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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 - STEP-D222; BRIEF: This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD. ; DRUG USED: Rexulti; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Norepinephrine (Noradrenaline), Serotonin 5-HT1A receptor, Serotonin 5-HT2A receptor; THERAPY: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria - The current depressive episode must be equal to or greater than 8 weeks in duration - Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments. Exclusion Criteria: - Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug. - Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration. - Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder - Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder. ; PRIMARY OUTCOME: Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score.; SECONDARY OUTCOME 1: Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) 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 I - MTN-037; BRIEF: The purpose of this study is to evaluate the safety and pharmacokinetics of PC-1005 gel when used as a rectal microbicide in HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal intercourse. ; DRUG USED: PC-1005; DRUG CLASS: Non-NME; INDICATION: HIV / AIDS; TARGET: Herpes Simplex Virus (HSV), Human Immunodeficiency Virus (HIV) , Human Papillomavirus (HPV), Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Allergy and Infectious Diseases (NIAID); CRITERIA: Inclusion Criteria: - Men and women (cis or transgender) who are 18 years or older at Screening, verified per site standard operating procedure (SOP) - Able and willing to provide written informed consent - HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in the protocol and willing to receive HIV test results - Able and willing to provide adequate locator information, as defined in site SOP - Available to return for all study visits and willing to comply with study participation requirements - In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee - At Screening, history of consensual receptive anal intercourse (RAI) at least once in their lifetime per participant report - Willing to not take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation (including the time between Screening and Enrollment) - Willing to follow abstinence requirements for the duration of study participation (See the protocol for additional information) - For participants of childbearing potential: a negative pregnancy test at Screening and Enrollment - For participants of childbearing potential: Per participant report at Enrollment, using an effective method of contraception and intending to use an effective method for the duration of study participation; these include: - Hormonal methods, excluding vaginal rings - Intrauterine device (IUD) inserted at least 42 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions) - Sterilization of participant or partner at least 42 days prior to Enrollment - Self-identifies as having sex with women exclusively Exclusion Criteria: - At Screening: - Hemoglobin Grade 1 or higher* - Platelet count Grade 1 or higher* - White blood count Grade 2 or higher* - Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher* - Serum creatinine greater than 1.3x the site laboratory upper limit of normal (ULN) - International normalized ratio (INR) greater than 1.5x the site laboratory ULN - History of inflammatory bowel disease by participant report - * As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017 - Note: Otherwise eligible participants with an exclusionary test result can be re-tested during the screening process. If a participant is re-tested and a non-exclusionary result is documented within 45 days of providing informed consent for screening, the participant may be enrolled. - Known adverse reaction to latex or polyurethane (ever) - Anticipated use of and/or unwillingness to abstain from the following medications during study participation: - Anticoagulant medications - Rectally-administered medications - Known adverse reaction to any of the components of the study product - Use of pre-exposure prophylaxis (PrEP) for HIV prevention within 1 month prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation - Use of post-exposure prophylaxis (PEP) for potential HIV exposure within the 3 months prior to Enrollment - Condomless RAI and/or penile-vaginal intercourse with a partner who is known to be HIV-positive or whose status is unknown in the 6 months prior to Enrollment - Non-therapeutic injection drug use in the 12 months prior to Enrollment - Participation in research studies involving drugs, medical devices, genital or rectal products, or vaccines within 30 days of the Enrollment Visit - Gynecologic, genital, or rectal procedure (e.g., tubal ligation, dilation and curettage, piercing, hemorrhoidal resection, polyp removal) 60 days or less prior to Enrollment, or rectal biopsy, 7 days or less prior to Enrollment. Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap test as well as IUD insertion/removal are not exclusionary. Anoscopy and endoscopy without rectal biopsies are not exclusionary - Per participant report, medical records, clinical diagnosis and/or diagnostic testing at either Screening or Enrollment: - Diagnosis or treatment of any anogenital sexually transmitted infection (STI) in the past 3 months (including window between Screening and Enrollment) - Symptoms, clinical or laboratory diagnosis of active pharyngeal, anorectal infection or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment) - Current symptomatic urinary tract infection (UTI) - Infections requiring treatment include Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) infection, syphilis, active herpes simplex virus (HSV) lesions, anogenital sores or ulcers, or symptomatic genital warts, chancroid, pelvic inflammatory disease (PID), symptomatic bacterial vaginosis (BV), symptomatic vaginal candidiasis, other vaginitis, and trichomoniasis. - Note: Otherwise eligible participants with an exclusionary UTI, BV and/or candida finding may be re-tested during the screening process. - Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is permitted since treatment is not required. - Participants who meet any of the following additional criteria will be excluded from the study: - Pregnant or breastfeeding at either Screening or Enrollment or planning to become pregnant or begin breastfeeding during study participation. Note: A documented negative pregnancy test performed by study staff is required for inclusion; however, a self-reported pregnancy is adequate for exclusion from screening/enrollment into the study. - Last pregnancy outcome 90 days or less prior to Screening - Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives. ; PRIMARY OUTCOME: Frequency of Grade 2 or Higher Adverse Events (AEs); SECONDARY OUTCOME 1: Participant Self-report Gel Acceptability - Ease of Use[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/ INO-9112 (US/Asia); BRIEF: This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen [HBsAg] and Hepatitis B core antigen [HBcAg]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants. ; DRUG USED: INO-1800; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B Prevention (Vaccines, Antiviral); TARGET: Hepatitis B/HBV; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Inovio Pharmaceuticals; CRITERIA: INCLUSION CRITERIA: - Chronic Hepatitis B virus infection - Negative for Hepatitis A IgM, C, D and HIV - Liver biopsy, Fibroscan® or equivalent elastography-based test obtained within the past 6 months demonstrating liver disease without evidence of bridging fibrosis or cirrhosis supported by platelet count greater than the central laboratory LLN at screening - Positive for Hepatitis B surface antigen (≥250 IU/mL at screening) - Nucleos(t)ide treatment for at least 1 year with ongoing nucleos(t)ide analogue treatment at randomization - HBV DNA <90 IU/mL for ≥6 months prior to randomization - Screening laboratory values within normal range - ALT ≤1.5x upper limit of normal (ULN) from 2 measurements separated by at least 14 days during the 6 months prior to randomization and ALT at screening ≤1.5x ULN - AST, TBili, DBili, GGT, Alk Phos and albumin within normal range or judged to be not clinically significant by PI and medical monitor at screening - For men and women who are not postmenopausal [i.e. ≥ 12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone (FSH), if not on hormone replacement] or surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females) agreement to remain abstinent or use 1 highly effective or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and at least through week 12 after last dose EXCLUSION CRITERIA: - Pregnant or breastfeeding females - Positive serum pregnancy test at screening or positive urine pregnancy test at randomization - Use of topical corticosteroids at or near the intended administration site - Autoimmune disorders, transplant recipients, other immunosuppression including any concurrent condition requiring the use of immunosuppressive/immunomodulating agents (eye drop-containing and infrequent inhaled corticosteroids are permissible) - Need for systemic antiviral treatment (other than for chronic hepatitis B infection) - Documented history or other evidence of decompensated liver disease (e.g., ascites, bleeding from esophageal varices, Child-Pugh clinical classification B or C) - History of liver cirrhosis demonstrated by biopsy, Fibroscan® or equivalent elastography-based test - History of other evidence of a medical condition associated with chronic liver disease [e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis (NASH), toxin exposure, thalassemia, etc.] - Documented history or other evidence of metabolic liver disease within 1yr of randomization - Abnormal renal function including serum creatinine >ULN or calculated creatinine clearance <70 mL/min (using the Cockcroft Gault formula) - History of or suspicion of HCC - Screening alpha fetoprotein ≥13 ng/mL - Prior history or current malignancy other than adequately treated BCC, unless history of BCC is near intended administration site - History of significant medical conditions [e.g., cardiac (including ventricular or supraventricular arrhythmias), renal disease, pulmonary, gastrointestinal, neurological] - Significant acute infection (e.g., influenza, local infection) or any other clinically significant illness within 2 weeks of randomization - Administration of any blood product within 3 mon of randomization - History of seizures (unless seizure free for 5yrs) ; PRIMARY OUTCOME: Safety Assessment (Composite of multiple measures: pain (VAS), adverse events, lab abnormalities, changes in vital signs); SECONDARY OUTCOME 1: Immunogenicity Assessment[/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 - 1361.1; BRIEF: The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin & metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously. ; DRUG USED: Trijardy XR; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: AMP-activated protein kinase (AMPK), Dipeptidyl peptidase IV (DPP-IV, DPP-4), SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Healthy male or female subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests - Age of 18 to 55 years (incl.) - BMI of 18.5 to 29.9 kg/m2 (incl.) - Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation - Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion: Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device Sexually abstinent A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) Surgically sterilised (including hysterectomy) Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone above 40 U/L and estradiol below 30 ng/L is confirmatory) Exclusion criteria: - Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator - Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance - Any evidence of a concomitant disease judged as clinically relevant by the investigator - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders - Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair) - Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders - Further exclusion criteria apply ; PRIMARY OUTCOME: Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz); SECONDARY OUTCOME 1: Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Single and Repeated Dose; BRIEF: The purpose of this study is to determine if MultiStem® can safely be given to patients with acute leukemia, chronic myeloid leukemia, or myelodysplasia after they have received hematopoietic stem cell transplantation. ; DRUG USED: MultiStem; 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: Athersys, Inc; CRITERIA: Inclusion Criteria: - Patients of either sex aged 18-65 years of age - Diagnosis of acute myeloid or lymphoblastic leukemia (second or subsequent remission, if not in remission, then <20% bone marrow blasts), chronic myelogenous leukemia resistant to or intolerant of tyrosine kinase inhibitor therapy (accelerated phase, first chronic phase with TKI resistance, or second chronic phase), or myelodysplastic syndrome (intermediate/high or high risk by International Prognostic Scoring System (IPSS), lower risk by IPSS with patient having progressed after prior therapy. Complete remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment and <5% blasts in the marrow within 28 days of enrollment. - Life expectancy of at least 100 days - Patients scheduled for allogeneic bone marrow transplant or peripheral blood stem cell transplant (PBST) procedure - Family-related or unrelated donors - HLA matching should either be matched related or matched unrelated donors, 6/6 match or 5/6 single allelic mismatch, with provision that the DRB1 is molecularly matched - Performance status (ECOG ≤2) - Signed informed consent Exclusion Criteria: - Active infection - Known allergies to bovine or porcine products - Renal function: Serum creatinine >2 mg/dL or creatinine clearance ≤50 mL/min - Hepatic function: Screening ALT or AST ≥3x than the upper limit of normal for the laboratory OR total bilirubin ≥2.0 mg/dL (Exception: acceptable if patient is identified with pre-existing condition e.g., Gilberts disease that will contribute to baseline elevations of bilirubin) - Pulmonary function: FEV1, FVC, DLCO ≤50% predicted - Cardiac function: left ventricular ejection fraction ≤50% - Patient received an investigational agent within 30 days prior to transplant - The patient is pregnant, has a positive serum BhCG, or is lactating - Patient on corticosteroids at a dose >0.25 mg/kg/day - Planned non-myeloablative transplant - Planned cord blood transplant - Prior allogeneic myeloablative HSCT - HIV seropositive, HTLV seropositive, hepatitis B or C seropositive, varicella virus active infection, or syphilis active infection - Other serious medical or psychiatric illness that, in the investigators opinion, would not permit the patient to be managed according to the protocol ; PRIMARY OUTCOME: maximum tolerated dose; SECONDARY OUTCOME 1: incidence of grade III/IV GVHD[/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 - 2102 - Safety; BRIEF: This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration. ; DRUG USED: Tesidolumab; DRUG CLASS: Biologic; INDICATION: Dry Age-Related Macular Degeneration (Dry AMD)/Geographic Atrophy (Ophthalmology); TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD - ETDRS best corrected visual acuity of 60 letters or worse in the study eye. Exclusion Criteria: - Retinal disease other than AMD in study eye which, in the investigators opinion, may pose a safety risk or interfere with the study. - Choroidal neovascularization due to a cause other than AMD. - In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period. - Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration. - Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye. - Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye. - Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation. - Any medical condition likely to interfere with the patients participation in the study, or likely to cause serious adverse events during the study. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.; SECONDARY OUTCOME 1: To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - (U.S & Europe); BRIEF: This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to: - Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib - Learn more about the side effects of ART4215 alone and in combination with talazoparib - Learn more about the effectiveness of ART4215 alone and in combination with talazoparib - Learn more about the effectiveness of ART4215 alone and in combination with niraparib ; DRUG USED: ART4215; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: DNA; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Artios Pharma Ltd; CRITERIA: General Inclusion Criteria: - Signed informed consent - Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter (except in Germany where local regulation requires the longer of 21 days or 5 half-lives washout), and recovered from the acute effects of therapy. Palliative radiotherapy must have completed 1 week prior to start of study treatment. - At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 (PCWG-3) for patients with prostate cancer - Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor - Willingness to abide by protocol defined contraceptive requirements for the duration of the study. - Estimated life expectancy of ≥12 weeks Additional inclusion criteria for participants in dose escalation (Part A1): - Advanced or metastatic cancer, which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study - Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis Additional inclusion criteria for participants in dose escalation (Part A2): - Advanced or metastatic cancer for which a PARP inhibitor is an appropriate treatment option. Participants may have received prior treatment with PARP inhibitor - Optional baseline biopsy for BRCA1/2 mutations and prior PARP inhibitor - Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis Additional inclusion criteria for participants in dose escalation (Part A3): - Advanced or metastatic cancer for which a PARP inhibitor is an appropriate treatment option. Prior treatment with PARP inhibitor - Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis Additional inclusion criteria for participants in dose expansion (Part B1): - Advanced or metastatic solid tumors that have undergone disease progression during treatment with a PARP inhibitor for an approved indication - At least 1 measurable lesion assessable using standard techniques by RECIST v1.1 or PCWG-3 guidelines - Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis Additional inclusion criteria for participants in dose expansion (Part B2): - Advanced or metastatic cancer that is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study with characteristics indicative of sensitivity to pol theta inhibition - No prior treatment with a PARP inhibitor and must not have a disease for which there is an approved PARP inhibitor - At least 1 measurable lesion assessable using standard techniques by RECIST v1.1 or PCWG-3 guidelines - Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis Additional inclusion criteria for participants in dose expansion (Part B3): - HER2-negative locally advanced or metastatic breast cancer - Deleterious or suspected deleterious germline or somatic BRCA1 or BRCA2 mutation - No more than 3 prior chemotherapy-inclusive regimens (including antibody conjugates) - Prior treatment with a taxane or anthracycline unless contraindicated - No or </= 1 month of prior treatment with a PARP inhibitor - At least 1 measurable lesion assessable using standard techniques by RECIST v1.1 - Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis General Exclusion Criteria: - Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within the protocol defined timeframe after the last administration of study specified treatment. - Men who plan to father a child while in the study or within the protocol defined timeframe after the last administration of study specified treatment. - Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: opportunistic HIV/AIDs-related infection(s) within the past 12 months, hepatitis B virus, or hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated [including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)] that is not in remission - Have MDS/AML or features suggestive of MDS/AML - Ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic) - Moderate or severe cardiovascular disease - Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment; stable brain metastases are eligible - Received a live vaccine within 30 days before the first dose of study treatment - History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patients participation for the full duration of the study, or is not in the best interest of the patient to participate - Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study - Significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment - Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study Additional exclusion criteria for participants in dose expansion (Part B3): - First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy - Inflammatory breast cancer - Known hypersensitivity to any of the components of talazoparib - Prior treatment with a PARP inhibitor that was discontinued due to a treatment related toxicity. Additional exclusion criteria for participants in dose escalation (Part A3): • Hypersensitivity to any of the components of niraparib ; PRIMARY OUTCOME: Part A: Number of participants with dose limiting toxicities (DLTs) from ART4215 monotherapy, in combination with talazoparib or in combination with niraparib; SECONDARY OUTCOME 1: Part B3: Number of participants with adverse events following administration of ART4215 in combination with talazoparib[/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 - 242-12-233 (Pediatric); BRIEF: The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in pediatric participants who completed Study 242-12-232 (NCT01856634). ; DRUG USED: Delamanid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tuberculosis; TARGET: Cell wall synthesis, Tuberculosis; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Successfully completed Trial 242-12-232 - Confirmed diagnosis of MDR-TB OR - Presumptive diagnosis of pulmonary or extrapulmonary MDR-TB including one of the following: - Clinical specimen suggestive of tuberculosis disease - Persistent cough lasting > 2 weeks - Fever, weight loss, and failure to thrive - Findings on recent chest radiograph (prior to Visit 1) consistent with TB AND - Household contact with a person with known MDR-TB or with a person who died while appropriately taking drugs for sensitive TB OR - On first-line TB treatment but with no clinical improvement - Negative urine pregnancy test for female participants who have reached menarche - Written informed consent/assent Exclusion Criteria: - Participants who have not completed Trial 242-12-232 - Laboratory evidence of active hepatitis B or C - Children with body weight < 5.5 kg - For participants with human-immunodeficiency virus (HIV) co-infection, cluster difference-4 (CD4) cell count ≤ 1000/mm^3 for children 1-5 years old, and ≤ 1500/mm^3 for children less than 1 year old - History of allergy to metronidazole and any disease or condition in which metronidazole is required - Use of amiodarone within 12 months or use of other predefined antiarrhythmic medications within 30 days prior to first dose of delamanid - Serious concomitant conditions - Pre-existing cardiac conditions - Abnormalities in Screening electrocardiogram (ECG) [including atrio-ventricular (AV) block, blood brain barrier (BBB) or hemi-block, QRS prolongation > 120 milliseconds (ms), or QT interval corrected by Fridericias formula (QTcF) > 450 ms in both males and females] - Concomitant condition such as renal impairment characterized by serum creatinine levels > 1.5 mg/dL, hepatic impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN)), or hyperbilirubinemia characterized by total bilirubin > 2x ULN - Current diagnosis of severe malnutrition or kwashiorkor - Positive urine drug screen (Groups 1 and 2 only) - Rifampicin and/or moxifloxacin within 1 week prior to the first dose of delamanid and/or any prior or concurrent use of bedaquiline - Lansky Play Performance Score < 50 (not applicable for children < 1 year old) or Karnofsky Score < 50 - Administered an investigational medicinal product (IMP) within 1 month prior to Visit 1 other than delamanid given as IMP in Trial 242-12-232 - Pregnant, breast-feeding, or planning to conceive or father a child within the timeframe described in the informed consent form (Groups 1 and 2 only) ; PRIMARY OUTCOME: Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE); SECONDARY OUTCOME 1: Baseline QT Interval (QTcB) Effect[/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 - HeFH (CL-1003); BRIEF: The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH) ; DRUG USED: Praluent; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Must meet the World Health Organization criteria for heFH 2. Participants must be on a stable statin dose, with or without ezetimibe, for at least 6 weeks before screening 3. Serum LDL-C levels ≥ 100 mg/dL at screening 4. Willing to follow the NCEP ATPIII TLC diet, or an equivalent diet plan, starting at screening and continuing until the last study visit 5. A negative urine/serum pregnancy test at each screening visit and start of the study, for women of childbearing potential Key Exclusion Criteria: 1. Participants with homozygous FH (clinically or by previous genotyping) 2. Use of a medication (other than a statin or EZE) to alter serum lipids within 42 days (6 weeks) before screening including, but not limited to: - Fibrates - Niacin (>500 mg/day) - Omega-3 fatty acids (>1000 mg/day of DHA/EPA) - Bile acid resins 3. Use of nutraceuticals or OTC medications that may alter lipid levels that are not stable for at least 6 weeks before screening and are not planned to remain constant throughout the study. Examples include: - Omega-3 fatty acids (≤1000 mg/day of DHA/EPA) - Niacin (≤500 mg/day) - Plant stanols, such as found in Benecol, flax seed oil, psyllium - Red yeast rice 4. Disorders known to influence lipid levels, such as nephrotic syndrome, significant liver disease, Cushings disease, untreated hypothyroidism (patients on stable thyroid replacement for at least 12 weeks before the full screening visit, who are metabolically euthyroid by thyroid-stimulating hormone (TSH) testing are allowed) 5. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before the full screening visit) 6. Fasting serum TG >350 mg/dL screening 7. LDL apheresis within 12 months before screening ; PRIMARY OUTCOME: Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis; SECONDARY OUTCOME 1: Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/IIa - 18184; BRIEF: To investigate the safety and tolerability of ascending repeated oral doses of BAY1817080 in healthy volunteers(Part1). To investigate the safety, tolerability and efficacy of BAY1817080 in patients with refractory chronic cough(Part2). ; DRUG USED: BAY-1817080; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Cough; TARGET: P2 (Purine) Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: Part 1 - Male; healthy according to complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12 lead ECG, clinical laboratory tests - Age: 18-45 years (inclusive) at the first screening visit. - Non-smoker for at least the past 6 months and with a pack year history of equal to or less than 5 years. - Subjects who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously when having sexual intercourse with women of childbearing potential (one method used by the subject and one method used by the partner) during the study and for 90 days after receiving the investigational medicinal product and not to act as sperm donor for 90 days after dosing. [Acceptable methods of contraception include for example: (a) condoms (male or female) with or without a spermicidal agent, (b) diaphragm or cervical cap with spermicide, (c) intrauterine device, (d) hormone-based contraception. Part 2: - Age: >18 years at the first screening visit - Refractory chronic cough for at least one year: - that has been shown to be unresponsive to at least 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip or unexplained cough, and - for which no objective evidence of an underlying trigger can be determined after investigation. - Score of >40 mm on the Cough Severity visual analogue scale (VAS) at screening. - For male patients: Male patients who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for 90 days after receiving the investigational medicinal product and not to act as sperm donor for 90 days after dosing. [Acceptable methods of contraception include for example: (a) condoms (male or female) with or without a spermicidal agent, (b) diaphragm or cervical cap with spermicide, (c) intrauterine device, (d) hormone-based contraception. --For female patients: Confirmed post-menopausal woman (defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL) or Woman without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification) or Woman of childbearing potential that agrees to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for at least 10 days after the last dose. Acceptable methods of contraception include for example: (a)condoms (male or female) with or without a spermicidal agent (b)diaphragm or cervical cap with spermicide (c) intrauterine device (d)hormone-based contraception. Exclusion Criteria: Part 1 - Relevant diseases potentially interfering with the studys aims (e.g.respiratory diseases) within the four weeks before screening or between screening and randomization - Any febrile illness within the four weeks before screening or between screening and randomization - Medical history of hypogeusia/dysgeusia or the subject has a dysfunction in his/her ability to taste, as revealed by the taste disturbance questionnaire during screening and the pre dose procedures - Use of any over-the-counter cough mixture within the 24 hours before screening Part 2: - FEV1 or FVC of less than 60% of predicted normal, at screening - History of upper or lower respiratory tract infection or recent significant change in pulmonary status within the 4 weeks before baseline visit. - Current smoking habit or history of smoking within the 6 months before the screening visit. - History of smoking (at any time) for more than 20 pack-years in total (20 cigarettes per pack) ; PRIMARY OUTCOME: Frequency of treatment emergent adverse events in study part 1; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Extension to Studies 2202/2206 (Japan); BRIEF: The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies. ; DRUG USED: ACC-001; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria. - Screening brain MRI scan is consistent with the diagnosis of AD. - MMSE score 10 and above. Exclusion Criteria: - Significant neurological diseases other than AD. - Brain MRI evidence of vasogenic edema during the preceding studies. - Clinically significant illness. ; PRIMARY OUTCOME: Number of Treatment Emergent Adverse Events (AEs) by Severity; 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 - P08683; BRIEF: The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) despite MTX therapy. The primary hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as measured by the percentage of participants who achieve American College of Rheumatology 20 (ACR 20) response after 12 weeks of treatment. ; DRUG USED: MK-8457; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: ; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Diagnosis of rheumatoid arthritis for at least 6 months prior to screening - Active rheumatoid arthritis as defined by the presence of >= 6 swollen joints (of 66 count) and >= 6 tender joints (of 68 joint count) - C-reactive protein blood level >0.9 mg/dL - Anti-citrullinated protein antibody positive and/or rheumatoid factor positive at screening - American College of Rheumatology Functional Class I, II, or III - Received methotrexate for a minimum of 3 months prior to screening with a regionally appropriate stable weekly dose for at least 4 weeks prior to screening - If using oral corticosteroids, the participant must be on a stable dose of 10 mg prednisone - No history of either untreated, latent, or active tuberculosis prior to baseline - Participants of reproductive potential must agree to remain abstinent or use 2 acceptable methods of birth control Exclusion Criteria: - Presence of inflammatory disease other than rheumatoid arthritis, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease - Positive hepatitis B surface antigen or hepatitis C test result or the presence of Human immunodeficiency virus (HIV) infection - HIV positive - User of recreational or illicit drugs or has had a history (within the previous 2 years) of drug or alcohol abuse or dependence - Females of childbearing potential who are pregnant, intend to become pregnant, or are lactating; - Severe opportunistic infection within 6 months prior to study start. ; PRIMARY OUTCOME: Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12; SECONDARY OUTCOME 1: Change From Baseline in Disease Activity Score (DAS28) as Measured by Erythrocyte Sedimentation Rate (ESR) 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 I - ADVL1513 (Pediatric); BRIEF: This phase I trial studies the side effects and best dose of entinostat in treating pediatric patients with solid tumors that have come back or have not responded to treatment. Entinostat may block some of the enzymes needed for cell division and it may help to kill tumor cells. ; DRUG USED: Entinostat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Histone Deacetylase (HDAC); THERAPY: Monotherapy; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Patients must have a body surface area (BSA) of >= 1.17 m^2 at time of study enrollment - Patients must be able to swallow intact tablets - Patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors or lymphoma, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG) - Patients must have either measurable or evaluable disease - Patients current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life - Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score - Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately - Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment - Solid tumor patients: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea) - Lymphoma patients: - a waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e. corticosteroid, vincristine, thioguanine[6MP], and/or methotrexate) - >=14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy; additionally, patients must have fully recovered from all acute toxic effects of prior therapy; Note: cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy - Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days must have elapsed from the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment - Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1 - Hematopoietic growth factors: >= 14 days must have elapsed from the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator - Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days must have elapsed from the last dose of interleukins, interferon or cytokines (other than hematopoietic growth factors) - Stem cell infusions (with or without traumatic brain injury [TBI]): - Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days must have elapsed from infusion and no evidence of graft versus host disease (GVHD) - Autologous stem cell infusion including boost infusion: >= 42 days must have elapsed from infusion - Cellular therapy: >= 42 days must have elapsed from last dose of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.) - External beam radiation (XRT)/external beam irradiation including protons: >= 14 days must have elapsed after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation - Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days must have elapsed from the last dose of systemically administered radiopharmaceutical therapy - Histone deacetylase (HDAC) inhibitors: Patients must not have received prior therapy with entinostat; patients who have received therapy with other HDAC inhibitors are eligible - Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment) - Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment) - Hemoglobin >= 8.0 g/dl, with or without transfusion (within 7 days prior to enrollment) - Patients with known bone marrow metastatic disease will not be eligible - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows: - 1 to < 2 years: 0.6 mg/dL for males and females - 2 to < 6 years: 0.8 mg/dL for males and females - 6 to < 10 years: 1.0 mg/dL for males and females - 10 to < 13 years: 1.2 mg/dL for males and females - 13 to < 16 years: 1.5 mg/dL for males and 1.4 mg/dL for females - > = 16 years: 1.7 mg/dL for males and 1.4 mg/dL for females (within 7 days prior to enrollment) - Bilirubin (sum of conjugated + conjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) = 135 U/l; for the purpose of this study, the ULN for SGPT is 45 U/l (within 7 days prior to enrollment) - Serum albumin >= 2 g/dl (within 7 days prior to enrollment) - All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines Exclusion Criteria: - Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method both during and for 3 months after participation in this study; abstinence is an acceptable method of contraception; those who become pregnant while on treatment with entinostat must discontinue immediately and consult their treating physician - Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid - Patients who are currently receiving another investigational drug are not eligible - Patients who are currently receiving other anti-cancer agents are not eligible - Patients requiring concurrent administration of valproic acid are not eligible for this trial - Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial - Patients with a BSA ˂ 1.17 m^2 at time of study enrollment are not eligible - Patients who are not able to swallow intact tablets are not eligible - Patients with a known history of corrected QT (QTc) prolongation (> 480 msec), or known history of ventricular tachycardia, ventricular fibrillation or Torsades de pointes are not eligible - Patients who have an uncontrolled infection are not eligible - Patients who have received a prior solid organ transplantation are not eligible - Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible - Patients with a history of allergy to medications that have a benzamide structure (e.g., metoclopramide, procarbazine, domperidone, cisapride etc.) are not eligible ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (R2PD) of Entinostat; SECONDARY OUTCOME 1: Antitumor Activity of Entinostat[/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 - PLX-COV-01 (Severe); BRIEF: This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications. ; DRUG USED: PLX Cells; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Pluristem Ltd.; CRITERIA: Key Inclusion Criteria: - Willing and able to provide written informed consent, or with a legal representative who can provide informed consent. - Male or non-pregnant female adult 40-80 years of age at time of enrollment. - Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization. - Meets definition of ARDS according to Berlin criteria. Key Exclusion Criteria: - Body weight under 55 kg (121 lbs) - Serum creatinine level of over 1.5 mg/dL at time of randomization. - Total Bilirubin ≥2 mg/dL at time of randomization. - Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin. - Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization. - Chronic Obstructive Pulmonary disease GOLD stage above II. ; PRIMARY OUTCOME: Number of ventilator free days; SECONDARY OUTCOME 1: All-cause mortality[/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 - V72_28E1; BRIEF: The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72_28 study. ; DRUG USED: Bexsero; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: For naïve subjects newly enrolled: 1. Healthy infants and children according to the following age groups: 1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age), 2. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age). 3. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age). 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator. For Subjects who participated in the V72_28 study (Follow-on Subjects): 1. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 2. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 3. in good health as determined by medical history, physical examination, clinical judgment of the investigator 4. who have completed the vaccination course in the V72_28 study and have received their last vaccination 24 to 36 months before enrollment in V72_28E1 Exclusion Criteria: For naïve subjects newly enrolled: 1. History of any serogroup B meningococcal vaccine administration; 2. Previous known or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization; 4. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine; 5. Pregnancy or nursing (breastfeeding) mothers; 6. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry; 7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example): - Receipt of any chronic immunosuppressive therapy - Receipt of any chronic immunostimulants - Immune deficiency disorder, or known HIV infection 8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable). 9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 10. Subjects parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 11. Intent to participate in another clinical study during this study. 12. Family members and household members of study staff; 13. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study. 14. Any significant chronic infection. 15. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). For Subjects who participated in the V72_28 study (Follow-on Subjects): Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1. ; PRIMARY OUTCOME: Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains; SECONDARY OUTCOME 1: Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - South Korea; BRIEF: The objective of the study is to evaluate tolerability and safety of CBT101 in patients who underwent curative surgery and adjuvant therapy for solid cancer ; DRUG USED: APL-101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy; LEAD SPONSOR: CHABiotech CO., Ltd; CRITERIA: Inclusion Criteria: 1. Male and female adults aged 19 years and older 2. Patients with solid tumors as below (1) histologically or cytologically confirmed solid tumors (2) 4 - 12 weeks of last adjuvant therapy after radical operations and adjuvant therapy 3. Life expectancy 6 months 4. Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1 Exclusion Criteria: 1. History of leptomeningeal carcinomatosis or spinal cord compression 2. History of peritoneal carninomatosis 3. Hemoglobine less than 9.0g/dL 4. Absolute Neutrophil Count (ANC) less than 1.5x10^3/mm^3 5. Platelet count less than 75x10^9/L 6. Total bilitbinn grater than 1.5 times te upper limit of normal 7. Alanine amino transferase (ALT) greater than 3 times the upper limit of normal 8. Alanine phospatase (ALP) greater than 2.5 times the upper limit of normal 9. Uncontrolled hypertension 10. Intensive insuline therapy 11. Active infectious disease 12. Patients with hypersensitivity history or allergy to investigational product 13. Pregmant of lactating woman 14. Patients who have participated in another clinical trials witin 30 days before the start of this clinical trial 15. Patients judged to be inappropriate for this study by the investigator with other reasons ; PRIMARY OUTCOME: Dose limiting toxicity (DLT); SECONDARY OUTCOME 1: Disease-free survival rate (DFS)[/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 - S01 (Healthy Males); BRIEF: The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 32731 in healthy male subjects. The trial will be performed in three parts. In Part 1, single doses of LEO 32731 will be administered to healthy male subjects. In Part 2, the effect of food on the single oral dose pharmacokinetic will be investigated. In Part 3, multiple doses of LEO 32731 will be administered to healthy male subjects. ; DRUG USED: Orismilast; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: 1. Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the study restrictions. 2. Subjects will be Caucasian males between 18 and 55 years of age and with a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive. 3. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is NOT acceptable). Exclusion Criteria: 1. Subjects who are not, or whose partners are not willing to use appropriate contraception (such as condom) with spermicidal foam/gel/film/cream/suppository from the time of the first dose until 3 months after the final dosing occasion. Male subjects whose partners are of child-bearing potential must also agree to use an additional highly effective method of contraception 2. Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety. 3. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety. 4. Subjects who have received any medications, including St Johns Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety. 5. Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion. 6. Subjects who have donated any blood, plasma or platelets in 3 months prior to screening or who have made donations on more than two occasions within the 12 months preceding the first dose administration. 7. Subjects with a significant history of drug allergy as determined by the Investigator. 8. Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator. 9. Subjects who have a supine blood pressure and supine pulse rate at screening higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 50 bpm, respectively 10. Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits). 11. Subjects with a positive urine drug screen or alcohol breath test result at screening or first admission. 12. Subjects who smoke or who have smoked in the 3 months prior to first dose administration. 13. Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator. 14. Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator. 15. Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies. 16. Subjects who have confirmed active/latent tuberculosis (TB). 17. Subjects who, in the opinion of their General Practitioner (GP) or the Investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol. 18. Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study; such as QTcB interval >450 msec, 2nd or 3rd degree Atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome defined as PR<110 msec, confirmed by a repeat ECG. 19. Subjects who have previously taken part in or withdrawn from this study. 20. Subjects who, in the opinion of the Investigator, should not participate in the study. ; PRIMARY OUTCOME: Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate and oral body temperature), ECG, telemetry and clinical laboratory.; SECONDARY OUTCOME 1: LEO 32731 and metabolites in blood and urine[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 305; BRIEF: The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD. ; DRUG USED: Mydayis; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine, Norepinephrine (Noradrenaline); THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: 1. Subject must be 6-17 years of age, inclusive, at the time of consent. 2. Subjects parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the ICH GCP Guideline E6 (1996) and applicable regulations before completing any study-related procedures. 3. Subject and parent/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration. 4. Subject, who is a female and of child-bearing potential, must not have a positive serum beta human chorionic gonadotropin pregnancy test at the Screening Visit (Visit 1) and must have a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol. 5. Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities. 6. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation. 7. Subject has an ADHD-RS-IV Total Score >28 at the Baseline Visit (Visit 2). 8. Subject is functioning at an age-appropriate level intellectually, as determined by the study Investigator. 9. Subject is currently not on ADHD therapy, or is not completely satisfied with any aspect of their current ADHD therapy. 10. Subject is able to swallow a capsule whole. Exclusion Criteria: 1. Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining clinician, will contraindicate treatment with SHP465 or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit 1) interview of the K-SADS-PL and additional modules if warranted by the results of the initial interview. Subjects may continue participation in a behavioral modification program during the study as long as they have been participating in the program for at least 1 month at the time of the Baseline Visit (Visit 2). 2. Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary. 3. Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator. 4. Subject is underweight based on Centers for Disease Control and Prevention body mass index (BMI)-for-age sex-specific values at the Screening Visit (Visit 1). Underweight is defined as a BMI <3rd percentile 5. Subject is significantly overweight based on Centers for Disease Control and Prevention BMI-for-age sex specific values at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >97th percentile for this study 6. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that, in the Investigators opinion, would prohibit the subject from completing the study or would not be in the best interest of the subject. The additional conditions would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary. 7. Subject has a history of seizure (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis of Tourettes Disorder. Subject has a history of tics that are judged by the Investigator to be exclusionary. 8. Subjects blood pressure measurements exceed the 90th percentile for age, sex, and height (based on the Blood Pressure Levels by Age and Height Percentile [for boys and girls]) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2) 9. Subject has a known history of hypertension 10. Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant medication. 11. Subject has a known family history of sudden cardiac death or ventricular arrhythmia. 12. Subject has any clinically significant ECG or clinically significant laboratory abnormality at the Screening Visit (Visit 1). 13. Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone and thyroxine at the Screening Visit (Visit 1). Treatment with a stable dose of thyroid medication for at least 3 months is permitted. 14. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product. 15. Subject has failed to respond, based on Investigator judgment, to an adequate course(s) (dose and duration) of amphetamine therapy 16. Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded. 17. Subject has a positive urine drug result at the Screening Visit (Visit 1) (with the exception of subjects current stimulant therapy, if any) or the Baseline Visit (Visit 2), if repeated unless the Investigator can verify that the positive result at the Screening Visit (Visit 1) is attributed to medication that has been prescribed to the subject and will be discontinued prior to the Baseline Visit (Visit 2). A positive result at the Screening Visit (Visit 1) attributed to a prescribed medication requires a re-test and a negative result at the Baseline Visit (Visit 2) to confirm subject eligibility. 18. Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening Visit (Visit 1). 19. Subject has previously completed, discontinued, or was withdrawn from this study. 20. Subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements. 21. Subject is required to take or anticipates the need to take medications that have central nervous system effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary. 22. Subject is female and is pregnant or lactating ; PRIMARY OUTCOME: Change From Baseline in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4); SECONDARY OUTCOME 1: Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Formulation Comparison (Germany); BRIEF: To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test ; DRUG USED: BAY1003803; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy - Age: 18-64 years Exclusion Criteria: - Severe disease within the last 4 weeks prior to the first study drug administration as determined by the investigator - Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid (Pretreatment) in the 4 weeks before first treatment and/or planned during the trial, except for allowed topical treatment on the face, ears and scalp - Systemic treatment depending on kind of treatment within 4 weeks and 6 months prior and/or planned during the trial - Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium, beta-blockers or angiotensin-converting-enzyme inhibitors (AEC inhibitors) unless on a stable dose for 3 months before study medication initiation - Clinico-chemical parameters of clinically significant deviation ; PRIMARY OUTCOME: Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound; 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 - LIMBER-304 (w/Ruxolitinib); BRIEF: The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy. ; DRUG USED: Parsaclisib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: p110 delta/PIK3CD; THERAPY: Combination; LEAD SPONSOR: Incyte Corporation; CRITERIA: Inclusion Criteria: - Diagnosis of PMF, PPV-MF, or PET-MF. - DIPSS risk category of intermediate-1, intermediate-2, or high. - Treated with ruxolitinib for ≥ 3 months with a stable dose for at least the last 8 weeks prior to Day 1 - Palpable spleen of ≥ 5 cm below the left costal margin on physical examination at the screening visit. - Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of ≥ 10 using the Screening Symptom Form. - Participants with an ECOG performance status score of 0, 1, or 2. - Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF. - Life expectancy of at least 24 weeks. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib). - Use of experimental drug therapy for MF or any other standard drug used for MF (whether for treatment of MF or another indication) with the exception of ruxolitinib, within 3 months of starting study drug, and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better. - Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications. - Recent history of inadequate bone marrow reserve. - Inadequate liver and renal function at screening. - Active bacterial, fungal, parasitic, or viral infection that requires therapy. - Active HBV or HCV infection that requires treatment or at risk for HBV reactivation. - Known HIV infection. - Uncontrolled, severe, or unstable cardiac disease that in the investigators opinion may jeopardize the safety of the participant or compliance with the Protocol. - Active invasive malignancy over the previous 2 years. - Splenic irradiation within 6 months before receiving the first dose of study drug. - Concurrent use of any prohibited medications. - Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements. - Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study. - Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. - Currently breastfeeding or pregnant. - Any condition that would, in the investigators judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. - History of Grade 3 or 4 irAEs from prior immunotherapy. - Receipt of any live vaccine within 30 days of the first dose of study drug - Unwillingness to receive RBC transfusions to treat low hemoglobin levels. - Known hypersensitivity or severe reaction to parsaclisib or ruxolitinib or excipients of parsaclisib/matching placebo or ruxolitinib formulations. ; PRIMARY OUTCOME: Proportion of participants achieving targeted reduction in spleen volume; SECONDARY OUTCOME 1: Proportion of participants who have a targeted reduction in Total Symptom Score (TSS)[/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 - Proof of Concept (EMPATHY); BRIEF: The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients. ; DRUG USED: MP0420; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: SARS-CoV-2; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Part A Inclusion Criteria: 1. Men and women ≥ 18 years of age on the day of inclusion (no upper limit). 2. Presence of two or more of the following COVID-19 symptoms with an onset within 7 days of dosing: Feeling hot or feverish, cough, sore throat, low energy, or tiredness, headache, muscle or body aches, chills or shivering, and shortness of breath. 3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test). 4. Understand and agree to comply with the planned study procedures. 5. The patient or legally authorized representative give signed informed consent. Part A Exclusion Criteria: 1. Requiring hospitalization at time of screening, or at time of study drug administration. 2. Oxygen saturation (SpO2) ≤ 93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300, respiratory rate ≥ 30 per minute, and heart rate ≥ 125 per minute. In India, patients with a respiratory rate ≥ 24 per minute or with an oxygen saturation ≤ 93% on room air (SpO2) are not eligible. 3. Known allergies to any of the components used in the formulation of the ensovibep or placebo. 4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking intervention. 5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. 6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing. 7. Prior or concurrent use of any medication for treatment of COVID-19, including antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and nonsteroidal anti-inflammatory drugs [NSAIDs]) are permitted. Prior vaccination for COVID-19 is permitted. 8. Are concurrently enrolled or were enrolled within the last 30 days or within 5 half-lives (whichever is longer) in any other type of medical research judged not to be scientifically or medically compatible with this study. 9. Are pregnant or breast feeding. 10. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception at the time of dosing and for 11 weeks after dosing of study drug. Highly effective contraception methods include: 1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (i.e., calendar, ovulation, symptothermal, and postovulation methods) and withdrawal are not acceptable methods of contraception. 2. Female sterilization (have had bilateral surgical oophorectomy [with or without hysterectomy], total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 3. Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient. 4. Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF). 11. Patients in the USA who are at high risk of progression to severe COVID-19 illness or hospitalization must not be enrolled in Part A of this study as a placebo-controlled study may not be appropriate in this patient population due to the availability of anti-viral mAbs under EUA in the USA. ; PRIMARY OUTCOME: Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8; SECONDARY OUTCOME 1: Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause[/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 - MM-001; BRIEF: Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw. ; DRUG USED: CC-99712; DRUG CLASS: Biologic; INDICATION: Multiple Myeloma (MM); TARGET: Antibody-drug Conjugate (ADC), B-cell maturation antigen (BCMA); THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Participants must satisfy the following criteria to be enrolled in the study: Inclusion - Participant is ≥ 18 years of age at the time of signing the ICF. - Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease - Participant must have measurable disease. - Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Exclusion Criteria - Participant has symptomatic central nervous system involvement of MM. - Participant had a prior autologous stem cell transplant ≤ 3 months prior to starting CC-99712. - Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99712 or is on systemic immunosuppression for graft-versus host disease. - Subject is a pregnant or lactating female. - Subject has known human immunodeficiency virus (HIV) infection. - Subject has active hepatitis B or C (HBV/HCV) infection. Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: 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 - SWEAPEA; BRIEF: The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients. ; DRUG USED: AZD1981; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Chemoattractant Receptor-Homologous Molecule (CRTH2); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception - 6 months history of asthma according to ATS definition - Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2 - Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal - A total ACQ5 score of 1.5 or more Exclusion Criteria: - Respiratory infection significantly affecting the asthma - Any significant disease and disorder that may put the patient at risk or influence study results - Any clinically relevant abnormal findings - A smoking history of more than 10 pack years - Intake of oral, rectal or parenteral glucocorticosteroids ; PRIMARY OUTCOME: Pre-bronchodilator FEV1 at the Clinic; SECONDARY OUTCOME 1: Morning and Evening PEF[/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 - FLAURA; BRIEF: To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer ; DRUG USED: Tagrisso; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Male or female, aged at least 18 years. 2. Pathologically confirmed adenocarcinoma of the lung. 3. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy. 4. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R). 5. Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status. 6. Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents). 7. Provision of informed consent prior to any study specific procedures, sampling, and analysis. 8. World Health Organization Performance Status of 0 to 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks Exclusion Criteria: 1. Treatment with any of the following: - Prior treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC. - Prior treatment with an EGFR-TKI. - Major surgery within 4 weeks of the first dose of study drug. - Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. - Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4. - Alternative anti-cancer treatment - Treatment with an investigational drug within five half-lives of the compound or any of its related material. 2. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug. 3. Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids. 4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 5. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291. 6. Any of the following cardiac criteria: - Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value. - Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. - Any patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval. 7. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 8. Involvement in the planning and/or conduct of the study ; PRIMARY OUTCOME: Median Progression Free Survival (PFS) (Months); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - TheraP; BRIEF: This open label, randomised, stratified, 2-arm, multicentre, phase 2 trial aims to determine the activity and safety of Lu-PSMA vs cabazitaxel in men with progressive metastatic castration resistant prostate cancer ; DRUG USED: Lutetium 177Lu-PSMA-617; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Prostate-specific Membrane Antigen (PSMA), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Australian and New Zealand Urogenital and Prostate Cancer Trials Group; CRITERIA: Inclusion Criteria: 1. Male aged 18 or older with metastatic adenocarcinoma of the prostate defined by: - Documented histopathology of prostate adenocarcinoma OR - Metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) 2. Castration-resistant prostate cancer (defined as disease progressing despite castration by orchiectomy or ongoing Luteinizing Hormone-Releasing Hormone (LHRH) analog 3. Progressive disease with rising PSA on 3 consecutive measurements, and PSA ≥ 20 ng/mL 4. Target or non-target lesions according to RECIST 1.1 5. Prior treatment with docetaxel 6. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined as a minimum uptake of SUVmax 20 at a site of disease, and SUVmax > 10 at sites of measurable disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact) 7. ECOG Performance status 0 to 2 8. Assessed by a medical oncologist as suitable for chemotherapy with cabazitaxel 9. Adequate renal function: • Cr Cl ≥ 40mL/min (Cockcroft-Gault formula) 10. Adequate bone marrow function: - Platelets ≥ 100 x10 billion /L - Hb ≥ 90g/L (no red blood cell transfusion in last 4 weeks) - Neutrophils > 1.5 x10 billion/L 11. Adequate liver function: - Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin) - AST or ALT ≤ 2.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases) 12. Estimated life expectancy > 12 weeks 13. Study treatment both planned and able to start within 21 days of randomisation 14. Willing and able to comply with all study requirements, including all treatments (cabazitaxel or Lu-PSMA); and, the timing and nature of all required assessments 15. Signed, written informed consent Exclusion Criteria: 1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components 2. Site(s) of disease that are FDG positive with minimal PSMA expression defined as FDG intensity > 68Ga-PSMA activity OR 68Ga-PSMA SUVmax < 10 3. Sjogrens syndrome 4. Prior treatment with cabazitaxel or Lu-PSMA 5. Contraindications to the use of corticosteroid treatment 6. Active malignancy other than prostate cancer 7. Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety 8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse 9. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception ; PRIMARY OUTCOME: Prostate Specific Antigen response rate (PSA RR); SECONDARY OUTCOME 1: Pain Response (PPI and Analgesic 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 - 203 ; BRIEF: AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine the recommended dose of CAEL-101 to facilitate progression of further clinical trials and evaluate safety and tolerability of CAEL-101 in combination with the standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy and daratumumab . ; DRUG USED: CAEL-101; DRUG CLASS: Biologic; INDICATION: Amyloid light-chain (AL) Amyloidosis; TARGET: Amyloid - light chain; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study. 1. AL amyloidosis Mayo stage I, II or IIIa 2. For Part A only, measurable hematologic disease defined by at least one of the following: 1. involved/uninvolved free light chain difference (dFLC) > 5mg/dL or 2. free light chain (FLC) > 5mg/dL with abnormal Kappa/Lambda ratio or 3. serum protein electrophoresis (SPEP) m- spike > 0.5 g/dL Patients with confirmed AL amyloid diagnosis without measurable disease may be enrolled with consultation and approval by the Sponsor Medical Monitor or their designee. 3. a. For Part A, currently on and continuing OR planned to start concurrent chemotherapy with CyBorD administered weekly as SoC. b. For Part B, currently on and continuing OR planned to start concurrent chemotherapy with CyBorD and daratumumab administered as SoC. Key Exclusion Criteria: Patients who meet any of the following criteria will not be permitted entry to the study. 1. Any form of secondary, hereditary, senile, localized, dialysis-related or leukocyte chemotactic factor 2-related (ALECT2) amyloidosis 2. Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma. Patients with signs and/or symptoms attributable ONLY to amyloidosis and who do NOT meet IMWG definition of smoldering myeloma may be enrolled upon approval of the medical monitor. 3. Supine systolic blood pressure < 90 mmHg or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of > 20 mmHg despite medical management (e.g., midodrine, fludrocortisones) in the absence of volume depletion 4. Receiving dialysis 5. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or percutaneous cardiac intervention with recent stent, coronary artery bypass grafting or major cerebrovascular accident within 6 months prior to screening 6. Left ventricular ejection fraction (LVEF) < 45 percent by echocardiogram or multigated acquisition scan (MUGA) ; PRIMARY OUTCOME: Dose Limiting Toxicity; SECONDARY OUTCOME 1: Safety parameters to be assessed separately for Parts A (CAEL 101 when administered in combination with standard-of-care CyBorD) and B (CAEL 101 when administered in combination with standard-of-care CyBorD and daratumumab)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 301 (Canada); BRIEF: This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years. ; DRUG USED: FP187; DRUG CLASS: Non-NME; INDICATION: Psoriasis; TARGET: NF-Kappa B (nuclear factor kappa-light-chain-enhancer of activated B cells) , NRF2; THERAPY: Monotherapy; LEAD SPONSOR: Forward-Pharma GmbH; CRITERIA: Inclusion Criteria: - adult patients, >=18 years of age; - clinical diagnosis of stable moderate to severe plaque psoriasis for at least 6 months; - clinical diagnosis of plaque psoriasis with an affected body surface area of no less than 10% and least 10 on the PASI scale and on the sPGA score at least as moderate; - Besides psoriasis, patient is in good general health - Patients with a DLQI score of at least 10 Exclusion Criteria: - Pustular forms of psoriasis, erythrodermic or guttate psoriasis; - Known immunosuppressive diseases; - Presence of another serious or progressive disease including skin malignancies; - Active skin disease; - Use of topical medical treatment or UVB treatment during the 2 weeks preceding randomization; - Use of systemic anti-psoriatic treatment preceding randomization: methotrexate, cyclosporine, steroids or PUVA (psoralen + UVA treatment) treatment within 4 weeks; biological treatment within 12 weeks; Stelara within 20 weeks; acitretin within 6 months; - Treatment with Fumaderm® or other Dimethyl Fumarate containing products within 12 weeks prior randomization; - Treatment with drugs influencing the course of psoriasis (e.g., antimalarial drugs, lithium) within 4 weeks prior to randomization; - Treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within 3 months prior to randomization; - On-going stomach or intestinal problems; - Aspartate transaminase (AST), Alanine transaminase (ALT) > 2 x upper normal limit (ULN), or Gamma-glutamyltransferase (γ-GT) > 2.5 x ULN; - Creatinine Clearance < 60 ml/min; - Leucopenia, eosinophilia or lymphopenia; - Protein in the urine test; ; PRIMARY OUTCOME: Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline; 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 - Basal Insulin w/ or w/o Metformin; BRIEF: This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator) - HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive) - Body mass index (BMI) 20-45 kg/m^2 (both inclusive) Exclusion Criteria: - Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant - Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness - Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening - Impaired liver or renal function - Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg) - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigators opinion could interfere with results of the trial - Known or suspected abuse of alcohol or narcotics ; PRIMARY OUTCOME: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26; SECONDARY OUTCOME 1: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26[/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 - innovaTV 301 ; BRIEF: This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take. ; DRUG USED: Tivdak; DRUG CLASS: Biologic; INDICATION: Cervical Cancer; TARGET: Antibody-drug Conjugate (ADC), Tissue Factor; THERAPY: Monotherapy; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria - Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and: - Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: - paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or - paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or - paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent - Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required. - Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted. - Measurable disease according to RECIST v1.1 as assessed by the investigator. - Has ECOG performance status of 0 or 1 prior to randomization. - Has life expectancy of at least 3 months. Exclusion Criteria - Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above. - Has clinically significant bleeding issues or risks. This includes known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry. - Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack >1 month prior to screening is allowed). - Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (e.g. Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants. Cataracts alone is not an exclusion criterion. - Major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration. - Peripheral neuropathy ≥grade 2. - Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met. ; PRIMARY OUTCOME: Overall survival (OS); SECONDARY OUTCOME 1: Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II (Healthy Volunteers); BRIEF: This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV). ; DRUG USED: Fludase; DRUG CLASS: Biologic; INDICATION: Influenza (excluding vaccines); TARGET: Glycosaminoglycans (GAGs); THERAPY: Monotherapy; LEAD SPONSOR: Ansun Biopharma, Inc.; CRITERIA: Inclusion Criteria: 1. Male and female subjects in generally good health in the opinion of the investigator as determined by vital signs, medical history, and a targeted physical exam based on medical history. 2. Subjects must be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures. 3. Be 18 to 70 years of age (inclusive). 4. Subjects must weigh at least 55 kg and must have a Body Mass Index (BMI) of no greater than 35.99 5. Febrile, oral temperature >100°F (37.8°C) and one or more of the following: - Respiratory symptom (cough, sore throat, nasal symptoms) - Constitutional symptom (headache, myalgia, sweat/chills, prostration) 6. Positive rapid antigen test (RAT) for influenza performed using FDA-Cleared and CLIA-Waived commercially available rapid antigen test. A subject may be enrolled following a positive RAT of any manufacturer. Test may be conducted by a primary care physician prior to study enrollment if documentation of a positive RAT can be provided (documentation may consist of subjects medical records and must be included in subject documentation). A subject with a negative RAT result may still enroll if the sponsor and investigator agree that there is a known influenza outbreak circulating in the community. Blood pressure within normal limits (systolic 90-150 mmHg; diastolic 50-95 mmHg) and heart rate between 45 and 140 beats per minute. 7. Blood pressure within normal limits (systolic 90-150 mmHg; diastolic 50-95 mmHg) and heart rate between 45 and 140 beats per minute. 8. Onset of illness no more than 48 hours prior to diagnosis. Note: Time of onset of illness is defined as either (1) the time when the temperature was first measured as elevated (at least one degree (°C) of elevation temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom or the presence of at least one constitutional symptom. 9. Female subjects must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, practicing abstinence or practicing two effective methods of birth control. Acceptable methods may include intrauterine device, spermicide, barrier and hormonal contraception. A female subject must agree to practice an acceptable method of birth control during study period and for 12 weeks after study terminates. All female subjects regardless of menopausal status or surgical history must have had a negative urine pregnancy test (urine betahuman chorionic gonadotropin [hCG]) during the screening visit. The urine pregnancy test must be sensitive to at least 50 mU/mL of beta-hCG. 10. Male subjects must agree to use a medically accepted form of contraception from time of enrollment to 12 weeks after study termination. Exclusion: 1. Have received any investigational drug or vaccine within 8 weeks prior to study drug dosing. 2. Have had a serious adverse reaction or hypersensitivity to any drug. 3. Have received blood products within 6 months of study enrollment. 4. Have concurrent cystic fibrosis, emphysema or previous episodes of anaphylaxis. 5. Have sickle-cell disease. 6. Allergy or history of allergy to milk or lactose. 7. Any history of congenital or acquired bleeding abnormalities. 8. Existence of any surgical, medical, or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug. 9. Use of antiviral influenza medications within 10 days prior to screening (subjects will be prohibited from taking antiviral influenza medications during the course of the trial). 10. Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening. 11. Known hypersensitivity to DAS181. 12. Women who are pregnant (urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding. 13. Uncontrolled seizure disorder or history of seizure activity within 12 months prior to study participation. 14. Any significant findings in the subjects medical history or physical examination that, in the opinion of the investigator, would affect subject safety or compliance with the dosing schedule. 15. Documented infection other than IFV in past 2 weeks. 16. Subjects with previous or current history of asthma or COPD requiring acute or chronic medication. 17. Subjects with acute diagnosis of a chronic medical condition within the last 3 months. 18. Subjects with a chronic medical condition that have initiated or changed dosing or regimen of prescription medications for their chronic medical condition within the last 3 months (any changes in chronic medications during the 28 day enrollment period will be captured in the source documentation under concomitant medications). 19. Subjects with previous or current history of the following systemic disorders: immunological disorders, HBV, HCV or cirrhosis, transplant recipients, HIV infection, or other immunosuppressive illness. 20. Subjects with cancer or history of hematologic malignancy. Cancer is defined as any active neoplastic diseases excluding noninvasive basal cell carcinoma. 21. Subjects who have had or are scheduled to have surgery within 30 days of initiation of the study. 22. Subjects who have donated or lost more than 500 mL of blood in the two months prior to screening. 23. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance. ; PRIMARY OUTCOME: Level of influenza viral load as Area Under the Curve at Day 5 (AUC0 d5) as measured by a) quantitative polymerase chain reaction (quantitative PCR) and b) 50% tissue culture infectious dose (TCID50) in cell culture; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - CALINA; BRIEF: This study aims to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria. ; DRUG USED: Coartem; DRUG CLASS: New Molecular Entity (NME); INDICATION: Malaria; TARGET: Mitochondrial Electron Transport Chain, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Male or female neonates/infants 2. Body weight <5 kg but ≥ 2 kg 3. In Cohort 1, infants aged >28 days; in Cohort 2, neonates aged 1 to ≤28 days (3 subgroups: 1-7 days; 8-14 days; 15-28 days) 4. Microscopically confirmed diagnosis of P. falciparum malaria (or mixed infections): - in Cohort 1 of ≥500 and <100,000 parasites/µL asexual P. falciparum parasitemia - in Cohort 2 of ≥100 and <100,000 parasites/µL asexual P. falciparum parasitemia - in Cohort 2, either congenital or neonatal - either symptomatic or asymptomatic Exclusion Criteria: 1. Head circumference < - 2 SD z-score in cm following WHO age and sex-specific reference curves (suspicion of microcephaly) 2. Presence of severe malaria (according to WHO 2015 definition) 3. HIV status : - in Cohort 1, patients or patients mothers current treatment with ARV - in Cohort 2, mothers known HIV positive status at patients birth or mothers current treatment with ARV 4. Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants) (WHO 2005) 5. Presence of any clinically significant neurological condition: - any episode of convulsion during the present illness (in keeping with the IMCI list of general danger signs) - known neurological disorders (e.g. chronic seizure disorders, cerebral palsy) 6. Presence of clinically significant abnormality of the hepatic and renal systems 7. Patients unable to swallow or whose drinking is impaired 8. Known hypersensitivity of the patient or either patients parent to artemether, lumefantrine, any of the excipients of Coartem®/Riamet® Dispersible tablet, or to drugs of similar chemical classes 9. History of malabsorption or previous gastrointestinal surgery, or history of radiation therapy that could affect drug absorption or metabolism, or any other disorder or history of a condition that could interfere with drug absorption, distribution, metabolism, or excretion 10. Known family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease 11. Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia) 12. Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities 13. Patients who received any antimalarial drug, including antibiotics with antimalarial activity, within 14 days of trial start, or any other prohibited drug (see Table 6-2) 14. Patients who received an investigational drug within 5 half-lives of enrollment or participated in an investigational study or within 30 days, whichever is longer ; PRIMARY OUTCOME: Artemether Cmax; SECONDARY OUTCOME 1: Lumefantrine Day 8 concentration (C168h)[/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 - Safety; BRIEF: The purpose of this study is to determine the safety and preliminary effectiveness of human central nervous system stem cells (HuCNS-SC®) transplantation in patients with Connatal Pelizaeus-Merzbacher Disease (PMD). ; DRUG USED: HuCNS-SC; DRUG CLASS: Biologic; INDICATION: Pelizaeus-Merzbacher Disease (PMD); TARGET: Stem Cells/Other Cell Therapies; THERAPY: Combination; LEAD SPONSOR: StemCells, Inc.; CRITERIA: Inclusion Criteria: - Confirmed clinical diagnosis of connatal PMD - Molecular genetic confirmation of mutation in the proteolipid protein 1 (PLP1) gene - MRI consistent with PMD as interpreted by a qualified neuroradiologist Exclusion Criteria: - Other significant congenital brain abnormality not related to PMD - Previous participation in gene transfer or cell transplant trial - Presence of neurological signs and symptoms not consistent with PMD - Current or prior malignancy - Prior organ, tissue or bone marrow transplant ; PRIMARY OUTCOME: Safety assessment through clinical neurological and MRI evaluation.; SECONDARY OUTCOME 1: MRI examination for post-transplant myelination[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - w/Everolimus; BRIEF: Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric participants with recurrent/refractory solid tumors. Phase 2, utilizing Simons optimal 2-stage design, will be conducted to estimate the antitumor activity of lenvatinib in combination with everolimus in pediatric participants with selected recurrent/refractory solid tumors including Ewing sarcoma, rhabdomyosarcoma, and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome measure. ; DRUG USED: Lenvima; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Fibroblast Growth Factor Receptor (FGFR) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria - ≥2 years and <18 years of age for enrolment in Phase 1 or ≥2 years and ≤21 years of age for enrolment in Phase 2. - Recurrent or refractory solid tumors - Phase 1: All solid tumors (measurable or evaluable disease), including primary central nervous system (CNS) tumors; exclusion of hepatoblastoma and lymphomas. Participants with diffuse intrinsic pontine glioma, optic pathway glioma, or pineal tumors with elevated tumor markers (alpha-fetoprotein [AFP] and beta-human chorionic gonadotropin [ß-hCG][or human chorionic gonadotropin [hCG])do not require histological or cytological confirmation of diagnosis - Phase 2: Ewing sarcoma, Rhabdomyosarcoma, High Grade Glioma (HGG) (all must have measurable disease); exclusion of Diffuse Intrinsic Pontine Glioma - Histologically or cytologically confirmed diagnosis - Measurable disease that meets the following criteria (Phase 2): 1. RECIST 1.1 (for all tumor types except HGG): At least 1 lesion of ≥1.0 cm in the longest diameter for a non lymph node or ≥1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computed tomography /magnetic resonance imaging (CT/MRI) 2. Response Assessment in Neuro-Oncology (RANO) for high grade glioma (HGG): At least one lesion must be measurable as defined as a bi dimensionally contrast enhancing lesion with clearly defined margins by CT or MRI scan, with a minimal diameter of 1 cm, and visible on 2 axial slices which are preferably at most 5 mm apart with 0 mm skip Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion - Karnofsky performance score ≥50 for participants>16 year of age and Lansky play score ≥50 for participants ≤16 years of age. Neurologic deficits in participants with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score - Prior Therapy - Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy - Cytotoxic chemotherapy or other chemotherapy known to be myelosuppressive: ≥21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea) - Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil counts): ≥7 days after the last dose of agent - Monoclonal antibodies: ≥21 days or 3 half-lives (whichever is shorter) of the antibody must have elapsed after the last dose of a monoclonal antibody (including checkpoint inhibitors). Toxicity related to prior antibody therapy must be recovered to Grade ≤1 - Corticosteroids: If used to modify immune adverse events related to prior therapy, ≥14 days must have elapsed since last dose of corticosteroid. Participants receiving corticosteroids, who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment, are not eligible - Hematopoietic growth factors: ≥14 days after the last dose of a long-acting growth factor or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur - Interleukins, interferons, and cytokines (other than hematopoietic growth factors): ≥21 days after the completion of interleukins, interferons or cytokines (other than hematopoietic growth factors) - Stem cell infusions (with or without total body irradiation): Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor leukocytes infusion or boost infusion: ≥84 days after infusion and no evidence of graft versus host disease; Autologous stem cell infusion including boost infusion: ≥42 days - Cellular Therapy: ≥42 days after the completion of any type of cellular therapy (eg, modified T cells, natural killer cells, dendritic cells, etc) - Radiotherapy (XRT)/External Beam Irradiation including Protons: ≥14 days after local XRT; ≥150 days after total body irradiation, craniospinal XRT or if radiation to ≥50% of the pelvis; ≥42 days if other substantial bone marrow radiation. - Radiopharmaceutical therapy: ≥42 days after systemically administered therapy. - Vascular endothelial growth factor (VEGF)/VEGF receptor (VEGFR)-targeted or mammalian target of rapamycin (mTOR)-targeted therapies: Must not have received prior exposure to lenvatinib; May have previously progressed on an mTOR inhibitor; No more than 2 prior VEGF/VEGFR-targeted therapies (For Phase 2 only); Must not have received prior VEGF/VEGFR-targeted therapy in combination with an mTOR inhibitor (For Phase 2 only) - Adequate bone marrow function for participants with solid tumors without known bone marrow involvement - Adequate bone marrow function for participants with known bone marrow metastatic disease - Adequate renal function - Adequate liver function - Adequate cardiac function - Adequate neurologic function - Adequate blood pressure (BP) control with or without antihypertensive medications - Adequate coagulation - Adequate pancreatic function - Adequate metabolic function - Adequate glycemic control - Participants must have a minimum body surface area (BSA) of 0.6 m^2 at study entry. Exclusion Criteria - Participants who have had or are planning to have the following invasive procedures - Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrolment - Central line placement or subcutaneous port placement is not considered major surgery. External central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment - Fine needle aspirate within 7 days prior to enrolment - Surgical or other wounds must be adequately healed prior to enrolment - For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy - Participants who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrolment - Participants having an active infection requiring systemic therapy. - Participants with a known history of active hepatitis B (defined as hepatitis B surface antigen reactive or hepatitis B virus- deoxyribonucleic [DNA] detected) or known active hepatitis C virus (HCV, defined as HCV- Ribonucleic acid [RNA] detected). Note: No testing for hepatitis B and hepatitis C is required unless mandated by the local health authority. - Known to be human immunodeficiency virus (HIV) positive. Note: HIV testing is required at screening only when mandated by the local health authority - Clinical evidence of nephrotic syndrome prior to enrolment - Gastrointestinal bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrolment - Thrombotic/ thromboembolic event requiring systemic anticoagulation within 90 days prior to enrollment - Evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment for Participants with HGG - Diagnosis of lymphoma - Radiographic evidence of major blood vessel invasion/infiltration. - Evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease) - Participants who are currently receiving enzyme-inducing anticonvulsants - Participants chronically receiving strong cytochrome P450 3A4 (CYP3A4)/P-glycoprotein (P-gp) inhibitors or inducers within 7 days prior to study enrollment - Females who are breastfeeding or pregnant. For females of childbearing potential, a negative screening pregnancy test must be obtained within 72 hours before the first dose of study drug - Males who have not had a successful vasectomy (confirmed azoospermia) or if they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 7 days after lenvatinib discontinuation or 4 weeks after discontinuation of everolimus). No sperm donation is allowed during the study period and for 7 days after lenvatinib discontinuation or 4 weeks after discontinuation of everolimus. ; PRIMARY OUTCOME: Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus; SECONDARY OUTCOME 1: Phase 1: Objective Response Rate (ORR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ZMK-301 (Osteoarthritis of the Knee); BRIEF: ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults. ; DRUG USED: ThermoProfen; DRUG CLASS: Non-NME; INDICATION: Arthritis Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: ZARS Pharma Inc.; CRITERIA: Inclusion Criteria: - Patient is 18 through 75 years of age - Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year. Exclusion Criteria: - Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin). - Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs. - Patient has a relevant history of serious gastrointestinal disease. - Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control. - Patient is taking warfarin, heparin, or low molecular weight heparin. - Patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint). - Patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment. ; PRIMARY OUTCOME: The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.; SECONDARY OUTCOME 1: Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Adults; BRIEF: GSK3335065 is being developed as a treatment for acute pancreatitis with the intent of reducing 3-hydroxykynurenine (3HK) levels to the normal range (or lower) and maintaining them at this level throughout the treatment period. This study will utilize an adaptive design and is divided into 3 parts. Part A will consist of 8 cohorts (1-8) and is Single Ascending Dose (SAD) of GSK3335065 by IV bolus in males. Part B will be initiated after completion of dosing in Part A. It will involve ascending IV bolus doses of GSK3335065 followed by IV constant infusion for 7 days in males and will consist of four cohorts (9-12). Part C consists of a single dose of GSK3335065 by IV bolus (cohort 13), and a single dose followed by continuous infusion over 7 days (cohort 14) in females of non-child bearing potential (WONCBP). Total 64 subjects will be evaluated in the study of which Part A will include 16 healthy male subjects, Part B will include 32 healthy male subjects and Part C will include 16 WONCBP. In Part A, cohorts 1 and 2 will last up to 19 weeks and cohorts 3 to 8 will last up to 7 weeks and Part B will last up to 13 weeks. In Part C cohort 7 will last up to 7 weeks and cohort 8 will last for 13 weeks. ; DRUG USED: GSK3335065; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatitis; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria - Subjects must be 18 to 50 years of age inclusive, at the time of signing the informed consent. In Part C (WONCBP) subjects must be between 18 and 60 years of age. - Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. - A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. - Body weight greater than 50 kilogram (kg) and body mass index (BMI) within the range 18.5 - 32 kilogram per meter square (kg/m^2). - Length of time required for abstinence or use of contraceptives should take into account the reproductive toxicity profile including genotoxicity and teratogenicity, the size of the molecule, and the number of doses. Male subjects must agree to use contraception during the treatment period and for at least 2 days after the last dose of study treatment and refrain from donating sperm during this period. Only female subjects of WONCBP are eligible to participate. - Capable of giving signed informed consent. Exclusion Criteria - ALT and bilirubin greater than 1.5 times upper limit of normal (ULN) (isolated bilirubin greater than 1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%). - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones) - QTc corrected by Fridericias formula(QTcF) greater than 450 millisecond (msec) from a mean of triplicate readings taken 5 mins apart - Clinically significant abnormal echocardiogram - The subject has a history or current evidence of depression, bipolar disorder, suicidal ideation and behavior, or a lifetime history of suicide attempt - Cardiac troponin (cTn) or Brain natriuretic peptide (BNP) greater than ULN - Use of prohibited medication - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, subjects with presence of hepatitis B core antibody (HBcAb) should also be excluded. - A positive pre-study drug/alcohol screen - A positive test for human immunodeficiency virus (HIV) antibody - Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 84 days. - Poor or unsuitable venous access - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 gram of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. - History of smoking within 6 months of the study. ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A; SECONDARY OUTCOME 1: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration (AUC[0-t]) for GSK3335065-Part A (Cohorts 1 and 2)[/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 - MAGELLAN-2; BRIEF: The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C virus (HCV) infection. ; DRUG USED: Mavyret; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Male or female, at least 18 years of age at time of screening. - Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6) infection. - Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or subject received a cadaveric or living donor kidney at least 3 months before screening. - Subjects must be documented as non-cirrhotic. - Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine. Exclusion Criteria: - Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. - Clinical history of fibrosing cholestatic hepatitis post-transplant. - Re-transplantation of the liver or kidney. - Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening. - History of post-transplant complications related to hepatic or renal vasculature. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With On-treatment Virologic Failure[/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 - MEL11; BRIEF: Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response. ; DRUG USED: ALVAC; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System; THERAPY: Combination; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion Criteria : - A pathologically confirmed diagnosis of malignant melanoma with at least one measurable metastatic lesion with a minimum lesion size of 20 mm, based on radiological assessment (or 10 mm if assessed by spiral computed tomography [CT] scan ) as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Stages IIIc, IVa, or IVb only, according to the American Joint Committee on Cancer (AJCC) staging system for melanoma). Cutaneous metastasis (assessed by physical examination) must be at least 10 mm. CT scan or magnetic resonance imaging (MRI) is required to rule out brain metastases. - Patients who received prior treatment for their metastatic disease must have objective evidence of disease progression. - Aged ≥ 18 years on the day of inclusion - IRB-approved informed consent form signed - Able to attend all scheduled visits and to comply with all trial procedures - For a woman, inability to bear a child or negative serum pregnancy test - For a woman of child-bearing potential, using an effective method of contraception or abstinence during the study and at least 4 weeks after the last study treatment - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months. - Adequate hematologic, hepatic, and renal function (at pre-defined laboratory values). - Fully recovered from surgery, if applicable. Exclusion Criteria : - Receipt of two or more previous therapies for metastatic melanoma. - Receipt of chemotherapy or another therapy for metastatic melanoma within the last four weeks - Receipt of adjuvant interferon therapy within the last six months - Concurrent receipt of radiotherapy for the metastatic disease, unless for palliative purposes - Participation in another clinical trial within the four weeks preceding the first trial treatment - Planned participation in another clinical trial during the present trial period - Known Human Immunodeficiency Virus (HIV) infection or hepatitis B (Ag HBs) or hepatitis C seropositivity - Presence of active autoimmune disease (excluding vitiligo) - Systemic hypersensitivity to bovine products or to any of the vaccine components, including egg products or Neomycin (used to prepare the vaccine), or history of a life-threatening reaction to granulocyte-macrophage colony stimulating factor (GM-CSF) or interferon (IFN)-α2b - Current alcohol or drug addiction that may interfere with the ability to comply with trial procedures - Significant co-morbid medical conditions, including pre-existing renal disease, cirrhosis, or major depression, which in the estimation of the investigator would preclude safe participation in the study or the accurate interpretation of data. - A calculated glomerular filtration rate (GFR) <60 mL/min (based on the Cockroft-Gault formula). - Previous receipt of a modified canarypox virus (ALVAC)-based vaccine. ; PRIMARY OUTCOME: Summary of Disease Progression in Study Participants, Intent-to-treat Population; SECONDARY OUTCOME 1: Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat 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 III - GLOW - w/Venetoclax (First-Line); BRIEF: The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC). ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Adult participants who are: (a) greater than or equal to (>=) 65 years old or, (b) 18 to 64 years old and have at least 1 of the following: 1. Cumulative Illness Rating Scale (CIRS) score > 6 2. Creatinine clearance (CrCl) estimated less than (<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation - Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria - Measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node > 1.5 centimeter (cm) in longest diameter - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (<=) 2 - Active CLL/SLL requiring treatment per the iwCLL criteria Exclusion Criteria: - Prior anti-leukemic therapy for CLL or SLL - Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53 mutation detected at a threshold of >10 percent (%) variable allele frequency (VAF) - Major surgery within 4 weeks of first dose of study treatment - Known bleeding disorders (example, von Willebrands disease or hemophilia) - Central nervous system (CNS) involvement or suspected Richters syndrome ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Minimal Residual Disease (MRD) Negative 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 Ib - w/PF05082566; BRIEF: This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation. ; DRUG USED: Poteligeo; DRUG CLASS: Biologic; INDICATION: Solid Tumors; TARGET: Chemokine Receptor 4 (CCR4); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy. Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC, bladder, or ovarian carcinomas which have progressed on standard therapy, or for which no standard therapy is available. - Measurable disease by RECIST version 1.1. - For Expansion Cohorts only: patients must have tumor accessible for biopsies (core needle biopsy or excision preferred). - Age 18 years. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate bone marrow, renal and liver function. - Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment. - Male and female patients of childbearing potential and at risk for pregnancy must agree to use two (2) highly effective methods of contraception throughout the study and for 60 days after the last dose of assigned study treatment. Exclusion Criteria: - Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis. - Therapeutic or experimental monoclonal antibodies in last 60 days prior registration. - Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy, 5 half-lives since completion of prior systemic anticancer therapy is allowed. - Systemic steroids, any other form of immunosuppressive therapy or radiation therapy within 14 days prior to registration. - Live vaccine within 30 days prior to registration. - Severe hypersensitivity reaction to treatment with another monoclonal antibody, known or suspected hypersensitivity to study drugs or any component of their formulation. - History of autoimmune disease or known inflammatory bowel disease. - Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical therapy) or any of the following within 12 months prior to registration: myocardial infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac dysrhythmias, atrial fibrillation or QTcF interval >470 msec. ; PRIMARY OUTCOME: Number of Participants With Dose Limiting Toxicities (DLT); SECONDARY OUTCOME 1: Number of Participants With Treatment-Emergent Adverse Events (All Causalities)[/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 - MIST2; BRIEF: This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 300U dose. Participation will last 1 year. ; DRUG USED: Botox - Therapeutic; DRUG CLASS: Biologic; INDICATION: Benign Prostatic Hyperplasia (BPH); TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); CRITERIA: Inclusion Criteria: - Male at least 50 years of age. - Voided volume => 125 ml. - Maximum urinary flow < 15 ml/sec. - AUA symptom severity score => 8. - Patient signed informed consent prior to the performance of any study procedures. - Patient able to complete the study protocol in the opinion of the investigator. Exclusion Criteria: - Any prior surgical intervention for BPH. - Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH). - Overactive bladder without bladder outlet obstruction. - Enrolled in another treatment trial for any disease within the past 30 days. - Men interested in future fertility. - Previous exposure to botulinum toxin. - On alpha-blocker within the past 48 hours. - On any 5-alpha-reductase inhibitor within the past month. - Post void residual > 350 ml. - On phenylephrine, pseudoephedrine, imipramine, an anticholinergic, or cholinergic medication within the past 2 weeks. - On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months. - Clinically significant renal or hepatic impairment as determined by abnormal creatinine or AST levels (based on local institutional values). - Serum prostate specific antigen level > 8 ng/ml (Hybritech). For those with a PSA between 4-8 ng/ml, the PSA elevation must be considered to be from a benign cause in the opinion of the PI. This decision can be based on PSA velocity, previous TRUS biopsy, percent free PSA, or other clinical estimations in keeping with sound urologic care. - Active urinary tract disease or biopsy of the prostate within the past 6 weeks. - Daily use of a pad or device for incontinence required. - Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months. - On aminoglycosides or any drug that interfere with neuromuscular transmission. - Eaton-Lambert syndrome, hemophilia, hereditary clotting factors deficiency, or bleeding diathesis. - Penile prosthesis or artificial urinary sphincter. - History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or bladder neck obstruction. - Known primary neurologic conditions such as multiple sclerosis, myasthenia gravis or Parkinsons disease, or other neurological diseases known to affect bladder function. - Documented bacterial or acute prostatitis within the past year. - Two documented urinary tract infections of any type in the past year (UTI defined as > 100,000 colonies per ml urine from midstream clean catch or catheterized specimen). - History of bladder calculi. - Patients must be off aspirin, NSAIDS, and Coumadin for 7 or more days prior to botulinum toxin injection. - Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years). - Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, hypersensitivity to botulinum toxin or anesthetics used in the study, syncope, uncontrolled diabetes. ; PRIMARY OUTCOME: Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.; 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 - PROTECT-COVID-19; BRIEF: The aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS). ; DRUG USED: Ruconest; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: University Hospital, Basel, Switzerland; CRITERIA: Inclusion Criteria: - Informed Consent as documented by signature - admitted to the hospital because of confirmed (by a positive SARS-CoV-2 PCR result) COVID-19 infection - evidence of pulmonary involvement on CT scan or X-ray of the chest (e.g. ground glass opacities) - symptom onset within the previous 10 days OR shortness of breath within the previous 5 days. Symptoms include fever or one respiratory symptom (patients presenting later may have already progressed to an inflammatory state that is potentially not amenable to C1INH treatment). Respiratory symptoms include cough, sore throat, hemoptysis, shortness of breath, runny nose, or chest pain. - expected to remain an inpatient over the next three calender days from time of enrolment - at least one additional risk factor for progression to mechanical ventilation: 1) arterial hypertension, 2) >50 years, 3) obesity (BMI>30.0 kg/m2), 4) cardiovascular disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) C-reactive protein of >35mg/L, 7) oxygen saturation at rest in ambient air of <94%. Cardiovascular disease includes a history of coronary artery disease, cerebrovascular disease, peripheral artery disease, rheumatic heart disease, congenital heart disease and of recent (< 3 months) deep vein thrombosis or pulmonary embolism. Chronic pulmonary disease includes a history of chronic obstructive pulmonary disease, asthma, occupational lung disease, interstitial lung disease or of pulmonary hypertension. Chronic renal disease is defined as a history of an estimated glomerular filtration rate (according to the Chronic Kidney Disease Epidemiology Collaboration equation) < 60ml/min/1.73 m2 for at least three months. Exclusion Criteria: - Contraindications to the class of drugs under study (C1 esterase inhibitor), e.g. known hypersensitivity or allergy to class of drugs or the investigational product - Treatment with tocilizumab or another Il-6R or Il-6 inhibitor before enrolment - History or suspicion of allergy to rabbits - Women who are pregnant or breast feeding - Active or planned treatment with any other complement inhibitor - Liver cirrhosis (any Child-Pugh score) - Incapacity or inability to provide informed consent - Currently admitted to an ICU or expected admission within the next 24 hours - Currently receiving invasive or non-invasive ventilation (with the exception of high-flow oxygen therapy). - In the opinion of the treating time, death is deemed to be imminent and inevitable within the next 24 hours - Participation in another study with investigational drug within the 30 days preceding and during the present study with the following exemptions: 1) participation in COVID-19 drug trials started at least 48 hours before admission (e.g. postexposure prophylaxis with hydroxychloroquine) and 2) participation in COVID-19 drug trials during ICU admission - Previous enrolment into the current study - Enrolment of the investigator, his/her family members, employees and other dependent persons - Any uncontrolled or significant concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements ; PRIMARY OUTCOME: Disease severity; SECONDARY OUTCOME 1: Time to clinical improvement[/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 - Recurrent Symptomatic Ascites; BRIEF: The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites. ; DRUG USED: Removab; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Cluster of Differentiation 3 (CD3), Epithelial cell surface antigen (Ep-CAM)/ CD326; THERAPY: Monotherapy; LEAD SPONSOR: Neovii Biotech; CRITERIA: Inclusion Criteria: - Signed and dated informed consent - Histologically confirmed diagnosis of epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer; any stage at diagnosis [International Federation of Gynecology and Obstetrics (FIGO) Stages I through IV]. - Progression on or ≤ 12 months after primary platinum-based systemic or intraperitoneal (IP) chemotherapy OR relapse following reinduction ≥ 12 months after primary chemotherapy. - Have refused, failed, or have been deemed not suitable candidates for gemcitabine or liposomal doxorubicin. - Recurrent symptomatic malignant ascites requiring therapeutic paracentesis - At least 1 therapeutic paracentesis within 4 weeks prior to baseline paracentesis - Age ≥ 18 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Life expectancy ≥ 16 weeks - Serum creatinine ≤ 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin ≤ 1.5 x ULN - Absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3 - Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility). - Willingness of patients of childbearing potential to use an effective contraceptive method (i.e., oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion. Exclusion Criteria: - Acute or chronic systemic infection - Exposure to investigational drugs, chemotherapy or radiotherapy 21 days prior to the first dose of catumaxomab - Major surgery 2 weeks prior to first dose - Previous treatment with mouse or rat antibodies - Known or suspected hypersensitivity to catumaxomab or other monoclonal antibodies - Body mass index (BMI) < 19 (body weight after paracentesis to be used for calculation of BMI) - Serum albumin level < 2.0 g/dL - Reduced nutritional status requiring predominantly parenteral nutrition (> 50% of energy intake). Permanent naso-gastric (NG) feeding tube. - Ileus in a location that precludes paracentesis - Extensive liver metastases (> 70% organ volume comprises malignancy) - Documented brain metastases - History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia 3 months prior to the first dose of catumaxomab - Portal vein obstruction or portal vein thrombosis diagnosed by computed tomography (CT) scan at screening - Persistent massive pleural effusion or inadequate respiratory function of any other etiology (except if related to ascites symptoms) in the opinion of the investigator - Any other condition which, according to the investigator, results in an undue risk to the patient by participating in the study - Prior exposure to catumaxomab ; PRIMARY OUTCOME: The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.; SECONDARY OUTCOME 1: Puncture/Paracentesis-free Survival (PuFS)[/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 - OSLER-1 (OLE); BRIEF: The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia. ; DRUG USED: Repatha; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Combination; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703) Exclusion Criteria: - Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study - Have an unstable medical condition, in the judgment of the investigator - Known sensitivity to any of the products to be administered during dosing - Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s) ; PRIMARY OUTCOME: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric (Ages 0-9) - On Peritoneal Dialysis ; BRIEF: The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2). ; DRUG USED: Zemplar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperparathyroidism (Secondary); TARGET: Parathyroid Hormone (PTH); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT). - Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial Screening. - For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participants age as described in the protocol. - For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participants age as described in the protocol. Exclusion Criteria: - Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient. - Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit. - Participant has had a parathyroidectomy within 12 weeks prior to Screening. - Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to more than > 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to Dosing. - Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study. - Participant is unable to take oral medications. ; PRIMARY OUTCOME: Percentage of Participants Who Achieve Positive Response During Dosing Period 1; SECONDARY OUTCOME 1: Percentage of Participants Who Achieve a Positive Response During Dosing Period 2[/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 - MOMENTUM 1; BRIEF: The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome. ; DRUG USED: Belviq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dravet Syndrome (Epilepsy); TARGET: Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Key Inclusion Criteria: Participants must meet all of the following criteria to be included in this study: 1. Male or female, age 2 years and older at the time of informed consent 2. Diagnosis of epilepsy with Dravet syndrome 3. Has at least 4 convulsive seizures during the 4 weeks of baseline 4. Current treatment with antiepileptic drugs must be stable for at least 4 weeks before screening, and be expected to remain stable throughout the study Key Exclusion Criteria: Participants who meet any of the following criteria will be excluded from this study: 1. Use of lorcaserin within 4 weeks before screening, or any history of it being discontinued due to lack of efficacy or adverse reactions 2. Use of fenfluramine within 2 months before screening, any history of lack of fenfluramine efficacy, or any history of valvulopathy at baseline with history of fenfluramine use 3. Recent or concomitant use of serotonergic medications or monoamine oxidase inhibitors 4. Presence of progressive central nervous system disease other than Dravet syndrome ; PRIMARY OUTCOME: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks); SECONDARY OUTCOME 1: Percentage of 50% Responders for Convulsive Seizures in the Core Treatment Period (14 Weeks) Compared to Baseline[/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 - IDH1/IDH2 Mutation; BRIEF: This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in Gliomas, that harbor an IDH1 and/or IDH2 mutation. ; DRUG USED: AG-881; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Isocitrate Dehydrogenase (IDH); THERAPY: Monotherapy; LEAD SPONSOR: Institut de Recherches Internationales Servier; CRITERIA: Inclusion Criteria: - Patient must be ≥18 years of age - Patient must have histologically or cytologically confirmed solid tumor, including glioma, with documented IDH1 and/or IDH2 gene-mutation. Patients in the dose escalation phase must have disease that has recurred or progressed following standard therapy and/or therapy with an inhibitor of mutant IDH1 and/or IDH2, or that has not responded to this therapy. Patients in the expansion phase may have previously untreated disease - Patient must have evaluable disease by RECIST v1.1 for patients without glioma or by RANO or RANO LGG criteria for patients with glioma - Patients with glioma must have a baseline brain MRI scan - Patient must have archived primary tumor biopsies or surgical specimens, or biopsies of recurrent or metastatic samples - Patient must be amenable to serial peripheral blood sampling, urine sampling, and tumor biopsies during the study - Patient must be able to understand and willing to sign an informed consent - Patient must have ECOG PS of 0 to 2 - Patient must have expected survival of ≥3 months - Patient must have adequate bone marrow function as evidenced by absolute neutrophil count ≥1.5 ×10^9/L; hemoglobin >9 g/dL (Patients are allowed to be transfused to this level); platelets ≥75 × 10^9/L - Patient must have adequate hepatic function as evidenced by: Serum total bilirubin ≤1.5 × upper limit of normal (ULN), unless considered due to Gilberts disease or disease involvement; Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤2.5 × ULN. For patients with bone metastases and/or suspected disease-related liver or biliary involvement, AST, ALT and ALP must be ≤5 × ULN - Patient must have adequate renal function as evidenced by: Serum creatinine ≤2.0 × ULN or Creatinine clearance >40 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimated: (140-Age) x (weight in kg) x (0.85 if female)/72 x serum creatinine - Patient must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer - Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to first study drug administration. Patients with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy or tubal occlusion or who have not experienced natural menopause (i.e., who have not menstruated at all) for at least 24 consecutive months (i.e., have had menses at any time in the preceding 24 consecutive months). Women with reproductive potential as well as fertile men and their partners who are female with reproductive potential must agree to abstain from sexual intercourse or to use two highly effective forms of contraception from the time of giving informed consent, during the study, and for 90 days (females and males) following the last dose of AG 881 Exclusion Criteria: - Patients who received systemic anticancer therapy or radiotherapy <21 days prior to their first day of study drug administration - Patients who received an investigational agent (including AG-120 or AG-221) <14 days prior to their first day of study drug administration. In addition, the first dose of AG-881 should not occur before a period ≥5 half-lives of the investigational agent (other than AG-120 or AG-221) has elapsed. - Patients with gliomas who have had prior treatment with bevacizumab (Avastin) are excluded - Patients who are pregnant or breast feeding - Patients with an active severe infection that required anti-infective therapy or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, patients with tumor fever may be enrolled) - Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within approximately 28 days of C1D1 - Patients with a history of myocardial infarction within the 6 months prior to screening - Patients with known unstable or uncontrolled angina pectoris - Patients with a known history of severe and/or uncontrolled ventricular arrhythmias - Patients with QTc interval ≥450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) - Patients taking medications that are known to prolong the QT interval unless they can be transferred to other medications within ≥5 half-lives prior to dosing, or unless the medications can be properly monitored during the study. - Patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C - Patients with known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally - Patients with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including those used to control symptoms, within 1 month of first dose - Glioma patients with evidence of intracranial or intratumoral hemorrhage either by MRI or CT scan ; PRIMARY OUTCOME: Safety/Tolerability; incidence of adverse events; SECONDARY OUTCOME 1: Pharmacokinetic profiles including max concentration (Cmax), time to maximum concentration (Tmax), AUC, and elimination half-life[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - XPORT-MEL-033; BRIEF: Approximately 40 participants with locally advanced or metastatic melanoma will be enrolled in 20 sites in the United States into 1 of the following 2 arms: Primary resistance to initial checkpoint inhibitor (CPI) therapy in Arm A and Acquired resistance to initial CPI therapy in Arm B. Participants who have disease progression (PD) after discontinuation of CPIs, especially in neoadjuvant or adjuvant therapy, will be considered to have acquired resistance in this study. Participants will receive study treatment (Selinexor and Pembrolizumab) until PD, intolerable toxicity or withdrawal from the study, whichever occurs first. ; DRUG USED: Xpovio; DRUG CLASS: New Molecular Entity (NME); INDICATION: Melanoma; TARGET: Exportin-1/CRM1/XPO1, Immune System, Interferon-beta (IFNb), SARS-CoV-2; THERAPY: Combination; LEAD SPONSOR: Karyopharm Therapeutics Inc; CRITERIA: Inclusion Criteria: - Age greater than or equal to (≥) 18 years at the time of informed consent. - Participant must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy. 1. Participants must have confirmed PD per Response Evaluation Criteria in Solid Tumors (RECIST) on or within 12 weeks of the last dose of anti-PD-1/L1 monotherapy or combination therapy (including relatlimab or other anti-LAG-3 mAb) per Society for Immunotherapy in Cancer Guidelines (Kluger,2020). 2. Arm A (primary resistance): participant has disease progression after receiving at least 6 weeks of prior anti-PD-1/L1 mAb with the best response as PD, or stable disease (SD) less than (<) 6 month (participants with a partial response [PR] or complete response [CR] who have disease progression within 6 months will be considered to have primary resistance in this study). 3. Arm B (secondary/acquired resistance): participant has disease progression after receiving at least 6 months of prior anti-PD-1/L1 mAb with the best response as CR, PR, or SD greater than (>) 6 months (participants who have disease progression after neoadjuvant or adjuvant therapy, will be considered to have secondary resistance in this study). 4. Participants who progress on or within 12 weeks after elective discontinuation of anti-PD-1/L1 mono or combination treatment in the absence of PD or treatment limiting toxicity must have confirmed PD per RECIST. - Participants should have at least 1 prior line of CPI therapy but no more than 2. - Measurable disease according to RECIST v1.1. - Participants with stable previously treated brain metastases are permitted in this study. - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (≤) 1. - Adequate bone marrow function at screening, defined as: 1. Absolute neutrophil count (ANC) ≥1.5 * 10^9 per liter (L). 2. Hemoglobin ≥10 gram per deciliter (gm/dL) (≥6.2 millimoles per liter [mmol/L]). 3. Platelet count ≥100 * 10^9/L. - Serum direct bilirubin ≤1.5 * upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 * ULN (with confirmed liver metastases: AST and ALT ≤5 * ULN). - Calculated creatinine clearance (CrCl) ≥15 milliliters per minute (mL/min) based on the Cockcroft and Gault formula. - Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Childbearing potential excludes: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy. - Male participants who are sexually active must use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Male participants must agree not to donate sperm during the study treatment period. - Written informed consent signed in accordance with federal, local, and institutional guidelines. Exclusion Criteria: - Metastatic uveal or ocular melanoma. - Active central nervous system (CNS) metastases or other CNS (e.g., meningeal) involvement. - Participants must have resolution or improvement of immune-mediated treatment related adverse reactions related to prior treatment(s) to Grade ≤1 without steroid maintenance therapy or his or her previous baseline prior to the corresponding CPI therapy a. History of immune-mediated treatment related adverse reactions leading to discontinuation of prior anti-programmed death protein 1 (PD-1), anti-programmed death protein ligand 1 (PD-L1), or anti programmed death protein ligand 2 (PD-L2) monoclonal antibodies (mAbs) or severe hypersensitivity reaction to any mAb or any excipients which in the opinion of the Investigator precludes future use of anti-PD-1/PDL1 therapy. - Concurrent systemic steroid therapy higher than physiologic dose (>10 milligrams per day [mg/day] of prednisone or equivalent). - Previous treatment with selinexor or other exportin 1 (XPO1) inhibitors. - Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as: 1. Not recovered from major surgery ≤28 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted. 2. Have ongoing clinically significant anti-cancer therapy-related toxicities Common Terminology Criteria for Adverse Events (CTCAE) Grade >1. In specific cases, participants whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsors Medical Monitor 3. Had last dose of previous anti-cancer therapy ≤14 days prior to Day 1 dosing 4. Palliative radiotherapy >14 days prior to the study is allowed 5. Received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug (whichever is shorter), prior to Cycle 1 Day 1 (C1D1). - Live-attenuated vaccine (e.g., nasal spray influenza vaccine) ≤14 days prior to the intended C1D1. - Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (e.g., vomiting, or diarrhea that is CTCAE version 5.0 grade >1). - Life expectancy less than (<) 4 months based on the opinion of the Investigator - Active pneumonitis requiring steroid therapy. - Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral). - Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigators opinion, could compromise the participants safety, prevent the participant from giving informed consent, or being compliant with the study procedures. - Female participants who are pregnant or lactating. - Active hepatitis B virus treated with antiviral therapy for hepatitis B within 8 weeks with a viral load >100 international units per milliliter (IU/mL). - Untreated hepatitis C virus positive without documentation of negative viral load per institutional standard. - Human immunodeficiency virus positive with CD4+T-cells ≤350 cells per microliter, positive viral load per institutional standard, and a history of acquired immunodeficiency syndrome defining opportunist infections in the last year. ; 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 II - Post-Transplant AML; BRIEF: This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing). ; DRUG USED: MT-401; DRUG CLASS: Biologic; INDICATION: Acute Myelogenous Leukemia (AML); TARGET: Melanoma antigen-encoding gene (MAGE), NY-ESO-1 (Cancer-testis antigen), PRAME/MAPE/OIP4, Stem Cells/Other Cell Therapies, Survivin, Synovial Sarcoma X (SSX) Breakpoint Family, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Marker Therapeutics, Inc.; CRITERIA: Inclusion Criteria 1. First allogeneic HSCT, in ≤ CR2, and MRD negative prior to transplant (including matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as: - Adjuvant therapy for AML (Group 1) at 85-130 days post-HSCT defined as patients with CRMRD; or - Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as - First relapse (MRD+ or frank relapse) post-HSCT - Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT - Safety Lead-in defined as patients who fit all the criteria for Group 2 only 2. Are ≥18 years of age 3. Karnofsky/Lansky score of ≥60 4. Life expectancy ≥12 weeks 5. Adequate blood, liver, and renal function - Blood: Hemoglobin ≥7.0 g/dL (can be transfused) - Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper limit of normal - Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated creatinine clearance ≥45mL/min 7. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant. 8. In Group 2, patients may receive bridging therapy at the investigators discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit Exclusion Criteria 1. Clinically significant or severely symptomatic intercurrent infection 2. Pregnant or lactating 3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401 4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401 5. Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401 ; PRIMARY OUTCOME: Safety Lead-In; 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 IIb/III - 1218.23 (vs. voglibose, Japan); BRIEF: The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks. ; DRUG USED: Tradjenta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1. 2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase) 3. Age: >= 20 and <= 80 4. Body Mass Index (BMI) <= 40 kg/m2 Exclusion criteria: 1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1 2. Impaired hepatic function 3. History of severe allergy/hypersensitivity 4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1 5. Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3 ; PRIMARY OUTCOME: Change From Baseline in HbA1c at Week 12; SECONDARY OUTCOME 1: Relative Efficacy Response of HbA1c 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 IIb - w/PEG/RBV and GS-9451 or GS-9190; BRIEF: This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus (HCV) Infection. ; DRUG USED: Ledipasvir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Male or female, aged from 18 to 70 years old, inclusive - Chronic HCV infection for at least 6 months prior to Baseline - Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. - Monoinfection with HCV genotype 1 - HCV RNA > 10^4 IU/mL at Screening - Prior treatment and adherence (as defined by receiving at least 80% of the prescribed treatment) with one course of a pegylated interferon-alfa (Pegasys or Peg-Intron) and RBV - The subjects medical records must include sufficient detail of prior treatment with pegylated interferon-alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either - Non-Responder: Subject did not achieve undetectable HCV RNA levels during or at the end of a treatment period of at least 12 weeks duration. Within Nonresponders, subjects will be further defined as Null or Partial Responders if they had < 2 log10 or ≥ 2 log10 reduction, respectively, in HCV RNA during the first 12 weeks of treatment - Responder: Subject achieved undetectable HCV RNA during treatment. Within Responders, subjects will be further defined as Relapsers if they had undetectable HCV RNA at the end of at least 42 weeks of treatment but detectable HCV RNA levels observed within 1 year of the end of treatment and Breakthrough subjects if they achieved undetectable HCV RNA levels during the treatment period but detectable HCV RNA at the end of treatment. - No prior treatment with an oral HCV antiviral (exclusive of RBV). - Body mass index (BMI) 18-36 kg/m2, inclusive. - Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericias formula) ≤ 450 msec for males and ≤ 470 msec for females - Creatinine clearance ≥ 50 mL/min. - Agree to use two forms of highly effective contraception for the duration of the study and for 6 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at Screening and Baseline Exclusion Criteria: - Discontinued prior treatment with pegylated interferon-alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up. - Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH) - Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), or another HCV genotype, hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed. - Current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone are excluded, however stable buprenorphine maintenance treatment for at least 6 months is not exclusionary - Receiving any of the prohibited concomitant medications. ; PRIMARY OUTCOME: Sustained Virologic Response (SVR); SECONDARY OUTCOME 1: Sustained Virologic Response(SVR) of each regimen administered for 24 to 48 weeks[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/Rucaparib; BRIEF: Background: Drugs known as poly-adenosine diphosphate ribose polymerase (PARP) inhibitors are known to help stop tumor growth in patients with breast, ovarian cancers and many other cancers including prostate and pancreatic cancers. Many research studies done in animals and human cells have shown that these types of drugs can improve how well chemotherapy works. Standard chemotherapy can be too toxic to be combined with PARP inhibitors. In this study, we use a new form of chemotherapy called PLX038 (PEGylated SN38) to see if it can be safely combined with PARP inhibitors to shrink tumors. Objective: To find a safe combination of PLX038 and rucaparib, and to see if this mix will cause tumors to shrink. Eligibility: People age 18 and older with solid tumors, small cell lung cancer (SCLC), or small cell cancer outside their lungs. Design: Participants will be screened with: Physical exam Blood tests Records of their diagnosis (or they will have a tumor biopsy). A review of their symptoms and medications. A review of their ability to perform their normal activities. Electrocardiograms, to measure the electrical activity of the heart. Computed tomography (CT) scans of the chest, abdomen, and pelvis. CT scans are a series of X-rays. Participants will get PLX038 by intravenous catheter on Day 1 of each cycle (1 cycle = 21 days). For this, a small plastic tube is put into an arm vein. They will take rucaparib twice daily by mouth on Days 3 to 19 of each cycle. They will keep a medicine diary. Participants may give a hair sample. They may have optional tumor biopsies. Screening tests are repeated throughout the study. About 30 days after treatment ends, participants will have a safety follow-up visit. They will give blood samples, talk about their health, and get a physical exam. Then they will be called or emailed every 6 months.... ; DRUG USED: PL-0264; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Topoisomerase I (Topo-I); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: - INCLUSION CRITERIA: - Subjects with: - histologically confirmed solid tumors (Phase I), OR - histologically or cytologically confirmed small cell lung cancer (SCLC) (Phase II), OR - histologically or cytologically confirmed extra-pulmonary small cell carcinomas (Phase II). - Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of PLX038 (PEGylated SN38) in combination with rucaparib in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials. - Subjects must have progressed on or after standard first-line systemic chemotherapy and have no effective treatment options. - Participants must have disease that is not amenable to potentially curative resection. - Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. - Participants with asymptomatic brain metastases and treated brain metastases are eligible. - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. - Adequate hematological function defined by: - white blood cell (WBC) count greater than or equal to 3 x 10^9/L, - absolute neutrophil count (ANC) greater than or equal to 1.5 x10^9/L, - platelet count greater than or equal to 100 x 10^9/L, - Hemoglobin (Hgb) greater than or equal to 9 g/ dL - Adequate hepatic function defined by: - a total bilirubin level less than or equal to 1.5 x upper limit of normal (ULN), - an aspartate aminotransferase (AST) level less than or equal to 2.5xULN, (less than or equal to 5X ULN if liver metastasis) - an alanine transaminase (ALT) level less than or equal to 2.5 xULN, (less than or equal to 5X ULN if liver metastasis). - Adequate renal function defined by: - Creatinine OR Measured, or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl): < 1.5x institution upper limit of normal OR greater than or equal to 45 mL/min/1.73 m^2 for participant with creatinine levels greater than or equal to 1.5 X institutional ULN. Note: Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard. - The effects of the study treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment and up to 6 months after the last dose of the study drug (s). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. - Subjects must be able to understand and willing to sign a written informed consent document. EXCLUSION CRITERIA: - Participants who are receiving any other investigational agents. - Systemic anti-cancer treatment or major surgery within 2 weeks prior to enrollment. - Radiotherapy within 24 hours prior to enrollment. - Participants who require treatment with strong inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A) or with uridine diphosphate glucuronosyltransferase 1A1 gene (UGT1A1) inhibitors during the planned period of investigational treatment with PLX038. - Participants with known Gilberts syndrome. - Participants homozygous for the UGT1A1*28 variant allele with severely reduced UGT1A1 activity. - Participants with known human immunodeficiency virus (HIV), hepatitis C virus (HCV), Hepatitis B virus (HBV) status on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and/or pharmacodynamic interactions. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to PLX038 or rucaparib. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that may impair the participants tolerance of study treatments. - Pregnant women are excluded from this study because PEGSN38 and rucaparib potential for teratogenic or abortifacient effects are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with PEGSN38 and rucaparib, breastfeeding should be discontinued if the mother is treated with study drugs. ; PRIMARY OUTCOME: Phase II: Clinical Benefit Rate; SECONDARY OUTCOME 1: Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib[/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 - JAVELIN HEAD AND NECK 100; BRIEF: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer. ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: INCLUSION CRITERIA - Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx - HPV negative disease, Stage III, IVa, IVb; non-oropharyngeal HPV positive disease Stage III, IVa, IVb, HPV positive oropharyngeal disease T4 or N2c or N3 - No prior therapy for advanced stage SCCHN; eligible for definitive CRT with curative intent. - Available tumor samples for submission or willing to undergo further tumor biopsies: - Age ≥18 years (≥19 in Korea;20 years in Japan and Taiwan). - ECOG Performance Status 0 or 1 - Adequate bone marrow function - Adequate renal function - Adequate liver function - Pregnancy test (for patients of childbearing potential) negative at screening EXCLUSION CRITERIA - Prior immunotherapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways. - Major surgery 4 weeks prior to randomization. - Prior malignancy requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score 6) either curatively treated or deemed to not require treatment, ductal IS carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer. - Active autoimmune disease - Any of the following in the 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. - Active infection requiring systemic therapy. - Use of immunosuppressive medication at time of randomization - Prior organ transplantation including allogenic stem-cell transplantation. - Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. - Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection - Vaccination within 4 weeks prior to randomization. - Current use of or anticipated need for treatment with other anti-cancer drugs. - Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 60 days after the last dose of avelumab/placebo (whichever is later). ; PRIMARY OUTCOME: Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator; SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - WL-1001-02-06 (ECH); BRIEF: The purpose of this study is to evaluate the safety and efficacy of intranasally administered civamide nasal solution in the prevention of cluster headaches during an episodic cluster headache period. ; DRUG USED: Civanex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Migraine and Other Headaches; TARGET: TRPV1, transient receptor potential vanilloid receptor 1, VR-1; THERAPY: Monotherapy; LEAD SPONSOR: Winston Laboratories; CRITERIA: Inclusion Criteria: - Written IRB-approved informed consent has been obtained and signed, within 12 months of entering into the Baseline Period (Day -3). - Male or female 18 years or older. - Subject has ≥2 year history of episodic cluster headache with at least 2 previous episodic cluster headache periods. - Cluster Headaches must meet the following International Headache Society Diagnostic Criteria : - Severe, unilateral, orbital, superorbital and/or temporal pain lasting 15 to 180 minutes untreated. - Headache is associated with at least one of the following which have to be present on the side of the pain: - Conjunctival injection - Lacrimation - Nasal Congestion - Rhinorrhea - Forehead and facial sweating - Miosis - Ptosis - Eyelid edema or - A sense of restlessness or agitation - The current episodic cluster headache period is expected to last at least 5 weeks but no more than 24 weeks from the time of entry into the Baseline Period (Day -3), based on the average duration of the subjects usual episodic cluster headache period. - At least one cluster headache (but no more than 8) daily on each of the three days of the Baseline Period (Days -3, -2, -1) immediately preceding Study Day 1. - The subject is in generally good health, other than history of episodic cluster headache. - The subject agrees not to begin any new concurrent medications or restricted medications during their participation in study. - All females of childbearing potential must have a negative urine and/or serum pregnancy test prior to entry into the Treatment Period. - Females of childbearing potential agree to use an approved form of birth control or to abstain from sexual activity during the study. - Subject can read and write in the local language and can be expected to reliably follow study procedures. Exclusion Criteria: - Clinical, historical or previous laboratory evidence of significant cardiovascular, renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological (not including cluster headaches), psychological, or other systemic disease that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject. - Presence of a significant nasal disorder. - Initiation of a medication, discontinuation of a medication or a change in the regimen of existing medication(s) or therapies for prophylaxis of cluster headaches in the 17 days prior to entering the Treatment Period (Study Day 1). - Use of systemic steroids to treat the current cluster headache episode. - Use of restricted medications/treatments within the given time period prior to the Treatment Period and throughout the study (Table 1 of Protocol) - Subject has difficulty distinguishing his/her episodic cluster headache attacks from other types of headaches, such as tension type headaches. - Presence of chronic paroxysmal hemicrania, transformed migraine, or analgesic rebound headaches. - Females who are pregnant, breast-feeding, or planning to become pregnant during the study. - Subject has a history of alcohol and/or drug abuse within 12 months prior to the Screening Visit.. - Subject has known hypersensitivity to or contraindication to the use of civamide, capsaicin, or to any excipient of the clinical formulation. - Subject has participated in another investigational study or taken another investigational drug within the past 4 weeks. - Subject has participated in prior efficacy studies of intranasal civamide: WL-1001-02-01, WL-1001-02-02, WL-1001-02-03 or WL-1001-02-05. (This does not include any subject who entered the screening period for study WL-1001-02-01, WL-1001-02-02, WL-1001-02-03 or WL-1001-02-05 but did not randomize to treatment). ; PRIMARY OUTCOME: The Percent Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 of the Post-Treatment Observation Period for the Modified Intent-to-Treat Population; SECONDARY OUTCOME 1: The Percent Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 of the Post-Treatment Observation Period for the Intent-to-Treat and Per Protocol Populations[/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 - DETERMINE-reduced; BRIEF: International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Reduced Ejection Fraction (HFrEF) ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of signed informed consent prior to any study specific procedures - Male or female, aged ≥18 years - Documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 8 weeks - LVEF≤40% - Elevated NT-proBNP levels - Patients should receive background standard of care as described below: All HFrEF patients should be treated according to locally recognised guidelines on standard of care treatment with both drugs and devices, as appropriate. Guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated. Therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) before visit 1 and include (unless contraindicated or not tolerated): - an ACE inhibitor, or ARB or sacubitril/valsartan and - a beta-blocker and - if considered appropriate by the patients treating physician; a mineral corticoid receptor antagonist - 6MWD≥100 metres and ≤425 metres at enrolment and randomization. Exclusion Criteria: - Presence of any condition that precludes exercise testing - Participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial - Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor - Type 1 diabetes mellitus - eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at enrolment, unstable or rapidly progressing renal disease at time of randomisation - Systolic BP <95 mmHg on 2 consecutive measurements - Systolic BP ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements - Current acute decompensated HF or hospitalisation due to decompensated HF <4 weeks prior to enrolment - MI, unstable angina, coronary revascularization ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization. - Stroke or transient ischemic attack within 12 weeks prior to enrolment. - Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD. - Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization - HF due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease ; PRIMARY OUTCOME: Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 16 (Higher Scores Represent Less HF Symptom Frequency and Burden).; SECONDARY OUTCOME 1: Change From Baseline at the End of the Study in the Total Time Spent in Light to Vigorous Physical Activity, as Assessed Using a Wearable Activity Monitor (Accelerometer).[/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 - CL-19 - AbCONTOUR2 ; BRIEF: This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. ; DRUG USED: LIPO-202; DRUG CLASS: Non-NME; INDICATION: Fat Removal; TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Evofem Inc.; CRITERIA: Inclusion Criteria: - Healthy male or non-pregnant female subjects - Capable of providing written consent. - BMI < 30 kg/m2 - Stable diet and exercise routine - Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat Exclusion Criteria: - Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen. - Plan on starting a weight loss or exercise program during the study. - Known hypersensitivity to study drugs ; PRIMARY OUTCOME: Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response; SECONDARY OUTCOME 1: Percent Change in Waist Circumference[/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 - CMV; BRIEF: AVX601, a bivalent alphavirus replicon vaccine expressing three CMV proteins (gB, pp65 and IE1) is a candidate vaccine against cytomegalovirus (CMV). The objectives of this Phase 1 study are to test the safety of the vaccine and the immune response to the vaccine in healthy volunteers who have not previously been infected with CMV. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on three occasions over 6 months. The study will last 12 months and will have a total of 12 visits. ; DRUG USED: AVX601; DRUG CLASS: Vaccine; INDICATION: Cytomegalovirus (CMV) Infection (Antiviral); TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: AlphaVax, Inc.; CRITERIA: Inclusion Criteria: 1. Between 18 and 45 years of age, inclusive 2. Good general health without significant physical examination findings or clinically significant abnormal laboratory results 3. Available to participate for the entire study period of approximately 12 months 4. For women of childbearing potential, a negative urine pregnancy test at screening and before each immunization, and agreement to consistently use contraception from 28 days prior to enrollment until the last protocol visit, for sexual activity that could lead to pregnancy 5. Acceptable laboratory parameters: - negative CMV serology - hemoglobin ≥ 11.2 g/dL for women, ≥ 12.8 g/dL for men - white blood cell count 3,300 - 12,000 cells/mm3 - platelet count 125,000 - 550,000/mm3 - alanine aminotransferase (ALT) within normal range for study laboratory - serum creatinine within normal range for study laboratory - normal urine dipstick (negative glucose, negative hemoglobin, and negative or trace protein) - negative hepatitis B virus (HBV) and hepatitis C virus (HCV) blood tests - negative HIV blood test 6. Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to CMV or the alphavirus vector if such assays become available 7. Willingness to participate in the study as evidenced by signed informed consent obtained before screening Exclusion Criteria: 1. Venous access deemed inadequate for the phlebotomy demands of the study 2. Women who are breast feeding 3. In female subjects, a positive urine pregnancy test at screening or on the day of any vaccine injection 4. Receipt of any vaccine within 30 days prior to enrollment 5. Use of any investigational agent within 30 days prior to enrollment 6. Receipt of immunoglobulin or blood products within 60 days prior to enrollment 7. Use of cytotoxic medications within 6 months prior to enrollment 8. Use of systemic corticosteroids within 6 months prior to enrollment (except that participants who have completed a course of prednisone, at up to 20 mg per day for up to 7 days, at least 1 month prior to enrollment are eligible for enrollment) 9. History of serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema or abdominal pain 10. History of immunodeficiency or autoimmune disease 11. History of diabetes mellitus 12. History of splenectomy 13. History of malignancy within the last 3 years (except that participants with a diagnosis of basal cell carcinoma of the skin are eligible for enrollment) 14. Psychiatric condition that may interfere with the ability to comply with the protocol requirements. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years. 15. History of medical, occupational or family problems as a result of alcohol or illicit drug use during the past 12 months 16. Any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation ; PRIMARY OUTCOME: evaluate safety of AVX601 based on teh frequency of Grade 2,3,or 4 systemic reactogenicity events; SECONDARY OUTCOME 1: evaluate the immunogenicity of AVX601 in healthy volunteers after 3 doses of vaccine[/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 - anaSTILLs; BRIEF: The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Stills disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset Stills disease). ; DRUG USED: Kineret; DRUG CLASS: Biologic; INDICATION: Juvenile Rheumatoid Arthritis; TARGET: IL-1 Receptor (IL-1R); THERAPY: Monotherapy; LEAD SPONSOR: Swedish Orphan Biovitrum; CRITERIA: Inclusion Criteria: 1. Signed informed consent. 2. Male and female patients with a body weight ≥ 10 kg. 3. Diagnosis of Stills disease. 4. If currently on glucocorticoid treatment, a stable dose for at least 1 week prior to randomization. 5. If currently on methotrexate treatment, a stable dose for at least 8 weeks prior to randomization. 6. Active disease. 7. Female patients of childbearing potential must use an effective method of contraception during the study (abstinence being a possible option) as well as present a negative pregnancy test prior to randomization. 8. Negative interferon-gamma release assay or Purified protein derivative ( PPD) test within 2 months prior to randomization. If not available, a test should be performed at day of randomization. Exclusion Criteria: 1. Diagnosis of Stills disease more than 6 months prior to randomization. 2. Previous randomization into this study. 3. Participation in another concurrent clinical interventional study within 30 days of randomization. 4. Treatment with an investigational drug within 5 half-lives prior to randomization. 5. Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor. 6. Use of the following therapies prior to randomization: - Narcotic analgesics within 24 hours prior to randomization. - Dapsone or etanercept within 3 weeks prior to randomization. - Intraarticular, intramuscular or intravenous administration of glucocorticoids or intravenous immunoglobulin (Ig) within 4 weeks prior to randomization. - Intravenous Ig with proven Stills disease modifying effect, leflunomide, infliximab or adalimumab within 8 weeks prior to randomization. - Thalidomide, cyclosporine, mycophenolate mofetil, 6-mercaptopurine, azathioprine, cyclophosphamide, chlorambucil or any other immunosuppressant within 12 weeks prior to randomization. - Tocilizumab within 12 weeks prior to randomization or any other immunomodulatory medication within 4 half-lives prior to randomization - Rituximab within 26 weeks prior to randomization. 7. Live vaccines within 1 month prior to randomization. 8. Known presence or suspicion of active, chronic or recurrent bacterial, fungal or viral infections, including tuberculosis, HIV infection or hepatitis B or C infection. 9. Clinical evidence of liver disease or liver injury. 10. Presence of severe renal function impairment. 11. Presence of neutropenia. 12. Presence or suspicion of MAS at baseline. 13. A diagnosis of MAS within the last 2 months prior to randomization. 14. History of malignancy within 5 years. 15. Known hypersensitivity to E coli-derived proteins, or any components of Kineret® (anakinra). 16. Pregnant or lactating women. 17. Foreseeable inability to cooperate with given instructions or study procedures. 18. Presence of any medical or psychological condition or laboratory result that in the opinion of the investigator can interfere with the patients ability to comply with the protocol requirements or makes the patient not appropriate for inclusion to the study and treatment with IMP. ; PRIMARY OUTCOME: Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.; SECONDARY OUTCOME 1: Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - NINTTO; BRIEF: Osteoporosis is a reduction in bone density that increases the risk of fractures; particularly of the spine, hip and wrist. Osteoporosis is estimated to affect 200 million women worldwide - approximately one tenth of women aged 60, one-fifth of women aged 70, two-fifths of women aged 80 and two-thirds of women aged 90. Treating osteoporosis and the associated fractures costs the NHS more than two billion pounds per annum. Teriparatide is a drug currently prescribed for some osteoporosis patients by their doctor to be taken by injection. It is currently the only drug available which promotes the deposition of new bone as opposed to preventing resorption. This is the drug treatment we will be studying in this clinical trial. The drug is of a type that cannot normally be taken as a swallowed pill. This type of drugs tends to be delivered by injection, as is currently the case for teriparatide. Injections have numerous limitations and are disliked by patients. This trial will assess how well the nasal spray devices work, how long the drug stays in the nose and also how well the drug enters the bloodstream. ; DRUG USED: CP046; DRUG CLASS: New Molecular Entity (NME); INDICATION: Osteoporosis / Osteopenia; TARGET: Parathyroid Hormone Receptor (PTHR); THERAPY: Monotherapy; LEAD SPONSOR: Nottingham University Hospitals NHS Trust; CRITERIA: Inclusion Criteria: - Be a postmenopausal healthy female and aged greater than 55 years of age - Be able to give voluntary informed consent and from whom written consent to participate has been obtained - Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments - Be willing to abstain from alcohol for 24 hours before each dose and until the end of each study day - Be willing to abstain from smoking for 24 hours before each dose and until the end of each study day - Be willing to avoid caffeine from midnight the evening prior to each study day Exclusion Criteria: - Have a history of alcohol or drug abuse and failure of urine tests for drug abuse - Have had any investigational drug administered within the previous 3 months. - Failed to satisfy the investigators assessment of fitness to participate based on a completed health screening - Have consumed alcohol or tobacco within 24 hours of start of each study day - Have consumed caffeinated drink after midnight prior to each study day - Have participated in a similar study involving the use of radioisotopes in the previous 3 months such that participating in the current study would exceed the recommended yearly exposure limit (5mSv) - Have any presently active infectious diseases (such as influenza) - Have a known hypersensitivity to teriparatide or to any of the excipients in the formulation - Have a history of nasal disorders/problems - Have a history of allergic rhinitis - Have an increased baseline risk of osteosarcoma - Have Pagets disease - Have a history of any malignancy or radiotherapy - Have a history of diabetes - Have a history of hypercalcaemia - Are taking any forbidden medications - see Appendix 2 - Inability to use both of the intranasal delivery devices - Have a condition that prohibits MRI scans - Have positive HIV or Hepatitis B or C test results or engage in a lifestyle that increases the risk of the possibility of these infections ; PRIMARY OUTCOME: Area under the plasma concentration time curve (AUC) of teriparatide for six hours after each single administration.; SECONDARY OUTCOME 1: The percentage of radiolabelled formultation deposited and cleared from the nose measured by gamma scintigraphy[/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 - GWPCARE2; BRIEF: To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. ; DRUG USED: Epidiolex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dravet Syndrome (Epilepsy); TARGET: Cannabinoid reuptake/Endocannabinoid system, Cannabinoid-1 (CB1) receptor, Cannabinoid-2 (CB2) receptor, GPR55, Serotonin 5-HT1A receptor; THERAPY: Monotherapy; LEAD SPONSOR: Jazz Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Participant must have been male or female, aged between 2 and 18 years (inclusive). - Participant must have had a documented history of Dravet syndrome that was not completely controlled by current antiepileptic drugs. - Participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks. - All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study. Key Exclusion Criteria: - Participant had clinically significant unstable medical conditions other than epilepsy. - Participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy. - Participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study. - Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products. - There were plans for the participant to travel outside their country of residence during the study. - Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia-Suicide Severity Rating Scale (Childrens) at screening. ; PRIMARY OUTCOME: Change In Convulsive Seizures During The Treatment Period Compared To Baseline; SECONDARY OUTCOME 1: Change In Total Seizures During The Treatment Period Compared To Baseline[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FREEDOM-Ev (Ext.); BRIEF: This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity. ; DRUG USED: Orenitram; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: United Therapeutics; CRITERIA: Inclusion Criteria: - Participated in United Therapeutics Study TDE-PH-310 - All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication. - Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication. Exclusion Criteria: - The subject was pregnant or lactating. - The subject had received infused or inhaled prostacyclin therapy for 29 days or more. - The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event. - The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study. ; PRIMARY OUTCOME: Number of Adverse Events; SECONDARY OUTCOME 1: Change in 6-Minute Walk Distance 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/III - University of Kansas; BRIEF: Inclusion body myositis (IBM) is the most common progressive and debilitating muscle disease beginning in persons over 50 years of age. This study will assess the safety and tolerability of Arimoclomol in IBM as compared to placebo over 4 months of treatment. ; DRUG USED: Miplyffa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sporadic Inclusion Body Myositis (sIBM); TARGET: SOD1; THERAPY: Monotherapy; LEAD SPONSOR: Richard Barohn, MD; CRITERIA: Inclusion Criteria: - Meet the diagnostic criteria for definite or probable IBM (Griggs 1995) - Muscle function adequate for quantitative muscle testing - Age > 50 years - Women must be postmenopausal or status post hysterectomy - For any patient currently taking medication for IBM, they must remain on current dosage for the extent of the study and last dosage change must be > 30 days previous to enrollment Exclusion Criteria: - Presence of any one of the following medical conditions: diabetes mellitus or patients taking anti-diabetic medications, chronic infection, chronic renal insufficiency, cancer other than skin cancer less than 5 years previously, multiple sclerosis or prior episode or central nervous system demyelination, or other chronic serious medical illnesses - Presence of any of the following on routine blood screening: WBC < 3000, platelets < 100,000, hematocrit < 30%, BUN > 30 mg%, creatine > 1.5 mg%, symptomatic liver disease with serum albumin < 3 g/dl, PT or PTT > upper range of control values - Women who are pregnant or lactating - History of non-compliance with other therapies - Coexistence of other neuromuscular disease - Drug or alcohol abuse within the last 3 months - Inability to give informed consent - Known bleeding disorder - Use of potentially renal toxic drugs - Prior difficulties with local anesthetic ; PRIMARY OUTCOME: Count of Adverse Events Reported; SECONDARY OUTCOME 1: Heat Shock Protein 70 (HSP70) Levels in the Tissue[/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 - CTCL; BRIEF: To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA). ; DRUG USED: Resiquimod; DRUG CLASS: Non-NME; INDICATION: Cutaneous T-Cell Lymphoma (CTCL) - NHL; TARGET: Toll-like receptor 7 (TLR7), Toll-like receptor 8 (TLR8); THERAPY: Monotherapy; LEAD SPONSOR: Galderma R&D; CRITERIA: Inclusion Criteria: - Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months - Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3 distinct lesions Exclusion Criteria: - CTCL that is stage IIB or great or stage IIA with stage N2 with >5% circulating Sezary cells or CD8+ or large cell transformation or Progressive CTCL - History of autoimmune disease - Laboratory test values at screening outside of the normal range and judged clinically significant by the investigator - Current participation in another clinical trial of a drug or device or past participation within 4 weeks before Baseline or participant is in exclusion period from a previous clinical trial ; PRIMARY OUTCOME: Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12; SECONDARY OUTCOME 1: Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score 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 - ANX1001 (Healthy Males); BRIEF: The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating anxiety disorders through evaluation of brain activation patterns using imaging technology in healthy volunteers. ; DRUG USED: JNJ-42165279; DRUG CLASS: New Molecular Entity (NME); INDICATION: Generalized Anxiety Disorder (GAD); TARGET: Fatty Acid Amide Hydrolase (FAAH); THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion criteria - Good general health - Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg - Must adhere to required contraception during and for 3 months after study - Must agree to not donate sperm during and for 3 months after study - Must agree to not donate blood during and for 1 month after study - Able to speak and understand English fluently Exclusion criteria: - Clinically significant medical or psychiatric illness - Any contraindication to magnetic resonance imaging - Unable to pass hearing test - Alcohol or substance abuse; excessive nicotine or caffeine use - Recently received an investigational drug, vaccine, or invasive medical device - Unable to abide by protocol restrictions on use of other medications ; PRIMARY OUTCOME: Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior); SECONDARY OUTCOME 1: Brain activity patterns in multiple areas of the emotional brain neurocircuitry[/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 - ExpeditionPRO; BRIEF: The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimers disease (AD). ; DRUG USED: Solanezumab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimers Association (NIA-AA) diagnostic criteria. - Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening. - Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening. - Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS). - Scores >0 on the Functional Activities Questionnaire (FAQ). - Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology. Exclusion Criteria: - Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD. - Has known allergy to humanized monoclonal antibodies. - Has an ongoing clinically significant laboratory abnormality, as determined by the investigator. - Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E. - Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI. - Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.) ; PRIMARY OUTCOME: Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score; SECONDARY OUTCOME 1: Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)[/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 - ESCaPE-CMD; BRIEF: This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16. ; DRUG USED: CLBS16; DRUG CLASS: Biologic; INDICATION: Angina; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Lisata Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Men or women age ≥18 - History of and currently experiencing angina at least 3 times per week - No obstructive coronary artery disease - On stable medical therapy for 30 days prior to enrollment - Must agree to use a reliable and acceptable method of contraception for the duration of participation - Written informed consent Exclusion Criteria: - Myocardial infarction within 90 days - Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG) - Diagnosis of other specific cardiac disease - Must meet LVEF and GFR requirements - Current use of coumadin or DOACs - Hypersensitivity to G-CSF, apheresis or study product components - Positive for HIV, hepatitis B or hepatitis C - Active inflammatory or autoimmune disease, or chronic immunosuppressive state - Drug abuse - Pregnant or lactating - Malignant neoplasm within 5 years - History of Sickle Cell Disease - Participation in another clinical study within 90 days ; PRIMARY OUTCOME: Change From Baseline in Coronary Flow Reserve; SECONDARY OUTCOME 1: Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine[/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 - IND3-08-04b; BRIEF: The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain. ; DRUG USED: Tivorbex; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Iroko Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: - Patient is male or female between 18 and 65 years of age - For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control - Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures - Patient must be willing to stay at the study site ≥ 72 hours Exclusion Criteria: - Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs - Patient has a current disease or history of a disease that will impact the study or the patients well-being - Patient has used or intends to use any of the medications that are prohibited by the protocol - Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test - Patient has taken another investigational drug within 30 days prior to screening ; PRIMARY OUTCOME: The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48); SECONDARY OUTCOME 1: VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.[/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 - HZNP-HZN-825-301 (dcSSc); BRIEF: This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug. ; DRUG USED: HZN-825; DRUG CLASS: New Molecular Entity (NME); INDICATION: Scleroderma; TARGET: Lysophosphatidic acid receptor 1 (LPAR1), Lysophosphatidic acid receptor 3 (LPAR3); THERAPY: Monotherapy; LEAD SPONSOR: Horizon Therapeutics Ireland DAC; CRITERIA: Inclusion Criteria: 1. Written informed consent. 2. Male or female between the ages of 18 and 75 years, inclusive, at Screening. 3. Meets the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria for SSc with a total score of ≥9 (Van den Hoogen et al., 2013). 4. Classified as having skin involvement proximal to the elbow and knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001). 5. At the time of enrollment, less than or equal to 72 months (6 years) since the onset of the first SSc manifestation, other than Raynauds phenomenon. 6. Skin thickening from SSc in the forearm suitable for repeat biopsy. 7. mRSS units ≥15 at Screening. 8. FVC ≥45% predicted at Screening, as determined by spirometry. 9. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. Exclusion Criteria: 1. Positive for anti-centromere antibodies with the exception that subjects who are positive for both anti-centromere and anti-topoisomerase 1 antibodies may be enrolled. 2. Diagnosed with sine scleroderma or limited cutaneous SSc. 3. Diagnosed with other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogrens syndrome. 4. Scleroderma renal crisis diagnosed within 6 months of the Screening Visit. 5. Any of the following cardiovascular diseases: 1. uncontrolled, severe hypertension (≥160/100 mmHg) or persistent low blood pressure (systolic blood pressure <90 mmHg) within 6 months of Screening, 2. myocardial infarction within 6 months of Screening, 3. unstable cardiac angina within 6 months of Screening. 6. DLCO <40% predicted (corrected for hemoglobin). If severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure is of clinical concern for any subject, consider using a DLCO up to 6 months before the Screening Visit. 7. Pulmonary arterial hypertension (PAH) by right heart catheterization requiring treatment with more than 1 oral PAH-approved therapy or any parenteral therapy. Treatment is allowed for erectile dysfunction and/or Raynauds phenomenon/digital ulcers. 8. Corticosteroid use for conditions other than SSc within 4 weeks prior to Screening (topical steroids for dermatological conditions and inhaled/intranasal/intra-articular steroids are allowed). 9. Use of any other non-steroid immunosuppressive agent, small biologic molecule, cytotoxic or anti-fibrotic drug within 4 weeks of Screening, including cyclophosphamide, azathioprine (Imuran®) or other immunosuppressive or cytotoxic medication. Exceptions include mycophenolate mofetil (CellCept®), mycophenolic acid (Myfortic®), methotrexate and low-dose prednisone, as follows: use of CellCept ≤3 g/day, Myfortic ≤2.14 g/day, methotrexate ≤20 mg/week and prednisone ≤10 mg/day (or equivalent dosing of glucocorticoids) is allowed. Subjects taking CellCept, Myfortic or methotrexate must have been doing so for ≥6 months and the dose must have been stable for ≥4 weeks prior to the Day 1 Visit. Prednisone must have been at a stable dose for ≥8 weeks prior to the Day 1 Visit. It is acceptable to be on background low-dose prednisone and anti-malarial drug along with CellCept, Myfortic or methotrexate. Rituximab must not have been used within 6 months of the Day 1 Visit. 10. Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease (fungal infections of nail beds are allowed) at the time of randomization. 11. Use of a United States Food and Drug Administration-approved agent for SSc or an investigational agent for any condition within 90 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the trial. 12. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 13. Women of childbearing potential or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 1 month after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period. 14. Pregnant or lactating women. 15. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the subject. 16. Previous enrollment in this trial or participation in a prior HZN-825 or SAR100842 clinical trial. 17. Known history of positive test for human immunodeficiency virus (HIV). HIV testing is optional based on Investigator assessment, institutional practices or local guidelines to rule out suspected HIV or potential for a positive HIV result. Subject consent is required prior to HIV testing. 18. Active hepatitis (hepatitis B: positive hepatitis B surface antigen and positive anti-hepatitis B core antibody [anti-HBcAb] and negative hepatitis B surface antibody [HBsAb] or positive for HBcAb with a positive test for HBsAb and with presence of hepatitis B virus DNA at Screening; hepatitis C: positive anti-hepatitis C virus [anti-HCV] and positive RNA HCV). 19. Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis. 20. Previous organ transplant (including allogeneic and autologous marrow transplant). 21. International normalized ratio >2, prolonged prothrombin time >1.5 × the upper limit of normal (ULN) or partial thromboplastin time >1.5 × ULN at Screening. 22. Alanine aminotransferase or aspartate aminotransferase >2 × ULN. 23. Estimated glomerular filtration rate <30 mL/min/1.73 m^2 at Screening. 24. Total bilirubin >2 × ULN. Subjects with documented diagnosis of Gilberts syndrome may be enrolled if their total bilirubin is ≤3.0 mg/dL. 25. Any other condition that, in the opinion of the Investigator, would preclude enrollment in the trial. ; PRIMARY OUTCOME: Change in FVC (forced vital capacity) percent predicted from Baseline to Week 52; SECONDARY OUTCOME 1: Change from Baseline in HAQ-DI (Health Assessment Questionnaire - Disability Index) at Week 52[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - 003 (Lactose Intolerance); BRIEF: RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products). ; DRUG USED: RP-G28; DRUG CLASS: New Molecular Entity (NME); INDICATION: Food Allergies; TARGET: Bacteria-miscellaneous; THERAPY: Monotherapy; LEAD SPONSOR: Ritter Pharmaceuticals, Inc.; CRITERIA: Inclusion/Exclusion Criteria: - Female subjects must be non pregnant, and non lactating. Females of childbearing potential must use adequate birth control during study participation - Medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance. - Must be free from any disorder known to be associated with gastrointestinal disease: irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohns disease (CD), Celiac disease, diverticulitis, chronic constipation, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, small intestine bacterial overgrowth syndrome (SIBO), active gastric or duodenal ulcers, or history of severe ulcers. - Must be nicotine free. ; PRIMARY OUTCOME: Change from baseline in abdominal pain; 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 - Japan; BRIEF: The primary objective of this study is to assess the effect of treatment with ABX-EGF on best overall objective response rate by modified RECIST (confirmed complete or partial response) in Japanese subjects with metastatic colorectal cancer. ; DRUG USED: Vectibix; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Metastatic colorectal adenocarcinoma; - Subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including those who relapsed during or within 6 months from the completion of adjuvant therapy using the above agents; - Tumor expressing EGFr levels by immunohistochemistry (membrane staining must be positive in 1% of evaluated tumor cells). Exclusion Criteria: - Subjects who have prior experimental or approved antibodies (eg, bevacizumab) within 3 months before enrollment; - Subjects who have prior EGFr targeting agents; - Chemotherapy other than fluoropyrimidine (including oral agents such as UFT, TS-1), irinotecan, and oxaliplatin (or raltitrexed) for colorectal carcinoma in accordance with specified regimens (leucovorin and levamisole are not considered as chemotherapy ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SHINE - vs. Paclitaxel (FGFR2 Amplified); BRIEF: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification. ; DRUG USED: ABSK091; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastric Cancer; TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Female or male aged 25 or over - Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction ) - Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy. - At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) - Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification Exclusion Criteria: - Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil) - Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment - With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment. - Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section. - Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism. ; PRIMARY OUTCOME: Median Progression Free Survival; SECONDARY OUTCOME 1: Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)[/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 - Plasma Therapy-Resistant (Adults) (C08-002A); BRIEF: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS). ; DRUG USED: Soliris; DRUG CLASS: Biologic; INDICATION: Hemolytic Uremic Syndrome (HUS); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Exclusion Criteria: 1. TTP, (defined as ADAMTS-13 activity <5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory 2. Malignancy within 5 years of screening 3. Typical HUS (Shiga toxin +) 4. Known HIV infection 5. Identified drug exposure-related HUS. 6. Infection-related HUS 7. HUS related to bone marrow transplant 8. HUS related to vitamin B12 deficiency 9. Renal function status requiring chronic dialysis 10. Patients with a confirmed diagnosis of sepsis 11. Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease 12. Pregnancy or lactation 13. Unresolved meningococcal disease 14. Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome 15. Any medical or psychological condition that, in the opinion of the investigator, could increase the patients risk by participating in the study or confound the outcome of the study 16. Patients who have received previous treatment with eculizumab 17. Patients receiving IVIG within 8 weeks or Rituximab therapy within 12 weeks of screening. 18. Patients receiving other immunosuppressive therapies such as steroids, mTOR inhibitors or tacrolimus are excluded unless: [1] part of an established post-transplant anti-rejection regime, [2] patient has confirmed anti-CFH antibody requiring immunosuppressive therapy, and [3] dose of such medications have been unchanged for at least 4 weeks prior to the screening period or [4] patient is experiencing an acute aHUS relapse immediately after transplant 19. Patients receiving Erythrocyte Stimulating Agents (ESAs) unless already on a stable dose for at least 4 weeks prior to the screening period, or a washout period of at least 2 weeks from the last dose of ESA therapy. 20. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures beginning 4 weeks prior to screening and throughout the entire trial. 21. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients ; PRIMARY OUTCOME: Platelet Count Change From Baseline to 26 Weeks; SECONDARY OUTCOME 1: Percentage of Patients With Complete TMA Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - w/ Carboplatin + Etoposide; BRIEF: The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with carboplatin and etoposide followed by BMS-833923 alone in subjects with extensive-stage Small Cell Lung Cancer (SCLC). ; DRUG USED: BMS-833923; DRUG CLASS: New Molecular Entity (NME); INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Hedgehog Signaling Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed small cell lung cancer, without prior chemotherapy treatment - Men and Women at least 18 years old - Eastern Cooperative Oncology Group (ECOG) status 0-2 Exclusion Criteria: - Significant cardiovascular disease - Prior treatment of small cell lung cancer is not permitted, except for palliative radiation to a limited field excluding the chest (e.g. for painful metastasis). - Symptomatic brain metastases - Women pregnant or breastfeeding - Women of childbearing potential (WOCBP) unwilling/unable to use acceptable method to avoid pregnancy - Uncontrolled medical disorder or active infection - Concurrent therapy with any other investigational product ; PRIMARY OUTCOME: Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide; SECONDARY OUTCOME 1: Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: 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 III; BRIEF: At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period. ; DRUG USED: Xeomin; DRUG CLASS: Biologic; INDICATION: Cervical Dystonia; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Merz Pharmaceuticals GmbH; CRITERIA: Main Inclusion Criteria: - Male or female outpatients between ages 18 and 75 years inclusive) - A clinical diagnosis of cervical dystonia (i.e. spasmodic torticollis) with predominantly rotational form and a need for injection (determined by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score) - TWSTRS-Total score >= 20 - TWSTRS-Severity score >= 10 - TWSTRS-Disability score >= 3 - TWSTRS-Pain score >= 1 - On a stable dose of medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period - For pre-treated patients only: Source documentation of the last two consecutive injection sessions with Botulinum Toxin and stable therapeutic response directly prior to trial entry - For pre-treated patients only: At least 10 weeks must have been passed between the last injection with Botulinum Toxin for cervical dystonia and baseline - For pre-treated patients only: The most recent injection with Botulinum Toxin must have been maximal 300 Units of type A or 12,000 Units of type B Main Exclusion Criteria: - Traumatic torticollis or tardive torticollis - TWSTRS-Severity score for anterocollis >= 2 points (pure anterocollis) - TWSTRS-Severity score for retrocollis >= 2 points (pure retrocollis) - Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation) - Hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin Type A - Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial - Current swallowing disorder of any origin (dysphagia scale >= 3, i.e. severe, with swallowing difficulties and requiring a change in diet) - Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spine syndrome - Treatment with Botulinum Toxins for any indication other than cervical dystonia within 4 months prior to baseline and during the trial ; PRIMARY OUTCOME: Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo; SECONDARY OUTCOME 1: Change From Baseline in the TWSTRS-Total 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 I/II - 1315.7; BRIEF: Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia. Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic anemia. ; DRUG USED: BI 836858; DRUG CLASS: Biologic; INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Cluster of Differentiation 33 (CD33/SIGLEC-3); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Documented diagnosis of Myelodysplastic Syndromes (MDS) according to World Health Organization (WHO) criteria that meets International Prognostic Scoring System (IPSS) classification of low or intermediate-1 risk disease at screening as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC). - Phase I dose escalation: patients who experienced Erythropoiesis-Stimulating Agents (ESA) treatment failure or do not qualify (serum erythropoietin level > 500 U) for ESA treatment, and are refractory to or not amenable or eligible for established MDS therapy (Hypomethylating Agents (HMA), lenalidomide) - Phase I expansion: - Expansion cohort 1 (pre-treated): patients who experienced ESA treatment failure or do not qualify (serum erythropoietin level > 500 U) for ESA treatment and are refractory to established MDS therapy (HMA and /or lenalidomide) - Expansion cohort 2 (untreated): patients who experienced ESA treatment failure or do not qualify (serum erythropoietin level > 500 U) for ESA treatment and who have not received prior HMA and/or lenalidomide (because not amenable or eligible for these treatments). - Phase II: patients who experienced ESA treatment failure or do not qualify (serum erythropoietin level > 500 U) for ESA treatment. For definition of further details of the phase II patients to be included the protocol will be amended based on Phase I results - Patient is non-responsive to, refractory to, or intolerant of ESAs, or ESAs are contraindicated or unavailable, or a documented serum erythropoietin level of > 500 U/L. - Eastern Cooperative Oncology Group (ECOG) Performance Status <=2. - Age >= 18 years. - Written informed consent which is consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation. Exclusion criteria: - Patient with IPSS category of Int-2 or high-risk MDS. - Phase II only: Patients with a deletion 5q cytogenetic abnormality. - Treatment within 28 days prior to Cycle 1 Day 1 with: i) long acting erythropoiesis stimulating agents, ii) long acting Granulocyte colony-stimulating factor (G-CSF), iii) granulocyte- macrophage colony stimulating factor (GM-CSF), iv) 5-aza, lenalidomide or decitabine, or v) iron chelation and within 14 days prior to Cycle 1 Day 1 with short acting erythropoiesis stimulating agents and short acting G-CSF. - Patient previously received allogeneic bone marrow or stem cell transplantation. - Second malignancy currently requiring active therapy (except for hormonal/antihormonal treatment, e.g. in prostate or breast cancer). - Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN). - Bilirubin >1.5 mg/dL, except for Gilberts Syndrome or hemolysis. - Serum creatinine >2.0 mg/dL. - Known human immunodeficiency virus (HIV) infection and/or active hepatitis B infection (defined as presence of Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA). - Presence of concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia. - Psychiatric illness or social situation which in the opinion of the Investigator would limit compliance with trial requirements. - Patient receiving concomitant therapy, which in the opinion of the Investigator is considered relevant for the evaluation of the efficacy or safety of the trial drug. - Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for 6 months after the last administration of BI 836858, i.e. combination of two forms of effective contraception (defined as hormonal contraception, intrauterine device, transdermal patch, implantable or injectable contraceptive, bilateral tubal ligation etc.). Women of childbearing potential are defined as females who: - Have experienced menarche and - Are not postmenopausal (12 months with no menses without an alternative medical cause) and - Are not permanently sterilized (e.g. hysterectomy, bilateral oophorectomy or bilateral salpingectomy - Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception (defined as hormonal contraception, intrauterine device, condom with spermicide, etc.) during the trial and for 6 months after the last administration of BI 836858. - Pregnant or nursing female patients. - Treatment with another investigational agent under the following conditions: - Within two weeks (4 weeks for biologics) of first administration of BI 836858, or if the half-life of the previous product is known, within 5 times the half-life, whichever is longer. - Patient has persistent toxicities from prior MDS therapies which are determined to be relevant by the Investigator. - Concomitant treatment with another investigational agent while participating this trial. - Chronic use, as defined by > 2 weeks of a corticosteroid agent that is >= 20 mg/day of prednisone or its equivalent, within 4 weeks prior to first administration of BI 836858. - Treatment with an immunomodulatory agent within 4 weeks prior to first administration of BI 836858. - Patient received prior treatment with a CD33 antibody. - In the opinion of the Investigator patient is unable or unwilling to comply with the protocol. - Further exclusion criteria apply ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD) (Phase I); SECONDARY OUTCOME 1: Number of Patients With Red Blood Cell (RBC) Transfusion Independency (Phase I)[/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 - New Formulation; BRIEF: A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity. ; DRUG USED: RotaTeq; DRUG CLASS: Vaccine; INDICATION: Rotavirus Vaccines; TARGET: Immune System, Rotavirus; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Parent or legal guardian agrees to have infant participate by giving written informed consent Exclusion Criteria: - History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery - History of intussusception - Known or suspected impairment of immunological function, including Severe Combined Immunodeficiency (SCID) - Prior administration of any rotavirus vaccine - Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD) - Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination. - Residing in a household with an immunocompromised person - Prior receipt of a blood transfusion or blood products, including immunoglobulins - Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study - Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study ; PRIMARY OUTCOME: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]; SECONDARY OUTCOME 1: Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability[/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 - 011 - vs. Furosemide; BRIEF: Part I is a 3-period, active comparator-controlled, fixed sequence study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-7145 compared to furosemide in participants with moderate-to-severe renal insufficiency (RI) without heart failure (HF). Primary hypothesis for Part I is that at least one well-tolerated dose of MK-7145 will produce a greater 24hr urinary excretion of sodium (UNa) on the 1st day of MK-7145 dosing than 80 mg furosemide (on the 1st day of furosemide dosing) in participants with moderate-to-severe RI. If MK-7145 is safe at natriuretic doses in RI in Part I of this study, MK-7145 will be investigated in participants with heart failure (HF) and RI (Part II). Part II is 4 period, fixed sequence, active comparator controlled (in Period 1), titration (in Periods 2, 3 and 4) study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a titration regimen of MK-7145 compared to an optimized stable maintenance regimen of furosemide or torsemide in participants with New York Heart Association (NYHA) Class II and III heart failure and moderate or severe renal insufficiency. The primary hypothesis for Part II is that at least one dose of MK-7145, titrated according to a fixed dose titration regimen, will be associated with a reduction in N-terminal pro-brain natriuretic peptide (NT-proBNP) compared to furosemide or torsemide (at 24 hours post morning dose on the last dosing day of each period) in participants with NYHA class II/III HF with moderate or severe RI. ; DRUG USED: MK-7145; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Potassium channels; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: Parts I and II - If female, must be of non-child bearing potential or, if of child-bearing potential agrees to use at least 2 acceptable contraceptive measures - Body Mass Index (BMI) >=17.5 and <=38 kg/m^2 - No present history of clinically significant uncontrolled arrhythmias on electrocardiogram (ECG) - Nonsmoker or a light smoker consuming up to an average of 20 cigarettes (or equivalent tobacco product) per day. Part I Only - Estimated creatinine clearance of ≤45 mL/min. Part II Only - Class II or III heart failure as specified by the New York Heart Association (NYHA) functional classification for heart failure with NT-proBNP >=1000 pg/mL on clinically optimized therapy with a stable dose (for at least 2 weeks) of furosemide or torsemide - Estimated creatinine clearance of ≤45 mL/min Exclusion Criteria: Parts I and II - Mentally or legally institutionalized and/or incapacitated, has significant emotional problems or has a history of a clinically significant psychiatric disorder over the last 5 years. This includes any mood disorder requiring concomitant use of lithium - Diagnosed with acute coronary syndrome or acute cardiovascular (CV) event, or has been hospitalized for HF exacerbation within less than 3 months of study entry - Unstable angina pectoris - Diabetes requiring high dose peroxisome proliferator-activated receptor (PPAR) antagonist (e.g. >30 mg of pioglitazone) or unstable insulin use - Infectious disease requiring concomitant use of aminoglycosides - Low plasma potassium (hypokalemia) - Recent (within 6 months) history of stroke, uncontrolled seizures, or uncontrolled major neurological disorder - Urinary retention, hydronephrosis or hydroureter - Active nephrocalcinosis, nephrolithiasis, or hypercalciuria - Functional disability that can interfere with rising from a semi-recumbent position to the standing position - History of malignant neoplastic disease - Unable to refrain from the use of medication, including prescription and non-prescription drugs such as high-dose aspirin (≥325 mg/day), non-steroidal anti-inflammatory drugs (NSAIDs), human immunodeficiency virus (HIV) protease inhibitors (ritonavir, indinavir, nelfinavir), macrolide antibiotics (erythromycin, telithromycin, clarithromycin), chloramphenicol, azole antifungals (fluconazole, ketoconazole, itraconazole, nefazodone, aprepitant, verapamil, diltiazem, etc.), anticonvulsants and mood stabilizers (e.g., phenytoin, carbamazepine, oxcarbazepine), barbiturates (phenobarbital), HIV non-nucleoside reverse transcriptase inhibitors (efavirenz, nevirapine, etravirine), rifampicin, modafinil, St Johns wort, cyproterone (antiandrogen, progestin), etc. beginning approximately 2 weeks (or 5 half-lives), prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods) until the poststudy visit - Consumes excessive amounts of alcohol, defined as greater than 5 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day - Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day - Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks - Regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months ; PRIMARY OUTCOME: Change From Baseline in First 24hr Urinary Sodium (UNa) (Part 1); SECONDARY OUTCOME 1: Fold Change From Baseline for Serum Creatinine at 24-hours Post Treatment Day 5 Morning Dose (Part 1)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - HBeAG-Negative Chronic Hepatitis B; BRIEF: This randomized controlled trial is designed to evaluate safety, effectiveness and pharmacokinetic-pharmacodynamic (PK/PD) relationships associated with three different Nitazoxanide (NTZ) treatment regimens added to Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF) or Entecavir (ETV) in treating Chronic Hepatitis B (CHB). ; DRUG USED: Alinia; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis B (HBV) Treatment (Antiviral); TARGET: PKR (double-stranded RNA-activated protein kinase), Pyruvate:ferredoxin oxidoreductase (PFOR) ; THERAPY: Monotherapy; LEAD SPONSOR: Romark Laboratories L.C.; CRITERIA: Inclusion Criteria: 1. Age at least 21 years 2. CHB virus infection (serum HBsAg-positive for at least 6 months or serum HBsAg-positive and negative immunoglobulin M (IgM) antibodies to Hepatitis B Virus (HBV) core antigen (IgM anti-HBc)) 3. Hepatitis B e Antigen (HBeAg) negative 4. Virologically suppressed (HBV DNA less than the lower limit of quantitation) for at least 12 months on Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF) or Entecavir (ETV) therapy 5. Quantitative HBsAg greater than 100 IU/mL 6. Alanine Aminotransferase (ALT) below 1.5 times the upper limit of normal 7. Able to comply with the study requirements Exclusion Criteria: 1. Unable to take oral medications 2. Females who are pregnant, breast-feeding or not using birth control. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an intrauterine device (IUD), or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. In addition, female subjects should have a baseline pregnancy test and should agree to continue an acceptable method of birth control for the duration of the study (including follow-up) if sexually active. 3. Any investigational drug therapy within 30 days prior to enrollment 4. Other causes of liver disease 5. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV) based on an enzyme immunoassay (EIA) 6. History of alcoholism or with an alcohol consumption of greater than 40 g per day 7. Clinically unstable 8. Any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed 9. History of hypersensitivity or intolerance to NTZ or any of the excipients comprising the NTZ tablets 10. Hepatocellular carcinoma 11. Decompensated liver disease including history of ascites, bleeding esophageal varices, portal hypertension or hepatic encephalopathy 12. FibroScan® score greater than 11 or history of cirrhosis on liver biopsy 13. Creatinine clearance <65 ml/minute (by the Cockcroft-Gault equation using ideal body weight) 14. History of clinically relevant psychiatric disease, seizures, central nervous system dysfunction, severe pre-existing cardiac, renal, pathologic bone fracture or other risk factors for osteoporosis, hematological disease or medical illness that in the investigators opinion might interfere with therapy 15. Malignant disease within 3 years of trial entry 16. Rheumatological conditions, inflammatory bowel disease or psoriasis requiring or anticipated to require biological/immunosuppressive therapies 17. Subjects taking or anticipated to need medications considered to be major CYP2C8 substrates ; PRIMARY OUTCOME: Mean Change in Quantitative Hepatitis B Surface Antigen (qHBsAg); SECONDARY OUTCOME 1: Sustained HBsAg Loss With Suppression of HBV DNA for 24 Weeks After the End of Treatment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Neuroblastoma (Seattle Childrens); BRIEF: Patients with recurrent or refractory neuroblastoma are resistance to conventional chemotherapy. For this reason, the investigators are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and kill the neuroblastoma cell through the recognition of CD171, a protein expressed of the surface of the neuroblastoma cell in patients with neuroblastoma. This is a phase 1 study designed to determine the maximum tolerated dose of the CAR+ T cells. ; DRUG USED: JCAR023; DRUG CLASS: Biologic; INDICATION: Neuroendocrine Tumors (NET); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 171 (CD171) / L1CAM, Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Seattle Childrens Hospital; CRITERIA: Inclusion Criteria: - Prior diagnosis of NB or ganglioneuroblastoma either by histologic verification and/or demonstration of tumor cells in the bone marrow with increased catecholamine levels. - Male or female subjects ≤ 26 years of age - Diagnosis of high risk NB at initial diagnosis or if non-high risk at time of initial diagnosis must have had evidence of metastatic progression when > 18 months of age. - Measurable or evaluable disease - Lansky or Karnofsky performance status score of ≥ 50 - Life expectancy of ≥ 8 weeks. - Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment onto this study. - ≥ 7 days since last chemotherapy or biologic therapy administration - No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment. Topical Administration (e.g. inhaled or dermatologic) is allowed. - ≥ 3 half-lives or 30 days from time of last dose of anti-tumor directed antibody therapy, whichever is shorter from time of enrollment - ≥ 6 weeks from myeloablative therapy and autologous stem cell transplant (timed from stem cell infusion). Patients who received stem cell infusion following non-myelo-ablative therapy are eligible once they meet all other eligibility requirements. Patient must NOT have received a prior allogeneic hematopoietic stem cell transplant. - No prior genetically modified cell therapy that is still detectable. - Must not be receiving external beam radiation therapy at the time of study enrollment. ≥ 12 weeks from prior I131 MIBG therapy. - Adequate organ function - Adequate laboratory values - Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C antibody within 3 months prior to enrollment. For patients with positive Hepatitis C Ab, negative PCR testing must be documented in order to be eligible. Exclusion Criteria: - History of relevant CNS pathology or current relevant CNS pathology (non-febrile seizure disorder requiring ongoing anti-epileptic medications, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder). Patients may have CNS intracranial tumor. - Pregnant or breast-feeding - Unable to tolerate apheresis procedure including placement of temporary apheresis catheter if necessary - Presence of active malignancy other than NB - Presence of known intracranial metastatic neuroblastoma. Skull based disease with soft tissue extension is allowed. - Presence of active severe infection - Presence of any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy. - Presence of a primary immunodeficiency/bone marrow failure syndrome - Receiving any other anti-cancer agents or radiotherapy at the time of study entry - Unwilling or unable to provide consent/assent for participation in the study and 15-year follow-up ; PRIMARY OUTCOME: Dose Limiting Toxicity; SECONDARY OUTCOME 1: Response (Tumor response will be evaluated by the revised International Neuroblastoma Response Criteria)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/Irinotecan; BRIEF: Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage. ; DRUG USED: Zepzelca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: DNA; THERAPY: Combination; LEAD SPONSOR: PharmaMar; CRITERIA: Inclusion Criteria: 1. Voluntarily signed and dated written informed consent prior to any specific-study procedure. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. 4. Life expectancy ≥ 3 months. 5. Histologically or cytologically confirmed diagnosis of advanced disease of any of the following tumor types: For the Lurbinectedin Escalation Group and the Irinotecan Escalation Group: 1. Glioblastoma. 2. Soft-tissue sarcoma (excluding gastrointestinal stromal tumors [GIST]). 3. Endometrial carcinoma. 4. Epithelial ovarian carcinoma (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas) regardless of platinum sensitivity. 5. Mesothelioma. 6. Gastroenteropancreatic neuroendocrine tumors (GEP-NET). 7. Small cell lung cancer (SCLC). 8. Pancreatic adenocarcinoma. 9. Gastric carcinoma. 10. Colorectal carcinoma (CRC). For the Intermediate Escalation Group: 1. Endometrial carcinoma. 2. SCLC. 3. Other solid tumors may be included, if appropriate, after discussion between the Investigators and the Sponsor. For the Phase II expansion stage: 1. Glioblastoma. 2. Soft tissue sarcoma (including synovial sarcoma), 3. Endometrial carcinoma. 4. SCLC. 5. Neuroendocrine tumors. - Group 1: NENs grade 3 (Ki-67 >20%) according to the 2019 WHO classification of tumors of the digestive system, of gastroenteropancreatic origin or unknown primary site (lung primary tumors will be excluded). - Group 2: Well differentiated pancreatic neuroendocrine tumors (P-NETs) grade 2 (Ki-67 3-20%) or low grade 3 (Ki-67 21-55%) according to the 2019 WHO classification of tumors of the digestive system. 6. The number of prior lines of therapy allowed per patient will be as follows: For the Phase I Escalation Stage: No more than two prior lines of cytotoxic-containing chemotherapy regimens for advanced disease For the Phase II Lurbinectedin Expansion Stage: - For SCLC, one prior line of platinum-containing chemotherapy with/without antibodies against programmed cell death protein-1 (PD-1) or programmed death ligand-1 (PD-L1). - For NENs, - In Group 1 (patients with NENs of gastroenteropancreatic origin or unknown primary site, excluding lung primary tumors), progression to first-line platinum-based chemotherapy; and - In Group 2 (patients with well differentiated P-NETs), no more than three prior lines of systemic therapy (that may include somatostatin analogues, chemotherapy, everolimus and/or sunitinib). - For all other tumor types, no more than two prior lines of cytotoxic-containing chemotherapy regimens for advanced disease. There is no limit for prior targeted therapy, hormonal therapy and immunotherapy (such as nivolumab). 7. Phase II expansion stage: Tumor-specific cohort(s) at the RD: 1. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. For patients with glioblastoma: Measurable disease according to RECIST v.1.1 and Response Assessment in Neuro-Oncology (RANO) criteria. 2. Documented disease progression per RECIST v.1.1 during or immediately after last therapy according to any of the aforementioned criteria. For patients with glioblastoma: Documented disease progression per RECIST v.1.1 and RANO criteria. 8. At least three weeks since the last anticancer therapy, (including immunotherapy, investigational drugs and radiotherapy), and at least six weeks since nitrosoureas and mitomycin C (systemic). For biological/investigational anticancer therapies given orally, the aforementioned period of at least three weeks could be changed for one of at least five half-lives (whichever occurred first), provided that the therapy is given as single agent and not combined with other drugs. If this is not the case, this exception will not be acceptable. For patients with glioblastoma: at least 12 weeks since the end of radiotherapy, except if: 1. The patient has a new lesion outside of the radiotherapy field, or 2. The patient has undergone brain surgery to remove the tumor before study entry, and progressive disease has been confirmed histologically. Note: washout periods will be referred to the day of first cycle administration (Day 1), not to the day of registration (Day 0). 9. Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ 7 days before inclusion in the trial): 1. Platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 9.0 g/dL and absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L. 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × the upper limit of normal (ULN), even in the presence of liver metastases. 3. Alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN if disease-related/in the case of liver metastases). 4. Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN. 5. International Normalized Ratio (INR) < 1.5 (except if patient is on oral anticoagulation therapy). 6. Calculated creatinine clearance (CrCL) ≥ 30 mL/minute (using Cockcroft-Gault formula). 7. Creatine phosphokinase (CPK) ≤ 2.5 × ULN. 8. Albumin ≥ 3.0 g/dL 10. Recovery to grade ≤ 1 or to baseline from any adverse event (AE) derived from previous treatment (excluding alopecia and/or cutaneous toxicity and/or peripheral neuropathy and/or fatigue grade ≤ 2). Exclusion Criteria: 1. Concomitant diseases/conditions: 1. History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within the previous year. 2. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment. 3. Myopathy or any clinical situation that causes significant and persistent elevation of CPK (> 2.5 × ULN in two different determinations performed one week apart). 4. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C. Known Gilbert disease. 5. Active uncontrolled infection. 6. Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B. 7. Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or sub-occlusion or paralysis. 8. Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days. 9. Any other major illness that, in the Investigators judgment, will substantially increase the risk associated with the patients participation in this study 10. Active Coronavirus disease (COVID-19) (this includes positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal/oropharyngeal swabs or nasal swabs by PCR). 11. Hypersensitivity to any of the study drugs or their excipients. 2. Prior treatment with lurbinectedin, trabectedin (Yondelis®) or topoisomerase I inhibitors (irinotecan, topotecan, etc.). Prior topoisomerase inhibitors (e.g., irinotecan) are only allowed in patients with colorectal carcinoma 3. Prior bone marrow or stem cell transplantation, or radiation therapy in more than 35% of bone marrow. 4. Known brain metastases or leptomeningeal disease involvement. Glioblastoma lesions (primary or locally advanced) are eligible. Exception: patients with brain metastases are eligible provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment (patients taking steroids in the process of already being tapered within two weeks prior to screening are allowed). Brain CT-scan or MRI results must be provided at baseline. 5. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception. Women of childbearing potential (WOCBP) must agree to use an effective contraception method to avoid pregnancy during the course of the trial (and for at least six months after the last infusion). Fertile male patients must agree to refrain from fathering a child or donating sperm during the trial and for four months after the last infusion. 6. Limitation of the patients ability to comply with the treatment or follow-up protocol. ; PRIMARY OUTCOME: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Safety evaluation[/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 - 501; BRIEF: The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994, administered to patients with asthma can achieve a clinically meaningful increase in pulmonary function (Forced Expiratory Volume in one second: FEV1) while maintaining an acceptable safety profile. The study will characterize the bronchodilator effect, dose and safety of PL-3994 in a population of moderately severe, stable asthmatics following overnight withdrawal of beta-2 agonists. ; DRUG USED: PL-3994; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Natriuretic Peptide Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Palatin Technologies, Inc; CRITERIA: Inclusion Criteria: - Subject has provided written informed consent - The subject is male or female >18 to 65 years of age - Patient has a clinical history of asthma as defined by the National Asthma Education and Prevention Program. - Documented bronchodilator response to albuterol as defined by the American Thoracic Society (> 200 mL and > 12% increase in FEV1 after bronchodilator inhalation) - FEV1 post-bronchodilator of between 55% and 80% predicted. - Currently taking 200-1000 mcg (fluticasone equivalent) of inhaled corticosteroids - All inclusion criteria met within the past 12 months. - If the subject or subjects partner is of child-bearing potential, a medically acceptable form of contraception will be used for three months prior to the screening visit (females only), for the duration of the study and for one month following the last dose of the study drug. Medically acceptable contraceptives include: (1) surgical sterilization, (2) FDA-approved female hormonal contraceptives, (3) an intrauterine device (IUD), (4) condoms with spermicide, or (5) diaphragm with spermicide. If the subject had a vasectomy greater than 6 months prior to the screen visit, this will also be acceptable. Exclusion Criteria: - Current diagnosis, as per subject or investigator or screening assessment, of: - unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy - psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia or any other uncontrolled psychiatric condition - significant neurological disease - current or history of any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to screening - acute or chronic disease requiring frequent changes in medications or changes in dosages of chronic therapy - history of alcohol abuse within the past 5 years - positive result for the alcohol and/or drug tests at screening or check-in - positive for HIV, or Hep B&C at screening - blood donation within 30 days of screening or plasma donation within 7 days of screening - weight > 100 kg or < 50 kg - clinically significant electrocardiogram (ECG) at screening - any clinically significant (per the investigator) lab abnormalities - any fever or other clinically significant physical exam abnormalities - History of COPD or any other lung disease - Greater than 10 packs per year smoking history and any cigarette smoking within the past 12 months - Patients unable to withhold bronchodilator treatment for 12 hours prior to dosing - Patients with hypoxia at screen or Check -in Visit 2, Day 1 or Visit 3, Day 7 (oxygen saturation measured by pulse oximetry [SpO2] < 90%) - Tachycardia (heart rate > 100 beats/min) at screening - Currently being treated for Hypertension or taking any other medications that affect blood pressure significantly. - Currently taking any medications that inhibit PDE activity or which affect the cyclic guanisine mono-phosphate (cGMP) pathway (e.g. theophylline). These medications will be prohibited during the study and for at least 5 half- lives prior to Check-in Visit 2, Day 1 or Visit 3, Day 7 so that cGMP measurements will not be affected. - Hypotension (systolic blood pressure < 110 mmHg) at Screening or Check-in Visit 2, Day 1 or Visit 3, Day 7 - Chronic kidney disease defined as estimated glomerular filtration rate (eGFR) <50 mL/m2. - Diagnosis of heart failure or history of hospitalization for congestive heart failure. - History of coronary artery disease defined as prior myocardial infarction, prior revascularization procedure, or >50% coronary artery obstruction by angiography. - Prior history of stroke or transient ischemic attack. - Female patients of childbearing potential who are nursing or have a positive pregnancy test at Screening or Check -in Visit 2, Day 1 or Visit 3, Day 7 - Any major disability or disease with expected survival less than 6 months - Administration of any investigational drug or implantation of investigational device, or participation in another trial, within 30 days of screening. - Inability to perform acceptable, quality serial spirometry ; PRIMARY OUTCOME: Change in Forced Expiratory Volume in one second (FEV1); SECONDARY OUTCOME 1: Change in Forced Vital Capacity (FVC)[/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 - OVATION 2 (w/Neoadjuvant Chemotherapy); BRIEF: This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone. ; DRUG USED: GEN-1; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: IL-12 (Interleukin-12) and IL-12 receptor; THERAPY: Combination; LEAD SPONSOR: Imunon; CRITERIA: Inclusion Criteria: 1. Patients must have suspected histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report. 2. Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV. 3. Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.). 4. Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl. 2. Renal function: Creatinine ≤1.5 x institutional upper limit normal (ULN). 3. Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN. 4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1. 5. Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. 6. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted. 7. Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria. 8. Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry. 9. Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol. 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information. 11. Patients must be at least 18 years old. Exclusion Criteria: 1. Patients who have received prior treatment with IMNN-001. 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other agents used in this study. 3. Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration. 4. Patients receiving treatment for active autoimmune disease. Active refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. 5. Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. 6. Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease. 7. Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease. 8. Patients with known active hepatitis. 9. Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy. 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial. 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study. 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy. ; PRIMARY OUTCOME: PFS; 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 - ROSE (HER2-); BRIEF: The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer. ; DRUG USED: Cyramza; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participant is able to provide signed informed consent - Participant is female and ≥ 18 years of age or older if required by local laws or regulations - Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis - Participant has measurable and/or non-measurable disease - Participants primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC) - Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer - Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization - Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization - Participant completed all prior radiotherapy with curative intent ≥ 3 weeks prior to randomization - Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting ≥ 2 weeks prior to randomization - Participants left ventricular ejection fraction is within normal institutional ranges - Participant has resolution to grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade ≤ 2 - Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Participant is amenable to compliance with protocol schedules and testing - Participant has adequate hematological functions [absolute neutrophil count (ANC) ≥ 1500 cells/microliter (mcL), hemoglobin ≥ 9 grams/deciliter (g/dL), and platelets ≥ 100,000 cells/mcL and ≤ 850,000 cells/mcL] - Participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase ≤ 5.0 times the ULN] - Participant has serum creatinine ≤ 1.5 x ULN. If serum creatinine > 1.5 x ULN the calculated creatinine clearance should be > 40 milliliters/minute (mL/min) - Participants urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA); if urine protein ≥ 2+, a 24-hour urine collection must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study - Participant must have adequate coagulation function as defined by international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices) - Women of childbearing potential must implement adequate contraception in the opinion of the investigator - Participant has not received prior biologic therapy for metastatic or locally recurrent and inoperable breast cancer Exclusion Criteria: - Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years - Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80 - Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF) - Participant has a history of chronic diarrheal disease within 6 months prior to randomization - Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization - Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization - Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders - Participant has active, high risk bleeding (such as, via gastric ulcers or gastric varices) within 14 days prior to randomization - Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy - Participant has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator - Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease - Participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness - Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen. - Participant is pregnant or lactating ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - 101 (FGFR 1, 2, 3); BRIEF: This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment does not exist or is not indicated. The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally administered daily to these patients, in order to determine the recommended dose. The main objective of Part B is to evaluate the safety profile at the recommended dose, in a larger cohort of these patients. ; DRUG USED: Debio 1347; DRUG CLASS: New Molecular Entity (NME); INDICATION: Solid Tumors; TARGET: Fibroblast Growth Factor Receptor (FGFR) ; THERAPY: Monotherapy; LEAD SPONSOR: Debiopharm International SA; CRITERIA: Inclusion Criteria - Meets protocol-specified criteria for qualification and contraception - Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications - Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Exclusion Criteria: - Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters - Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the safety or well-being of the participants offspring (such as through pregnancy or breast-feeding) 3. the analysis of results ; PRIMARY OUTCOME: Part A: Percentage of Participants With Dose-Limiting Toxicities (DLTs) From Debio 1347; SECONDARY OUTCOME 1: Part A: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)[/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 - CL-22 (Central Abdominal Bulging); BRIEF: Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected. ; DRUG USED: LIPO-202; DRUG CLASS: Non-NME; INDICATION: Fat Removal; TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Neothetics, Inc; CRITERIA: Inclusion Criteria: - Provided consent - Healthy male or non-pregnant female subjects - BMI < 30 kg/m2 - Stable diet and exercise routine - Central abdominal bulging that is at least Slight Bulge, Not Flat Exclusion Criteria: - Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen - Plan on starting a weight loss or exercise program during the study. - Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control. - Known hypersensitivity to study drugs - Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202 ; PRIMARY OUTCOME: Safety: vital signs, physical exams, laboratory tests; 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 - Healthy Toddlers and Infants; BRIEF: Primary objectives: - To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection). - To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) - To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8) - To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8) Secondary objectives: - To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) - To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8) - To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8) - In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel - In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX]) ; DRUG USED: SP0202; DRUG CLASS: Vaccine; INDICATION: Pneumococcal (Streptococcus pneumoniae) Vaccines (Antibacterial); TARGET: Immune System, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi Pasteur, a Sanofi Company; CRITERIA: Inclusion criteria : Toddlers and infants: - Participant and parent/guardian are able to attend all scheduled visits and to comply with all study procedures - Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 5.5 lbs or 2.5 kg Specifically for toddlers: - Aged 12 to 15 months on the day of the first study visit - Participant has received 3 doses of Prevnar 13 and 3 doses of diphteria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b antigens in infancy Specifically for infants: - Aged 42 to 89 days on the day of the first study visit Exclusion criteria: Toddlers and infants - Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure - Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated - Blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems - Active tuberculosis - History of S. pneumoniae infection or disease, confirmed either serologically or microbiologically - History of any neurologic disorder, including any seizures and progressive neurologic disorders - History of Guillain-Barré syndrome - Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances - Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigators opinion - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigators opinion - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw - Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and know congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion - Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives - In an emergency setting, or hospitalized involuntarily - Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C / ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has resolved - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study Specifically for toddlers - Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 2), except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines - Receipt of immune globulins, blood or blood-derived products in the past 3 months - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - History of diphtheria, tetanus, pertussis, poliomyelitis, and/or H. influenzae type b infection or disease Specifically for infants - Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 6), except for influenza vaccination or COVID-19 vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, and COVID-19 vaccines as applicable per local recommendations - Receipt of immune globulins, blood or blood-derived products since birth. - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth - Previous vaccination against S. pneumoniae - Previous vaccination against the following antigens: diphteria, tetanus, pertussis, H. influenzae type b, poliovirus, rotavirus, measles, mumps, rubella, and varicella - Receipt of more than 1 previous dose of hepatitis B vaccine - History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, varicella, H. influenzae type b, and/or rotavirus infection or disease - History of intussusception The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Number of participants reporting immediate adverse events (AEs); SECONDARY OUTCOME 1: Geometric mean (GM) of serotype specific opsonophagocytic (OPA) titers for all pneumococcal serotypes included in the SP0202 formulations in toddlers[/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 - INSPIRE (Switchover Study); BRIEF: Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset Pompe disease who have been receiving treatment with recombinant human acid alpha-glucosidase (rhGAA) for 48 weeks or longer. Ambulatory patients who have mild to moderate respiratory impairment will switch directly to receive BMN 701 20 mg/kg by IV infusion every other week. All participants will receive active drug. No dose of existing therapy will be missed - experimental drug is started immediately. ; DRUG USED: BMN-701; DRUG CLASS: Biologic; INDICATION: Pompe Disease; TARGET: Glycogen; THERAPY: Monotherapy; LEAD SPONSOR: BioMarin Pharmaceutical; CRITERIA: Inclusion Criteria: - Willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any study-related procedures. - Diagnosed with late-onset Pompe disease based on 2 currently or previously documented GAA gene mutations, and endogenous GAA activity <75% of the lower limit of the normal adult range reported by the testing laboratory, as assessed by dried blood spot or whole blood assay. - Has received prior treatment with commercial rhGAA as defined by ALL of the following: 1. has received treatment with commercial rhGAA for ≥ 48 weeks (but no more than 20% of the study population can have received treatment for ≥ 6 years). 2. has received > 80% of all scheduled treatments in the prior 48 weeks and ≥ 4 out of the prior 6 scheduled treatments. 3. has received and completed the last two infusions without a drug-related adverse event resulting in dose interruption. 4. has received last treatment of commercial rhGAA ≥ 10 and ≤ 31 days prior to anticipated initiation of treatment with BMN 701. - ≥ 18 years of age at the time of enrollment in the study. - Sexually active subjects must be willing to use two known effective methods of contraception while participating in the study and for at least 4 months following the last dose of BMN 701. - Females of childbearing potential must have a negative pregnancy test at Screening and Baseline visits and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to Screening, or who have had total hysterectomy. - Has ≥ 30% predicted upright FVC and < 80% predicted upright FVC. - Has ≤60% predicted MIP. - Is able to ambulate ≥75 meters and ≤500 meters on the 6MWT conducted during the Screening visit (use of assistive devices such as walker, cane, or crutches, is permitted with consistent use throughout the study). - Is willing and able to comply with all study procedures. Exclusion Criteria: - Use of any investigational product or investigational medical device within 4 weeks prior to Screening, or requirement for any investigational agent other than BMN 701 prior to completion of at least the first 24 weeks of all scheduled study assessments. - Received any investigational medication for Pompe disease within the prior 12 months. - Has a diagnosis of diabetes and/or is currently being treated with or anticipated to require treatment with hypoglycemic agents during the course of the study. - Has been treated with any immunosuppressive medication other than glucocorticosteroids within the prior 12 months. - Requires noninvasive ventilatory support while awake and in the upright position. - Has previously been enrolled to this study. - Breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study. - Concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the Investigator, might compromise subject safety, study treatment compliance and completion of the study, or the integrity of the data collected for the study. - Has known hypersensitivity to BMN 701 or its excipients. ; PRIMARY OUTCOME: Percent Predicted Maximum Inspiratory Pressure (MIP); SECONDARY OUTCOME 1: Percent Predicted Maximum Expiratory Pressure (MEP)[/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 - Open Label; BRIEF: The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM). ; DRUG USED: AU-011; DRUG CLASS: Biologic; INDICATION: Uveal Melanoma; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Aura Biosciences; CRITERIA: Inclusion Criteria: - Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) - Have no evidence of metastatic disease confirmed by imaging - Be treatment naïve for IL/CM Exclusion Criteria: - Have known contraindications or sensitivities to the study drug or laser - Active ocular disease ; PRIMARY OUTCOME: Treatment related AEs and treatment related serious adverse events (SAEs).; SECONDARY OUTCOME 1: Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - RELY-30 (Baylor); BRIEF: The subject has a type of lymph gland cancer called Lymphoma. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers; they both have shown promise, but have not been strong enough to cure most patients. Investigators hope that both will work better together. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to test whether these genetically modified T cells given after chemotherapy will be more effective at killing cancer cells. The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells (CD30.CAR T cells) seem to kill some of the tumor, but they dont last very long and so their chances of fighting the cancer are unknown. Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions, and that this may not happen if there are too many other T cells in circulation. Because of that, doctors may use chemotherapy drugs to decrease the level of circulating T cells prior to the CD30.CAR T cells infusion. This is called lymphodepletion CD30.CAR T cells have previously been studied in lymphoma patients. ; DRUG USED: TT11 CD30 CAR-T; DRUG CLASS: Biologic; INDICATION: Hodgkins Lymphoma; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 30 (CD30) / TNFRSF8, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Baylor College of Medicine; CRITERIA: PROCUREMENT Inclusion Criteria: 1. Diagnosis of relapsed/refractory HL or NHL. 2. CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time) 3. Hgb ≥ 7.0 (may be a transfused value) 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. 5. Karnofsky or Lansky score of > 60% TREATMENT Inclusion Criteria: 1. Diagnosis of relapsed/refractory HL or NHL. 2. CD30-positive tumor as assayed in a CLIA certified pathology laboratory. 3. Age 16 to 75 for the first three patients on a dose level; thereafter, if no DLT, patients aged 12 to 75 can be treated on that dose level. 4. Bilirubin 1.5 times or less than the upper limit of normal. 5. AST 3 times or less than the upper limit of normal. 6. Estimated GFR > 70 mL/min. 7. Pulse oximetry of > 90% on room air 8. EKG shows no significant arrhythmias 9. Karnofsky or Lansky score of > 60%. 10. Available autologous T cells with greater than or equal to 15% expression of CD30CAR determined by flow-cytometry. 11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy. 12. Adequate pulmonary function with FEV1, FVC and DLCO (or DLCO/VA, as clinically appropriate) greater than or equal to 50% of expected corrected for hemoglobin. 13. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom. 14. Informed consent explained to, understood by and signed by patient or guardian. PROCUREMENT Exclusion Criteria: 1. Active infection with HIV or HTLV (can be pending at this time). 2. Active bacterial, fungal or viral infection. TREATMENT Exclusion Criteria: 1. Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks. 2. Received anti-CD30 antibody-based therapy within the previous 4 weeks. 3. Subjects with rapidly progressive disease, defined as kinetic failure to previous chemotherapy. 4. Bulky disease (defined as a 10 cm mass or mediastinal disease with a transverse diameter exceeding 33% of the transthoracic diameter). 5. History of hypersensitivity reactions to murine protein-containing products. 6. Pregnant or lactating. 7. Tumor in a location where enlargement could cause airway obstruction. 8. Current use of systemic corticosteroids at a dose equivalent to 0.5 mg/kg/day of prednisone or higher. 9. Active hemorrhagic cystitis. 10. Active bacterial, viral or fungal infection. 11. Symptomatic cardiac disease (NYHA Class III or IV disease). ; PRIMARY OUTCOME: Number of Patients with Dose-Limiting Toxicities (DLT); SECONDARY OUTCOME 1: Median Number of T cells transduced with the vector[/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 - CMAU868X2201 (BKV/Kidney Transplant Recipients); BRIEF: This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients. ; DRUG USED: MAU868; DRUG CLASS: Biologic; INDICATION: Antiviral - Other Treatments; TARGET: ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria; - Male or female recipients of a first or second kidney or kidney-pancreas transplant who weigh at least 30 kg and are at least 7 years of age (in the US, 18 years of age or above) at the time of transplantation. - Recipients of organs from a heart-beating deceased, non-heart-beating deceased, living unrelated, or human leukocyte antigen (HLA)-mismatched living related donor. - Recipients who are treated with lymphocyte-depleting induction therapy (e.g., rabbit antithymocyte globulin, alemtuzumab). Subjects treated with rabbit antithymocyte globulin must receive a total dose of at least 3 mg/kg. Subjects treated with alemtuzumab must receive a total dose of at least 20 mg. - Recipients of a kidney with a cold ischemia time (CIT) <36 hours. Exclusion Criteria: - Recipients of organs from identical twins or living, HLA-matched, related donors. - ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant (isolated positive B cell crossmatches are not an exclusion criterion). - Recipients who are treated with non-lymphocyte-depleting induction therapy (e.g., basiliximab) or no induction therapy. - Recipients who are treated or planned to be treated with mTOR inhibitors as part of their initial immunosuppression regimen post-transplantation. - Recipients who require antibody-depletion prior to transplantation and in the opinion of the investigator are likely to require antibody-depletion after transplantation. Antibody-depleting therapies include but are not necessarily limited to plasmapharesis, immunoadsorption, and IVIg. - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by hCG testing. - Current clinical, radiographic, or laboratory evidence of active or latent tuberculosis (TB) or any history, in the opinion of the investigator, that confers a risk of reactivation of TB and precludes the use of conventional immunosuppression. - History of splenectomy or asplenia. - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of investigational drug. ; PRIMARY OUTCOME: Incidence of BK viremia; SECONDARY OUTCOME 1: Pharmacokinetics of MAU868[/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 - 16007; BRIEF: Study to assess the relative Bioavailability To assess the relative bioavailability of three formulations of nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles To assess the pharmacokinetics (PK) of nifurtimox To investigate the safety and tolerability of nifurtimox. ; DRUG USED: Lampit; DRUG CLASS: Non-NME; INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: DNA; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria - Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 12 weeks after the last administration of study drug. The definition of adequate contraception will be based on the judgment of the investigator and on local requirements. Acceptable methods of contraception include, but are not limited to: (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception. Subjects must agree to utilize two reliable and acceptable methods of contraception simultaneously. - Women of childbearing potential with confirmed last menstrual period by anamnesis and negative serum pregnancy test (beta-human chorionic gonadotropin [βhCG]) at screening and negative urine pregnancy test (βhCG) at pre-dose of each treatment. - Women of non-childbearing potential, such as surgically sterile women with either written documentation of surgical sterility or negative serum pregnancy test (βhCG) at screening and negative urine pregnancy test (βhCG) at pre-dose of each treatment. - Male subjects who agree not to act as sperm donors for 12 weeks after last administration of study drug. - Age: 18 to 45 years (inclusive) at screening. - Body mass index (BMI): ≥18 and <29.9 kg/m². - Written informed consent must be provided before any study-specific tests or procedures are performed. - Male/female patient diagnosed with chronic Chagas disease: - Previous diagnosis of acute or chronic Chagas disease by a health clinic prior to screening for the study. The diagnosis of chronic Chagas disease may be made by clinical findings, supported by antibody titers if available. If there is a known history of acute disease, it is preferable to have documentation of parasites on the blood smear, if available. Exclusion Criteria - Incompletely cured pre-existing diseases (except chronic Chagas disease without active GI condition) for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal. - Acute Chagas disease. (During the acute phase, the parasite on a blood smear may be seen under a microscope. Different antibodies are present, depending on the course of the disease). - Known hypersensitivity to the study drug (active substance or excipients of the preparations) - Unstable or uncontrolled medical condition such as hypertension or diabetes, decompensated heart failure, GI conditions that would interfere with the absorption of the study drug (e.g. GI ulceration, peptic ulceration, GI bleeding, gastroesophageal reflux, or other GI disease affecting gastroesophageal junction), conditions that could potentially have an impact on drug metabolism or elimination (renal, hepatic such as known hepatic or biliary abnormalities), or any clinically relevant active infections in the opinion of the investigator within 4 weeks before the screening visit, e.g. clinically relevant history or presence of significant respiratory (e.g. interstitial lung disease), hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic (e.g. diabetes), and dermatological or connective tissue disease. - Use of systemic or topical medicines or substances which oppose the study objectives (including clinical treatment with nifurtimox and benznidazole) or which might influence them within 4 weeks before the first study drug administration, e.g. an investigational drug, any drug altering GI motility and/or gastric pH (e.g. antacids, anticholinergic, para-sympatholytics), any drug known to induce liver enzymes (e.g. dexamethasone, barbiturates, St. Johns Wort [hypericum perforatum]), any drug known to inhibit liver enzymes (e.g. ketoconazole, macrolides). - Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the QT interval over 450 msec using Bazetts formula (QTcB). (Clinically stable subjects with Chagas-related heart disease and pacemaker in place for >1 year and evaluated by a cardiologist ≤6 months before the first dose of study drug will not be excluded.) - Systolic blood pressure <100 or >140 mmHg (after resting in supine position for a minimum of 3 minutes). - Diastolic blood pressure <50 or >90 mmHg (after resting in supine position for a minimum of 3 minutes). - Findings that would exclude the subject in the investigators judgment, e.g. enlarged liver, irregular heartbeat, undiagnosed acute illness, and melanoma. - Positive pregnancy test. - Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV 1+2). - Positive urine drug screening.. ; PRIMARY OUTCOME: AUC(0-tlast) of nifurtimox; SECONDARY OUTCOME 1: Number of participants with adverse events[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - SCNSL1 (Italy); BRIEF: This prospective trial will assess the activity and feasibility of a new high-dose methotrexate-based high-dose sequential chemotherapy combination in patients with B-cell lymphomas and CNS involvement at diagnosis or relapse. Selected drugs, with a well-documented anti-lymphoma activity, will be administered at high doses to increase blood-brain barrier penetration and CNS bioavailability as well as to reduce potential cross-resistance. ; DRUG USED: Rituxan; DRUG CLASS: Biologic; INDICATION: Primary Central Nervous System Lymphoma (PCNSL) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: IRCCS San Raffaele; CRITERIA: Inclusion Criteria: 1. Histologically confirmed diagnosis of diffuse large-cell, follicular or mantle cell lymphoma 2. CNS involvement (brain, meninges, cranial nerves, eyes, and/or spinal cord) at diagnosis or relapse after conventional chemotherapy 3. Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination. Neuroimaging alone is acceptable only when stereotactic biopsy is formally contraindicated. 4. Age 19-65 years 5. ECOG performance status 0-3 6. Adequate bone marrow (PLT > 100000 mm3, Hb > 9 g/dl, ANC > 2.000 mm3), renal (creatinine clearance > 60 mL/min), cardiac (VEF > 50%), and hepatic function (total serum bilirubin < 3 mg/dL, AST/ALT and gammaGT < 2.5 per upper normal limit value), within 1 week prior to study start (unless the abnormality is due to lymphoma involvement) 7. Absence of symptomatic coronary artery disease, cardiac arrhythmias not well controlled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease) 8. Absence of HIV infection 9. No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix and carcinoma of the skin and of other cancers without evidence of disease at least from 5 years 10. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 11. Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation 12. No treatment with other experimental drugs within the 6 weeks previous to enrolment 13. Give written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice Exclusion Criteria: - NA ; PRIMARY OUTCOME: Event-free survival; SECONDARY OUTCOME 1: Response duration[/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 - ADmIRe; BRIEF: The reason for this study is to see if the study drug LY3375880 is safe and effective in adults with moderate-to-severe atopic dermatitis (AD). ; DRUG USED: LY3375880; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-33 (Interleukin-33)IL-33 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Participants must have diagnosis of AD >= 12 months according to the American Academy of Dermatology criteria. - Participants must have moderate to severe AD at screening and randomization. - Participants must have inadequate response to topical medications within 6 months of screening (or history of intolerance). Exclusion Criteria: - Participants must not have concurrent treatment with topical or systemic treatments for AD. ; PRIMARY OUTCOME: Percentage of Participants Achieving Validated Investigators Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement; SECONDARY OUTCOME 1: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)[/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 - PHYOX; BRIEF: This is a double-blind, placebo-controlled, dose escalation trial of DCR-PHXC in Healthy Volunteers (HVs) and patients with Primary Hyperoxaluria (PH). Once safety has been established in HV, PH patients with a confirmed diagnosis of PH1 and PH2 will be enrolled across multiple dosing cohorts. The study design will allow enrollment of PH patient cohorts at a given dose level once safety has been demonstrated in HV at that dose level. The study will be conducted in two parts: Part A: Single ascending dose (SAD) in HV; Part B: SAD in patients with PH1 and PH2 (lagging Part A by 1 dose level cohort). ; DRUG USED: Nedosiran; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperoxaluria; TARGET: Lactate Dehydrogenase A (LDHA); THERAPY: Monotherapy; LEAD SPONSOR: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company; CRITERIA: Group A (HVs) Major Inclusion Criteria: - Willing and able to provide informed consent and comply with study requirements. - Male or female subjects between 18 and 55 years of age, inclusive. - Subject must have a body mass index (BMI) 19.0 to 32 kg/m2, inclusive. - Non-smokers, at least 1-month tobacco free, and willing to remain tobacco free through end of study (EOS). - Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Group A (HVs) Major Exclusion Criteria: - Presence of any medical condition, including but not limited to: Severe intercurrent illness, known causes of active liver disease. - Routine or chronic use of more than 3 grams of acetaminophen (Tylenol) daily. - History of kidney stones. - Use of any investigational agent within 90 days before the first dose of study medication. - History of donation of more than 450 mL of blood within 90 days prior to dosing in the clinical research center or planned donation less than 30 days after receiving Investigational Medicinal Product (IMP). - Plasma or platelet donation within 7 days of dosing and through EOS. - History of reactions to an oligonucleotide-based therapy. - Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after last dosing of IMP. - Plasma or platelet donation within 7 days of dosing and through EOS. Group B (PH1 and PH2 patients) Major Inclusion Criteria: - Willing and able to provide informed consent and comply with study requirements. - Male or female, at least 6 years of age. - Minimum body weight of 25 kg. - Genetic confirmation of PH1 and PH2 disease. - Meet the 24 hour urine oxalate excretion requirements. - Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2. - If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 4 weeks. Group B (PH1 and PH2 patients) Major Exclusion Criteria: - Prior renal and/or hepatic transplantation. - Currently receiving dialysis. - Participation in any clinical study where they received an investigational agent within 4 months before enrollment. - Presence of any medical condition, including but not limited to: Severe intercurrent illness, known causes of active liver disease. - Liver function test (LFT) abnormalities. - History of reactions to an oligonucleotide-based therapy. ; PRIMARY OUTCOME: Number of patients with Treatment-Related Adverse Events (TEAEs); 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 - CHRONOS-4; BRIEF: The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents. ; DRUG USED: Aliqopa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of B lymphocyte antigen CD20 positive iNHL with histological subtype limited to: - Follicular lymphoma G1-2-3a - Small lymphocytic lymphoma with absolute lymphocyte count <5x10E9/L at study entry - Lymphoplasmacytoid lymphoma / Waldenström macroglobulinemia (LPL / WM) - Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal) - Patients must have relapsed (recurrence after complete response or presented progression after partial response) or progressed after at least one but at most three prior lines of therapy, including rituximab, and/or rituximab biosimilars, and/or anti-CD20 monoclonal antibody (e.g. obinutuzumab) -based immunochemotherapy and alkylating agents (if given concomitantly is considered one line of therapy). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy with single agent rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody can be considered a previous regimen in the case the patient responded to it); at least 2 consecutive cycles of polychemotherapy; autologous transplant; or radioimmunotherapy. Previous exposure to other PI3K Inhibitors (except copanlisib) is acceptable provided there is no resistance (resistance defined as no response (response defined as partial response [PR] or complete response [CR]) at any time during therapy, or progressive disease (PD) after any response (PR/CR) or after stable disease within 6 months from the end of the therapy with a PI3K inhibitor. - Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease. - Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal and positive immunofixation test. - Male or female patients ≥ 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Life expectancy of at least 3 months - Availability of fresh tumor tissue and/or archival tumor tissue at Screening - Adequate baseline laboratory values as assessed within 7 days before starting study treatment. - Left ventricular ejection fraction ≥ 50% Exclusion Criteria - Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended. - Rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody (e.g. obinutuzumab) resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last date of rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody administration, including maintenance with these drugs). - HbA1c > 8.5% at screening - History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator) - Known lymphomatous involvement of the central nervous system - Known history of human immunodeficiency virus (HIV) infection - Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy as per rituximab label. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA. - Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.CMV PCR test is considered positive if, the result can be interpreted as a CMV viremia according to local standard of care. - Uncontrolled hypertension despite optimal medical management (per investigator´s assessment) - Congestive heart failure > New York Heart Association (NYHA) class 2 ; PRIMARY OUTCOME: Safety run-in_Determination of the recommended Phase-III dose (RP3D) of copanlisib in combination with standard immunochemotherapy assessed by the occurrence of dose-limiting toxicities / adverse events; SECONDARY OUTCOME 1: Safety run-in_Best Overall Response (BOR)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - w/Azacitidine (US); BRIEF: The main purpose of this study is to determine the safe and recommended dose of APR-246 in combination with azacitidine as well as to see if this combination of therapy improves overall survival. ; DRUG USED: Eprenetapopt; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: p53; THERAPY: Combination; LEAD SPONSOR: H. Lee Moffitt Cancer Center and Research Institute; CRITERIA: Inclusion Criteria: - Has signed the Informed Consent (ICF) and is able to comply with protocol requirements. - Has adequate organ function according to study protocol guidelines. - Age ≥18 years at the time of signing the informed consent form. - Documented diagnosis of myelodysplastic syndrome (MDS), MDS/ myeloproliferative neoplasm (MPN), chronic myelomonocytic leukemia (CMML) or oligoblastic AML (20-30% myeloblasts) by World Health Organization (WHO) criteria. - Documentation of a TP53 gene mutation by NGS based on central or local evaluation. - For TP53 mutant patients with lower risk MDS (i.e., low or intermediate-1 risk by the International Prognostic Scoring System (IPSS)) and isolated deletion of 5q (del(5q)), failure of prior treatment with at least 4 full cycles of lenalidomide defined as no response to treatment, loss of response at any time point, progressive disease, or intolerance to therapy. - An Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 is required. - If of childbearing potential, negative pre-treatment urine or serum pregnancy test. - If of childbearing potential, willing to use an effective form of contraception such as hormonal birth control, intrauterine device or double barrier method during chemotherapy treatment and for at least six months thereafter. Exclusion Criteria: - Known history of HIV or active hepatitis B or active hepatitis C infection (testing not mandatory). - Has any of the following cardiac abnormalities (as determined by treating MD): a. Symptomatic congestive heart failure; b. Myocardial infarction less than or equal to 6 months prior to enrollment; c. Unstable angina pectoris; d. Serious uncontrolled cardiac arrhythmia; e. QTc ≥ 470 msec - Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of signing consent. Potential participants with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (e.g., cervix) may enroll irrespective of the time of diagnosis. - Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of MDS, MDS/MPN, CMML or AML within 14 days of the first day of study drug treatment. - No concurrent use of erythroid stimulating agents, G-CSF, GM-CSF is allowed during study except in cases of febrile neutropenia where G-CSF can be used for short term. Growth factors must be stopped 14 days prior to study. - Women who are pregnant or breastfeeding. ; PRIMARY OUTCOME: Phase 1b: Maximum Tolerated Dose (MTD); SECONDARY OUTCOME 1: Phase 2: Duration of Response[/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 - Hepatic Impairment; BRIEF: The purpose of this study is to evaluate the effect of varying degrees of hepatic function on the single dose PK of IV TAK-954. ; DRUG USED: TAK-954; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroenterologic Disorders; TARGET: Serotonin 5-HT4 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Male and female participants (non-childbearing potential), with a body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m^2) (All participants). 2. Participants with hepatic impairment who are medically stable as determined by the investigator, based on medical history and clinical evaluations including physical examinations, clinical laboratory tests, vital sign measurements, and 12-lead ECGs performed at the Screening Visit and at check-in on Day -1 (Group 1 to 3). 3. Healthy participants (Group 4). Exclusion Criteria: Participants who have: 1. A history of hepatic carcinoma, hepatorenal syndrome, or presence of a liver mass by ultrasound, CT or MRI, or acute liver disease caused by an infection or drug toxicity (Group 1 to 3). 2. Have severe hepatic encephalopathy ([greater than] > Grade II Portal Systemic Encephalopathy Score) (Group 1 to 3). 3. Surgical porto-systemic shunts, including transjugular intrahepatic portosystemic shunt (Group 1 to 3). 4. A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to trial entry (Group 1 to 3). 5. Bilirubin levels above 5 times the upper limit of normal (ULN) at screening or Day -1 for Groups 1 and 2, there is no limit for Group 3. 6. Severe/advanced ascites and/or pleural effusion which requires emptying and albumin supplementation, as judged by the investigator (Group 1 to 3). 7. Renal creatinine clearance (CLcr) less than or equal to (<=) 50 milliliter per minute (mL/min), calculated using the Cockcroft-Gault equation from the serum creatinine measurement taken at screening (Group 1 to 3). 8. Who have a history of clinically significant endocrine, gastrointestinal (GI) (including motility disorder and intestinal obstruction), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases will be excluded from the trial (Group 4). ; PRIMARY OUTCOME: Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free); SECONDARY OUTCOME 1: Number of Participants With Clinically Significant Physical Examination Findings[/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/Peg-IFN/RBV (PN038); BRIEF: This is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of treatment with Peg-IFN and RBV. ; DRUG USED: Grazoprevir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Treatment naive - Chronic, compensated HCV GT1 infection - Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis - No evidence of cirrhosis or hepatocellular carcinoma by biopsy or noninvasive testing (e.g. FibroScan and/or FibroTest) - Must agree to use two acceptable methods of birth control from at least 2 weeks prior to first dose and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations Exclusion Criteria: - Non-GT1 HCV infection, including a mixed GT infection (with a non-GT1) or a non-typeable genotype. - Documented to be Human Immunodeficiency Virus (HIV) positive or co-infected with hepatitis B virus - Hepatocellular carcinoma (HCC) or under evaluation for HCC - Participating in or has participated in a study with an investigational compound or device within 30 days of signing informed consent - Diabetic and/or hypertensive with clinically significant ocular examination findings - Current or history of central nervous system trauma, seizure disorder, stroke or transient ischemic attack - Chronic pulmonary disease - Current or history of any clinically significant cardiac abnormalities/dysfunction - Active clinical gout within the last year - History of gastric surgery or history of malabsorption disorders - Active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin) - Pregnant, lactating, expecting to conceive or donate eggs, or male participant planning to impregnate or provide sperm donation or with a female partner who is pregnant - Current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric disorders - Evidence or history of chronic hepatitis not caused by HCV ; PRIMARY OUTCOME: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point[/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/IIa - w/REGN2810 and INO-9012; BRIEF: Phase 1/2 trial to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with cemiplimab (REGN2810), with radiation and chemotherapy, in subjects with newly-diagnosed glioblastoma (GBM). ; DRUG USED: INO-5401; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Immune System, Prostate-specific Membrane Antigen (PSMA), Reverse Transcriptase, Wilms Tumor Protein 1 (WT1); THERAPY: Combination; LEAD SPONSOR: Inovio Pharmaceuticals; CRITERIA: Inclusion Criteria: - Newly-diagnosed brain cancer with histopathological diagnosis of GBM; - Karnofsky Performance Status (KPS) rating of >/=70 at baseline; - Receive dexamethasone equivalent dose </=2 mg per day, stable or decreased for >/= three days prior to Day 0; - Recovery from the effects of prior GBM surgery as defined by the Investigator; - Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator; - Adequate organ function as demonstrated by hematological, renal, hepatic laboratory assessments; - Agree that during the trial, men will not father a child, and women cannot be or become pregnant. Participants must be of non-child bearing potential or agree to use one highly effective or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period and at least through week 12 after last dose; - Ability to tolerate magnetic resonance imaging (MRI). Exclusion Criteria: - Presence of greater than 1 cm x 1 cm residual tumor enhancement on postoperative MRI; - Multifocal disease or leptomeningeal disease (LM) disease on post-operative MRI; - Not scheduled to start radiation within 42 days of surgical resection of tumor; - Dexamethasone equivalent dose >2 mg per day; - Prior treatment with an agent that blocks the PD-1/PD-Ligand 1 pathway; - Receipt of previous approved or investigative immune modulatory agent within 28 days of receiving the first dose of treatment; - Prior treatment with idelalisib; - Past, current or planned treatment with tumor treatment fields; oncolytic viral treatment; or prior exposure to an investigational agent or device within 28 days of receiving the first dose of treatment; - Allergy or hypersensitivity to cemiplimab or to any of its excipients; - History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments; - Ongoing or recent (within 5 years) evidence of autoimmune disease that required treatment with systemic immunosuppressive treatments; - Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose of trial treatment, other than dexamethasone for the underlying disease under investigation, as noted in the inclusion criteria; - History of clinically significant, medically unstable disease which, in the judgment of the investigator, would jeopardize the safety of the subject, interfere with trial assessments or endpoint evaluation, or otherwise impact the validity of the trial results. ; PRIMARY OUTCOME: Percentage of Participants with Adverse Events (AEs); SECONDARY OUTCOME 1: Overall survival at 18 months (OS18)[/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 - ASERTAA ; BRIEF: Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients. ; DRUG USED: Envarsus XR; DRUG CLASS: Non-NME; INDICATION: Kidney Transplant Rejection; TARGET: Calcineurin phosphatase ; THERAPY: Monotherapy; LEAD SPONSOR: Veloxis Pharmaceuticals; CRITERIA: Inclusion criteria: - Age ≥18-80 old, male or female - African Americans - Willing to give written informed consent and to comply with study visits and restrictions, including being able to speak, write and understand English - Pt who have received a primary or secondary transplant - Pt least 6 (six) mth post-transplant and on a stable dose of tacrolimus - BMI ≥19 - Pt who are sero-positive for Hepatitis B or C positive may also be enrolled - Pt maintained on concurrent immunosuppression with stable doses during screening - Pt on a proton PPI remain on the same PPI formulation and dose during the PK portion of the study. - During PK phase Only: Pt taking any medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit, and pomegranate products), or medications must continue the same dose and are willing to continue the same dose/routine - During PK phase Only: the patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food Exclusion Criteria: - Evidence of acute rejection episode within the past three months - Pt not Africa-American - Recipients of organ transplants other than kidney - Known to be HIV positive at transplant - Pt with recurrent focal segmental glomerulosclerosis (FSGS) - Pt with any severe medical condition (including infection) requiring acute or chronic treatment - Pt with a positive DSA - Pt with a positive BK virus results - GFR < 25 ml/min measured by MDRD4 as SOC within last 30 days - Patients with AST, ALT, total bilirubin > 2.5 x ULN or evidence of severe liver disease - Pt with WBC < to 2000/mm3 or ANC < to 1500 mm3 with PLT < 75,000/mm3 or HGB < 8 g/dl - Pt with mental or physical conditions or known non-adherence - Presence of intractable immunosuppressant complications of side effects resulting in dose adjustment of tacrolimus - Exposed to investigational therapy within 30 days prior to enrollment - No anticipated changes in the immunosuppressive regimen, other than those specified by the study protocol - Pt with severe diabetic gastroparesis or other severe GI disturbances - Pt who have underwent gastric banding or gastric bypass at any time pre or post-transplant - Pregnant or nursing (lactating) women, or planning to become pregnant - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC of method ; PRIMARY OUTCOME: Evaluation of AUC(0-24) for Envarsus XR and IR-Tac; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Pilot Study; BRIEF: Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of psoriasis ; DRUG USED: Photocil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Sunlight/UV Radiation; THERAPY: Monotherapy; LEAD SPONSOR: Applied Biology, Inc.; CRITERIA: Inclusion Criteria: - Diagnosed with psoriasis vulgaris confirmed by a dermatologist - Psoriasis lesions affecting at a minimum 5% of the facial, legs, or arms surface area - Age: 18 to 65 - Participants able to give informed consent Exclusion Criteria: - Subject did not respond to prior phototherapy treatment - Subject completed phototherapy for same lesion(s) in last 6 months - Subject has previous history of skin cancer - Subject has previous history of photosensitivity - Subject has a history of herpes (HSV I or II) outbreaks - Subject has previous history of autoimmune disease may be excluded at investigators discretion - Subject is currently taking of immunosuppressive or photosensitizing drugs - Subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. These patients may be excluded at investigators discretion - Subject is pregnant or lactating women ; PRIMARY OUTCOME: Percent Lesion Clearance; SECONDARY OUTCOME 1: [/INST]No</s>