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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - MOR-007 (<5 Years); BRIEF: This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of administration of the first dose of study drug, diagnosed with MPS IVA (Morquio A Syndrome) for up to 208 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: - Less than 5 years of age at the time of the first study drug infusion - 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 - Written informed consent provided by parent or legally authorized representative after the nature of the study has been explained and prior to any research-related procedures. Exclusion Criteria: - Previous hematopoietic stem cell transplant (HSCT). - Previous treatment with BMN 110. - Known hypersensitivity to any of the components of BMN 110. - Major surgery within 3 months prior to stuy entry or planned major surgery during the 52-week treatment period. - Use of any investigational product or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments. - Concurrent disease or condition, including but not limited to symptomatic cervical spine instability, clinically significant spinal cord compression, or severe cardiac disease that would interfere with study participation or safety as determined by the Investigator. - Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study. ; PRIMARY OUTCOME: To Evaluate Safety and Tolerability of Infusions of BMN 110 at a Dose of 2.0 mg/kg/Week Over a 52-week Period in MPS IVA Subjects Less Than 5 Years of Age at Time of First Study Drug Infusion; SECONDARY OUTCOME 1: Percent Change From Baseline to Week 52 in Urinary Keratan Sulfate Measures[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - w/Trametinib (Japanese Patients); BRIEF: This is an open-label, multicenter, non-randomized, single arm, phase II study to assess efficacy and safety of the dabrafenib and trametinib combination in Japanese patients with any line, stage IV NSCLC harboring a confirmed BRAF V600E mutation. Patients will receive oral dabrafenib twice daily and oral trametinib once daily combination therapy. Patients may continue study treatment until disease progression, unacceptable adverse events, start of a new anti-cancer therapy, consent withdrawal, death, or end of the study. Patients who have met the criteria for disease progression (PD) according to RECIST v1.1 may continue to receive study treatment if the investigator believes the patient is receiving clinical benefit and the patient is willing to continue on study treatment. After discontinuation of study treatment, all patients will be followed for survival until death, lost to follow-up, withdrawal of consent, or end of study. ; DRUG USED: Tafinlar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Histologically- or cytologically-confirmed diagnosis of NSCLC stage IV (according to AJCC Staging 7th Edition) - Presence of a BRAF V600E mutation in lung cancer tissue. BRAF V600E mutation tested by local laboratory (e.g. study center laboratory, local laboratory company) with proper quality control and license to operation by local health authority is allowed. - Measurable disease according to RECIST v1.1. Exclusion Criteria: - Previous treatment with a BRAF inhibitor (including but not limited to dabrafenib, vemurafenib, encorafenib, and XL281/BMS-908662) or MEK inhibitor (including but not limited to trametinib, cobimetinib, binimetinib, AZD6244, and RDEA119) prior to start of study treatment - Patients with brain metastases are excluded if their brain metastases are: - Symptomatic OR - Treated (surgery, radiation therapy) but not clinically and radiographically stable 3 weeks after local therapy (as assessed by contrast enhanced magnetic resonance imaging [MRI] or computed tomography [CT]), OR - Asymptomatic and untreated but >1 cm in the longest dimension - History of malignancy with confirmed activating RAS mutation at any time. - History of interstitial lung disease or pneumonitis - A history or current evidence of retinal vein occlusion (RVO) - Current evidence of unstable aneurysm or one that needs treatment Other protocol-defined inclusion/exclusion may apply. ; PRIMARY OUTCOME: Overall Response Rate (ORR) by investigator assessment; SECONDARY OUTCOME 1: Duration of response (DOR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Male Volunteers; BRIEF: This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design. ; DRUG USED: BAY1834845; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: Interleukin-1 receptor-associated kinase 4 (IRAK4); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Healthy male subject - Age: 18 to 50 years (inclusive) at the first screening visit - Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m² Exclusion Criteria: - Clinically relevant findings in the physical examination - Relevant diseases within the last 4 weeks prior to the first study drug administration - Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal - Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration ; PRIMARY OUTCOME: Frequency of treatment-emergent adverse events (TEAEs); 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 - 205 (w/Tarceva); BRIEF: A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1 randomization scheme. ; DRUG USED: Linsitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: IGF-1R (Insulin-like Growth Factor-1 Receptor) ; THERAPY: Combination; LEAD SPONSOR: Astellas Pharma Inc; CRITERIA: Inclusion Criteria: - Histologically confirmed locally advanced or metastatic stage IIIB or IV NSCLC - Have experienced Complete Response (CR), Partial Response (PR) or Stable Disease (SD) following completion of 4 cycles of first-line platinum-based chemotherapy and are not progressing at time of entry into study (prior completed first-line combination bevacizumab therapy is permitted; however, current use of maintenance bevacizumab is not permitted. A maximum interval of 28 days between the last day of the treatment cycle and randomization - Patient has recovered from prior chemotherapy-related toxicity to ≤ grade 2 - EGFR mutation status must be confirmed for participation in the study. EGFR analysis can be performed either by central or local laboratory. If analysis is done locally, verifiable documentation confirming the EGFR mutation status must be submitted for review and approval by APGD prior to randomization. If no local result is available, formalin-fixed, paraffin-embedded archival tissue representative of the tumor or in the absence of archival tissue, a fresh tumor tissue sample of sufficient size to perform EGFR mutation analysis must be submitted centrally. Results of the central analysis must be available prior to randomization. Additionally, subjects should provide tissue blocks centrally for biomarker analysis whenever possible. Ideal tissue requirement: block with ≥5 mm2 tumor area sufficient to provide four 4-micron, and five 10-micron sections) - Measurable disease (for those patients with PR or SD after first-line platinum-based chemotherapy) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) - Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) 0 - 1 - Previous adjuvant or neo-adjuvant treatment is permitted - Must be able to take oral medication - Fasting glucose ≤ 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic antihyperglycemic therapy is permitted if the dose has been stable for ≥ 4 weeks at the time of randomization - Adequate hematopoietic, hepatic, and renal function defined as follows: - Neutrophil count ≥ 1.5 x 109/L - Platelet count ≥ 100 x 109/L - Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) - AST and ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if patient has documented liver metastases - Serum creatinine ≤ 1.5 x ULN - Potassium, magnesium and calcium within normal limits (supplementation and retesting is permitted) Female patient must be either: - Of non child bearing potential: - post-menopausal (defined as at least 1 year without any menses) prior to Screening, or - documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening) - Or, if of childbearing potential: - must have a negative urine pregnancy test at Screening, and - must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 30 days after final study drug administration - Female patient must not be breastfeeding at Screening or during the study period and for 30 days after final study drug administration - Female patient must not donate ova starting at Screening and throughout the study period and for 30 days after final study drug administration - Male patient and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 30 days after final study drug administration - Male patient must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration - Prior radiation therapy is permitted provided patients have recovered from acute toxic effects of radiotherapy prior to randomization. A minimum of 28 days must have elapsed between the end of radiotherapy and randomization - Prior surgery is permitted provided that the surgery was performed 21 days prior to randomization and adequate wound healing has occurred prior to randomization - Patients must provide written (signed) informed consent to participate in the study and for use of tumor tissues Exclusion Criteria: - Prior exposure to agents directed at the Human Epidermal Receptor (HER) axis (eg, erlotinib, gefitinib, cetuximab, and trastuzumab) - Malignancies other than NSCLC within past 3 years (exceptions if curatively treated: basal or squamous cell carcinoma of skin; locally advanced prostate cancer; ductal carcinoma in situ of breast; in situ cervical carcinoma; and superficial bladder cancer) - Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy - Prior insulin-like growth factor receptor (IGF-1R) - Prior investigational agent within 21 days prior to randomization - Concurrent use of maintenance bevacizumab - History of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohns disease, ulcerative colitis, etc) - History (within last 180 days) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea) - History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded - Mean QTcF interval > 450 msec based on independent central reviewer analysis of screening visit ECGs - Use of drugs that have a known risk of causing Torsades de Pointes (TdP) are prohibited within 14 days prior to randomization - Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded - Use of potent CYP3A4 inhibitor such as ketoconazole, clarithromycin, atazanavir, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), or voriconazole - Use of proton pump inhibitors such as omeprazole. Use of H2-receptor antagonists such as ranitidine are not excluded - History of cerebrovascular accident (CVA) within 180 days prior to randomization or that resulted in ongoing neurologic instability - Active infection, serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization), or serious chronic illness that would impair the ability of the patient to receive study drug - History of any psychiatric or neurologic condition that might impair the patients ability to understand or to comply with the requirements of the study or to provide informed consent - Pregnant or breast-feeding females - Symptomatic brain metastases that are not stable, require steroids, or that have required radiation and/or other related treatment (e.g., anti-epileptic medication) within 21 days prior to randomization - History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug - Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening or during the course of the study ; PRIMARY OUTCOME: The Progression Free Survival (PFS) of maintenance OSI-906 plus erlotinib, or placebo plus erlotinib in patients with nonprogression following four cycles of first-line platinum-based chemotherapy for advanced NSCLC in the overall population; SECONDARY OUTCOME 1: Overall survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - EB90; BRIEF: A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms. In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours after each sexual activity. The following hypotheses will be tested: Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual events. The number of satisfying sexual events will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone. Lybridos, as compared to placebo, will significantly increase sexual desire/arousal. Sexual desire/arousal will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone. Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase the number of satisfying sexual events and sexual desire/arousal. ; DRUG USED: Lybridos; DRUG CLASS: Non-NME; INDICATION: Female Sexual Arousal Disorder; TARGET: Androgen receptors, Serotonin 5-HT1A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Emotional Brain NY Inc.; CRITERIA: Inclusion Criteria: Subjects must meet all of the following criteria: 1. Provision of written informed consent 2. Females between 21 and 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained health care professional. 3. Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 5 for definition) 4. Be involved in a stable relationship and have a partner who will be accessible for the majority of the study duration 5. Healthy with normal medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Subjects who meet any of the following criteria are not eligible to participate in the study: Cardiovascular Conditions 1. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity 2. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. For subjects ≥ 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg 3. Systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 50 mmHg. Gynecological and Obstetric Conditions 4. Use of any contraceptive containing antiandrogens (e.g. Cyproteron acetate) or(anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel) 5. Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 μg/day of estrogen 6. Positive test result for Chlamydia or gonorrhea 7. Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women of child bearing potential prior to the administration of study medications.) 8. Lactating or delivery in the previous 6 months prior to signing Informed Consent Form 9. Significant abnormal Pap smear in the previous 12 months prior to signing Informed Consent Form 10. History of bilateral oophorectomy 11. Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns 12. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night sweating) in combination with elevated FSH levels (>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms) Other Medical Conditions 13. Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase > 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) < 60.00 mL/min based on the Cockcroft-Gault formula) 14. Any current endocrine disease or endocrinopathy (e.g. uncontrolled thyroid dysfunction) as determined by medical history, basic physical examination and/or laboratory values significantly outside normal range of the central laboratory; or uncontrolled diabetes mellitus (HbA1c > 7.5%) 15. Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory (free testosterone: > 1.1 ng/dL, and total testosterone > 80 ng/dL) 16. Any current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results or which exclude from use of buspirone and/or testosterone 17. History of hormone-dependent malignancy (including all types of breast cancer) 18. Vision impairment, such as partial or complete blindness or color blindness 19. Dyslexia 20. Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection) 21. History of serotonin syndrome Psychological/Psychiatric Factors 22. History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered 23. (Psychotherapeutic and/or pharmacological treatment for) a psychiatric disorder that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for buspirone and/or testosterone use 24. Current psychotherapeutic treatment for female sexual dysfunction 25. Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision (DSM-IV-TR)) 26. A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subjects ability to complete the study or precludes the subjects participation in the study (mild or moderate alcohol consumption is allowed but must be stopped 12 hours before the Stroop task). 27. A score of > 65 at the STAI-Y2 questionnaire 28. Positive test result for illicit drugs Concomitant Medications 29. Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole clarithromycin, erythromycin and saquinavir) 30. Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St Johns wort, rifampin) 31. Use of selective serotonin reuptake inhibitors, tricyclic antidepressants or other antidepressants 32. Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid],spironolactone) 33. Use of medication (including herbs) that would compromise the validity of study results 34. Use of testosterone therapy within 6 months before study entry prior to signing the Informed Consent Form General 35. Illiteracy, unwillingness, or inability to follow study procedures 36. Participation in other clinical trials within the last 30 days 37. Any other clinically significant abnormality or condition which, in the opinion of the investigator, might interfere with the participants ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for buspirone and/or testosterone use ; PRIMARY OUTCOME: Satisfactory Sexual Episodes; SECONDARY OUTCOME 1: Sexual satisfaction[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Branebrutinib; BRIEF: The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166 and of branebrutinib, each versus placebo, for the treatment of participants with moderate to severe atopic dermatitis. ; DRUG USED: BMS-986166; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: Sphingosine 1-Phosphate Receptor (S1P-R) ; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of Hanifins and Rajkas (E-HR) criteria at Screening - Disease duration of at least 24 months since diagnosis by any criteria - Documented history of inadequate control of AD by a stable regimen (≥ 4 weeks) of topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of randomization, or inappropriateness of therapy due to side effects or safety risks leading to prior discontinuation - Application of fixed doses of an additive-free, basic bland emollient twice-daily for ≥ 7 days before baseline visit and for the duration of the study Exclusion Criteria: - Any major illness/condition or evidence of an unstable clinical condition or local active infection/infectious illness that, in the investigators judgment, will substantially increase the risk to the participant if he or she participates in the study or interfere with the interpretation of study results - Clinically relevant cardiovascular conditions or pulmonary conditions - High likelihood - based on participant history, and investigator judgement - of requiring rescue therapy in < 4 weeks prior to randomization - Evidence of acute flare between the Screening and Baseline/ Randomization - Skin lesion(s) and/or pruritus due to conditions other than AD that would interfere with the study specified assessments Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Mean Percentage Change From Baseline in EASI Score at Week 16; SECONDARY OUTCOME 1: Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - FG-PRE-101 (Israel); BRIEF: A study to establish safety, tolerability, and efficacy of PresbiDrops (CSF-1) in presbyopic subjects. ; DRUG USED: CSF-1; DRUG CLASS: Non-NME; INDICATION: Refractive Errors (Ophthalmology); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Orasis Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria: 1. Men and women between 40 and 65 years of age (inclusive). 2. Subjects who provide written informed consent to participate in the study. 3. Subjects have signs of presbyopia upon ophthalmic examination. 4. Subjects have normal presbyopia with low distance refraction (sphere no greater than ±0.75 diopter cylinder no greater than ±0.75 diopter cylinder [DC], refraction along any principal meridian no greater than 1.00 diopter). 5. Subjects must have best corrected vision of 20/20 in both eyes, and currently depend on reading glasses or bifocals in which the near addition is > +1.00 diopter. 6. Subjects in general good health in the opinion of the Investigator as determined by medical history. 7. Women with childbearing potential must have a negative urine pregnancy test at Screening and be willing and able to use a medically acceptable method of birth control or they must be postmenopausal. Acceptable methods of birth control in this study include: Vasectomy, tubal ligation, consistent use of an approved oral contraceptive (birth control pill), intrauterine device (IUD), hormonal implants, contraceptive injection or a double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam). Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form. 8. Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study. Exclusion Criteria: 1. History of macular disease or any other ocular conditions or congenital malformation. 2. Any medical condition known to affect the structure of the uvea, cornea, lens, or retina or main function of the eyes. 3. No cataract or minimal nuclear sclerosis. 4. Severe dry eye. 5. Any topical ophthalmic medications, other than artificial tears (up to a maximum of 4 times per day) and medications that are associated with fluctuation of accommodative capacity and/or pupil size, unless on a stable dose for at least 3 months before the Screening visit. 6. Contact lenses for the past three months before the Screening visit. 7. A difference of more than 0.50 diopter between the manifest spherical equivalent and the wave front refraction spherical equivalent. 8. Pupil size less than 2,5 mm in either eye prior to dilation at ambient light of 8-15 lux prior to the Baseline visit. 9. A history of herpes (of any kind) in either eye. 10. Cataract surgery and/or refractive surgery in either eye. 11. Known contraindication, hypersensitivity, and/or allergy to any study drugs or excipients. 12. Any acute illness (eg, acute infection) within 48 hours of first study drug administration, which is considered of significance by the Investigator. 13. Participation in another clinical trial with drugs received within 30 days of Screening. 14. Pregnant or currently lactating women. ; PRIMARY OUTCOME: Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected near distance visual acuity; SECONDARY OUTCOME 1: Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected intermediate distance visual acuity[/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 - ENESTxtnd; BRIEF: This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase ; DRUG USED: Tasigna; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Myelogenous Leukemia (CML); TARGET: BCR-ABL Fusion Protein, KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: -Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry Exclusion Criteria: - Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide - Uncontrolled congestive heart failure or hypertension - Myocardial infarction or unstable angina pectoris within past 12 months - Known T315I mutations - QTcF >450 msec - Significant arrhythmias Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: The Percentage of Patients Achieving MMR by 12 Months; SECONDARY OUTCOME 1: Time to Molecular Response at 24 Months[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Subject; BRIEF: This phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult subjects. ; DRUG USED: CSL730; DRUG CLASS: Biologic; INDICATION: Autoimmune Disorders; TARGET: Fc receptors; THERAPY: Monotherapy; LEAD SPONSOR: CSL Behring; CRITERIA: Inclusion Criteria: - Healthy male or female adult subjects aged ≥ 18 to ≤ 55 years - Females must be either postmenopausal or sterile - Body weight between ≥ 50 and ≤ 110 kg and body mass index between ≥ 18.0 kg/m2 and ≤ 30 kg/m2 Exclusion Criteria: - History or current evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis, or history of liver disease, drug reaction, or aminotransaminase elevations, if known); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic (including history of migraine); psychiatric; immunologic; dermatologic; oncologic (subjects with resected cervical or skin cancer [except melanoma] who have had no evidence of disease in the last 5 years are eligible), that precludes designation of healthy subjects as judged by the Investigator - History or evidence of congenital or acquired immunosuppressive condition(s), including positive serology for human immunodeficiency virus infection or taking immunosuppressive agents. - Evidence of active or latent tuberculosis - Hospitalization within 3 months before IP administration or planned hospitalization at any time during the study. - History of any drug allergy, hypersensitivity (excluding hay fever) or intolerance to latex or any drug product - A positive test result for drugs of abuse. - Smokers within 3 months before Screening. ; PRIMARY OUTCOME: Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity; SECONDARY OUTCOME 1: Maximum concentration (Cmax) for CSL730 in serum samples[/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 - Or BMS-986142 (Moderate to Severe); BRIEF: The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögrens syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm. ; DRUG USED: BMS-931699; DRUG CLASS: Biologic; INDICATION: Sjogrens Syndrome; TARGET: Cluster of Differentiation 28 (CD28) /ICOS and B7RP-1 Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects diagnosed or classified as having moderate to severe primary Sjögrens Syndrome based on the 2016 ACR-EULAR Sjögrens Syndrome Classification Criteria for at least 16 weeks prior to screening - ESSDAI ≥ 5 including disease activity (any score > 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy - Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody - Unstimulated whole saliva secretion > 0.01 ml/min - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted Exclusion Criteria: - Secondary Sjögrens syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis, vasculitis) - Very severe primary Sjögrens syndrome or severe complications of primary Sjögrens syndrome at the time of the screening visit - Active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection - Any significant concurrent medical condition at the time of screening or baseline visit - Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit - Previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit - Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit - Oral corticosteroids > 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: Mean Change From Baseline in ESSDAI; SECONDARY OUTCOME 1: Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers; BRIEF: The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug. ; DRUG USED: Egalet-004; DRUG CLASS: Non-NME; INDICATION: Chronic Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Egalet Ltd; CRITERIA: Inclusion Criteria: - Non-smokers - ≥18 and ≤55 years of age - BMI ≥19 and ≤30.0 Exclusion Criteria: - Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment - History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening - Allergic to hydrocodone, hydromorphone, other opioids, or related drugs - Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration - Pregnant or breast-feeding ; PRIMARY OUTCOME: To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24; SECONDARY OUTCOME 1: To evaluate safety and tolerability of Egalet® hydrocodone formulations. Hematology, biochemistry, urinalysis, ECG, vital signs (including pulse oximetry), and adverse events monitoring.[/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 - SUMMIT (HFpEF); BRIEF: The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity. ; DRUG USED: Tirzepatide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Preserved Ejection Fraction (Chronic HFpEF); TARGET: GIP Receptor (GIPR)/Glucose-Dependent Insulinotropic Polypeptide Receptor, GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50% - Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure - Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening, - Stable dose of heart failure medications within 4 weeks of screening - Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²) - 6MWD 100-425m - KCCQ CSS ≤80 Exclusion Criteria: - Have had a major cardiovascular event within the last 90 days of screening - Have had acute decompensated heart failure within 4 weeks of screening - Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions - Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular hear disease - HbA1c ≥9.5% or uncontrolled diabetes - History of proliferative diabetic retinopathy or diabetic maculopathy - Have a history of pancreatitis - eGFR <15 mL/min/1.73 m² or requiring dialysis at screening ; PRIMARY OUTCOME: A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category; SECONDARY OUTCOME 1: Percent Change from Baseline in Body Weight Loss[/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 209 - vs. Ixabepilone; BRIEF: The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading. ; DRUG USED: Halaven; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion criteria: 1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease. Exclusion criteria: 1. Subjects who have received prior ixabepilone therapy. 2. Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment. 3. Subjects with pre-existing neuropathy Grade greater than or equal to 2. 4. Subjects with a history of diabetes mellitus Type 1 or 2. 5. Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection. 6. Subjects with missing digits required for vibration assessment. 7. Subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy. ; PRIMARY OUTCOME: Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs); SECONDARY OUTCOME 1: Percentage of Participants With an Incidence of Treatment-emergent Myalgia/Arthralgia[/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/Cabozantinib; BRIEF: This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily. ; DRUG USED: Welireg; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: Hypoxia Inducible Factor-2 Alpha (HIF-2a); THERAPY: Combination; LEAD SPONSOR: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Inclusion Criteria: - Has locally advanced or metastatic RCC with predominantly clear cell subtype - Has at least one measurable lesion as defined by RECIST version 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Has adequate organ function defined as follows: - Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening; - Serum creatinine level ≤ 2.0 × upper limit of normal (ULN) - Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilberts disease *Cohort 1: Participants must not have received prior systemic therapy for advanced or metastatic ccRCC - Cohort 2: Participants must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccRCC Exclusion Criteria: - Has received prior treatment with belzutifan or other HIF2α inhibitors - Has received prior treatment with cabozantinib - Has had radiation therapy for bone metastases within two weeks of starting study drug - Has a history of untreated brain metastases or history of leptomeningeal disease or spinal cord compression - Has failed to recover from the reversible effects of prior anticancer therapy - Has uncontrolled or poorly controlled hypertension - Is receiving anticoagulant therapy - Has had any major cardiovascular event within 6 months prior to study drug administration - Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results - Has had major surgery within 3 months before first study drug administration - Has an active infection requiring systemic treatment - Is participating in another therapeutic clinical trial ; PRIMARY OUTCOME: Overall Response Rate (ORR); 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 IIa - EVIDENCES VIII (Liver Transplant Recipients); BRIEF: This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD. ; DRUG USED: Lipaglyn; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: PPAR alpha, PPAR gamma; THERAPY: Monotherapy; LEAD SPONSOR: Zydus Therapeutics Inc.; CRITERIA: Inclusion Criteria: - Able and willing to give written informed consent. - Males or females, 18 to 75 years of age. - Patients who are at least 6 months post-transplant for nonalcoholic steatohepatitis (NASH) or cryptogenic cirrhosis thought to be secondary to NASH are eligible for enrolment. - The presence of NAFLD determined by MRI-PDFF prior to enrollment. - Patients with ≤20% variance in the levels of ALT, AST, ALP and total bilirubin between Visit 1 and Visit 1.1. - History of medical compliance with immunosuppression. - Female subjects of non-child bearing potential or on highly effective contraception. For male subjects with female partners of childbearing potential, willing to follow highly effective contraception measures during the study, either by the male participant or his female partner or both. Exclusion Criteria: - Pregnant or lactating females. - Patient with abnormal transaminases due to secondary intercurrent illness. - Patients with bile duct strictures. - Other causes of chronic liver disease after liver transplantation including autoimmune, viral, and alcoholic liver disease. - Graft cirrhosis as defined by: 1. Cirrhosis on historical liver biopsy. 2. Evidence of cirrhosis on imaging including portal venous collaterals. 3. Prior history of decompensated liver disease including ascites, hepatic encephalopathy or variceal bleeding. 4. Evidence of esophageal varices on prior endoscopy. - Body mass index (BMI) <18 kg/m². - Subjects with change in body weight >5% in the 3 months prior to enrollment. - Subjects requiring corticosteroid or anticoagulation therapy. - History of myopathies or evidence of active muscle diseases. - Unstable cardiovascular disease. - History of bladder disease and/or hematuria or has current hematuria unless due to a urinary tract infection. - Active malignancy post-liver transplantation. - History of malignancy in the past 5 years and/or active neoplasm. - History of chronic rejection of liver transplant graft. - Acute cellular rejection of liver transplant graft within the past 6 months. - Evidence of Acute cellular rejection (ACR) or chronic rejection (CR) or alternative etiologies to NAFLD. - Poorly controlled diabetes as defined by an HbA1c >8.5% within the past 6 months. - History of excessive alcohol intake. - Subject tests positive for a urine drug screen. - Subject has a history of chronic (uncontrolled) pain. ; PRIMARY OUTCOME: Number of participants with adverse events assessed by CTCAE; SECONDARY OUTCOME 1: Hepatic fat[/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 - FLU-MI7A-201; BRIEF: This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years. Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose. ; DRUG USED: H7N9 VLP Influenza Vaccine; DRUG CLASS: Vaccine; INDICATION: Pandemic Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: Novavax; CRITERIA: Inclusion Criteria: 1. Healthy adult male or female, 18 to 64 years of age, 2. Willing and able to give informed consent prior to study enrollment, 3. Able to comply with study requirements, and 4. Women of child-bearing potential must have a negative urine pregnancy test prior to each vaccination, and will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility, or ≥50 years of age and without menses for ≥1 year are exempt from urine pregnancy testing. Exclusion Criteria: Subjects will be excluded if they meet any of the following criteria: 1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. - Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the Investigator. - Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. - Note that illnesses or conditions may be exclusionary, even if otherwise stable and clinically minor, due to therapies used to treat them (see exclusion criteria 3, 5, 8, 9). 2. Any grade 1 or higher (as based on the Toxicity Grading Scale [TGS]) abnormality in ALT, AST, alkaline phosphatase, total bilirubin, blood urea nitrogen, or creatinine levels. 3. Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 2 above. Note that any abnormal vital sign may be repeated at the Investigators discretion. 4. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination. 5. History of a serious reaction to prior influenza vaccination. 6. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine. 7. Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time. 8. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination. 9. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. 10. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 11. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration). 12. Known disturbance of coagulation. 13. Women who are pregnant or breastfeeding, or plan to become pregnant during the study. 14. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse. ; PRIMARY OUTCOME: Assessment of Safety; SECONDARY OUTCOME 1: Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9.[/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 - I6X-MC-JBDA; BRIEF: The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body. ; DRUG USED: LY3009120; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cancer; TARGET: Raf kinase; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Advanced or metastatic cancer - Other available therapies have failed to cure the cancer - The cancer that has no proven effective therapy - The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) - Able to swallow capsules Exclusion Criteria: - Have active cancer in the brain or spinal cord - Have an active infection of any kind (fungal, viral, or bacterial) - Have a cancer of the blood - Are pregnant or breastfeeding - Have some types of eye problems or impairments ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) of LY3009120; SECONDARY OUTCOME 1: Number of Participants With Tumor Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DETECT; BRIEF: This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children. The stimulation test will use a new growth hormone stimulating substance called macimorelin. By now, only adults in the USA can get this new stimulation test. The results of this study are expected to help children and teenagers with suspected GHD to get the macimorelin stimulation test. The macimorelin test will be compared to a clonidine and an arginine test. Both are known standard stimulation tests. Altogether two macimorelin tests are planned to be performed in the study, to show how repeatable macimorelin tests results are (under a set of similar conditions). ; DRUG USED: Macrilen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Ghrelin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: AEterna Zentaris; CRITERIA: Inclusion Criteria: 1. Informed consent of subject, parent(s) or legally acceptable representative (LAR) of subject and child assent, if appropriate, must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Male and female pediatric subjects from 2 to less than 18 years of age at the time of signing informed consent. 3. Indication for the performance of growth hormone stimulation test. 4. Presence of a height measurement minimum 6 and maximum 18 months prior to screening. Exclusion Criteria: 1. Established diagnosis of a disease that is sufficient to explain growth deficiency or metabolic disorders that are also associated with short stature (e.g., Turner syndrome, skeletal dysplasias, celiac disease, etc.). 2. Ongoing growth hormone therapy. 3. Presence of hypothyroidism and/or adrenal insufficiency without adequate and stable replacement therapy treatment for at least 30 days prior to first GHST. 4. Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g., somatostatin analogues, clonidine, levodopa and dopamine agonists) or provoking the release of somatostatin (antimuscarinic agents e.g., atropine). 5. Medical history of ongoing clinically symptomatic psychiatric disorders. 6. 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds, prolongation of the QTc interval over 450 milliseconds, or any other clinically significant abnormal electrocardiogram results at the V2 pre-dose electrocardiogram (ECG) as judged by the investigator. 7. Previous participation in this trial. Participation is defined as signed informed consent. 8. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. 9. Known or suspected hypersensitivity to trial product(s) or related products; 10. Any disorder, which in the investigators opinion might jeopardize subjects safety or compliance with the protocol. 11. Concomitant treatment with any drugs that might prolong QT/QTc Note: A subject who receives such treatment will not be a candidate for this study, if his/her condition does not allow for a treatment-free period of at least 5 elimination half-lives of the drug that might prolong QT/QTc before the GHST; 12. Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage (aspartate amino transferase (AST), alkaline phosphatase (ALT), gamma-glutamyl transferase (GGT) > 2.5 x upper limit of normal (ULN); creatinine or bilirubin > 1.5x ULN); 13. Current active malignancy other than non-melanoma skin cancer; 14. Female of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). 15. Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). 16. Lack of ability or willingness to give informed consent by the subject and/or his/her legal representative; 17. Anticipated non-availability for trial visits/procedures. ; PRIMARY OUTCOME: Area under the Receiver Operator Characteristic curve (ROC AUC) based on GH concentration during GHST following macimorelin administration; SECONDARY OUTCOME 1: Sensitivity for the macimorelin GHST[/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 - R668-AD-1307; BRIEF: The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD). ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female, 18 years or older; 2. Chronic AD that had been present for at least 3 years before the screening visit; 3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable; 4. Willing and able to comply with all clinic visits and study-related procedures. Exclusion Criteria: 1. Prior participation in a Dupilumab clinical trial; 2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit; 3. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment: - Systemic corticosteroids; - Immunosuppressive/immunomodulating drugs; - Phototherapy for AD; 4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit; 5. Treatment with certain biologics; 6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit; 7. Planned major surgical procedure during the participants participation in this study; 8. Participant was a member of the investigational team or his/her immediate family; 9. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 10. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study; Note: The information listed above is not intended to contain all considerations relevant to a participants potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed. ; PRIMARY OUTCOME: Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16; SECONDARY OUTCOME 1: Percentage of Participants With Investigators Global Assessment (IGA) Score of 0 or 1 at Week 16[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - w/Febuxostat; BRIEF: This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout. ; DRUG USED: RDEA3170; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gout; TARGET: URAT1 (urate trans-porter 1, SLC22A12/Solute carrier family 22, member 12); THERAPY: Combination; LEAD SPONSOR: Ardea Biosciences, Inc.; CRITERIA: Inclusion Criteria: - Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity. - Meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout. - Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2. - Screening serum urate level ≥ 8 mg/dL. - Free of any clinically significant disease or medical condition, per the Investigators judgment. Exclusion Criteria: - Unable to take colchicine for gout flare prophylaxis. - History or suspicion of kidney stones. - Any gastrointestinal disorder that affects motility and/or absorption. - Unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants. - Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator. - Estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period. - Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing. - Unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study. ; PRIMARY OUTCOME: Serum Urate Maximum Percentage (%) Change (Emax, CB); SECONDARY OUTCOME 1: Maximum Observed Plasma Concentration (Cmax)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - DYVINIA (Vulvodynia); BRIEF: This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia. The study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2). Both Stage 1 and Stage 2 will consist of a double-blind period (with treatment cycle 1; Dysport or placebo) followed by an open label treatment period. One or two optimally safe and effective doses of Dysport selected from Stage 1 will be further investigated in the Stage 2. ; DRUG USED: Dysport; DRUG CLASS: Biologic; INDICATION: Neuropathic Pain; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Ipsen; CRITERIA: Inclusion Criteria: - Premenopausal - Have vulvodynia for at least 6 months and for no more than 15 years - Have provoked pain at the vestibule on a Q tip test Exclusion Criteria: - Deep pain during intercourse - Have genitourinary or gastrointestinal conditions which may interfere with the study - Previous surgery that according to investigators judgement may impact on study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1); SECONDARY OUTCOME 1: Mean Change From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point Numeric Rating Scale (NRS) During the DB Treatment Period at Week 6 and Week 12 (Stage 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 - ADNC-0726; BRIEF: This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation. ; DRUG USED: LFB-R593; DRUG CLASS: Biologic; INDICATION: Hemolytic Disease of the Newborn (HDN); TARGET: Rh Factor; THERAPY: Monotherapy; LEAD SPONSOR: Laboratoire français de Fractionnement et de Biotechnologies; CRITERIA: Inclusion Criteria: - Healthy RhD-negative volunteers - Males and definitively sterile females - No prior sensitization to RhD antigen Exclusion Criteria: - Healthy RhD-positive volunteers ; PRIMARY OUTCOME: Clearance of RhD-positive red blood cells; 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 - 0118 (w/Obinutuzumab); BRIEF: The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated. ; DRUG USED: Zydelig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: p110 delta/PIK3CD, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Not a candidate for fludarabine therapy based on either: 1. creatinine clearance < 70 mL/min, or 2. Cumulative Illness Rating Scale score > 6, by assessment of the investigator - Diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) - No prior therapy for CLL other than corticosteroids for disease complications. - CLL that warrants treatment - Presence of measurable lymphadenopathy - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion Criteria: - Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation) - Known presence of myelodysplastic syndrome - Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization - Ongoing liver injury - Ongoing drug-induced pneumonitis - Ongoing inflammatory bowel disease - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation - Ongoing immunosuppressive therapy other than corticosteroids - Concurrent participation in another therapeutic clinical trial - Undergone major surgery within 30 days prior to randomization - Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idelalisib, obinutuzumab, or chlorambucil - History of non-infectious pneumonitis - Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Progression-Free Survival; SECONDARY OUTCOME 1: Overall Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - TRANSCEND; BRIEF: This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patients body and how well JCAR017 works in treating patients with non-Hodgkins lymphoma whose disease has come back or has not responded to treatment. ; DRUG USED: Breyanzi; DRUG CLASS: Biologic; INDICATION: Non-Hodgkins Lymphoma (NHL); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Juno Therapeutics, a Subsidiary of Celgene; CRITERIA: Inclusion Criteria: 1. Age ≥18 years 2. Relapsed or refractory B-cell NHL, including 1. DLBCL cohort (no longer enrolling): DLBCL, not otherwise specified (NOS; includes transformed DLBCL from indolent histology [tDLBCL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (Swerdlow 2016), primary mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 lines of systemic therapy or after auto-HSCT. 2. MCL cohort: MCL (diagnosis must be confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization [FISH], or PCR) with relapsed or refractory disease after at least 2 prior lines of systemic MCL therapy. Subjects must have been treated with an alkylating agent, Brutons tyrosine kinase inhibitor (BTKi), and rituximab (or other CD20-targeted agent). 3. PET-positive disease by Lugano classification 4. Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function 7. Adequate vascular access for leukapheresis procedure 8. Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy. 9. Participants must agree to use appropriate contraception. Exclusion Criteria: 1. Active central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study) 2. History of other primary malignancy not in remission for at least 2 years (The following are exempt from the 2-year limit: nonmelanoma skin cancer, definitively treated stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear) 3. Treatment with alemtuzumab within 6 months of leukapheresis or fludarabine or cladribine within 3 months of leukapheresis 4. Active hepatitis B, hepatitis C, or Subjects with a history of or active human immunodeficiency virus (HIV) infectionare excluded. Subjects with active hepatitis B, or active hepatitis C are also excluded. Subjects with a negative PCR assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy 5. Uncontrolled systemic fungal, bacterial, viral, or other infection 6. Presence of graft-vs-host disease (GVHD) 7. History of cardiovascular disease 8. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, or psychosis 9. Pregnant or nursing women 10. Use of the following: - Therapeutic doses of corticosteroids (defined as >20 mg/day prednisone or equivalent) within 7 days of leukapheresis or 72 hours prior to JCAR017 administration. Physiologic replacement, topical, and inhaled steroids are permitted. - Low dose chemotherapy (e.g., vincristine, rituximab, cyclophosphamide ≤300 mg/m2) given after leukapheresis to maintain disease control must be stopped ≥7 days prior to lymphodepleting chemotherapy. - Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis. - Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosfamide, bendamustine) within 2 weeks of leukapheresis. - Experimental agents within 4 weeks of leukapheresis unless no response or disease progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis - Immunosuppressive therapies within 4 weeks of leukapheresis and JCAR017 administration (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolyate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti IL6, or anti-IL6R) - Donor lymphocyte infusions (DLI) within 6 weeks of JCAR017 administration - Radiation within 6 weeks of leukapheresis. Subjects must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. Radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks prior to leukapheresis. - Allo-HSCT within 90 days of leukapheresis 11. Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JCAR017 treatment in this protocol for subjects receiving retreatment 12. Progressive vascular tumor invasion, thrombosis, or embolism 13. Venous thrombosis or embolism not managed on a stable regimen of anticoagulation ; PRIMARY OUTCOME: Treatment-related adverse events (AEs) as assessed by CTCAE v4.03; SECONDARY OUTCOME 1: Complete response (CR) rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PRONTO-T2D; BRIEF: The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D). ; DRUG USED: Lyumjev; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening. - Have been treated for at least 90 days prior to screening with: - Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or - Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily - Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations: - Metformin - Dipeptidyl peptidase-4 (DPP-4) inhibitor - Sodium glucose cotransporter 2 (SGLT2) inhibitor - Sulfonylurea - Meglitinide - Alpha-glucoside inhibitor - Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening. - Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening. Exclusion Criteria: - Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults. - Have hypoglycemia unawareness as judged by the investigator. - Have had any episode of severe hypoglycemia within the 6 months prior to screening. - Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening. - Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening. ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26; SECONDARY OUTCOME 1: 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand[/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 - 01-IIIA; BRIEF: The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer. ; DRUG USED: Vicineum (Intratumoral); DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Epithelial cell surface antigen (Ep-CAM)/ CD326, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Sesen Bio, Inc.; CRITERIA: Inclusion Criteria: Disease Characteristics - The patient must be 18 years of age or older. - The patient must have squamous cell carcinoma of the head and neck. - The squamous cell carcinoma must be Ep-CAM positive. - ECOG performance status of 0, 1, 2 or 3. - 12 week life expectancy Prior/Concurrent Therapy - The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy). - The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour. - The patients disease must be refractory. - There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug. Patient Characteristics - The patient must have adequate hepatic function [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN]. - The patient must have adequate renal function (serum creatinine < 1.5 × ULN). - The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin >8 g/dL. - The patient must have prothrombin time and partial thromboplastin time within normal limits. Other • Women of childbearing potential and male patients must agree to use a highly effective contraceptive method. Exclusion Criteria: - The patient has clinically significant distant metastases. - The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy. - The patient has a nasopharyngeal tumour. - The patient has AIDS, hepatitis C or hepatitis B. - The patient has clinically significant renal or hepatic disease. - Tumors are prone to bleeding. - The patient is pregnant or lactating. - The patient requires blood thinning medications and can not safely discontinue the medication. - The patient is currently enrolled in another clinical trial. ; PRIMARY OUTCOME: Survival; SECONDARY OUTCOME 1: Tumour response, safety and quality of life[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb - CAPTIVATE ; BRIEF: The purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS). ; DRUG USED: Olorinab; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pain Indications; TARGET: Cannabinoid-2 (CB2) receptor; THERAPY: Monotherapy; LEAD SPONSOR: Arena Pharmaceuticals; CRITERIA: Main Study Inclusion Criteria: - Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or predominant diarrhea (IBS-D) according to Rome IV criteria at Visit 1 (Screening) - Per the Rome IV diagnostic algorithm for IBS, participants 50 years of age and over are to have had one of the following with a result that rules out causes of abdominal pain other than IBS: 1. Colonoscopy (within 10 years of Visit 1 [Screening]) 2. Flexible sigmoidoscopy and double contrast barium enema (within 5 years of Visit 1 [Screening]) 3. Computed tomography colonography (within 5 years of Visit 1 [Screening]) Main Study Exclusion Criteria: - Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U) - Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical judgment of the Investigator (or designee) - Any colonic or major abdominal surgery (eg, bariatric surgery [including gastric banding], stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). History of cholecystectomy is exclusionary for participants with IBS-D. For participants with IBS-C, a history of cholecystectomy more than 6 months prior to Visit 1 (Screening) is allowed. Procedures such as appendectomy, hysterectomy, caesarean section, or polypectomy are allowed as long as they have occurred at least 3 months prior to Visit 1 (Screening). Long-Term Extension Inclusion Criteria: •All participants must have completed the Main Study (including both Visit 8 [Week 12] and Visit 9 [Week 14]) Long-Term Extension Exclusion Criteria: - Participant meets any exclusion criteria from the Main Study at the time of assessing eligibility for the LTE, unless approved by the Sponsor in advance. - Participant had less than 75% overall compliance with eDiary entries during the Main Study. - Participant deviated from the prescribed dosage regimen during the Main Study (ie, overall study treatment compliance less than 85% or more than 115%), unless approved by the Sponsor in advance. ; PRIMARY OUTCOME: Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12; SECONDARY OUTCOME 1: Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12[/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 - Relapsed MB; BRIEF: This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB. ; DRUG USED: Odomzo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Hedgehog Signaling Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients with histologically confirmed diagnosis of MB, who have experienced relapse or progression after standard-of-care therapy including radiotherapy. Patients currently receiving steroids must have been on a stable (or decreasing) dose for at least 5 days before initiating study therapy. - Only patients with a test result, using the 5-gene Hh signature assay, indicating Hhpathway activated MB are eligible for this study. All available tumor material obtained at any time during the course of the patients disease should be submitted for these analyses - At least one measurable lesion defined as lesion(s) that can be accurately measured in at least two dimensions and is ≥ 10 mm in each dimension by Gadolinium (Gd)-MRI, irrespective of slice thickness/reconstruction interval, for CNS lesions and CT or MRI (with or without contrast) for non-CNS lesions. All patients with CNS lesions must have a brain MRI with and without gadolinium and a spine MRI with gadolinium within 2 weeks prior to first dose of study treatment. - Performance Status corresponding to ECOG score of 0, 1, or 2: 1. Karnofsky performance status score ≥ 50 for patients >16 years of age 2. Lansky performance status score ≥ 50 for patients ≤ 16 years of age - Adequate bone marrow function as defined as: 1. Peripheral absolute neutrophil count (ANC) ≥ 1.5 x 109/L 2. Platelet count ≥ 80 x 109/L 3. Hemoglobin (Hgb) ≥ 9 g/dL - Serum CK ≤1.5 ULN Exclusion Criteria: - Prior treatment with a Smoothened inhibitor Systemic anticancer treatment within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies). - Focal radiation therapy within 4 weeks before first dose of study treatment, or full spinal radiotherapy within 3 months before first dose of study treatment. - Patients who have neuromuscular disorders that are associated with elevated CK (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). - Patients receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 or are metabolized by CYP2B6 and CYP2C9, that have narrow therapeutic indices that cannot be discontinued at least 2 weeks before first dose of study treatment and for the duration of the study - Patients receiving unstable or increasing doses of corticosteroids. If patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms, dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment. ; PRIMARY OUTCOME: Percentage of Participants With Overall Response Rate (ORR) According to Independent Review Committee (IRC) From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016; SECONDARY OUTCOME 1: Progression Free Survival (PFS) According to IRC From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016[/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 - BE ACTIVE; BRIEF: This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis. ; DRUG USED: Bimekizumab; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: UCB Biopharma S.P.R.L.; CRITERIA: Inclusion Criteria: - Subject has a documented diagnosis of adult-onset PsA classified by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must have at Baseline tender joint count (TJC) >=3 out of 78 and swollen joint count (SJC) >=3 out of 76 - Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative - Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis - Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline - Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit - Subjects taking methotrexate (MTX) (<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization - Subjects taking leflunomide (LEF; <=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16 - Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have: 1. experienced an inadequate response to previous treatment given for at least 3 months 2. been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation) 3. lost access to TNF inhibitor for other reasons Exclusion Criteria: - Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1 - Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit - Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis - Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline - Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection - Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis - Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included: 1. <= 3 excised or ablated basal cell carcinomas of the skin 2. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening 3. Actinic keratosis (-es) 4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening ; PRIMARY OUTCOME: ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12; SECONDARY OUTCOME 1: ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - (Advanced Cancer); BRIEF: The objective of this study is to determine a recommended Phase 2 dose range of LY2875358 that may be safely administered to participants with advanced cancer. In Part A and Part A2 of this study, escalating doses of LY2875358 as monotherapy and in combination with erlotinib will be evaluated for safety and tolerability, respectively. Part B is a dose-confirmation segment for LY2875358 therapy in 5 different types of cancer: nonsquamous non-small cell lung cancer (NSCLC), castrate resistant prostate cancer (CRPC) with bone metastases, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), or uveal melanoma with liver metastases, and for LY2875358 in combination with trametinib in participants with uveal melanoma with liver metastases. ; DRUG USED: Emibetuzumab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Part A: Have histological or cytological evidence of cancer (solid tumor, lymphoma, or multiple myeloma) that is advanced and/or metastatic and an appropriate candidate for experimental therapy - Part A2: Histologic or cytologic diagnosis of advanced Non Small Cell Lung Cancer (NSCLC), Stage IIIB with malignant pleural effusion or Stage IV, completed at least 1 prior systemic regimen, and eligible for erlotinib therapy. - Part B: Candidate for experimental therapy after standard therapies used or non-eligible for standard therapies. Histological or cytological evidence of 1 of the 5 tumor types: - Castrate-resistant prostate cancer (CRPC) with bone metastasis: --Progressive Disease in the setting of castrate level of testosterone - Renal Cell Carcinoma (RCC): --Histologic diagnosis of either clear-cell or papillary RCC (metastatic and unresectable, or bilateral, multifocal, unresectable RCC localized to kidneys). - NSCLC: --Histologic or cytologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV - Hepatocellular Carcinoma (HCC) --Histologic or cytologic diagnosis of hepatocellular carcinoma - Uveal Melanoma with liver metastasis - Part A: Have the presence of measurable or nonmeasurable disease as defined by the RECIST v1.1 (Eisenhauer et al. 2009) or Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) or have measureable disease for multiple myeloma. - Part A2 & B (RCC, NSCLC, HCC, and uveal melanoma): Have measurable disease as defined by RECIST v1.1. - Give written informed consent prior to any study-specific procedures. - Adequate organ function. - Performance status of less than or equal to 2 on ECOG scale. - Discontinued all previous cancer therapies, and any agents that have not received regulatory approval, for at least 21 days and recovered from the acute effects of therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days. - Reliable and available for the duration of the study and willing to follow study procedures. - Males and females (reproductive potential): Use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug. - Females (childbearing potential): Have had a negative serum pregnancy test before the first dose of study drug and not be breast-feeding. - Estimated life expectancy that will permit the participants to complete 8 weeks of treatment. Exclusion Criteria: - Serious preexisting medical conditions - Symptomatic central nervous system malignancy or metastasis (screening not required). - Acute or chronic leukemia. - Active infection including HIV, hepatitis A, B or C - Have second primary malignancy that may affect the interpretation of results. - Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C. - Patients with active alcohol abuse, as determined by the treating investigator. - Part A2: Unable to swallow tablets. Intolerant of therapy with erlotinib. Concomitant treatment with the cytochrome P450 3A (CYP3A) modulators. Must not have received treatment with any of these modulators within 14 days of study treatment. - Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction 6 months prior to study drug - QTc greater than 470 msec. - Received previous treatment with any c-MET experimental therapeutic. - Part B Expansion Cohort 1 (CRPC): 1. Increasing use of daily doses of opioid analgesics within 28 days prior to enrollment in the study. 2. Neuroendocrine prostate cancer. 3. Patients who have a solitary bone metastasis that has been irradiated are not eligible. - Part B Expansion Cohort 6 (LY2875358 plus trametinib in participants with uveal melanoma with liver metastasis): Contra-indications for trametinib ; PRIMARY OUTCOME: Recommended Phase 2 dose range of LY2875358 monotherapy and in combination with erlotinib; SECONDARY OUTCOME 1: Pharmacokinetics: Maximum plasma concentration (Cmax)[/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 - MAD/SAD; BRIEF: The primary purpose of this study is to determine the safety and tolerability of SLN124 for the treatment of non-transfusion-dependent (NTD) β-thalassaemia and low risk myelodysplastic syndrome. ; DRUG USED: SLN124; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thalassemia; TARGET: Transmembrane protease, serine 6 (Tmprss6); THERAPY: Monotherapy; LEAD SPONSOR: Silence Therapeutics plc; CRITERIA: Inclusion Criteria: - Age ≥ 18yrs; BMI 18-35 kg/m2 - β-thalassaemia intermedia or compound heterozygous HbE/β-thalassaemia - Non-transfusion dependent: ≤ 5 units red cells in last 6 months and transfusion-free for ≥8 weeks - Hb between 5 & 11 g/dL - Ferritin > 250 µg/L and /or liver iron ≥ 3mg Fe/g dry weight and TSAT >40% Exclusion Criteria: - Haemoglobin S/β-thalassaemia, homozygous β-0 thalassaemia or α thalassaemia - ALT/AST > 1.5 x upper limit normal or cirrhosis - eGFR < 60 mL/min/1.73m2 - Platelets <100 or > 1000 x 109/L - Untreated B12/folate deficiency - Iron chelation therapy unless stable for ≥8 weeks - Daily NSAID, therapeutic dose anticoagulant, ESA ≤12 weeks or stable dosing of hydroxyurea ≤ 6 months - Significant cardiac disease (MI in 6 months, NYHA class III-IV heart failure, long QT) - HIV or active hepatitis B/C or malignancy within 5 year ; PRIMARY OUTCOME: # of participants with all AEs as assessed by CTCAE V4.0 included injection site reaction, will be measured from baseline to post dose follow up; SECONDARY OUTCOME 1: Biomarkers will be measured from baseline to post dose follow up[/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 - RESPONSE 2; BRIEF: This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polycythemia Vera (PV); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, Non-palpable spleen, Phlebotomy dependent, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2. Exclusion Criteria: Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, excluding specific skin cancers, Previously received treatment with a JAK inhibitor, Being treated with any investigational agent, Women who are pregnant or nursing. Other inclusion/exclusion criteria apply. ; PRIMARY OUTCOME: Number of Participants Achieving Hematocrit (Hct) Control at Week 28; SECONDARY OUTCOME 1: Number of Participants Achieving a Complete Hematological Remission at Week 28[/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 - ELEVATE-RR (vs. Ibrutinib); BRIEF: This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia. ; DRUG USED: Calquence; 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: Acerta Pharma BV; CRITERIA: Inclusion Criteria: - Men and women ≥ 18 years of age. - ECOG performance status of 0 to 2. - Diagnosis of CLL. - Must have ≥ 1 of the following high-risk prognostic factors: - Presence of 17p del by central laboratory. - Presence of 11q del by central laboratory. - Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment - Must have received ≥ 1 prior therapies for CLL. - Meet the following laboratory parameters: - Absolute neutrophil count (ANC) ≥ 750 cells/μL or ≥ 500 cells/μL in participants with documented bone marrow involvement, and independent of growth factor support 7 days before assessment. - Platelet count ≥ 30,000 cells/μL without transfusion support 7 days before assessment. Participants with transfusion-dependent thrombocytopenia are excluded. - Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN). - Total bilirubin ≤ 1.5 x ULN. - Estimated creatinine clearance ≥ 30 mL/min. Exclusion Criteria: - Known CNS lymphoma or leukemia. - Known prolymphocytic leukemia or history of, or currently suspected, Richters syndrome. - Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. - Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor or a B-cell lymphoma-2 (BCL-2) inhibitor. - Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug. - Prior radio- or toxin-conjugated antibody therapy. - Prior allogeneic stem cell or autologous transplant. - Major surgery within 4 weeks before first dose of study drug. - Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence. - Significant cardiovascular disease within 6 months of screening. - Known history of infection with human immunodeficiency virus (HIV). - History of stroke or intracranial hemorrhage within 6 months before randomization. - History of bleeding diathesis. - Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug. - Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor/inducer. ; PRIMARY OUTCOME: Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment; SECONDARY OUTCOME 1: Number of Participants With Treatment-emergent Infections Grade >= 3[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - ECOG/NCI; BRIEF: This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog) works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. ; DRUG USED: Halaven; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate - Progressive metastatic disease or stable metastatic disease with rising PSA - Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure - Patients who have not undergone bilateral orchiectomy must continue luteinizing hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist therapy (e.g. abarelix) while receiving study treatment - Patients who did not have an orchiectomy must have a testosterone level < 50 ng/dL to confirm androgen suppression within the past 4 weeks - ECOG performance status 0-2 - Adequate bone marrow function - Bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal - Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min - Fertile patients must use effective contraception - A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression - At least 4 weeks since prior chemotherapy or radiotherapy - At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression - Disease progression after antiandrogen withdrawal must be confirmed by rising PSA after the required 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on antiandrogen therapy) - More than 4 weeks since prior estrogen, estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or any other hormonal therapy (including megestrol, finasteride, ketoconazole, or systemic corticosteroids) - Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided the patient has been receiving the bisphosphonate for >= 4 weeks and there is evidence of disease progression Exclusion Criteria: - Active angina pectoris - Known New York Heart Association class III-IV heart disease - Myocardial infarction within the past 6 months - Evidence of ventricular dysrhythmias or other unstable arrhythmia (rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint) - Peripheral neuropathy > grade 2 - Other prior malignancy (excluding nonmelanomatous skin cancer treated with curative intent) unless the malignancy was treated with curative intent and the patient has been disease free for >= 5 years - Serious concurrent medical illness or active infection that would preclude study treatment - No concurrent strong inhibitors or inducers of CYP3A4 - More than 2 prior chemotherapy regimens for hormone-refractory disease - Other concurrent investigational agents - Other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy - Concurrent palliative radiotherapy - Concurrent estrogen, estrogen-like agents, or any other hormonal therapy - Carcinomatous meningitis or brain metastases - Prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes - Concurrent therapeutic anticoagulation with warfarin (Unfractionated heparin [standard, low-dose, or adjusted dose] or low molecular weight heparin allowed ; PRIMARY OUTCOME: Proportion of Patients With PSA Response; SECONDARY OUTCOME 1: Proportion of Patients With Measurable Disease Response[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - STOPTRAFFIC-1; BRIEF: This phase Ib/II trial studies the side effects and best dose of SX-682 that can be given alone and in combination with nivolumab in treating patients with RAS-Mutated, microsatellite stable (MSS) colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). SX-682 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 alone and together with nivolumab may kill more tumor cells. ; DRUG USED: SX-682; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Chemokine (C-X-C motif) Receptor 1 (CXCR1) / IL8R , Chemokine (C-X-C motif) Receptor 2 (CXCR2) / IL-8 receptor, Chemokine Receptor; THERAPY: Combination; LEAD SPONSOR: M.D. Anderson Cancer Center; CRITERIA: Inclusion Criteria: 1. Participants must have the nature of the study explained to them. 2. Non-English speaking participants will be eligible for participation with involvement of the MD Anderson Language Assistance department in the informed consent process (per MD Anderson SOP 04_Informed Consent Process). 3. Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, pharmacokinetic collections, and other requirements of the study. 4. Participants must provide a signed and dated IRB approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines for both the study and exploratory biomarker analyses (e.g., CMS4 and others) on archival tissue. 5. Participants must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization. 6. The ICF and HIPAA authorization must be obtained before conducting any procedures that do not form a part of the subjects normal care. 7. After signing the ICF and HIPAA Authorization, participants will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/exclusion criteria: 1. Men and women, ages > 18 years of age. Both men and women of all races and ethnic groups, regardless of preferred language, are eligible for this trial. 2. Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum that is metastatic or unresectable. 3. Tumor is determined to be RAS-mutated (KRAS or NRAS) and microsatellite stable/proficient in mismatch repair, as assessed by IHC and/or PCR/NGS in a CLIA environment. 4. Received at least two prior regimens of therapy for unresectable or metastatic CRC including fluoropyrimidine-, oxaliplatin-, and irinotecan-based regimens. Participants who relapse within 6 months of adjuvant chemotherapy composed of oxaliplatin and a fluoropyrimidine will have their adjuvant therapy count as one prior regimen. 5. For the expansion cohort, pre-treatment primary tumor tissue (i.e., archived paraffinembedded) or from an unresectable metastatic site must be available for biomarker analyses. Biopsy should be excisional or core needle. Fine needle aspirates or other cytology samples are insufficient. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1. . 7. Must have measurable disease with at least 1 unidimensional measurable lesion per RECIST v1.1 (see Appendix 2). 8. Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration. 9. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to first dose: -WBC > 3000/µL -Neutrophils > 1500/ µL -Platelets > 100,000/µL -Hemoglobin > 9.0 g/dL (may have been transfused) -Creatinine < 1.5 mg/dL -AST/ALT < 2.5 X ULN for participants with no liver metastases < 5 X ULN for subjects with liver metastases -Bilirubin < 1.5 mg/dL (unless diagnosed with Gilberts syndrome, who can have total bilirubin < 3.0 mg/dL) -INR or PT < 1.5 X ULN unless the participants is receiving anticoagulant therapy -aPTT or PTT < 1.5 X ULN unless the participants is receiving anticoagulant therapy 10. Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula >60 ml/min. 11. Life expectancy > 12 weeks as judged by the treating physician. 12. Participants Re-enrollment: This study permits the re-enrollment of a participants that has discontinued the study as a pre-treatment failure (i.e., participants has not been treated with SX-682). If re-enrolled, the participant must be re-consented. Exclusion Criteria: 1. Active brain metastases or leptomeningeal metastases. Participants with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI - except where contraindicated, in which CT scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases. 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. 2. Participants with bulky liver metastases (liver metastases >3cm) are not eligible. a) Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the participants to receive protocol therapy, or interfere with the interpretation of study results. Specifically: 1. Participants with active, non-infectious pneumonitis. 2. Participants with interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. b) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. c) Participants with active, known or suspected autoimmune disease (Appendix 3). Subjects 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. d) Participants with a condition (including organ or bone marrow transplant) requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. e) Use of other investigational drugs (drugs not marketed for any indication) or medications at immunosuppressive doses within 28 days before study drug administration. f) Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy for mCRC. g) Anticancer treatment within 21 days before the start of trial treatment [e.g., cytoreductive therapy, radiotherapy (with the exception of palliative radiotherapy delivered in a normal organ-sparing technique), immune therapy, or cytokine therapy]. Note: Participants on maintenance anti-hormonal treatment to prevent recurrence and secondary cancers are eligible for participation. h) Major surgery as determined by the investigator within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted). i) Participants who have received a live-virus vaccine within 30 days before study drug administration. j) Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment. k) Participants who are taking any drug that is known to prolong QTc interval within at least 2 weeks before the start of trial drug and during the conduct of the trial. l) Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation. 3. Physical and Laboratory Test Findings a) Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection (HBV surface antigen positive and HBV core antibody positive with reflex to positive HBV DNA or HBV core antibody positive alone with reflex to positive HBV DNA or positive HCV antibody with reflex to positive HCV RNA). b) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). c) Active tuberculosis (history of exposure or history of positive tuberculosis test plus presence of clinical symptoms, physical or radiographic findings). d) ECG demonstrating a QTc interval >470 msec or patients with congenital long QT syndrome. 4. Allergies and Adverse Drug Reaction a) History of allergy to study drug components (excipients: hydroxpropylmethylcellulose phthalate (hypromellose phthalate or HPMCP), microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, and silicon dioxide). b) History of severe hypersensitivity reaction to any monoclonal antibody (Grade ≥ 3 NCICTCAE v5). c) History of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma. 5. Sex and Reproduction Status 1. Women of childbearing potential (WOCBP) must use method(s) of contraception as indicated in Appendix 4 while on study and for 5 months after the last dose of SX-682 or nivolumab. A WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes. 2. Women under the age of 62 with a history of being postmenopausal must have a documented serum follicle stimulating hormone, (FSH) level > 40 mIU/mL. 3. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. 4. Women must not be breastfeeding. 5. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year while on study and for a period at least 6 months after the last dose of study drug. 6. Women who are not of childbearing potential and azoospermic men do not require contraception. ; PRIMARY OUTCOME: Incidence of adverse events (AEs); 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 - w/Nivolumab; BRIEF: The study will evaluate the clinical activity of sitravatinib in combination with nivolumab in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the neoadjuvant setting prior to nephrectomy. ; DRUG USED: Sitravatinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: EPH receptor B4 (EPHB4), Hepatocyte growth factor receptor (c-Met, HGFR), RET, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Mirati Therapeutics Inc.; CRITERIA: Inclusion Criteria: 1. Imaging results consistent with locally-advanced RCC 2. Candidate for partial or complete nephrectomy as part of treatment plan. 3. Measurable disease per RECIST version 1.1. 4. ECOG performance status 0 or 1. 5. Adequate bone marrow and organ function. Exclusion Criteria: 1. Prior systemic anti-tumor treatment for RCC. 2. Patients who are receiving any other investigational agents. 3. Clinical status indicating that immediate surgery (within 6 weeks) is warranted regardless of whether neoadjuvant therapy is to be administered, as assessed by the treating surgeon. 4. Inability to undergo baseline tumor biopsy. 5. Active or prior documented autoimmune or immunocompromising conditions. 6. Uncontrolled hypertension. ; PRIMARY OUTCOME: Percentage of Participants Who Achieved a Point in Time Objective Response (Either Complete or Partial Response [CR or PR]) Prior to Surgery; SECONDARY OUTCOME 1: Number of Participants Who Experienced 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 III - PEOPLE; BRIEF: This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study. ; DRUG USED: Viaskin Peanut; DRUG CLASS: Biologic; INDICATION: Food Allergies; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: DBV Technologies; CRITERIA: Inclusion Criteria: - Subjects who completed the PEPITES study. Exclusion Criteria: - Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches. - Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma. ; PRIMARY OUTCOME: % of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE; 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 - Chronic Kidney Disease; BRIEF: The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function. ; DRUG USED: Heplisav-B; DRUG CLASS: Vaccine; INDICATION: Hepatitis B Prevention (Vaccines, Antiviral); TARGET: Immune System, Toll-like receptor 9 (TLR9); THERAPY: Monotherapy; LEAD SPONSOR: Dynavax Technologies Corporation; CRITERIA: Inclusion Criteria: - be 18 to 75 years of age; - progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m²; - be clinically stable in the opinion of the investigator; - be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV); - if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection; - is not scheduled to undergo a kidney transplant in the next 12 months; - be able and willing to provide informed consent. Exclusion Criteria: - if female, is pregnant, breastfeeding, or planning a pregnancy; - has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV; for example, current intravenous drug use, has unprotected sex with known HBV/HIV positive partner; - has known history of autoimmune disease; - has previously received any HBV vaccine; - has a history of sensitivity to any component of study vaccines; - has current illness other than renal disease or has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results; - is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin; - has uncontrolled diabetes or hypertension; - is unwilling or unable to comply with all the requirements of the protocol; - has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period; - has received the following prior to the first injection: - 3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis) - 7 days: intravenous iron - 21 days: any inactivated virus vaccine - 28 days: - any live virus vaccine - systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids - granulocyte or granulocyte-macrophage colony-simulating factor (G/GM-CSF), any other investigational medicinal agent - At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotide ; PRIMARY OUTCOME: Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response; SECONDARY OUTCOME 1: Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - KEYNOTE-052 (First-Line); BRIEF: This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants and by programmed cell death ligand 1 (PD-L1) status. With Amendment 4, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Histologically- or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies) - Ineligible for cisplatin therapy - No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed) - Available tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated - Measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - Adequate organ function - Female participants of childbearing potential have a negative urine or serum pregnancy test; surgically sterile, or willing to use 2 acceptable methods of birth control, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment - Male participants must be willing to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment Exclusion Criteria: - Disease that is suitable for local therapy administered with curative intent - Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment - Prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic treatment 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 - Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from AEs due to a previously administered agent - Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active autoimmune disease that has required systemic treatment in past 2 years - Evidence of interstitial lung disease or active non-infectious pneumonitis - Active infection requiring systemic therapy - Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment - Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor - Known human immunodeficiency virus (HIV) - Known active Hepatitis B or C - Received a live virus vaccine within 30 days of planned start of study treatment ; PRIMARY OUTCOME: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants; SECONDARY OUTCOME 1: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All 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 - VICTOR; BRIEF: VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV infection. ; DRUG USED: Ziresovir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Syncytial Virus (RSV) Treatment; TARGET: RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: Ark Biosciences Inc.; CRITERIA: Inclusion Criteria: - Male or female patients of any race or ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months. - Diagnosis of RSV infection by virological means, which may include rapid diagnostic point-of-care testing, within 96 hours preceding screening for Part 1 and 72 hours for Part 2. - Patient must weigh >3 kg at screening and be within the 10th and 90th percentiles (inclusive) for the patients age, based on the local child growth standards, i.e. the Australian Paediatric Endocrine Group Growth Charts. - The parent / legal guardian of the patient must have provided written informed consent for the patient to participate. - For patients aged <12 months, an occipito-frontal head circumference within the normal range for age and gender. Exclusion Criteria: - The patient has taken, is currently taking or requires any restricted medications. - Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged <6 months). - Participation in an investigational drug or device study within 30 days prior to the date of screening. - Requires vasopressors or inotropic support at the time of enrolment. - Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome). - Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at the time of enrolment. - Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, a history of surgery for diaphragmatic hernia). - Left to right shunt meriting corrective therapy. - Renal failure including renal anomalies likely to be associated with renal insufficiency (e.g. clinical conditions of renal dysplasia, polycystic renal disease, renal agenesis). - Clinical evidence of hepatic decompensation (e.g. hepatic disorder with associated coagulopathy or associated encephalopathy). - Cerebral palsy with microcephaly, chronic or persistent feeding difficulties or seizures. - Symptomatic because of inborn errors of metabolism (e.g. mitochondrial disorders, disorders of carbohydrate metabolism, glycogen storage disorders). - Congenital or acquired immunodeficiency (e.g. congenital agammaglobulinaemia, common variable immunodeficiency, immunosuppressive therapy other than glucocorticoid or montelukast therapy forming part of care directed by the treating physician). - For Part 2 of this study, children with a history of having received palivizumab or any other monoclonal agent directed against RSV in the preceding 120 days. This exclusion criterion does not apply to Part 1. - Evidence of active or uncontrolled respiratory, cardiac, hepatic, central nervous system or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrolment. - A history of epilepsy or seizures including febrile seizures. - Allergy to test medication or constituents. - Weight less than 10th percentile or greater than 90th percentile for age and gender adjusted for any prematurity. - The patients parent or legally acceptable representative is an employee of the investigator or the study center, with direct involvement in the proposed study or other studies under the direction of that investigator of the study center, or any family members of the employees or the investigator. - Failure to satisfy the investigator of fitness to participate for any other reason. ; PRIMARY OUTCOME: Incidence of Adverse Events during the study; SECONDARY OUTCOME 1: Area under the plasma concentration-time curve from time 0 to infinity (AUC)[/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 - First-In-Human; BRIEF: The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed Refractory Multiple Myeloma (RRMM). ; DRUG USED: M3258; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Participants having Eastern Co-operative Oncology Group (ECOG) Performance Status less than or equals to (<=) 1 - Adequate hematological, hepatic and renal function as defined in the protocol - Participant must have measurable disease of Multiple Myeloma (MM) and received greater than (>) 3 prior lines of therapy for MM including a Proteasome Inhibitors (PI), an Immunomodulatory Imide Drug (IMiD) and an anti-CD38 mAb or who are refractory to at least PI agent (carfilzomib or bortezomib) and IMiD according to the International Myeloma Working Group (IMWG) criteria - Participant must have documented evidence progressive disease as defined by the IMWG criteria either on or after their last regimen - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Any condition, including any uncontrolled disease state that in the Investigators opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation. - An active second malignancy or evidence of disease of cancer (other than MM) before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsors medical monitor, is considered cured with minimal risk of recurrence within 3 years). - Cerebrovascular accident/stroke (< 6 months prior enrollment) or neurologic instability per clinical evaluation due to tumor involvement of the Central Nervous System - Diagnosis of fever within 1 week prior to study intervention administration - Part B: Participants planning to undergo a stem cell transplant should not be enrolled to reduce disease burden prior to transplant. - Other protocol defined exclusion criteria could apply ; PRIMARY OUTCOME: Part A: Number of Participants With Dose-Limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0; SECONDARY OUTCOME 1: Part A: Number of Participants With Treatment-Emergent Changes From Baseline in Vital Signs - Maximal Body Temperature Increase[/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 - R/R HL; BRIEF: The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL). ; DRUG USED: Camidanlumab Tesirine; DRUG CLASS: Biologic; INDICATION: Hodgkins Lymphoma; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 25 (CD25); THERAPY: Monotherapy; LEAD SPONSOR: ADC Therapeutics S.A.; CRITERIA: Inclusion Criteria: 1. Written informed consent must be obtained prior to any procedures. 2. Male or female participant aged 18 years or older. (16 years or older at US based sites) 3. Pathologic diagnosis of classical Hodgkin lymphoma (cHL). 4. Patients with relapsed or refractory cHL, who have received at least 3 prior lines of systemic therapy (or at least 2 prior lines in HSCT ineligible patients) including brentuximab vedotin and a checkpoint inhibitor approved for cHL (e.g., nivolumab or pembrolizumab). Note 1: Receipt of HSCT to be included in the number of prior therapies needed to meet eligibility. 5. Measurable disease as defined by the 2014 Lugano Classification. 6. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available). Note 1: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred. Note 2: If a sufficient amount of tissue is not available, a fresh biopsy may be taken, provided the procedure is not deemed high-risk and is clinically feasible, and provided it is approved locally. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 8. Adequate organ function as defined by Screening laboratory values within the following parameters: 1. Absolute neutrophil count (ANC) ≥ 1.0 × 103/μL (off growth factors at least 72 h). 2. Platelet count ≥ 75 × 103/μL without transfusion in the past 2 weeks. 3. ALT, AST, or GGT ≤ 2.5 × the upper limit of normal (ULN) if there is no liver involvement; ALT or AST ≤ 5 × ULN if there is liver involvement. 4. Total bilirubin ≤ 1.5 × ULN (participants with known Gilberts syndrome may have a total bilirubin up to ≤ 3 × ULN with direct bilirubin ≤ 1.5 × ULN). 5. Blood creatinine ≤ 3.0 × ULN or calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault equation. Note: A laboratory assessment may be repeated a maximum of two times during the Screening Period to confirm eligibility. 9. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential. 10. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9.5 months after the last dose of Camidanlumab Tesirine. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6.5 months after the participants receives his last dose of Camidanlumab Tesirine. Exclusion Criteria: 1. Previous treatment with Camidanlumab Tesirine. 2. Participation in another investigational interventional study. Being in follow-up of another investigational study is allowed. 3. Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD25 antibody. 4. Allogenic or autologous transplant within 60 days prior to start of study drug. 5. Active graft-versus-host disease (GVHD), except for non-neurologic symptoms as a manifestation of mild (≤ Grade 1) chronic GVHD. 6. Post-transplantation lymphoproliferative disorders. 7. Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsors medical monitor and Investigator agree and document should not be exclusionary. 8. History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögrens syndrome, autoimmune vasculitis [e.g., Wegeners granulomatosis]) (subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled). 9. History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis). 10. History of recent infection (within 4 weeks of Cycle 1, Day 1 [C1D1]) considered to be caused by one of the following pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Note: An influenza test and a pathogendirected SARS CoV-2 test (such as polymerase chain reaction) are mandatory and must be negative before initiating study treatment (tests to be performed 3 days or less prior to dosing on C1D1; an additional 2 days are allowed in the event of logistical issues for receiving the results on time). 11. Participants known to be or having been infected with human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV), and require anti-viral therapy or prophylaxis. Note: Serology testing is mandatory for patients with unknown status. 12. History of Stevens-Johnson syndrome or toxic epidermal necrolysis. 13. Failure to recover ≤ Grade 1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (except ≤ Grade 2 neuropathy or alopecia), due to previous therapy, prior to screening. 14. Hodgkin lymphoma (HL) with central nervous system involvement, including leptomeningeal disease. 15. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath). 16. Breastfeeding or pregnant. 17. Significant medical comorbidities, including uncontrolled hypertension (blood pressure [BP] ≥ 160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 3 months prior to screening, severe uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease. 18. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug, except shorter if approved by the Sponsor. 19. Use of any other experimental medication within 30 days prior to start of study drug. 20. Any live vaccine within 4 weeks prior to start of study drug and planned live vaccine administration after starting study drug. 21. Congenital long QT (measure between Q wave and T wave in the electrocardiogram) syndrome, or a corrected QTc interval of ≥ 480 ms, at screening (unless secondary to pacemaker or bundle branch block). 22. Any other significant medical illness, abnormality, or condition that would, in the Investigators judgment, make the participants inappropriate for study participation or put the participant at risk. ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Duration of Response (DOR)[/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 - 20120295; BRIEF: To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine. ; DRUG USED: Aimovig; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura. - History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day. - ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations. - Demonstrated at least 80% compliance with the eDiary. Exclusion Criteria: - History of cluster headache or hemiplegic migraine headache - Unable to differentiate migraine from other headaches - Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine . - Received botulinum toxinin head or neck region within 4 months prior to screening. - Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase ; PRIMARY OUTCOME: Change From Baseline in Monthly Migraine Days; SECONDARY OUTCOME 1: Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - vs. Forteo ; BRIEF: A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis ; DRUG USED: ZP PTH (Daily); DRUG CLASS: Non-NME; INDICATION: Osteoporosis / Osteopenia; TARGET: Parathyroid Hormone Receptor (PTHR); THERAPY: Monotherapy; LEAD SPONSOR: Zosano Pharma Corporation; CRITERIA: Inclusion Criteria: - Healthy postmenopausal women age 50 years or older - At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray absorptiometry (DXA) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility - Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, AND a T-score of at least < -1.0 at the lumbar spine; or A T-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral fracture; Exclusion Criteria: - Active hepatitis; - Active pancreatitis; - Unstable cardiac disease; - Unstable pulmonary disease; - Celiac disease; - Hyper- or hypo-parathyroidism; - Hyperthyroidism; - Cushings disease; - Osteomalacia; - Pagets disease; - Osteogenesis imperfecta; - Known blood disorders; - History of kidney stones; - Impaired renal function; - Autoimmune diseases; - Bone metastases or a history of skeletal malignancies; - Cancer history that includes any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for at least 1 year from the time of original resection; - Any condition or disease that may interfere with the ability to have or the evaluation of a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or >1 lumbar vertebral fracture in L1-L4; - More than 4 vertebral fractures in T4-L4; - Bilateral hip replacements; - Use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time; - Have received methotrexate or immunomodulatory agents with antiproliferative activity; - With known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis; - With known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its analogs, or components of the Macroflux® systems; - Who, in the opinion of the investigator, should not participate in the study, or may not be capable of following the study schedule for any reason; and - Unwillingness or inability to abide by the requirements of the study. - Have received any intravenous (IV) administered bisphosphonates in the past 24 months, or >2 doses of IV administered bisphosphonates total; - Use of oral bisphosphonates before randomization, including investigational bisphosphonates, unless: <6 months of treatment and off for 6 months, or 6-12 months of treatment and off for 2 years, or >12 months of treatment and off for 5 years; ; PRIMARY OUTCOME: Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24; SECONDARY OUTCOME 1: Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12[/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 - Chronic Migraine Prophylactic (Japan); BRIEF: To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 [monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months] compared with placebo for preventive treatment in Chronic Migraine patients ; DRUG USED: Ajovy; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition [beta version] criteria) or clinical judgment suggests a migraine diagnosis - Patient fulfills the criteria for Chronic migraine in baseline information collected during the 28 day screening period - Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent. - Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator. Exclusion Criteria: - Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses - Patient suffers from unremitting headaches, defined as having headaches for more than 80% of the time that he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if the patient has headaches 80% or less of the time they are awake on most days. - Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator ; PRIMARY OUTCOME: Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of Investigational Medicinal Product (IMP); SECONDARY OUTCOME 1: Mean Change From Baseline in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP[/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 - REPRISE (resistant G-negative); BRIEF: To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections. ; DRUG USED: Avycaz; DRUG CLASS: Non-NME; INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Beta-lactamase, Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Patient must be ≥18 and ≤90 years of age - Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after - Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection Exclusion Criteria: - Patient has an APACHE II score >30 (cIAI patients only) - Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.) - Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised - Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period. ; PRIMARY OUTCOME: Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set; SECONDARY OUTCOME 1: Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.[/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; BRIEF: The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol (LDL-C). ; DRUG USED: ALN-PCS02; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Alnylam Pharmaceuticals; CRITERIA: Inclusion Criteria: - Elevated LDL-C of >3.0 mmol/L and <5.7 mmol/L - Fasting triglyceride concentration ≤2.8 mmol/L - Body weight >60.0 kg; body mass index (BMI) between 19.00 kg/m2 and <35.00 kg/m2 - Adequate blood counts, liver and renal function - May not received any lipid lowering drug/agent within the 30 days prior to the screening - Non-smokers for at least 3 months - Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control - Males agree to use appropriate contraception - Willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent Exclusion Criteria: - Known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection - Multiple drug allergies or know sensitivity to oligonucleotide - History of drug abuse and/or alcohol abuse - Receiving an investigational agent within 3 months prior to study drug administration - Subjects with safety laboratory test results deemed clinical significant by the Investigator; - Received prescription drugs within 4 weeks of first dosing - Subjects who have donated more than 500 mL of blood within the 3 months prior to ALN-PCS02 or placebo administration; - Received megadose vitamin therapy or dietary supplements within 4 weeks prior to screening - Subjects who have used prescription drugs within 4 weeks of first dosing - Considered unfit for the study by the Principal Investigator - Employee or family member of the sponsor or the clinical study site personnel ; PRIMARY OUTCOME: The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation.; SECONDARY OUTCOME 1: Pharmacokinetics (PK) of ALN-PCS02 (Cmax, tmax, t1/2, AUC0-last, CL).[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - JAVELIN Solid Tumor; BRIEF: This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Escalation revised dosing regimen cohort. Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase . ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria for dose escalation and expansion phase: - Signed written informed consent - Male or female participants aged greater than or equal to 18 years - Participants must have histologically or cytologically proven metastatic or locally advanced solid tumors, for which no standard therapy exists or standard therapy has failed. Availability of tumor archival material or fresh biopsies is optional for participants in dose escalation - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months - Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST 1.1, except for participants with metastatic castrate-resistant prostate cancer (mCRPC) or metastatic breast cancer (MBC) who may be enrolled with objective evidence of disease without a measureable lesion - Adequate hematological, hepatic and renal function as defined in the protocol - Effective contraception for both male and female participants if the risk of conception exists - Other protocol defined inclusion criteria could apply Inclusion Criteria for expansion phase: - Participants must have relapsed, refractory, or progressive disease following last line of treatment (with the exception of the gastric and gastroesophageal junction (GEJ) cancer cohort, which does not require progression). Availability of tumor archival material or fresh biopsies (excluding bone biopsies) is mandatory for eligibility in the expansion cohorts. For participants in the MBC cohort, the biopsy or surgical specimen must have been collected within 90 days prior to the first investigational medicinal product (IMP) administration. Specifically, the following will be required: - NSCLC post platinum doublet: Histologically or cytologically confirmed stage IIIB or stage IV NSCLC that has progressed after 1 line of platinum-containing doublet chemotherapy. Participants should have received only 1 line of platinum-containing treatment for metastatic disease (i.e., adjuvant treatment with a platinum-containing regimen is not sufficient for eligibility because not received in the context of a metastatic disease). Participants in the NSCLC cohort will only be enrolled in USA - NSCLC first line: Stage IV (per 7th International Association for the Study of Lung Cancer [IASLC] classification) or recurrent NSCLC that is histologically proven. Participants must not have received treatment for their metastatic or recurrent disease. No activating epidermal growth factor receptor (EGFR) mutation nor ALK translocation/re-arrangement - Gastric and GEJ cancer: Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction, treated with first-line chemotherapy combination with or without disease progression. Participants should have received no more than 1 line of treatment for metastatic disease. Participants should not have been treated with trastuzumab (but can be Human Epidermal growth factor Receptor 2 [HER2] positive). Participants who received any platinum containing doublet or triplet as a neoadjuvant chemotherapy strategy, but are not ultimately candidates for surgery will also be eligible, as long as they did not have progressive disease after completion of the neoadjuvant chemotherapy. In addition, participants with gastric cancer can enter in the study if their white blood cell (WBC) and lymphocyte count is as defined in the protocol - MBC: Participants must have histologically confirmed locally advanced or MBC and have tumor that is refractory to or progressive after standard of care therapy. Participants must have received no more than 3 prior lines of cytotoxic therapy for metastatic disease. Participants must have received a taxane and an anthracycline, unless contra-indicated - Secondary expansion cohorts: Metastatic colorectal cancer (mCRC), Metastatic castrate-resistant prostate cancer (mCRPC), melanoma, ovarian cancer, ACC, mesothelioma, urothelial carcinoma and renal cell carcinoma as defined in the protocol - Efficacy expansion cohorts: Gastric and GEJ cancer (third line), ovarian cancer (platinum Refractory + liposomal doxorubicin), urothelial carcinoma, and HNSCC as defined in the protocol - Other protocol defined inclusion criteria for expansion phase could apply Exclusion Criteria for dose escalation and expansion phase: - Concurrent treatment with a non-permitted drug - Prior therapy with specific antibody/drug targeting T cell co-regulatory proteins (immune checkpoints) - Concurrent anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of trial treatment; or concurrent systemic therapy with immunosuppressive agents, use of hormonal agents within 7 days before the start of trial treatment as defined in the protocol. Note: Participants receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumab. - Previous malignant disease other than the target malignancy to be investigated in this trial within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ - Rapidly progressive disease (for example, tumor lysis syndrome) - Active or history of central nervous system metastases - Receipt of any organ transplantation including allogeneic stem-cell transplantation - Significant acute or chronic infections as defined in the protocol - Active or history of any autoimmune disease (Participants with diabetes Type 1, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies - Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma - Persisting toxicity related to prior therapy greater than Grade 1 NCI-CTCAE v4.0, however sensory neuropathy less than or equal to Grade 2 is acceptable - Pregnancy or lactation period - Known alcohol or drug abuse - Clinically significant (that is, active) cardiovascular disease - All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the Participants tolerance of trial treatment - Any psychiatric condition that would prohibit the understanding or rendering of informed consent - Legal incapacity or limited legal capacity - Non-oncology vaccine therapies for prevention of infection disease (for example, seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of study drug administration. Vaccination while on study is also prohibited except for administration of the inactivated influenza vaccine ; PRIMARY OUTCOME: Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PADDINGTON; BRIEF: The primary objective of this study is to provide biological samples from patients with Huntingtons disease to allow characterisation of the pharmacological mechanism of action of SEN0014196. ; DRUG USED: SEN196; DRUG CLASS: New Molecular Entity (NME); INDICATION: Huntingtons Disease; TARGET: SIRT1; THERAPY: Monotherapy; LEAD SPONSOR: Siena Biotech S.p.A.; CRITERIA: Inclusion Criteria: - Patients with early Huntingtons Disease (age: 18 to 70 years), i.e. genetically confirmed (CAG repeat length ≥36) HD, motor signs of HD (motor score of the UHDRS > 5) and a TFC of ≥7. - All patients will have a body weight greater than 50 kg. - Female subjects must be surgically sterile or post-menopausal, no spontaneous menstruation for at least one year before the first dose, non-lactating and have a negative urine pregnancy test. Male subjects participating in the trial and their female contraception from the time of taking the first dose of the study drug until three months after taking the last dose. This must include a condom or other barrier method. - All subjects must be capable of providing written informed consent. - Subjects must have no clinically significant and relevant history that could affect the conduct of the study and evaluation of the data, as ascertained by the Investigator through detailed medical history and screening assessments. Exclusion Criteria: - Participation in a study of an investigational drug within 30 days of the baseline visit. - Subjects with presence of psychosis and/or confusional states. - Subjects with clinically significant laboratory or ECG abnormalities at Screening. - Subjects with clinically relevant hematological, hepatic, cardiac or renal disease. - A medical history of infection with human immunodeficiency virus, hepatitis C and/or hepatitis B. - Any relevant condition, behaviour, laboratory value or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study. - Subjects who have previously received histone deacetylase inhibitors e.g. vorinostat or have participated in a clinical trial using compound suspected of interfering with protein acetylation status. - A history of malignancy of any type within 2 years prior to screening. A history of surgically excised nonmelanoma skin cancers is permitted. - Subjects with a significant history of drug allergy as determined by the Investigator. - Subjects who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator. ; PRIMARY OUTCOME: To determine the change from baseline of a series of pharmacodynamic markers in peripheral blood mononuclear cells; SECONDARY OUTCOME 1: To determine the safety and tolerability following repeated doses of SEN0014196 over two weeks at two dose levels in patients with Huntingtons disease[/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 - A041-03; BRIEF: Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks the development of blood vessels that supply tumors. ; DRUG USED: Dalantercept; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Activin-like kinase 1, Bone morphogenetic protein (BMP); THERAPY: Monotherapy; LEAD SPONSOR: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; CRITERIA: Key Inclusion Criteria: - Histologically and/or cytologically confirmed, recurrent or metastatic SCCHN of mucosal origin (oral cavity, oropharynx, hypopharynx or larynx) not amenable to further local therapy (surgery, or radiation including re-irradiation); patients with unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if they meet all other entry criteria. - Previously treated with at least one platinum-containing regimen or contraindicated for treatment with a platinum containing therapy. (Note: platinum therapy can occur upfront or after recurrence of disease. Failure of platinum therapy is not required.) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: - Nasopharyngeal carcinoma, paranasal sinus, salivary gland or primary skin SCCHN. - Any other active malignancy for which chemotherapy or other anti-cancer therapy is indicated. - Chemotherapy or other anti-cancer therapy or radiation therapy within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known. - Treatment with another investigational drug or device, or approved therapy for investigational use, within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known. - Major surgery within 4 weeks prior to study day 1 (patients must have recovered completely from any previous surgery prior to study day 1). - Clinically significant cardiovascular risk. - Clinically significant active pulmonary risk. - Clinically significant active bleeding. - Peripheral edema ≥ Grade 1 within 4 weeks prior to study day 1. - Pregnant or lactating female patients. ; PRIMARY OUTCOME: Objective Response Rate (ORR); SECONDARY OUTCOME 1: Safety and Tolerability[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FLASHLYTE - 25310 (Neg Symptoms); BRIEF: This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm. ; DRUG USED: Bitopertin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Glycine Neurotransmitter Transporter (GlyT-1); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype - Predominant negative symptoms - With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics) Exclusion Criteria: - Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder) - Body Mass Index (BMI) of less than (<) 17 or greater than (>) 40 kilograms per meter square (kg/m^2) - Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS) - A severity score of 3 or greater on the Parkinsonism item of the Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism) ; PRIMARY OUTCOME: Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population); SECONDARY OUTCOME 1: Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - China; BRIEF: A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients. ; DRUG USED: T101; DRUG CLASS: Vaccine; INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: Hepatitis B/HBV, Immune System; THERAPY: Combination; LEAD SPONSOR: Tasly Tianjin Biopharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: Patients must meet all the following inclusion criteria to be enrolled in this study: - 1. Patients between the ages of 18 and 60 years, male or female; - 2. Body weight is no less than 45kg for female and no less than 50kg for male; - 3. Meets the diagnosis and treatment standards of chronic hepatitis B in Chinas 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B; - 4. Currently, should have taken nucleoside (acid) analogues for 1 year or more; - 5. HBV DNA<100 IU/ml; HBsAg is positive and no more than 3000 IU/ml；HBeAg is negative； - 6. Be able to understand and sign informed consent. Exclusion Criteria: Patients with any of the following items will not be enrolled in this study: - 1. Pregnant or lactating women; male or female who have planned to have children from the start of the study to sixth month after the end of the study. - 2. Have received interferon treatment within 6 months prior to the screening; - 3. Have taken strong immunomodulators (such as adrenocortical hormone, thymosin alpha 1, thymosin 5, etc.) within 6 months before the screening, and the course of treatment was more than 2 weeks; - 4. Have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) within 6 months before screening, and the course of treatment was more than 2 weeks; - 5. Currently or previously diagnosed or suspected with cirrhosis or liver cancer; or AFP > 50ng/ml; - 6. Liver diseases caused by other causes: including alcoholic hepatitis, drug hepatitis, autoimmune liver disease; - 7. Currently be infected of HAV, HCV, HDV, HEV, HIV and syphilis; - 8. Have mental diseases, including but not limited to depression, anxiety, mania, schizophrenia; - 9. Uncontrolled epilepsy; - 10. Complicated with serious systemic diseases, including but not limited to: autoimmune diseases (such as psoriasis, systemic lupus erythematosus, etc.); not well controlled cardiovascular disease (such as high blood pressure, unstable angina pectoris, heart failure, etc.), endocrine system disease (such as thyroid function hyperfunction or loss, diabetes, etc.), respiratory system diseases (such as pulmonary infection, chronic obstructive pulmonary disease and pulmonary interstitial diseases, etc.), digestive system diseases (e.g., chronic colitis, etc.), kidney disease (such as chronic kidney disease, renal insufficiency, etc.), blood system diseases (such as autoimmune anemia, hemophilia, etc.); currently or previously diagnosed or suspected with malignant tumor; - 11. Fundus diseases, such as not well controlled retinopathy, etc.; - 12. Laboratory neutrophil count<1.5×109/L; platelet count <90×109/L; - 13. Prothrombin time was extended by more than 3 seconds compared with the upper limit of normal reference value (ULN); - 14. ALT>1.5×ULN; TBIL>2×ULN; SCR>1.5×ULN; serum creatine kinase >3×ULN; ALB<35g/L; - 15. ANA>1:1000, anti-smooth muscle antibody>1:1000, thyrotropic hormone receptor antibody >2×ULN; - 16. Allergic constitution or allergic to experimental drugs and excipients; - 17. Plan to receive or have already had an organ transplant; - 18. Participated in any clinical trial or taken any IMP (investigational medical product) within 3 months prior to the trial; - 19. Other cases that could not be enrolled in the judgement of the investigators. ; PRIMARY OUTCOME: All the observed or reported AEs (adverse events); SECONDARY OUTCOME 1: The percentage of Subjects HBsAg decrease ≥ 1 log[/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 - BRIGHT 1003; BRIEF: This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases. ; DRUG USED: Daurismo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Hedgehog Signaling Pathway; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO 2008 Classification and previously untreated. - Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. The patients may not have had a prior therapy for their AML. - AML patients include de novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML) - For a diagnosis of AML, a bone marrow blast count of 20% or more is required. - For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have 10-19% bone marrow blasts - Adequate Organ Function - ECOG Performance Status 0, 1, or 2 Exclusion Criteria: - AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation. - Patients with known active uncontrolled central nervous system (CNS) leukemia. ; PRIMARY OUTCOME: Number of Participants With Dose-limiting Toxicities (DLTs) at Phase 1B; SECONDARY OUTCOME 1: Overall Survival (OS) at Phase 1B[/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/Tamoxifen or Aromatase Inhibitor; BRIEF: This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of Q-122 for the treatment of Vasomotor Symptoms (VMS) versus placebo. Participants who meet all eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2 treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be followed for a 2-week, drug-free, follow-up period after their last dose of blinded Q-122/placebo before termination from the study. ; DRUG USED: Q-122; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Combination; LEAD SPONSOR: Que Oncology; CRITERIA: Inclusion Criteria: 1. Be a female, aged between 18 - 70 years on the day of informed consent. 2. Have a history of or current breast cancer and currently taking tamoxifen or an aromatase inhibitor. 3. On a stable dose of TAM or an AI for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study. 4. Experience an average of at least 50 moderate to severe hot flashes/week for the 2 weeks immediately preceding the Run-In Visit (i.e., during the Screening period). 5. If on thyroid medication, on a stable dose for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study. 6. Willing and able to complete the daily participant diary, attend all study visits, and participate in all study procedures. 7. Able to provide informed consent. Exclusion Criteria: 1. Childbearing potential, pregnancy, or lactation except in patients who are on stable dose of AI in combination with luteinizing hormone releasing hormone agonists such as Zoladex, Leuprolide (Lupron) or equivalent. Non-childbearing potential is defined as physiologically incapable of becoming pregnant by one of the following: - Has had a partial or complete hysterectomy or - Has had a bilateral oophorectomy or - Has had a bilateral tubal ligation or fallopian tube inserts or - Is post-menopausal (amenorrhea > 1 year) confirmed by levels of follicle stimulating hormone (FSH). FSH levels may be lower in menopausal women treated with tamoxifen when compared with FSH levels appropriate for confirming menopause in women not treated with tamoxifen. For those patients who are on stable dose of tamoxifen, confirmation of menopause is based on the clinical opinion of the PI and medical monitor on a case-by-case basis. 2. Currently experiencing undiagnosed vaginal bleeding. 3. Women with advanced breast cancer (Stage 4). 4. Greater than 60% reduction in the frequency of moderate to severe hot flashes during the 1-week single blind Run-In period or inability to correctly record hot flashes and/or drug dosing in the participant diary. 5. Participation in another clinical or surgical trial within 30 days prior to screening or during the study without the prior written consent of the Medical Monitor. 6. Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122 at PI discretion. 7. Untreated overt hyperthyroidism. 8. Have any other medical condition, clinically important systemic disease or significant co-morbidities or any finding during Screening that in the judgment of the investigator puts the participant at increased risk by participation in this study, or that may affect the reliability of participant diary entries. 9. Known inability to complete all study visits and study assessments for scheduling or other reasons. 10. BMI > 40 kg/m2; Participants with a BMI greater than 40 kg/m2 may be enrolled on a case-by-case basis if approved by the Medical Monitor and if the participant is not deemed at increased risk of adverse effects based on body habitus and cardiovascular health. 11. Women with a history of, or current evidence of, abuse of alcohol or any drug substance, or who regularly drink more than 3 standard drinks per day. 12. Uncontrolled systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg on 3 consecutive readings within the screening visit. 13. Abnormal laboratory findings: 1. Hemoglobin < 9.5 g/dL (g/L); or any abnormal values that are deemed clinically significant by the investigator should be discussed with the medical monitor before being deemed ineligible. 2. Fasting ALT, AST, GGT, or bilirubin greater than twice the upper limit of normal that is confirmed on a second sample. 3. <60 eGFR mL/min/1.73 m2. 14. In the opinion of the investigator, have substantial risk of disease progression within the 3 months following screening and/or who potentially may require further treatment for their breast cancer during the study period including follow-up. 15. Any other reason which in the investigators opinion makes the participant unsuitable for a clinical trial. 16. On any medications, either prescription or over-the-counter that are being taken solely for the purpose of treating VMS including SSRI/SNRI, gabapentin or pregabalin. ; PRIMARY OUTCOME: Hot Flash Severity Score (HFSS); 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 - EPIC-E; BRIEF: The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC. ; DRUG USED: Vepoloxamer; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Mast Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Completed participation in study MST-188-01 (EPIC study) - Subject age 4 through 65 years - Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia - Subject requires hospitalization Exclusion Criteria: - Subject has acute chest syndrome - Subjects laboratory results indicate inadequate organ function - Subject is pregnant or nursing an infant - Subject had a painful crisis requiring hospitalization within the preceding 14 days - Subject has been transfused within the past 14 days - Subject has complications related to SCD ; PRIMARY OUTCOME: Safety as measured as the incidence of adverse events; SECONDARY OUTCOME 1: Rate of re-hospitalization for recurrence of VOC[/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 - CNS Lymphoma (Denmark); BRIEF: The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain. ; DRUG USED: Rituxan; DRUG CLASS: Biologic; INDICATION: Primary Central Nervous System Lymphoma (PCNSL) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: University of Aarhus; CRITERIA: Inclusion Criteria: - Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment. - Patients treated with steroids alone are eligible - No signs of lymphoma outside the CNS - ECOG performance status 0-4 - Age > 17 and < 76 years - Written informed consent from the patient or guardian Exclusion Criteria: - Cardiac failure > 3 - Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication - Previous malignancy unless disease free for at least five years - Active infection. - Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre. - Positive HIV status - Organ transplantation - Serious psychiatric illness - Prior radiotherapy to the brain - Concomitant anti-inflammatory medication that cannot be discontinued - Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula - Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L - Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits of normal. - Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: response rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - w/FOLFIRI (3rd, 4th Line); BRIEF: A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer ; DRUG USED: Masitinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR); THERAPY: Combination; LEAD SPONSOR: AB Science; CRITERIA: Inclusion Criteria: - Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum. - Patient in third line or fourth line of treatment for metastatic colorectal cancer. - Patient with measurable lesions according to RECIST criteria (version 1.1). - Patient with ECOG equal to or less than 2. - Patient with adequate organ function - Other inclusion criteria may also apply Exclusion Criteria: - Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib. - More than 3 prior chemotherapy regimens for metastatic colorectal cancer. - Pregnant, intent to be pregnant, or nursing female patient - Patient with any chronic inflammatory bowel disease - Patient treated for a cancer other than colorectal cancer within five years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ. - Other exclusion criteria may also apply ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Survival rates[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 402 (Adjunctive); BRIEF: The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. ; DRUG USED: Caplyta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: Intra-Cellular Therapies, Inc.; CRITERIA: Inclusion Criteria: - male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder - experiencing a current major depressive episode - treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms Exclusion Criteria: - any subject unable to provide informed consent - any female subject who is pregnant or breastfeeding - any subject judged to be medically inappropriate for study participation ; PRIMARY OUTCOME: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score; SECONDARY OUTCOME 1: Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - FITE19 (Hospitalized Patients); BRIEF: This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60. ; DRUG USED: PTC299; DRUG CLASS: New Molecular Entity (NME); INDICATION: COVID-19 Treatment; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: PTC Therapeutics; CRITERIA: Inclusion Criteria: - Signed and dated informed consent document(s). - Agrees to the collection of nasopharyngeal swabs and venous blood and all other protocol-specified procedures. - Male or non-pregnant female adult ≥18 years of age at time of enrollment. - Hospitalized and has laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). - Symptom onset was ≤10 days prior to screening. - Has oxygen saturation SpO2 <94% on room air. - Has at least one of a respiratory rate >24 breaths/minute or cough. - Lung involvement as confirmed by radiographic infiltrates observed on imaging (chest X-ray, computed tomography (CT) scan, or an equivalent test). - Women of childbearing potential (as defined in [CTFG 2014]) must have a negative pregnancy test at screening and agree to abstinence or the use at least one of the following highly effective forms of contraception (with a failure rate of <1% per year when used consistently and correctly). Contraception or abstinence must be continued for the duration of the study following discharge from the hospital, and for up to 50 days after the last dose of study drug: i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal ii) progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, and implantable iii) intrauterine device iv) intrauterine hormone-releasing system v) vasectomized partner with confirmed azoospermia All females will be considered of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea in the appropriate age group without other known or suspected cause) or have been sterilized surgically (for example, bilateral tubal ligation, hysterectomy, bilateral oophorectomy). - Men sexually active with women of childbearing potential who have not had a vasectomy must agree to use a barrier method of birth control during the study following discharge from the hospital and for up to 50 days after the last dose of study drug. Exclusion Criteria: - Requires mechanical ventilation. - Current participation in any other interventional study. - Alanine transaminase/aspartate transaminase levels ≥3 times the upper limit of normal (×ULN) or total bilirubin (Tbili) ≥2×ULN. - Lymphocyte count <500 lymphocytes/microliter (μL) or hemoglobin <11 grams/deciliter (g/dL). - Stage 4 severe chronic kidney disease or requiring dialysis (that is, estimated glomerular filtration rate <30). - Any other condition, that in the opinion of the Investigator, may be cause to exclude the participant from the study. - Use of steroids (except dexamethasone), sensitive CYP2D6 substrates, CYP2C inducers, IL-6 neutralizing antibodies, IL-6 receptor inhibitors, or any investigational therapy. - Pregnancy or breast feeding. - Anticipated transfer to another hospital which is not a study site within 72 hours. - Known allergy to PTC299 or excipients. ; PRIMARY OUTCOME: Time From Randomization to Respiratory Improvement; SECONDARY OUTCOME 1: Number of Participants Requiring Invasive Ventilation[/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 - LAUNCH; BRIEF: Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML. ; DRUG USED: Dilanubicel; DRUG CLASS: Biologic; INDICATION: Bone Marrow and Stem Cell Transplant - Graft vs. Host Disease (GVHD) Prophylaxis; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Nohla Therapeutics, Inc.; CRITERIA: Key Criteria: Inclusion Criteria: - Age ≥ 18 (or legal age of majority for sites outside US). - Untreated de novo or secondary acute myeloid leukemia (AML), including AML that has progressed from myelodysplastic syndrome (MDS), and histologically documented diagnosis - Eligible for at least 2 cycles of standard of care AML chemotherapy that will result in moderate to severe myelosuppression and have curative intent - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 or Karnofsky Status of 50 to 100. - Adequate cardiac, renal, and hepatic functions. Exclusion Criteria: - Extramedullary disease in the absence of bone marrow or blood involvement - Acute promyelocytic leukemia (APL) with PML-RARA - Prior AML therapy, with the exception of intrathecal chemotherapy or emergent radiation for myeloid sarcoma. - Concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or radiation - Prior allotransplant, including allogeneic hematopoietic cell transplant or solid organ allogeneic transplant - Known hypersensitivity or history of hypersensitivity to dimethylsulfoxide (DMSO) - Active/chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection ; PRIMARY OUTCOME: Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection; SECONDARY OUTCOME 1: Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy[/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 - TITAN (2nd Line) (Roche); BRIEF: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals. ; DRUG USED: Tarceva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - adult patients >=18 years of age; - histologically documented, locally advanced or recurrent or metastatic NSCLC; - measurable disease; - disease progression during 1-4 cycles of platinum-based chemotherapy. Exclusion Criteria: - any other malignancies within the last 5 years; - unstable systemic disease. ; PRIMARY OUTCOME: Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010); SECONDARY OUTCOME 1: Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - inTandem3 (Safety); BRIEF: This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D). ; DRUG USED: Zynquista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participants had given written informed consent to participate in the study in accordance with local regulations - Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent - Participants were being treated with insulin or insulin analog - Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol - At the Screening Visit, A1C was between 7.0% to 11.0% - Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test Exclusion Criteria: - Use of antidiabetic agent other than insulin or insulin analog at the time of screening - Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening - Chronic systemic corticosteroid use - Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator ; PRIMARY OUTCOME: Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization; SECONDARY OUTCOME 1: Change From Baseline in A1C[/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 - NS001 (Shoulder Impingement Syndrome); BRIEF: Objective: This purpose of this pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with shoulder impingement syndrome. ; DRUG USED: Synera; DRUG CLASS: Non-NME; INDICATION: Acute Pain; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Injury Care Medical Center; CRITERIA: Inclusion Criteria: - be at least 18 years of age. - have pain associated with shoulder impingement syndrome in a single shoulder (minimum 2-week duration). - have tenderness at the attachment site of the rotator cuff tendons. - have positive Hawkins and Neers signs. - report an average pain intensity score of 4 (on an 11-point scale) over the past 24 hours at the Screening/Baseline visit. Exclusion Criteria: - have used any topically applied pain medication on the target treatment area within 14 days preceding Study Day 1, such as non-steroidal anti-inflammatory drugs (NSAIDs), menthol, methyl salicylate, local anesthetics (including Lidoderm®), or steroids. - have used any injected medication within 60 days preceding Study Day 1, such as local anesthetic (lidocaine) or steroids. - have a clinically significant illness within 14 days of Screening/Day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study. - are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.) - have a history of and/or past diagnosis of severe hepatic disease. - have participated in a clinical trial of an unapproved drug within 30 days prior to screening. - are pregnant, breastfeeding, or a female of childbearing potential and not practicing an acceptable method of birth control. - are unable or unwilling, in the opinion of the investigators, to comply with all study procedures and cooperate fully with research staff. - have filed a disability claim or are currently receiving disability payments for shoulder impingement syndrome. ; PRIMARY OUTCOME: Pain Intensity; SECONDARY OUTCOME 1: Patient Global Assessment of Treatment Satisfaction[/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 - Predictable Motor Fluctuations; BRIEF: The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by: - ON time with no dyskinesia or non-troublesome dyskinesia - OFF time ; DRUG USED: DM-1992; DRUG CLASS: Non-NME; INDICATION: Parkinsons Disease (PD); TARGET: Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: Depomed; CRITERIA: Inclusion Criteria: 1. Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinsons disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when on. 2. Patients should be able to differentiate between the ON and OFF states with an average daily OFF time of ≥ 2.5 hours at study entry. 3. On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit. 4. Non CD/LD containing anti-Parkinsons medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration. 5. Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). 6. Mini Mental State Examination (MMSE) ≥ 26 at screening visit. 7. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization. 8. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation. Exclusion Criteria: 1. Patients with atypical or drug-induced Parkinsons disease. 2. Patients with a known history of hypersensitivity to levodopa or carbidopa. 3. Patients who receive treatments with dopamine receptor blocking agents 4. Patients with a history of seizures except of childhood febrile seizure. 5. Patients with dementia. 6. Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years. 7. Patients with any history of gastric surgery other than vagotomy and pyloroplasty. 8. Patients with an immune-compromised state. 9. Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5. 10. Patients with a calculated creatinine clearance (Clcr) < 50 mL/min using the Cockcroft-Gault equation. 11. Patients who have a difficulty swallowing tablets. 12. Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit. 13. Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results. ; PRIMARY OUTCOME: The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent OFF Time.; 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 - Rota-090; BRIEF: The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study. ; DRUG USED: Rotarix; DRUG CLASS: Vaccine; INDICATION: Rotavirus Vaccines; TARGET: Immune System, Rotavirus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol. - Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure. - A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination. - Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days). - Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: - Child in care - Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. - Administration of long-acting immune-modifying drugs at any time during the study period. - Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. - Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS). - History of IS. - Family history of congenital or hereditary immunodeficiency. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Major congenital defects or serious chronic illness. - Previous vaccination against RV. - Previous confirmed occurrence of RVGE. - GE within 7 days preceding the study vaccine administration. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. - Hypersensitivity to latex. - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. ; PRIMARY OUTCOME: Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C); SECONDARY OUTCOME 1: Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Progressive MS; BRIEF: A multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites. ; DRUG USED: NurOwn; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Brainstorm-Cell Therapeutics; CRITERIA: Inclusion Criteria: 1. Males and females ages 18 to 65 years old, inclusive, at the Screening Visit. 2. Clinical diagnosis of Progressive MS (Primary and Secondary) based on the 2017 revised MacDonald Criteria and confirmation by the Investigator that the disease has entered the progressive stage for at least 6 months prior to enrollment. 3. No evidence of clinical MS relapse or high dose pulse corticosteroid treatment within 6 months prior to screening 4. Disability status at screening with an Expanded Disability Status Scale (EDSS) 3.0-6.5, inclusive. 5. Able to walk 25 feet in 60 seconds or less. 6. Stable dose of non-excluded MS Disease Modifying Therapy for at least 6 months prior to Screening Visit (Visit 1). 7. Women of childbearing potential shall either be surgically sterile, or must agree not to become pregnant for the duration of the study. Women must be willing to undergo a serum pregnancy test at screening, and at the conclusion of the study. Participants of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study and for at least 3 months following the last transplantation. For those women who are sexually active and using oral contraceptives, a second form of barrier contraception is required. Men must be willing to consistently use two forms of contraceptive if their partners are of childbearing age. 8. Capable of providing informed consent and willing and able to follow study procedures, including willingness to undergo multiple/repeated lumbar puncture. Exclusion Criteria: 1. Prior stem cell therapy of any kind. 2. Active participation in any other MS interventional study or use of unapproved MS investigational therapy within 90 days prior to the Screening Visit (Visit 1). 3. Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate study procedures for any other reason. 4. History of clinically significant autoimmune disease (excluding thyroid disease) that may confound study results, in the opinion of the Investigator and the medical monitor, myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis. 5. Any unstable clinically significant medical condition other than multiple sclerosis (e.g., within six months of Screening Visit (Visit 1), had myocardial infarction, angina pectoris, and/or congestive heart failure), treatment with anticoagulants that, in the opinion of the investigator, would compromise the safety of participants. 6. Any history of malignancy within the previous 5 years, except for non-melanoma localized skin cancers (with no evidence of metastasis, significant invasion, or reoccurrence within three years of Screening Visit (Visit 1)). 7. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value >3.0 times the upper normal limit. 8. Serum creatinine value >2.0 times the upper normal limit. 9. Positive test for Hepatitis B (HBV; surface antigen (HBsAg) and antibodies to core antigen (IgG and IgM anti-HBc)), Hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2. 10. Current use of immunosuppressant medication or use of such medication within 6 months of study enrollment (aside from Rituximab or other approved B-cell immunotherapy). Alemtuzumab (Lemtrada), Cladribine (NDA submitted), Natalizumab (Tysabri), S1P modulators (Gilenya) are excluded for safety reasons due to the known risk of systemic autoimmune disease, malignancy, opportunistic infections, and cardiovascular toxicity associated with these therapies, as well as theoretical effects on MSC-NTF cell homing and migration, that may be associated with Natalizumab and/or S1P modulators (Gilenya). 11. Any history of acquired or inherited immune deficiency syndrome. 12. Any history of either substance abuse within the past year, or unstable psychiatric disease according to the Investigators judgment. 13. Pregnant women or women currently breastfeeding. 14. Subjects for whom MRI is contraindicated (i.e., have a pacemaker or other metallic implanted device, or are unable to remain in the machine for period of time needed to acquire a scan. ; PRIMARY OUTCOME: Number of Participants With Treatment-emergent Adverse Events; SECONDARY OUTCOME 1: Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT)[/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 - 002 - w/Gemcitabine and Oxaliplatin; BRIEF: The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with gemcitabine and oxaliplatin (GEMOX) in participants with relapsed or refractory B-Cell NHL. ; DRUG USED: MT-3724; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Cluster of Differentiation 20 (CD20), Protein synthesis; THERAPY: Combination; LEAD SPONSOR: Molecular Templates, Inc.; CRITERIA: Inclusion Criteria: 1. Be adequately informed about the study and fully consent to participation as demonstrated by signing the written informed consent form before any screening procedure. 2. Be aged ≥18 years on the date of signing the informed consent form. 3. Have relapsed or refractory B-cell NHL that, in the investigators opinion, could benefit from MT-3724+GEMOX therapy. At least one histologically documented relapse of NHL, by: 1. Bone marrow biopsy (FNA is not acceptable) or 2. Excisional lymph node biopsy or 3. Core biopsy of any involved organ (FNA not acceptable) 4. CD20-positive histology must have been confirmed at any time during NHL disease course and documented in the medical history 5. If no histology is available after any relapse the investigator can consult the medical monitor to discuss if the patient can be included 4. All subtypes of B-cell NHL may be considered for Part 1 (MT-3724 dose escalation). Only histologically documented DLBCL (including mixed histology) may be considered for Part 2 (expansion cohort). 5. Have received all approved therapies for NHL that are applicable for the patient in the opinion of the treating physician. 1. Patients refractory to treatment are eligible. 2. Patient who have progressed following CAR T-cell therapy are also eligible. 6. Have measurable disease by Lugano Classification for NHL 1. >1.5 cm longest diameter (LDi) for lymph nodes 2. >1 cm LDi for extranodal disease 7. Have ECOG performance score of ≤2. 8. Have adequate bone marrow function, as determined by: 1. Absolute neutrophil count (ANC) ≥1,000/mm3 and 2. Platelet count ≥50,000 mm³ 9. Have adequate kidney function, assessed by thecreatinine clearance (CLcr) to be ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula. . a. At the investigators discretion,calculated estimated CLcr of < 50mL/min may be verified eGFR based on the 24-hour urine collection. Subjects with GFR ≥50 mL/min will be eligible irrespective of the estimated CLcr result. 10. Have adequate hepatic function, as determined by: 1. Total bilirubin ≤1.5 x ULN, or ≤3 x ULN for subjects with Gilberts Syndrome and 2. Aspartate aminotransferase (AST) ≤3 x ULN (or ≤ 5.0 x ULN if liver involvement) and 3. Alanine aminotransferase (ALT) ≤3 x ULN (or ≤ 5.0 x ULN if liver involvement). 11. Have adequate coagulation, as determined by: 1. INR or PT ≤1.5 x ULN 2. aPTT ≤1.5 x ULN 12. Have adequate serum albumin, as determined by: a. Albumin ≥ 3.0 g/dL 13. Women of reproductive potential must have a negative pregnancy test during the screening period within 72 hours before the start of treatment. Women not of reproductive potential are female subjects who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy,bilateral salpingectomy). 14. Subjects of reproductive potential and their partners must agree to either to abstain continuously from heterosexual intercourse or to use a reliable birth control method between signing the informed consent until 6 months following the last dose of MT-3724 or GEMOX . The investigator or a designated associate should advise the subject how to achieve adequate contraception. The following birth control methods may be considered as adequate 1. Condoms (male or female) with or without a spermicidal agent; 2. Diaphragm or cervical cap with spermicide; 3. Intrauterine device; 4. Hormone-based contraception: Established use of oral, injected, or implanted hormonal methods of contraception; 5. True abstinence; 6. Vasectomy is an acceptable method for a male subject or male partner of a female subject. Exclusion criteria: 1. History or current evidence of neoplastic disease that is histologically distinct from NHL except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer, or any other previous cancer curatively treated >2 years before the start of treatment. 2. Current evidence of new or growing brain or spinal metastases during screening. 3. History of allogeneic hematopoietic stem cell transplant within 180 days before the start of treatment. 4. Current evidence of acute or chronic Graft versus Host Disease. 5. Current evidence of CTCAE Grade >1 toxicity (except for hair loss, and those toxicities 6. Current evidence of incomplete recovery from surgery before the start of treatment, or planned surgery at any time during the study until the EoT Visit, except minor elective interventions deemed acceptable by the investigator. 7. History or current evidence of significant (CTCAE Grade ≥2) infection or wound within 4 weeks before the start of treatment. 8. Patients with uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to start of study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis may not be enrolled. 9. Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation. 10. Patients with known active Hepatitis C, HIV or a present history of Hepatitis B 11. Women who are pregnant or breastfeeding 12. History or current evidence of hypersensitivity to any study drugs, or current evidence of hypersensitivity requiring systemic steroid doses ≥20 mg/day Prednisone equivalent 13. Received any amount of anti-CD20 MAb therapy within the following periods before the start of treatment 1. Rituximab (Rituxan®): 84 days; if a subject had received rituximab within 37 Weeks before the start of treatment, then a serum rituximab level must be negative (<500 ng/mL) at the screening period 2. Obinutuzumab (Gazyva®): 184 days 3. Ofatumumab (Arzerra®): 88 days 14. Received therapy for NHL (except anti-CD20 Mab listed above) within 4 weeks before the start of treatment 15. Any investigational drug treatment from 4 weeks or 5 half-lives of the agent before the start of treatment, whichever is longer, until the EoT Visit 16. Received radiotherapy to tumor lesions that would be chosen as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between the radiotherapy and the screening according to the Lugano Classification for NHL. a. Palliative radiotherapy to non-target lesions is allowed at the investigators discretion after consultation with the Medical Monitor and sponsor. 17. Received any vaccines within 28 days of the start of treatment, or likely to require vaccines at any time from the start of treatment until 28 days after the last dose of MT-3724. Injectable flu vaccine (inactivated or recombinant) is permitted at the investigators discretion 18. Received systemic immune modulators within 2 weeks before the start of treatment including but not limited to systemic corticosteroids >20 mg/day of prednisone equivalent, cyclosporine and tacrolimus. Corticosteroids for pre-medication and NSAIDs are permitted. 19. Received any investigational drug treatment within 4 weeks or within 5 half-lives of the therapeutic agent before the start of treatment, whichever is longer, until EoT Visit ; PRIMARY OUTCOME: Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724[/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 - ANGLeD; BRIEF: This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases. ; DRUG USED: ANG1005; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Secondary; Metastases); TARGET: Cluster of Differentiation 91 (CD91) / Low density lipoprotein receptor-related protein 1 (LRP1), Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Angiochem Inc; CRITERIA: Inclusion Criteria: 1. ≥ 18 years old 2. HER2-negative breast cancer 3. At least 2 months of expected survival 4. Newly diagnosed leptomeningeal carcinomatosis 5. Documented history of brain metastasis that has been previously treated with radiation therapy 6. Neurologically stable 7. Eastern Cooperative Oncology Group performance status grade ≤2 8. Adequate laboratory test results prior to first dose 9. Patients who are fertile must agree to remain abstinent or use reliable method of birth control Exclusion Criteria: 1. Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt 2. Prior treatment with ANG1005 3. Patients who have not had radiotherapy for their brain metastases 4. Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure 5. Patients for whom intrathecal therapy is the most appropriate therapy for leptomeningeal disease 6. Pregnancy or lactation and patients planning to be pregnant during the study 7. Peripheral neuropathy > Grade 2 8. Evidence of severe or uncontrolled diseases 9. Presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV 10. History of interstitial lung disease 11. Severe conduction disturbance 12. Central nervous system disease requiring immediate neurosurgical intervention 13. Known allergy to paclitaxel or any of its components 14. Contra-indication for contrast-enhanced MRI ; PRIMARY OUTCOME: Overall survival; SECONDARY OUTCOME 1: Central nervous system 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 - Dose Escalation; BRIEF: This study is a Phase 1/2, first-in-human, open-label, dose-escalation, and expansion study designed to characterize the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of IMGC936 administered by intravenous (IV) infusion. ; DRUG USED: IMGC936; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: A Disintegrin and Metalloproteinase 9 (ADAM9), Antibody-drug Conjugate (ADC), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: ImmunoGen, Inc.; CRITERIA: Inclusion Criteria: 1. Participants with histologically proven, relapsed or refractory, unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), colorectal cancer (CRC), gastroesophageal cancer, or pancreatic cancer for whom no therapy with demonstrated clinical benefit is available. 1. NSCLC: Participants must have been treated with 1 to 4 prior lines of systemic therapy with no more than 2 chemotherapy containing lines. 2. TNBC: Participants must have been treated with 1 to 4 prior lines of systemic therapy for metastatic disease, excluding adjuvant therapies. 3. CRC: Participants must have been treated with 1 to 3 prior lines of systemic therapy. 4. Gastroesophageal cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy. 5. Pancreatic cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy, with no more than 2 chemotherapy containing lines. 2. Either measurable or non-measurable disease per RECIST 1.1 and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) obtained within 28 days of C1D1. - Dose escalation: Participants may have non-measurable or measurable disease - Dose expansion: Participants must have measurable disease 3. Age ≥ 18 years old. 4. Archival formalin-fixed paraffin-embedded (FFPE) tissue must be available. Participants may undergo a fresh tumor biopsy using a low risk, medically routine procedure to obtain a specimen for testing if a tumor sample is not available. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. If ECOG performance status is an inappropriate performance measurement for participant enrollment (eg, chronically non-ambulatory), then Karnofsky performance status must be ≥ 70. 6. Life expectancy ≥ 12 weeks. 7. Acceptable laboratory parameters as follows: - Platelet count ≥ 75 × 1000/μL without transfusion within 28 days prior to initiation of study drug. - Absolute neutrophil count ≥ 1.5 × 1000/μL in the absence of any growth factor support within 21days prior to initiation of study drug. - Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN); for participants with hepatic metastases, ALT and AST ≤ 5 × ULN. - Total bilirubin ≤ 1.5 × ULN, except participants with Gilberts syndrome, who may enroll if the conjugated bilirubin is within normal limits. - Estimated glomerular filtration rate (eGFR) >30mL/min/1.73m2 or an estimated creatinine clearance of >30 mL/min. - Urinalysis protein and white occult blood cells within normal limits. - Negative serum pregnancy test for females of childbearing potential (FOCBP). 8. FOCBP, defined as not surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and between menarche and 1-year post menopause, must have a negative serum pregnancy test performed within 72 hours prior to initiation of study drug administration. Female participants must abstain from egg donation during the study. 9. FOCBP and male participants with partners of FOCBP must agree to use highly effective methods of contraception, from the time of consent through 28 weeks after discontinuation of study drug administration. Male participants must abstain from sperm donation during the study. 10. FOCBP is not pregnant or breastfeeding, or a male participant is not expecting to father children within the projected duration of the study, starting with screening visit through 28 weeks after the last dose of study drug. Exclusion Criteria: 1. Active central nervous system (CNS) disease within the last 6 months. 2. Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision. 3. Participants who had prior therapies within the specified times below: - Systemic antineoplastic therapy at least 5 half-lives or 4 weeks (whichever is shorter) prior to initiation of study drug. - Mediastinal or pelvic radiation therapy within 6 weeks prior to initiation of study drug administration. Palliative, limited field radiation for symptom control to soft tissues, or bone lesions within 2 weeks prior to initiation of study drug. 4. Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia). 5. Clinically significant cardiovascular disease including but not limited to: - Myocardial infarction or unstable angina within 6 months prior to initiation of study drug. - Stroke or transient ischemic attack within 6 months prior to initiation of study drug. - Current clinically significant cardiac arrhythmias, e.g., atrial fibrillation that are not well controlled with optimal medical intervention. - Current uncontrolled hypertension: systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg. - Current congestive heart failure (New York Heart Association class III-IV). - Current pericarditis or clinically significant pericardial effusion. - Current myocarditis. - Left ventricular ejection fraction (LVEF) of < 50% by scan - QTc interval > 480 msec 6. Clinically significant pulmonary compromise, including pneumonia, pneumonitis, or a requirement for supplemental oxygen (excluding for sleep apnea) or history of ≥ Grade 3 drug-induced or radiation pneumonitis. 7. Serious concurrent illness or clinically relevant active infection, including, but not limited to the following: - Active hepatitis B or C infection (whether or not on active antiviral therapy). - Human immunodeficiency virus infection. - Cytomegalovirus infection. - Active COVID-19/SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines/standards. - Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to initiation of study drug. 8. History of prior bone marrow, stem cell, or solid organ transplantation. 9. Second primary invasive malignancy that has not been in remission for greater than 2 years except nonmelanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ. 10. Major trauma or major surgery within 4 weeks prior to initiation of study drug. 11. Any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the study site. 12. Known hypersensitivity to any ingredient or any excipient contained in the drug formulation 13. Vaccination with any live virus vaccine within 4 weeks prior to initiation of study drug. Inactivated annual influenza vaccination is allowed. ; PRIMARY OUTCOME: During dose escalation measure incidence and severity of Treatment Emergent Adverse Events by CTCAE v5.0; SECONDARY OUTCOME 1: During dose escalation and expansion to characterize study drug concentration[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - US (Tumor Immunity); BRIEF: Open-label, single-arm, multi-center, Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP 301 in patients with unresectable/unresected metastatic melanoma. This proof of concept study will be undertaken in male and female patients with unresectable Stage III and IV melanoma. Patients with unresectable/unresected mucosal melanoma may be enrolled after consultation with the Medical Monitor. ; DRUG USED: Telomelysin; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Oncolytic Virus Therapy, Telomerase, Tumor Cells; THERAPY: Monotherapy; LEAD SPONSOR: Syneos Health; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically confirmed malignant melanoma at Screening that is unresectable/unresected Stage IIIB, IIIC, IIID or IV. Patients with unresectable mucosal melanoma may be enrolled after consultation with the Medical Monitor. 2. Patients must have received and failed or refused available therapy for unresectable/unresected Stage III or IV melanoma. 3. Patients must be ≥ 18 years of age. 4. At least 2 cutaneous, subcutaneous and/or lymph node target lesions that are greater or equal to 1 cm in the longest diameter. One of the cutaneous, subcutaneous and/or lymph node target lesions should be designated at Screening as a noninjected target lesion. Willing to have biopsy specimens taken at Screening and at Week 6. 5. Life expectancy of ≥ 6 months from the first OBP-301 treatment. 6. Karnofsky Performance Status Scale (KPS) score of ≥ 70. 7. Adequate organ function, hematologic status, coagulation status, kidney function, and liver function as follows: - Absolute neutrophils > 1,500/µL - Hemoglobin > 9 g/dL, without transfusion or hematopoietic growth factor - Platelets > 100,000/µL. Patients with ≤ 100,000 platelet count may be allowed into the study on a case-by-case basis after consultation with the Medical Monitor. - Serum creatinine < 2 × upper limit of normal (ULN) - Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × ULN except for patients with known liver metastases, in which case aspartate transaminase or alanine transaminase may be ≤ 5.0 × ULN - Total bilirubin < 2.0 mg/dL (≤ 3.0 mg/dL for patients with known Gilberts syndrome) - Serum lactate dehydrogenase (LDH) levels < 1.5 × ULN 8. Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed. 9. Patients of reproductive potential must use effective contraception for the duration of the study and for 3 months (90 days) after the last administered injection of OBP-301. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device. Exclusion Criteria: 1. Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before the first OBP-301 administration. 2. Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before the first OBP-301 administration. 3. Patients who have had radiotherapy within the last 4 weeks before the first OBP-301 administration. 4. Effects of any other prior therapies not reverted to ≤ Grade 1 (or ≤ Grade 2 for alopecia and peripheral neuropathy). 5. Patients who have any liver metastases or visceral metastasis of ≥ 3 cm, plus evidence of progression meeting irRC 1.0 within 1 month before the first OBP-301 administration. 6. Patients with clinically active brain metastases. However, patients with previously currently stable brain metastases on medication (i.e., steroids and/or anti-seizure medications) may be enrolled after consultation with the Medical Monitor. 7. Patients known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). 8. Patients diagnosed with additional malignancy within 3 years before the first OBP-301 administration with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers. 9. Patients requiring chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids or cyclosporine should be evaluated by the Medical Monitor for enrollment eligibility. 10. Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures. 11. Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after the last OBP-301 administration. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of OPB-301. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months. ; PRIMARY OUTCOME: Evaluate objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions; SECONDARY OUTCOME 1: Overall Response Rate at weeks 6, 12, 18, and 24 in the combined and individual injected lesions[/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 - I6M-MC-SSAD; BRIEF: The main purpose of this study is to learn more about the safety and side effects of the study drug known as LY3090106 in participants with Sjögrens Syndrome (SS). The study will also evaluate how much of the study drug gets into the blood stream and how long it takes the body to remove it. ; DRUG USED: LY3090106; DRUG CLASS: Biologic; INDICATION: Sjogrens Syndrome; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have a confirmed diagnosis of SS by the American-European Consensus Group criteria with active disease (at any level), as per judgment of the investigator (participants with another concurrent, stable connective tissue disease may be eligible for inclusion, with written approval from the sponsor). - Are seropositive for auto-antibodies associated with SS (anti-SSA or anti-SSB) at screening, or documented within 6 months prior to screening. Exclusion Criteria: - Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug, are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or have received: - Any nonbiologic investigational product within 30 days or 5 half-lives (whichever is longer) of study baseline, - Any biologic investigational product within 3 months or 5 half-lives (whichever is longer) of study baseline, or any leukocyte depleting agent within 12 months of baseline, - Have synthetic disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive use as follows: - Any treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study, - Unstable prescribed dose of other synthetic DMARDs (eg, hydroxychloroquine, methotrexate, leflunomide, sulfasalazine, or gold salts) within 28 days prior to baseline or if the dose of drug is planned to be increased during the study. (Stable prescriptions are allowed.) - Cytotoxic or immunosuppressive drugs including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to screening or planned treatment during the study. - Have had treatment with biologic DMARDs as follows: - Etanercept, adalimumab, or anakinra <4 weeks before baseline or planned treatment during the study. - Infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks before baseline or planned treatment during the study. - Rituximab, belimumab or other leukocyte depleting agent <12 months before baseline or planned treatment during the study. Note: other biologic agents may be allowed after written approval from the sponsor. - Have a prescribed dose >10 milligrams (mg)/day of oral prednisone (or equivalent) within 28 days before baseline, or plan to increase >10 mg/day during the study. (Stable prescriptions ≤10 mg/day are allowed.) Treatment with inhaled or parenteral corticosteroids within 28 days prior to baseline is prohibited. A single intra-articular corticosteroid injection is permitted within 28 days prior to baseline if no more than 40 mg triamcinolone (or equivalent) is administered. The treated joint should be excluded from any joint-specific evaluations during the study. - Have an unstable prescribed dose of a cholinergic stimulant (eg, pilocarpine, cevimeline) within 28 days prior to baseline. (Stable prescriptions are allowed.) - Have an unstable prescribed dose of cyclosporine eye drops within 28 days prior to baseline. (Stable prescriptions are allowed.) ; PRIMARY OUTCOME: Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration; SECONDARY OUTCOME 1: Pharmacokinetics: Maximum Concentration (Cmax) of LY3090106[/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 - TRIA-201; BRIEF: This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH ; DRUG USED: HM15211; DRUG CLASS: Biologic; INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: GIP Receptor (GIPR)/Glucose-Dependent Insulinotropic Polypeptide Receptor, GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Hanmi Pharmaceutical Company Limited; CRITERIA: Inclusion Criteria: - United States Sites: Adults ≥ 18 to ≤ 70 years. - Korean Sites: Adults ≥ 19 to ≤ 70 years. - BMI ≥ 18 kg/m2, with stable body weight (defined as change < 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier. - Subjects have a diagnosis of noncirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7. - MRI-PDFF performed at screening with ≥ 8% steatosis. Exclusion Criteria: - Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilsons disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV). - Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease >12. - Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines). - Type 1 diabetes subjects, or T2DM subjects on insulin and/or GLP-1 receptor agonist therapy, or other therapies not allowed for this study ; PRIMARY OUTCOME: pharmacodynamic (PD) effect of HM15211; 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 - LUMINA-1; BRIEF: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia ; 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 18-75 2. UPCR ≥ 1 g protein/g creatinine (or at 113 mg.mmol) at screening 3. Diagnosis of FSGS based on renal biopsy or high risk genetic variant 4. Diagnosis of one of primary FSGS based on characteristic histopathology, medical history and clinical course or FSGS secondary to genetic variants associated with increased risk or severity. 5. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2 6. Clinical stable blood pressure not to exceed 145/95 mmHg 7. RAAS blockers must be stable for at least 4 weeks prior to screening and projected to remain stable through week 12, unless adjustments are required for management of hypertension. 8. Immunosuppressive or immunomodulatory therapy must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12 9. Glucocorticoids must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12. 10. Both genders of childbearing potential must agree to use adequate contraception during and for at least 3 months after the last dose of study drug. 11. Subjects must be willing and able to give written Informed Consent and to comply with protocol requirements. 12. Subjects must be judged to be otherwise fit for the study by the Investigator. - Exclusion Criteria: 1. Pregnant or nursing 2. History of organ transplantation 3. On an organ transplant waiting list or anticipated organ transplant within 6 months of screening 4. Anti-CD20 monoclonal antibodies within 20 months of screening are exclusionary. Subjects that used anti CD20 monoclonal antibodies prior to week 20 are allowed with confirmed recovery of CD20+ B cell population to within normal range 5. Plasmapheresis within 12 weeks of screening 6. BMI ≥40 7. Participation in any clinical study of an investigational product within 12 weeks or 5 half-lives of screening 8. Currently on dialysis or likely to require dialysis during the blinded treatment phase of the study. 9. History or presence of any form of cancer within 5 years of screening except excised basal cell or squamous cell carcinoma or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or completed resected without evidence or recurrence. 10. Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months following discontinuation of treatment, will be considered to have a negative HCV screening test 11. Renal disease associated with disorders other than FSGS that is active or has significant risk of progressing during the course of the study. 12. Disorders that are associated with FSGS lesions. 13. Evidence of tuberculosis. 14. Evidence of hepatic disease with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin) 15. Hematologic abnormalities as follows: Hb <8 g/dL, platelets <50,000, ANC <1000 cells/µL) at baseline. 16. QTcF greater than 450 msec. 17. History of alcohol or illicit drug abuse or of lithium, pamidronate and interferon. Recreational use of cannabis is not excluded where legal. 18. History of gastrointestinal conditions that may interfere with study medication compliance. 19. Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon dioxide). 20. History or presence of systemic disorder other than FSGS that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study; topical or inhaled glucocorticoids and immune modulators are not excluded. 21. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation. 22. Subjects taking strong CYP3A4 inducers or strong CYP3A4 inhibitors within two weeks prior to screening. 23. Subjects taking lithium or interferon; subjects taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e. occasional NSAIDS for pain or fever is discouraged, but is not excluded). - ; PRIMARY OUTCOME: Change From Baseline in UPCR at Week 12; SECONDARY OUTCOME 1: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OLE; BRIEF: This is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212 (NCT02344004). ; DRUG USED: Arikayce; DRUG CLASS: Non-NME; INDICATION: Respiratory Tract Infections (Excluding Pneumonia) (Antibacterial); TARGET: Bacterial ribosome, Cell wall synthesis, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Insmed Incorporated; CRITERIA: Key Inclusion Criteria: 1. had successfully completed the Month 6 and End of Treatment visits in Study INS-212 2. had not achieved the INS-212 protocol definition of culture conversion by Month 6 in Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212. Key Exclusion Criteria: 1. achieved culture conversion without relapse or recurrence in the Study INS-212 study by Month 6 ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Number of Participants Achieving Culture Conversion by Month 6 and Month 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Interaction w/Diltiazem; BRIEF: The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468 ; DRUG USED: Daridorexant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Insomnia; TARGET: Hypocretin/orexin receptor ; THERAPY: Combination; LEAD SPONSOR: Idorsia Pharmaceuticals Ltd.; CRITERIA: Inclusion Criteria: - Signed informed consent - Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening - Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests Exclusion Criteria: - Any contraindication to the study drugs - History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs - History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0 - Any circumstances or conditions, which, in the opinion of the investigator, may affect the subjects full participation in the study or compliance with the protocol ; PRIMARY OUTCOME: Maximum plasma concentration (Cmax) of ACT-541468; 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 - TDU11685 (Part I); BRIEF: Study objectives: - Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945. - Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945. ; DRUG USED: SAR113945; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: IkappaB kinase (IKK); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Diagnosis of primary knee osteoarthritis, based upon the following: - X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation - Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72. - Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis. Exclusion criteria: - Patients younger than 40 years - Women of child bearing potential. - Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level >30 IU/L. - Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Pagets disease, Ehlers-Danlos Syndrome, Gauchers disease, Sticklers syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy. - Presence of local skin abnormality at the affected knee joint. - Intra-articular injection within 3 months. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Pain, Stiffness and Physical Function sub-scales from the WOMAC Index; SECONDARY OUTCOME 1: Pharmacokinetics (Cmax)[/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 - HUDSON; BRIEF: This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms. ; DRUG USED: Enhertu; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Topoisomerase I (Topo-I); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria: - At least 18 years of age at the time of signing the informed consent form. - Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing. - Patients eligible for second- or later-line therapy, who must have received an antiPD1/PD-L1 containing therapy and a platinum-doublet regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The patient must have had disease progression on a prior line of antiPD1/PD-L1 therapy. - ECOG/WHO performance status of 0 to 1, and a minimum life expectancy of 12 weeks. - Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed. - Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Exclusion Criteria: - Patients whose tumour samples have targetable alterations in EGFR and/or ALK at initial diagnosis are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded. - Active or prior documented autoimmune or inflammatory disorders. - Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). - Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control. - Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients, or history of severe hypersensitivity reactions to other monoclonal antibodies. - Patient has spinal cord compression or symptomatic brain metastases. - Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Patients may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors for the treatment of bone metastases. - history of active primary immunodeficiency ; PRIMARY OUTCOME: Assessment of the efficacy of each treatment by evaluation of objective response rate; SECONDARY OUTCOME 1: Disease control rate (DCR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy.[/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 - DME/RVO (003); BRIEF: Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion ; DRUG USED: GB-102; DRUG CLASS: Non-NME; INDICATION: Macular Edema from Retinal Vein Occlusion (RVO) (Ophthalmology); TARGET: Angiogenesis, Platelet-derived growth factor (PDGF), VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Graybug Vision; CRITERIA: Inclusion Criteria: - Males or females ≥ 21 years of age - Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab) - Demonstrated response to prior anti-VEGF treatment since diagnosis - BCVA of 31 letters or better Exclusion Criteria: - History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke - Uncontrolled hypertension, diabetes mellitus or IOP - Chronic renal disease ; PRIMARY OUTCOME: Occurrence of Adverse Events (AEs) Across All Study Visits; SECONDARY OUTCOME 1: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits[/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 - 005 (Hematologic Malignancies); BRIEF: This is a study to determine the recommended dose of birabresib (MK-8628) for further studies in participants with acute myeloid leukemia (AML) including AML de novo and AML secondary to myelodysplastic syndrome (MDS) and in participants with diffuse large B cell lymphoma (DLBCL). The recommended dose will be established by evaluating dose limiting toxicity (DLT), safety, tolerability, and early efficacy signals. ; DRUG USED: MK-8628; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Myelogenous Leukemia (AML); TARGET: BET Proteins/Bromodomains, BRD4 (Bromodomain Containing 4); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Diagnosis of AML (AML de novo and post-MDS) or DLBCL - AML participants must have the following malignancy criteria: measurable and evaluable disease per tumor response criteria; ≥ 5% bone marrow blasts without alternate causality; and > 90 days since allogeneic stem cell transplantation relapse in participants relapsing after transplant - AML participants who are Philadelphia chromosome positive must have received ≥ 2 lines of therapy, including 2 bcr-abl tyrosine-kinase (TK) inhibitors (among imatinib, nilotinib and dasatinib), or only 1 line including 1 TK inhibitor if the relapse/refractoriness is associated with the detection of a resistance mutation to these inhibitors - AML participants < 60 years old must be in second or further relapse or relapsing after allogeneic stem cell transplantation regardless of number of relapses - AML participants ≥ 60 years old in first relapse with a disease-free interval < 12 months, or further relapse. First relapse is also applicable to AML post-MDS patients who have received prior treatment for MDS, but have not received prior treatment for AML. - DLBCL participants must have the following malignancy criteria: measurable and evaluable disease per tumor response criteria and ≥ 1 tumor mass that is ≥ 15 mm (long axis of lymph node) or ≥ 10 mm (short axis of lymph node or extranodal lesions) on spiral CT scan; failed 2 standard lines of therapy (at least one containing an anti-CD20 monoclonal antibody), or for whom such treatment is contraindicated. - Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 - An interval of ≥3 weeks since chemotherapy (≥ 6 weeks for nitrosoureas or mitomycin C), immunotherapy, hormone therapy or any other anticancer therapy or surgical intervention resection, or ≥3 half-lives for monoclonal antibodies, or ≥ 5 half-lives for other non-cytotoxic agents (whichever is longer) - Female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start) - Female and male participants of reproductive potential must agree to use adequate contraception starting from the first dose of trial treatment through 90 days after the last dose of study medication Exclusion Criteria: - Known primary central nervous system (CNS) malignancy or symptomatic or untreated CNS metastases - History of prior or concomitant malignancies within 3 years of study start - Has other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within 1 year of study start - Known history of human immunodeficiency virus (HIV) and/or active Hepatitis B or C infections - Has one of the following cardiac-related conditions: Congestive heart failure; angina pectoris; myocardial infarction (within 1 year of study start); uncontrolled hypertension; or uncontrolled arrhythmias - Is receiving other concomitant anticancer treatment - Has received high dose chemotherapy followed by autologous stem cell transplantation less than 90 days prior to first dose of study treatment - Is receiving concomitant therapy with strong CYP3A4 or CYP2A6 inhibitors or inducers - Is pregnant or breast-feeding - Participation in a clinical trial involving an investigational drug within 30 days of study start - Known additional malignancy that is progressing or requires active treatment - Has been previously treated with a Bromodomain and Extra-terminal (BET) inhibitor - Has acute promyelocytic leukemia, clinically uncontrolled disseminated intravascular coagulation, or peripheral cytopenia - Has chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD - Has uncontrolled disease-related metabolic disorder - Unable to swallow oral medications, or has gastrointestinal condition deemed to jeopardize intestinal absorption. ; PRIMARY OUTCOME: Percentage of Participants With a Dose Limiting Toxicity (DLT); SECONDARY OUTCOME 1: Percentage of Participants Who Experienced At Least One Adverse Event (AE)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - PK/Safety (Belgium); BRIEF: Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab. ; DRUG USED: Cyltezo; DRUG CLASS: Biosimilar; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: Healthy males according to the following criteria: 1. Based upon a complete medical history, including the physical examination, vital signs (blood pressure [BP] and pulse rate [PR]), 12-lead electrocardiogram (ECG), and clinical laboratory tests; 2. Age-greater than or equal to 18 years and less than or equal to 55 years; 3. Body mass index (BMI) =18.5 to =29.9 kg/m2; and 4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation. Exclusion criteria: 1. Any clinically relevant abnormal finding of the medical examination (including blood pressure (BP), pulse rate (PR), and electrocardiogram (ECG) deviating from normal and of clinical relevance; 2. Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders, or diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders; 3. History of relevant orthostatic hypotension, fainting spells, or blackouts; 4. Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation; 5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients); 6. Intake of prescribed or over-the-counter drugs with a long half-life (greater than 24 hours) within at least one month or at least 5 half-lives of the respective drug (whichever is longer) prior to administration or during the trial; 7. Previous exposure of a biologic drug; 8. Use of drugs which might reasonably influence the results of the trial prior to dosing and at any time during the trial; 9. Intake of an investigational drug in another trial within two months prior to intake of study medication in this trial or intake of an investigational drug during the course of this trial; 10. Smoker (greater than 10 cigarettes or greater than 3 cigars or greater than 3 pipes/day); 11. Inability to refrain from smoking during days of confinement at the trial site; 12. History of alcohol abuse (estimated average more than 4 units/day); 13. Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the study medication administration and until Day 7 post study medication administration; 14. Unwillingness/inability to limit alcohol intake to a maximum of three units per day until e.o.s.; 15. Current drug abuse; 16. Blood donation (more than 100 mL within four weeks prior to administration of the study medication or during the trial); 17. Vigorous exercise 72 hours prior to dosing. Unwilling to avoid vigorous exercise for 7 days post dosing. Contact sport should be avoided during the entire study; 18. Any out-of-range laboratory values considered clinically significant by the investigator; subjects with creatine kinase (CK) values three times the upper limit of normal (ULN) at Day -1 are excluded from participation; 19. Subjects considered unsuitable for inclusion by the investigator (e.g., inability to understand and comply with the study requirements or presence of any condition which, in the opinion of the investigator, would not allow safe participation in the study); or 20. Inability to comply with dietary regimen of trial site. 21. Subjects with known Human immunodeficiency virus (HIV), Acquired Immunodeficiency Syndrome, other clinically significant immunological disorders, or auto-immune disorders, (e.g., Rheumatoid arthritis (RA), lupus erythematosus, scleroderma, etc.); 22. Subject has received a live or attenuated vaccine within 12 weeks prior to enrolling in the trial; or 23. Positive finding in Interferon-gamma-release assay testing (IGRA-T). In cases where at the screening visit the IGRA result is indeterminate, the subject will have a PPD skin test performed, provided that the screening period timeframe can be maintained. If not, the subject will not be enrolled in this study. ; PRIMARY OUTCOME: Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®; SECONDARY OUTCOME 1: AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®[/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 - OPH 1000 ; BRIEF: The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). ; DRUG USED: Fovista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Platelet-derived growth factor (PDGF); THERAPY: Monotherapy; LEAD SPONSOR: Ophthotech Corporation; CRITERIA: Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD Exclusion Criteria: - Any of the following underlying diseases including: - Diabetic retinopathy. - History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment. - History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation. - Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. - Stroke (within 12 months of trial entry). - Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition. Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the E10030 formulation. ; PRIMARY OUTCOME: Ophthalmic DLTs; SECONDARY OUTCOME 1: adverse events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - HMR-2001; BRIEF: Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59. ; DRUG USED: HMR59; DRUG CLASS: Biologic; INDICATION: Dry Age-Related Macular Degeneration (Dry AMD)/Geographic Atrophy (Ophthalmology); TARGET: Cluster of Differentiation 59 (CD59); THERAPY: Monotherapy; LEAD SPONSOR: Hemera Biosciences; CRITERIA: Inclusion Criteria: 1. Advanced dry AMD with GA in the study eye 2. BCVA in the study eye of 80 or less ETDRS letters (Snellen equivalent 20/25 or worse) 3. Total cumulative GA lesion size 2.5 mm2 to 12.5 mm2 in the study eye as confirmed by the reading center during the Screening Period. Exclusion Criteria: 1. GA secondary to non-AMD etiologies in the study eye (i.e. myopia, inherited retinal diseases). 2. GA associated with the presence of an RPE rip. 3. GA contiguous with peripapillary atrophy. 4. Active CNV secondary to wet AMD in the study eye and currently receiving anti-VEGF ocular treatment within the previous 18 months. 5. Subretinal fibrosis in the macula from CNV both clinically and imaged on SD-OCT in the macula. 6. Previous macular laser photocoagulation (i.e. focal or grid laser for macular edema), photodynamic therapy (PDT), ocular/orbital radiation, laser to CNV, or subretinal surgery for CNV in the study eye. 7. History of conditions in the study eye which might alter visual acuity or interfere with study testing including proliferative diabetic retinopathy (PDR), clinically significant macular edema (CSME), central retinal vein occlusion (CRVO), hemi retinal vein occlusion (HRVO), macular branch retinal vein occlusion, and optic neuropathy. 8. Active uncontrolled glaucoma with at least one of the following: IOP>30 mmHg despite maximum medical treatment with glaucoma medications, cup-to-disc ratio of >0.9, visual field defects secondary to glaucoma that involve the macula, or optic atrophy from glaucoma. 9. Active acute or chronic infectious uveitis, retinitis, or conjunctivitis (excluding blepharitis) ; PRIMARY OUTCOME: Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24; SECONDARY OUTCOME 1: Incidence of conversion from dry to wet age-related macular degeneration[/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 III - STR1VE; BRIEF: Phase 3 pivotal US trial studying open-label intravenous administration of onasemnogene abeparvovec-xioi in spinal muscular atrophy (SMA) Type 1 participants. ; DRUG USED: Zolgensma; DRUG CLASS: Biologic; INDICATION: Spinal Muscular Atrophy; TARGET: Survival of Motor Neuron (SMN) Protein; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Gene Therapies; CRITERIA: Inclusion Criteria: - Participants with SMA Type 1 as determined by the following features: a. Diagnosis of SMA based on gene mutation analysis with bi-allelic SMN1 mutations (deletion or point mutations) and 1 or 2 copies of SMN2 (inclusive of the known SMN2 gene modifier mutation (c.859G>C))2 - The first 3 participants enrolled must meet the criteria for the Intent-To-Treat Population - Participants must be < 6 months (< 180 days) of age at the time of onasemnogene abeparvovec-xioi infusion - Participants must have a swallowing evaluation test performed prior to administration of gene replacement therapy - Up-to-date on childhood vaccinations. Seasonal vaccinations that include palivizumab prophylaxis (also known as Synagis) to prevent respiratory syncytial virus (RSV) infections are also recommended in accordance with American Academy of Pediatrics - Parent(s)/legal guardian(s) willing and able to complete the informed consent process and comply with study procedures and visit schedule Exclusion Criteria: - Previous, planned or expected scoliosis repair surgery/procedure during the study assessment period - Pulse oximetry < 96% saturation at screening while the participant is awake or asleep without any supplemental oxygen or respiratory support, or for altitudes > 1000 m, oxygen saturation < 92% awake or asleep without any supplemental oxygen or respiratory support Pulse oximetry saturation may decrease to < 96% after screening provided that the saturation does not decrease by ≥ 4 percentage points - Tracheostomy or current use or requirement of non-invasive ventilatory support averaging ≥ 6 hours daily over the 7 days prior to the screening visit; or ≥ 6 hours/day on average during the screening period or requiring ventilatory support while awake over the 7 days prior to screening or at any point during the screening period prior to dosing - Participants with signs of aspiration/inability to tolerate non-thickened- liquids based on a formal swallowing test performed as part of screening. Participants with a gastrostomy tube who pass the swallowing test will be allowed to enroll in the study - Participants whose weight-for-age is below the third percentile based on World Health Organization (WHO) Child Growth Standards - Active viral infection (includes human immunodeficiency virus [HIV] or positive serology for hepatitis B or C, or Zika virus) - Serious non-respiratory tract illness requiring systemic treatment and/or hospitalization within 2 weeks prior to screening - Upper or lower respiratory infection requiring medical attention, medical intervention, or increase in supportive care of any manner within 4 weeks prior to screening - Severe non-pulmonary/respiratory tract infection within 4 weeks before administration of gene replacement therapy or concomitant illness that creates unnecessary risks for gene replacement therapy such as: a. Major renal or hepatic impairment b. Known seizure disorder c. Diabetes mellitus d. Idiopathic hypocalcuria e. Symptomatic cardiomyopathy - Known allergy or hypersensitivity to prednisolone or other glucocorticosteroids or their excipients - Concomitant use of any of the following: drugs for treatment of myopathy or neuropathy, agents used to treat diabetes mellitus, or ongoing immunosuppressive therapy, plasmapheresis, immunomodulators such as adalimumab, immunosuppressive therapy within 3 months prior to gene replacement therapy - Anti-adeno-associated virus serotype 9 (AAV9) antibody titer > 1:50 as determined by Enzyme-linked Immunosorbent Assay (ELISA) binding immunoassay. Should a potential participant demonstrate Anti-AAV9 antibody titer > 1:50, he or she may receive retesting within 30 days of the screening period and will be eligible to participate if the Anti-AAV9 antibody titer upon retesting is ≤ 1:50 - Clinically significant abnormal laboratory values (gamma glutamyl- transpeptidase [GGT], ALT, and AST > 3 × ULN, bilirubin ≥ 3.0 mg/dL, creatinine ≥ 1.0 mg/dL, hemoglobin [Hgb] < 8 or > 18 g/dL; white blood cell [WBC] > 20,000 per cmm) prior to gene replacement therapy - Participation in recent SMA treatment clinical study (with the exception of observational Cohort studies or non-interventional studies) or receipt of an investigational or commercial compound, product, or therapy administered with the intent to treat SMA at any time prior to screening for this study. Oral β-agonists must be discontinued at least 30 days before gene therapy dosing. Inhaled albuterol specifically prescribed for the purposes of respiratory (bronchodilator) management is acceptable and not a contraindication at any time prior to screening for this study - Expectation of major surgical procedures during the study assessment period - Parent(s)/legal guardian(s) unable or unwilling to comply with study procedures or inability to travel for repeat visits - Parent(s)/legal guardian(s) unwilling to keep study results/observations confidential or to refrain from posting confidential study results/observations on social media sites - Parent(s)/legal guardian(s) refuses to sign consent form - Gestational age at birth < 35 weeks (245 days) ; PRIMARY OUTCOME: Achievement of Independent Sitting for at Least 30 Seconds; SECONDARY OUTCOME 1: Ability to Thrive[/INST]Yes</s>