patients for whom there is no further standard therapy available at the time of enrollment (Part A) - Patients with a histologically-confirmed, advanced solid malignancy meeting one of the following criteria: (1) indication for which pembrolizumab is approved or (2) relapsed, refractory, or progressive disease following at least 1 prior therapy and for which no further standard therapy is a available (Parts C and D) Exclusion Criteria: - Patients with carcinomatous meningitis or active central nervous system (CNS) metastases - Patients with recent (within 14 days) or serious ongoing infection - Patients requiring systemic treatment with corticosteroids (greater than 10 mg prednisone equivalents) or immunosuppressive medications within 14 days of enrollment - Patients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapy - Known active or latent tuberculosis - Uncontrolled diabetes mellitus - History of interstitial lung disease - Gastrointestinal abnormality that would affect absorption of SGN-2FF - Patients tested positive for hepatitis B or with a known, active hepatitis C infection - Women who are pregnant or breastfeeding - Patients with deep vein thrombosis (DVT) - Contraindication to prophylactic anticoagulation ; PRIMARY OUTCOME: The number of participants with adverse events that are related to treatment; SECONDARY OUTCOME 1: Pharmacokinetic assessments[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - w/CRLX101 (NCI Study) ; BRIEF: Background: EP0057 consists of a sugar molecule cyclodextrin linked to a chemotherapy drug called camptothecin. The combined molecule or nanoparticle drug conjugate travels through the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule. Olaparib is a drug that may stop cancer cells from repairing the DNA damage caused by chemotherapy. Researchers want to see how safe it is to give EP0057 and olaparib together and to see how well the combination treats a specific type of lung cancer called small cell lung cancer (SCLC). Objectives: To test the safety and maximum dose of EP0057 and olaparib together. To test how well they treat small cell lung cancer. Eligibility: Adults 18 and older with small cell lung cancer. Design: Participants will be screened with standard cancer care tests. Participants will get the 2 study drugs in 28-day cycles. EP0057 will be given every 2 weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a day most days. Participants will keep a pill diary. For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits. At study visits, participants may have: - Blood and hair samples taken - History and Physical exam - Questions about health and side effects - Pregnancy test - Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin. - CT scan - Injection of EP0057 (twice per cycle) - Olaparib prescription <TAB> Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will have a physical exam and blood tests. They may have a tumor biopsy. The study team will call the patient every 3 months for follow up after completing the study treatment. ; DRUG USED: Lynparza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: - INCLUSION CRITERIA: - Phase I - Patients must have histologically or cytologically confirmed advanced solid tumor that is resistant or refractory to standard therapy. - A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade <= 1 from all reversible toxicities related to prior therapy is required at study entry. - Patients do not need to have measurable disease to enroll on phase I. - Age 18 years. - ECOG performance status <=2 - Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed. - Patients must have normal organ and marrow function as defined below: - leukocytes >=3,000/mcL - absolute neutrophil count >=1,500/mcL without growth factor support - platelets >=100,000/mcL without growth factor support - hemoglobin >=9 g/dL, and no blood transfusion within 4 weeks. OR - Hemoglobin >10 g/dL, and no blood transfusion within 2 weeks. - total bilirubin <=1.5 x ULN (unless Gilbert s Disease) - AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal (<= 5X ULN if liver mets) - creatinine <= ULN OR - creatinine clearance >= 51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal. -The effects of EP0057 and olaparib on the developing human fetus are unknown. For this reason and because these agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as: - Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, - LH and FSH levels in the post-menopausal range for women under 50, - radiation-induced oophorectomy with last menses >1 year ago, - chemotherapy-induced menopause with >1 year interval since last menses, - or surgical sterilization (bilateral oophorectomy or hysterectomy). - Negative urine pregnancy test < =3 days prior to C1D1 (women of childbearing potential only) - Patient 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. INCLUSION CRITERIA: - Phase II SCLC - Age >=18 years. - Patients must have histologically or cytologically confirmed diagnosis of SCLC from a CLIA-certified laboratory. - Have received and progressed during or after a platinum-based standard chemotherapy regimen and/or an immune-checkpoint inhibitor - Patients could have received any number of therapies for relapsed or progressive disease, including re-treatment with original frontline regimen. A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade <= 1 from all reversible toxicities related to prior therapy is required at study entry. No previous irradiation to the site of measurable or evaluable disease, unless that site had subsequent evidence of progression. - Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors, version (RECIST 1.1). - Radiographic evidence of disease progression after initial therapy should have been documented. - ECOG performance status <=2. - Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed. - Patients must have normal organ and marrow function as defined below: - Leukocytes >=3,000/mcL - absolute neutrophil count >=1,500/mcL without growth factor support - platelets >=100,000/mcL without growth factor support - hemoglobin >=9 g/dL, and no blood transfusion within 4 weeks. OR - hemoglobin >10 g/dL, and no blood transfusion within 2 weeks. - total bilirubin <=1.5 x ULN (unless Gilbert s Disease) - AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal (<= 5X ULN if liver mets) - creatinine <= ULN OR - creatinine clearance >=51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal. - The effects of EP0057 and olaparib on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of child-bearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as: - Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, - LH and FSH levels in the post-menopausal range for women under 50, - radiation-induced oophorectomy with last menses >1 year ago, - chemotherapy-induced menopause with >1 year interval since last menses, - or surgical sterilization (bilateral oophorectomy or hysterectomy). INCLUSION CRITERIA: for Urothelial Carcinoma Expansion Cohort (accrual to the cohort ended with amendment version 08/17/2022) - Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis from a CLIA-certified laboratory, with measurable disease by RECIST (version 1.1) including lymphadenopathy and visceral metastatic disease - Male or female patients >= 18 years of age. - Patient must have received at least one platinum based regimen of chemotherapy and/or an immune-checkpoint inhibitor if appropriate with progressive disease. - Prior antiangiogenic and radiation therapy are permitted (2-week washout from therapy is required). - Bisphosphonates and denosumab are permitted if on a stable dose for >=4 weeks. - ECOG 0 2 - Patients must have normal organ and marrow function as defined below: - leukocytes >=3,000/mcL - absolute neutrophil count >=1,500/mcL without growth factor support - platelets >=100,000/mcL without growth - factor support - hemoglobin >=9 g/dL, and no blood transfusion within 4 weeks. OR - hemoglobin >10 g/dL, and no blood transfusion within 2 weeks. - total bilirubin<TAB> <=1.5 x ULN (unless Gilbert s Disease) - AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal (<= 5X ULN if liver mets) - creatinine <= ULN -The effects of EP0057 and olaparib on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of child-bearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as: - Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, - LH and FSH levels in the post-menopausal range for women under 50, - radiation-induced oophorectomy with last menses >1 year ago, - chemotherapy-induced menopause with >1 year interval since last menses, - or surgical sterilization (bilateral oophorectomy or hysterectomy). - Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of olaparib. - Ability to understand and the willingness to sign a written informed consent document. - Willingness to release archival tissue sample for research purposes, if available INCLUSION CRITERIA for mCRPC Expansion Cohort (accrual to the mCRPC cohort ended with amendment version 7/27/2021) - Patients must have metastatic, progressive, castrate resistant prostate cancer (mCRPC). - Documented histopathological confirmation of prostate cancer from a CLIA-certified laboratory. - All patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy. - Patients must have received prior treatment with enzalutamide and/or abiraterone with the exception of patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel treatment or who progress within one month of the last docetaxel dose. - Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]) - Patients must have undergone bilateral surgical castration or must agree to continue on GnRH agonists/antagonists for the duration of the study. - ECOG performance status <= 2 - Patients must have adequate bone marrow, hepatic, and renal function with: - leukocytes >=3,000/mcL - absolute neutrophil count >=1,500/mcL without growth factor support - platelets >=100,000/mcL without growth factor support - Hemoglobin >=9 g/dL, and no blood transfusion within 4 weeks. OR - hemoglobin >10 g/dL, and no blood transfusion within 2 weeks. - total bilirubin <=1.5 x ULN (<=3 (SqrRoot) ULN for subjects with Gilbert s Disease) - AST(SGOT)/ALT(SGPT) <=3 X institutional upper limit of normal (<= 5X ULN if liver mets) - creatinine <= ULN OR --creatinine clearance >=51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal. - Men must be at least 18 years of age. - Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consent. - Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation and for 120 days after last dose of study drug. Sexually active subjects and their female partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 3 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must also agree to use both a barrier method and a second method of birth control during the course of the study and for 3 months after the last dose of study drug(s). Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. Patients who were treated for metastatic castrate-sensitive prostate cancer with docetaxel and androgen deprivation therapy who progress on docetaxel treatment or who progress within one month of the last docetaxel dose are eligible. EXCLUSION CRITERIA: - Phase I and II SCLC and UC Expansion Cohort (note: accrual to the UC cohort ended with amendment version 08/17/2022) - Patients who are receiving any other investigational agents. - Persistent toxicities (>= CTCAE grade 2) with the exception of alopecia and neuropathy, caused by previous cancer therapy - Patients who have had prior treatment with olaparib or other camptothecin inhibitors (UC expansion Cohort Only). - Patients with myelodysplastic syndrome/acute myeloid leukemia or active pneumonitis; or baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated. - Hypersensitivity to study therapies ... ; PRIMARY OUTCOME: Expansion: To determine overall response rate of EP0057 plus olaparib in patients with mCRPC; SECONDARY OUTCOME 1: To determine safety in patients on expansion cohorts: table of toxicities including type, severity, time of onset, time of resolution and probable association with study regimen[/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 - Trigeminal Neuralgia (Food Effect); BRIEF: The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants. ; DRUG USED: Vixotrigine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuropathic Pain; TARGET: Sodium Channel Nav1.7 (SCN9A); THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: - Must have a body mass index between 18 and 30 kg/m2, inclusive. - Must be in good health as determined by the Investigator, based on medical history and screening evaluations. - Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe. Key Exclusion Criteria: - History of, or positive test result at Screening for, human immunodeficiency virus (HIV). - Positive test result at Screening for hepatitis C virus antibody. - Positive test result at Screening for hepatitis B virus (defined as positive for hepatitis B surface antigen and/or hepatitis B core antibody). - Previous exposure to BIIB074. - Consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of Day -1 and an unwillingness to refrain from product use during study participation. - History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug screen or alcohol breath test at Screening or Day -1, or an unwillingness to refrain from alcohol, or illicit or recreational drugs, during the study. - History or evidence of habitual use of tobacco- or nicotine-containing products within 90 days of Screening, or a positive cotinine screen at Screening or Day -1. Note: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax); SECONDARY OUTCOME 1: Number of participants experiencing 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 IIb - ASPIRE - C206 (w/PEG/RBV); BRIEF: The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV). ; DRUG USED: Olysio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Tibotec Pharmaceuticals, Ireland; CRITERIA: Inclusion Criteria: - Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C virus (HCV) and HCV RNA positive - Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL - Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment) - Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication Exclusion Criteria: - Has an evidence of decompensated liver disease - Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV) - Has a medical condition which is a contraindication to Peg-INF or RBV therapy - Have had history of, or any current medical condition which could impact the safety of the patient in the study ; PRIMARY OUTCOME: The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24); SECONDARY OUTCOME 1: The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During 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 III - ShORe (w/Ranibizumab); BRIEF: A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52. ; DRUG USED: OPT-302; DRUG CLASS: Biologic; INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Opthea Limited; CRITERIA: Inclusion Criteria: - Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye. - An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye. Main Exclusion Criteria: - Any previous treatment for neovascular AMD. - Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging. - Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study. ; PRIMARY OUTCOME: Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters; SECONDARY OUTCOME 1: Proportion of participants gaining 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters[/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/PT003; BRIEF: ; DRUG USED: Breztri Aerosphere; DRUG CLASS: Non-NME; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR), Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: ; CRITERIA: ; 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 I - SGN123-001; BRIEF: The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients. ; DRUG USED: SGN-CD123A; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Antibody-drug Conjugate (ADC), IL-3 (Interleukin-3) Receptor/CD123; THERAPY: Monotherapy; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens - Patients may be eligible after only 1 previous regimen if in a high risk category - Adequate baseline renal and hepatic function - Eastern Cooperative Oncology Group Status of 0 or 1 - CD123-detectable leukemia Exclusion Criteria: - Cerebral/meningeal disease related to underlying malignancy - Promyelocytic leukemia - History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide <50% predicted - Prior hematopoietic stem cell transplant - Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine) - Cardio or cerebral vascular event within 6 months ; PRIMARY OUTCOME: Type, incidence, severity, seriousness, and relatedness of adverse events; SECONDARY OUTCOME 1: Blood concentrations of SGN-CD123A, total antibodies, and metabolites[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RE-MODEL (Knee-EU); BRIEF: A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery) ; DRUG USED: Pradaxa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria Inclusion criteria (selected): - Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement - Written Informed Consent Exclusion criteria Exclusion criteria (selected): - Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia. - Active malignant disease or current cytostatic treatment - Known severe renal insufficiency - Liver disease expected to have any potential impact on survival, or elevated aspartate aminotransferase (AST) or alanine transaminase (ALT) > 2x upper limit of normal - Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months - Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control - Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran - Contraindications to enoxaparin - Participation in a clinical trial during the last 30 days ; PRIMARY OUTCOME: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period; SECONDARY OUTCOME 1: Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Sexual Dysfunction - 318 (US/CA); BRIEF: The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning. ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Is a man or a woman aged between 18 and 55 years, inclusive, who is currently being treated with selective serotonin reuptake inhibitor (SSRI) monotherapy (only citalopram, paroxetine, or sertraline allowed) for at least 8 weeks, which was prescribed to treat a major depressive episode (MDE), according to the DSM-IV-TR criteria. 2. Is currently stable; and has a Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score of ≤3. 3. Is currently experiencing treatment-emergent sexual dysfunction (TESD; defined as a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score ≤41 for women and ≤47 for men), considered to be attributable to the current SSRI monotherapy and is suitable for a switch. Exclusion Criteria: 1. Has previously participated in a Lu AA21004 clinical study. 2. Has 1 or more the following: any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; as assessed by the Mini International Neuropsychiatric Interview Version 6.0.0); current or history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR; current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to Screening (subject must also have negative urine drug screen prior to Baseline); presence or history of a clinically significant neurological disorder (including epilepsy); neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc); or any Axis II disorder that might compromise the study. 3. Has sexual dysfunction associated with an etiology other than SSRI treatment or current MDE (e.g., due to a medical condition, such as diabetes or hypertension, a medication, a genital anatomical deformity, or alcohol abuse). 4. Is nonsexually active or anticipates decreasing frequency of sexual activity (ie, sexual activity anticipated to lead to orgasm or that would normally lead to orgasm, which can include sexual intercourse, oral sex, masturbation, sexual fantasies, and/or thinking of sexual activity) during the course of the study below the level at study initiation. 5. Is a male with a history of premature ejaculation in the past year. 6. Has had major relationship changes during the preceding SSRI treatment period or plans to have major relationship changes during the course of the study. 7. Has a sexual partner(s) who plans to initiate treatment for sexual dysfunction during the study. ; PRIMARY OUTCOME: Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8; SECONDARY OUTCOME 1: Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PK; BRIEF: The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum observed serum concentration (Cmax). ; DRUG USED: Prolia; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: RANK Ligand (RANKL); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Postmenopausal women (postmenopausal is defined as no vaginal bleeding or spotting for at least 12 months) - Low bone mineral density (BMD) as determined by screening BMD T-scores of the lumbar spine (L1 to L4), or total evaluable vertebrae (if fewer than L1 to L4), or total hip ≤ -1.0 - Receiving a 50 mg dose of etanercept once weekly ≥ 6 months prior to screening and expected to continue etanercept treatment at this dose and frequency through end of study (EOS) - If currently taking methotrexate (MTX), receiving a stable dose (7.5 to 20 mg/week) of MTX ≥ 8 weeks prior to screening - Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 400 IU vitamin D daily upon enrollment Exclusion Criteria: - Type 1 diabetes; OR poorly controlled Type 2 diabetes (hemoglobin A1c (HbA1c) > 8.0% at screening; HbA1c ≤ 8.0% within 6 months of screening is acceptable if supporting laboratory documentation is available) - History of heart failure, coronary artery bypass graft, or cardiac arrhythmia; OR history of acute coronary syndrome - Comorbid autoimmune disease, demyelinating disease, or hematologic abnormalities - History of joint replacement in hand and/or wrist; OR history of fused joint in hand and/or wrist - Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw; OR active dental or jaw condition that requires oral surgery, or non-healed dental/oral surgery; OR planned invasive dental procedure(s) during the course of the study - Previous exposure to denosumab ; PRIMARY OUTCOME: Area Under the Serum Concentration-time Curve From 0 to 168 Hours (AUC0-168) for Etanercept; SECONDARY OUTCOME 1: Time to Maximum Serum Concentration (Tmax) of Etanercept[/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 - Advanced Solid Tumors; BRIEF: Many patients have cancers that have increased activity of a protein called STAT3 that contributes critically to the development and growth of their cancer. Despite our knowledge of STAT3s importance to cancer, scientists and doctors have not developed a drug that targets it and that patients can take to treat their cancer more effectively than treatments that are now available. Tvardi Therapeutics, Incorporated has developed a compound, TTI-101, which can be given by mouth and acts as a direct inhibitor of STAT3. Administration of TTI-101 to mice demonstrated that it blocked growth of cancers of the breast, head and neck, lung, and liver and it was safe when administered at high doses to mice, rats, and dogs. In this application, Tvardi is proposing to further develop TTI-101 for treatment of solid tumors for which the prognosis is dismal. The investigators will determine how safe it is when administered to patients with cancer, determine whether an adequate dose can be administered to patients with cancer that will block STAT3 in their cancer, and determine whether treatment with TTI-101 leads to reduced growth of their cancer. ; DRUG USED: TTI-101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: STAT3 Transcription Factor; THERAPY: Monotherapy; LEAD SPONSOR: Tvardi Therapeutics, Incorporated; CRITERIA: Inclusion Criteria All of the following inclusion criteria must be fulfilled for eligibility: 1. Age ≥18 years; 2. For patients with solid tumors (not unresectable HCC): Patients with histologically confirmed diagnosis of locally-advanced, inoperable, metastatic and/or treatment refractory solid tumors for whom there are no available therapies that will confer clinical benefit; 3. For patients with unresectable HCC: Patients with histologically confirmed diagnosis of locally advanced, inoperable, unresectable HCC who have failed first and second lines of therapy and Child-Pugh is A or beyond second line if the performance status is preserved and Child-Pugh is A. 4. Eastern Cooperative Oncology Group Performance status 0-1; 5. Hemoglobin ≥9.0 g/dL, neutrophil count ≥1.0 x 109/l, platelets ≥75 x 109/L; 6. Adequate renal function capability, as calculated by creatinine clearance >40 ml/min using the Cockroft-Gault formula; 7. Adequate liver function defined as total bilirubin <1.5 x ULN, and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <3 x ULN. For subjects with liver involvement, AST/ALT <5 x ULN; For subjects with liver involvement, AST/ALT <5 x ULN; 8. Measurable disease using clinically appropriate criteria for the type of malignancy, RECIST v 1.1 for solid tumors; 9. Negative pregnancy test at the screening visit for women of childbearing potential, defined as: female subjects after puberty unless they have been postmenopausal for at least two years, are surgically sterile, or are sexually inactive and will remain so for the course of the trial; 10. Willingness to avoid pregnancy and breast feeding beginning two weeks before the first TTI-101 dose and ending three months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must use adequate contraception in the judgment of the Investigator, such as a two-barrier method or a one-barrier method with spermicide or intrauterine device during trial treatment dosing and for 3 months after the last dose of the study; and 11. Ability to read and understand the informed consent form and willingness and ability to give informed consent and demonstrate comprehension of the trial before undergoing any trial activities. Exclusion Criteria Subjects are ineligible to enroll in this trial if they fulfill any of the following exclusion criteria: 1. Previous therapy with: 1. Standard therapy including chemotherapy, immunotherapy, biologic therapy, or any other anticancer therapy within 28 days (or five elimination half-lives for non-cytotoxic drugs, whichever is shorter) of Day 1 of trial drug treatment (6 weeks for nitrosureas or mitomycin); 2. Any investigational agent within 28 days of Day 1 of trial drug treatment or 5 half-lives for a small molecule/targeted therapy; 2. Extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation within 5 years from enrollment; Ongoing toxicity (except alopecia) due to a prior therapy, unless returned to baseline or Grade 1 or less; 3. Major surgical intervention or participation in a therapeutic clinical trial within 28 days from Day 1 of the first dose of TTI-101; 4. Significantly impaired cardiac function such as unstable angina pectoris, congestive heart failure with New York Heart Association (NYHA) class III or IV, myocardial infarction within the last 12 months prior to trial entry; signs of pericardial effusion, serious arrhythmia (including QTc prolongation of >470 ms and/or pacemaker) or prior diagnosis of congenital long QT syndrome or left ventricular ejection fraction <50% on screening echocardiogram; 5. History of cerebral vascular accident or stroke within the previous 2 years; 6. Uncontrolled hypertension (>160/100mm Hg); 7. History of Grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition as TTI-101 (hydroxyl-naphthalene sulfonamides); 8. Known active metastases in the central nervous system (unless stable by brain imaging studies for at least 1 month without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants); 9. History of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the investigational product; 10. Known human immunodeficiency virus (HIV); 11. Subjects with chronic hepatitis B virus (HBV) infection, unless screening viral load <100 IU/mL on stable doses of antiviral therapy. Note: Subjects with chronic HCV infection are allowed to enroll in the study but do not have a defined maximum viral load requirement for study entry; 12. Legal incapacity or limited legal capacity; 13. Pregnant or lactating women; 14. Any other condition, which in the opinion of the investigator, might impair the subjects tolerance of trial treatment, the safety of the individual subject, or the outcome of the trial; 15. Previous treatment of the current malignancy with a STAT inhibitor. ; PRIMARY OUTCOME: Maximum Tolerated Dose of TTI-101; SECONDARY OUTCOME 1: Pharmacodynamics of TTI-101 in patients[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - VX18-121-101; BRIEF: The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF). ; DRUG USED: Symdeko; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Key Inclusion Criteria: - Part 1: Heterozygous for F508del and an MF mutation (F/MF) - Part 2: Homozygous for F508del (F/F) - FEV1 value ≥40% and ≤90% of the predicted mean for age, sex, and height Key Exclusion Criteria: - History of clinically significant cirrhosis with or without portal hypertension - Lung infection with organisms associated with a more rapid decline in pulmonary status - History of solid organ or hematological transplantation Other protocol-defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Absolute Change in Sweat Chloride (SwCl) Concentrations[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 16004; BRIEF: This study will evaluate the bioequivalence as well as safety and tolerability of a novel 30 mg tablet of nifurtimox compared to the corresponding marketed 120 mg tablet in adult subjects suffering from chronic Chagas disease when administered after a high-fat / high-calorie test meal. This study is a necessary step for the development of an age appropriate pediatric oral dosage form for the treatment of Chagas disease in endemic countries according to the recommendations provided by current international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage Forms). ; DRUG USED: Lampit; DRUG CLASS: Non-NME; INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Upon consent, women of childbearing potential must use 2 forms of highly effective contraception for the duration of the study and for 12 weeks after the last drug administration. The definition of highly effective contraception will be left at the discretion of the investigator and will be in line with ICH Topic M 3 (R2): Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals - Male subjects who are sterile, not sexually active or agree to use 2 forms of highly effective contraception during the study and for 12 weeks after receiving the study drug. The definition of highly effective contraception will be left at the discretion of the investigator and will be in line with ICH ICH Topic M 3 (R2): Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals - Male/female subject diagnosed with chronic Chagas disease: Previous diagnosis of acute or chronic Chagas disease by a health clinic prior to screening for the study. The diagnosis of chronic Chagas disease may be made by clinical findings, supported by antibody titers if available. If there is a known history of acute disease, it is preferable to have documentation of parasites on the blood smear if available - Age: 18 to 45 years (inclusive) at the first screening visit - Body mass index (BMI): above/equal 18 and below/equal 29.9 kg / m² Exclusion Criteria: - Incompletely cured pre-existing diseases (except chronic Chagas) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal - Acute Chagasdisease (During the acute phase, the parasite on a blood smear may be seen under a microscope. Different antibodies are present, depending on the course of the disease) - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) - Unstable or uncontrolled medical condition such as hypertension or diabetes; decompensated heart failure, gastrointestinal (GI) conditions that would interfere with the absorption of the study drug (e.g. GI ulceration, peptic ulceration, GI bleeding, gastroesophageal reflux, or other GI disease affecting gastroesophageal junction), conditions that could potentially have an impact on drug metabolism ar elimination (renal, hepatic such as known hepatic or biliary abnormalities), or any clinically relevant active infections in the opinion of the investigator within 4 weeks before the screening visit e.g. clinically relevant history or presence of significant respiratory (e.g., interstitial lung disease), hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic (e.g., diabetes), and dermatological or connective tissue disease - Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before the first study drug administration, e.g. an investigational drug, any drug altering gastrointestinal motility and /or gastric pH (e.g. antacids, anticholinergic, para-sympatholytics), any drug known to induce liver enzymes (e.g. dexamethasone, barbiturates, St. Johns Wort [hypericum perforatum]), any drug known to inhibit liver enzymes (e.g. ketoconazole, macrolides) - Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec - Systolic blood pressure below 100 or above 140 mmHg (after at least 15 min supine) - Diastolic blood pressure below 50 or above 90 mmHg (after at least 15 min supine) - Heart rate below 45 or above 95 beats / min (after at least 15 min supine) - Findings that would exclude the subject in the physicians judgment e.g. enlarged liver, irregular heartbeat, undiagnosed acute illness, melanoma ; PRIMARY OUTCOME: Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point [AUC(0-tn)]; SECONDARY OUTCOME 1: Number of participants with 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 III - TDF2; BRIEF: This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection. ; DRUG USED: Truvada; DRUG CLASS: Non-NME; INDICATION: HIV Prevention; TARGET: Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Centers for Disease Control and Prevention; CRITERIA: Inclusion Criteria: - citizen of Botswana 18-39 years old - sexually active - HIV uninfected - Hepatitis B and C uninfected - Calculated creatinine clearance >= 60 mL/min - hemoglobin >= 8 gm/dL - ALT and AST <= 2x ULN - total bilirubin <= 1.5 mg/dL - total serum amylase <= 1.5x ULN - Serum phosphorus >= 2.2 mg/dL - willing to use hormonal contraception (females) - living within 1 hours travel of study clinic - pass comprehension test - willing and able to give informed consent Exclusion Criteria: - 18-20 without parent/guardian consent - history of significant renal or bone disease - any chronic illness requiring ongoing prescription medication - pregnant or breastfeeding - planning to move away from site in the next year - participating in another HIV prevention or vaccine safety trial - any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements ; PRIMARY OUTCOME: Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms; SECONDARY OUTCOME 1: Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts[/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 - SUPPORT-1; BRIEF: This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored. ; DRUG USED: CMX-2043; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Ischemix, LLC; CRITERIA: Inclusion Criteria: - Subjects who have stable coronary artery disease undergoing elective PCI. - Female subjects not of child-bearing potential. - Absence of ST segment depression >1.0 mm and absence of ST elevation >1.0 mm in any lead on the baseline 12-lead ECG. - subjects with CK-MB and troponin-T levels lower than the upper limit of normal. - Subjects free of acute injuries or illnesses. Exclusion Criteria: - Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease. - Subjects who had had an MI within 14 days prior to the PCI procedure. - Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD). - Subjects with history of TIA/stroke within 90 days or any intracranial bleed. - Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal. - Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements. - Subjects with a history of alcohol or drug abuse. - Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive. - Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct. - Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results. - Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent. ; PRIMARY OUTCOME: Safety as measured by changes in CK-MB; SECONDARY OUTCOME 1: Cardiac biomarkers[/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 - NeoADAURA; BRIEF: This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer ; DRUG USED: Tagrisso; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Male or female, at least 18 years of age. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative - Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]). - Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures). - Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing - A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q). Exclusion Criteria: - Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. - History of another primary malignancy (including any known or suspected synchronous primary lung cancer), except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease; Any synchronous Stage IA primary lung cancer that is ≤2 cm and planned to be resected during surgery for the Stage II to IIIB N2 lung tumour. - Patients who have pre-operative radiotherapy treatment as part of their care plan - Mixed small cell and NSCLC histology - Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC - T4 tumours infiltrating the great vessels, the carina, the trachea, the oesophagus, the heart, and/or the vertebral body; and/or any bulky N2 disease. - Patients who are candidates to undergo only segmentectomies or wedge resections - Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug - Prior treatment with EGFR-TKI therapy - Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior) ; PRIMARY OUTCOME: Major Pathological Response (MPR); SECONDARY OUTCOME 1: Pathological complete response (pCR)[/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/dasatinib/cytarabine; BRIEF: PRI-724 is a new investigational drug being studied to treat subjects with cancer who have advanced myeloid malignancies. PRI-724 is thought to work by blocking the Wnt signaling pathway that cancer cells need to grow and spread (metastasize). ; DRUG USED: OP-724; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: CREBBP (CREB binding protein, CBP, RSTS, KAT3A), WNT Signaling Pathway; THERAPY: Combination; LEAD SPONSOR: Prism Pharma Co., Ltd.; CRITERIA: Inclusion Criteria 1. Patients 18 years or older 2. Part I: Patients with one of the following histologically- or cytologically-proven conditions: relapsed/refractory AML, relapsed/refractory MDS, or advanced CML in AP or BP (i.e., Acute Group patients). 3. Part II: Patients with one of the following documented conditions: CML in CP that is Philadelphia chromosome (Ph)-positive (by cytogenetics) or BCR-ABL1-positive by fluorescent in situ hybridization [FISH], or PCR), as well as resistant to at least 2 FDA-approved tyrosine kinase inhibitors (TKIs); or a myeloproliferative neoplasia which includes: PMF and myelofibrosis secondary to polycythemia vera (PV) and essential thrombocythemia (ET) myelofibrosis (MF) (with intermediate-1, intermediate-2 or high risk disease according to the International Working Group [IWG] prognostic scoring system) (i.e., Non-Acute Group patients). 4. Part III: - Arm A: Patients with AML who are 65 years of age or older with refractory or relapsed disease, or who have not received prior therapy but are not eligible to receive intensive frontline chemotherapy (i.e., Acute Group patients); - Arm B: Patients with CML in AP or BP, either newly diagnosed or failing TKI therapy (i.e., Acute Group patients); - Arm C: Patients with CML in CP after failure of 2 FDA-approved TKIs (i.e., Non-Acute group patients) 5. Performance status 0-2 of the Eastern Cooperative Oncology Group (ECOG) scale 6. Patients must have been off all prior therapy for leukemia except hydroxyurea for 1 week prior to entering this study and recovered from the toxic effects of that therapy 7. Adequate organ function as defined by: - Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥60 mL/min - Total bilirubin ≤2 x ULN (≤5 x ULN if considered due to Gilberts syndrome or hemolysis) - Alanine aminotransferase (ALT) ≤3xULN 8. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. 9. Women of childbearing potential and men should practice effective methods of contraception. Women of childbearing potential should have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin within 7 days prior to the start of PRI 724. Exclusion Criteria 1. Patients receiving any other investigational agents 2. Patients who are pregnant or breast-feeding 3. Known hypersensitivity to any of the components of PRI-724 4. Pretreatment QTcF interval >470 msec (females) or >450 msec (males) 5. Known active hepatitis B, hepatitis C 6. Serious uncontrolled medical disorder or active systemic infection or current unstable or decompensated medical condition, which makes it undesirable or unsafe for the patient to participate in the study including: New York Heart Association (NYHA) Class 3 or 4, myocardial infarction within 3 months, uncontrolled angina within 3 months, history of clinically significant ventricular arrhythmia, diabetes mellitus with ketoacidosis, or chronic obstructive pulmonary disease (COPD) requiring hospitalization in 6 months prior to the start of treatment with PRI-724. 7. Any other condition, including mental illness or substance abuse deemed by the Investigator to be likely to interfere with a patients ability to sign informed consent, cooperate, and participate in the study 8. Patients on full dose anticoagulants or any dose of warfarin; patients on prophylactic dose of low-molecular weight or unfractionated heparin are allowed. 9. Patients who have demonstrated intolerance to dasatinib 100 mg daily will not be eligible for Part III/Arm B or C of the study. ; PRIMARY OUTCOME: DLT (Dose Limiting Toxicity); SECONDARY OUTCOME 1: Preliminary Efficacy Endpoints[/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 - 101 (U.S.); BRIEF: This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase is complete and no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D). ; DRUG USED: PT-112; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Apoptosis (Cell Death), Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Promontory Therapeutics Inc.; CRITERIA: Key Inclusion Criteria: - Male >/= 18 years of age - Histologically or cytologically confirmed adenocarcinoma of the prostate. - Document current evidence of metastatic castration-resistant prostate cancer (mCRPC), where metastatic status is defined as having documented metastatic lesion(s) on either bone scan or CT/MRI scan. - Patients who have received at least three prior intended life-prolonging therapies for metastatic disease. - Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1. - Progressive disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor marker(s). - Adequate organ function based on laboratory values. - If there is a known history of brain metastases, either treated or untreated, the disease must be stable. Key Exclusion Criteria: - Any cytotoxic chemotherapy within 21 days prior to initiation of study drug. - Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug. - Bone marrow reserve which is not adequate for participation in this trial. - Radiotherapy within 14 days prior to baseline. - Fraction of radiotherapy to >25 % of active bone marrow. - Major surgery within 28 days prior to initiation of study drug. ; PRIMARY OUTCOME: Initial design: Comparison of two dose levels, administered on Days 1 and 15 of each 28-day cycle:; SECONDARY OUTCOME 1: Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria[/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 - ZA-201; BRIEF: This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion. ; DRUG USED: Zoenasa; DRUG CLASS: Non-NME; INDICATION: Ulcerative Colitis (UC); TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), EGFR (Epidermal Growth Factor Receptor), NF-Kappa B (nuclear factor kappa-light-chain-enhancer of activated B cells) , PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Altheus Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years. - They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild to moderate active disease. - Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI score of 4-10, inclusive, with a Physicians rating of disease score of 2 points or less (mild or moderate active ulcerative colitis), rectal bleeding score of 1 or more (based on subject diary), and mucosal appearance score (based on endoscopy) of 1 point or more at baseline. - Laboratory data: - White blood cell count between 4.0 - 12.0 K/mm3 - Platelet count: 150 - 500 K/mm3 - Hemoglobin > 10.0 g/dL - Total bilirubin < 1.5 mg/dL - Aspartate aminotransferase < 100 u/dL - Alanine aminotransferase < 100 u/dL - Alkaline phosphatase < 250 u/dL - Blood urine nitrogen < 40 mg/dL - Creatinine < 1.5 mg/dL - Satisfies one of the following: - Female subjects of childbearing potential must have a negative urine pregnancy test at screening; surgically sterile, post-menopausal, abstinent, or patient or partner agree to use a medically appropriate form of birth control from screening to until 1 month after the last dose of study medication. - Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening to until 1 month after the last dose of study medication. - They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. Exclusion Criteria: - They have documented history of proximal or universal ulcerative colitis, proctitis or active proctitis confined to 15cm or less from the anal verge. - They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis. - They receive a Physicians rating of disease severity as part of the modified UCDAI of 3 (severe disease) or an aggregate score of 11 or greater. - They have shown prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations. - Their stool contains enteric pathogens or Clostridium difficile toxins. - They have a history of recurrent Clostridium difficile infection. - They have prior history of biologic therapy within the previous 4 years. - They have received systemic steroids or immunosuppressants within the previous 4 weeks. - Treatment in the last 14 days that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) or mesalamine enema (Rowasa®). - Treatment in the last 7 days that included mesalamine (5-ASA) via oral administration (e.g. Asacol®, Lialda®, balsalazide, etc). - They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm. - Positive pregnancy test or lactating subjects. - There is evidence of chemical substance abuse. - They have had repeated anti-inflammatory drug treatment (longer than 3 days at doses that exceed those available without a prescription) within the previous 7 days (with exception of aspirin at doses of 325mg/day or less for prophylaxis of cardiac disease), or initiated new non-steroidal anti-inflammatory (NSAID) treatment within the last 30 days. - They have a known allergy to N-acetylcysteine or mesalamine, or have a history of serious AEs related to their use (including, but not limited to pancreatitis or hepatitis). - They have a history of failure to retain enemas. - Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease. - Use of any investigational medication within the previous 90 days. - Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome. ; PRIMARY OUTCOME: Change in modified UCDAI at 6 weeks; SECONDARY OUTCOME 1: Change in modified UCDAI at 3 weeks[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - E03; BRIEF: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease. ; DRUG USED: Amiselimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Inflammatory Bowel Disease (IBD); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - A body mass index (BMI) ranging from 16 to 34 kg/m2 - Subjects who were diagnosed as Crohns Disease or Ulcerative Colitis at least 6 months prior to Screening, clinically confirmed either by radiological, endoscopic or histological examination. - Subjects who have had at least one flare within 18 months prior to Screening. - Confirmed medical records of inflammatory lesions in intestinal tract Exclusion Criteria: - Present or past history of clinically significant gastrointestinal surgery. - Present or past history of clinically significant stenosis, stricture or fistula in small intestine or colon. - Known hypersensitivity to any formulation excipients. ; PRIMARY OUTCOME: Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events; SECONDARY OUTCOME 1: Pharmacodynamic effect of MT-1303 on lymphocyte count[/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 - MDS-003 - 5q deletion; BRIEF: This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Must understand and voluntarily sign an informed consent form - Age 18 years or older at the time of signing the informed consent - Must be able to adhere to the study visit schedule and other protocol requirements. - Diagnosis of low or intermediate-1-risk International Prognostic Scoring System (IPSS) Myelodysplastic Syndromes (MDS) without an abnormality of chromosome 5 involving a deletion between bands q31 and q33. - Red blood cell (RBC) transfusion-dependent anemia defined as having received greater than or equal to 2 units of RBCs within 8 weeks of the first day of study drug treatment. - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. - Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. - Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. - WCBP must agree to have pregnancy tests every 4 weeks while on study drug. Exclusion Criteria: - Pregnant or lactating females - Prior therapy with lenalidomide. - An abnormality of chromosome 5 involving a deletion between bands q31 and q33. - Lab Abnormality: Absolute neutrophil count (ANC) <500 cell/mm^3 (0.5*10^9/L) - Lab Abnormality: Platelet count <50,000/mm^3 (50*10^9/L) - Lab Abnormality: Serum creatinine >2.5 mg/dL (221 mmol/L) - Lab Abnormality: Serum total bilirubin >2.0 mg/dL (34 mmol/L) - Prior greater than or equal to grade 3 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) allergic reaction/hypersensitivity to thalidomide. - Clinically significant anemia due to factors such as iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding - If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be > 20% and serum ferritin not less than 50 ng/mL - Use of hematopoietic growth factors within 7 days of the first day of study drug treatment. - Prior greater than or equal to grade 3 NCI CTC rash or any desquamation (blistering) while taking thalidomide. - Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisone) within 28 days of the first day of study drug treatment. - Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study drug treatment. - Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for greater than or equal to 3 years. - Use of any other experimental therapy within 28 days of the first day of study drug treatment. ; PRIMARY OUTCOME: Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence; SECONDARY OUTCOME 1: Participants With Adverse Experiences[/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 - NeoSphere (w/Herceptin); BRIEF: This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. ; DRUG USED: Perjeta; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - female patients, >=18 years of age; - locally advanced, inflammatory or early stage invasive breast cancer; - HER2 positive (HER2+++ by IHC or FISH/CISH+). Exclusion Criteria: - metastatic disease (Stage IV) or bilateral breast cancer; - previous anticancer therapy or radiotherapy for any malignancy; - other malignancy, other than cancer in situ of the cervix, or basal cell cancer; - insulin-dependent diabetes; - clinically relevant cardiovascular disease. ; PRIMARY OUTCOME: Percentage of Participants Achieving Pathological Complete Response (pCR); SECONDARY OUTCOME 1: Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography[/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 - RAMP 201; BRIEF: This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC) ; DRUG USED: VS-6766; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K), Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Verastem, Inc.; CRITERIA: Inclusion Criteria: - Histologically proven LGSOC (ovarian, peritoneal) - Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease. - Measurable disease according to RECIST 1.1 - An Eastern Cooperative Group (ECOG) performance status ≤ 1. - Adequate organ function - Adequate recovery from toxicities related to prior treatments - Agreement to use highly effective method of contraceptive, if necessary Exclusion Criteria: - Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy - Co-existing high-grade ovarian cancer or another histology - History of prior malignancy with recurrence <3 years from the time of enrollment - Major surgery within 4 weeks - Symptomatic brain metastases requiring steroids or other interventions - Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy - For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor - Active skin disorder that has required systemic therapy within the past year - History of rhabdomyolysis - Concurrent ocular disorders - Concurrent heart disease or severe obstructive pulmonary disease - Subjects with the inability to swallow oral medications ; PRIMARY OUTCOME: Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib; SECONDARY OUTCOME 1: Overall Response Rate as assessed by Investigator[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SWOG-S0777; BRIEF: This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients must have newly diagnosed multiple myeloma with measurable disease; patients with non-secretory multiple myeloma (MM) based upon standard M-component criteria (i.e., measurable serum/urine M-component) are not eligible for this study; exception: patients with non-secretory MM will be eligible only if the baseline serum Freelite is elevated (Note that serum Freelite must be drawn; serum light chains are not acceptable); all tests for establishing baseline disease status must be completed within 28 days prior to registration and documented on the baseline and follow-up tumor assessment form for multiple myeloma - Patients must have received no prior chemotherapy for this disease; patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis); prior steroid treatment is allowed provided treatment was not more than 2 weeks in duration; patients must not have received any prior treatment with bortezomib or lenalidomide - Patients must have a Zubrod performance status (PS) of 0 - 3; NOTE: patients with PS 3 are eligible only if it is documented by the treating physician that the patients multiple myeloma is the central cause of his/her disability; patients who have a PS of 3 due to other concurrent medical conditions are not eligible for this trial - Platelet count >= 80 x 10^3/mcL; must be obtained within 28 days prior to registration; exception: patients with biopsy-proven heavy-marrow involvement, as defined by having at least 30% marrow cellularity, with > 50% of the cells being malignant plasma cells (documented marrow results required); in this case, although there are no required lower limits of normal for the blood counts, the treating physician must use his/her medical judgment as to the appropriateness of this study therapy for these patients - Absolute neutrophil count (ANC) >= 1 x 10^3/mcL; must be obtained within 28 days prior to registration; exception: patients with biopsy-proven heavy-marrow involvement, as defined by having at least 30% marrow cellularity, with > 50% of the cells being malignant plasma cells (documented marrow results required); in this case, although there are no required lower limits of normal for the blood counts, the treating physician must use his/her medical judgment as to the appropriateness of this study therapy for these patients - Hemoglobin (including patients who have been either transfused or treated with erythropoietin [EPO]) >= 9 g/dL; must be obtained within 28 days prior to registration; exception: patients with biopsy-proven heavy-marrow involvement, as defined by having at least 30% marrow cellularity, with > 50% of the cells being malignant plasma cells (documented marrow results required); in this case, although there are no required lower limits of normal for the blood counts, the treating physician must use his/her medical judgment as to the appropriateness of this study therapy for these patients - Patients must be offered participation in the Myeloma Specimen Repository for banking and future research; with the patients consent, bone marrow aspirates and serum specimens will be submitted to the Myeloma Specimen Repository for additional testing and banking (including SNP testing); patient consent must be obtained before specimens may be submitted - Patients must have baseline skeletal survey to include lateral skull, anterior-posterior (AP) pelvis and posterior-anterior (PA) chest within 28 days prior to registration - Institutions must submit a local cytogenetics report and fluorescence in situ hybridization (FISH) analysis report obtained prior to enrollment to S0777; for FISH analysis two probes will be utilized: LSI 13 (RBI) 13q14 SpectrumOrange Probe for detection of chromosome 13 deletion and LSI p53 (17p13.1) SpectrumOrange probe for detection of tumor protein (p)53 locus on chromosome 17; if these exact probes are not available locally, it is acceptable to submit results using local protocol; this must be noted on the prestudy form; NOTE: it is not required that the results of the FISH analysis be known prior to registration, only that pre-registration specimens be drawn and sent for analysis prior to registration, and the FISH analysis report be submitted - Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity must have these conditions attended to prior to registration (i.e., intramedullary rod, I.V. antibiotics, plasmapheresis) - Patients must have a calculated or measured creatinine clearance > 30 cc/min; measured creatinine clearance or serum creatinine used in calculation must be obtained within 28 days prior to registration - Patients must not have uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, myocardial infarction within the last 6 months, history of treatment for clinically significant ventricular cardiac arrhythmias, poorly controlled hypertension, or poorly controlled diabetes mellitus; patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration - Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocol - Patients must not be hepatitis B, hepatitis C or human immunodeficiency virus (HIV) positive; patients must have a negative hepatitis B and HIV test performed within 28 days prior to registration; exception: treatment-sensitive HIV infection patients will be eligible provided that immunological and virologic indices are indicative of favorable long-term survival prospects on the basis of HIV infection, but whose life expectancy is limited predominantly by multiple myeloma rather than HIV infection in the judgment of the treating physician - Patients must not have a history of cerebral vascular accident with persistent neurologic deficits - Patients must be able to take aspirin 325 mg daily (or enoxaparin 40 mg subcutaneously [SQ] daily if patient is unable to take aspirin) as prophylactic anticoagulation; exception: patients receiving anticoagulation therapy such as Coumadin or heparin will NOT receive aspirin, and therefore need not be able to take it - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure - No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years - Patients must be offered participation in gene expression profiling (GEP) molecular studies for the evaluation of genetic polymorphisms - All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional federal guidelines - At the time of patient registration, the treating institutions name and identification (ID) number must be provided to the statistical center in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base ; PRIMARY OUTCOME: Progression-free Survival; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - PROPEL (US); BRIEF: The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC). ; DRUG USED: PTG-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: Integrin Alpha-4 beta-7/LPAM; THERAPY: Monotherapy; LEAD SPONSOR: Protagonist Therapeutics, Inc.; CRITERIA: Inclusion Criteria include: - Male and female subjects age 18 to 80 years, inclusive - Diagnosis of UC for at least 2 months prior to screening - Moderate to severe active UC as defined by Mayo Score of 6 to 12 inclusive (range of 0-12) at baseline with endoscopy score of at least 2 (range 0-3) - Subject must have had an inadequate response, loss of response to or intolerance to at least of of the following medications: immunomodulators, TNF-alpha antagonists or corticosteroids - Subject is unlikely to conceive, as defined by one of the following: a) subject is male, b) subject is surgically sterilized female, c) subject is post-menopausal female >= 45 years of age with clinical documentation of menopause, or d) subject is woman of child bearing potential (WOCBP) and agrees to abstain from heterosexual activity, use adequate hormonal contraception or use double barrier contraception. - For WOCBP, a negative pregnancy test at screening and within 24 hours of first dose of study medication Exclusion Criteria include: - Subject has Crohns Disease (CD), indeterminate colitis (IC) or presence or history of fistula with CD - History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or is at imminent risk of colectomy - History or current evidence of colonic dysplasia or adenomatous colonic polyps - Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile, infection with hepatitis B or C virus, infection with human immunodeficiency virus, infection requiring hospitalisation or intravenous antimicrobial therapy, or opportunistic infection within 6 months, any infection requiring antimicrobial therapy within 2 weeks, history of more than one episode of herpes zoster or any episode of disseminated zoster - Live virus vaccination within one month prior to screening - Subject has a concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results or poses additional risk to the subject - Known primary or secondary immunodeficiency - History of myocardial infarction, unstable angina, transient ischaemic attack, decompensated heart failure requiring hospitalisation, congestive heart failure (NYHA Class 3 or 4), uncontrolled arrhythmias, cardiac revascularisation, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening - Clinically meaningful laboratory abnormalities at screening - Pregnant or lactating females - Any surgical procedure requiring general anaesthesia within one month prior to screening, or planned elective surgery during the study - History of malignant neoplasms or carcinoma in situ within 5 years prior to screening - History of any major neurological disorders, as judged by the Investigator, or positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist - Current or recent history of alcohol dependence or illicit drug use within 1 year prior to screening. - Subject is mentally or legally incapacitated at the time of screening visit or has a history of clinically significant psychiatric disorders that would impact the subjects ability to participate in the trial according to the investigator - Unable to attend study visits or comply with procedures - Concurrent participation in any other interventional study. ; PRIMARY OUTCOME: Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AM7D; BRIEF: The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes. ; DRUG USED: Nesina; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - Has historical diagnosis of Type 2 Diabetes Mellitus. - Has been treated with diet and exercise for at least 2 months prior to Screening, and has a Glycosylated Hemoglobin concentration between 7.5% and 10.0%, inclusive at Screening. - Has received less than 7 days of any antidiabetic medication within 2 months prior to Screening. - Body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2 (except for Asian or Asian-descendant subjects for whom the range is between 20 and 35 kg/ m^2, inclusive). - Fasting C-peptide concentration greater than or equal to 0.8 ng/mL. - Regularly using other, non-excluded, medications must be on a stable dose for at least the 4 weeks prior to Screening. - Females of childbearing potential and males who are sexually active agree to routinely use adequate contraception from Screening throughout the duration of the study. - Able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete patient diaries. Exclusion Criteria: - Hemoglobin less than 12 g/dL for males and less than 10 g/dL for females at Screening Visit. - Has a history of any hemoglobinopathy that may affect determination of Glycosylated Hemoglobin. - Has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. - Has a history of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery. - Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma. - Has systolic blood pressure greater than or equal to 150 mmHg and /or diastolic pressure greater than or equal to 90 mmHg at Screening visit. - Has New York Heart Association Class III to IV heart failure. - Has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 90 days prior to Screening. - Has Alanine aminotransferase greater than 3 times the upper limit of normal at Screening. - Has a history of alcohol or substance abuse with the 2 years prior to Screening. - Serum creatinine greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.4 mg/dL for females. - Has history of cancer, other than squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to Screening. - Has a history of infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus. - Has any major illness or debility that in the investigators opinion prohibits the subject from completing the study. - Has received any investigational drug within the 90 days prior to Screening. - Has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors, metformin or related compounds. - Has used oral or systematically injected glucocorticoids or weight loss drugs prior to 2 months to screening. ; PRIMARY OUTCOME: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26; SECONDARY OUTCOME 1: Change From Baseline in HbA1c 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 III - CheckMate 017 (Squamous; vs. Docetaxel); BRIEF: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Men and women ≥18 years of age - Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease) - Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease - Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient Exclusion Criteria: - Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) - Subjects with carcinomatous meningitis - Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll - Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization - Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) - Prior treatment on the first line study CA184104 first line NSCLC study - Prior treatment with Docetaxel - Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity - Treatment with any investigational agent within 14 days of first administration of study treatment ; PRIMARY OUTCOME: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint; SECONDARY OUTCOME 1: Objective Response Rate (ORR) in All Randomized Participants[/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 - STAND; BRIEF: The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit. ; DRUG USED: Adakveo; DRUG CLASS: Biologic; INDICATION: Sickle Cell Anemia; TARGET: Selectins; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Written informed consent must be obtained prior to any screening procedures 2. Male or female patients aged 12 years and older on the day of signing informed consent. Adolescent include patients aged 12 to 17 years old and adults ≥ 18 years 3. Confirmed diagnosis of SCD by hemoglobin electrophoresis or high performance liquid chromatography (HPLC) [performed locally]. All SCD genotypes are eligible, genotyping is not required for study entry 4. Experienced at least 2 VOCs leading to healthcare visit within the 12 months prior to screening visit as determined by medical history. Prior VOC leading to healthcare visit must resolve at least 7 days prior to Week 1 Day 1 and must include: 1. Pain crisis defined as an acute onset of pain for which there is no other medically determined explanation other than vaso- occlusion - 2. which requires a visit to a medical facility and/or healthcare professional, 3. and receipt of oral/parenteral opioids or parenteral nonsteroidal anti-inflammatory drug (NSAID) analgesia Acute chest syndrome (ACS), priapism and hepatic or splenic sequestration will be considered VOC in this study 5. If receiving HU/HC or L-glutamine (local HA approved medicinal product), must have been receiving the drug for at least 6 months and at a stable dose for at least 3 months prior to Screening visit and plan to continue taking it at the same dose and schedule until the subject has reached one year of study treatment. Patients who have not been receiving such drug must not have received it for at least 6 months prior to Screening visit to be included. Patients must have evidence of insufficient control of acute pain, such as at least one VOC leading to healthcare visit while on HU/HC or L-Glutamine treatment. If receiving erythropoietin stimulating agent, must have been receiving the drug for at least 6 months prior to Screening visit and plan to continue taking the treatment to maintain stable Hb levels at least until the subject has reached one year of study treatment 6. Patients must meet the following central laboratory values prior to Week 1 Day 1: - Absolute Neutrophil Count ≥1.0 x 109/L - Platelet count ≥75 x 109/L - Hemoglobin: for adults (Hb) ≥4.0 g/dL and for adolescents (Hb) ≥5.5 g/dL - Glomerular filtration rate ≥ 45 mL/min/1.73 m2 using CKD-EPI formula in adults, and Shwartz formula in adolescents - Direct (conjugated) bilirubin < 2.0 x ULN - Alanine transaminase (ALT) < 3.0 x ULN 7. ECOG performance status ≤2.0 for adults and Karnofsky ≥ 50% for adolescents Key Exclusion Criteria: 1. History of stem cell transplant. 2. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning on undergoing an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted. 3. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction. 4. Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to Screening visit or plans to participate in another investigational drug trial. 5. 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 15 weeks after stopping treatment. 6. Concurrent severe and/or uncontrolled medical conditions which, in the opinion of the Investigator, could cause unacceptable safety risks or compromise participation in the study. 7. History or current diagnosis of ECG abnormalities indicating significant risk of safety such as: - Concomitant clinically significant cardiac arrhythmias (e.g ventricular tachycardia), and clinically significant second or third degree AV block without a pacemaker - History of familial long QT syndrome or know family history of Torsades de Pointes 8. Not able to understand and to comply with study instructions and requirements. 9. Received prior treatment with crizanlizumab or other selectin targeting agent ; PRIMARY OUTCOME: Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to a Healthcare Visit; SECONDARY OUTCOME 1: Annualized Rate of All VOCs Leading to a Healthcare Visit and Treated at Home Over the First-year Post Randomization (Key Secondary)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/Regorafenib; BRIEF: Phase I: Determine the maximum tolerated dose of combination of Regorafenib with Refametinib through a dose escalation study, all tumor types that meet certain inclusion/exclusion criteria can be entered. After the recommended dose is determined, the Phase II portion of the study will evaluate tolerability and efficacy of the combination treatment in patients with breast cancer, lung cancer, or colorectal cancer, respectively. ; DRUG USED: BAY 86-9766; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Criteria for the Phase 1b: - Patients with locally advanced or metastatic solid tumors who have either relapsed following, or progressed through, standard therapy; have a current disease state for which there is no standard effective therapy; is not a candidate for, or is unwilling to undergo, standard therapy in cases where no curative option exists. - Cohort-specific criteria for Phase 2: - CRC (Colorectal cancer): Patients with metastatic CRC and known KRAS (Kirsten rat sarcoma viral oncogene homolog) status who are eligible for treatment with regorafenib in accordance with the approved labeling. - NSCLC (Non-small-cell lung cancer): Patients with NSCLC and known KRAS status after platinum based chemotherapy. - Breast cancer: Patients with Her-2 negative breast cancer after anthracycline and taxane based chemotherapy. - Baseline tumor tissue to conduct molecular and / or genetic studies should be available from all study patients enrolled in this study. (optional in Phase 1b) - Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. (applicable only in Phase 2) - Male or female patients ≥ 18 years of age (only female patients in breast cancer cohort of Phase 2). - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Life expectancy of at least 3 months - Adequate bone marrow, liver and renal function - Cardiac function within normal range Exclusion Criteria: - Prior treatment with refametinib or regorafenib. - Metastatic brain or meningeal tumors - Uncontrolled hypertension despite optimal medical management - History of cardiac disease - Arterial or venous thrombotic or embolic events - Any hemorrhage or bleeding event - History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR). - Any condition that was unstable or which could jeopardize the safety of the patient and his/her compliance in the study. - Excluded previous therapies and medications: - Radiotherapy within 3 weeks prior to start of treatment - Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 28 days or 5 drug half-lives (if drug half-life in patients is known), whichever is shorter (or within 6 weeks for mitomycin C) before start of the study treatment ; PRIMARY OUTCOME: Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib; SECONDARY OUTCOME 1: Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Refametinib and Its Metabolite M-11[/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 - Chronic Idiopathic Cough (CIC); BRIEF: The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic idiopathic cough. The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester Cough Questionnaire (LCQ) will be evaluated. ; DRUG USED: XEN-D0501; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Cough; TARGET: TRPV1, transient receptor potential vanilloid receptor 1, VR-1; THERAPY: Monotherapy; LEAD SPONSOR: Xention Ltd; CRITERIA: Inclusion Criteria: - Male/female subjects aged 18 or over with chronic idiopathic cough Exclusion Criteria: - Clinically significant medical history - Abnormal laboratory results, ECGs or vital signs ; PRIMARY OUTCOME: Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - PROMOTE; BRIEF: The purpose of this study is to evaluate the effect Ulimorelin in patients with enteral feeding intolerance. ; DRUG USED: LP101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroenterologic Disorders; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Lyric Pharmaceuticals; CRITERIA: Inclusion Criteria: - Men and non-pregnant women aged 18 years and above - Intubated and mechanically ventilated in the ICU - Receiving continuous nasogastric, orogastric, or percutaneous gastric tube feeding, with no contraindication to advancing feedings per the feeding protocol - A 12-Fr or larger nasogastric, orogastric, or percutaneous gastric feeding tube, with its distal tip at least 10 cm below the gastroesophageal junction and visible in the stomach on a routine radiographic examination within 24 hours of screening - Enteral feeding intolerance, defined as a GRV of ≥ 500 mL on one or more measurements Expected to remain intubated, mechanically ventilated, and receiving nasogastric feeding for at least 72 hours Exclusion Criteria: - Inability to obtain written informed consent to participate in the study from the patient or legally authorized representative - Prior use during the current ICU admission of parenteral nutrition or trophic feeding, defined as a prescription to receive ≤ 20 mL/hr of enteral feeding for more than 24 hours prior to screening [N.B., parenteral nutrition may be initiated post randomization provided that the supplemental nutrition is coordinated with the calories and protein targets of the Prescribed Total Volume (PTV) and reduced as enteral feeding is advanced] - Weight prior to ICU admission exceeding 150.0 kg - Suspicion or confirmation of active bowel obstruction, perforation, or leakage - History of esophageal or gastric surgery prior to or during the current hospital admission - Use of any of the following prokinetic medications during the current ICU admission: domperidone, cisapride, neostigmine, or opioid antagonists, including alvimopan, naloxone, naltrexone, or analogs of naloxone or naltrexone; erythromycin or azithromycin [N.B., azithromycin is permitted for treatment of pulmonary infections up to 48 hours before randomization, but not thereafter through Day 5. Up to 2 doses of metoclopramide are permitted, provided that drug is not administered within 10 hours of the first dose of study drug or at any time through Day 5. If a patient receives metoclopramide during the screening period, a radiologic examination must confirm that the feeding tube remains visible in the stomach after the final dose of drug during screening and to prior to the start of baseline gastric emptying measurements and has not migrated to the duodenum. Use of clarithromycin for any indication is not excluded. Propofol must be discontinued before screening. However, its use may be permitted under special circumstances subsequent to the first dose of study drug but not in excess of 12 hours administration over the 5-day study period.] - Patients clinical condition is deteriorating rapidly, or the Investigator does not consider there to be a reasonable expectation that the patient will complete the study Childs C cirrhosis or Alanine Aminotransferase (ALT) ≥1000 U/L ; PRIMARY OUTCOME: The daily average (mean) percentage of target daily protein received through enteral nutrition by mechanically ventilated and tube-fed patients with EFI, Days 1 through 5; SECONDARY OUTCOME 1: The daily average (mean) percentage of target daily calories received through enteral nutrition by mechanically ventilated and tube-fed patients with EFI, Days 1 through 5[/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 - EST-01; BRIEF: Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist. ; DRUG USED: Evamist; DRUG CLASS: Non-NME; INDICATION: Menopause (including Hormone Replacement Therapy [HRT]); TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta); THERAPY: Monotherapy; LEAD SPONSOR: Lumara Health, Inc.; CRITERIA: Inclusion Criteria: - Post menopausal women, - Ages 35 or older, - Frequent moderate to severe hot flushes, - Qualifying general medical health Exclusion Criteria: - Disqualifying gynecological disorders, - Disqualifying dermatological disorders, - Disqualifying concurrent conditions ; PRIMARY OUTCOME: Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day; 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 - Open-label Rollover (w/Erlotinib or Paclitaxel); BRIEF: The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment. ; DRUG USED: Linsitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Astellas Pharma Global Development, Inc.; CRITERIA: Inclusion Criteria: - Subject must currently be participating in an Astellas sponsored linsitinib trial that has ended with respect to the overall study analysis. - Subject must not have met criteria for discontinuation or have progressed on the current linsitinib study in which they are participating. - Subject must be deriving benefit from continued treatment. ; PRIMARY OUTCOME: Number of subjects with 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 I - w/Doxorubicin, Vinblastine & Dacarbazine (Pediatric); BRIEF: The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL). ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Hodgkins Lymphoma; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: Each participant must meet all the following inclusion criteria to be enrolled in the study: 1. Histologically confirmed CD30+ classical HL. 2. Advanced stage, newly diagnosed HL (Stage III and Stage IV disease). 3. Treatment-naive HL. 4. Have performance scores of greater than or equal to (>=) 50 for Lansky Play-performance or Karnofsky Performance Status. 5. Have bidimensional measurable disease as documented by radiographic technique per International Working Group (IWG) criteria. 6. Have adequate blood counts, renal and liver function as defined in the protocol. Exclusion Criteria: 1. Nodular lymphocyte predominant HL. 2. Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML. 3. Any sensory or motor peripheral neuropathy. 4. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications. 5. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks before the first study protocol therapy. 6. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of AVD. 7. Known human immunodeficiency virus positive. 8. Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection, as determined by hepatitis B DNA or hepatitis C RNA, respectively, in blood. 9. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 10. Use of any strong or listed moderate cytochrome P450 (CYP) 3A4 inhibitors less than (<) 2 weeks before the first dose of protocol therapy (please refer to the Study Manual for an example list of prohibited CYP3A4 inhibitors). 11. Any of the following cardiovascular conditions or values within 6 months before the first dose of protocol therapy: - Shortening fraction of <27 percent (%) by echocardiogram or, if echocardiogram not feasible, ejection fraction of <50% by radionuclide angiogram (RNA or MUGA [multiple-gated acquisition scan]). - New York Heart Association Class III or IV heart failure. - Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. ; PRIMARY OUTCOME: Phase 1: Recommended Dose of Brentuximab Vedotin in Combination With Doxorubicin, Vinblastine, and Dacarbazine in a Pediatric Population; SECONDARY OUTCOME 1: Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb)[/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 - Adults w/Blood Cancers; BRIEF: The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo. ; DRUG USED: Shingrix; DRUG CLASS: Vaccine; INDICATION: Chickenpox and Shingles - Vaccines and Treatments; TARGET: Immune System, Varicella Zoster Virus (VSV); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject. - A male or female, aged 18 years or older at the time of study entry. - Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition. - Life expectancy greater than or equal to 12 months, as assessed by the investigator. - Female subjects of non-childbearing potential may be enrolled in the study. - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. - Female subjects of childbearing potential may be enrolled inthe study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination, and - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: - Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled). - Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy. - Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure). - Human immunodeficiency virus (HIV) infection by clinical history. - Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subjects underlying disease, is allowed. - Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo. - Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine. - Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. - Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. - Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo). ; PRIMARY OUTCOME: Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations; SECONDARY OUTCOME 1: Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMPOWER 22; BRIEF: This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenofovir disoproxil (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections. ; DRUG USED: Islatravir; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV Prevention; TARGET: Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization. - Sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 days prior to screening. - High risk for HIV-1 infection. - Not pregnant or breastfeeding, and one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or is a WOCBP and is using an acceptable contraceptive method during the intervention period and for at least 42 days after the last dose. - A WOCBP must have a negative pregnancy test within 24 hours prior to the first dose of study intervention. Exclusion Criteria: - Hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. - Findings of chronic hepatitis B virus (HBV) infection or past HBV. - Current or chronic history of liver disease. - History of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer. - Past or current use of cabotegravir, lenacapavir, or any other long-acting HIV prevention product. - Currently participating in or has participated in an interventional clinical study with an investigational compound or device, within 30 days prior to Day 1. - Expecting to conceive or donate eggs at any time during the study. ; PRIMARY OUTCOME: Incidence Rate Per Year of Confirmed HIV-1 Infections; SECONDARY OUTCOME 1: Incidence Rate per Year of Confirmed HIV-1 Infections Among Participants[/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 - Plaque Test; BRIEF: The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz. ; DRUG USED: Enstilar; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: Glucocorticoid Receptor (GR), Vitamin D receptor; THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: 1. Subjects having signed and dated an informed consent 2. Age 18 years or above 3. Either sex 4. All skin types 5. Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. Exclusion Criteria: 1. Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding 2. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer)for experimental biological products prior to randomisation and during the study 3. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study 4. Use of phototherapy within the following time periods prior to randomisation and during the study: - PUVA or Grenz ray therapy (4 weeks) - UVB (2 weeks) 5. Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study: - Potent or very potent (WHO group III-IV) corticosteroids 6. Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study: - WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis) - Topical retinoids - Vitamin D analogues - Topical immunomodulators (e.g. calcineurin inhibitors) - Anthracen derivatives - Tar - Salicylic acid 7. Subjects using emollients on the target plaques within one week before randomisation and during the study 8. Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study 9. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis 10. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history 11. Subjects with any of the following conditions present on the test area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin 12. Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas 13. History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency) 14. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments) 15. Subjects with current participation in any other interventional clinical trial, based on interview of the subject 16. Subjects with known or suspected hypersensitivity to component(s) of the investigational products 17. Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis 18. Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit 19. Subjects impossible to contact in case of emergency 20. Subjects who are known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state) 21. Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation 22. Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom 23. Subjects previously randomised in this trial ; PRIMARY OUTCOME: Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline; SECONDARY OUTCOME 1: Change in Clinical Sign Scores[/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 - Chronic/Spontaneous ; BRIEF: The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines. ; DRUG USED: LY3454738; DRUG CLASS: Unknown; INDICATION: Urticaria; TARGET: Cluster of Differentiation 200 (CD200) / OX2; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Must agree to use appropriate birth control throughout the study - Must have a diagnosis of CSU for at least 6 months - Must have CSU symptoms for at least 8 consecutive weeks despite taking anti-histamines - Must agree to take an anti-histamine every day during the trial - Must be willing to enter information about symptoms in an electronic diary twice a day Exclusion Criteria: - Must not have a cause, other than CSU, for itching, hives, and/or angioedema (swelling beneath the skin) - Must not have a current or recent active infection requiring antibiotics - Must not have a history of anaphylaxis (severe, life threatening allergic reaction) - Must not have asthma requiring medications other than short acting beta agonists (albuterol, etc.) - Must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for CSU ; PRIMARY OUTCOME: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7); SECONDARY OUTCOME 1: Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7)[/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 - KEYNOTE-086 (mTNBC); BRIEF: This is a two-part study of pembrolizumab monotherapy in participants with metastatic triple-negative breast cancer (mTNBC). Part 1 of the study will examine the efficacy and safety of pembrolizumab monotherapy as first line or above treatment in participants who have received either no prior systemic treatment or at least one prior systemic treatment for metastatic breast cancer. Part 2 of the study, if done, will expand the investigation of pembrolizumab treatment in a subgroup of participants from Part 1 and will only start after enrollment in Part 1 has been completed. There will be no hypothesis testing in this study. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy. For second line plus monotherapy (Parts 1 and 2): - Has received at least one systemic treatment for metastatic breast cancer - Has documented disease progression on or after the most recent therapy - Prior treatment must include an anthracycline and a taxane in the neoadjuvant, adjuvant, or metastatic setting For first line monotherapy (Part 1): - Has received no prior systemic treatment for metastatic breast cancer - Has PD-L1-positive mTNBC. For second line plus monotherapy (Part 2): - Has PD-L1 strong positive mTNBC For all parts: - Has mTNBC confirmed by a central laboratory - For biomarker analysis, adequate newly obtained core or excisional biopsy of a not-previously-irradiated metastatic tumor lesion (mandatory) - Has measurable metastatic disease - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment - Male participants should agree to use an adequate method of contraception starting with the first dose of study treatment through 120 days after the last dose of study treatment - Has adequate organ function Exclusion Criteria: - Is currently participating and receiving study treatment, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to study Day 1 - Has received prior anti-cancer monoclonal antibody (mAb) therapy for direct anti-neoplastic treatment within 4 weeks prior to study Day 1 - Has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks prior to study Day 1 - Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered within at least 2 weeks prior to study Day 1 - Has an active autoimmune disease requiring systemic treatment in past 2 years - Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment - Has known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer - Has radiographically-detectable central nervous system (CNS) metastases and/or carcinomatous meningitis - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis or a history of interstitial lung disease - Has an active infection requiring systemic therapy - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study - Is pregnant, 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 received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40, CD137) or has participated in Merck MK-3475 (pembrolizumab) study - Has a known history of human immunodeficiency virus (HIV) - Has known active Hepatitis B or C - Has received a live vaccine within 30 days of planned start of study treatment ; PRIMARY OUTCOME: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Central Imaging Vendor (CIV) in All Cohort A Participants; SECONDARY OUTCOME 1: ORR Per RECIST 1.1 by CIV in All Cohort B Participants[/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 - w/Paclitaxel; BRIEF: Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC) ; DRUG USED: Vistusertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically proven squamous non-small cell lung cancer (NSCLC) where treatment with weekly paclitaxel is an appropriate treatment option. 2. Relapsed or refractory disease after at least one line of prior therapy. Subjects must have previously received appropriate line(s) of standard of care (SOC) treatment. 3. Measurable disease by RECIST v1.1 criteria 4. Life expectancy of at least 12 weeks. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. Radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy, or immunotherapy during the previous 3 weeks (4 weeks for investigational medicinal products and 6 weeks for nitrosoureas and Mitomycin-C) before treatment. 2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or Grade 1 toxicities which, in the opinion of the Investigator, should not exclude the patient. 3. Known leptomeningeal involvement, brain metastases or spinal cord compression. 4. History of hypersensitivity (> Grade 2) to active or inactive excipients of AZD2014, drugs containing Cremophor, taxanes or structurally/chemically similar drugs 5. Current refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated product or previous significant bowel resection that would preclude adequate absorption of AZD2014 6. Patients with Diabetes Type I or uncontrolled Type II (HbA1c > 59 mmol/mol assessed locally) as judged by the Investigator 7. Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study and from which the patient has not yet recovered 8. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening (with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening), defined as: - Absolute neutrophil count 1500 cells/mm3 (1.5 x 109/L) - Platelet count 100.000 cells/mm3 (100 x 109/L) - Haemoglobin 9.0 g/dL 9. Adequate hepatic and renal function defined as: - Serum aspartate transaminase (AST) or alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) if no demonstrable liver metastases or 5 x ULN in the presence of liver metastases - Alkaline phosphatase (ALP) < 5 x ULN - Serum bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilberts syndrome or of non-hepatic origin) - Estimated Creatinine Clearance 50 ml/min (Cockcroft-Gault) or serum creatinine 1.5 x ULN ; PRIMARY OUTCOME: Percentage of Patients Who Have a Partial Response or Complete Response Through Measurement of Tumour Lesion Sizes; SECONDARY OUTCOME 1: Number of Patients Who Experienced at Least One Adverse Event (AE) or Serious Adverse Event (SAE)[/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 - ANEMONE; BRIEF: The study will evaluate the safety and efficacy of orally-administered M5049 in Coronavirus disease 2019 (COVID-19) pneumonia participants who are hospitalized but not on mechanical ventilation. ; DRUG USED: M5049; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: Toll-like receptor 7 (TLR7), Toll-like receptor 8 (TLR8); THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Participant provides signed informed consent prior to the initiation of any study assessments - Has laboratory-confirmed SARS-CoV-2 Infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization - Has chest imaging consistent with COVID-19 pneumonia (as per locally accepted guidelines) If chest imaging is not available during Screening, please discuss with Medical Monitor or designee regarding evidence of probable COVID-19 pneumonia for study participant eligibility - Not on mechanical ventilation or ECMO - Has an SpO2 less than (<) 94 percent in room air And able to maintain a partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) greater than or equal to (>=) 150 (Or equivalent SpO2/FiO2 >=190) with a maximum FiO2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 Liter), assess their current baseline oxygen requirements for eligibility - Requires hospitalization - Other protocol defined inclusion criteria may apply Exclusion Criteria: - Any condition that could interfere with the study objectives, conduct or evaluation in the opinion of the Investigator or Sponsor or designee - Significantly uncontrolled medical illness (eg, cardiovascular disease, hypertension, diabetes mellitus, obstructive lung disease, neurological associated with seizures (example: cerebrovascular accident/stroke, acute brain infection, traumatic brain injury, progressive brain disease, congenital brain disease or neuropsychiatric disorder) - Known active infection other than COVID-19 - Pregnancy or Breastfeeding - Other protocol defined exclusion criteria may apply ; PRIMARY OUTCOME: Time to Recovery; SECONDARY OUTCOME 1: Percentage of Participants Alive and Not Requiring Supplemental Oxygenation[/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 - DA9801-DN-001 (US Safety Study); BRIEF: To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain in subjects with diabetic neuropathic pain compared to their baseline values. ; DRUG USED: NB-01; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Nerve growth factor (NGF)/receptor; THERAPY: Monotherapy; LEAD SPONSOR: NeuroBo Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - Must be 18 to 75 years of age - Diagnosed with Type I or Type II diabetes - HbA1c ≤ 12% at the time of screening - Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the lower extremities for more than 3 months prior to screening and with no adequate relief from other treatments - Has an average pain score of ≥ 4 for 24 hours at least 4 days out of the week prior to randomization as assessed by the 11-point Likert NRS. - If female of childbearing potential, subject must have a negative serum pregnancy test at screening - Understands and is willing to participate in the clinical study and can comply with study procedures and visits. - Normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-reported questionnaires - Subject is willing and able to give informed consent Exclusion Criteria: - Evidence of another type of neuropathic pain caused by a condition other than diabetes - Pain from another source as severe or greater than the pain under study - BMI (Body Mass Index) > 37 kg/m2 - Clinical signs of infection related to sores of any type on the legs - Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or subject or physician anticipates use of any of these therapies by the subject during the course of the study - Previous participation in the Treatment Phase of this Protocol - History of drug or alcohol abuse, within the past 6 months - Malignant disease not in remission for 5 years or more that has been medically or surgically treated without evidence of metastases - Presence of one or more medical conditions, as determined by medical history, which seriously compromises the subjects ability to complete the study, including history of poor adherence with medical treatment, renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study: c) One or more abnormal blood biochemistry analyte result that is ≥ 3 times that of the upper limit of the normal range; d) For laboratory results that are significantly lower than the normal range, specific criteria will be used to judge subject eligibility for randomization for Total protein, Albumin, and Hemoglobin or Platelets. - Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV) - New York Heart Association (NYHA) Class III and IV congestive heart failure (CHF), as defined by the following criteria: a)Class III: Symptoms with moderate exertion b)Class IV: Symptoms at rest - Pregnant or breast feeding - Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria: d) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/m, OR; e) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, OR; f) Are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation. - Subjects with a diagnosis of psychiatric disorders such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or suicidality/suicide ideation - Administration of local anesthetic shot or systemic steroids within two months of screening - Subjects not willing to undergo a two-week washout period for pharmacologic and non-pharmacologic pain management techniques ; PRIMARY OUTCOME: Change in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS); SECONDARY OUTCOME 1: Percentage Change in Clinic Visit Pain Score at the 12-week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - CTO-1 (Canada); BRIEF: A prospective, three-center, phase I safety and tolerability dose escalation study, evaluating 28 subjects in 4 discrete dose cohorts of acute intracoronary injected collagenase ranging from 300 - 1200 µg prior to routine standard-of-care percutaneous revascularization procedures in subjects with chronic total coronary artery occlusions (CTOs). ; DRUG USED: MZ-004; DRUG CLASS: Biologic; INDICATION: Coronary Artery Disease; TARGET: Collagen; THERAPY: Monotherapy; LEAD SPONSOR: Sunnybrook Health Sciences Centre; CRITERIA: Inclusion Criteria: Candidates for this study must meet ALL of the following inclusion criteria: - Subject is willing and able to provide an informed consent - Subject is willing and able to comply with the study procedures and follow-up - Subject is 35 years of age or older - Women who are non-reproductive, or reproductive women who are willing and able to practice effective birth control methods. A urine pregnancy test should be done at the screening/Day0 on all reproductive women of child bearing ability - Subjects with CTO (older than 6 weeks or unknown duration based on the investigators assessment of appropriateness for the study) with a clinical indication for revascularization. In subjects with occlusions of unknown duration, there must be absence of any identifiable ischemic event in the 6 weeks prior to enrolment in the study - At least 1 previously failed attempt to cross the CTO - Absence of pericardial effusion on 2D Echocardiogram Exclusion Criteria: Candidates for this study who meet any of the following criteria at the time of the screening visit are NOT eligible to be enrolled in this study: - Culprit vessel is a saphenous vein graft occlusion - True ostial LAD, LCX or RCA occlusions (since collagenase delivery will be unreliable) - Presence of moderate or large pericardial effusion on echocardiogram within 2 weeks of the procedure - Major side branch (1.5 mm diameter) within 3 mm proximal to the occlusion. (This is to prevent the infusate being diverted through a side branch and to prevent ischemia during the prolonged period of time during the infusion) - Renal dysfunction (creatinine greater than 2 x ULN) - Severe calcification (collagenase can not degrade calcium) based on consensus of 2 interventional cardiologists after review of coronary angiogram. - Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure - Subject is a pregnant or lactating female (women of childbearing potential must have a negative serum beta-HCG within 24 hours prior to the inclusion) - Subject is or has been partaking in another investigational product clinical study within 30 days of Screening/Day0 - Subjects with bleeding abnormalities (e.g. Factor VIII deficiency) and /or subjects that have experienced any medically documented active site of bleeding within 30 days of the screening visit, such as, but not limited to, the gastrointestinal or genitourinary tract or intercerebral hemorrhage. - Subjects with recent acute coronary syndrome (ACS) (< 4 weeks). For those patients who had ACS ≥ 4weeks ago, only the non-culprit vessel from the recent ACS can be considered eligible for this study if all other inclusion and exclusion criteria have been met. ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Efficacy[/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 - BETA PRIME; BRIEF: This is the first clinical trial of AdAPT-001 for the treatment of cancer. AdAPT-001 is an oncolytic virus that is injected directly into the tumor. The purpose of this study is to find out the highest dose of AdAPT-001 that is safe and tolerable. This is the first step in studying whether it can be used to treat others with cancer in the future. ; DRUG USED: AdAPT 001; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Transforming Growth Factor-beta (TGF-beta) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: EpicentRx, Inc.; CRITERIA: Inclusion Criteria: 1. Subject is capable of understanding the purpose and risks of the study and has provided written Informed Consent. 2. Subject is male or female, aged at least 18 years. 3. Subject has a histologically or cytologically confirmed diagnosis of an advanced malignant solid tumor(s) who have received all conventional therapies considered appropriate by Investigator and have a tumor that is easily accessible and/or palpable for treatment. Ultrasound guidance may be used to aid administration. 4. Subjects Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening. 5. Subject has acceptable liver function at Screening, as evidenced by: 1. Bilirubin < 1.5 x ULN (upper limit of normal) 2. AST (SGOT) and ALT (SGPT) < 3.0 x ULN (upper limit of normal) 3. Alkaline Phosphatase < 2.5 x ULN (upper limit of normal) 6. Subject has a Serum Creatinine < 1.5 x ULN (upper limit of normal) 7. Subject has acceptable hematologic status at Screening, as evidenced by: 1. Absolute neutrophil count > 1,500 cells/mm3; > 1.5 x 109/L, and 2. Platelet count > 75,000/mm3; > 75.0 x 109/L, and 3. Hemoglobin (HGB) ≥ 8.0 g/dL; ≥ 5.6 mmol/L 8. Subject has an INR < 1.5 9. Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least one year), and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subjects final dose of AdAPT-001. Medically acceptable contraception is defined as either: 1) usage by at least one of the partners of a barrier method of contraception, together with usage by the female partner, commencing at least three months prior to Study Day 1, of a stable regimen of any form of hormonal contraception or an intra-uterine device, or 2) usage by the couple of a double-barrier method of contraception. Use of a single-barrier method alone or abstinence alone is not considered adequate. 10. Subject is willing and able to comply with all protocol procedures, evaluations and rescue measures. 11. OPTIONAL: Archival formalin-fixed paraffin-embedded block(s) or previously cut archival tissue for at least 5 unstained slides (if available). Exclusion Criteria: 1. Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder. 2. A known uncontrolled active bacterial, fungal, or viral infection. No subject with an active SARS-CoV-2 infection (within 14 days of a positive test) 3. Known positive history of human immunodeficiency virus (HIV) test 4. Subjects who have active hepatitis. 5. If female, subject is pregnant and/or breastfeeding. 6. Subjects with active autoimmune disease or history of autoimmune disease that might recur and may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. Note: Subjects in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before AdAPT-001), but currently or previously treated with any of the following steroid regimens were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; prophylactic short-term use of corticosteroids. 7. Prior adenoviral therapy for any indication except vaccination against infectious disease. Subjects receiving COVID-19 or live vaccination, cannot start treatment until 7 days after completing the vaccination. Recommend waiting at least 28 days from AdAPT-001 dose prior to receiving COVID-19 vaccination. Concurrent treatment with Evusheld is allowed. 8. Chemotherapy or immunotherapy within 14 days of study treatment. Hormonal therapy (including tamoxifen, aromatase inhibitors, and gonadotropin releasing hormone agonists) is allowed. Concurrent treatment with bisphosphonate and RANK ligand inhibitor is allowed. ; PRIMARY OUTCOME: Dose Limiting Toxicities (DLT); SECONDARY OUTCOME 1: Anti-tumor activity of AdAPT-001[/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 - 122 (Mono vs. Combo); BRIEF: This randomized phase II trial studies how well trebananib with or without bevacizumab, pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate works in treating patients with kidney cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor. Immunotherapy with monoclonal, such as bevacizumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pazopanib hydrochloride, sorafenib tosylate, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. It is not yet known whether giving trebananib with or without bevacizumab, pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate is more effective in treating kidney cancer. ; DRUG USED: Trebananib; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC); TARGET: Angiopoietins; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients must have histologically or cytologically confirmed renal cell carcinoma except medullary or collecting duct subtypes; sarcomatoid differentiation will be allowed - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam - Patients must have documented radiologic or clinical progressive disease following at least one prior anti-VEGF regimen administered either as a single agent or in combination with other agents for at least 8 weeks; the prior anti-VEGF treatment regimen must have included bevacizumab, pazopanib, sorafenib or sunitinib administered not more than 12 weeks before study entry; Note: enrollment not more than 8 weeks after the last dose of anti-VEGF therapy is encouraged; nevertheless, intercurrent therapy with an mTOR inhibitor (everolimus or temsirolimus) will be allowed if progression on that treatment is observed within 12 weeks of the prior anti-VEGF therapy - Any number of prior regimens is allowed; prior investigational therapy is allowed - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) - Life expectancy of greater than 3 months - Leukocytes >= 3,000/mcL - Absolute neutrophil count >= 1,500/mcL - Platelets >= 100,000/mcL - Total bilirubin =< institutional upper limits of normal - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal - Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =< upper limit of normal (ULN) per institutional laboratory range - International normalized ratio (INR) =< 1.5 - Creatinine within normal institutional limits OR creatinine clearance > 40 mL/min per 24 hour (h) urine collection or calculated according to the Cockcroft-Gault formula - Urinary protein =< 100 mg/dL in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 h urine sample - Generally well-controlled blood pressure with systolic blood pressure =< 140 mmHg AND diastolic blood pressure =< 90 mmHg prior to enrollment; the use of anti-hypertensive medications to control hypertension is permitted - Patients must have a tumor site amenable to biopsy as determined by the treating investigator; any questions regarding suitability of a site for biopsy will be adjudicated by the principal investigator - Patients must be willing to consent to tumor biopsy for research purposes - Patients should have archival tumor tissue (either unstained slides or tumor blocks) available for retrieval - The effects of AMG 386 are known to be detrimental to fetal development; for this reason and because inhibitors of angiogenesis as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of AMG 386; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of AMG 386 and bevacizumab, pazopanib, sunitinib, or sorafenib administration - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Intolerance of prior treatment with bevacizumab, pazopanib, sorafenib, or sunitinib; Note: subjects who required a dose reduction of pazopanib, sorafenib, or sunitinib during prior therapy MAY be eligible if they tolerated the agent after dose level reduction (to a minimum of dose level -2 as defined in this protocol) - Central nervous system metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least one week; a CT or MRI to evaluate for central nervous system (CNS) disease is required for symptomatic patients only - History of venous or arterial thromboembolism within 12 months prior to enrollment/randomization - History of clinically significant bleeding within 6 months of enrollment/randomization - Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria in Adverse Events (CTCAE) version 3.0 or 4.0 >= grade 2 in severity except alopecia - Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor - Clinically significant cardiovascular disease within 12 months prior to enrollment/randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent - Major surgery within 28 days prior to enrollment or still recovering from prior surgery - Minor surgical procedures except placement of tunneled central venous access device within 3 days prior to enrollment - Non-healing wound, ulcer (including gastrointestinal), or fracture - Subject not consenting to the use of highly effective contraceptive precautions (e.g., double barrier method [i.e., condom plus diaphragm]) during the course of the study and for 6 months after administration of the last study medication - History of allergic reactions attributed to compounds of similar chemical or biologic composition to AMG 386 or the anti-VEGF agent used in study - History of allergic reactions to bacterially-produced proteins - Patients who have had anti-VEGFR tyrosine kinase inhibitor within 1 week, mTOR inhibitor within 1 week or anti-VEGF antibody therapy within 3 weeks prior to entering the study; patients who have had other forms of chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients who have not yet completed at least 21 days (30 days for prior monoclonal antibody therapy) since ending other investigational device or drug trials, or who are currently receiving other investigational treatments - Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP450 3A4) are ineligible; caution is advised for patients requiring weak or moderate CYP450 3A4 inhibitors or inducers; specifically prohibited medicines include indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. Johns wort, and troglitazone - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant women are excluded from this study because AMG 386, bevacizumab, pazopanib, sorafenib, and sunitinib are inhibitors of angiogenesis with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AMG 386, breastfeeding must be discontinued if the mother is treated with AMG 386 - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib, sorafenib, or sunitinib; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated - Inability to take oral medications on a continuous basis; patients who are to take pazopanib, sorafenib, or sunitinib and are unable to swallow pills whole are ineligible (the pills cannot be crushed or broken) - Any condition which in the investigators opinion makes the subject unsuitable for study participation ; PRIMARY OUTCOME: Observed Response Rate; SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - HER2-; BRIEF: This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2. ; DRUG USED: Taselisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: p110 alpha/PIK3CA, p110 delta/PIK3CD, p110 gamma/PIK3CG, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Age >=18 years - For paclitaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease - For docetaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease or histologically documented advanced (Stage IV) or recurrent NSCLC - For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines - Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment - Evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) v.1.1 - Life expectancy >=12 weeks - Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening - Adequate hematologic and end organ function - Use of highly effective form of contraception Exclusion Criteria: - Prior anti-cancer therapy - Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor - Known significant hypersensitivity to any components of study treatment - Grade >=2 peripheral neuropathy - Type 1 or Type 2 diabetes - Grade >=2 hypercholesterolemia or hypertriglyceridemia - Congenital long QT syndrome - Active congestive heart failure or ventricular arrhythmia ; PRIMARY OUTCOME: Safety: Incidence of adverse events; SECONDARY OUTCOME 1: Area under the curve from time 0 to the last measurable concentration (AUC0-last)[/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 - GEM-3; BRIEF: This study is an intra-patient comparison of KB105 and placebo-administered Target Areas. The primary objectives of this study are to evaluate safety and Investigator Global Assessment (IGA) scale improvement of topically administered KB105. ; DRUG USED: KB105; DRUG CLASS: Biologic; INDICATION: Congenital Ichthyosis; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Krystal Biotech, Inc.; CRITERIA: Inclusion Criteria: - Genetic diagnosis of TGM1-deficient ARCI with a null TGM-1 mutation; - Clinical diagnosis of lamellar ichthyosis; - Age: 18 years old or older; - Individual site IGA score of 3 to 4 at the target areas - Subject is, in the opinion of the Investigator, able to understand thestudy, cooperate with the study procedures, and is willing to return to the clinic for all required follow-up visits; - Except for their moderate-to-severe ARCI, subject is in good general health; and - Willing and able to give consent/assent. Exclusion Criteria: - Medical instability limiting ability to travel to the investigative center; - Medical illness expected to complicate participation, such as an active infection with: HIV, hepatitis B (as determined by hepatitis B surface antigen screening), hepatitis C (as determined by detection of hepatitis C antibodies or a positive result of hepatitis C); - Patient has a physical condition or other dermatological disorder (e.g., atopic, seborrheic, or contact dermatitis, psoriasis, tinea infections, etc.) which, in the Investigators opinion, might impair evaluation of the Target Areas or which exposes the patient to unacceptable risk by study participation; - Pregnant or breast-feeding women, or women planning to become pregnant or to breast-feed. Women of childbearing potential must have a negative urine pregnancy test at the Screening visit and Day 1 visit and must commit to using an acceptable form of contraception during the entire study period, up to three months after last KB105 administration. Women using oral contraception must also have done so for 3 months prior to Baseline or will be willing to use a combination of barrier methods. To be considered not of childbearing potential, women must be post-menopausal for at least 1 year or surgically sterile - Known allergy to any of the constituents of the product - Hypersensitivity to local anesthesia (e.g., lidocaine/prilocainecream) - Current enrollment in a clinical trial - Treatment with an investigational drug or investigational device within 30 days prior to Day 1 - Male who is not surgically sterile nor willing to use effective forms of contraception from Day 1 until 3 months following the last dose of study drug. - Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: Visual Index for Ichthyosis Severity (VIIS) scale, lamellar (L) standard[/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/Daratumumab + Dexamathasone +/- Bortezomib; BRIEF: This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd). Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd). ; DRUG USED: Venclexta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status <= 2. - Participant has relapsed or refractory multiple myeloma with documented evidence of progression that occurred during or after the participants last treatment regimen based on investigators determination of International Myeloma Working Group (IMWG) criteria. - Measurable disease confirmed by central lab at Screening, defined by at least 1 of the following: Serum M-protein >= 1.0 g/dL (>= 10 g/L), OR Urine M-protein >= 200 mg/24 hours, OR Serum free light chain (FLC) >= 10 mg/dL, provided serum FLC ratio is abnormal in participants who do not have measurable disease by Serum Protein Electrophoresis (SPEP) or Urine Protein Electrophoresis (UPEP) criteria. - Participant has received previous multiple myeloma treatment as defined in the protocol. - Bone marrow aspirate samples have been collected. - To qualify for Part 1 and 3, the participant must be t(11;14) positive as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing. - Participants must have adequate hematologic, renal and hepatic function. Exclusion Criteria: - Previous treatment with venetoclax or other B-Cell Lymphoma 2 (BCL-2) inhibitor - For participants in Parts 1 and 2: Previous treatment with daratumumab or other anti-CD38 therapy. For participants in Part 3: Prior daratumumab or other anti-CD38 antibody therapy exposure that meets ANY of the following criteria: - Failure to achieve at least a PR to most recent therapy with daratumumab or other anti-CD38 therapy. - Daratumumab or other anti-CD38 antibody therapy was discontinued due to toxicity. - Relapse within 60 days of intensive treatment (at least every other week) of daratumumab or other anti-CD38 antibody therapy. - Prior treatment with daratumumab or other anti-CD38 antibody within 6 months prior to first dose of study drug. - For participants in Part 2 and 3: - Participant is refractory to any proteasome inhibitor, defined as progression on or within 60 days of the last dose of a proteasome inhibitor-containing regimen. - Participant has had prior treatment with proteasome inhibitor within 60 days prior to first dose of study drug. - Treatment with anti-myeloma chemotherapy, radiotherapy, biological, immunotherapy or an investigational therapy, including targeted small molecule agents within 2 weeks or 5 half-lives (whichever is longer and/or applicable) before first dose. - Treatment with anti-myeloma monoclonal antibodies within 6 weeks prior to first dose. - Recent corticosteroid therapy at a cumulative dose equivalent to >= 140 mg of prednisone, cumulative dose equivalent to >= 40 mg of dexamethasone, or a single dose equivalent to >= 40 mg of dexamethasone within 2 weeks prior the first dose of study drug. - Known central nervous system involvement of multiple myeloma. - Significant history of medical conditions as listed in the protocol. - History of other active malignancies including myelodysplatic syndromes (MDS) within the past 3 years with the exceptions of: - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin. - Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment - Previous malignancy with no evidence of disease confirmed and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study. - Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. - Has a hypersensitivity or allergy to any of the components of study therapy, excipient or boron. - Known allergies, hypersensitivities, or intolerance to monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products (see daratumumab prescribing information). ; PRIMARY OUTCOME: Overall Response Rate (ORR); SECONDARY OUTCOME 1: Minimal Residual Disease (MRD)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - High-Risk Acute Leukemia/Myelodysplasia; BRIEF: Allogeneic hematopoietic stem cell transplantation is a life-saving procedure in patients with blood cancers. Cord blood (CB) represents an alternative source of stem cells, which is associated with a lower risk of relapse, especially in the presence of minimal residual disease in the setting of acute leukemia and myelodysplasia. Furthermore, CB has the added advantage of being associated with a low risk of chronic graft versus host disease (GVHD). Unfortunately, CB transplants are hampered by a higher risk of transplant related mortality (TRM) when compared to bone marrow/peripheral blood transplants because of the limited cell dose of CB. In the previous UM171 trial (NCT02668315), the CB expansion protocol using the ECT-001-CB technology (UM171 molecule) has proven to be technically feasible and safe. UM171 expanded CB was associated with a median neutrophil recovery at day (D)+18 post transplant. Amongst 22 patients who received a single UM171 CB transplant with a median follow-up of 18 months, risk of TRM (5%) and grade 3-4 acute GVHD (10%) were low. There was no moderate-severe chronic GVHD. Thus, overall and progression free survival at 12 months were impressive at 90% and 74%, respectively. The UM171 expansion protocol allowed access to smaller, better HLA matched CBs as >80% of patients received a 6-7/8 HLA matched CB. Interestingly there were 5 patients who had already failed an allogeneic transplant and 5 patients with refractory/relapsed acute leukemia/aggressive lymphoma. Despite this high risk population, progression was 20% at 12 months. Hence, in this new trial, investigators are targeting patients with high and very high-risk acute leukemia/myelodysplasia to test the antileukemia effect of this new graft, a UM171 expanded CB. ; DRUG USED: ECT001; DRUG CLASS: Biologic; INDICATION: Hematologic Cancer; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Ciusss de LEst de lÎle de Montréal; CRITERIA: Inclusion Criteria: 1. Presence of high-risk acute leukemia/myelodysplasia defined as one of the following: I. Acute Myeloid Leukemia: 1. Primary induction failure (no CR or CRi after ≥ 2 courses of induction therapy or after ≥ 1 induction containing high dose Ara-C) 2. Chemorefractory relapse (no CR or CRi after 1 chemointensive treatment) 3. Relapse after allogeneic or autologous transplant 4. High risk AML in CR1: i) any adverse genetic abnormality as defined by European Leukemia Net excluding FLT3 mutation; ii) secondary or therapy related AML excluding good risk genetic abnormalities (as defined by ELN); or iii) any other poor risk feature known to be associated with a PFS or DFS ≤40% at 2 years after conventional transplantation. 5. CR2 excluding good risk genetic abnormalities defined by ELN 6. ≥CR3 II. Acute Lymphoid Leukemia 1. Primary induction failure (≥ 2 inductions) 2. Chemorefractory relapse (at least 1 intensive induction chemotherapy; blinatumomab, inotuzumab or CAR-T cells may be considered as an equivalent) 3. Relapse after allogeneic or autologous transplant 4. High risk ALL in CR1: Ph like ALL or any other poor risk feature known to be associated with an PFS or DFS ≤40% at 2 years after conventional transplantation. 5. ≥CR2 6. MRD+ within 1 month of start of conditioning regimen. III. Myelodysplastic syndrome 1. Relapse after allogeneic or autologous transplant 2. ≥10 % blasts within 1 month of start of conditioning regimen 3. Very poor cytogenetics (>3 abnormalities) 4. Any poor risk feature known to be associated with a PFS or DFS ≤40% at 2 years after conventional transplantation 5. TP53 mutation 6. ≥40 years old and RAS or JAK2 mutation 7. CMML with HCT-specific CPSS score high or intermediate-2 8. Stable disease (absence of CR/PR/HI) after 6 cycles of azacitidine (or another demethylating agent) 9. Progressive disease while on azacitidine (or another demethylating agent) 2. 18-70 years old 3. Availability of 2 CBs ≥ 4/8 HLA match when A, B, C and DRB1 are performed at the allele level. I. Cord to be expanded: 1. CD34+ cell count >0.5 x 105/kg and TNC>1.5 x 107/kg (these numbers are all pre-freeze) 2. Needs to be erythrodepleted by bank prior to cryopreservation 3. Must come from a cord bank that is FACT (Foundation for the Accreditation of Cellular Therapy) accredited, FDA approved or eligible for NMDP IND. II. Non-expanded CB/back-up cord: 1. Pre-freeze TNC count ≥ 2.0 x 107/kg with CD34+ cells ≥1.5 x 105/kg or TNC count ≥ 1.5 x 107 TNC/kg with CD34+ cells ≥1.7 x 105/kg. If a single cord does not meet these criteria, 2 back up cords will be an acceptable alternative with a minimum for each of 1.5 x 107/kg TNC and 1 x 105/kg CD34+ cells; another acceptable HSC back up source could be a haploidentical donor with medical clearance prior to starting conditioning regimen. 2. Must come from a cord bank that is FACT accredited, FDA approved or eligible for NMDP IND 4. Karnofsky score ≥ 70% 5. Bilirubin < 2 x upper limit of normal (ULN) unless felt to be related to Gilberts disease or hemolysis; AST and ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 5 x ULN. 6. Estimated or measured creatinine clearance ≥ 60 ml/min/1.73m2. 7. Hematopoietic cell transplantation specific comorbidity index (HCT-CI) ≤5 for patients < 60 years old; HCT-CI ≤3 for patients < 60 years old and acute leukemia not in CR/CRi; HCT-CI ≤3 for patients 60-65 years old; HCT-CI ≤1 if 66-70 years old. 8. Left ventricular ejection fraction ≥ 40% 9. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and diffusing capacity corrected for hemoglobin (DLCOc) ≥ 50% of predicted 10. Signed written informed consent 11. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrolment and must be willing to use an effective contraceptive method while enrolled in the study. Exclusion Criteria: 1. Patient never treated with cytotoxic chemotherapy and planned conditioning regimen does not include 12 Gy TBI (exceptions allowed if approved by PI). 2. Allogeneic myeloablative transplant within 6 months. 3. Autologous hematopoietic stem cell transplant within 6 months. 4. Planned use of ATG in conditioning regimen (exceptions allowed if approved by PI in which case ATG must be adjusted for weight/lymphocyte count and given more than 1 week prior to transplant; any patient who receives ATG will have immune recovery studies but will not be counted with rest of patients and will be analyzed separately). 5. Planned use of an HLA matched CB (8/8 allele matched) 6. Uncontrolled infection. 7. Presence of a malignancy other than the one for which the CB transplant is being performed, with an expected survival estimated to be less than 75% at 5 years. 8. Seropositivity for HIV. 9. Hepatitis B or C infection with measurable viral load. Patients with chronic hepatitis B or C infection regardless of viral load require clear documentation of absence of cirrhosis by either fibroscan or biopsy. If fibroscan is the method used, the test must be unequivocally negative. 10. Liver cirrhosis. 11. Active central nervous system involvement 12. Chloroma > 2 cm 13. ≥50% blasts in marrow in an evaluable marrow sample (>25% of normal cellularity for age) collected less than one month prior to start of conditioning regimen. 14. Peripheral blasts >1000/mm3 15. Pregnancy, breastfeeding or unwillingness to use appropriate contraception. 16. Participation in a trial with an investigational agent within 30 days prior to entry in the study. 17. Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and tests. 18. Any abnormal condition or laboratory result that is considered by the PI capable of altering patients condition or study outcome. ; PRIMARY OUTCOME: Transplant Related Mortality (TRM); SECONDARY OUTCOME 1: Neutrophil Engraftment[/INST]No</s>