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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 - Feasibility; BRIEF: This phase I trial studies the sides effects and best dose of pembrolizumab in treating participants with thymoma or thymic cancer that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Thymic Carcinoma; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: - Unresectable thymoma or thymic carcinoma. - Any line of prior therapy allowed. - Be willing and able to provide written informed consent/assent for the trial. - Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. - Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen. - Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS. - No history of or current diagnosis of a significant autoimmune disease or paraneoplastic autoimmune disease, i.e. myasthenia gravis, Lambert-Eaton, systemic lupus, rheumatoid arthritis. For minor autoimmune disorders such as psoriasis, arthritis (not including rheumatoid arthritis), Raynauds disease; these are allowed onto trial. - No active hepatitis or diagnosis of human immunodeficiency virus (HIV) disease. - No prior malignancy unless it was cured over 2 years ago; i.e. prostate cancer, or early stage (I-III) solid tumors. Patients with a prior basal skin cancer or squamous cell carcinoma of the skin or in situ cervical malignancy that have undergone curative treatment are excluded from this requirement. - Absolute neutrophil count >= 1500/mcL (within 10 days of treatment initiation). - Platelets >= 100000mcL (within 10 days of treatment initiation). - Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) (within 10 days of treatment initiation). - Serum creatinine OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) =< 1.5 X upper limit of normal (ULN) OR >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (within 10 days of treatment initiation). Note: Creatinine clearance should be calculated per institutional standard. - Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 10 days of treatment initiation). - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases (within 10 days of treatment initiation). - Albumin >= 2.5 mg/dL (within 10 days of treatment initiation). - International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (within 10 days of treatment initiation). - Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours 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 subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. - Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. 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 the first dose of treatment. - Has a 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. - Has a known history of active TB (Bacillus tuberculosis). - Hypersensitivity to pembrolizumab or any of its excipients. - Has 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 adverse events due to agents administered more than 4 weeks earlier. - Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent. - Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study. - Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. - 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. - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four 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. - Has 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, etc.) is not considered a form of systemic treatment. - Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis. - Has an active infection requiring systemic therapy. - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subjects participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. - Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). - Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus (HCV) ribonucleic acid (RNA) [qualitative] is detected). - Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed. ; PRIMARY OUTCOME: Incidence of adverse events; SECONDARY OUTCOME 1: Progression-free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/IIa - SELECT-HD; BRIEF: This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of WVE-003 in adult patients with early-manifest HD who carry the targeted single nucleotide polymorphism (SNP) - SNP3. ; DRUG USED: WVE-003; DRUG CLASS: New Molecular Entity (NME); INDICATION: Huntingtons Disease; TARGET: Huntingtin ; THERAPY: Monotherapy; LEAD SPONSOR: Wave Life Sciences Ltd.; CRITERIA: Inclusion Criteria: 1. Presence of the A variant of SNP3 on the same allele as the pathogenic CAG triplet expansion 2. Ambulatory, male or female patients aged ≥25 to ≤60 years 3. Clinical diagnostic motor features of HD, defined as Unified Huntingtons Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4 4. UHDRS Total Functional Capacity Scores ≥9 and ≤13 Exclusion Criteria: 1. Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years 2. Received any other study drug, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer, with the exception of the following: a. Received WVE-120101 or WVE-120102 within the last 3 months 3. Implantable CNS device that may interfere with ability to administer study drug via lumbar puncture or undergo MRI scan 4. Inability to undergo brain MRI (with or without sedation) 5. Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture 6. Previously received tominersen ; PRIMARY OUTCOME: Safety: Proportion of patients with adverse events (AEs); SECONDARY OUTCOME 1: Maximum concentration (Cmax) of WVE-003 in plasma[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - 4002 (CKD); BRIEF: The primary objective of this study is to compare the change in estimated glomerular filtration rate (eGFR) from baseline to Week 8 between placebo and GCS-100 treatment. The secondary objective is to determine the safety and tolerability of GCS-100 administered for 8 weeks relative to placebo. In addition, the study will measure the effect of GCS-100 on circulating galectin-3 and other markers of disease activity. ; DRUG USED: GCS-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: Galectin-3; THERAPY: Monotherapy; LEAD SPONSOR: La Jolla Pharmaceutical Company; CRITERIA: Inclusion Criteria: 1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent 2. Subject is ≥18 and ≤75 years of age; patients >75 years old may be included at the request of the investigator and discretion of the Medical Monitor 3. Subject has an eGFR of 15 - 44 mL/min/1.73m2 determined using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (see Section 10.1) 4. Patients with CKD diagnosis >12 months and stable, in the opinion of the investigator, within the past 3 months 5. Subject is willing and able to comply with all protocol requirements 6. Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least 1 year) and male subjects with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the study period Exclusion Criteria: 1. Treatment with an experimental (unlicensed) drug within 4 weeks or ≤5 half-lives prior to screening 2. Kidney disease due to systemic lupus erythematosus (regardless of whether active or in remission), any form of vasculitis (regardless of whether active or in remission), IgA nephropathy, multiple myeloma, polycystic kidney disease, untreated obstructed nephropathy or any other causes that, in the opinion of the investigator, may put the subject at an increased risk 3. Planned renal replacement therapy of any kind within 6 months of randomization 4. Previous solid organ transplant 5. Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening 6. Subject has clinical laboratory values of: 1. Hemoglobin: ≤9 g/dL 2. Total bilirubin: >1.5X the upper limit of normal (ULN) 3. ALT and/or AST: >2.5X ULN 7. Current treatment with immunosuppressive agents, except for topical agents or inhaled steroids when conditions are chronic and stable 8. Treatment with any form of IV iron therapy within 4 weeks prior to screening 9. Known history of cancer (excluding non-melanoma skin cancer that is not being actively treated) within 5 years of screening 10. Known history of human immunodeficiency virus, active hepatitis C virus (HCV), active hepatitis B virus (HBV), or prior history of infection with HBV (HBcAb positive); if adequate hepatic function has been documented for patients with HCV or prior history of hepatitis B without evidence of cirrhosis, the Medical Monitor may approve their enrollment 11. Clinically relevant active infection and/or a serious co-morbid medical condition, such as recent myocardial infarction (within the last 6 months), unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, severe or uncontrolled chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis. 12. Subject had major surgery within 4 weeks of randomization 13. If female, subject is pregnant or breastfeeding 14. Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk ; PRIMARY OUTCOME: Change in estimated glomerular filtration rate (eGFR) from baseline relative to placebo after administration of GCS-100 for 8 weeks in patients with chronic kidney disease (CKD) and baseline eGFR of 15 - 44 mL/min/1.73m2; SECONDARY OUTCOME 1: Number of adverse events as a measure of safety and tolerability of GCS-100 administered for 8 weeks relative to placebo in patients with CKD[/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: This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with progressive supranuclear palsy (PSP). ; DRUG USED: ABBV-8E12; DRUG CLASS: Biologic; INDICATION: Progressive Supranuclear Palsy; TARGET: Tau proteins; THERAPY: Monotherapy; LEAD SPONSOR: C2N Diagnostics; CRITERIA: Key Inclusion Criteria: - Meets NINDS-SPSP possible or probable criteria as modified for NNIPPS and AL-108-231 clinical trials - Brain MRI at Screening is consistent with PSP; - Stable medications for Parkinsonism for at least 2 months prior to Screening; - Agree to use protocol specified methods of contraception. Key Exclusion Criteria: - Signs of a progressive neurological disorder that better meets the criteria for types of neurological disorders other than PSP; - Currently on any other biologic or immunomodulatory therapy; - Subjects that reside at a skilled nursing or dementia care facility; - Diagnosis of any other significant unrelated neurological or psychiatric disorders that could account for cognitive deficits; - Untreated major depression at baseline evaluation, based on clinical judgment and results in geriatric depression scale; - Unable to tolerate MRI scan at Screening or any other contraindication to MRI; - Any contraindication to or unable to tolerate lumbar puncture at Screening, including use of anti-coagulant medications. ; PRIMARY OUTCOME: Safety and tolerability, as measured by number of participants experiencing adverse events (AEs), serious AEs, and abnormalities in clinical laboratory tests, vital signs, ECGs, MRI, and physical and neurological exams.; SECONDARY OUTCOME 1: Immunogenicity as measured by the number of participants developing anti drug antibodies.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 001; BRIEF: This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study using two dose levels of an investigational vaccine directed against S. aureus and Candida. The study is designed to evaluate the safety, tolerability and immunogenicity of the investigational vaccine, NDV-3 ; DRUG USED: NDV-3; DRUG CLASS: Vaccine; INDICATION: Staphylococcal Vaccines and Other Staphylococcus-Specific Agents (Antibacterial); TARGET: Candida, Staphylococcus; THERAPY: Monotherapy; LEAD SPONSOR: NovaDigm Therapeutics, Inc.; CRITERIA: Inclusion Criteria: 1. Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent document prior to screening. The informed consent document will be written in English, therefore the subject must have the ability to read and communicate in English. 2. Completed the screening process within 30 days prior to dosing. 3. Healthy male and female subjects 18-50 years of age, inclusive, at the time of dosing. 4. No clinically significant deviation from normal as judged by the investigator(s) in the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. 5. Female subjects must be: - of childbearing potential and practicing an acceptable method of birth control described below as judged by the investigator(s); or - of postmenopausal status (no menses) for at least 1 year and has a documented FSH level ≥ 40 mIU/mL; or - sterile (surgically [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy] or the Essure® Procedure). Exclusion Criteria: 1. Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing. 2. Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s). 3. Clinical laboratory test values outside the accepted range. 4. When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody. 5. Reports a clinically significant illness during the 28 days prior to dosing (as determined by the clinical investigators). 6. Demonstrates a positive drug screen for non-prescription drugs. 7. Reports a history of allergic response(s) to nickel or anaphylaxis (or other serious reactions) to aluminum. 8. Reports receiving any live attenuated vaccine including FluMist® within 6 weeks prior to dosing or any licensed inactivated vaccine within 3 weeks prior to dosing. 9. Reports the use of any immunosuppressive drugs, including systemic corticosteroids, within 4 weeks prior to dosing. 10. Reports the use of any medications or treatments that may alter immune responses to the study vaccine within 3 weeks prior to dosing (e.g., cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal antibodies, radiation therapy). 11. Reports a history of clinically significant allergies including food or drug allergies or anaphylaxis (or other serious reactions) to vaccines. 12. Reports a history of drug or alcohol addiction or abuse within the past year. 13. Reports receiving any blood products within 3 months prior to dosing and throughout the study. 14. Reports donating blood within 28 days prior to dosing. All subjects will be advised not to donate blood for four weeks after completing the study. 15. Reports donating plasma (e.g. plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for four weeks after completing the study. 16. Reports an intolerance of direct venipuncture. 17. Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study (females only). 18. Demonstrates a positive pregnancy screen (females only). 19. Any other medical and/or social (e.g. non-compliant) reason which, in the opinion of the investigator(s), would prevent participation in the study. - ; PRIMARY OUTCOME: The primary objective of this study is to assess the safety and tolerability of one dose of NDV-3 vaccine compared to placebo at two different dose levels.; SECONDARY OUTCOME 1: The secondary objective is to compare the humoral and cellular immune responses between the two dose levels compared to placebo at several time points over a 6 month 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 IIb - Europe; BRIEF: The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer. ; DRUG USED: TG4010; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: IL-2 (Interleukin-2), Immune System, Mucin 1 (MUC-1); THERAPY: Combination; LEAD SPONSOR: Transgene; CRITERIA: Inclusion Criteria: - Histologically confirmed non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma, or large cell carcinoma); - Histological documentation of MUC1 antigen expression on the primary tumor or on metastasis, as defined by a positive staining by immuno-histo-chemistry in at least 25% of the tumor cells in the conditions described in the technical documentation of the monoclonal antibody; - Patients will have stage IIIb wet (with pleural or pericardial effusion) or IV disease, with no prior systemic therapy for advanced disease except for adjuvant treatment. Prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted; - At least one measurable lesion by Computed Tomography (CT-scanner) according to WHO criteria (lesion accurately measured in two dimensions with longest diameter equal or greater to 10 mm with spiral CT scan); - Adequate hematological, hepatic, and renal function: - Hemoglobin >= 10.0 g/dL; WBC >= 3.0x10e9/L including neutrophils >= 1.5x10e9/L and total lymphocytes count >= 0.5x10e9/L; platelets count >= 100x10e9/L; - Bilirubin =< 2x the upper limit of normal and serum transaminases =< 3x the upper limit of normal; - Glomerular Filtration Rate higher than 60 ml/mn according to Cockcroft formula; - Performance status 0 or 1 on the ECOG scale (Appendix 2); - Minimum estimated life expectancy of 4 months; - Written informed consent from patient. Exclusion Criteria: - Concomitant brain metastases. If previous brain metastases were treated, the absence of evolution is to be demonstrated by the MRI or scanner performed at baseline; - Prior history of other malignancy except basal cell carcinoma and intra-epithelial cervical cancer or other cancer with complete response since at least 5 years; - History of any form of systemic therapy for advanced non-small cell cancer of the lung except for (neo)adjuvant treatment; - Previous (within 4 weeks prior to day 1) or concomitant long term treatment with systemic steroids, immunosuppressive / immunomodulating drugs (e.g. Cyclosporine, corticoïds); - Positive serology for HIV or HCV; positive antigens for hepatitis B; - Serious concomitant medical disorder; - Major surgery within 4 weeks prior to day 1; - Patient with an organ allograft; - Allergy to eggs; - Participation in another experimental protocol during the study period, or within 4 weeks prior to day 1; - Pregnancy at the entry or women who are breast feeding; - Patient without adequate protection against pregnancy during the conduct of the study and for 3 months after the last injection of TG4010 and/or chemotherapy; - History of substance abuse; - Patient unable or unwilling to comply with the protocol requirements. ; PRIMARY OUTCOME: Progression free survival at 6 months; SECONDARY OUTCOME 1: Response Rate according to WHO 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 - HALO-DMD-03; BRIEF: This study, HALO-DMD-03, is a follow-on study to HALO-DMD-01 and HALO-DMD-02, and allows continued open-label access to HT-100 for subjects who have completed these studies. HALO-DMD-03 will provide safety and strength and function data on continuous long-term dosing. Data from this study will be used to inform the safety, tolerability, and dose selection for a future trial of HT-100 in boys with Duchenne Muscular Dystrophy (DMD). ; DRUG USED: HT-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Duchenne Muscular Dystrophy (DMD); TARGET: Collagen; THERAPY: Monotherapy; LEAD SPONSOR: Akashi Therapeutics; CRITERIA: Inclusion Criteria: 1. Completed both previous studies HALO-DMD-01 and HALO-DMD-02 2. Ability to provide written informed consent 3. Ability to understand and follow site and protocol instruction for the entire duration of the study Exclusion Criteria: Answering yes to any of the following make the subject NOT eligible to participate in the study. 1. Clinically significant major disease not related to DMD that would make it not safe to be in the study or affect ability to follow the protocol 2. History of severe allergic or anaphylactic reactions 3. Recent report of drug/alcohol abuse ; PRIMARY OUTCOME: Number of adverse events by severity and relationship; SECONDARY OUTCOME 1: Cardiovascular Magnetic Resonance[/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 - CR108062; BRIEF: The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults. ; DRUG USED: MVA-BN Filo/Ad26.ZEBOV; DRUG CLASS: Vaccine; INDICATION: Ebola; TARGET: Ebola Virus, Marburg virus; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Vaccines & Prevention B.V.; CRITERIA: Inclusion Criteria: - Participant must be healthy in the Investigators clinical judgment on the basis of medical history, physical examination and vital signs performed at Screening - Participant must be healthy on the basis of clinical laboratory tests and electrocardiogram (ECG) (only in participants >50 years) performed at Screening. If the results of the laboratory screening tests and ECG are outside the institutional normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study - A woman of childbearing potential must have a negative urine β-human chorionic gonadotropin [beta-hCG] pregnancy test at Screening and a negative urine [beta-hCG] pregnancy test immediately prior to each study vaccine administration - A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to dose 1 vaccination until at least 3 months after the dose 2 vaccination, unless a vasectomy was performed more than 1 year prior to Screening - Participant must pass the test of understanding (TOU) - Additional Inclusion Criteria for HIV-infected participants a) participants must have a positive HIV-1 and/or -2 serology test within 6 months of screening, including the day of screening; b) participants must have a Screening CD4+ cell count >200 cells/microliter (mcL); c) in part 1, all participants must be on a stable highly active antiretroviral therapy (HAART) regimen for 4 weeks prior to Screening, in part 2 participants with screening CD4+ cell count <350 cells/mcL must also be on a stable HAART regimen for 4 weeks prior to Screening Exclusion Criteria: - Has received any candidate Ebola vaccine - Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to epidemic Ebola areas less than 1 month prior to Screening - Has received any experimental candidate Ad26- or MVA-based vaccine in the past or received any other investigational drug or investigational vaccine or used an invasive investigational medical device within 3 months prior to Screening - Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products - Presence of significant conditions (eg, history of seizure disorders, (auto)immune disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis treatment, other systemic infections) or clinically significant findings during screening of medical history, ECG (only in participants >50 years), physical examination, vital signs or laboratory testing for which, in the opinion of the investigator, participation would not be in the best interest of the participants (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments ; PRIMARY OUTCOME: Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events; SECONDARY OUTCOME 1: Number of Participants With Adverse Events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DREAM-T2D; BRIEF: In Phase 1 and 2 studies already conducted, Metformin DR, with its targeted delivery to the distal small intestine, has shown the potential to be a safe and effective way to improve glycemic control in patients with T2DM and CKD with less systemic metformin exposure. The primary purpose of this Phase 3 clinical study is to collect pivotal data confirming the safety and efficacy of Metformin DR in T2DM patients with varying renal function from normal up to CKD3B. ; DRUG USED: NewMet; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK); THERAPY: Monotherapy; LEAD SPONSOR: Anji Pharma; CRITERIA: Inclusion Criteria: 1. Is male or female and at least 18 years old 2. Has body mass index 20.0 to 45.0 kg/m2 (inclusive) 3. Has T2DM 4. Has HbA1c of 7.0% to 9.5%, inclusive, at Visit 1A and HbA1c value of 7.0% to 10.5%, inclusive, at Week -2 (Visit 3/3A as applicable) 5. Has an eGFR value of ≥30 mL/min/1.73 m2 based on the CKD-EPI equation at Visit 1A and Visit 3/3A (Week -2) 6. Stable treatment with a metformin preparation or a combination product containing metformin for 8 weeks prior to Visit 1A 7. If treated with the following medications, must be on a stable regimen for a minimum of 6 weeks prior to Visit 1B 1. Drugs known to affect body weight, including prescription medications (e.g., phentermine, phentermine/topiramate, orlistat, lorcaserin, bupropion/naltrexone) and over-the-counter anti-obesity agents 2. Hormone replacement therapy (female patients) and testosterone (male patients) 3. Oral contraceptives (female patients) 4. Antihypertensive agents including ACEi/ARB 5. Lipid-lowering agents 6. Thyroid replacement therapy 7. Antidepressant agents 8. Ability to understand and willingness to adhere to protocol requirements Exclusion Criteria: 1. Is currently on dialysis, has been on any dialysis within 1 year of Visit 1B, or is expected to undergo dialysis during the study period 2. Has a history of lactic acidosis 3. Has a fasting plasma glucose (FPG) value >240 mg/dL (>13.3 mmol/L) at Week -2 (Visit 3/3A as applicable) 4. An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN at Visit 1B or Visit 3/3A (Week -2) (except in case of documented Gilberts syndrome) 5. Has a fasting plasma lactate value >2 mol at Visit 1B 6. Has a bicarbonate value ≤20 mEq/L at both Visit 1A and 1B. If bicarbonate value is <20 at Visit 3/3A or 4, patient may be excluded if the investigator considers this clinically significant 7. A history of >5% weight change within 12 weeks prior to Visit 1A 8. Has mean BP measurements >180 mmHg (systolic BP) or >100 mmHg (diastolic BP) at Visit 1A or Visit 3/3A, which can be rechecked within 1 week (Note: re-screening is allowed 6 weeks after initiation/modification of antihypertensive agents if the patient is screen failed due to BP only) 9. Oral antidiabetic agent or insulin use that is not stable for 8 weeks prior to randomization (i.e., change in oral medication dose or basal insulin dose increased or decreased by more than 20% during the 8 weeks prior to Visit 4 [Day 1]) 10. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications: 1. Prescribed metformin preparation after initiation of metformin washout following Visit 1B 2. Greater than 10 consecutive days of systemic corticosteroids by oral, intravenous, or intramuscular route within 12 weeks of Visit 1B; inhaled, intranasal, ophthalmic, topical, or intra-articular corticosteroids are not exclusionary 3. Planned use of proton pump inhibitors after Visit 2 (Week -6); such use could potentially affect the DR and PK of Metformin DR. Proton pump inhibitor treatment may be replaced by other treatment (such as H2 receptor antagonists [excluding ranitidine], or calcium carbonate antacids) prior to Visit 4 (Day 1), if appropriate per the judgment of the Investigator 4. Cationic drugs that are eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, flecainide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) within 1 week of Visit 3 (Week 2) 5. Iodinated contrast dye within 1 week prior to Visit 3 (Week -2) 6. Investigational drug within 8 weeks (or 5 half-lives of the investigational drug, whichever is greater) of the date of the first dose of randomized study medication 7. Metformin DR or double-blind matching placebo for Metformin DR at any time prior to Visit 1B 11. Has a clinically significant medical condition as judged by the Investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions: 1. Hepatic disease 2. Gastrointestinal disease, including but not limited to: i. History or presence of inflammatory bowel disease or other severe gastrointestinal disease, particularly those that may impact gastric emptying, such as gastroparesis and pyloric stenosis ii. Prior or expected surgical gastrointestinal procedure that may impact the gut hormonal response to study medication such as gastric bypass surgery or gastric banding surgery iii. Active diagnosis of pancreatitis c. Endocrine disorder other than T2DM or hypothyroidism on replacement therapy d. Cardiovascular disease, including history of stroke, decompensated heart failure New York Heart Association Class III or IV, myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft or angioplasty within 3 months prior to Visit 1A (screening) e. Central nervous system diseases such as epilepsy f. Psychiatric or neurological disorders that in the Investigators opinion would cause the patient to be noncompliant with study procedures g. Organ transplantation h. Chronic or acute infection requiring systemic antibiotic treatment i. Orthostatic hypotension or syncope j. Active malignancy within the past 5 years with exception of basal cell and squamous cell carcinoma 12. Known allergy or hypersensitivity to Metformin DR, Metformin IR, or placebo or any inactive component of study medication, active comparator, or placebo, unless the reaction is deemed irrelevant to the study by the Investigator (prior history of gastrointestinal intolerance to metformin is not exclusionary) 13. Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within 1 year prior to Visit 1B 14. A physical, psychological, or historical finding that, in the Investigators opinion, would make the patient unsuitable for the study 15. Any verified clinically significant abnormality identified on physical examination, laboratory tests, ECG, vital signs, or any adverse event (AE) at the time of Visit 1B through Visit 4 that, in the judgment of the Investigator or any Sub-investigator, would preclude safe completion of the study or constrains efficacy assessment 16. Currently abuses drugs or alcohol or has a known history of abuse that in the Investigators opinion would cause the patient to be noncompliant with study procedures 17. Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 8 weeks prior to Visit 1B, or is planning to donate blood or have a blood transfusion during the study 18. Prior or planned major surgery of any kind (requiring overnight hospitalization) within 6 months of Visit 1B 19. Patients insufficiently compliant with study medication during the placebo run-in phase (<85% or >115%) as assessed at Visit 4 20. Is screening for the study at more than one clinical site or is participating in any other clinical study 21. Is currently pregnant (confirmed by serum pregnancy test at Visit 1B) or breastfeeding or plans to become pregnant during the course of the study 22. Women of childbearing potential not willing to use highly effective method(s) of birth control during the entire study, or who are unwilling or unable to be tested for pregnancy 23. If the patient has evidence of coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection), the patient cannot be enrolled in the study 24. Is employed by Anji Pharma (that is an employee, contract worker, or designee of the company). ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: HbA1c response (Metformin DR vs. placebo)[/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 - AL008; BRIEF: The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD ; DRUG USED: MDX; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Alcobra Ltd.; CRITERIA: Inclusion Criteria: 1. Adult males and females, 18 to 50 years old, inclusive, at screening visit 2. Diagnosed with ADHD based on 1. DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS V1.2) 2. SCID clinical interview 3. Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above) 4. Female subjects with childbearing potential must agree to use effective contraceptive and have negative urine pregnancy test at screening visit 5. Able to attend the clinic regularly and reliably 6. Able to swallow tablets/capsules 7. Able to understand, read, write and speak Hebrew fluently to complete study related materials 8. Able to understand and sign written informed consent to participate in the study Exclusion Criteria: 1. Subjects who were non-responder to at least two ADHD treatments 2. Subjects with any medical or psychiatric condition (e.g. schizophrenia, personality disorder as diagnosed by DSM-IV) or clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by medical history, physical examination, neurological exam, laboratory tests or ECG or based on the opinion of the Investigator; common diseases such as hypertension, type 2 diabetes mellitus, hyperlipidemia, etc. are allowed per the Investigators judgment, as long as they are stable and controlled by medical therapy that is constant for at least 8 weeks prior to randomization and throughout the study 3. Any prescription or non-prescription ADHD medications during the 7 days prior to the screening visit 4. Known or suspected HIV-positive or with advanced diseases such as AIDS, Hepatitis C, Hepatitis B or tuberculosis 5. History of allergy or sensitivity to B complex vitamins 6. History or suspicion of PDD, NLD or other psychotic conditions 7. Use of Vitamin B throughout the study 8. Use of ADHD medications throughout the study 9. Use of any psychiatric medications throughout the study 10. Use of investigational medication/treatment in the past 30 days prior to the screening visit per the discretion of the Investigator 11. Use of any medication or food supplement not considered acceptable by the clinical Investigator or the medical monitor during the 14-day period before randomization 12. Current (or history within the last 6 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine). Subjects should also agree to refrain from consuming abnormally high amounts of caffeine during the study. 13. Suicidality, defined as either active suicidal plan/intent or active suicidal thoughts, in the 6 months before the Screening Visit or no lifetime suicide attempt. 14. Blind subjects 15. Any relation to the Sponsor, Investigator or study staff 16. Any condition, which in the opinion of the Principal Investigator would place the subject at risk or influence the conduct of the study or interpretation of results, including (but not limited to) abnormally low intellectual capacity. 17. Subjects who cannot fully comprehend the implications of the protocol or comply with its requirements or are capable to follow the study schedule for any reason 18. Pregnancy, lactation or inadequate contraceptive method - ; PRIMARY OUTCOME: Conners Adult ADHD Rating Scales (CAARS™); SECONDARY OUTCOME 1: Test of Variables of Attention (TOVA) (Change in ADHD Score From Screening to Visit 6)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RAY - vs. Temsirolimus (ex-US); BRIEF: The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Mantle Cell Lymphoma - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of mantle cell lymphoma (MCL) - Received at least 1 prior rituximab-containing chemotherapy regimen (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a > 6 month treatment-free interval) - Documented relapse or disease progression following the last anti-MCL treatment - At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma - Eastern Cooperative Oncology Group performance status grade 0 or 1 - Protocol-defined hematology and biochemistry laboratory values Exclusion Criteria: - Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of randomization - Prior treatment with temsirolimus, other mTOR inhibitors, ibrutinib, or other Brutons tyrosine kinase (BTK) inhibitors - Known central nervous system lymphoma - Received an allogeneic or autologous hematopoietic stem cell transplant <=6 months from the date of randomization and on immunosuppressive therapy or have evidence of active graft versus host disease - Diagnosed or treated for malignancy other than MCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before randomization, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated cervical carcinoma in situ without evidence of disease - History of stroke or intracranial hemorrhage within 6 months prior to randomization - Requires anticoagulation with warfarin or equivalent vitamin K antagonist - Requires treatment with strong CYP3A inhibitor - Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification - Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection or any uncontrolled active systemic infection requiring intravenous antibiotics - Woman who is pregnant or breast-feeding - Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigators opinion, could compromise the patients safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Overall Response Rate (ORR)[/INST]Yes</s>

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

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Repeat-Dose (Knee); BRIEF: This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee ; DRUG USED: Zilretta; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: - Written consent to participate in the study - Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions - Male or female ≥ 40 years of age - Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening - Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA - Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the index knee based on X-ray performed during Screening - Qualifying score for WOMAC A at Screening and Day 1/Baseline - Index knee pain for >15 days over the last month (as reported by the patient) - Body mass index (BMI) ≤ 40 kg/m2 - Ambulatory and in good general health - Willingness to abstain from use of protocol-restricted medications during the study Exclusion Criteria: - Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease - History of infection in the index knee joint - Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening - Presence of surgical hardware or other foreign body in the index knee - Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening - IA corticosteroid (investigational or marketed) in index knee within 3 months of Screening - IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening - IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening - Oral corticosteroids (investigational or marketed) within 1 month of Screening - Any other IA drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy and amniotic fluid injection) - Prior administration of FX006 - Women of child-bearing potential not using effective contraception or who are pregnant or nursing ; PRIMARY OUTCOME: Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006; 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 - INSPIRE; BRIEF: The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy. ; DRUG USED: LIQ861; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostaglandin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Liquidia Technologies, Inc.; CRITERIA: Inclusion Criteria: - signed informed consent by patient prior to study enrollment - 18 years of age or older - If female of childbearing potential, a negative pregnancy test at the Baseline Visit and agrees to practice adequate birth control throughout the duration of the study. If the patient is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control is not necessary. - The patient has been diagnosed with PAH belonging to the following subgroups of the updated Nice Clinical Classification Group 1 (Simonneau, Gatzoulis et al. 2013), which include: 1. Idiopathic PAH (1.1), or 2. Heritable PAH (1.2), or 3. Drug and toxin induced PAH (1.3), or 4. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair - The patient has been diagnosed with PAH and is NYHA Functional Class II - IV at Screening. 1. has documented stable doses of approved inhaled therapy for at least 3 months prior to screening and is willing and able to transition from their prescribed dose of inhaled therapy to study drug, or 2. has documented stable doses of no more than two approved oral therapies for at least 3 months prior to screening and is willing and able to add LIQ861 to their treatment regimen. - The patient can complete a baseline six-minute walk distance (6MWD) ≥ 150 m. - The patient has had evidence of FEV1 ≥ 60% and FEV1/FVC ratio ≥ 60% during the 6-month period prior to enrollment. Exclusion Criteria: - The patients clinical condition is such that, in the opinion of the Investigator, they are not expected to remain clinically stable for the duration of the study. - Patients with PH in the Updated Nice Classification Groups 2-5, or PAH Group 1 subgroups not covered by the inclusion criteria (e.g., associated with portal hypertension [1.4.3] or with schistosomiasis [1.4.5]). - The patient is currently taking oral prostacyclin analogues or agonists, including treprostinil and selexipag. - The patient has had any PAH medication (except for anticoagulants) discontinued within 14 days of Baseline. - The patient has had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for pulmonary hypertension added within 30 days of Baseline. - The patient has uncontrolled systemic hypertension as evidenced by persistent systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg. - The patient has a history of hemodynamically significant left-sided heart disease including, but not limited to: aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease (CAD). - The patient has had an atrial septostomy. - The patient has any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, end stage renal disease, etc.). - The patient is taking any excluded medications listed in the Investigators Brochure, namely inhibitors and inducers of CYP2C8 - The patient has a hypersensitivity or allergy to any of the ingredients of LIQ861 or other clinically relevant allergies (clinical relevance per Investigator judgment). - The patient has had a pulmonary infarction (defined as infarction in more than one lung segment documented by V/Q scan or pulmonary angiography) within two weeks of Screening. - The patient has had a stroke or transient ischemic attack (TIA) within six months of Screening. - The patient has evidence of an active uncontrolled sepsis or systemic infection during Screening. - The patient is pregnant or lactating. - The patient has any musculoskeletal disease or any other disease that would limit ambulation. - The patient has participated in an investigational product or device study within the 30 days prior to Screening. - The patient has current evidence of drug abuse in the opinion of the Investigator. - The patient has severe hepatic impairment as evidenced by any history of ascites AND encephalopathy. - The patient has severe renal impairment (eGFR < 35). - The patient is taking inhaled treprostinil doses of greater than 90 μg (more than 15 breaths). Additional Exclusion Criteria for PK Sub-Study: - The patient meets any of Primary Exclusion Criteria #1 - 19. - The patient has moderate or severe renal impairment (eGFR < 60). - The patient is taking inhaled treprostinil doses of greater than 72 μg (more than 12 breaths). ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/Doxorubicin (China); BRIEF: The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is safe and effective in the treatment of advanced hepatocellular carcinoma (HCC). ; DRUG USED: BCT-100; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Arginine; THERAPY: Combination; LEAD SPONSOR: Bio-Cancer Treatment International Limited; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of HCC according to the European Association for the Study of the Liver criteria - Known underlying HCC etiology specified by hepatitis B, hepatitis C, post alcoholic cirrhosis, or other - HCC lesion(s) which are not resectable and which are measurable by C-T scan - Progression of or non-response of HCC lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization - No cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational; - Males or females from 18 to 75 years-old, inclusive; - Ability and willingness to provide written informed consent; - Karnofsky performance status of 80% or above and expected survival of more than 12 weeks; and, - Negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period Exclusion Criteria: - Advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a Child-Pugh score of C - Significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 µmol/L, evidence of bile duct obstruction, serum albumin <30 g/L, serum SGOT >5 x upper limit of normal, ANC <1.0 x 10^9/L, platelets <100 x 10^9/L, or INR >2.0 - Significant cardiac or pulmonary disease defined by New York Heart Association (NYHA) Class III or IV, VEF <50% by echo or MUGA, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ECG - Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - Significant active infection including HIV requiring oral or parenteral anti-infective therapies; - Use of investigational drug(s) within 4 weeks of enrollment; or, - Prior treatment with arginine depleting agent. ; PRIMARY OUTCOME: Plasma arginase and arginine levels,as well as tumour response, i.e. an effect on growth in the milieu of arginine depletion.; SECONDARY OUTCOME 1: Overall Survival, Time to Progression[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CP-00002; BRIEF: The proposed pilot study aims to gain experience with the first clinical use of the to-be marketed drug-device combination product, the sc2Wear Furosemide Combination Product and to assess methods and procedures for evaluation of product performance. The objectives of this study are: - To gain first in man experience of a novel drug-device combination product - To evaluate the suitability of the methods and procedures for evaluating of the performance of the sc2Wear Pump ; DRUG USED: Furoscix; DRUG CLASS: Non-NME; INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Na-K-Cl cotransporter (NKCC2); THERAPY: Monotherapy; LEAD SPONSOR: scPharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Male and female Subjects ≥18 years of age 3. New York Heart Association (NYHA) Class II-IV Heart Failure. 4. In the opinion of the Investigator, able to participate in the study. 5. If Subject is on oral diuretic, willing to suspend the oral furosemide or other loop diuretic treatment on the day of treatment (use of oral diuretic within 8 hours of start of treatment is not recommended) 6. If Subject has significant body hair on the abdomen, willing to clip or shave the area where the device will be placed prior to treatment. 7. Has the ability to understand the requirements of the study, and is willing to comply with all study procedures. Exclusion Criteria: 1. Contraindication to furosemide. 2. History of chronic skin conditions requiring medical therapy. 3. Skin reaction to medical adhesives or history of poor skin adherence of adhesives. 4. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc. 5. Diabetic patients currently using an insulin pump and/or interstitial glucose monitors. 6. Clinically significant abnormalities at Screening in safety laboratory tests. 7. Hypokalemia - Potassium of < 3.6 mmol/L. 8. Systolic BP (SBP) < 90 mm Hg. 9. Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment. 10. History of major abdominal surgery affecting the site of device placement. 11. Participation in another trial, within 30 days prior to Screening. 12. History of hepatitis B, hepatitis C, or HIV 13. History of current or recent alcohol abuse. 14. Female subject who is pregnant or lactating. 15. Any surgical or medical condition that in the opinion of the Investigator may interfere with participation in the study or that may affect the outcome of the study. ; PRIMARY OUTCOME: Absence of Major Product Failure; SECONDARY OUTCOME 1: Local Pain Tolerance[/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 - ROCCELLA; BRIEF: This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis. ; DRUG USED: GLPG1972; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Aggrecanases; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Male participants or female participants of non-childbearing potential and not breastfeeding. - Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2. - Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology. - History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month. - Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits. - Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics Exclusion Criteria: - Severe clinical knee malalignment according to the investigator. - Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side). - Knee prosthesis already foreseen within the study period (whichever side). - Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side). - Previous osteotomy on the inferior limbs (whichever side). - Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study. - Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study. - Other pathologies affecting the target knee. - Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil. ; PRIMARY OUTCOME: Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52; SECONDARY OUTCOME 1: Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee[/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 - Study 713; BRIEF: Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones. ; DRUG USED: Reloxaliase; DRUG CLASS: Biologic; INDICATION: Hyperoxaluria; TARGET: Oxalate; THERAPY: Monotherapy; LEAD SPONSOR: Allena Pharmaceuticals; CRITERIA: Inclusion Criteria: - History of enteric or idiopathic hyperoxaluria or kidney stones - Urinary oxalate ≥ 50 mg/24 hours Exclusion Criteria: - Hyperuricosuria - Glomerular filtration rate < 45 mL/min/1.73m2 - Hypercalcemia or hyperthyroidism - Autoimmune disorder requiring systemic steroids - Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure ; PRIMARY OUTCOME: Mean change in urinary oxalate excretion (mg/24h); SECONDARY OUTCOME 1: Percent change in urinary oxalate excretion[/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 - ORATORIO (PPMS); BRIEF: This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020. ; DRUG USED: Ocrevus; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria) - EDSS at screening from 3 to 6.5 points - Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than (>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0 - Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose Exclusion Criteria: - History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening - Inability to complete an MRI (contraindications for MRI) - Known presence of other neurologic disorders - Known active infection or history of or presence of recurrent or chronic infection - History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved) - Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab) - Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study ; PRIMARY OUTCOME: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period; SECONDARY OUTCOME 1: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind 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 - Study 0092; BRIEF: The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia. ; DRUG USED: TD-9855; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fibromyalgia; TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Theravance Biopharma; CRITERIA: Inclusion Criteria: - • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM) - Informed consent - 18 to 65 years of age - Discontinue therapy with adrenergic-acting drugs, and certain other medications - Only acetaminophen or NSAID as rescue pain medication - No narcotic pain meds or benzodiazepines - Only non-benzodiazepines as rescue hypnotics Exclusion Criteria: - Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI) - Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or providers judgment) - Risk of suicide (investigator opinion and/or C-SSRS) - Recent history of substance or alcohol abuse - BMI <18 or ≥45 - Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea - Abnormal lab values (liver, kidney, thyroid, and others) ; PRIMARY OUTCOME: Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries; SECONDARY OUTCOME 1: Fibromyalgia Impact Questionnaire (FIQ)[/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 - iLLUMINATE (w/Gazyva); BRIEF: The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL. ; 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: Combination; LEAD SPONSOR: Pharmacyclics LLC.; CRITERIA: Inclusion Criteria: Disease Related: 1. Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria. 2. Age 65 yrs and older OR if less than 65 years, must have at least one of the following criteria: - Cumulative Illness Rating Score (CIRS) >6 - Creatinine clearance estimated <70 mL/min using Cockcroft-Gault equation. - Del 17p by fluorescence in situ hybridization (FISH) or TP53 mutation by polymerase chain reaction (PCR) or Next Generation Sequencing 3. Active disease meeting at least 1 of the following IWCLL criteria for requiring treatment: - Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and thrombocytopenia - Massive, progressive, or symptomatic splenomegaly - Massive nodes (at least 10 cm longest diameter), or progressive or symptomatic lymphadenopathy. - Progressive lymphocytosis with an increase of more than 50 percent over a 2-month period or a lymphocyte doubling time (LDT) of <6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of <30,000/µL, LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded. - Autoimmune hemolytic anemia and/or immune thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy. - Autoimmune hemolytic anemia is defined by at least one marker of hemolysis (indirect bilirubin above the upper limit of normal (ULN) not due to liver disease, increased lactate dehydrogenase (above ULN) without alternative etiology, or increased absolute reticulocytosis (above ULN) or bone marrow erythropoiesis in the absence of bleeding AND at least one marker direct or indirect autoimmune mechanism (positive direct antiglobulin for immunoglobulin G [IgG] or C3d, cold agglutinins). - Immune thrombocytopenia is defined by platelets ≤100,000/µL and increased megakaryocytes on the bone marrow exam. - Constitutional symptoms, defined as one or more of the following disease-related symptoms or signs, documented in the patients record prior to randomization: - unintentional weight loss >10 percent within 6 months prior to screening. - significant fatigue (inability to work or perform usual activities). - fevers >100.5°F or 38.0°C for 2 or more weeks prior to screening without evidence of infection. - night sweats for more than 1 month prior to screening without evidence of infection. 4. Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node >1.5 cm in the longest diameter in a site that has not been previously irradiated. An irradiated lesion may be assessed for measurable disease only if there has been documented progression in that lesion since radiotherapy has ended. Laboratory 5. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening and randomization. 6. Adequate hepatic and renal function 7. Men and women ≥ 18 years of age. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: 1. Any prior treatment of CLL or SLL 2. Evidence of central nervous system (CNS) involvement with primary disease of CLL/SLL 3. History of other malignancies, except: - Malignancy treated with curative intent and with no known active disease present for ≥3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician. 4. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura 5. Known or suspected history of Richters transformation. 6. Concurrent administration of >20mg/day of prednisone within 7 days of randomization unless indicated for prophylaxis or management of allergic reactions (eg, contrast) 7. Known hypersensitivity to one or more study drugs 8. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug. 9. Any uncontrolled active systemic infection or an infection requiring systemic treatment that was completed ≤ 7 days before randomization. 10. Known bleeding disorders or hemophilia. 11. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 12. Known history of human immunodeficiency virus (HIV) or active with hepatitis B virus (HBV) or hepatitis C virus (HCV). 13. Major surgery within 4 weeks of randomization. 14. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigators opinion, could compromise the subjects safety or put the study outcomes at undue risk. 15. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization. 16. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. 17. Concomitant use of warfarin or other vitamin K antagonists. 18. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor. 19. Lactating or pregnant 20. Unwilling or unable to participate in all required study evaluations and procedures. 21. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations). ; PRIMARY OUTCOME: Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30; SECONDARY OUTCOME 1: Primary Analysis: PFS in High-Risk Sub-Population (del17p/TP53 Mutation/Del 11q) Based on IRC Assessment - Kaplan Meier Landmark Estimates at Month 30[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 1108 (Adolescents); BRIEF: An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis. ; 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 (all subjects) - Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA. - Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area. - A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA. - PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1. - PGA score of at least mild on scalp at SV1, SV2 and V1. - A serum albumin-corrected calcium below the upper reference limit at SV2. Inclusion Criteria (for subjects performing HPA axis assessment) - Psoriasis vulgaris on trunk and/or limbs affecting at least 10% BSA. - Psoriasis vulgaris on the scalp affecting at least 20% of total scalp area. - PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1. - PGA score of at least moderate on scalp at SV1, SV2 and V1. - Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge). Exclusion Criteria (all subjects): - A history of hypersensitivity to any component of LEO 90100. - Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial: 1. etanercept - within 4 weeks prior to V1 2. adalimumab, infliximab - within 2 months prior to V1 3. ustekinumab - within 4 months prior to V1 4. experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to V1 - Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial. - PUVA therapy within 4 weeks prior to V1. - UVB therapy within 2 weeks prior to V1 or during the trial. Exclusion Criteria (for subjects performing HPA axis assessment): - A history of serious allergy, allergic asthma or serious allergic skin rash. - Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide) - Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial. - Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial. ; PRIMARY OUTCOME: Number of Subjects With Adverse Events (AEs); SECONDARY OUTCOME 1: Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Gemcitabine (NCI); BRIEF: This randomized phase II clinical trial studies how well gemcitabine hydrochloride and WEE1 inhibitor MK-1775 work compared to gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of time. Gemcitabine hydrochloride may prevent tumor cells from multiplying by damaging their deoxyribonucleic acid (DNA, molecules that contain instructions for the proper development and functioning of cells), which in turn stops the tumor from growing. The protein WEE1 may help to repair the damaged tumor cells, so the tumor continues to grow. WEE1 inhibitor MK-1775 may block the WEE1 protein activity and may increase the effectiveness of gemcitabine hydrochloride by preventing the WEE1 protein from repairing damaged tumor cells without causing harm to normal cells. It is not yet known whether gemcitabine hydrochloride with or without WEE1 inhibitor MK-1775 may be an effective treatment for recurrent ovarian, primary peritoneal, or fallopian tube cancer. ; DRUG USED: AZD1775; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Tyrosine Kinases, Wee1 Inhibitor ; THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients must have histologically or cytologically confirmed epithelial ovarian, primary peritoneal and fallopian tube carcinoma; all histologic subtypes of epithelial ovarian cancer are eligible, but only patients with high grade serous ovarian cancer will be considered for the statistical analysis; non-high grade serous cancers will be allowed in an exploratory cohort - Patients must be platinum-resistant (platinum-free interval < 6 months) or have platinum-refractory disease as per Gynecologic Cancer Intergroup Committee (GCIC) criteria; disease progression has to be radiologic or clinical; biomarker progression with CA125 after a platinum based regimen would not be sufficient evidence of disease progression; the patients must have had radiological progression to that regimen - 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 > 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam - There is no limitation in the number of prior lines of therapy - Patients must have completed any prior chemotherapy, radiotherapy or major surgery at least 4 weeks before receiving study treatment; ongoing toxicities related to treatment must be =< grade 1 and patients with grade 2 alopecia or peripheral neuropathy can also be included; palliative radiation to < 10% of bone marrow is permissible if completed within one week of commencing study treatment as long as the toxicities secondary to palliative radiotherapy are limited to grade 1; the lesions that have received radiation treatment immediately before will be excluded as target lesions; previously irradiated lesions can be considered as targeted lesions, as long as there is prove of radiological progression - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) - Life expectancy of greater than 3 months - Leukocytes >= 3,000/mcL - Absolute neutrophil count >= 1,500/mcL - Platelets >= 100,000/mcL - Hemoglobin >= 90 g/L - Blood transfusions are allowed at any time during the screening, treatment or follow-up period, according to the center recommendations - Prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) =< 1.5 upper limit of normal (ULN) - Total bilirubin =< 1.5 x institutional upper limit of normal; unless due to Gilberts syndrome - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal (5 x if liver metastases) - Creatinine =< 1.5 × institutional upper limit of normal OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients with creatinine levels above 1.5 x institutional limit of normal - Patients must be able to tolerate oral medication and not have evidence of active bowel obstruction - Note: patients can have a history of prior bowel obstruction, provided the patient is not having symptoms of bowel obstruction at the time of enrolment and the bowel obstruction is not anticipated to recur during the participation in the study - Patients must have disease amenable to biopsy and must be willing to undergo a paired biopsy for correlative analyses (the first biopsy within 28 days prior to start of treatment and the second biopsy while on treatment) - Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately - Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal; postmenopause is defined as amenorrhea >= 12 consecutive months; Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or any other reversible reason - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who previously received gemcitabine for the treatment of recurrent disease - Patients who are receiving any other investigational agents - Patients with clinically or radiologically unstable brain metastases are excluded from this clinical trial - Note: patients with stable brain metastases after treatment, for at least 3 months prior to enrolling on this trial, could participate in the study; patients should be off, or on a stable dose of steroids - History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD 1775 (MK-1775) or gemcitabine - Patients taking the following prescription or non-prescription drugs or other products (i.e. grapefruit juice) are ineligible: sensitive cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) substrates, CYP3A4 substrates with a narrow therapeutic index, moderate to potent inhibitors/inducers of CYP3A4; patients would be eligible if the medications can be discontinued two weeks prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication - Pregnant and breastfeeding women are excluded from this study - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible - Uncontrolled intercurrent illness including, but not limited to, myocardial infarction within 6 months, congestive heart failure, symptomatic congestive heart failure, unstable angina pectoris, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, active liver disease or cerebrovascular disease with previous stroke, or psychiatric illness/social situations that would limit compliance with study requirements ; PRIMARY OUTCOME: Progression Free Survival; SECONDARY OUTCOME 1: Objective 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 - Urothelial Cancer; BRIEF: The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy. ; DRUG USED: Volasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bladder Cancer; TARGET: Polo-like kinase 1 (Plk1); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Histologically or cytologically confirmed urothelial cancer of the bladder, ureters or renal pelvis. 2. Patients with stage III, IV or recurrent urothelial cancer of the bladder, ureter or renal pelvis after failure or recurrence after first line or adjuvant/neoadjuvant chemotherapy. Recurrence is defined as relapse within 2 years after cessation of prior first-line chemotherapy. 3. Male or female patient aged 18 years or older 4. Life expectancy of at least three (3) months 5. Eastern Co-operative Oncology Group performance score of 2 or less 6. At least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT 7. The patient must have given written informed consent prior to inclusion into the trial which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation Exclusion criteria: 1. More than one prior regimen of chemotherapy including prior adjuvant therapy 2. Brain metastases 3. Patients with bone metastasis as the only site of disease are excluded 4. Serious illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety, interfere with the evaluation of the safety of the test drug or limit compliance with trial requirements. 5. QTc prolongation deemed clinically relevant by the investigator 6. Second malignancy currently requiring active therapy 7. Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia) 8. Absolute neutrophil count (ANC) <1,500/µl 9. Platelet count <100,000/µl 10. Hemoglobin <9 g/dl 11. Total bilirubin >1.5 mg/dl 12. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN in case of known liver metastases 13. Serum creatinine >1.5 x ULN 14. Chemo-, Radio- or immunotherapy within the past 4 weeks. This does not apply to steroids and bisphosphonates. 15. Active infectious disease, or HIV, Hepatitis-B or -C infection 16. Active drug or alcohol abuse 17. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial 18. Pregnancy or breast feeding 19. Treatment with any investigational drug within the past 4 weeks or within less than four half-life times of the investigational drug before treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant. 20. Prior treatment with Polo-like kinase 1 (Plk1) inhibitor 21. Patient unable to comply with the protocol 22. Any known hypersensitivity to the trial drugs or their excipients ; PRIMARY OUTCOME: Objective Tumour Response According to RECIST Criteria; SECONDARY OUTCOME 1: Progression-free Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Advanced Malignancies; BRIEF: This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors. ; DRUG USED: MVR-T3011; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Herpes Simplex Virus (HSV), IL-12 (Interleukin-12) and IL-12 receptor, Immune System, Oncolytic Virus Therapy, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: ImmVira Pharma Co. Ltd; CRITERIA: Key Inclusion Criteria: 1. Age 18 years or older. 2. Disease progression after standard of care (SOC) therapy or in the opinion of 3. The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy. Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease. ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1/PDL1 blockade after receiving at least 2 doses alone or in combination. iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies. iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic disease. Phase 2a Part 2 i.v. Arm E - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement. Participants must have received at least one line but no more than three lines of prior anti-cancer therapies. 4. Measurable disease per RECIST version 1.1. 5. Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7. Life expectancy > 12 weeks. 8. Demonstrate adequate organ function as defined by acceptable laboratory testing results. 9. Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011. WCBP must have a negative serum pregnancy test prior to W1D1. 10. Last dose of previous anticancer therapy ≥ 21 days, radiotherapy > 21 days, or surgical intervention > 21 days prior to the first dose of T3011. 11. Recovered from all prior anticancer therapy toxicities. 12. Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments. 13. Capable of understanding and complying with protocol requirements. 14. Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed. Key Exclusion Criteria: 1. Have only uninjectable tumors.. 2. Patients with injectable tumors impinging upon major airways or blood vessels. 3. HNSCC only: Prior re-irradiation field containing carotid artery. 4. Greater than 3 distant metastatic lymph node regions and/or metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)/5 cm (sarcoma) unless the lesion is to be injected. 5. Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy. 6. Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis/interstitial lung disease. 7. Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12. 8. Requires continued concurrent therapy with any drug active against HSV. 9. Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled. 10. Primary or acquired immunodeficient states. 11. Pregnant or lactating. 12. Prior organ transplantation. 13. Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011. 14. Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment. 15. History of or current central nervous system metastases. 16. History of seizure disorders within 6 months of Screening. 17. Active oral or skin herpes lesion at Screening. 18. Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids. 19. Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias. 20. History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody. 18. Active infection with SARS-CoV-2 virus. 21. Participants with moderate to large amount of pleural effusion, ascites or pericardial effusion who need drug or medical intervention. 22. Other systemic conditions or organ abnormalities that, in the opinion of the investigator, may interfere with the conduct and/or interpretation of the current study. ; PRIMARY OUTCOME: Safety and tolerability of escalating doses T3011; SECONDARY OUTCOME 1: Overall response rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 195071; BRIEF: This is a phase 1, single-center, first-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male volunteers and Japanese participants with moderate to severe atopic dermatitis. ; DRUG USED: DS-2741; DRUG CLASS: ; INDICATION: Atopic Dermatitis (Eczema); TARGET: Calcium release-activated channels (CRAC); THERAPY: Monotherapy; LEAD SPONSOR: Daiichi Sankyo Co., Ltd.; CRITERIA: Inclusion Criteria: - For Part 1 and Part 3: - Japanese healthy male subjects. - Age ≥20 and ≤45 years upon providing informed consent. - Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening. - For Part 2: - Japanese Male or female, Age ≥20 upon providing informed consent. - Diagnosed with chronic atopic dermatitis (AD) at least 3 years before screening and by the criteria of Hannifin and Rajka at screening. Exclusion Criteria: - For Part 1 and Part 3: - Having a history of atopic dermatitis - Having a history of hypersensitivity to drugs or other substances or being idiosyncratic - Having alcohol or drug dependence, etc. - For Part 2: - Having an active dermatological disease other than AD, which, in the investigators opinion, would affect study assessments. - Having a history of serious disease in the study potentially endangering the participant, as judged by the investigator or sub-investigator. - Having a chronic or acute infection requiring treatment within 28 days before screening. - Having superficial skin infections within 7 days before screening. - Having a history of recurrent oral herpes and recurrent genital herpes. - Having a history of parasitic infection or invasive, opportunistic infection such as histoplasmosis despite infection resolution, etc. ; PRIMARY OUTCOME: Incidence of adverse events among participants receiving DS-2741a (Part 1 and Part 3); SECONDARY OUTCOME 1: Characterize pharmacokinetic parameter maximum plasma concentration (Cmax) of plasma DS-2741a (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 III - MIST-2 (US); BRIEF: This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PH) vs. placebo. Participants attended 3 visits. At each visit, after baseline measurements, either the study drug or placebo was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals. ; DRUG USED: MicroStat; DRUG CLASS: Non-NME; INDICATION: Other Ophthalmological Indications (Ophthalmology); TARGET: Alpha 1 Adrenergic Receptor , Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eyenovia Inc.; CRITERIA: Inclusion Criteria: - Ability to provide written consent and return for all study visits - Photopic pupil diameter <= 3.5 mm in each eye Exclusion Criteria: - Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride - History of benign prostatic hyperplasia - Use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant, anticonvulsant, or cholinergic drug - History of closed-angle glaucoma - Anatomically narrow anterior chamber angles - Ocular surgery or laser treatment of any kind - History of chronic or acute uveitis - History of traumatic iritis or hyphema - History of traumatic mydriasis or angle recession - History of heterochromia - Irregularly-shaped pupil secondary to ocular trauma or congenital defect. - History of neurogenic pupil disorder - History of anterior chamber intraocular lens (IOL) or iris-fixated IOL - History of iris surgery, iris atrophy, or iris-cornea apposition/touch - Unwilling or unable to discontinue use of contact lenses at treatment visits. - Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye disease managed using artificial tears. - Presence of a severe/serious ocular condition, or any other unstable medical condition that, in the Investigators opinion, may preclude study treatment and/or follow-up - Pregnancy or lactation ; PRIMARY OUTCOME: Change in Pupil Diameter From Baseline; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - PK/PD (Canada); BRIEF: Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3 medication comparator. ; DRUG USED: Lypdiso; DRUG CLASS: Non-NME; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Sterol Regulatory Element-Binding Proteins (SREBPs); THERAPY: Monotherapy; LEAD SPONSOR: Matinas Biopharma, Inc; CRITERIA: Inclusion Criteria: Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified: 1. Adult male or female subject, 18-70 years of age, inclusive. 2. Light- or non-smoking, male and female subjects, 18 to 70 years of age. Note: subjects that regularly smoke greater than 10 cigarettes per day will not be considered light-smokers and should not be included. Additionally, the use of any cigars, pipes, vapor inhalers or any other tobacco containing product is prohibited within 6 months prior to drug administration. 3. Body mass index (BMI) ≥ 19 and ≤ 40 (kg/m2). 4. No clinically significant findings in vital signs measurements. The acceptable range for seated systolic blood pressure is 90-150 mmHg and for diastolic blood pressure is 50-95 mmHg. 5. No clinically significant abnormal laboratory values that, in the opinion of the investigator, would compromise the subjects safety or the integrity of the study results. 6. Either have: elevated triglyceride levels (2.26 to 4.52 mmol/L [200 to 400 mg/dL]), or · triglyceride levels 2.26 to 3.95 mmol/L (200 to 350 mg/dL) and are on stable statin therapy. 7. Total cholesterol levels ≤ 7.75 mmol/L (≤ 300 mg/dL). 8. Hemoglobin ≥ 135 g/L for males or ≥ 120 g/L for females at screening. 9. No clinically significant findings in a 12-lead electrocardiogram (ECG) 10. Have no significant diseases. 11. Willing to use an acceptable, effective method of contraception. 12. Be informed of the nature of the study and give written consent prior to any study procedure. 13. Have no clinically significant findings from a physical examination. Exclusion Criteria: Subjects may be excluded from the study if there is evidence of any of the following criteria at screening, check-in, or at any time during the study, as appropriate: 1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurological, or psychiatric disease in the opinion of the PI. 2. Personal or familial history of bleeding disorder(s), thromboembolic disease, clinical GI bleeding, or any history of GI surgery except uncomplicated appendectomy or cholecystectomy, or colorectal surgery for polyps, nonmalignant tumors, or diverticula. 3. Positive urine drug/alcohol testing at screening or check-in. 4. Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV). 5. History or presence of alcoholism or drug abuse within the past 2 years. 6. Known sensitivity or allergy to fish, shellfish, gelatin or omega-3 products. 7. Subject is a female who is pregnant or lactating. 8. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration 9. Donation of blood or significant blood loss within 56 days prior to check- in. 10. Participation in another clinical trial within 30 days prior drug administration. ; PRIMARY OUTCOME: Bioavailability comparison after single and multiple doses over a 24 hour period at day 1 and day 14; SECONDARY OUTCOME 1: Comparison of baseline changes of triglycerides and other related lipid protein parameter levels over 14 days[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa ; BRIEF: The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to standard of care (SOC; control) in subjects with open surgical wounds. ; DRUG USED: HemaMax; DRUG CLASS: Biologic; INDICATION: Wound Healing; TARGET: IL-12 (Interleukin-12) and IL-12 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Neumedicines Inc.; CRITERIA: Inclusion Criteria: - Scheduled to undergo colostomy reversal where the midline wound is closed and the stoma site (wound) is kept open to heal by secondary intention at the time of operation but expected to close between 4 and 6 weeks (per the judgment of the investigator). - Able to receive the dose of study drug within 24-36 hours post-operatively and demonstrate stable vital signs without unresolved major organ failure/dysfunction requiring critical care/monitoring for at least 24 hours prior to receiving study drug. - Agree to use accepted highly effective methods of birth control (defined as one that results in a low failure rate (i.e., <1% per year when used consistently and correctly) and continue for 3 months following receipt of study drug: 1. Sexual abstinence (males and females), 2. Vasectomized partner (females), 3. Condom with spermicide (males) in combination with another non-hormonal barrier method (females 4. Females on hormonal birth control should be on these medications for at least 3 years without complications. - Agree to use accepted highly effective methods of birth control (defined as one that results in a low failure rate (i.e., <1% per year when used consistently and correctly): 1. Sexual abstinence (males and females),Vasectomized partner (females), 2. Condom with spermicide (males) in combination with another non-hormonal barrier method (females), must agree to use for at least 3 months following receiving the study drug. 3. Females on hormonal birth control should be on these medications for at least 3 years without complications. - Surgically sterile (does not have a uterus or has had bilateral tubal ligation) or post-menopausal (no menstrual period for a minimum of 1 year) (females). - A negative serum pregnancy test at the time of enrollment into the study for women of childbearing potential. - Laboratory values for white blood cells (WBCs), neutrophils, lymphocytes and platelets prior to study drug administration on Day 1 as shown below: 1. WBCs > 3500 cells/µL, 2. Neutrophils > 2000 cells/µL, 3. Lymphocytes > 1000 cells/µL, 4. Platelets > 140,000 /µL. - All other clinical chemistry and coagulation laboratory values at enrollment must be either within the reference range or considered to be not clinically significant by the investigator and sponsor. Hematological laboratory values that are outside of the reference range must be reported to be above the upper limit of normal and not be reported as clinically significant. Exclusion Criteria: - Concurrent infections of unremovable prosthetic materials (e.g., permanent cardiac pacemaker battery packs, or joint replacement prostheses). - Undergoing a significant major planned concomitant surgical procedure other than hysterectomy or receiving antibiotic therapy within the week (7 days) prior to the date of surgery other than perioperative antibiotic therapy. - Preoperative evaluation that suggests an intra-abdominal process that might preclude full closure of the skin by secondary intention. - Treatment (e.g., chemotherapy, radiation) for cancer in the last 3 months. - Concomitant use of systemic steroid hormones, i.e. > 10 mg/day prednisone or equivalent. - Concomitant use of any immunosuppressive or immunomodulatory drugs. - History of Crohns disease or Ulcerative colitis. - Known history of drug or alcohol abuse within the past year. A positive screening urine toxicology will also exclude patients from this study. - Medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures. - Preoperative prothrombin time (PT), ALT, AST, and creatinine > 1.5 times upper limit of normal. - Lactating females. - Postsurgical life expectancy ≤ 60 days, in the investigator or sponsors opinion. - Refusal to accept medically indicated blood products. - Participation within 30 days before the start (dosing) of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated. - Presence of prosthetic cardiac valve. - Known medical history (carrier or disease) of human immunodeficiency virus (HIV), Hepatitis A, Hepatitis B, or Hepatitis C, or other diseases known to be autoimmune in origin. - Known medical history of tuberculosis or liver cirrhosis. - Current or prior treatment with growth factors or hyperbaric therapy in the last 30 days preceding study day 1. - History of sensitivity to the study medication, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical/research monitor, contraindicates their participation. - Uncontrolled intercurrent illness, including, but not limited to, ongoing or serious active infection (not including eligible surgical wounds), symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, metastatic cancer, chronic obstructive pulmonary disease (COPD; (using home oxygen therapy). - Insulin-requiring diabetes. - BMI > 40. - Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety of the study drug, or prevent compliance with the study ; PRIMARY OUTCOME: Safety and tolerability of NM-IL-12 (Number of subjects with adverse events); SECONDARY OUTCOME 1: Incidence of surgical site infections at the midline site (wound) and at the stoma site (wound) that occur within the period from surgery through postop day 42.[/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 - LUMINA-2; BRIEF: An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome ; DRUG USED: CCX140; DRUG CLASS: New Molecular Entity (NME); INDICATION: Focal Segmental Glomerulosclerosis (FSGS); TARGET: Chemokine Receptor 2 (CCR2); THERAPY: Monotherapy; LEAD SPONSOR: ChemoCentryx; CRITERIA: Inclusion Criteria: 1. Male or female subjects aged 18 years and older 2. Primary FSGS based on renal biopsy findings consistent with FSGS and based on presentation of histopathology, medical history and clinical course OR subjects with genetic risk factors with presentations that are otherwise consistent with primary FSGS 3. Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening Exclusion Criteria: 1. Pregnant or nursing 2. History of organ transplantation, including renal transplantation 3. Currently on an organ transplant waiting list or theres a reasonable possibility of getting an organ transplant within 6 months of screening 4. Histological FSGS subtype of collapsing variant 5. Subjects who initiated, discontinued or changed dose of anti-CD20 monoclonal antibodies within 16 weeks (4 months) prior to screening are excluded. Subjects who initiated treatment with anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening are permitted if deemed safe by the investigator and only if they intend to remain on continued, unchanged therapy at a dosing interval that has been documented to achieve continuous B cell depletion for the given patient. 6. Subjects who discontinued Rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening without confirmed recovery of CD20+ B cell population to within normal range are excluded. Subjects who discontinued rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening with confirmed recovery of CD20+ B cell population to within normal range are permitted in the study. UPCR and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history. 7. Body Mass Index (BMI) ≥ 40 ; PRIMARY OUTCOME: Changes from baseline in urine protein to creatinine ratio (UPCR); 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 - SARC028 (Monotherapy); BRIEF: The purpose of this study is to determine the efficacy of pembrolizumab in patients with advanced sarcomas. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Sarcoma; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Sarcoma Alliance for Research through Collaboration; CRITERIA: Inclusion Criteria: - Age ≥ 18 years (Age ≥ 12 years for patients with bone sarcomas). - Histologically confirmed diagnosis of unresectable, recurrent, and/or metastatic high grade soft-tissue or bone sarcoma of one of the following subtypes: soft tissue sarcomas (leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma), and bone sarcomas (Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]). - ECOG Performance Status of 0 or 1. - At least one site of measurable disease on CT/MRI scans as defined by RECIST 1.1. Baseline imaging must be performed within 30 days of dosing. - At least one site of accessible disease for pre- and post-treatment core biopsies for at least 20 patients per arm on the expansion cohorts. - Patients may have received 1-3 prior systemic therapies in the metastatic setting. - Adequate organ function within 14 days of dosing - Must be willing to provide and have available archival tissue for PD-L1 testing. - Written, voluntary informed consent. - Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study. - Effective methods of birth control include: surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence. - Life expectancy of >12 weeks. - Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression for at least 4 weeks prior to screening, have no evidence of new or enlarging brain metastases, and are off steroids for at least 7 days before first dose of pembrolizumab. Exclusion Criteria: - Prior systemic therapy targeting PD-1: PD-L1 axis. - Patients who are curable by conventional multidisciplinary management. - Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol. - Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to screening or who have not recovered adequately from side effects of such therapy. - Patients who have active infections requiring therapy. - Patients that are known to be positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive), or Hepatitis C (HCV RNA [qualitative] is detected); patients with negative Hepatitis C antibody testing may not need RNA testing. - Patients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial. - Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames: - Patients with active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study. - Women who are pregnant or nursing/breastfeeding. - Known hypersensitivity to pembrolizumab or another mAb. - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. - Patients with untreated central nervous system disease. Patients with controlled treated CNS lesions who have undergone surgery or stereotactic radiosurgery and stable for 4 weeks are eligible. - Inability to comply with protocol required procedures. - Patients with medical conditions that require chronic systemic corticosteroid therapy or require any other form of immunosuppressive medication. However, patients using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening. - Patients with the risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis). - Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment. ; PRIMARY OUTCOME: Objective Response Rate; SECONDARY OUTCOME 1: Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Rituximab (Study 201); BRIEF: This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL). ; DRUG USED: Fimepinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Histone Deacetylase (HDAC), PI3K/AKT pathway; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Curis, Inc.; CRITERIA: Inclusion Criteria: 1. Age ≥ 18 years. 2. At least 2 but no more than 4 prior lines of therapy for the treatment of de novo DLBCL and ineligible for (or failed) autologous or allogeneic stem cell transplant (SCT) (salvage therapy, conditioning therapy and maintenance with transplant will be considered one prior treatment). NOTE: For follicular lymphoma transformed to DLBCL (t-FL/DLBCL), single agent non-cytotoxic therapy will not be considered as a line of therapy. 3. Histopathologically confirmed diagnosis of one of the following: - RR DLBCL per the 2008 World Health Organization (WHO) classification of hematopoietic and lymphoid tumors (Swerdlow et al, 2008). - High grade B-cell lymphoma (HGBL), with MYC and BCL2 and/or BCL6 rearrangements or DLBCL, NOS per the 2016 revision of the WHO classification of lymphoid neoplasms (Swerdlow et al, 2016). - Diagnosis of t-FL/DLBCL is allowed. However, other B-cell lymphomas including other transformed indolent lymphomas/DLBCL per the 2008 WHO classification, and Burkitt lymphoma are not eligible. Exclusion Criteria: 1. Known primary mediastinal, ocular, epidural, testicular or breast DLBCL. 2. Active CNS involvement of their malignancy. 3. Known allergy or hypersensitivity to phosphatidylinositol 3 kinase (PI3K) inhibitors or any component of the formulations used in this study. 4. Cytotoxic anticancer therapy (e.g., alkylating agents, anti-metabolites, purine analogues) or any other systemic anticancer therapy within 2 weeks of study entry. 5. Radiotherapy delivered to non-target lesions within one week prior to starting study treatment or delivered to target lesions that will be followed on the study (note: prior sites of radiation will be recorded). 6. Treatment with experimental therapy within 5 terminal half-lives (t1/2) or 4 weeks prior to enrollment, whichever is longer. 7. Current or planned glucocorticoid therapy, with the following exceptions: - Doses ≤ 10 mg/kg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of CUDC-907. - Inhaled, intranasal, intraarticular, and topical steroids are permitted. ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Median 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 III - 010; BRIEF: This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Subjects will then be followed to assess time to healing. ; 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: 1. Be a healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigators discretion) be included in the study; 2. Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous year. The majority of their cold sore recurrences proceeded by a well-defined history of prodromal symptoms including redness, pain, burning, tingling, itching, swelling or a tight sensation of the lip at the site of the outbreak; 3. Be willing to refrain from using systemic or topical antiviral agents or systemic corticosteroids within 4 weeks prior to study drug administration and for the duration of the cold sore recurrence; 4. Be willing to refrain from using any topical pharmaceutical or cosmetic products other than the study medication in or around the nasal and perioral areas for the duration of the cold sore recurrence; 5. Be willing to refrain from participation in another clinical trial; 6. Be willing and able to use phone or internet to obtain the combination to unlock their study medication kit; 7. Be able to read and write in English and understand and comply with the protocol requirements; 8. Be able to give informed consent and have signed a written informed consent form. Exclusion Criteria: 1. Known hypersensitivity to one of the drug ingredients, including soybean oil, polysorbate (Tween), alcohol, EDTA, or cetylpyridinium chloride (found in some mouthwashes and lozenges); 2. Severe chronic illness including renal failure, severe respiratory or cardiac disease, chronic infections, immunodeficiency syndrome, uncontrolled diabetes mellitus or untreated severe thyroid disease; 3. Received (within the last 6 months) or receiving chemotherapy; 4. Significant skin disease on the face (such as atopic dermatitis, cystic acne, severe rosacea, eczema, psoriasis or other chronic vesiculobullous disorders) or lesions, wounds, abrasions, piercings, tattoos, irritation or other skin conditions on or around the nasal and perioral areas that would interfere with the treatment or assessment of the primary lesion complex. Subjects with mild controlled psoriasis, eczema, acne or dermatitis or other conditions may be included if the condition does not interfere with the ability to evaluate a herpes labialis lesion or local skin irritation; 5. Previously received herpes vaccine; 6. Active alcohol or drug abuse; 7. Prior randomization into any NanoBio study; 8. Any condition that would potentially make them unable to participate for the entire trial period; 9. Known allergies to topical creams, ointments or other topical medications. ; PRIMARY OUTCOME: Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.; SECONDARY OUTCOME 1: Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage[/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 - B2302 (Familial Chylomicronemia); BRIEF: The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia [HLP] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1). ; DRUG USED: LCQ908; DRUG CLASS: New Molecular Entity (NME); INDICATION: Familial Chylomicronemia Syndrome (FCS)/Lipoprotein Lipase Deficiency (LPLD); TARGET: Diglycerol Acyltransferase (DGAT); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Written informed consent given before any assessment was performed for Period I. 2. Male and female patients ages at least 18 years of age. 3. Fasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) at Screening. 4. An established diagnosis of FCS (HLP Type I) confirmed through ultracentrifugation or by documented medical history of a fasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) and by documentation of any of the following at Screening or during the Screening Period: - Confirmed homozygote or compound heterozygote for known loss-of-function mutations in Type I-causing genes (such as LPL, apo C II, GPIHBP1, or LMF1) - Post heparin plasma LPL activity of ≤ 20% of normal - Confirmed presence of LPL inactivating antibodies 5. History of pancreatitis. Key Exclusion Criteria: 1. Current pancreatitis, pancreatitis was required to be inactive for at least 1 week prior to the screening Visit. 2. Treatment with fish oil preparations within 4 weeks prior to randomization. 3. Treatment with bile acid binding resins (i.e., colesevelam, etc.) within 4 weeks prior to randomization. 4. Treatment with fibrates within 4 weeks prior to randomization. 5. Glybera [alipogene tiparvovec (AAV1-LPLS447X)] gene therapy exposure within the two years prior to screening. 6. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 7. Any surgical or medical conditions, acute or unstable chronic disease which may, based on the investigators opinion, jeopardize the patient in case of participation in the study or might significantly alter the absorption, distribution, metabolism or excretion of the study drug. 8. History of drug or alcohol abuse within the 12 months prior to randomization or evidence of such abuse at screening. 9. Evidence of liver disease or liver injury as indicated by abnormal liver function tests such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT), or serum bilirubin. 10. Estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2 or history of chronic renal disease. 11. Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, or any other limitation of participation based on local regulations. 12. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 13. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test. 14. 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 100 days after discontinuation of investigational study drug. ; PRIMARY OUTCOME: Percent Change in Fasting Triglycerides From Baseline to 12 Weeks; SECONDARY OUTCOME 1: Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - VAT00002; BRIEF: The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination. ; DRUG USED: Coronavirus Vaccine (Sanofi/GSK); DRUG CLASS: Vaccine; INDICATION: COVID-19 Prevention; TARGET: Immune System, SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria: -Aged 18 years or older on the day of inclusion. - -A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is of non-childbearing potential. To be considered of non-childbearing potential, a female mut be post-menopausal for at least 1 year or surgically sterile. OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination (ie, second dose of primary series or booster injection). A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. - -Informed consent form has been signed and dated. Able to attend all scheduled visits and to comply with all study procedures. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies (Original Phase 2 Cohort). For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3. Does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination to 3 weeks after the second vaccination despite encouragement by the investigator to receive the authorized vaccine available to them at the time of enrollment. Supplemental cohorts: for participants originally enrolled in the Phase II cohort of the study, informed consent has to be signed and dated for transitioning to Supplemental Cohort 2. Supplemental cohorts, Booster arms: received a complete primary vaccination series with an authorized/conditionally approved mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer/BioNTech]) or adenovirus-vectored COVID-19 vaccine (ChAdOx1 nCoV-19 [Oxford University/AstraZeneca] or Ad26.CoV2.S [J&J/Janssen]), with the last dose administered a minimum of 4 months prior to inclusion but not longer than 10 months prior to inclusion. Exclusion Criteria: -Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on Investigator or designees judgment. Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigators judgment. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigators judgment. Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. Receipt of solid-organ or bone marrow transplants in the past 180 days. Receipt of anti-cancer chemotherapy in the last 90 days. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. Applicable to Original Phase II Cohort, Supplemental Cohort 1 and Cohort 2 Comparator Group: Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]). Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Exclusion criterion for the Supplemental Cohort 1 and Cohort 2 comparator group: positive rapid diagnostic test for SARS-CoV-2 antibodies at time of enrollment. Exclusion criterion for participants in Supplemental Cohort 2 who were primed as participant in the Original Phase II Cohort of the present study: Receipt of authorized/conditionally approved COVID-19 vaccine after enrollment in Original Phase 2 Cohort. Exclusion criterion for all Booster groups: Documented virologically-confirmed SARS-CoV-2 infection (by NAAT) after first dose of primary immunization. ; PRIMARY OUTCOME: Presence of immediate adverse events; SECONDARY OUTCOME 1: Neutralizing antibody titer at all pre-defined time points[/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 - APRiCOT-P; BRIEF: This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer. ; DRUG USED: Capoxigem; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Combination; LEAD SPONSOR: Tragara Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic. 2. Life expectancy greater than or equal to 3 months. 3. Patients must have measurable disease by RECIST. 4. ECOG PS of 0, 1, or 2. 5. Negative serum pregnancy test at the time of first dose for women of childbearing potential. Exclusion Criteria: 1. Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4). 2. RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment. 3. Evidence of New York Heart Association class III or greater cardiac disease. 4. History of myocardial infarction, stroke, ventricular arrhythmia. 5. Symptomatic central nervous system metastases. 6. Pregnant or nursing women. 7. Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs). 8. History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months. 9. Previous anti-EGFR kinase therapy. ; PRIMARY OUTCOME: Progression Free Survival; SECONDARY OUTCOME 1: Overall Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ONTIME; BRIEF: The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients. ; DRUG USED: Estybon (Intravenous); DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: PI3K/AKT pathway, Polo-like kinase 1 (Plk1); THERAPY: Monotherapy; LEAD SPONSOR: Onconova Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - MDS diagnosis confirmed within 6 weeks prior to entry according to WHO or FAB classification - MDS classified as follows, according to WHO and FAB classification: - RAEB-1 (5% - 9% BM blasts) - RAEB-2 (10% - 19% BM blasts) - CMML (10% - 20% BM blasts) and WBC < 13,000/μL - RAEB-t (20% - 30% BM blasts), with following criteria: - o WBC < 25 x 10E9/L at entry - o Stable WBC at least 4 weeks prior to entry and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukopheresis. - At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin <10 g/dL) - Progression according to 2006 International Working Group (IWG) criteria any time after start of azacitidine or decitabine during past 2 years; or failure to achieve complete or partial response or hematological improvement (according to 2006 IWG) after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine during past 2 years; or relapse after initial complete or partial response or hematological improvement (according to 2006 IWG criteria) observed after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine during past 2 years; or, intolerance to azacitidine or decitabine defined by drug-related ≥Grade 3 liver or renal toxicity leading to discontinuation during the past 2 years. - Did not respond to, relapsed after, not eligible for, or opted not to do bone marrow transplantation - Off other MDS treatments for at least 4 weeks; Filgrastim (G-CSF) and erythropoietin allowed before and during the study as clinically indicated. - No need for induction chemotherapy - ECOG status 0, 1 or 2 - Willing to adhere to protocol prohibitions and restrictions - Patient (or a legally authorized representative) must sign informed consent form to indicate patients understanding studys purpose and procedures and willingness to participate Exclusion Criteria: - Anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding) unless stabilized for 1 week after RBC transfusion. - Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia - Active infection not adequately responding to appropriate therapy - Total bilirubin ≥1.5 mg/dL not related to hemolysis or Gilberts disease. - Alanine transaminase (ALT)/aspartate transaminase (AST) ≥2.5 x upper limit of normal (ULN) - Serum creatinine ≥2.0 mg/dL - Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 mEq/L) - Pregnant or lactating females - Patients unwilling to follow strict contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device, double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study - Females with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin pregnancy test at screening - Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start - Uncontrolled hypertension (defined as systolic pressure ≥160 mmHg and/or diastolic pressure ≥110 mmHg) - New onset seizures (within 3 months prior to first dose of ON 01910.Na) or poorly controlled seizures - Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy - Prior treatment with low-dose cytarabine during past 2 years Investigational therapy within 4 weeks of starting ON 01910.Na - Psychiatric illness or social situation that limits the patients ability to tolerate and/or comply with study requirements ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Overall response (complete and partial remission) according to 2006 IWG 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 - VERONICA (w/Fulvestrant; ER+/HER2-); BRIEF: This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic Breast Cancer (MBC) who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks. As of 9th October 2020, participants in the Venetoclax + Fulvestrant arm, have all discontinued Venetoclax treatment and have continued on Fulvestrant treatment alone. ; DRUG USED: Venclexta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: B-cell lymphoma 2 (Bcl-2)/Bcl-2 Family; THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histological or cytological confirmation of estrogen receptor-positive (ER+) invasive carcinoma of the breast. ER+, HER2- negative invasive carcinoma of the breast with evaluable sample for BCL-2 IHC value at the time of screening. Participants who were originally diagnosed with HER2-positive breast cancer that converted to HER2-negative MBC are not eligible. - Evidence of metastatic or locally advanced disease not amenable to surgical or local therapy with curative intent. - Be postmenopausal or pre- or perimenopausal women amenable to being treated with the luteinizing hormone-releasing hormone (LHRH) agonist goserelin. - Participants must not have received more than two prior lines of hormonal therapy in the locally advanced or metastatic setting. In addition, at least one line of treatment must be a CDK4/6i AND participants must have experienced disease recurrence or progression during or after CDK4/6i therapy, which must have been administered for a minimum of 8 weeks prior to progression. - Participants for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at the time of entry into the study, as per national or local treatment guidelines. - Women of childbearing potential (i.e., not postmenopausal for at least 12 months or surgically sterile) must have had a negative serum pregnancy test result at screening, within 14 days prior to the first study drug administration. - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods with a failure rate of <1% per year during the treatment period and for up to 2 years after the last dose of study drug (or based on the local prescribing information for fulvestrant). Women must refrain from donating eggs during this same period. - Willing to provide tumor biopsy sample. - Had at least one measurable lesion via RECIST v1.1. - Had an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. - Had adequate organ and marrow function. - Had a life expectancy > 3 months. - To full fill the coagulation requirements for patient with or without therapeutic anticoagulation. Exclusion criteria: - Prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), venetoclax, or any agent whose mechanism of action is to inhibit BCL-2. - Pregnant, lactating, or intending to become pregnant during the study. - Known untreated or active Central Nervous System (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control. - Prior chemotherapy in the locally advanced or metastatic setting regardless of the duration of the treatment. - Any anti-cancer therapy received within 21 days of the first dose of study drug, including chemotherapy, radiotherapy, hormonal therapy, immunotherapy, antineoplastic vaccines, or other investigational therapy. (Radiotherapy with palliative intent to non-target sites is allowed). - Concurrent radiotherapy to any site or prior radiotherapy within 21 days of Cycle 1 Day 1 or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response) or prior radiotherapy to > 25% of bone marrow. - Current severe, uncontrolled, systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic or infectious disease. - Any major surgery within 28 days of the first dose of study drug or anticipation of the need for major surgery during the course of study treatment. - Consumption of one or more of the following within 3 days prior to the first dose of study drug: Grapefruit or grapefruit products; Seville oranges including marmalade containing Seville oranges; Star fruit (carambola). - Administration within 7 days prior first dose of study treatment of Steroid therapy for anti-neoplastic intent, Strong or moderate CYP3A inhibitors or Strong or moderate CYP3A inducers. - Need for current chronic corticosteroid therapy (> 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids). - Known infection with (human immunodeficiency virus) HIV or human T-cell leukemia virus 1. - Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day). - Positive test results for hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody at screening. Participants who were positive for HCV antibody should have been negative for HCV by PCR to be eligible for study participation. Participants with a past or resolved hepatitis B virus (HBV) infection (defined as having a positive total HBcAb and negative hepatitis B surface antigen [HbsAg]) may be included if HBV DNA is undetectable. These participants should have been willing to undergo monthly DNA testing. - Participants who had a positive HCV antibody test are eligible for the study if a PCR assay is negative for HCV RNA. - History of other malignancies within the past 5 years except for treated skin basal cell carcinoma, squamous cell carcinoma, non-malignant melanoma <= 1.0 mm without ulceration, localized thyroid cancer, or cervical carcinoma in-situ. - Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study. - Cardiopulmonary dysfunction. - Other medical or psychiatric conditions that, in the opinion of the investigatory, may interfere with the participants participation in the study. - Inability or unwillingness to swallow pills or receive intramuscular (IM) injections. - History of malabsorption syndrome or other condition that would interfere with enteral absorption. - History of inflammatory bowel disease (e.g., Crohns disease or ulcerative colitis) or active bowel inflammation (e.g., diverticulitis). - Concurrent hormone replacement therapy. - Inability to comply with study and follow-up procedures. - History or active cardiopulmonary dysfunction. - Known hypersensitivity to any of the study medications (fulvestrant, venetoclax) or to any of the excipients. ; PRIMARY OUTCOME: Clinical Benefit Defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) Lasting >= 24 Weeks, as Determined by the Investigator According to RECIST v1.1; 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/II - PANTHERA; BRIEF: Gastric cancer is one of the major health problems worldwide, and one of the leading cause of death especially in Asia. Though the cytotoxic chemotherapy is the main treatment option, newer and molecularly targeted agents are recently incorporated to improve the survival outcome. Human epidermal growth factor receptor 2 (HER2, ErbB2) is a transmembrane tyrosine kinase receptor and is overexpressed or amplified in 10-20% of gastric cancer. Recently, Trastuzumab for Gastric Cancer (ToGA) study reported the clinical benefit of trastuzumab for HER2 positive gastric cancer patients. However, because the majority of patients develop intrinsic or acquired resistance within 1 year, elucidating the molecular mechanisms for trastuzumab resistance is warranted to improve the survival outcome of HER2 positive gastric cancer patients. A growing body of preclinical and clinical evidence shows that the immune system contributes substantially to the therapeutic effects of monoclonal antibody, trastuzumab in solid tumors. Pembrolizumab is a potent and highly selective humanized monoclonal antibody designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Based on strong rationale in exploring the impact of combining trastuzumab with anti-PD-1 inhibitor in HER2 positive cancer, we suggest multicenter phase IB/II study to determine antitumor activity and safety of pembrolizumab in combination with standard treatment (trastuzumab, capecitabine, and cisplatin) in patients with HER2 positive gastric cancer. ; DRUG USED: Herzuma; DRUG CLASS: Biosimilar; INDICATION: Gastric Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Combination; LEAD SPONSOR: Yonsei University; CRITERIA: Inclusion Criteria: 1. HER2 positive advanced gastric cancer 2. Be willing and able to provide written informed consent/assent for the trial. 3. Be 19 years of age on day of signing informed consent. 4. Have measurable disease based on RECIST 1.1. 5. performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale. 6. Demonstrate adequate organ function 7. Female subject of childbearing potential should have a negative urine or serum pregnancy or be willing to use birth control. Exclusion Criteria: 1. 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 the first dose of treatment. 2. Has a 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. 3. Has a known history of active Bacillus Tuberculosis 4. Hypersensitivity to pembrolizumab or any of its excipients. 5. Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier. 6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent. 7. Has a known additional malignancy that is progressing or requires active treatment within 3 years. 8. Has known active central nervous system metastases and/or carcinomatous meningitis. 9. Has active autoimmune disease that has required systemic treatment in the past 2 years 10. Has known history of, or any evidence of active, non-infectious pneumonitis. 11. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 12. Has known active Hepatitis B or Hepatitis C 13. Has received a live vaccine within 30 days of planned start of study therapy. ; PRIMARY OUTCOME: The recommended dose of phase II; SECONDARY OUTCOME 1: Duration of 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 Ib/II - w/Talazoparib + Binimetinib; BRIEF: This Phase 1b/2 study will examine the effects of the study drugs, avelumab, binimetinib and talazoparib when given in a 2 (doublet) or 3 (triplet) drug combination, in patients with locally advanced or metastatic RAS-mutant solid tumors. The Phase 1b part of the study will assess if the different study drugs can be given together safely and which doses to use for further research. Phase 2 will test if the study treatments have an effect on tumor size and growth, and gather more information about potential side effects. ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent as follows: 1. Metastatic pancreatic ductal adenocarcinoma; or 2. Phase 2 only: Stage IIIb/IV NSCLC or other advanced solid tumors with documented positive KRAS or NRAS mutation as determined using a validated test performed in a CAP/CLIA-certified laboratory (or other comparable local or regional certification). - Have had disease progression during or following at least 1 and not more than 2 prior lines of treatment for advanced or metastatic disease. - Patients with NSCLC must have previously received treatment with an anti-PD-1 or anti-PD-L1 agent for advanced disease. - Measurable disease as per RECIST v1.1 criteria. - Provision of a baseline tumor sample. - Age ≥18 years (Japanese patients must be ≥20 years old) - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. - Adequate bone marrow, renal and liver functions. - Adequate cardiac function. - Informed consent provided. Exclusion Criteria: - Prior treatment with avelumab, a PARP inhibitor or MEK inhibitor. - Prior systemic anti-cancer therapy within 2 weeks prior to study enrollment. - Persisting toxicity related to prior therapy. - Current use of immunosuppressive medication. - Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, uveitis or iritis. - Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. - Diagnosis of myelodysplastic syndrome (MDS). - Known symptomatic brain metastases requiring steroids. - Known history of testing positive for HIV or hepatitis. - Clinically significant (ie, active) cardiovascular disease. - History of thromboembolic or cerebrovascular events. - Current or anticipated use of a P-gp inhibitor, inducer, or inhibitor of breast cancer resistance protein (BCRP) - Uncontrolled hypertension. - Concurrent neuromuscular disorder that is associated with the potential of elevated creatinine kinase. - Known history of Gilberts syndrome. - History or current evidence of retinal degenerative disease, retinal vein occlusion (RVO) or current risk factors for RVO. - Other acute or chronic medical or psychiatric condition. ; PRIMARY OUTCOME: Number of Participants With Dose Limiting Toxicities (DLTs) During the Primary DLT Evaluation Period (Cycle 1) in Phase 1b; SECONDARY OUTCOME 1: Number of Participants With Adverse Events During the On-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 III - vs. Taxol; BRIEF: Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required. This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer. This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication. ; DRUG USED: Abraxane; DRUG CLASS: Non-NME; INDICATION: Breast Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Celgene Corporation; CRITERIA: Patients will be eligible for this trial if: - Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception - Sixteen years of age or older - Histologically or cytologically confirmed breast cancer (stage III or IV) with evidence of inoperable local recurrence or metastasis, with measurable disease - If patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane - No other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer - Suitable candidate for paclitaxel therapy - Hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dL - Chemistry levels at baseline of: AST and ALT of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dL; creatinine of less than or equal to 2 mg/dL; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis - Expected survival of at least 12 weeks - Patient or his/her representative has signed an informed consent form ; 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 III - SOLO 3 (BRCA Mutation; Relapsed) - vs. Chemotherapy; BRIEF: Comparison of olaparib vs. physicians choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets. ; DRUG USED: Lynparza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Patients must be ≥ 18 years of age - Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy. - Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) - At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment. - Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive - Patients must be suitable to start treatment with single agent chemotherapy based on physicians choice - Patients must have normal organ and bone marrow function measured within 28 days of randomisation, - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patients must have a life expectancy ≥ 16 weeks - Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing. Exclusion Criteria: - BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental - Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation - Any previous treatment with a Polyadenosine 5diphosphoribose polymerisation (PARP) inhibitor, including olaparib. - Patients who have platinum resistant or refractory disease - Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment - Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply). ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 131797; BRIEF: This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer. ; DRUG USED: Detectnet; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neuroendocrine Tumors (NET) - Imaging; TARGET: Somatostatin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Radiomedix, Inc.; CRITERIA: Inclusion Criteria: - Confirmed or suspicion of NET based on histology/ biopsy report. - Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET - CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date. Exclusion Criteria: - Pregnant, planning to be pregnant within the next two weeks - Inability to provide written consent. - Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug. ; PRIMARY OUTCOME: Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor; SECONDARY OUTCOME 1: Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging[/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 (Japan); BRIEF: This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days. ; DRUG USED: AZD5069; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Chemokine (C-X-C motif) Receptor 2 (CXCR2) / IL-8 receptor; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Japanese subjects with suitable veins for cannulation or repeated venepuncture. - Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg - Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product Exclusion Criteria: - History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subjects ability to participate in the study. - History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product. - Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator ; PRIMARY OUTCOME: Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry; SECONDARY OUTCOME 1: Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood[/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 - 0008; BRIEF: To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis. ; DRUG USED: PRT2761; DRUG CLASS: New Molecular Entity (NME); INDICATION: Allergic Conjunctivitis (Ophthalmology); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: ORA, Inc.; CRITERIA: Inclusion Criteria: - be at least 18 years old - be willing and able to avoid all disallowed medications and contact lenses - must have a pregnancy test if of childbearing potential - must be able to read an eye chart from 10 feet away Exclusion Criteria: - must not have any allergies to the study medications - must not have any ocular or non ocular condition that investigator feels will interfere with study parameters - must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial ; PRIMARY OUTCOME: Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1; 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 - APC-VP-CLN-001; BRIEF: The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly obtained with VentaProst titration. ; DRUG USED: VentaProst; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Aerogen Pharma Limited; CRITERIA: Inclusion Criteria: 1. Women and Men 18 to 75 years of age 2. Provide written informed consent 3. Willing and able to comply with all aspects of the protocol 4. For patients in Part I: 1. Undergo cardiac surgery on CPB 2. Clinically require treatment with and receive aerosolized epoprostenol 3. Demonstrate a clinically meaningful hemodynamic response to aerosolized epoprostenol 5. For patients in Part II: 1. Undergo cardiac surgery with CPB 2. Have perioperative pulmonary hypertension 3. Clinically require treatment with inhaled epoprostenol Exclusion Criteria: 1. Current smoker (i.e., within the last 30 days) 2. Emergency operative status 3. Upper and/or lower respiratory tract infection within four weeks of screening 4. Contraindication to transesophageal echocardiogram (TEE) including esophageal disease or unstable cervical spine 5. Renal or severe hepatic impairment 6. Thromboembolic disease treated with anticoagulant therapy 7. Bleeding disorders 8. Significant restrictive or obstructive lung disease 9. History of concurrent malignancy or recurrence of malignancy within two years prior to Screening 10. History of a diagnosis of drug or alcohol dependency or abuse within approximately the last three years 11. Recent history of stroke or transient ischemic attack 12. Significantly abnormal laboratory tests at Screening 13. Pregnant or breastfeeding 14. Treatment with an investigational drug, biologic, or device within 30 days 15. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for entry into this trial 16. Any condition where aerosolized epoprostenol is contraindicated 17. Known allergy or sensitivity to epoprostenol, any of its ingredients, or the diluent ; PRIMARY OUTCOME: Determination of the equivalent dose of VentaProst necessary to achieve a pharmacodynamic response that is comparable to Standard of Care; SECONDARY OUTCOME 1: Treatment-Emergent Adverse Events (TEAEs)[/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 - Forearms; BRIEF: The purpose of this study is to determine if the new ingenol derivative gels are as safe as and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for two consecutive days. ; DRUG USED: LEO 43204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Mitochondria, Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: - Must be male or female and at least 18 years of age. - Female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception - Ability to provide informed consent Exclusion Criteria: - location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma - undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to Visit 2 - use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 2 - use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of Visit 2 - Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to visit 2 - use of systemic retinoids - those who are currently participating in any other clinical trial - females who are pregnant or are breastfeeding - those known or suspected of not being able to comply with the requirements of the protocol or provide consent ; PRIMARY OUTCOME: Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm; SECONDARY OUTCOME 1: Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Docetaxel; BRIEF: The main purpose of this study is to evaluate the safety of the study drug ramucirumab in combination with weekly docetaxel in participants with stage IV non-small cell lung cancer (NSCLC) following disease progression after prior platinum-based chemotherapy. ; DRUG USED: Cyramza; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - The participant had disease progression on or after prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC. - Prior immunotherapy for NSCLC is allowed. - The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1. - The participant has histologically or cytologically confirmed NSCLC. - The participant has metastatic NSCLC disease (Stage IV) at the time of first dose of study treatment. - The participant has measurable disease at the time of first dose of study treatment documented by computed tomography (CT) scan or magnetic resonance imaging (MRI). - The participant has resolution to Grade ≤1 by the National Cancer Institute-common terminology criteria for adverse events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy. - The participant has adequate organ function. - The participants urine protein is <2+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <2 grams of protein in 24 hours to allow participation in the study. - For male participants, are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict), and to not donate sperm starting with the first dose of study treatment, during the study, and for at least 6 months following the last dose of study treatment or country requirements, whichever is longer. - For female participants, are surgically sterile, postmenopausal, or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict) during the study and for 6 months following the last dose of study treatment or country requirements, whichever is longer. - Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment. - The participant has a life expectancy of ≥3 months. Exclusion Criteria: - Prior therapy with docetaxel or ramucirumab. - The participant has received more than 1 prior chemotherapy regimen for locally advanced or metastatic NSCLC; however, prior maintenance chemotherapy for locally advanced or metastatic NSCLC is allowed. - The participants tumour contains small cell lung cancer. - The participant has undergone major surgery within 28 days prior to first dose of study treatment, or subcutaneous venous access device placement within 7 days prior to first dose of study treatment. Furthermore, any participant with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded. - The participant has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohns disease, ulcerative colitis, or chronic diarrhea. - The participant has peripheral neuropathy Grade ≥2 (NCI-CTCAE v 4.0). - The participant has an elective or a planned major surgery during the course of the trial. - The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy. - The participant has symptomatic, active, or untreated central nervous system (CNS) metastases. Brain metastases that are asymptomatic, stable and not requiring steroid use, and previously treated by radiation are allowed. The participant may have no evidence of Grade ≥1 CNS hemorrhage based on pretreatment MRI or I.V. contrast CT scan (performed within 21 days before first dose of study treatment). - The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer. - The participant has radiographic evidence of intratumor cavitation, regardless of tumor histology. - The participant has a history of uncontrolled hereditary or acquired thrombotic disorder. - The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, and anagrelide). Aspirin (acetylsalicylic acid) use at doses up to 325 milligrams/day is permitted. - Participants with a history of gross hemoptysis (defined as bright red blood or ≥1/2 teaspoon) within 2 months prior to first dose of study treatment. - The participant has clinically relevant congestive heart failure (New York Heart Association Class II-IV) or symptomatic or poorly controlled cardiac arrhythmia. - The participant has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to first dose of study treatment. - The participant has uncontrolled arterial hypertension ≥150 / ≥90 millimeters of mercury despite standard medical management. - The participant has had a serious or nonhealing wound, ulcer, or bone fracture ≤28 days prior to first dose of study treatment. - The participant has significant bleeding disorders, vasculitis, or experienced Grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to first dose of study treatment. - History of GI perforation and / or fistulae within 6 months prior to first dose of study treatment. ; PRIMARY OUTCOME: Percentage of Participants with Grade ≥3 Neutropenia; SECONDARY OUTCOME 1: Rate of Febrile Neutropenia[/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 - GSP 301- PoC; BRIEF: A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray, DYMISTA® and PATANASE®. ; DRUG USED: Ryaltris; DRUG CLASS: Non-NME; INDICATION: Allergic Rhinitis; TARGET: Glucocorticoid Receptor (GR), Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Glenmark Pharmaceuticals Ltd. India; CRITERIA: Inclusion Criteria: - Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test Exclusion Criteria: - Pregnant or lactating women - Patients with known hypersensitivity to any of the components of the formulation - Patients with a history of seasonal asthma during ragweed season. - Patient requiring chronic use of inhaled or systemic corticosteroids - Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening - Patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or Rhinitis Medicamentosa as determined by the Investigator. - Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, uncontrolled Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving MAO inhibitor therapy. ; PRIMARY OUTCOME: Change in mean post-treatment instantaneous Total Nasal Symptoms Score (iTNSS) for Molo 1 and Molo 2 compared with placebo from baseline to end of treatment; SECONDARY OUTCOME 1: Change in mean post-treatment iTNSS for Molo 1 and Molo 2 compared with reference products Dymista and Patanase[/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 - KCP-330-001 (Hematological Malignancies); BRIEF: The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer. ; DRUG USED: Xpovio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Exportin-1/CRM1/XPO1, Immune System, Interferon-beta (IFNb), SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Karyopharm Therapeutics Inc; CRITERIA: Inclusion Criteria 1. Malignancies that are refractory to or intolerant of established therapy known to provide clinical benefit. Patients must not be candidates for anti-tumor regimes known to provide clinical benefit. 2. All patients must have evidence of progressive disease on study entry. Previously untreated patients who are not chemotherapy candidates on Arm 2 may have advanced disease (without clear progression). There is no upper limit on the number of prior treatments provided that all inclusion criteria are met, and exclusion criteria are not met. Exclusion Criteria 1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1. 2. Patients with active graft versus host disease after allogeneic stem cell transplantation. At least 3 months must have elapsed since completion of allogeneic stem cell transplantation except for patients with AML, where at least 2 months must have elapsed; 3. Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); 4. Patients with active CNS malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months. Patient with malignant cells in their cerebrospinal fluid (CSF) without CNS symptom may be included. 5. Significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea. 6. Grade ≥2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1). 7. Macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity. 8. In the opinion of the investigator, patients who are significantly below their ideal body weight. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs); SECONDARY OUTCOME 1: Maximum Observed Plasma Concentration (Cmax) of Selinexor[/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 - APOLLO; BRIEF: This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence. ; DRUG USED: Botox - Therapeutic; DRUG CLASS: Biologic; INDICATION: Urinary Incontinence; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Allergan; CRITERIA: Inclusion Criteria: - Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months - Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB Exclusion Criteria: - Overactive Bladder caused by neurological condition - Patient has predominance of stress incontinence - History or evidence of pelvic or urological abnormality - Prior use of BOTOX for any urological condition ; PRIMARY OUTCOME: Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day; SECONDARY OUTCOME 1: Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day[/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 - w/Ipilimumab/Nivolumab (Emory); BRIEF: This randomized phase I trial studies how well anti-semaphorin 4D (anti-SEMA4D) monoclonal antibody VX15/2503 with or without ipilimumab or nivolumab work in treating patients with stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal cancer that has spread to the liver and can be removed by surgery. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread. ; DRUG USED: Pepinemab; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Semaphorin 4D/CD100; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Emory University; CRITERIA: Inclusion Criteria: - For patients with pancreatic cancer: - Stage I-III cytologically or histologically-proven pancreatic adenocarcinoma - Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection - Patients may have prior neoadjuvant chemotherapy, but no neoadjuvant chemoradiation - No cancer chemotherapy treatment 2 weeks prior to day 2 of treatment - For patients with metastatic colorectal cancer: - Stage IV histologically-proven colorectal adenocarcinoma - Liver metastasis confirmed to be surgically resectable, with surgery evaluation and planned resection; may have minimal extrahepatic disease that is determined to be resectable - Tumor must be confirmed to be microsatellite stable (MSS); if not already reported at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, we will be able to perform this at Emory University - No prior immunotherapy - No cancer chemotherapy treatment 2 weeks prior to day 1 of treatment - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Absolute neutrophil count ≥ 1,500 cells/µL - Platelets ≥ 100,000/µL - Hemoglobin ≥ 9.0 g/dL (may receive packed red blood cell [prbc] transfusion) - Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN - Albumin ≥ 3.0 g/dL - Serum creatinine ≤ 1.5 x ULN - Calculated creatinine clearance of ≥ 50 mL/min - International normalized ratio (INR) ≤ 1.5; anticoagulation is allowed only with low molecular weight heparin (LMWH); patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level < 1.1 U/mL are allowed on the trial - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures - Ability to understand and willingness to sign a written informed consent document - Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion - Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion - Female subjects of childbearing age must have a negative serum pregnancy test at study entry Exclusion Criteria: - Poor venous access for study drug administration - Determined not to be a surgical candidate due to medical co-morbidities - Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation) - Prior organ allograft or allogeneic bone marrow transplantation - Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism, psoriasis 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 (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease - Women who are pregnant or lactating - Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, 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 - Clinical evidence of bleeding diathesis or coagulopathy - Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for > 5 years; patients with prior in situ carcinomas are eligible provided there was complete removal - Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment - Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration - History of severe hypersensitivity reactions to other monoclonal antibodies - Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab ; PRIMARY OUTCOME: Evaluate treatment effects of the study drugs on tumor cluster of differentiation 8+ (CD8+) T cell infiltration between the treatment groups.; SECONDARY OUTCOME 1: Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events scale version 4.0[/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: The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP. ; DRUG USED: Idelvion; DRUG CLASS: Biologic; INDICATION: Hemophilia B; TARGET: Coagulation Factor IX; THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Male, 12 - 65 years, with body weight ≥ 30 kg and ≤ 120 kg - Documented severe Hemophilia B (FIX activity of ≤ 2%) or tested by the central laboratory at screening - Subjects who have received FIX products for > 150 exposure days (EDs) (estimated) - No confirmed prior history of FIX inhibitor (history of positive FIX inhibitor defined as two consecutive positive tests - a confirmatory test on a second, separately drawn sample shortly after the previous positive test) and confirmed no detectable FIX inhibitors (negative FIX inhibitor defined as < 0.6 Bethesda Units [BU] by the central laboratory at screening - Subjects can be treated on-demand or under prophylactic therapy - Signed Informed Consent/Assent Exclusion Criteria: - Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein - Any known congenital or acquired coagulation disorder other than congenital FIX deficiency - Platelet count < 100,000/µL - Immunocompromised (CD4 count < 200/mm3), (HIV positive subjects may participate in the study and protease inhibitors and antiviral therapy are permitted, at the discretion of the Investigator) - Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment - Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration > 5 times (x) the upper limit of normal (ULN) - Serum creatinine > 2 x ULN - Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment - Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration - Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry - Subject currently on a dose and/or regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the PK sampling period - Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance ; PRIMARY OUTCOME: Frequency of adverse events (AEs); SECONDARY OUTCOME 1: AUC to the last sample with quantifiable drug concentration (AUC0-t)[/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 - CL 01 (PK/Safety); BRIEF: An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers. ; DRUG USED: LIPO-102; DRUG CLASS: Non-NME; INDICATION: Thyroid Eye Disease (TED); TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Neothetics, Inc; CRITERIA: Inclusion Criteria: - Male and non pregnant female - 18-55 years old - Sufficient abdominal fat for injections - Signed informed consent Exclusion Criteria: - Known hypersensitivity to study drugs - Treatment with an investigational agent within 30 days before first dose ; PRIMARY OUTCOME: Safety: Laboratory tests, medical exams; SECONDARY OUTCOME 1: Pharmacokinetics[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - B04; BRIEF: The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to differentiate subjects with Parkinsons Disease from other movement disorders. ; DRUG USED: Florbenazine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Neurology - Imaging; TARGET: Vesicular monamine transporters (VMATs); THERAPY: Monotherapy; LEAD SPONSOR: Avid Radiopharmaceuticals; CRITERIA: Inclusion Criteria: - Males or females ≥ 40 years of age; - Presenting (within the last 3 months) for an initial evaluation to a movement disorders specialist with signs or symptoms suggestive of a movement disorder; - The subjects signs or symptoms were previously evaluated by a physician who was not a movement disorders specialist during the previous six months; - Absence of an established clinical movement disorder diagnosis; - Symptoms mild in intensity, this includes Hoehn & Yahr ≤ 2 (Exceptions are allowed for subjects who meet criteria for Hoehn & Yahr stage 3 due to early onset of postural instability and/or gait impairment out of proportion to his/her other Parkinson signs and symptoms); - Montreal Cognitive Assessment (MoCA) score ≥ 22; - Can tolerate imaging visit procedures; and - Provide written informed consent prior to study entry. Exclusion Criteria: - Have been referred to the movement disorders clinic primarily for the purpose of disease management (no diagnostic uncertainty exists on the part of the non-specialist or referring physician); - Have a previous movement disorder diagnosis given by a movement disorders specialist prior to the time of enrollment; - Have received a total of more than 90 days treatment with dopaminergic medications, including direct dopamine agonists or precursors (levodopa) or have received a total of more than 180 days treatment with MAO-B inhibitors, amantadine, anticholinergics or primidone or beta-blockers prescribed for treatment of tremor or signs of parkinsonism; - Have had a sustained and clinically meaningful response to anti-parkinsonian medications; - Are currently taking or have taken MAO-B inhibitors in the past 4 weeks; - Have a known CNS structural lesion such as stroke or tumor that likely accounts for their symptoms; - Have clinically meaningful cognitive impairment or dementia (mild cognitive problems as might be expected in the earliest stages of PD are not exclusionary); - Have current clinically significant cardiovascular disease or clinically important abnormalities on screening ECG (including but not limited to QTc > 450 msec); - Are currently taking medications that are known to cause QT-prolongation; - Are currently taking medications with narrow therapeutic windows (e.g. warfarin or other anticoagulant therapies); - Are currently taking tetrabenazine (TBZ), amphetamine type drugs; - Have a current clinically significant endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer (excluding localized basal cell carcinoma and in situ prostate cancer) that would interfere with completion of the study; - Have a recent history (within the past year) of alcohol or substance abuse or dependence; - Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable contraception. Females must not be pregnant (negative serum beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging), must not be breastfeeding at screening, must avoid becoming pregnant and use adequate contraceptive methods for 14 days prior to and 24 hours after administration of 18F-AV-133 for injection; - Have had prior intracranial surgery; and - Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days. ; PRIMARY OUTCOME: Sensitivity of visual read of AV-133 PET scan vs. standard of truth; SECONDARY OUTCOME 1: Inter-rater reliability of the visual read[/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 - THOR 201; BRIEF: A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of Decarboxylase Inhibitor to L-dopa Responsive Parkinsons Disease Patients ; DRUG USED: INP-103; DRUG CLASS: Non-NME; INDICATION: Parkinsons Disease (PD); TARGET: Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: Impel Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Adult males and females, 40 to 80 years of age (inclusive) at the time of Screening (Visit1) 2. Diagnosed with Idiopathic PD (by UK Brain Bank Criteria) with Modified Hoehn & Yahr (H&Y) Stage I-III during an ON period at Visit 1 3. Subjects who are prone to (and recognize) OFF episodes (when their usual PD medication has worn off) 4. Shown to be responsive to L-dopa medication (≥ 30% improvement in MDS-UPDRS Part III Motor Examination score) as assessed during the Screening period (Visit 2) 5. On a stable dose of L-dopa containing medication for at least 2 weeks prior to Visit 1 (up to 1200 mg/day) with no single dose exceeding 250 mg. All other anti-PD medication (e.g. dopamine agonists [DAs], monoamine oxidase-B inhibitor (MAOB-I) or catechol-O-methyl transferase (COMT) inhibitors ARE allowed if the subject has been on a stable dose for at least 30 days prior to Visit 1. 6. Willing to omit their (usual) PD drugs (e.g. usual regular anti-PD medication including any L-dopa containing medication, DAs and/or COMT inhibitors and any required anti-OFF treatment) from 22:00 pm the evening prior to study dosing until 120 minutes post study treatment dosing. Cohorts 1, 2 and 3 ONLY WILL take oral benserazide 25 mg on arrival at the research site (at 60 ± 5 minutes before dosing with INP103 or placebo). Cohort 4 will omit oral benserazide and subjects may be dosed once OFF episode has been confirmed and all baseline assessments have been completed. 7. If female and of childbearing potential must agree to use adequate contraception (see Section 4.4) during the study 8. Able and willing to attend the necessary visits at the study centre 9. Willing to provide voluntary written informed consent signed prior to entry into the study Exclusion Criteria: 1. Severe dyskinesia (defined as per MDS-UPDRS) during a normal day that would significantly interfere with the subjects ability to perform study assessments 2. In receipt of L-dopa containing medication at > 1200 mg/day 3. History of significant psychotic episode(s) within the previous 12 months in the opinion of the Investigator, or currently receiving anti-psychotic medication at a moderate dose (quetiapine >50 mg/day, risperidone >1 mg/day or olanzapine >2.5 mg/day) 4. Mini Mental State Examination (MMSE) ≤ 25 as documented within the previous 36 months or as assessed by Investigator during Screening 5. History of suicidal ideation or attempted suicide within previous 12 months 6. Narrow-angle glaucoma 7. Presence of skin lesions that, in the opinion of the Investigator, may be cancerous 8. Females who are pregnant, planning a pregnancy or lactating 9. Subjects with any underlying physical condition that, in the opinion of the Investigator, would make it unlikely that the subject will comply with or be able to complete the study requirements 10. Use of any medication likely to interact with benserazide, carbidopa or INP103 (see Appendix 5) 11. Laboratory test abnormalities at Screening (Visit 1) deemed clinically significant by the Investigator. 12. History or presence of alcoholism or drug abuse within the 2 years prior to INP103 or placebo dosing 13. Administration of an investigational product in another trial within 30 days or 5 half-lives (whichever is longer) prior to INP103 or placebo dosing 14. Significant nasal congestion, physical blockage in either nostril, or significantly deviated nasal septum as evaluated by the PI or other suitably trained healthcare professional 15. Subjects who have previously shown hypersensitivity to L-dopa or benserazide (for Cohorts 1, 2 and 3), or L-dopa or carbidopa (for Cohort 4) or any of their excipients ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events; SECONDARY OUTCOME 1: AUC0-2hr for L-dopa[/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 - sIBM; BRIEF: This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis ; DRUG USED: BYM338; DRUG CLASS: Biologic; INDICATION: Sporadic Inclusion Body Myositis (sIBM); TARGET: Activin A; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis Exclusion Criteria: - Unable to walk at least 3 meters without assistance from another person - Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months - patients with a history or presence of renal impairment and/or liver disease Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Effect of BYM338 on Thigh Muscle Volume by MRI; SECONDARY OUTCOME 1: Effect of BYM338 on muscle function by Timed Get Up and Go test[/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 - Cytos; BRIEF: The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine. The antibodies will bind nicotine and prevent its passage into the brain. The successfully vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle of nicotine addiction. ; DRUG USED: NIC-002; DRUG CLASS: Vaccine; INDICATION: Smoking Cessation; TARGET: Immune System, Nicotinic Acetylcholine Receptors (nAChR) ; THERAPY: Monotherapy; LEAD SPONSOR: Cytos Biotechnology AG; CRITERIA: Inclusion Criteria: - Written informed consent - Age 18 to 70 years - Smokers: > 10 and ≤ 40 cigarettes per day and smoking history of more than 3 years - Fageström Test for Nicotine Dependence (FTND) score ≥ 5 - Female participant must meet one of the following criteria: a) no reproductive potential due to menopause, hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 additional months after the last immunization Exclusion Criteria: - Pregnant or nursing - History of severe allergy or immunological disorders - Blood donation within previous 30 days - Surgery within previous 30 days - Use of investigational drugs within previous 60 days - Significant cardiovascular disease: - angina pectoris - congestive heart failure - clinically significant murmurs - previous angioplasty or coronary artery bypass surgery - Active infectious disease: - WBC > 12 000 cells/µL - Seropositivity for Hepatitis B and C - History of risk behavior to acquire HIV - Significant hepatic disease - Significant renal disease - Significant hematological disorder - Significant pulmonary disease - History of malignancy - Autoimmune disease - Organic neurological disorder or significant psychiatric disorder - Use of psychoactive drug within one month before enrolment - Abuse of drugs or alcohol - Subjects using any concomitant medications due to chronic illness which bears a high risk of fluctuation in disease activity or exacerbations during a 12-months period such as coronary heart disease, asthma, severe COPD, chronic rheumatoid disease, diabetes, etc. should be excluded. - Obesity: BMI > 35 kg/m2 - Use of concomitant nicotine replacement treatment (NRT) at screening or visit 1 - Any planned surgical intervention during the study period ; PRIMARY OUTCOME: Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm; SECONDARY OUTCOME 1: Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CNVA237B2301; BRIEF: The study will assess efficacy, safety and tolerability of NVA237 compared to placebo in patients with poorly controlled asthma over 52 weeks of treatment. ; DRUG USED: Seebri Neohaler; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Written informed consent must be obtained before any assessment is performed; Male and female adult patients aged 18 to <75 years; Patients with a diagnosis of asthma (according to GINA 2012) for a period of at least 5 years prior screening; The diagnosis of asthma must have been made before the patient was 40; Increase in forced expiratory volume in 1 second (FEV1) of ≥ 12% and ≥ 200 mLs within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose); Pre-bronchodilator FEV1 of ≥ 50 and ≤ 80% of the predicted normal value for the patient; Patients who qualify for treatment (according to GINA 2012) and have been treated with a stable dose of a fixed dose inhaled corticosteriod (ICS) and long-acting β2 agonist (LABA) combination for at least 4 weeks prior to screening. Patient must be using a total daily dose of ICS of ≥800 μg/day of budesonide of equivalent; All patients must be symptomatic with a mean ACQ-5 score ≥ 1.5 at Visit 101 and Visit 102; A documented history of one or more asthma exacerbations in the previous 12 months that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation Exclusion Criteria: Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof: Muscarinic antagonist agents, sympathomimetic amines, lactose or any of the other excipients of the study drug, long and short acting beta-2 agonists, corticosteroids; Women of child-bearing potential; Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at Visit 101 (assessed by central reader) and at Visit 102 (assessed by investigator at the site); Patients with a body mass index (BMI) of more than 40 kg/m2; Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction, arrhythmia, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment; Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention (BPH patients who are stable on treatment can be considered); Patients who have had an asthma exacerbation that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation in the 6 weeks prior to screening; Patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note:10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.); Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging); Patients on Maintenance Immunotherapy (desensitization) for allergies must have been so for at least 3 months prior to run-in, and must be expected to remain unchanged throughout the course of the study; ; PRIMARY OUTCOME: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 26; SECONDARY OUTCOME 1: Time to First Moderate or Severe Asthma Exacerbation Over 52 Weeks of Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Progressive/Recurrent High-Grade Glioma; BRIEF: This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study. Stage 2, patients will receive GDC-0084 at a recommended dose for future studies. ; DRUG USED: Paxalisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC, PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Adult patients, >/= 18 years of age - Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to study entry - Karnofsky Performance Status of >/= 70 at screening - Confirmed measurable disease per RANO - Adequate hematologic and organ function Patients enrolled in Stage 1: - Histologically documented recurrent or progressive high-grade gliomas (WHO Grade III-IV) - Prior treatment with at least one regimen for gliomas (radiotherapy with or without chemotherapy for Grade III gliomas and radiotherapy with chemotherapy for Grade IV gliomas) and/or not considered to be a candidate for regimens known to provide clinical benefit Patients enrolled in Stage 2: - Histologically documented recurrent or progressive glioblastoma (WHO Grade IV gliomas) - Prior treatment with one or two regimens for glioblastoma (with the initial regimen consisting of radiotherapy with chemotherapy) Exclusion Criteria: - Treatment with anti-tumor therapy (approved or experimental) within 4 weeks prior to initiation of study drug - Requirement for anticoagulants such as warfarin or any other warfarin-derivative anticoagulants; low-molecular-weight heparin is permitted - Any contraindication to MRI examination - Evidence of Grade >/= 1 intracranial hemorrhage - Active congestive heart failure or ventricular arrhythmia requiring medication - Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse or cirrhosis - Unresolved toxicity from prior therapy with the exception of lymphopenia (for patients with prior temozolomide) and alopecia - Pregnant or lactating women ; PRIMARY OUTCOME: Safety: Incidence of adverse events; SECONDARY OUTCOME 1: Pharmacokinetics: Area under the concentration-time curve[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Everolimus; BRIEF: The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS. ; DRUG USED: Welireg; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Hypoxia Inducible Factor-2 Alpha (HIF-2a); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC) - Has had disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with both Programmed cell death 1 ligand 1 (PD-1/L1) checkpoint inhibitor and a vascular endothelial growth factor - tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination. - Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC. - A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of study intervention - A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP OR A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention for those randomized to belzutifan and for at least 8 weeks after the last dose of study intervention for those randomized to everolimus. - The participant (or legally acceptable representative if applicable) has provided documented informed consent for the study. - Has adequate organ function Exclusion Criteria: - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. (Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded.) - Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. (Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks (28 days) by repeat imaging.) - Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or IV congestive heart failure. (Medically controlled arrhythmia stable on medication is permitted.) - Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg. - Has moderate to severe hepatic impairment (Child-Pugh B or C). - Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study. - Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption). - Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan or everolimus) formulations. - Has received prior treatment with belzutifan or another hypoxia inducible factor 2α (HIF-2α inhibitor). - Has received prior treatment with everolimus or any other specific or selective target of rapamycin complex 1 (TORC1)/ phosphatidylinositol 3-kinase (PI3K)/ protein kinase B (AKT) inhibitor (e.g., temsirolimus) in the advanced disease setting. - Has received any type of systemic anticancer antibody (including investigational antibody) within 4 weeks before randomization. - Has received prior radiotherapy within 2 weeks prior to randomization. - Has had major surgery within 3 weeks prior to randomization. - Has received a live vaccine within 30 days prior to randomization. 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 (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed. - Is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. - Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St Johns Wort) or moderate (e.g., bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study. - Is currently participating in a study of an investigational agent or is currently using an investigational device. - Has an active infection requiring systemic therapy. - Has active bacillus tuberculosis (TB). - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization. - Has a known history of human immunodeficiency virus (HIV) infection. (Testing for HIV at screening is only required if mandated by local health authority. - Has a known history of Hepatitis B virus (HBV) (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV) (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection. ; PRIMARY OUTCOME: Progression-free Survival (PFS) per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR); SECONDARY OUTCOME 1: Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR[/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 - B1371026 (Healthy Volunteers); BRIEF: This study is intended to establish the bioequivalence (BE) of single 100 mg doses of glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation compared to the Phase 2 formulation. ; DRUG USED: Daurismo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: Hedgehog Signaling Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Healthy male and/or female subjects of non-child bearing potential who, at the time of screening, are 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 or clinical laboratory tests. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria: 1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 24 consecutive months with no alternative pathological or physiological cause; with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state; 2. Have undergone a documented hysterectomy and/or bilateral oophorectomy; 3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) are considered to be of childbearing potential. - Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). - Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. -. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: - A positive urine drug test. - Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subjects eligibility. - Subjects with family history of myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias. Subjects should be within normal range of potassium, magnesium and corrected calcium calculation at screening. - Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of investigational product and, refrain from sperm donation for the duration of the Study and for at least 90 days after the last dose of investigational product. ; PRIMARY OUTCOME: Maximum Observed Plasma Concentration (Cmax); SECONDARY OUTCOME 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)][/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib - w/MBG453 or Venetoclax; BRIEF: This is a phase 1b, multi-arm, open-label study of HDM201 in combination with MBG453 or venetoclax in subjects with AML or high-risk MDS. For all subjects, TP53wt status must be characterized by, at a minimum, no mutations noted in exons 5, 6, 7 and 8. Two treatment arms will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity of HDM201+MBG453 (treatment arm 1) and HDM201+venetoclax (treatment arm 2). - In the treatment arm 1, subjects will receive HDM201 in combination with MBG453. - In the treatment arm 2, subjects will receive HDM201 in combination with venetoclax. Venetoclax dose will be gradually increased (ramp-up) over a period of 4 to 5 days to achieve the daily target dose tested that will be subsequently continued. Upon the completion of the escalation part, MTD(s) and/or RD(s) of HDM201 in combination with MBG453 or venetoclax in AML and high-risk MDS subjects will be determined for each treatment arm. ; DRUG USED: HDM201; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Apoptosis (Cell Death), Mdm2; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Main Inclusion Criteria: - Male or female patients ≥ 18 years of age at the date of ICF signature who present with one of the following: 1. Relapsed/refractory AML following ≥1 prior therapies (but ≤3 prior therapies) who have relapsed or exhibited refractory disease (primary failure) and are deemed by the Investigator not to be candidates for standard therapy, including re-induction with cytarabine or other established chemotherapy regimens for patients with AML (patients who are suitable for standard re-induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded) 2. First line AML patient unfit for standard induction chemotherapy (includes both de novo and secondary AML), except in countries where approved therapies are available. Patients who are suitable for hematopoietic stem cell transplantation and willing to receive it are excluded. 3. High-risk MDS patient (high and very high-risk groups according to rIPSS) who have failed hypomethylating agent therapy. - ECOG performance status ≤ 1 - TP53wt tumor. At minimum exons 5, 6, 7 and 8 in the TP53 gene must be sequenced and determined to contain no mutations. The TP53 status must be obtained from a bone-marrow sample, collected no longer than 3 months before signing the main ICF. - Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutional guidelines and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy on this study. Exceptions may be considered after documented discussion with Novartis. Main Exclusion Criteria: Patients eligible for this study must not meet any of the following criteria: - Prior combination treatment with compounds having the same mode of action: - mdm2 or mdm4 inhibitors combined with TIM-3 inhibitors (for patients enrolled in treatment arm1) - mdm2 or mdm4 inhibitors combined with Bcl-2 inhibitor (for patients enrolled in treatment arm2) - History of severe hypersensitivity reactions to any ingredient of study drug(s) and other monoclonal antibodies (mAbs) and/or their excipients. - Patients with acute promyelocytic leukemia with PML-RARA. - Allogeneic stem cell transplant (HSCT) within last 6 months and/or active GvHD requiring systemic immunosuppressive therapy. - GI disorders impacting absorption of oral HDM201 or venetoclax. - Evidence of active bleeding or bleeding diathesis or major coagulopathy (including familial). - Patients with active, known or suspected autoimmune disease (treatment arm 1 only). Other eligibility criteria apply. ; PRIMARY OUTCOME: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety; SECONDARY OUTCOME 1: Overall Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Repeat Dosing; BRIEF: RV568 is being developed as a possible treatment of diseases such as smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma. The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose strengths of RV568 and a placebo will be tested in this study, which will be given by inhaling a liquid suspension from a nebuliser once a day for 2 weeks. ; DRUG USED: RV-568; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Respivert Ltd; CRITERIA: Inclusion Criteria: - Male or female aged 40-75 years inclusive at the time of signing the informed consent. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. - COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines, with symptoms compatible with COPD for at least 1 year prior to screening. - Severity of Disease: subjects who conform to the current severity classification for GOLD Stage II/III disease in terms of post-bronchodilator spirometry at screening (Post-salbutamol FEV1/FVC ratio of ≤ 0.70 and post-salbutamol FEV1 ≥ 40 % and ≤ 80 % of predicted normal values calculated using ECCS reference equations) - Demonstrated ability to use the I-neb AAD system at screening. - Subject is a current or previous smoker with a smoking history of ≥ 10 pack years Exclusion Criteria: - A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation - A history of > 1 hospitalisation for COPD in the previous 2 years prior to screening. - Evidence of cor pulmonale or clinically significant pulmonary hypertension or chronic (in the opinion of the Investigator) use of oxygen. - Upper or lower respiratory tract infection, including exacerbation of COPD, within 6 weeks of screening. - Other respiratory disorders: Subjects with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases or other active pulmonary diseases. - Subjects with a history of chronic disease including, but not limited to, sleep apnoea, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant. - Previous lung resection or lung reduction surgery. - Pregnant or nursing females. - Any abnormal or clinically significant ECG or laboratory values that the Investigator considers would put the subject at risk through participation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included if the Investigator and the sponsor representative agree it is unlikely to introduce additional risk factors and will not interfere with study procedures. - ALT > 2 x ULN at the screening visit. - A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody result, or positive test for HIV antibody at the screening visit (or within the 3 months prior to screening). - Positive test for drugs of abuse at screening that cannot be satisfactorily explained by a prescription history (e.g., recent use of codeine tablets). - History of alcohol abuse within the previous 6 months - Has had major surgery, (requiring general anesthesia) within 6 weeks before the screening visit, or will not have fully recovered from surgery, or planned surgery through the end of the study - Participated in any other clinical study of an NCE within 3 months, or in a study of a marketed drug within 1 month (or within 5 half-lives of the NCE or marketed drug, whichever is the longest) of first dose; or has participated in 4 studies in the previous 12 months. - A disclosed history, or one known to the Investigator, of significant noncompliance in previous investigational studies or with prescribed medications. - Allergy to any of the active or inactive ingredients in the study medication, or history of drug, or other allergy that, in the opinion of the Investigator or RespiVert medical monitor, would contraindicate their participation. - Donation of blood in excess of 500 mL within a 3 month period prior to dosing, or if study participation would result in blood loss in excess of 500 mL in a 3 month period. - Subject is mentally or legally incapacitated. - Has any condition or are taking a medication that, in the opinion of the Investigator, would make participation not be in the best interest (i.e., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments. - Is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the Investigator. - Any other reason that the Investigator considers makes the subject unsuitable to participate. - Subject has a history of unstable, or uncontrolled hypertension, or has been diagnosed with hypertension in last 6 months. ; PRIMARY OUTCOME: Safety and tolerability; SECONDARY OUTCOME 1: Plasma RV568 levels[/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 - Biomarker Study; BRIEF: The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma. ; DRUG USED: BMS-936559; DRUG CLASS: Biologic; INDICATION: Melanoma; 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 - Eastern Cooperative Oncology Group (ECOG) status = 0 to 1 - Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma - Subject must have histologic or cytologic confirmation of advanced Melanoma - Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria - Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies Exclusion Criteria: - Active or progressing brain metastases - Other concomitant malignancies (with some exceptions per protocol) - Active or history of autoimmune disease - Positive test for human immunodeficiency virus (HIV) 1&2 or known acquired immunodeficiency syndrome (AIDS) - History of any hepatitis - Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies ; PRIMARY OUTCOME: Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry; SECONDARY OUTCOME 1: Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs[/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 - CheckMate 069 - w/Ipilimumab; BRIEF: The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Key Inclusion Criteria: - Eastern Cooperative Oncology Group performance status of 0 or 1 - Histologically confirmed unresectable Stage III or Stage IV melanoma - No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized - Tumor tissue obtained in the metastatic setting or from an unresectable site must be provided for biomarker analyses and sent to the central laboratory. Biopsy should be excisional, incisional punch, or core needle. Fine needle aspirates or other cytology samples are insufficient - Known BRAF V600 mutation status as determined by an FDA-approved test. Patients with either V600 wild-type or V600 mutation-positive melanoma are eligible. Key Exclusion Criteria: - Active brain metastases or leptomeningeal metastases. Patients with treated brain metastases are eligible if there is no evidence of progression on magnetic resonance imaging scan for at least 8 weeks after completion of treatment and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration - Ocular melanoma - Patients with active, known, or suspected autoimmune disease. Those with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. ; PRIMARY OUTCOME: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants; SECONDARY OUTCOME 1: Progression-Free Survival (PFS) - BRAF Wild-type (WT) 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 II - 201; BRIEF: The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in terms of ratios using log-transformed UACR at Baseline and after a 12-week period of treatment. ; DRUG USED: TMX-049; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: Xanthine oxidase ; THERAPY: Monotherapy; LEAD SPONSOR: Teijin America, Inc.; CRITERIA: Inclusion Criteria: - Type 2 diabetes treated with ≥1 glucose-lowering medication for at least 12 months - UACR 200 to 3000 mg/g - eGFR ≥30 ml/min/1.73m2 - Treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB), but not both Exclusion Criteria: - History of Type 1 diabetes - Women who are breast feeding - Treatment with any uric acid-lowering therapy within previous 2 weeks - History of intolerance to any XO (xanthine oxidase) inhibitor - History of a gout flare requiring pharmacologic treatment - History or presence of tophaceous gout - History of immunosuppressant treatment for any known or suspected renal disorder - History of a non-diabetic form of renal disease - Glycosylated hemoglobin (HbA1c) >11% - sUA <4.0 mg/dL or >10.0 mg/dL - Positive urinary pregnancy test - Dialysis for acute renal failure within previous 6 months - Renal allograft in place or a scheduled kidney transplant within the next 22 weeks - Congenital or acquired solitary kidney ; PRIMARY OUTCOME: Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12; SECONDARY OUTCOME 1: Changes in Estimated Glomerular Filtration Rate (GFR)[/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 - Low Back Pain (EU); BRIEF: The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride prolonged release treatment during defined periods of evaluation. ; DRUG USED: Nucynta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Pain; TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Grünenthal GmbH; CRITERIA: Inclusion Criteria: - Participants must have signed an Informed Consent Form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it. - Participants are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women of childbearing potential must have a negative pregnancy test at screening. - Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain. - Participants must be at least 18 years of age. - Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months - If the Participant has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment. - Participants pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator. - Participants must be taking a WHO Step III analgesic on a daily basis for at least 3 months prior to the Screening Visit. - Participants must have responded to the WHO Step III analgesic, i.e., participants must have a confirmed average pain intensity score (NRS 3) of ≤5 points during the last 3 days prior to the Screening Visit. - Participants must report opioid-related side effects as the reason to change their analgesic. - Participants must report a rate of satisfaction with their previous analgesic regimen not exceeding fair on a subject satisfaction with treatment scale (5-point VRS). Exclusion Criteria: - Presence of a clinically significant disease or laboratory findings that in the Investigators opinion may affect efficacy or safety assessments. - Presence of active systemic or local infection that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments. - History of alcohol or drug abuse, or suspicion of in Investigators judgement. - Presence of concomitant autoimmune inflammatory conditions. - Known history of or laboratory values reflecting severe renal impairment. - Known history of moderately or severely impaired hepatic function. - History of or active hepatitis B or C within the past 3 months or history of HIV infection. - History of seizure disorder or epilepsy. - Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness. - Pregnant or breast-feeding. - History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including: - Subjects with acute or severe bronchial asthma or hypercapnia. - Subjects who have or are suspected of having paralytic ileus. - Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator. - Participation in another trial concurrently or within 4 weeks prior to the Screening Visit. - Known to or suspected of not being able to comply with the protocol and the use of the investigational medicinal product. - Use of monoamine oxidase inhibitors within 14 days before the Screening Visit. - Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (the doses must remain stable during the trial). - Presence of concomitant painful condition other than low back pain that could confound the subjects trial assessments or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia. - Any painful procedures during the trial (e.g., major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments. - Pending litigation due to chronic pain or disability. ; PRIMARY OUTCOME: Number of Participants That Responded to Treatment; SECONDARY OUTCOME 1: Average Pain Intensity Before the Start of Tapentadol Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Subjects; BRIEF: This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A). There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to assess alternative dose levels or formulations, if required. In each study part, each subject will receive a single dose of investigational medicinal product PWT-143 in each of 2 study periods (total of 2 single doses). ; DRUG USED: Zandelisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: MEI Pharma, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy males 2. Age 18 to 65 years of age 3. Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator 4. Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast 5. Must be willing and able to communicate and participate in the whole study 6. Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care 7. Must agree to use an adequate method of contraception Exclusion Criteria: 1. Healthy males 2. Age 18 to 65 years of age 3. Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator 4. Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast 5. Must be willing and able to communicate and participate in the whole study 6. Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care 7. Must agree to use an adequate method of contraception ; PRIMARY OUTCOME: The number of participants with and types of Adverse Events; SECONDARY OUTCOME 1: Tmax (time from dosing at which Cmax is determined)[/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 - DS-003 (1L); BRIEF: Phase 3 study to evaluate the efficacy and safety of dociparstat sodium in adults with newly diagnosed untreated AML with adverse or intermediate genetic risk. ; DRUG USED: DSTAT; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Chemokine (C-X-C motif) Ligand 12 (CXCL12)/Stromal Cell-Derived Factor 1 (SDF-1), Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Monotherapy; LEAD SPONSOR: Chimerix; CRITERIA: Inclusion Criteria: 1. Newly diagnosed, previously untreated AML (according to World Health Organization criteria) with at least 20% blasts in the peripheral blood or bone marrow. 2. Age ≥ 18 with Intermediate or Adverse genetic risk (per ELN criteria). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: 1. Acute promyelocytic leukemia (t(15;17)), myeloid sarcoma without bone marrow involvement, or blast transformation of chronic myelogenous leukemia. 2. Clinical evidence of active central nervous system leukemia. 3. AML treatment, including Vyxeos (CPX-351, liposomal cytarabine and daunorubicin), gemtuzumab ozogamicin, or any other prohibited concomitant AML therapy previously received or anticipated to start during the study. 4. Receiving any form of anticoagulant therapy (e.g., unfractionated heparin, low molecular weight heparin, coumadin, factor Xa inhibitors). Heparin flush of indwelling catheters is permitted. 5. Treatment with any other investigational agent within 28 days, or 5 half-lives, whichever is longer, prior to baseline. 6. Any major surgery or radiation therapy within 28 days prior to baseline. 7. Immediately life threatening, severe complications of leukemia such as pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation. 8. Active or uncontrolled bleeding at the time of randomization; a bleeding disorder, either inherited or caused by disease; history of known arterial-venous malformation, intracranial hemorrhage, or suspected or known cerebral aneurysm; or clinically significant gastrointestinal bleeding within the 3 weeks prior to randomization. 9. Presence of significant active or uncontrolled infection, including HIV or hepatitis B or C. 10. Active (uncontrolled, metastatic) second malignancy. 11. History of severe congestive heart failure or other cardiac disease that contraindicates the use of idarubicin or daunorubicin (e.g., cardiac ejection fraction <45%). 12. QTc >480 msec. 13. Severe renal impairment, as determined by calculated creatinine clearance <30 mL/min or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2. 14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) or total bilirubin >2x ULN. ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Event free survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 804P301; BRIEF: Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures ; DRUG USED: Oxtellar XR; DRUG CLASS: Non-NME; INDICATION: Partial Seizures (Epilepsy); TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Supernus Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - Capable of complying with the study procedures. - Able to provide written informed consent - Male or female aged 18 to 65 years, inclusive. - Diagnosis of partial onset seizures - Minimum of three seizures per 28 days - Receiving treatment with 1-3 AEDs - Refractory to at least one AED - No progressive neurological conditions by recent MRI/CT - Adequate birth control in women of child-bearing potential Exclusion Criteria: - Refractory to OXC for reasons of efficacy - Recent status epilepticus - Recent non-epileptic seizures - Current diagnosis of major depression - Recent suicidal plan or intent or more than one attempt - Current use of oxcarbazepine, felbamate for < 18 months, phenytoin with levels >15mcg/mL or frequent need for rescue benzodiazepines - Current use of sodium-lowering non-seizure medications. - Clinically significant hepatic, renal, or cardiovascular function - History of recent substance abuse - Females who are pregnant or lactating. - Hypersensitivity to OXC or related drugs - Difficulty swallowing study medication ; PRIMARY OUTCOME: PCH(T), ITT; SECONDARY OUTCOME 1: PCH(M)- ITT[/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 - TRINOVA-2 (w/Doxil); BRIEF: To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS) The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer. ; DRUG USED: Trebananib; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Angiopoietins; THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer - Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer - Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. - Female 18 years of age or older at the time the written informed consent is obtained - Adequate organ and hematological function Exclusion Criteria: - Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer - Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy - Subjects with primary platinum-refractory disease - Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy - History of central nervous system metastasis - Major surgery within 28 days prior to randomization or still recovering from prior surgery ; PRIMARY OUTCOME: To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications; SECONDARY OUTCOME 1: • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by 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 IIa - Russia/Latvia; BRIEF: This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing multiple sclerosis (MS) and to assess the maintenance of any such effects. ; DRUG USED: ATX-MS-1467; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Immune System, Myelin Basic Protein (MBP); THERAPY: Monotherapy; LEAD SPONSOR: Merck KGaA, Darmstadt, Germany; CRITERIA: Inclusion Criteria: - Male or female out-patients aged 18 to 65 years of age inclusive at the time of informed consent - Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures - Relapsing MS (relapsing-remitting multiple sclerosis [RRMS], secondary progressive multiple sclerosis [SPMS], as defined by the revised McDonald criteria [2010]) (11) - Clinical evidence of recent MS activity and radiological activity on gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) defined as defined in the protocol - Expanded disability status scale (EDSS) score 0-5.5 - Human leukocyte antigen-beta chain (HLA-DRB)1*15 positive - Neurological stability in the 30 days prior to Visit 5 (Study Day 1) - Prior vaccination against tuberculosis (TB) - If female, unless post-menopausal (for at least 2 years) or surgically sterilized, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467 - If male, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467 Exclusion Criteria: - Primary progressive MS - Inability to comply with MRI scanning, including contra-indications to MRI such as known allergy to gadolinium contrast dyes, claustrophobia, presence of a pacemaker, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, nerve stimulators - Previous treatment with beta-interferon, plasma exchange, intravenous gamma globulin within the 8 weeks prior to study Day 1 (Visit 5), steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to the Visit 2 MRI scan, glatiramer acetate, cytotoxic agents - Prior exposure to dimethyl fumurate (BG-12) or dirucotide, any disease-related T cell vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467 - Use of any investigational drug or experimental procedure for MS (including cytokine or anticytokine therapy) within the 30 days prior to screening (Visit 1) - Inadequate liver function as defined in the protocol. - Lymphocyte count less than (<)500 per micro liter (/mcL) or neutrophil count < 1500 mcL at screening or at any of the pre-treatment visits (Visits 2-4) - Major medical illness as defined in the protocol - Known history of active or chronic infectious disease or any disease which compromises immune function - Any renal condition that would preclude the administration of gadolinium - History of malignancy, including both solid tumor and hematological malignancies, but excluding basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved, in situ cervical cancer or prostatic cancer with normal prostatic specific antigen - Clinical evidence of severe uncontrolled depression, active suicidal ideation or suicide attempt - Any other significant medical or psychiatric conditions that, in the opinion of the Investigator, would preclude participation in the trial or impair the ability to give informed consent - Major surgery in the 4 weeks prior to screening (Visit 1) - Known hypersensitivity to the trial medication or diluents - Participation in another clinical trial within the 30 days prior to screening (Visit 1) - Pregnancy, lactation or a positive pregnancy test during screening (urine dipstick) or at Visit 4 (serum beta-human chorionic gonadotrophin [beta-hCG]), or intention to become pregnant or to breast-feed during the course of the trial - Legal incapacity or limited legal capacity ; PRIMARY OUTCOME: Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans; SECONDARY OUTCOME 1: Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)[/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 - Elevated IOP; BRIEF: This study will test the hypothesis that CF101, administered orally, will reduce intraocular pressure in patients with ocular hypertension and/or glaucoma. Eligible patients with elevated intraocular pressure will be evaluated and treated by ophthalmologist investigators, and will receive either CF101 pills or placebo (dummy) pills twice daily for 16 weeks. Ocular pressure, visual fields, and other aspects of safety and effectiveness will be monitored on a regular basis. ; DRUG USED: Piclidenoson; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Adenosine A3 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Can-Fite BioPharma; CRITERIA: Inclusion Criteria: 1. Male or female, 18 years of age and over; 2. Ocular hypertension or open-angle glaucoma in at least 1 eye, diagnosed as any of the following: 1. Untreated ocular hypertension without glaucomatous anatomic or VF changes; or 2. Glaucoma diagnosed within the past 2 months but untreated; 3. Previously treated glaucoma, provided that previous medication treatment has been inefficacious and/or intolerable, and has therefore been discontinued at least 3 weeks prior to Baseline; or 4. Currently treated glaucoma with inadequate IOP control, meaning that IOP remains above target pressure as judged by the Investigator despite ≥3 weeks of treatment with a standard topical regimen (for guidance, the European Glaucoma Society defines target pressure as follows: In most cases a peak IOP = 8 mm - 15 mmHg on a diurnal curve, or 30% IOP reduction from baseline); 3. In subjects receiving a standard topical treatment regimen (per 2.d. above), the regimen and dose have not changed within 3 weeks of Screening, and are expected to remain stable throughout the treatment period; 4. At both Screening and Baseline, IOP in at least 1 eye (candidate eye) is >21 mmHg at 0800-1000 hours and >21 mmHg in at least 1 measurement at least 3 hours following the first; 5. Corneal thickness between 500 and 580 microns in both eyes; 6. Corrected visual acuity +0.18 logMAR or better by Early Treatment Diabetic Retinopathy Study (ETDRS) methodology in the candidate eye (equivalent to 20/30); 7. Females of child-bearing potential must have a negative urine pregnancy test at screening and throughout the study, to be eligible for, and continue participation in, the study; 8. Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (eg, oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study; 9. Ability to complete the study in compliance with the protocol; and 10. Ability to understand and provide written informed consent. Exclusion Criteria: 1. IOP >32 mmHg in either eye; 2. History of angle-closure glaucoma; 3. Anatomically narrow angles in either eye (ie, ≥75% of the circumference of the angle must be ≥Grade 2 by Shaffer criteria ); 4. In subjects with glaucoma, advanced VF defect in either eye, determined on reliable testing using the Humphrey Full-Threshold Algorithm for the Glaucoma Hemifield Test, defined as either: 1. Mean deviation worse than -16 dB, or 2. Threat to fixation (sensitivity 10 dB or worse affecting either or both test points closest to the point of fixation in the upper hemifield and at either or both the corresponding test points in the lower hemifield); 5. In subjects with ocular hypertension, a score of >12 points on The Ocular Hypertension Treatment Study Group and European Glaucoma Prevention Study Group Primary Open-Angle Glaucoma Risk Table; 6. Documented disc hemorrhage within the past 5 years in either eye; 7. Secondary cause of IOP elevation; 8. Glaucoma laser treatment in candidate eye within the past 3 months; 9. Clinically significant ocular trauma to candidate eye within the past 6 months; 10. Any major ocular surgery in the past, including keratorefractive surgery, in candidate eye, except for uncomplicated cataract surgery performed greater than 6 months prior to Screening; 11. Astigmatism >3 diopters in either eye; 12. Clinically significant acute or chronic ocular disease (eg, corneal edema, uveitis, severe keratoconjunctivitis sicca, active ocular infection, active herpes simplex keratitis, blepharitis, or acute conjunctivitis) that might interfere with the study; 13. Concomitant contact lens use; 14. Concomitant use of systemic medication that may affect IOP (eg, beta blockers, corticosteroids, calcium channel blockers, ACE inhibitors, or carbonic anhydrase inhibitors); however, systemic antihypertensive medications are allowed providing that the dose and regimen have been stable for at least 3 months prior to Screening and are expected to remain stable throughout the trial; 15. Any abnormality preventing reliable applanation tonometry; 16. Presence of uncontrolled asthma; 17. Presence of uncontrolled arterial hypertension or symptomatic hypotension; 18. Significant cardiac arrhythmia or conduction block, congestive heart failure (New York Heart Association Class 3-4), or any other evidence of clinically significant heart disease or clinically significant findings on screening ECG; 19. Hemoglobin level <9.0 gm/L, at screening; 20. Platelet count <125,000/mm3, at screening; 21. White blood cell count <3500/mm3, at screening; 22. Serum creatinine level greater than 1.5 times the laboratorys upper limit of normal (ULN), at screening; 23. Liver aminotransferase levels greater than 2 times the laboratorys ULN, at screening; 24. Known or suspected immunodeficiency or human immunodeficiency virus positivity; 25. Known infection with hepatitis B or C; 26. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator; 27. Previous receipt of CF101; 28. History of malignancy within the past 5 years (excluding basal cell carcinoma of the skin and ≤3 cutaneous squamous cell carcinomas, all of which have been completely excised); 29. Active drug or alcohol dependence; 30. Significant acute or chronic medical, ophthalmic, neurologic, or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subjects ability to complete the study, and/or compromise the objectives of the study; 31. Participation in another investigational drug or vaccine trial concurrently or within 30 days; or 32. Other conditions which would confound the study evaluations or endanger the safety of the subject. ; PRIMARY OUTCOME: Intraocular Pressure in mmHg; SECONDARY OUTCOME 1: Safety of CF 101[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - SCALP; BRIEF: This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Chronic scalp psoriasis for at least the previous six months - Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected - Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy. Exclusion Criteria: - Forms of psoriasis other than chronic plaque - Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors) - Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy) - Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors - Use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer - Active, ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab - Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment - Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Psoriasis Scalp Severity Index 90 (PSSI 90); SECONDARY OUTCOME 1: Secondary: Investigators Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)[/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 (Healthy Volunteers); BRIEF: The purpose of the study is to investigate a drug called AG-519, which is being developed for the treatment of a disease called pyruvate kinase deficiency (also known as PK deficiency) and other forms of anemia. This study is a 5 part study with Part 1 enrolling healthy volunteers into single ascending dose (SAD) groups, Part 2 enrolling healthy volunteers into multiple ascending dose (MAD) groups and Part 3 enrolling healthy volunteers to investigate how much of the study drug is taken up by the body and how food affects the uptake of a prototype formulation of AG-519, Part 4 enrolling healthy volunteers of Japanese origin to compare to the results of subjects of non-Japanese origin, and Part 5 a non-randomized, open-label, multiple dose study enrolling healthy volunteers to further investigate how much of the study drug is taken up by the body when dosed over 14 days. ; DRUG USED: AG-519; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pyruvate Kinase Deficiency; TARGET: PKR (double-stranded RNA-activated protein kinase); THERAPY: Monotherapy; LEAD SPONSOR: Agios Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Healthy adult male or female subjects. Female subjects must be of non-childbearing potential. 2. Age 18 to 60 years inclusive at time of consent. 3. Body mass index (BMI) of ≥18.5 to ≤32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator. 4. Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG and laboratory investigations. 5. Subjects who are actively non-smokers and have not used other nicotine-containing products for at least 12 months prior to the screening assessment. 6. Must be willing and able to communicate and participate in the whole study. 7. Must provide written informed consent. 8. Must agree to use an adequate method of contraception. 9. Japanese subjects enrolled in Part 4 must be first generation: born in Japan, not having lived outside Japan for 5 to 10 years, able to trace maternal and paternal Japanese ancestry, with no significant change in lifestyle, including diet (at least one Japanese meal consumed per day), since leaving Japan. Exclusion Criteria: 1. Participation in a clinical research study within the previous 3 months. 2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee. 3. Subjects who have previously been enrolled in this study. 4. History of any drug or alcohol abuse in the past 2 years. 5. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine). 6. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening. 7. Any females of childbearing potential. 8. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening. 9. Subjects who, after 10 min of supine rest, have a systolic blood pressure (BP) ≥140 mmHg (≥150 mmHg in subjects >45 years of age) or a diastolic BP of ≥90 mmHg. 10. Male subjects with QTcF interval (Fridericias correction factor) ECG >450 msec, or female subjects with QTcF interval ECG >470 msec on screening or Day 1 (pre dose) ECG. 11. Subjects with a history of serious mental illness, that includes, but is not limited to schizophrenia, bipolar disorder, and major depression. 12. Subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency. 13. Subjects with a history of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions. 14. Subjects with any other medical or psychological condition, deemed by the investigator to be likely to interfere with a subjects ability to sign informed consent, cooperate, or participate in the study. 15. Subjects who have undergone major surgery within 6 months prior to screening. 16. Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator. 17. Positive drugs of abuse test result at screening or admission. 18. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results. 19. Subjects who are taking, or have taken, any prescribed or over-the-counter drug. 20. Subjects who have used St. Johns Wort within 28 days before the first dose of study drug. 21. History of cardiovascular, renal, hepatic, chronic respiratory or GI disease, or hematologic, lymphatic, neurolologic, endocrine, psychiatric, musculoskeletal, genitourinary, immunologic, dermatologic or connective tissue disease or disorders, as judged by the investigator. 22. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients, including history of allergy to sulfonamides. 23. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. 24. Donation or loss of greater than 400 mL of blood within the previous 3 months. 25. Failure to satisfy the investigator of fitness to participate for any other reason. ; PRIMARY OUTCOME: Incidence of Treatment-Emergent Adverse Events; SECONDARY OUTCOME 1: Cmax of AG-519[/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 - Fludarabine Refractory CLL (1); BRIEF: Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days). ; DRUG USED: Fodosine; DRUG CLASS: Non-NME; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Purine Nucleoside Phosphorylase (PNP); THERAPY: Monotherapy; LEAD SPONSOR: BioCryst Pharmaceuticals; CRITERIA: Inclusion Criteria: - Ages 18 years and older - Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria - Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy - Primary resistance to fludarabine-based therapy (no complete response [CR] or partial response [PR]) or progressive disease within 6 months of response to prior fludarabine containing regimen. - ECOG performance status of 0, 1, 2 or 3 - Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after - All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug. Exclusion Criteria: - Pregnant or nursing - Unable or unwilling to sign consent - Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy - Active serious infections that are not controlled by antibiotics - ECOG performance status 4 - Inadequate renal function: creatinine 2.0 or more unless related to the disease - Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease - Known positive test for HIV - Patients with known hepatitis B and/or hepatitis C active infection ; PRIMARY OUTCOME: Response rate after 2 cyclesof forodesine therapy.; 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 - GALILEO; BRIEF: To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE). To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anticoagulation; TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis (either native or valve-in-valve) - By iliofemoral or subclavian access - With any approved/marketed device Exclusion Criteria: - Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment - Any other indication for continued treatment with any oral anticoagulant (OAC) - Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma) - Any ongoing absolute indication for dual antiplatelet therapy (DAPT) at time of screening that is unrelated to the TAVR procedure - Clinically overt stroke within the last 3 months - Planned coronary or vascular intervention or major surgery - Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher - Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy ; PRIMARY OUTCOME: Number of Participants With Death or First Thromboembolic Event (DTE); SECONDARY OUTCOME 1: Number of Participants With Net-clinical Benefit[/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 - 2024; BRIEF: The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents. ; DRUG USED: GS-9688; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Toll-like receptor 8 (TLR8); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Adult males and non-pregnant, non-lactating females - Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels - On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening - HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening - Screening Electrocardiogram (ECG) without clinically significant abnormalities Key Exclusion Criteria: - Extensive bridging fibrosis or cirrhosis - Adults meeting any of the protocol defined exclusionary laboratory parameters at screening: - Alanine aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) - International normalized ratio (INR) > ULN unless the adult is stable on an anticoagulant regimen - Albumin < 3.5 g/dL - Direct bilirubin > 1.5x ULN - Platelet Count < 100,000/uL - Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method) - Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus - Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging - Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed. - Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease - Received solid organ or bone marrow transplant - Received prolonged therapy with immunomodulators or biologics within 3 months of screening - Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MOR-006 (Limited Ambulation); BRIEF: The primary objective of this study is to evaluate the effect of 2.0 mg/kg/week BMN 110 in a patient population that has limited ambulation, in a period of up to 144 weeks. ; DRUG USED: Vimizim; DRUG CLASS: Biologic; INDICATION: Mucopolysaccharidosis IV (MPS IV; Morquio Syndrome); TARGET: N-Acetylgalactosamine-6-Sulfate Sulfatase ; THERAPY: Monotherapy; LEAD SPONSOR: BioMarin Pharmaceutical; CRITERIA: Inclusion Criteria: - Is willing and able to provide written, signed informed consent (or their legally authorized representative) after the nature of the study has been explained and prior to performance of any research-related procedure. Patients who do not meet country and local age requirements for informed consent must be willing and able to provide written assent after the nature of the study has been explained and prior to performance of any research-related procedure. - Has documented clinical diagnosis of MPS IVA based on clinical signs and symptoms of MPS IVA and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IVA. - Is ≥ 5 years of age. - If sexually active, is willing to use an acceptable method of contraception while participating in the study. - Females of childbearing potential must have a negative pregnancy test at the Screening Visit and be willing to have additional pregnancy tests during the study. - Is willing and able to perform all study procedures as physically possible. Exclusion Criteria: - Is able to walk farther than a specified distance as assessed by the 6MWT. - Has previous hematopoietic stem cell transplant (HSCT). - Has received previous treatment with BMN 110. - Has a known hypersensitivity to any of the components of BMN 110. - Has had major surgery within 3 months prior to study entry or is planning to have a major surgery during the first 24 weeks of the study. - Has used any other investigational product or investigational medical device within 30 days prior to the Screening Visit or requires any investigational agent prior to completion of all scheduled study assessments. - Is pregnant or breastfeeding at the Screening Visit or planning to become pregnant (self or partner) at any time during the study. - Has a concurrent disease or condition, including but not limited to symptomatic cervical spine instability or severe cardiac disease or complete paralysis due to a spinal cord injury (defined as an inability to move arms and legs), that would interfere with study participation or safety as determined by the Investigator. - Has any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study. ; PRIMARY OUTCOME: Percent Change From Baseline in Speed as Measured in Functional Dexterity Test (FDT); SECONDARY OUTCOME 1: Percent Change From Baseline in Normalized Urine Keratan Sulfate (uKS)[/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 - CAPItello-281 (w/Abiraterone); BRIEF: This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause. ; DRUG USED: Capivasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Asymptomatic or mildly symptomatic, histologically-confirmed de novo hormone-sensitive prostate adenocarcinoma without small-cell tumours diagnosed within 180 days of randomisation - Consent to provide a FFPE tissue block (preferred) or slides. Tissue from bone metastases is not acceptable - A valid PTEN IHC result indicating PTEN deficiency (centralized testing) - Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion accurately assessed at baseline and suitable for repeated assessment with CT and/or MRI. PSMA PET identification only will not be eligible - Candidate for abiraterone and steroid therapy - Ongoing ADT with GnRH analogue, or LHRH agonists or antagonist, or bilateral orchiectomy (regardless of method) is from 0 days to a max. of 93 days prior to randomisation - Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks - Able and willing to swallow and retain oral medication - 7-day Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory(BFI) questionnaires and the analgesic diary during screening completed. Participants must complete a minimum of 4 successful assessments within a 7-day period prior to randomisation. - Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm - Capable of giving signed informed consent - Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples Exclusion Criteria: - Prior radical prostatectomy or definitive radiotherapy with therapeutic intent for prostate cancer. Palliative radiotherapy is allowed providing any wide field radiation therapy is completed more than 4 weeks before the start of study treatment - Major surgery (excluding placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of study treatment - Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment) - Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease - Any of the following cardiac criteria: i. Mean resting corrected QT interval (QTc) > 470 msec obtained from triplicate ECGs ii. History of QT prolongation associated with other medications that required discontinuation of that medication. iii. Family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives. iv. Medical history significant for arrhythmia which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. v. Any clinically important abnormalities in conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) vi. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, or any concomitant medication known to significantly prolong the QT interval vii. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, angioplasty, myocardial infarction, angina pectoris. viii. Congestive heart failure NYHA Grade ≥ 2 ix. Symptomatic hypotension - systolic blood pressure (SBP) <90 mmHg and/or diastolic blood pressure (DBP) <50 mmHg x. Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 95 mmHg). - Clinically significant abnormalities of glucose metabolism as defined by any of the following: i. Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment ii. HbA1c ≥8.0% (63.9 mmol/mol) - Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: i. Absolute neutrophil count < 1.5x 10^9/L ii. Platelet count < 100x 10^9/L iii. Haemoglobin < 9 g/dL (< 5.59 mmol/L) iv. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases. Elevated alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigators judgement v. Total bilirubin > 1.5x ULN (participants with confirmed Gilberts syndrome may be included in the study with a higher value) vi. Creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation) - As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or known active infection including hepatitis B, hepatitis C, and HIV - unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria: i. a superscan of bone scan, and ii. no soft tissue lesion that can be assessed by RECIST criteria - Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigators opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent - Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent - Previous allogeneic bone marrow transplant or solid organ transplant - History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease. - Treatment with any of the following: i. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment ii. Any investigational agents or study drugs from a previous clinical study within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment iii. Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long half-life (eg, biologics) iv. Strong inhibitors or strong inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St Johns wort). Note that adequate washout or dose reduction may be required for some CYP3A substrates prior to initiating Capivasertib dosing. - Drugs known to significantly prolong the QT interval and associated with Torsades de Pointes within 5 half-lives of the first dose of study treatment - Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives, whichever is longer. - History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class. - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). - Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. - Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone. ; PRIMARY OUTCOME: Radiographic Progression-free Survival (rPFS); 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 I - Healthy Adult Subjects; BRIEF: The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants. The secondary objectives of the study are: In Part A and Part B: - To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults - To assess the immunogenicity of single dose of REGN5713-5714-5715. In Part B: - To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715 - To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715. ; DRUG USED: REGN-5713-5714-5715; DRUG CLASS: Biologic; INDICATION: Allergy; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed prior to study drug dosing - Participant is in good health based on laboratory safety testing obtained at the screening prior to study drug dosing - Part B: Has a medical history of birch tree pollen-triggered allergic rhinitis (AR) symptoms with or without conjunctivitis (for at least 2 seasons) based on participants recall - Part B: Has positive skin prick test (SPT) with birch tree pollen extract (mean wheal diameter ≥5 mm greater than a negative control) in screening period Key Exclusion Criteria: - History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confound the results of the study or pose an additional risk to the participant by study participation - Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by study participation - Participation in any clinical research study evaluating another investigational drug or therapy within 90 days or at least 5 half-lives (whichever is longer) for an investigational biologic drug, or at least 28 days for other investigational products, or within 6 months for immunotherapy prior to the screening visit of the current trial - Pregnant or breastfeeding women - Part B: Receipt of study drug REGN5713-5714-5715 in Part A - Part B: Significant rhinitis or sinusitis outside of the birch pollen season or due to daily contact with other allergens causing symptoms, that is expected to coincide with the study NAC assessments as assessed by the investigator - Part B: A clinical history of asthma requiring chronic medication such as regular, inhaled corticosteroids for >6 months per year - Part B: History of birch allergy immunotherapy (SCIT, sublingual immunotherapy, or oral immunotherapy) in the 5 years prior to screening NOTE: Other protocol defined inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Incidence and severity of treatment-emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Total concentration of REGN5713 in serum over time[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - IIS-0039; BRIEF: This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. ; DRUG USED: Trodusquemine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Dopamine Reuptake, Neuropeptide Y (NPY)/Peptide YY (PYY) Receptors, Norepinephrine (Noradrenaline) Reuptake/Transporter, PTP-1b (Tyrosine phosphatase 1B inhibitor); THERAPY: Monotherapy; LEAD SPONSOR: Northwell Health; CRITERIA: Inclusion Criteria: - Signed, witnessed, and dated Institutional Review Board (IRB) approved Informed Consent Form (ICF). - Pathologically confirmed metastatic breast cancer with measurable disease. Metastatic sites must be measurable on CT, MRI, or FDG-PET/CT as per the revised RECIST v1.1 criteria or measurable disease on physical examination. A metastatic site must be biopsy proven - Life expectancy ≥3 months. - Patients enrolled must have received 2 or more lines of therapy and all patients with HER2 expressing tumors must have received HER2 targeted therapy. - Female Age ≥18 years. - Stable brain metastasis is permitted. This is not considered measurable disease. Stable brain metastasis is defined as no change on CT scan or MRI for minimum of 2 months AND no change in steroid dose for a minimum of 4 weeks - A negative serum pregnancy test, if female of reproductive potential. Reproductive potential defined as age < 55 or with no menses for < 1 year - Screening laboratory values as follows: Total bilirubin ≤1.5 times upper limit of normal (ULN). Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase)≤ 2.5 times ULN. Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min. Absolute neutrophil count >1,500 cells/mm3. Platelet count ≥100,000 plt/mm3. Hemoglobin ≥ 8 g/dL. Non-diabetic Exclusion Criteria: - Pregnant or breast-feeding - ECOG Performance Status greater than 2 ; PRIMARY OUTCOME: Maximally Tolerated Dose (MTD) of MSI-1436; SECONDARY OUTCOME 1: Area under the plasma concentration versus time curve (AUC)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - CTST-25; BRIEF: The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease. ; DRUG USED: CLP 1001; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Sodium; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Sorbent Therapeutics; CRITERIA: Inclusion Criteria: - Heart failure with New York Heart Association (NYHA) Classification II or III - Chronic kidney disease - Cardiac ejection fraction <40% - On heart failure therapy including an ACEI or ARB, and a BB - Willing to understand and comply with study procedures and provide written informed consent. Exclusion Criteria: - Hospitalization within 4 weeks of baseline visit - History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures - Current or anticipated dialysis during study - In the investigators judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subjects study participation unsafe - Drug or alcohol abuse ; PRIMARY OUTCOME: Change in Fecal Sodium Content; SECONDARY OUTCOME 1: Change in Fecal Weight[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 301; BRIEF: The objective of the study is to evaluate the safety and efficacy of a topical lotion. ; DRUG USED: Duobrii; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: Glucocorticoid Receptor (GR), Retinoic acid receptor (RARs); THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Key Inclusion Criteria: - Male or female, of any race, at least 18 years of age (inclusive). - Freely provides both verbal and written informed consent. - Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation. - Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. - Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment). Key Exclusion Criteria: - Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator. - Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator. - Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. - Is pregnant, nursing an infant, or planning a pregnancy during the study period. - Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device. ; PRIMARY OUTCOME: The Percentage of Participants With Treatment Success at Week 8; SECONDARY OUTCOME 1: Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - C03 (US and EU); BRIEF: MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of MIN-117 in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, including placebo, 2.5 mg MIN-117, or 5.0 mg MIN-117, in a 2:1:1 ratio. ; DRUG USED: MIN-117; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Alpha 1 Adrenergic Receptor , Dopamine Reuptake, Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Minerva Neurosciences; CRITERIA: Inclusion Criteria: - Participants must be able to read and understand the consent forms, complete study-related procedures, and communicate with the study staff. - Participants must have provided written consent to participate in the study and understand that they are free to withdraw from the study at any time. - Participants must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study in order to participate in the optional pharmacogenomic component of this study. Refusal to consent for this component does not exclude a participant from participation in the clinical study. - Participants must be aged 18 to 65 years, inclusive, at Screening (Visit 1). - Meet Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for diagnosis of moderate or severe major depression with anxious distress and without psychotic features at Screening based on clinical assessment and on the Structured Clinical Interview for DSM-5 (SCID-5). Their major depressive episode must be deemed valid using the Massachusetts General Hospital (MGH) State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps [pervasive, persistent, and pathological] (SAFER) criteria interview administered by remote, independent raters. - Participants must be within a body mass index (BMI) of ≥ 18 to < 35 kg/m2 (BMI = weight (kg)/height(m)2] at Screening (Visit 1). - Participants have a history of at least one previous episode of depression prior to the current episode. - Participant must have been treated with an antidepressant administered at an adequate dose and duration in the past for the treatment of Major Depression. An adequate treatment is defined as an antidepressant treatment for at least 4 weeks at at least the minimum therapeutic dose, for any particular antidepressant. - Current major depressive episode of at least 4 weeks in duration. - At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 40 on the patient rated Inventory of Depressive Symptoms self-report (IDS-SR30). - At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 18 on Hamilton Anxiety Scale (HAM-A). - At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 4 on the investigator-rated Clinical Global Impression of Severity Scale (CGI-S). - Participants must be outpatients at the time of randomization (Baseline [Day 1]). - Participants must be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, vital signs, blood chemistry, hematology, urinalysis, and electrocardiogram (ECG). - If female, the participant must: 1. be post-menopausal, or 2. have had a hysterectomy or tubal ligation or be otherwise incapable of pregnancy, or 3. must agree to consistent use of 2 methods of contraception for the duration of the study and until 90 days after the last dose of study medication. - Female participants of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and negative serum and urine pregnancy test at Baseline (Visit 2). Exclusion Criteria: - A DSM-5 diagnosis of current (active): panic disorder, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa. - History or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders, mood disorder with postpartum onset, somatoform disorders, fibromyalgia, or idiopathic medical conditions. - At significant clinical risk for suicidal or violent behavior. - History of treatment within last 6 months with electroconvulsive therapy (ECT), Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), or Transcranial Magnetic Stimulation (TMS). - Potential participant who in the opinion of the investigator should not discontinue, or participate in washout of a prohibited concomitant medication. - Potential participant who demonstrates a greater than 25% decrease in depressive symptoms as reflected by the IDS-SR30 total score from Screening visit to Baseline visit. - Active cardiovascular disease (including but not limited to: atrial fibrillation or flutter, second and third-degree atrioventricular heart block, resting supraventricular tachycardia > 100 beats per minute, unstable ischemic heart disease, valvular abnormality, sick sinus syndrome or other condition requiring pacemaker) or diastolic blood pressure > 105 mmHg. - Any serious, untreated, or unstable illnesses, such as: liver or renal insufficiency. - Any significant pulmonary, endocrine, or metabolic disturbances. - Documented disease of the central nervous system that could interfere with the study assessments (including by not limited to: stroke, tumor, multiple sclerosis, Parkinsons disease, Alzheimers disease, Huntingtons disease, seizure disorder requiring current anti-convulsants, traumatic brain injury or trauma, and neurosyphilis. - Hypothyroidism or hyperthyroidism, unless stabilized by appropriate medication for at least 3 months prior to Screening (a normal thyroid-stimulating hormone [TSH] is required prior to randomization at Baseline). - Any medical condition that can potentially alter oral enteral absorption (e.g., gastrectomy), metabolism (e.g., liver failure), or excretion (e.g., renal failure) of the study drug. - History of alcohol or substance use disorders (except nicotine and caffeine) meeting DSM-5 criteria within 1-year prior to Screening visit. - Positive alcohol and urine drug screen for opiates, cocaine, barbiturates, tetrahydrocannabinol, methadone, tricyclic antidepressants, benzodiazepines, and amphetamine/methamphetamine at Screening or Baseline. Patients with positive testing at Screening due to prescribed benzodiazepines, tricyclic antidepressants, barbiturates or opiates are accepted but must test negative at Baseline. - Male participants who have pregnant partners. - Received an experimental drug or used an experimental medical device within 60 days before the planned start of treatment (Day 1) or have participated in 2 or more clinical trials in the previous 2 years. - QT interval corrected with Fridericias formula (QTcF) at Screening or Baseline greater than 450 msec for males and 470 msec for females. - Positive hepatitis B surface antigen, or hepatitis C antibody or Human Immunodeficiency Virus (HIV) 1 and 2 antibodies at Screening. - Employees of the investigator or study center, when the employee has direct involvement in the proposed study or other studies under the direction of that investigator or study center; also family members of the employee or the investigator. ; PRIMARY OUTCOME: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score; SECONDARY OUTCOME 1: Change in Hamilton Anxiety Scale (HAM-A)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - Study 0108; BRIEF: The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). ; DRUG USED: ASKP1240; DRUG CLASS: Biologic; INDICATION: Transplant Rejection; TARGET: Cluster of Differentiation 40 (CD40); THERAPY: Monotherapy; LEAD SPONSOR: Astellas Pharma Global Development, Inc.; CRITERIA: Inclusion Criteria: - Subject is a recipient of a de novo kidney from a living or deceased donor Exclusion Criteria: - Subject has induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen - Subject has previously received or is receiving an organ transplant other than a kidney - Subject will receive a solitary kidney from a deceased donor < 5 years of age - Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours - Subject will receive a kidney that meets both Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. Note: a kidney that meets either ECD or DCD criteria is eligible for inclusion - Subject will receive an ABO incompatible donor kidney - Subject has a current calculated panel reactive antibody (cPRA) level >50% ; PRIMARY OUTCOME: Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review; SECONDARY OUTCOME 1: Glomerular Filtration Rate (GFR)[/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 - NODE-1 (PSVT); BRIEF: The primary objective of this study is to demonstrate the superiority of at least 1 dose of intranasal (IN) MSP-2017 (Etripamil) over placebo in terminating PSVT induced in an electrophysiology (EP) laboratory. ; DRUG USED: Etripamil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Supraventricular Tachycardia; TARGET: Calcium Channel; THERAPY: Monotherapy; LEAD SPONSOR: Milestone Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: - Male or female, aged 18 years and older at Screening - Has a history of PSVT - Is scheduled for an electrophysiology study and catheter ablation - Has provided written informed consent - Agrees to use a medically accepted form of contraception or abstinence to prevent pregnancy. Males must agree to use an acceptable form of contraception or abstinence from the time of study drug administration through the Follow-up Visit. Females must agree to use an acceptable form of contraception or abstinence from Screening until 30 days following study drug administration. Post-menopausal female subjects must be amenorrheic for ≥ 12 months prior to Screening or ≥ 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to Screening, if they do not wish to use an acceptable form of contraception or abstinence. Acceptable forms of contraception include: A condom and an intrauterine device; A condom and hormonal contraception; A condom and a diaphragm; Sterilization of the subject or the subjects partner(s) (sterilization procedure must have been performed 3 or more months prior); Hysterectomy of the subject or the subjects partner(s) - If a female of childbearing potential: Has a negative serum pregnancy test result at Screening (Screening must occur ≥7 days prior to randomization [ie, on or before Day -7]) and at the Treatment Visit (pre-PSVT induction); Has had a menstrual period within 28 days of the Treatment Visit. Exclusion Criteria: - Has a history of serious allergic reaction to verapamil (especially when administered intravenously) including rash, itching or swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing - Is currently participating in another drug or device study, or has received an investigational drug or device within 30 days of Screening - Has evidence of clinically significant cardiovascular, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, pulmonary, psychiatric, or renal disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of study results - Is a female who is breast feeding, pregnant, or planning to become pregnant during the study period - Has evidence of any clinically significant acute or chronic condition of the nasal cavity (e.g., rhinitis or deviated septum) which could interfere with IN administration of the study drug in either or both nasal cavities - Has any of the following at screening or at the Treatment Visit: Systolic blood pressure <100 mmHg, Diastolic blood pressure <50 mmHg - Has evidence of hepatic impairment, defined as: Alanine aminotransferase or aspartate aminotransferase levels that are greater than or equal to 3× upper limit of normal (ULN) or Bilirubin levels that are greater than or equal to 2× ULN, unless due to Gilberts syndrome - Has evidence of renal impairment, defined as an estimated glomerular filtration rate <30 mL/min (Modification of Diet in Renal Disease method) - Has taken digoxin, verapamil, diltiazem, or any Class I, II (e.g., beta blockers), or III antiarrhythmic drug less than the equivalent of 5 half-lives of this drug prior to the Treatment Visit - Has taken amiodarone within 30 days of the Treatment Visit - Has taken drugs of abuse which, in the opinion of the Investigator, would impact the validity of study results - Has had myocardial infarction, percutaneous coronary intervention, cerebrovascular accident, transient ischemic attack, unstable angina, or acute decompensation of heart failure within 6 months of Screening - Has a history or evidence of second- or third-degree atrioventricular block - Has an implanted device (e.g., pacemaker, or implantable cardioverter defibrillator) that precludes study participation in the opinion of the Investigator and Study Medical Monitor - Has a history or evidence of preexcitation syndrome (e.g., Wolff-Parkinson- White syndrome, short PR, etc.) - Has evidence of a QT interval (Bazetts correction) (QTcB) >455 milliseconds at Screening or at the Treatment Visit - Has a history or evidence of familial long QT syndrome, torsades de pointes, ventricular fibrillation, sustained ventricular tachycardia, Brugada syndrome, or sudden cardiac death - Has evidence of recurrent or chronic atrial tachycardia, atrial flutter, or atrial fibrillation; that could interfere with the current investigation; or - Has a history or evidence of congestive heart failure (except New York Heart Association Class I) or pulmonary edema In addition, randomized subjects who meet any of the following criteria at the Treatment Visit (Day 1) prior to study drug administration, will be excluded from participation in the study: - PSVT cannot be induced or the mechanism of PSVT is neither Atrioventricular reentrant tachycardia (AVRT) nor Atrioventricular nodal reentry tachycardia (AVNRT) - It is not possible to sustain an episode of PSVT for 5 minutes - The subject requires a continuous sedative (e.g., propofol), continuous analgesic, or inhaled anesthetic at any point until time 30. Minimally necessary dose(s) of benzodiazepine(s) (e.g., midazolam) and/or narcotic(s) (e.g., fentanyl) (given via single or multiple administration[s]) may be used at the Investigators discretion. The identity(-ies) and actual administered dose(s) of any benzodiazepine(s) and/or narcotic(s) should be recorded in the study documentation. Local anesthetic(s) may be used at the Investigators discretion; any use should be recorded in the study documentation - The subject has undergone prior ablation, and the subjects atrioventricular node function is abnormal in the opinion of the Investigator ; PRIMARY OUTCOME: The Percentage of Subjects Successfully Converted From PSVT to Sinus Rhythm Within 15 Minutes of Study Drug Administration; 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 - BRUIN CLL-321; BRIEF: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress. ; DRUG USED: Pirtobrutinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Loxo Oncology, Inc.; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria. - Previously treated with a covalent BTK inhibitor. - Eastern Cooperative Oncology Group (ECOG) 0-2. - Absolute neutrophil count ≥ 0.75 × 10^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement. - Hemoglobin ≥ 8 g/dL or ≥ 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement. - Platelets ≥ 50 × 10^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75 × 10^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count < 30 x 10^9/L are excluded. - AST and ALT ≤ 3.0 x upper limit of normal (ULN). - Total bilirubin ≤ 1.5 x ULN. - Estimated creatinine clearance of ≥ 30 mL/min. Exclusion Criteria: - Known or suspected Richters transformation at any time preceding enrollment. - Known or suspected history of central nervous system (CNS) involvement by CLL/SLL. - Ongoing drug-induced liver injury. - Active uncontrolled auto-immune cytopenia. - Significant cardiovascular disease. - History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days. - Active hepatitis B or hepatitis C. - Known active cytomegalovirus (CMV) infection. - Active uncontrolled systemic bacterial, viral, fungal or parasitic infection. - Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count. - Clinically significant active malabsorption syndrome or inflammatory bowel disease - Prior exposure to non-covalent (reversible) BTK inhibitor. - Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist. - Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers. - Vaccination with a live vaccine within 28 days prior to randomization. - Patients with the following hypersensitivity: 1. Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine. 2. Prior significant hypersensitivity to rituximab. ; PRIMARY OUTCOME: To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigators choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B); SECONDARY OUTCOME 1: To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - CIBI375A201; BRIEF: This is a phase 2 study to investigate the efficacy and safety of Pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 rearrangement who have failed at least 1 previous therapy ; DRUG USED: Pemazyre; DRUG CLASS: New Molecular Entity (NME); INDICATION: Biliary Tract Cancer; TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy; LEAD SPONSOR: Innovent Biologics (Suzhou) Co. Ltd.; CRITERIA: Inclusion Criteria: 1. Men and women, aged 18 or older. 2. Histologically or cytologically confirmed cholangiocarcinoma which was considered to be advanced/metastatic or surgically unresectable by the investigator through image examination. 3. Radiographically measurable disease per RECIST v 1.1 4. Documentation of FGFR2 rearrangement. 5. Documented disease progression after at least 1 line of prior systemic therapy. 6. ECOG performance status of 0~1. 7. Life expectancy ≥12 weeks. Exclusion Criteria: 1. Prior receipt of a selective FGFR inhibitor. 2. History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance). 3. Currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination. 4. Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed. ; PRIMARY OUTCOME: Objective response rate per RECIST 1.1; SECONDARY OUTCOME 1: PFS（PFS= first dose to progressive disease or death）[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Children (KP415.E01); BRIEF: The study is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy laboratory classroom study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD). ; DRUG USED: Azstarys; DRUG CLASS: New Molecular Entity (NME); INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine Reuptake, Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Zevra Therapeutics; CRITERIA: Inclusion Criteria: 1. Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) per clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 2. Subject must have a score of at least 3 (mildly ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale. 3. Subject, subjects parent/legal guardian and caregiver (if applicable) must understand and be willing and able to comply with all study procedures and visit schedule. Exclusion Criteria: 1. Subject with any clinically significant chronic medical condition that may interfere with the participants ability to participate in the study. 2. Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourettes Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. 3. Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood, or history of persistent neurological symptoms attributable to serious head injury. 4. Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible. 5. Subject has any history of attempted suicide or clinically significant suicidal ideation or subject has a C-SSRS score for suicidal ideation ≥2. 6. Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism, or excretion of study drug. 7. Subject has a history or presence of abnormal ECGs. ; PRIMARY OUTCOME: Change From Baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores; SECONDARY OUTCOME 1: Change From Baseline in Permanent Product Measure of Performance (PERMP) Rating Scale, Number of Problems Attempted (PERMP-A)[/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 - Safety; BRIEF: This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720. ; DRUG USED: Gilenya; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Sclerosis (MS); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis; CRITERIA: Inclusion Criteria: - 18-65 years of age, must have relapsing MS Exclusion Criteria: - Patients with a type of MS that is not relapsing - Patients with history of chronic immune disease - Patients with a history of certain cancers - Diabetic patients with certain eye disorders - Patients who are on certain immunosuppressive medications or heart medications - Patients with certain heart conditions - Patients with certain lung conditions Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS; SECONDARY OUTCOME 1: Incidence of macular edema[/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 - 08 - vs. Ezetimibe; BRIEF: The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Esperion Therapeutics, Inc.; CRITERIA: Key Inclusion Criteria: - Statin intolerant and statin tolerant - Fasting LDL-C between 130 mg/dL and 220 mg/dL - Fasting triglyceride less than or equal to 400 mg/dL - Body mass index (BMI) between 18 and 45 kg/m2 Key Exclusion Criteria: - History or current clinically significant cardiovascular disease - History or current type 1 diabetes or uncontrolled type 2 diabetes - Use of metformin or thiazolidinediones (TZD) within 3 months of screening - History of joint symptoms difficult to differentiate from myalgia - Uncontrolled hypothyroidism - Liver disease or dysfunction - Renal dysfunction or nephritic syndrome - Gastrointestinal (GI) conditions or prior GI procedures - HIV or AIDS - History or malignancy - History or drug or alcohol abuse within last 2 years - Use of experimental or investigational drugs within 30 days of screening - Use of ETC-1002 in a previous clinical study ; PRIMARY OUTCOME: Percent change in calculated low density lipoprotein-cholesterol (LDL-C); SECONDARY OUTCOME 1: Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C)[/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 - TRIAGE; BRIEF: To assess the efficacy and safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes ; DRUG USED: Epeleuton; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: 5-lipoxygenase (5LO); THERAPY: Monotherapy; LEAD SPONSOR: Afimmune; CRITERIA: Inclusion Criteria: 1. Patients diagnosed with type 2 diabetes mellitus at least 90 days prior to the first screening visit. 2. Patients with a HbA1C (glycosylated haemoglobin) between 7.0 - 10.0% (53-86 mmol/mol) (both inclusive) 3. Patients with a fasting triglyceride level ≥200 mg/dL (2.26 mmol/L) and <750mg/dL (8.46 mmol/L) at both screening visits. Note: If the triglyceride level is outside the required range at the second screening visit, an additional measurement can be obtained 1 week later, to confirm eligibility. Note: If a large difference in triglyceride level (>15%) is observed between screening 1 and screening 2, an additional measurement may be requested or patient may be deemed not eligible. 4. Patients who have been educated regarding diet and exercise at or before visit 1 (screening 1) and are willing to maintain and not alter a stable diet and activity routine throughout the study. 5. Patients who have been on a stable statin therapy at doses that are likely to achieve optimal LDL cholesterol and who are willing to continue this treatment throughout the study. Note: Stable statin therapy may consist of a statin with or without ezetimibe. 6. Patients with an LDL cholesterol level <130mg/dL (3.34 mmol/L) at both screening visits. 7. Patients who have a body mass index (BMI) ≥ 25kg/m2 and <50kg/m2. 8. Patients who have been on a stable daily dose of metformin (at least 1500mg or maximum tolerated dose for metformin monotherapy as documented in the subject medical record) and/or a sulfonylurea and/or a dipeptidyl peptidase-4 (DPP-4) inhibitor and/or a sodium-glucose transport protein 2 inhibitor (SGLT2i) and/or a GLP1-RA and/or basal insulin for at least 90 days prior to the day of first screening visit. Note: Dose of GLP1-RA must be stable for 6 months prior to baseline with no weight change >2kg for 3 months prior to baseline. Note: Dose of basal insulin must be stable for 4 months prior to baseline. All types of basal insulin are permitted, including insulin glargine, insulin degludec, insulin detemir, NPH insulin and pre-mixed insulin. 9. Female patients and male patients with female partners of childbearing potential must use highly effective contraceptive methods or have a sterilised partner for the duration of the study. Highly effective contraceptive methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include hormonal contraception, intrauterine device or sexual abstinence. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Note: Hormonal contraceptives must be on a stable dose for at least one month before baseline. Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. 10. Patients whose pre-study or screening clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator, and do not violate any inclusion or exclusion criteria 11. Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF). 12. Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent prior to initiation of any study specific activities or procedures. ; PRIMARY OUTCOME: Percent Change in Triglycerides From Baseline to Week 16; SECONDARY OUTCOME 1: % Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26[/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 - MIRNA - w/PF-06865571; BRIEF: The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy). ; DRUG USED: PF-05221304; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Acetyl-CoA carboxylase (ACAC, ACC); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition - BMI >/= 22.5kg/m2 Exclusion Criteria: - Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis - Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including- - unstable liver function tests, recent cardiovascular event(s) significant malignancies, ; PRIMARY OUTCOME: Resolution of NASH without worsening of fibrosis or improvement in fibrosis by 1>/= or both; SECONDARY OUTCOME 1: Percent change in liver fat[/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 - Study 201-01 (Healthy); BRIEF: The focus of the study is to evaluate the safety of multiple study drug administrations and the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will compare a liquid and gel product applied in different modes. ; DRUG USED: C16G2; DRUG CLASS: New Molecular Entity (NME); INDICATION: Periodontitis; TARGET: Streptococcus mutans; THERAPY: Monotherapy; LEAD SPONSOR: Armata Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Subjects are eligible to participate if they meet the following criteria: - Males and females, 18-75 years of age, inclusive, at the time the Informed Consent Form is signed - Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, monogamous relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit. - Male subjects only: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination. - Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening - Have a minimum of six unrestored bicuspids and molars with less than 50% of molars and bicuspids having restorations, crowns, sealants or are missing - Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes - Demonstrated ability to swish 10 mL of water for 4 minutes - Have a salivary and dental plaque S. mutans of 2.0 x 10^4 colony forming unit (CFU)s/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating - Willing to refrain from using non-study dentifrice and other non-study oral care products during the study - Willing to postpone elective dental procedures (e.g. dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination) - Able to understand and sign the Informed Consent Form prior to initiation of study procedures - Able to communicate with the Investigator/study site personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times Exclusion Criteria: Subjects are excluded from participation if any of the following apply: - Advanced periodontal disease - Active caries lesion(s) within 30 days prior to study drug administration (confirmed by dental examination and standard radiographs). - Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures - Pathologic lesions of the oral cavity (suspicious or confirmed) - Full or partial dentures, or orthodontic appliances, e.g. night guards, permanent retainers - Impaired salivary function (unable to provide 2 mL of stimulated saliva within 5 minutes) - Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the Investigator could influence the study outcome, within 30 days prior to Screening - Medical history indicating the woman is pregnant, breastfeeding/lactating or she has a positive urine pregnancy test - Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration (depending on the specifics, participation in an observational study is not necessarily excluded) - Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements ; PRIMARY OUTCOME: To evaluate the safety of multiple C16G2 Gel and/or C16G2 Rinse administrations in healthy adult subjects.; SECONDARY OUTCOME 1: To assess the targeted antimicrobial activity of C16G2 gel and rinse applications as measured by a reduction of dental plaque and salivary Streptococcus mutans (S. mutans).[/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/PD/Safety; BRIEF: The objective of this study is to identify a safe dose of MK-2248 in participants with Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from baseline. It is anticipated that once-daily administration of a safe and well tolerated dose of MK-2248 will reduce VL by at least 3 log10 IU/mL. ; DRUG USED: MK-2248; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - clinical diagnosis of chronic HCV defined by positive serology for HCV or positive HCV RNA for at least 6 months and detectable HCV RNA in peripheral blood ≥10^5 IU/mL at screening - Body Mass Index (BMI) ≥18 to <37 kg/m^2 - in good health other than HCV infection with normal laboratory values Exclusion Criteria: - history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease - history of cancer other than adequately treated non-melanomatous skin carcinoma, malignancies which have been successfully treated ≥10 years prior with no recurrence, or cancer that is unlikely to sustain a recurrence for the duration of the trial - history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food - positive for hepatitis B surface antigen or human immunodeficiency virus - had major surgery or lost 1 unit of blood within 4 weeks prior to screening - QTc interval ≥470 msec (males) or ≥480 msec (females) - received prior treatment with other HCV inhibitors - clinical or laboratory evidence of decompensated liver disease ; PRIMARY OUTCOME: Maximum change from baseline in VL; SECONDARY OUTCOME 1: Plasma concentration at 24 hours post-dose (C24hr) of MK-2248 and circulating metabolite(s)[/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/Letrozole (HR+/HER2-); BRIEF: Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in combination with letrozole (Femara) and of XL765 when given in combination with letrozole. After the MTD is established for each combination (Phase 2), subjects will be enrolled to evaluate the preliminary efficacy and safety of these combinations in subjects with breast cancer refractory to a non-steroidal aromatase inhibitor that is ER+/PGR+ and HER2-. Letrozole is used in the treatment of different types of breast cancer, but patients can develop resistance. Upregulation of PI3K activity is one of the most common characteristics of human cancer cells, including breast tumor cells. Activation of PI3K results in stimulation of AKT and mTOR kinases, resulting in the promotion of tumor cell proliferation and survival. Preclinical and retrospective clinical data suggest that aberrant activation of the PI3K pathway may play a role in aromatase inhibitor resistance in patients with ER+, HER2- breast cancer. XL147 is a potent inhibitor of PI3K, and XL765 is a potent dual inhibitor of PI3K and mTOR; therefore either of these compounds in combination with letrozole warrants clinical investigation. ; DRUG USED: SAR245408; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - The subject has histologically confirmed breast cancer that is ER+ and/or PGR+. - The subjects breast cancer is negative for HER2. - The subject has recurrent or metastatic breast cancer that is refractory to a nonsteroidal aromatase inhibitor and has either disease progression or disease recurrence. - Subjects previously treated with letrozole must be able to tolerate the approved dose and schedule of letrozole. - For subjects enrolled in Phase 2, either archival tumor samples must be available, or the subject must be willing to undergo a fresh biopsy. - In Phase 2, at least 30 subjects in each arm must have measurable disease - The subject is a postmenopausal female. - If a subject is currently receiving bisphosphonates, the subject must have received the bisphosphonates for at least 2 months before starting study treatment. - The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. - The subject has adequate organ and marrow function. - The subject has no other diagnosis of malignancy or evidence of other malignancy for 2 years before screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix). - The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document. Exclusion Criteria: - The subject has received prior treatment with a selective inhibitor of PI3K, AKT, and/or mTOR. - Certain restrictions on prior therapies apply. - The subject has not recovered from toxicity due to prior therapy to Grade ≤ 1 or to pre-therapy baseline. - The subject has untreated, symptomatic, or progressive brain metastases. - The subject has only non-measurable lesions, other than bone, skin, or chest wall metastasis - The subject has to start cytotoxic chemotherapy due to rapid progressive disease involving major organs. - The subject has prothrombin time/ International Normalized Ratio (PT/ INR) or partial thromboplastin time (PTT) test results at screening that are above 1.3 x the laboratory upper limit of normal. - The subject has uncontrolled significant intercurrent illness. - The subject has a baseline corrected QT interval (QTc) > 470 ms. - The subject has a diagnosis of uncontrolled diabetes mellitus. - The subject is known to be positive for the human immunodeficiency virus (HIV). - The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation(s). - The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee. ; PRIMARY OUTCOME: Safety and tolerability of XL147 and letrozole and XL765 and letrozole; SECONDARY OUTCOME 1: In Phase 2, to assess other clinical benefit and efficacy parameters[/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 - FerWonExt (Ext.); BRIEF: Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose. ; DRUG USED: Monoferric; DRUG CLASS: Non-NME; INDICATION: Anemia; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Pharmacosmos A/S; CRITERIA: Inclusion Criteria: 1. Completed one of the lead-in trials 2. Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials. 3. Haemoglobin (Hb) of ≤ 11 g/dL 4. Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 % 5. Willingness to participate and signing the informed consent form (ICF) Exclusion Criteria: 1. Intravenous (IV) iron treatment between the lead-in trial and screening 2. During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy 3. Received an investigational drug within 30 days of screening 4. Decompensated liver cirrhosis or active hepatitis 5. Pregnant or nursing women. 6. Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subjects disease management at risk or may result in the subject being unable to comply with the trial requirements ; PRIMARY OUTCOME: Number of Subjects With Adverse Drug Reactions (ADR); SECONDARY OUTCOME 1: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Ocular Surface Disease; BRIEF: To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications. ; DRUG USED: Pro-Ocular; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dry Eye (Ophthalmology); TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Glia, LLC; CRITERIA: Inclusion Criteria: 1. Male or female of any race, at least 18 years of age at Visit 1 Screening. 2. Has provided verbal and written informed consent. 3. Be able and willing to follow instructions, including participation in all study assessments and visits. 4. Currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime. 5. Suffers from at least two of the symptoms in the GLIA™ Glaucoma Medication Ocular Side Effect Symptoms Questionnaire at a severity of 2 (moderate) or more. 6. If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period. Exclusion Criteria: 1. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as corneal opacities and scars, dystrophies, epithelial scarring, infections, blood clots, etc. 2. Best corrected visual acuity (BCVA) at baseline <20/200. 3. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subjects participation in the study. 4. A woman who is pregnant, nursing an infant, or planning a pregnancy. 5. Has a known adverse reaction and/or sensitivity to the study drug or its components. 6. Routine use (more than twice a week) of a chlorinated swimming pool. 7. Unwilling or unable to cease using the following medications during the study period: Topical ocular cyclosporine (e.g. Restasis®), anti-histamines, antipsychotics, or eye gels. 8. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1. ; PRIMARY OUTCOME: Glaucoma medication ocular side effect symptoms; SECONDARY OUTCOME 1: Glaucoma medication ocular side effect signs[/INST]Yes</s>