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CT_efficiant

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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - PK/PD; BRIEF: The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the receptor for interleukin 6 (IL6R), is safe and effective after single or multiple administrations to patients with rheumatoid arthritis (RA). Patients will receive different single or multiple doses of either placebo or ALX-0061. ; DRUG USED: Vobarilizumab; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Ablynx, a Sanofi company; CRITERIA: Inclusion Criteria: - Body mass index (BMI) <35.0 kg/m2 - Diagnosed with rheumatoid arthritis (RA) according to the 2010 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria for at least 6 months prior to randomisation - Treatment with methotrexate (MTX) for at least 12 weeks prior to screening, with at least 4 weeks before screening at a stable dose, that will remain stable throughout the study period. Inadequate response or or intolerance to disease modifying antirheumatic drugs (DMARDs) (including MTX, where a patient may remain on treatment with %TX at a lower dose for improved tolerance, but with reduced effectiveness) - For patients (men and women) of reproductive potential, use of an acceptable method of contraception for the duration of the study. Female patients must be willing to use appropriate birth control measures that would prevent pregnancy starting from the time of signing the informed consent until 90 days after the last dose of study drug is administered - For single dose part: Disease Activity Score using 28 joint counts (DAS28) score >= 2.4 - For multiple dose part: DAS28 score >= 3.2 - For multiple dose part: swollen joint count >= 3 Exclusion Criteria: - A documented history of an autoimmune disease other than RA (other than secondary Sjögrens syndrome) - Functional class IV by ACR classification - Any new/additional biologic DMARD therapy, cytotoxic drugs and immunosuppressants within four weeks prior to screening, and between screening and Day 1 with the exception of ALX-0061 - Suspicion of active tuberculosis verified by quantiferon test and abnormal chest X-ray - Female patients who are pregnant during the study, or are breastfeeding - History of anaphylactic reactions to protein therapeutics - Participation in an investigational drug study within 60 days prior to drug administration except for the patients who participated in the single dose part of this study and who are eligible to participate in the multiple dose part - Donation of more than 300 mL of blood within 60 days prior to drug administration - Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for non-melanoma skin cancer or resected carcinoma in situ - Any current or recent (within 4 weeks prior to first dose) signs or symptoms of infection that requires parenteral antibiotic administration, any known active viral infection (hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]) that would impair the participation in the study - Major surgery (including joint surgery) within 8 weeks prior to screening and hospitalisation for a clinically relevant event within the 4 weeks prior to screening - Any other disease, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications - Administration of a live, attenuated vaccine within 1 month before dosing with ALX-0061, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose - For multiple dose part: contraindication to MRIs or the use of contrast agents for MRI scanning ; PRIMARY OUTCOME: Safety: number of treatment emergent adverse events (TEAEs); SECONDARY OUTCOME 1: Pharmacokinetics (PK): serum concentration of ALX-0061[/INST]No</s>
<s>[INST]<<SYS>>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 - 302 (Adjunctive); BRIEF: The studys purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD) ; DRUG USED: Troriluzole; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obsessive-Compulsive Disorder (OCD); TARGET: Glutamine; THERAPY: Monotherapy; LEAD SPONSOR: Biohaven Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subjects illness must be ≥ 1 year 2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject 3. Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed Exclusion Criteria: 1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD. 2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourettes disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results 3. Previous treatment in a study with troriluzole ; PRIMARY OUTCOME: The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS); SECONDARY OUTCOME 1: Frequency of SAEs and AEs leading to discontinuation[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Study 418; BRIEF: The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures, body weight and compare with the respective placebo groups.This study also assess the change from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset). ; DRUG USED: Bexagliflozin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Theracos; CRITERIA: Inclusion Criteria: - Male or female subjects ≥18 years old - Diagnosed with type 2 diabetes - Body mass index (BMI) ≤ 45 kg/m2 - HbA1c between 7 and 10% (inclusive) at screening - FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies - Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent - If taking anti-diabetic medication, dose and regimen must be stable for past 3 months - If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months - If taking lipid modifying therapy, dose and regimen must be stable for past 3 months - Blood glucose <250 mg/dL based on finger stick blood glucose for all subjects at randomization Exclusion Criteria: - Hemoglobinopathy that affects HbA1c measurement - Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor based therapy) - Genitourinary tract infection within 6 weeks of screening - Greater than 2 episodes of genitourinary tract infection in the past year - History of kidney stones, bladder malfunction or other significant risk factor for urinary tract infections - eGFR, as calculated by the modification of diet in renal disease study equation (MDRD), < 50 mL/min/1.73 m2 - Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULN - Diagnosis of retinopathy or significant nephropathy (eGFR < 50 mL/min/1.73 m2 - Uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >95) - Not willing to use effective birth control, if female with child-bearing potential - Life expectancy < 2 years - New York Heart Association (NYHA) Class 4 heart failure - Sera positive of HCV, HIV, or positive on drug screen - Currently participating in another interventional trial - Previous treatment with EGT0001442 or EGT0001474 - Not able to comply with the study scheduled visits ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c at 24 Weeks; SECONDARY OUTCOME 1: Changes in Systolic and Diastolic Blood Pressure at Week 24[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - R/R SCLC; BRIEF: A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose. ; DRUG USED: AMG 119; DRUG CLASS: Biologic; INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Delta-like 3 (DLL3), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subject has provided informed consent prior to initiation of any study-specific activities/procedures; - Age ≥ 18 years old at the time of signing the informed consent - Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen: - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor - Subjects with treated brain metastases are eligible provided they meet the following criteria: - - Definitive therapy was completed at least 2 weeks prior to enrollment. - - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor. - - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days. - Adequate organ function - Other inclusion criteria may apply Exclusion Criteria: - History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma. - History of organ transplant. - Major surgery within 28 days of enrollment. - Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment. - History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment. - Untreated or symptomatic brain metastases and leptomeningeal disease - Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. - Known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine). - Evidence of a bleeding diathesis. - Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. ≥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed. - Prior anti-cancer therapy as specified below: At least 21 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy with the exception of subjects who received AMG 119 in this study and are eligible for retreatment. - Primary immunodeficiency - History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment - Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen - Received live vaccine within 28 days prior to enrollment - Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B - Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C - History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion - Other exclusion criteria may apply ; PRIMARY OUTCOME: Incidence of dose limiting toxicities (DLTs); SECONDARY OUTCOME 1: Objective Response (OR)[/INST]No</s>
<s>[INST]<<SYS>>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 - SOLSTICE; BRIEF: This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately 525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.) All subjects will continue to receive the local standard of care for the duration of the study. ; DRUG USED: Losmapimod; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: p38 MAP kinase (MAPK); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects with a NSTEMI, defined as: symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, with most recent symptoms occurring within the 24 hours prior to presentation, without persistent ST-segment elevation on admission 12-lead ECG, and with Troponin (T or I) above the upper limit of normal (ULN) for the local institution within 18 hours of presentation. - Subject able to be randomized within 18 hours of presentation. - Subjects to be managed with an early invasive strategy, with PCI likely to occur at least 2 hours after the start of dosing [subjects who do not undergo PCI will not be withdrawn from the study]. - Male or female subject who is 45 years of age or older. - A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory), or child-bearing potential and agrees to use one of the contraception methods listed in the protocol for the duration of dosing and until the first follow-up visit (approximately 2 weeks post last-dose). - Negative urine or serum pregnancy test (in women of child-bearing potential only). - Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the first follow-up visit (approximately 2 weeks post last-dose). - QTcB or QTcF greater than 530 msec. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: - History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction [ejection fraction less than 30%] regardless of symptomatic status. - Suspected aortic dissection. - Severe aortic stenosis or other severe valvular disease. - Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study. - Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic or acute inflammation (e.g. inflammatory bowel disease, osteomyelitis, pneumonia, etc.). Intermittent conditions treated with short-term oral antibiotics (e.g. typical URI) or conditions that are not currently exacerbated (e.g. gout with no current flair) may be included. - History of myopathy or rhabdomyolysis. - Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - Known to be Hepatitis B or Hepatitis C positive. - Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal and topical steroids are allowed. A single prophylactic dose of systemic steroid is allowed at time of PCI for subjects with contrast allergy. - Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g. daunorubicin, doxorubicin, topotecan, mitoxantrone). - Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have been resected or ablated for cure are not exclusionary.. - Known alcohol or drug abuse within the past 6 months. - Previous exposure to GW856553. - Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of IP in the current study. - Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication non-compliance). - Unwillingness or inability to follow the procedures outlined in the protocol. - Previous MI or coronary artery bypass graft (CABG) surgery. - History of kidney transplant or a history of contrast nephropathy. - Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but is not limited to: intracranial aneurysm clips or other metallic objects; history of intra-orbital metal fragments that have not been removed by an MD; pacemakers and non-MR compatible heart valves; inner ear implants; history of claustrophobia in MR. - Allergy to MRI contrast enhancement agent (gadolinium). - Estimated creatinine clearance by Cockcroft-Gault formula < 30 mL/min. ; PRIMARY OUTCOME: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs); SECONDARY OUTCOME 1: Mean hsCRP Over Hospitalization Period and Through Week 14[/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 ; BRIEF: The purpose of this study is to evaluate the safety and efficacy of NIC5-15 in the treatment of Alzheimers Disease. ; DRUG USED: NIC5-15; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); TARGET: Gamma-secretase; THERAPY: Monotherapy; LEAD SPONSOR: Humanetics Corporation; CRITERIA: Inclusion Criteria: - NINCDS/ADRDA criteria for probable AD - MMSE between 12-27 - Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist with stable dose for at least 12 weeks - Home monitoring available for supervision of medications - Caregiver available to accompany patient to all visits and willing to participate in study as informant - Fluent in English or Spanish - Medical stability for this study as confirmed by review of records, internists physical exam, neurological exam, and laboratory tests - Stable doses of non-excluded medication - No evidence of hepatic insufficiency - Able to swallow oral medications - Ability to participate in the informed consent process Exclusion Criteria: - History of Diabetes Mellitus (OGTT criteria) requiring treatment with an excluded antidiabetic medication (see below) or history of hypoglycemia - Active hepatic or renal disease - Cardiac disease including history of congestive heart failure or current treatment for CHF; history of recent myocardial infarction - Use of another investigational drug within the past two months - History of clinically significant stroke - History of seizure or head trauma with disturbance of consciousness within the past two years - Major mental illness including psychotic disorders, bipolar disorder, or major depressive episode within the past two years Medication Exclusion - Current use of oral hypoglycemic agents including sulfonylureas and meglintinides - Current or past treatment with insulin for longer than two weeks - Current use of drugs with significant anticholinergic or antihistaminic properties ; PRIMARY OUTCOME: Change in Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score; SECONDARY OUTCOME 1: Change in Alzheimers Disease Cooperative Study Clinicians Global Impression of Change (ADCS-CCGIC) Score[/INST]No</s>
<s>[INST]<<SYS>>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 - 3587 - BEGIN (ONCE); BRIEF: This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes. ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months - Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days) - Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose - HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis - BMI (Body Mass Index) below or equal to 40.0 kg/m^2 Exclusion Criteria: - Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening) - Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors - Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty - Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigators opinion could interfere with the results of the trial - Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period - Known or suspected hypersensitivity to trial product(s) or related products ; PRIMARY OUTCOME: Change From Baseline in HbA1c (%) (Analysed by Central Laboratory); SECONDARY OUTCOME 1: Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes[/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; BRIEF: This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension. ; DRUG USED: Orenitram; DRUG CLASS: Non-NME; INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Combination; LEAD SPONSOR: United Therapeutics; CRITERIA: Subject Inclusion Criteria: 1. Voluntarily gave informed consent to participate in the study. 2. Are 18 to 75 years of age (inclusive) at Screening. 3. Women of childbearing potential must practice abstinence from intercourse when in line with their preferred and usual lifestyle, or use 2 different forms of highly effective contraception for the duration of the study, and for at least 30 days after discontinuing study medication. A negative urine pregnancy test is required at Screening and Baseline prior to initiating study medication. 4. Male subjects must consent to use a condom during intercourse for the duration of the study, and for at least 48 hours after discontinuing study medication. 5. Have a diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with HIV infection, PAH associated with repaired congenital systemic-to-pulmonary shunt, or PAH associated with appetite suppressant or toxin use. 6. If known to be positive for HIV infection, have a CD4 lymphocyte count of at least 200 cells/mm^3 assessed at Screening and are receiving current standard of care anti retroviral or other effective medication for the treatment of HIV infection. 7. Have a baseline 6MWD greater than or equal to 150 m in the absence of a concurrent injury, illness, or other confounding factor including, but not limited to, use of an aid for ambulation or connection to a nonportable machine, that would have prevented the accurate assessment of the subjects exercise capacity. 8. Are optimally treated with conventional pulmonary hypertension therapy with no additions, discontinuations, or dose changes for a minimum of 10 days prior to randomization. The exceptions are the discontinuation or dose changes of anticoagulants and/or dose change of diuretics. 9. Are receiving a PAH-approved oral monotherapy at a minimum dose that complies with the approved prescribing information for the product for at least 30 days prior to randomization and are receiving a stable dose for at least 10 days prior to randomization. 10. Have had previously undergone a cardiac catheterization within 3 years prior to the start of Screening or during the Screening Period, and the most recent assessment documented a pulmonary artery pressure mean of at least 25 mmHg, a pulmonary capillary wedge pressure (PCWP) (or in the event a PCWP could not be reliably obtained, a left ventricular end diastolic pressure [LVEDP]) less than or equal to 15 mmHg, and absence of unrepaired congenital heart disease (other than patent foramen ovale). If a reliable PCWP or LVEDP are unable to be obtained during cardiac catheterization, subjects with clinically normal left heart function and absence of clinically relevant mitral valve disease on echocardiography are eligible for enrollment. 11. Undergo echocardiography with evidence of clinically normal systolic and diastolic left ventricular function and absence of any clinically significant left sided heart disease (eg, mitral valve disease). Subjects with clinically insignificant left ventricular diastolic dysfunction due to the effects of right ventricular overload (ie, right ventricular hypertrophy and/or dilatation) are eligible. 12. Have a previous ventilation perfusion lung scan, high-resolution computerized tomography scan of the chest, and/or pulmonary angiography that are consistent with the diagnosis of PAH. 13. Have pulmonary function tests conducted within 6 months before Screening or during the Screening Period to confirm the following: 1. Total lung capacity is at least 60% 2. Forced expiratory volume at 1 second is at least 50% 14. In the opinion of the Principal Investigator, is able to communicate effectively with study personnel and is considered reliable, willing, and likely to cooperate with protocol requirements, including attending all study visits. Subject Exclusion Criteria: 1. Is pregnant or lactating. 2. Have previously received oral treprostinil. 3. Have received a PGI2 (except if used during acute vasoreactivity testing) within 30 days prior to randomization or have previous intolerance or significant lack of efficacy to any PGI2 or PGI2 analogue that resulted in discontinuation or inability to titrate that therapy effectively. 4. Have any background conventional therapies for PAH added, removed, or dose-adjusted within 10 days prior to randomization. The exceptions are removal or dose adjustments of anticoagulants and/or dose adjustments of diuretics. 5. Receive their first dose of a PAH-approved oral monotherapy less than 30 days prior to randomization, or have their PAH-approved oral monotherapy dose changed within 10 days prior to randomization, or the subject discontinues any PAH approved therapy within 30 days prior to Screening, or the subject has previously received 2 PAH approved oral therapies at the same time (specifically, a PDE5-I, an ERA, or a sGC stimulator) concomitantly for more than 90 days cumulatively. 6. Have any disease associated with PAH other than CTD, HIV infection, repaired (for at least 1 year) congenital systemic-to-pulmonary shunt, PAH associated with appetite suppressant/toxin use, or have an atrial septostomy. 7. Have a current diagnosis of uncontrolled sleep apnea as defined by their physician. 8. Have a history of ischemic heart disease, including a previous myocardial infarction or symptomatic coronary artery disease within 6 months prior to Screening or a history of left-sided myocardial disease as evidenced by a mean PCWP (or a LVEDP) greater than 15 mmHg or left ventricular ejection fraction less than 40% as assessed by either multigated angiogram, angiography, or echocardiography. 9. Have uncontrolled systemic hypertension as evidenced by systolic blood pressure (BP) greater than 160 mmHg or diastolic BP greater than 100 mmHg. 10. Have alanine aminotransferase or aspartate aminotransferase levels at least 3 times greater than the upper limit of normal, clinically significant liver disease/dysfunction, or known Child-Pugh Class C hepatic disease at Screening. 11. Have any other disease or condition that would interfere with the interpretation of study assessments. 12. Have a musculoskeletal disorder, is using a device to assist walking, or any disease that is likely to limit ambulation, or is connected to a machine that is nonportable. 13. Have an unstable psychiatric condition or is mentally incapable of understanding the objectives, nature, or consequences of the study, or has any condition which in the Investigators opinion would constitute an unacceptable risk to the subjects safety. 14. Is receiving an investigational drug, have an investigational device in place, or have participated in an investigational drug or device study within 30 days prior to Screening. 15. Have chronic renal insufficiency as defined by either a Screening creatinine value greater than 2.5 mg/dL or the requirement for dialysis. 16. Does not have 3 or more of the following left ventricular disease/dysfunction risk factors: 1. Body mass index at least 30 kg/m^2 2. History of essential hypertension 3. Diabetes mellitus (any type) 4. Historical evidence of significant coronary artery disease established by any 1 of the following: history of myocardial infarction, percutaneous coronary intervention, or angiographic evidence of coronary artery disease; positive stress test with imaging; previous coronary artery bypass graft; or stable angina. ; PRIMARY OUTCOME: Time to First Clinical Worsening Event; SECONDARY OUTCOME 1: Change in 6-Minute Walk Distance[/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 - VIDI; BRIEF: The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with diabetic macular edema (DME). This study will evaluate the percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3. ; DRUG USED: ASP8232; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Macular Edema (Ophthalmology); TARGET: Unknown; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Astellas Pharma Europe B.V.; CRITERIA: Inclusion Criteria: - Subject must have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% at Screening - Subject has definite retinal thickening due to diffuse diabetic macular edema (DME) involving the central macula based on evaluating investigators clinical evaluation and demonstrated by spectral domain-optical coherence tomography (SD-OCT) - Subject has central subfield thickness (CST) of at least 375 μm by SD-OCT with presence of intraretinal and/or subretinal fluid at screening visit and at the randomization visit - Subject has early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit Exclusion Criteria: - Subjects study eye has macular edema considered to be due to a cause other than DME - Subjects study eye has a decrease in BCVA due to causes other than DME that is likely to be decreasing BCVA by 3 lines or more - Subjects study eye has significant macular ischemia as shown on angiography - Subjects study eye has any other ocular disease that may cause substantial reduction in BCVA - Subject has active peri-ocular or ocular infection - Subjects study eye has a history of non-infectious uveitis - Subjects study eye has high myopia (-8 diopter or more correction) - Subjects study eye has a history of prior pars plana vitrectomy - Subjects study eye has a history of any ocular surgery within 3 months prior to Day 1 - Subjects study eye has a history of YAG capsulotomy within 3 months prior to Day 1 - Subjects study eye has a history of panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study through the Week 12 visit - Subjects study eye has a history of prior IVT, subtenon, or periocular, non-sustained release, steroid therapy within 3 months prior to Day 1 - Subjects study eye has a history of intravitreal sustained release dexamethasone therapy within 6 months prior to Day 1. - Subjects study eye has a history of intravitreal sustained release fluocinolone within 3 years prior to Day 1. - Subjects study eye has a history of prior treatment for DME with IVT anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1 - Subject has a history of prior treatment with any other (than previously listed) approved treatment which is not labeled for DME within 1 year prior to Day 1 - Subjects study eye has high-risk proliferative diabetic retinopathy (PDR) - Subject has uncontrolled glaucoma - Subject has media clarity, papillary constriction (i.e., senile miosis), or subject lacks cooperation that would interfere with any study procedures, evaluations or interpretation of data ; PRIMARY OUTCOME: Percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence tomography (SD-OCT) at Month 3; SECONDARY OUTCOME 1: Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - M10-467; BRIEF: This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term. ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Hidradenitis Suppurativa; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Abbott; CRITERIA: Inclusion Criteria: - Adults with stable, moderate to severe hidradenitis suppurativa - Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy. - Ability to administer subcutaneous injections - General good health otherwise Exclusion Criteria: - Prior anti-TNF therapy - Unstable antibiotic therapy for HS - Required medication washouts for other HS treatments - Prior exposure to Tysabri® (natalizumab); - Recent infection requiring treatment - Significant medical events or conditions that may put patients at risk for participation - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study; - History of cancer, except successfully treated skin cancer - Recent history of drug or alcohol abuse ; PRIMARY OUTCOME: Percentage of Participants Achieving Clinical Response at Week 16; SECONDARY OUTCOME 1: Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIb/III - MAB-N007; BRIEF: Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23. ; DRUG USED: Pagibaximab; DRUG CLASS: Biologic; INDICATION: Staphylococcal Vaccines and Other Staphylococcus-Specific Agents (Antibacterial); TARGET: Bacteria-miscellaneous, Staphylococcus, Streptococcus pneumoniae / Pneumococcus; THERAPY: Monotherapy; LEAD SPONSOR: Biosynexus Incorporated; CRITERIA: Inclusion Criteria: 1. In-patient at a Neonatal Intensive Care Unit (NICU) 2. Informed consent obtained from the legally authorized representative 3. Less than 48 hours old at the time of first infusion 4. Birth weight between 600 grams and 1200 grams 5. Estimated gestation age ≤33 weeks For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group. Exclusion Criteria: 1. Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation. 2. Infants with proven staphylococcal infection prior to randomization. 3. Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk. 4. Immunodeficiency other than due to prematurity. 5. Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study. 6. Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study 7. Uncontrolled seizures ; PRIMARY OUTCOME: The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.; 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 - 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 III - STEP 5; BRIEF: This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking dummy medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or dummy medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age more than or equal to 18 years at the time of signing informed consent - Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease - History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion criteria: - HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening - A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records ; PRIMARY OUTCOME: Percentage Change From Baseline (Week 0) to Week 104 in Body Weight; SECONDARY OUTCOME 1: Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Subjects; BRIEF: This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort. ; DRUG USED: XC130; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine Receptor - Unspecified; THERAPY: Monotherapy; LEAD SPONSOR: Xoc Pharmaceuticals; CRITERIA: Major Inclusion Criteria: - Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age. - Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening. - Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs. - Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol. Major Exclusion Criteria: - Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study. - History or presence of clinically significant medical, surgical or psychiatric condition or disease. - History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study. - History of clinically significant hypotension. - History of orthostatic hypotension in the 12 months prior to screening. - Clinically significant hypertension at screening. - History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse. ; PRIMARY OUTCOME: Incidence and severity of Adverse Events; SECONDARY OUTCOME 1: Maximum plasma concentration [Cmax] of XC13-A10H[/INST]No</s>
<s>[INST]<<SYS>>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 - PDIT; BRIEF: Ryanodex is being investigated as a potential adjuvant treatment for people suffering from psychostimulant drug-induced toxicity (PDIT), a life-threatening medical condition that results mainly from the abuse of certain illicit drugs, most notably methamphetamine, and related forms (MDMC or Molly; MDMA or Ecstasy). Ryanodex is approved for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for prevention of malignant hyperthermia in patients at high risk and in this study, will be investigated for the treatment of PDIT. The hypothesis of this study is that administration of Ryanodex as adjuvant treatment to Standard of Care (SOC) will improve the clinical outcome compared with SOC alone, in subjects with psychostimulant drug induced toxicity. Current SOC is defined as body cooling and supportive measures. ; DRUG USED: Ryanodex; DRUG CLASS: Non-NME; INDICATION: Substance Use Disorder; TARGET: Ryanodine Receptor (RyRs); THERAPY: Monotherapy; LEAD SPONSOR: Eagle Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Male and non-pregnant subjects diagnosed with psychostimulant drug induced toxicity as evidenced by all of the following: core body temperature of greater than or equal to 39.5 degrees C; organ dysfunction, as evidenced by a Logistic Organ Dysfunction System score of greater than or equal to 6 (In the event of any delay in obtaining the results for baseline LODS score determination, subject may be enrolled. After enrollment, if the pending baseline LODS score turns out to be less than 6, the subject will be withdrawn from the study and replaced); known or suspected us of a psychostimulant drug in the judgment of the Investigator; negative blood pregnancy test for females (in the event of any delay in obtaining pregnancy test result, subject may be enrolled and randomized if all of the other eligibility criteria are met). Exclusion Criteria: Diagnosed with or is suspected to have an acute, clinically severe infection, which may, in the opinion of the Investigator, may increase the subjects risk for participating in the study an/or may impair the ability of performing and/or interpreting study assessments; severe hyperthermia secondary to a condition other than a psychostimulant drug-induced toxicity; likelihood of head trauma in the past 3 months, or other systemic disease that might increase the subjects risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments; positive pregnancy test or evidence of active lactation; known history of allergy or hypersensitivity to dantrolene; known history of seizure disorders or epilepsy; current or prior use (within the past 2 weeks) of calcium channel blockers. - ; PRIMARY OUTCOME: Proportion of Subjects Who Achieved a Logistic Organ Dysfuction System (LODS) Total Score Less Than or Equal to 5; SECONDARY OUTCOME 1: Proportion of Subjects Who Achieved a LODS Total Score Less Than or Equal to 5 at Other Planned Time Points.[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - LAL-CL06; BRIEF: This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D). ; DRUG USED: Kanuma; DRUG CLASS: Biologic; INDICATION: Lysosomal Acid Lipase Deficiency ; TARGET: Cholesterol/Cholesteryl Ester, Triglycerides; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: 1. Participant was >8 months of age at the time of dosing. 2. Confirmation of LAL-D diagnosis as determined by the central laboratory or, for participants with prior hematopoietic stem cell transplant or liver transplant, historical enzyme activity or molecular genetic testing confirming a diagnosis of LAL-D. 3. Participants >8 months but <4 years of age at Screening had at least 1 of the following documented clinical manifestations of LAL-D: - Dyslipidemia - Elevated transaminases - Impaired growth - Suspected malabsorption - Other clinical manifestation of LAL-D 4. Participants ≥4 years of age at Screening had at least 1 of the following documented clinical manifestations of LAL-D: - Evidence of advanced liver disease - Histologically confirmed disease recurrence in participants with past liver or hematopoietic transplant - Persistent dyslipidemia - Suspected malabsorption - Other clinical manifestation of LAL-D Key Exclusion Criteria: 1. Participant had known causes of active liver disease other than LAL-D, which had not been adequately treated. 2. Participant received a hematopoietic stem cell or liver transplant <2 years from the time of dosing. 3. Participant with co-morbidities other than complications due to LAL-D, which were irreversible or associated with a high mortality risk within 6 months or would interfere with study compliance or data interpretation. ; PRIMARY OUTCOME: Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percent Change In Serum Lipids From Baseline To Week 144[/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 Pts - 12710A; BRIEF: Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD). ; DRUG USED: Trintellix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Serotonin 5-HT1A receptor, Serotonin 5-HT1B receptor , Serotonin 5-HT1D receptor , Serotonin 5-HT3 receptor, Serotonin 5-HT7 receptor, Serotonin Reuptake; THERAPY: Monotherapy; LEAD SPONSOR: H. Lundbeck A/S; CRITERIA: Inclusion Criteria: - The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study). - The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™. - The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline. - The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline - The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form. Exclusion Criteria: - The patient has participated in a clinical study <30 days prior to the Screening Visit. Other protocol defined inclusion and exclusion criteria may apply ; PRIMARY OUTCOME: Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment; SECONDARY OUTCOME 1: Change in CDRS-R Total Score During Treatment (at Week 2)[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - HoFH; BRIEF: The goal of this trial is to study the effects of AEGR-733 on LDL cholesterol, other lipids as well as measures of safety over the long-term. ; DRUG USED: Juxtapid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Microsomal Triglyceride Transfer Protein (MTP); THERAPY: Monotherapy; LEAD SPONSOR: Aegerion Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Males and females at least 18 years of age 2. Diagnosis of functional homozygous FH by at least one (a-c) of the following clinical criteria: - documented functional mutation(s) in both LDL receptor alleles or alleles known to affect LDL receptor functionality OR - skin fibroblast LDL receptor activity less than 20% normal OR - untreated TC greater than 500 mg/dL AND TG less then 300 mg/dL AND both parents have documented TC greater than 250 mg/dL 3. Concurrent lipid lowering medication/apheresis must be stable for at least 6 weeks before the baseline visit and must remain stable for the first 26 weeks. 4. Body weight at least 40 kg and less than 136 kg 5. Negative screening pregnancy test if female of child-bearing potential (females of child-bearing potential and all males must be following a medically accepted form of contraception) 6. Subjects must be willing to comply with all study-related procedures Exclusion Criteria: 1. Uncontrolled hypertension 2. History of chronic renal insufficiency 3. History of biopsy proven cirrhosis or abnormal LFTs at screening (AST or ALT greater than 2 x upper limit of normal and/or Total Bilirubin greater than or equal to 1.5 mg/dl unless patient has unconjugated hyperbilirubinemia due to Gilberts syndrome) 4. Chronic hepatitis B or chronic hepatitis C 5. Any major surgical procedure occurring less than 3 months prior to the screening visit 6. Cardiac insufficiency defined by the NYHA classification as functional Class III or Class IV 7. Previous organ transplantation 8. History of a non-skin malignancy within the previous 3 years 9. Male subjects reporting more than 2 drinks per day or females reporting more than 1 drink per day (1 drink= 12 oz beer, 1 oz hard liquor, 5 oz wine). 10. Participation in an investigational drug study within 6 weeks prior to the screening visit 11. Known significant gastrointestinal bowel disease or malabsorption such as inflammatory bowel disease or chronic pancreatitis requiring use of daily pancreatic enzymes. 12. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subjects safety or successful participation in the study. 13. Certain prohibited medications known to be potentially hepatotoxic, especially those that can induce microvesicular or macrovesicular steatosis. These include but are not limited to: accutane, amiodarone, heavy acetaminophen use (4g/day greater than 3 x q week), methotrexate, tetracyclines,and tamoxifen 14. Documented diagnosis of any of the following pulmonary conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis 15. Documented diagnosis of any of the following liver diseases: Nonalcoholic Steatohepatitis, Alcoholic liver disease, Autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilsons disease, hemochromatosis, alpha 1 anti-trypsin deficiency. 16. Current use of corticosteroids or betaine ; PRIMARY OUTCOME: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C); SECONDARY OUTCOME 1: Percent Change From Baseline in Total Cholesterol (TC)[/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 - FSV5-002 Ext.; BRIEF: This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months. ; DRUG USED: Helios; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Prostaglandin F receptor (FP)/PGF2 alpha receptor ; THERAPY: Monotherapy; LEAD SPONSOR: ForSight Vision5, Inc.; CRITERIA: Inclusion Criteria: 1. Completed FSV5-002 study. 2. Written informed consent prior to any study procedure. 3. Willingness to comply with the visit schedule. Exclusion Criteria: 1. Participation in an investigational drug or device study other than FSV5-002 within the past 6 months or anticipated participation during the study period. 2. Subjects who will require contact lens use during the study period. 3. Any condition or situation (such as uncontrolled systemic disease) that, in the Investigators opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subjects ability to participate in the study. ; PRIMARY OUTCOME: Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity; SECONDARY OUTCOME 1: Change From Baseline in Mean Intraocular Pressure (IOP)[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Daily rhGH; BRIEF: This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH. ; DRUG USED: Albutropin; DRUG CLASS: Biologic; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth hormone receptor (GHR); THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - males and females 18 years of age or over - diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection - treated with a stable dose of daily rhGH for at least 3 months prior to screening - stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening - Other criteria apply, please contact the investigator for more information Exclusion Criteria: - patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator - Presence of contraindications to rhGH treatment - patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening - patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year - patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening - presence of Prader-Willi syndrome, Turners syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushings syndrome in the past year. - patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8% - patients using weight reducing agents or appetite suppressants - Other criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: Percentage of participants with adverse events; SECONDARY OUTCOME 1: Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/ E/C/F/TAF vs. F/R/TAF; BRIEF: This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected participants. ; DRUG USED: Harvoni; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female individuals, without cirrhosis, treatment-naive or treatment-experienced with interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI). - Compensated cirrhotic individuals must be HCV treatment-naive. - No prior treatments with NS5A and NS5B or any HCV direct acting antivirals, except boceprevir, telaprevir and simeprevir, in combination with IFN and RBV - Currently on an ARV regimen (2 NRTI + a third agent) without change for 6 months prior to screening. - Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values (blips) of HIV-1 RNA ≥ 50 copies/mL followed by resuppression is allowed. - For individuals with 3 or more prior ARV regimens, a regimen history should be provided for approval by the Sponsor. - Note: Individuals that changed from TDF to TAF less than 6 months ago will be eligible as long as the TDF/ TAF change was the only change to the regimen. - Plasma HIV-1 RNA level < 50 copies/mL at the screening visit - Have no documented resistance to any of the HIV study agents at time in the past, including but not limited to the reverse transcriptase resistance mutations K65R, K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L, the combination of K103N+L100I, or 3 or more thymidine analog associated mutations (TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). If a historical genotype prior to first ARV is not available or individual had 3 or more prior ARV regimens, individual will have proviral genotype analysis for archived resistance prior to Day 1. - No history of HIV virologic failure - No evidence of Hepatitis B infection - Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min as estimated by Cockcroft-Gault formula Note: Other protocol defined Inclusion/ Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - KEYNOTE-002 (vs. Chemotherapy); BRIEF: This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after prior therapy. Initial Treatment Period: Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab, higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an open-label fashion. The starting pembrolizumab dose was initially blinded to Investigators and participants until Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of pembrolizumab. Switch-to-Pembrolizumab Treatment Period: Participants who were initially randomized to receive ICC and experienced progressive disease (PD) may have been eligible to switch to receiving pembrolizumab provided they met protocol-specified requirements for switching. Qualified participants were re-randomized to receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03, all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy - Participants must be refractory to ipilimumab - Participants with BRAF gene mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF gene and/or mitogen-activated protein kinase (MEK) protein inhibitor - Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy specimen (or specimen obtained within 60 days of consenting) - Radiographically measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks earlier - Disease progression within 24 weeks of last dose of ipilimumab - Participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug - Expected to require any other form of systemic or localized antineoplastic therapy while on study - Chronic systemic steroid therapy within 2 weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication - Known history of any other than the current malignancy excepting adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, breast cancer, or other in situ cancers - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active autoimmune disease or a history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents - Prior treatment with any other anti-programmed cell death (PD) agent - Active infection requiring systemic therapy - Known history of Human Immunodeficiency Virus (HIV) - Active Hepatitis B or Hepatitis C - Regular user (including recreational use of) illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) - Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study through 120 days after last dose of study drug ; PRIMARY OUTCOME: Progression-free Survival (PFS) - Initial Treatment Period; SECONDARY OUTCOME 1: Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I/II - MM-002 - w/Dex; BRIEF: The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for patients with relapsed and refractory multiple myeloma ; DRUG USED: Pomalyst; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Celgene Corporation; CRITERIA: Inclusion Criteria: - Must be greater than or equal to 18 years at the time of signing the informed consent form - Must be able to adhere to the study visit schedule and other protocol requirements - Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease. Patients must have received at least 2 prior therapies. Patients must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed PD. Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease) - Patients must have also undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen) - Measurable levels of myeloma paraprotein in serum (greater than or equal to 0.5 g/dL) or urine (greater than or equal 0.2 g/dL excreted in a 24 hour collection sample) - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 - Females of childbearing potential (FCBP) [An FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months)] must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 28 days after discontinuation of study drug and must agree to regular pregnancy testing during this timeframe. - All patients must also agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study - Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study even if he has undergone a successful vasectomy. Males must also agree to refrain from donating blood, semen or sperm during the above referenced timeframe. - All patients must agree not to share medication with another person. Exclusion Criteria: - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form. - Any serious concurrent medical conditions that may make the patient non-evaluable or put the patients safety at risk. - Pregnant or lactating females - Any of the following laboratory abnormalities: - Absolute neutrophil count (ANC) < 1,000 cells/mm3 - Platelet count < 75,000/mm3 for patients in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/mm3 for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells - Serum creatinine > 3.0 mg/dL - Serum glutamic oxaloacetic transaminase/Aspartate transaminase (SGOT/AST) or Serum Glutamic Pyruvate Transaminase/Alanine transaminase (SGPT/ALT) > 3.0 X upper limit of normal (ULN) - Serum total bilirubin > 2.0 mg/dL - Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following: - Basal or squamous cell carcinoma of the skin - Carcinoma in situ of the cervix or breast - Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b) - Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection - Hypersensitivity to thalidomide, lenalidomide, or dexamethasone - Peripheral neuropathy ≥ Grade 2 - Use of any anti-myeloma drug therapy within 14 days of the initiation of study drug treatment or use of any experimental non-drug therapy within 28 days of the initiation of study drug treatment - Radiation therapy within 14 days of initiation of study drug treatment Inability or unwillingness to comply with birth control requirements ; PRIMARY OUTCOME: Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1; SECONDARY OUTCOME 1: Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off[/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 - Study 0110; BRIEF: A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function. ; DRUG USED: Oxbryta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: Hemoglobin; THERAPY: Monotherapy; LEAD SPONSOR: Global Blood Therapeutics; CRITERIA: Inclusion Criteria: All subjects: - Males or females, 18 to 80 years old - Willing and able to give written informed consent Subjects with renal impairment: - Severe renal impairment (eGFR < 30 mL/min/1.73m2, not on dialysis) - Moderate renal impairment (30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2) - Mild renal impairment (60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2) Healthy subjects: - Match in age, gender and body mass index with renal impaired subjects - Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history Exclusion Criteria: All subjects: - Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device) - Any signs or symptoms of acute illness at screening or Day -1 - History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease Subjects with renal impairment: - History of clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (ALT, AST, GGT and total bilirubin) > 5 times the upper limit of normal within the past year ; PRIMARY OUTCOME: Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function; SECONDARY OUTCOME 1: Number of subjects with treatment-related Adverse events[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SOLO-Continue; BRIEF: The primary objective of the study was to assess the ability of different Dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with Dupilumab monotherapy compared to placebo. ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Regeneron Pharmaceuticals; CRITERIA: Key Inclusion Criteria: 1. Must have completed the treatment phase in 1 of the two 16-week initial treatment studies (R668-AD-1334 or R668-AD-1416). 2. Must have achieved at least 1 of the following 2 treatment success criteria: Investigator Global Assessment (IGA) = 0 or 1 (clear or almost clear) at week 16 OR Eczema Area and Severity Index >= 75% (EASI-75) (at least 75% reduction in EASI score from baseline to week 16) 3. Must be willing and able to comply with clinic visits and study-related procedures 4. Must provide signed informed consent 5. Must be able to understand and complete study-related questionnaires Key Exclusion Criteria: 1. Receipt of rescue medication for AD in the initial treatment study 2. Any conditions that require permanent discontinuation of study treatment in either initial treatment study 3. Planned or anticipated major surgical procedure during the participantss participation in this study 4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during this study 5. Women unwilling to use adequate birth control, if of reproductive potential* and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception, whenever engaging in heterosexual intercourse, throughout the duration of the study and for 120 days after last dose of study drug. These include hormonal contraceptives, intrauterine device, or double barrier contraception (e.g, condom + diaphragm), or a male partner with documented vasectomy. Additional requirements for acceptable contraception may apply in certain countries, based on local regulations. Investigators in these countries will be notified accordingly in a protocol clarification letter. (*For females, menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone level of >= 25 milli units per milliliter (mU/mL) must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception). ; PRIMARY OUTCOME: Difference Between Current Study Baseline and Week 36 in Percent Change in EASI From Parent Study Baseline (NCT02277743 and NCT02277769); SECONDARY OUTCOME 1: Percentage of Participants Maintaining Investigator Global Assessment (IGA) Response Within 1 Point of Baseline at Week 36[/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 - ORARIALS-01; BRIEF: A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS) ; DRUG USED: Miplyffa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: SOD1; THERAPY: Monotherapy; LEAD SPONSOR: ZevraDenmark; CRITERIA: Inclusion Criteria: - Subject meets revised El Escorial criteria for clinically possible, clinically probable / clinically probable ALS laboratory-supported, clinically definite ALS or clinically definite familial ALS laboratory-supported - 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath) - ALS Functional Rating Scale-Revised (ALSFRS-R) equal to or above 35 and erect (seated) Slow Vital Capacity (SVC) % predicted equal to or above 70% at Screening Exclusion Criteria: - Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of Screening and Baseline - Pregnant or breast-feeding - Current or anticipated use of diaphragmatic pacing - Any other relevant medically significant condition which could present risk to the subject or interfere with the assessment of safety or has an increased risk of causing death during the trial ; PRIMARY OUTCOME: Combined Assessment of Function and Survival (CAFS); SECONDARY OUTCOME 1: Time to Permanent Assisted Ventilation (PAV) / Tracheostomy / Death[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - GATSBY (vs. Taxane); BRIEF: This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks. Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy of at least 12 weeks from the first dose of study treatment - Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) - Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization - Participants must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease - HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization) - Participants must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy. - First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy. - Adjuvant or neoadjuvant therapy for AGC is allowed. Exclusion Criteria: - An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization - Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen. - Treatment with any investigational anticancer drug within 21 days of the first study treatment administration - More than one prior line of therapy for advanced gastric cancer - History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome - Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization - Peripheral neuropathy Grade >/=2 - Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia) - Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers) - Clinically significant bleeding within 30 days before enrollment - For female participants, current pregnancy or lactation - Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment - Infection with Human immunodeficiency virus (HIV) or hepatitis B virus, hepatitis C virus ; PRIMARY OUTCOME: Overall Survival (OS)- Phase 3; SECONDARY OUTCOME 1: Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - AFUGEM; BRIEF: To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2. ; DRUG USED: Abraxane; DRUG CLASS: Non-NME; INDICATION: Pancreatic Cancer; TARGET: Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: GERCOR - Multidisciplinary Oncology Cooperative Group; CRITERIA: Inclusion Criteria: 1. Signed and dated informed consent, and willing and able to comply with protocol requirements, 2. Histologically or cytologically proven adenocarcinoma of the pancreas, 3. Metastatic disease confirmed (stage IV), 4. No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >12 months), 5. At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1 guidelines, 6. Age ≥18 years, 7. ECOG Performance status (PS) 0-2, 8. Hematological status: neutrophils (ANC) >1.5x109/L; platelets >100x109/L; haemoglobin ≥9g/dL, 9. Adequate renal function: serum creatinine level <150µM, 10. Adequate liver function: AST (SGOT) and ALT (SGPT) ≤2.5xULN (≤5xULN in case of liver metastases) 11. Total bilirubin ≤1.5 x ULN, albumin ≥25g/L 12. Baseline evaluations performed before randomization: clinical and blood evaluations no more than 2 weeks (14 days) prior to randomization, tumor assessment (CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to randomization, 13. Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study and during at least six months after the end of study treatment (when applicable). All female patients with reproductive potential must have a negative pregnancy test (β HCG) within 72 hours prior to starting ABI-007 treatment. Breastfeeding is not allowed. Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least six months after the end of the study treatment, 14. Registration in a national health care system (CMU included for France). Exclusion Criteria: 1. History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy) 2. Local or locally advanced disease (stage I to III), 3. Patient uses warfarin, 4. Uncontrolled hypercalcemia, 5. Pre-existing permanent neuropathy (NCI grade ≥2), 6. Known dihydropyrimidine dehydrogenase (DPD) deficiency, 7. Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy), 8. Treatment with any other investigational medicinal product within 28 days prior to study entry, 9. Other serious and uncontrolled non-malignant disease (eg. active infection requiring systemic therapy, coronary stenting or myocardial infarction or stroke in the past 6 months), 10. Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C. 11. History or active interstitial lung disease (ILD), 12. Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years, 13. Patients with known allergy to any excipient of study drugs, 14. Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine and concomitant administration of prophylactic phenytoin ; PRIMARY OUTCOME: Progression-free survival (PFS); SECONDARY OUTCOME 1: Tumor Response Rate[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Persistent Asthma (China); BRIEF: Primary Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma Secondary Objectives: - To evaluate the safety and tolerability of dupilumab - To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life - To evaluate dupilumab systemic exposure and immunogenicity ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Adults and adolescent patients (≥12 years of age) with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma 2017 Guidelines and the following criteria: - Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1). - Patients requiring maintenance oral corticosteroids (OCS) with a stable dose ≤10 mg/day prednisone or equivalent will be allowed; OCS should be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1). - Pre-bronchodilator FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization. - Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization. - For patients not requiring maintenance OCS, screening blood eosinophil count ≥150 cells/μL or Fractional Exhaled Nitric Oxide (FENO) ≥25 parts per billion (ppb); for patients requiring maintenance OCS, there is no minimum requirement for blood eosinophil count and FENO level. Exclusion criteria: - Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, patient recruitment will be restricted to those who are ≥18 years of age). - Weight is less than 30 kg at the screening visit (Visit 1) or the randomization visit (Visit 2). - Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis) which may impair lung function. - A patient who experiences a severe asthma exacerbation (defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, treatment with systemic steroids, or treatment with systemic steroid at least twice the previous dose for patients on OCS maintenance) at any time from 1 month prior to the screening visit (Visit 1) up to and including the randomization visit (Visit 2). - Evidence of lung disease(s) other than asthma, either clinical or imaging evidence (eg, chest X-ray, computed tomography, and magnetic resonance imaging) within 3 months prior to the screening visit (Visit 1) as per local standard of care. - Current smoker or cessation of smoking within 6 months prior to the screening visit (Visit 1). - Previous smoker with a smoking history >10 pack-years. - Comorbid disease that might interfere with the evaluation of investigational medicinal product (IMP). The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Change in pre-bronchodilator forced expiratory volume (FEV1); SECONDARY OUTCOME 1: Annualized rate of severe exacerbation 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 - w/Erlotinib (NCI); BRIEF: This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together works in treating patients with locally advanced or metastatic pancreatic cancer that is refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ; DRUG USED: Koselugo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Combination; LEAD SPONSOR: National Cancer Institute (NCI); CRITERIA: Inclusion Criteria: - Histologically or cytologically proven adenocarcinoma of the pancreas - Patients must have locally advanced unresectable disease not amenable to curative resection or extrapancreatic metastases; patients must have EITHER radiographically measurable disease (defined as at least one lesion that can be accurately measured in at least one dimension [longest diameter to be recorded] as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography [CT] scan) AND/OR a serum CA19-9 measurement > 2 x ULN - One prior line of systemic therapy for advanced disease (locally advanced or metastatic) - The following represent acceptable examples meeting the definition of one prior line of therapy: - Gemcitabine as a single agent or in combination with other agents; patients receiving (a) gemcitabine initially alone, with the eventual addition of a second agent; or (b) gemcitabine as part of a combination regimen, followed by gemcitabine alone; are eligible - A non-gemcitabine-based regimen, including (but not limited to) leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) or any combination of components therein - Treatment as part of a clinical trial involving cytotoxic agents, small molecule inhibitors, monoclonal antibodies, and/or immunomodulatory agents - For patients with locally advanced disease, prior radiation to the primary tumor is allowable as long as there is clear evidence of disease progression (either radiographic locoregional disease progression and/or a rising CA19-9 level); patients may have received chemotherapy both concurrently and/or sequentially with (either before or after) the radiation and still be eligible for the study, as this would be considered all part of the same course of treatment - Treatment given in the adjuvant setting (radiation and/or chemotherapy, given either concurrently or sequentially) does not count as prior therapy as long as progressive disease occurs > 6 months following completion of treatment - Life expectancy of greater than 8 weeks - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Absolute neutrophil count (ANC) >= 1500/uL - Platelet count >= 100,000/uL - International normalized ratio (INR) =< 1.5 (except those subjects who are receiving full-dose warfarin) - Total bilirubin =< 2.0 mg/dL - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 times the upper limit of normal for subjects - Serum creatinine of =< 2.0 mg/dL - Pregnancy test for women of childbearing potential (serum or urine beta-human chorionic gonadotropin [HCG]) - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for four weeks after dosing with AZD6244 ceases; women of child-bearing potential must have a negative pregnancy test prior to entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; please note that the AZD6244 manufacturer recommends that adequate contraception for male patients should be used for 16 weeks post-last dose due to sperm life cycle - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients may not be receiving any other investigational agents - Patients with known brain metastases should be excluded from this clinical trial - History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 (or its excipient Captisol) or erlotinib - Previous mitogen-activated protein kinase kinase (MEK) or epidermal growth factor receptor (EGFR) inhibitor use - Patients with corrected QT (QTc) interval > 480 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that (i) meets New York Heart Association (NYHA) class III and IV definitions or (ii) is demonstrated by an left ventricular (LV) ejection fraction < 55% on baseline echocardiogram, are excluded - Required use of a concomitant medication that can prolong the QT interval - There are potential interactions between erlotinib and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and CYP3A4 promoters; although caution and careful monitoring are recommended when use of these compounds is necessary, use of these compounds does not exclude patients from participating in this trial - Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant women are excluded from this study; therefore, a negative pregnancy test is required for women of childbearing potential; breastfeeding should be discontinued if the mother is treated with AZD6244 - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible ; PRIMARY OUTCOME: Overall Survival (OS); 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 III - CLEAR (Ext.); BRIEF: This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe. ; DRUG USED: Zurampic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gout; TARGET: URAT1 (urate trans-porter 1, SLC22A12/Solute carrier family 22, member 12); THERAPY: Combination; LEAD SPONSOR: Ardea Biosciences, Inc.; CRITERIA: Inclusion Criteria: - Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. - Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit. - Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth Exclusion Criteria: - Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subjects ability to comply with the protocol requirements, or to complete the study. ; PRIMARY OUTCOME: Proportion of subjects with an sUA level that is < 6.0 mg/dL; SECONDARY OUTCOME 1: Resolution of at least 1 target tophi[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIa - 020; BRIEF: The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo for preventing migraines in participants with episodic migraine. After a 28-day Screening period during which baseline number of monthly migraine days was assessed, participants were randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2 weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the initial randomization. In the Run-out Period, participants who received placebo in the Treatment Period continued to receive placebo and participants who received MK-6096 in the Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as measured by the mean change from baseline in monthly migraine days averaged over the 12- week treatment period. ; DRUG USED: MK-6096; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Hypocretin/orexin receptor ; THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - History of migraine with or without aura for >1 year and with ≥4 and ≤14 migraine days per month in the 3 months prior to study - Male, female not of reproductive potential, or female of reproductive potential who is not pregnant by pregnancy test and agrees to use acceptable contraception Exclusion Criteria: - Pregnancy, breast-feeding, or expecting to become pregnant - Planning to donate egg or sperm during the study or within 90 days after last dose of study medication - Basilar or hemiplegic migraine headache - >50 years old at the age of migraine onset - ≥15 headache-days per month or medication taken for acute migraine or other headaches on more than 10 days per month in any of the three months prior to study - Migraine prophylactic medication (defined as medication taken daily to prevent migraines) taken in the 30 days prior to study - History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition (e.g., asthma, gastroesophageal reflux disease, etc.) - Clinical, laboratory, or electrocardiogram (ECG) evidence of uncontrolled hypertension, uncontrolled diabetes, human immunodeficiency virus (HIV) disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease - Myocardial infarction, unstable angina, coronary artery bypass surgery, or other revascularization procedure, stroke, or transient ischemic attack within 3 months of study - Other confounding pain syndromes (i.e., condition requiring daily use of opioids), psychiatric conditions such as uncontrolled major depression, dementia or significant neurological disorders other than migraine - Imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others. Exclude any prospective participant reporting suicidal ideation with intent, with or without a plan in the past 2 months or suicidal behavior in the past 6 months - History of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer - History of hypersensitivity to more than two chemical classes of drugs, including prescription and over-the-counter medications - Recent history (within the past 1 year) or current evidence of drug or alcohol abuse or recreational use of illicit drugs or prescription medications - Donated blood products or has had phlebotomy of >300 ml within 8 weeks of study, or intends to donate blood products or receive blood products within 30 days before study and throughout study - Consumption of 3 or more alcoholic drinks per day - Body Mass Index >40 kg/m^2 - History of transmeridian travel (across >3 time zones) or shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates needing to travel (across >3 time zones) at any time during the study. ; PRIMARY OUTCOME: Mean Change From Baseline in Monthly Migraine Days; SECONDARY OUTCOME 1: Mean Change From Baseline in Monthly Headache Days[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - EGSPZV2; BRIEF: This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via direct venous inoculation (DVI) compared with control groups receiving normal saline (NS) placebo by DVI. In addition, the study will also assess a second PfSPZ-based vaccination approach known as PfSPZ-CVac- the administration of non-irradiated, infectious PfSPZ (PfSPZ Challenge) (1x10^5 PfSPZ) under anti-malarial chemoprophylaxis (chloroquine) in younger adults ages 18 to 35 years for safety, tolerability, immunogenicity and efficacy against controlled human malaria infection (CHMI). ; DRUG USED: PfSPZ Vaccine; DRUG CLASS: Vaccine; INDICATION: Malaria; TARGET: Immune System, Interferon-gamma (IFN-g)/Type II Interferon, Plasmodium, T-Cell Receptor (TCR); THERAPY: Monotherapy; LEAD SPONSOR: Sanaria Inc.; CRITERIA: Inclusion Criteria: - Healthy males and females, based on clinical and laboratory findings - From the age 6 months to 65 years - Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or adolescents, children and infants with Z-score of the selected indicator ([weight-for-height], [(height and BMI) for age]) category within ±2SD as detailed in protocol - Long-term (at least one year) or permanent residence in the Baney district or Malabo city - Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study - Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period - Agreement to provide contact information of a third party household member or close friend to study team - Agreement not to participate in another clinical trial during the study period - Agreement not to donate blood during the study period - Able and willing to complete the study visit schedule over the study follow up period, including the hospitalizations required for protocol compliance - .Willingness to undergo HIV, hepatitis B (HBV) and hepatitis C (HCV) tests - Volunteer (subjects 18 years of age and older) or the parent / guardian signing the informed consent (for subjects <18 years of age) is able to demonstrate their understanding of the study by responding correctly to 10 out of 10 true/false statements (in a maximum of two attempts for those who failed to respond correctly to all true/false statements in the first attempt). - Signed written informed consent, in accordance with local practice, provided by adult volunteers, parents or legal representatives and relevant assent for children participants as applicable. - Free from malaria parasitemia by blood smear at enrollment and by PCR for group 1 - Has not been treated with any antimalarial medication for at least two weeks prior to the first immunization. - Free from helminth infections (detected by microscopy) at enrollment. - Female volunteers aged 9 years and above must be non-pregnant (as demonstrated by a negative urine pregnancy test), and provide consent/assent of their willingness to take protocol-defined measures not to become pregnant during the study and safety follow-up period. Exclusion Criteria: - Previous receipt of an investigational malaria vaccine in the last 5 years - Participation in any other clinical study involving investigational medicinal products including investigational malaria drugs within 30 days prior to the onset of the study or during the study period - History of arrhythmias or prolonged QT-interval or other cardiac disease, or clinically significant abnormalities in electrocardiogram (ECG) at screening - Positive family history in a 1st or 2nd degree relative for cardiac disease at age <50 years old - A history of psychiatric disease - Suffering from any chronic illness including; diabetes mellitus, cancer or HIV/AIDS - Any confirmed or suspected immunosuppressive or immune-deficient condition, including asplenia - History of drug or alcohol abuse interfering with normal social function - The use of chronic immunosuppressive drugs or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period - Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis - Positive HIV, hepatitis B virus or hepatitis C virus tests - Volunteers who are have risk factors for tuberculosis and/or signs and symptoms of tuberculosis (TB), plus a positive tuberculin skin test (TST). - Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, blood, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers - Any medical, social condition, or occupational reason that, in the judgment of the investigator, is a contraindication to protocol participation or impairs the volunteers ability to give informed consent, increases the risk to the volunteer because of participation in the study, affects the ability of the volunteer to participate in the study or impairs the quality, consistency or interpretation of the study data - History of non-febrile seizures or atypical febrile seizures ; PRIMARY OUTCOME: Incidence and type of Adverse Events; SECONDARY OUTCOME 1: Level of Antibodies against Pf proteins in volunteer sera[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Healthy Volunteers (Singapore); BRIEF: The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms of how much gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. ; DRUG USED: LY2608204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Hexokinase/Glucokinase; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Must be a healthy male or a female who cannot become pregnant - Must have body mass index (BMI) of 18.5 to 32 kg/m², inclusive - Blood pressure as well as blood and urine laboratory test results must be acceptable for the study - The veins must be suitable for easy blood collection - Must be willing to be available for the whole study and be willing to follow study procedures - Must have given written informed consent Exclusion Criteria: - Were in another new drug or medical research study in the last 30 days - Have participated in this study or any other study with LY2608204 before - Have taken drugs similar to LY2608204 (glucokinase activators) before and was found to be allergic to the drug - Have drug allergy to more than 3 types of medications given by injection - Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study - Electrocardiogram (ECG) readings are not suitable for the study - Are infected with hepatitis B - Are infected with human immunodeficiency disease virus (HIV) - Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study - Are unwilling to follow dietary restrictions/requirements for the study including (i) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay; (ii) consume only the meals provided during dosing day at the clinical research unit (CRU) - Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit - Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic - Have a history of drug or alcohol abuse - Have donated 450 milliliter (mL) or more of blood in the last 3 months (this is about the same as the usual volume given in a blood donation) - The study doctor thinks the subject should not participate for any other reasons ; PRIMARY OUTCOME: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]); SECONDARY OUTCOME 1: [/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase I - Renal Impairment; BRIEF: A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment. ; DRUG USED: Cotadutide; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor, Glucagon Receptor; THERAPY: Monotherapy; LEAD SPONSOR: MedImmune LLC; CRITERIA: Inclusion Criteria: - Must provide written informed consent - BMI greater than or equal to 17 and less than or equal to 40 kg/m2 - Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min) - Females of childbearing potential must use a highly effective form of contraception. Exclusion Criteria: - Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety. - Subjects on dialysis - Subjects with pancreatitis - Renal transplant subjects - Females pregnant or lactating ; PRIMARY OUTCOME: Maximum Observed Concentration of MEDI0382 (Cmax); SECONDARY OUTCOME 1: Time to maximum observed concentration (Tmax)[/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 - PROTECT; BRIEF: This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery. ; DRUG USED: Votrient (Oral); DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Cell Cancer (RCC); TARGET: KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Signed written informed consent - Diagnosis of RCC with clear-cell or predominant clear-cell histology - Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading. - pT2, G3 or G4, N0; or, - pT3, G any, N0; or, - pT4, G any, N0; or, - pT any, G any, N1 - Fulfill all of the following criteria of disease-free status at baseline: - Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique. - Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist. - Received no prior adjuvant or neo-adjuvant treatment for RCC - Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4) - Karnofsky performance scale (KPS) of ≥ 80 - Adequate organ system function Exclusion Criteria: - History of another malignancy. Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible - Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: - Active peptic ulcer disease - Inflammatory bowel disease (e.g. ulcerative colitis, Crohns disease), or other gastrointestinal conditions with increased risk of perforation - History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment - Active diarrhea of any grade - Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: - Malabsorption syndrome - Major resection of the stomach or small bowel - History of human immunodeficiency virus (HIV) infection - History of active hepatitis - Presence of uncontrolled infection. - History of any one or more of the following cardiovascular conditions within the past 6 months: - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina - Coronary artery bypass graft surgery - Symptomatic peripheral vascular disease - History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure - History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. - Corrected QT interval (QTc) > 480 milliseconds (msec) - Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values). - Evidence of active bleeding or bleeding diathesis - Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subjects safety, provision of informed consent, or compliance to study procedures - Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study. - Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug. - Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment. - Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation. - Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2). ; PRIMARY OUTCOME: Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo; SECONDARY OUTCOME 1: Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo[/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 - LATTE Rollover Study (w/Rilpivirine LA); BRIEF: This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants. Participants will rollover from the NCT01641809 (LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (less than [<]50 copies (c) per milliliter [mL]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The participants will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval). Duration of study will vary from country to country, until regimen receives regulatory approval and becomes commercially available. The study plans to enroll approximately 100 participants. Any participant who receives at least one dose of CAB LA and/or RPV LA and discontinues the CAB LA plus RPV LA regimen for any reason will enter a 52-week Long-Term Follow-Up (LTFU) phase. Those participants must remain on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and or RPV LA. ; DRUG USED: Cabenuva; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: HIV Integrase; THERAPY: Monotherapy; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent. - A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test at Day 1), not lactating, and at least with one of following conditions: (a) Non-reproductive potential defined as: (i) Pre-menopausal females with one of the conditions as documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. (ii) Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. (b) Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA. - The investigator is responsible for ensuring that participants understand how to properly use the methods of contraception. - Capable of giving signed informed consent. - Must have been on oral CAB 30 mg plus RPV 25 mg regimen through at minimum Week 300 of the LATTE study as per LATTE protocol dosing requirements and until Day 1 of the POLAR study. Any disruptions in dosing during LATTE must be discussed with the Medical Monitor for a final determination of eligibility. - Plasma HIV-1 RNA <50 c/mL at Week 300. If participant has plasma HIV-1 RNA >= 50 c/mL at Week 300 in LATTE, a single repeat to determine eligibility may be allowed ONLY after consultation with the medical monitor. Exclusion Criteria: - During the last 6 months of participation in LATTE, consecutive (2 or more sequential) plasma HIV-1 RNA measurements >=50 c/mL. - During the last 6 months of participation in LATTE, any HIV-1 RNA measurement >=200 c/mL. - Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposis sarcoma not requiring systemic therapy. - Participants with moderate to severe hepatic impairment determined by Child-Pugh classification. - Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participants ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. - Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. - Participants who, in the investigators judgment, pose a significant suicide risk. Participants recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. - Participants has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. - Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows; Participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. - Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment within 12 months must be excluded. (HCV treatment on study may be permitted, following consultation with the medical monitor). - Participants with HCV co-infection will be allowed entry into this study if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, and is not advanced. - Additional information (where available) on participants, with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. - In the event that recent biopsy or imaging data is not available or inconclusive, the fibrosis- 4 (Fib-4) score will be used to verify eligibility where Fib-4 score >3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation where the Fibrosis 4 Score Formula: age multiplied by aspartate amino transferase (AST) divided by platelets multiplied by square of alanine aminotransferase (ALT). - Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). - History of liver cirrhosis with or without hepatitis viral co-infection. - Ongoing or clinically relevant pancreatitis. - Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. - Ongoing malignancy other than cutaneous Kaposis sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization. - Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication. - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. - Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease. - Corrected QT interval (QTc (Bazett)) >450 millisecond (msec) or QTc (Bazett) >480 msec for participants with bundle branch block. - Any verified Grade 4 laboratory abnormality over the last 6 months in LATTE. A single repeat test is allowed to verify a result. - Any acute laboratory abnormality over the last 6 months in LATTE, which, in the opinion of the investigator, would preclude the participants participation in the study of an investigational compound. - ALT>=5 times upper limit of normal (ULN) or ALT >= 3 times ULN and bilirubin >= 1.5 times ULN (with >35 percent [%] direct bilirubin) over the last 6 months in LATTE. - Exposure to an experimental drug (with the exception of those in the LATTE study including CAB and RPV) or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study. - Treatment with any of the following agents within 28 days of Day 1: radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]); anti-coagulation agents. - Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. - Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility. - Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. ; PRIMARY OUTCOME: Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12; SECONDARY OUTCOME 1: Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - GO-AHEAD (nr-AxSpA); BRIEF: This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16. ; DRUG USED: Simponi (SQ); DRUG CLASS: Biologic; INDICATION: Axial Spondyloarthritis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration - Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs - Females of child-bearing potential must use contraception - No history of untreated latent or active tuberculosis Exclusion Criteria: - Fulfillment of modified New York criteria for ankylosing spondylitis - Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological agents - Any systemic inflammatory condition other than spondyloarthritis - Serious infection within 2 months - Any known malignancy or a history of malignancy within the previous 5 years - Has or had a substance abuse (drug or alcohol) problem within the previous 2 years ; PRIMARY OUTCOME: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16; SECONDARY OUTCOME 1: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 3725 - BEGIN: BB T1 Extension; BRIEF: ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: ; CRITERIA: ; PRIMARY OUTCOME: ; SECONDARY OUTCOME 1: [/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - NG101-201; BRIEF: The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment. ; DRUG USED: NG101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroparesis Therapy; TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Neurogastrx, Inc.; CRITERIA: Inclusion Criteria: - Adult patients with diabetic or idiopathic gastroparesis - Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain) - Documented evidence of no mechanical obstruction - Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test Exclusion Criteria: - Uncontrolled diabetes (defined as HgbA1c > 10%) - Severe postural symptoms or evidence of unexplained recurrent dizziness - Participant has received and tolerated domperidone and showed no notable symptomatic improvement in gastroparesis symptoms - Participant has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit. - Participant engages in daily recreational use of marijuana - Prolactin levels > 2 x ULN ; PRIMARY OUTCOME: Change of Severity of Nausea; SECONDARY OUTCOME 1: Change from Baseline of Symptoms[/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 - Hospitalized Infants and Children; BRIEF: The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR). ; DRUG USED: JNJ-64041575; DRUG CLASS: New Molecular Entity (NME); INDICATION: Respiratory Syncytial Virus (RSV) Treatment; TARGET: RNA synthesis, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participants hospitalized (or in emergency room [ER]) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization - Participants diagnosed with respiratory syncytial virus (RSV) infection using a polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without co-infection with another respiratory pathogen (respiratory virus or bacteria) - Participants who have an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to <=5 days from the anticipated time of randomization. Onset of symptoms is defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of respiratory or systemic symptoms of RSV infection - With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [participants gestational age was less than {<}37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), participant must be medically stable on the basis of physical examination, medical history, vital signs/peripheral capillary oxygen saturation (SpO2), and electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying condition in the study population and/or the RSV infection. This determination must be recorded in the participants source documents and initialed by the investigator. Participants with comorbidities will be allowed to be enrolled once the Independent Data Monitoring Committee (IDMC) has reviewed the pharmacokinetic (PK) and safety data of the highest dose that will be used in this study and once the IDMC has recommended opening recruitment to this group. Sites will be notified when the restriction is lifted - The participants estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the participants age Exclusion Criteria: - Participants who are not expected to survive for more than 48 hours - Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization - Participants who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection - Participants being treated with extracorporeal membrane oxygenation - Participant receiving chronic oxygen therapy at home prior to admission - Participants who have a poorly functioning gastrointestinal tract (that is, unable to absorb drugs or nutrition via enteral route) ; PRIMARY OUTCOME: Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load; SECONDARY OUTCOME 1: Number of Participants With Emergent Adverse Event[/INST]No</s>
<s>[INST]<<SYS>>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 - ZUMA-6 (w/Atezolizumab); BRIEF: The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL). Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 ; DRUG USED: Yescarta; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Autologous Chimeric Antigen Receptor T-cells (CAR-T), Cluster of Differentiation 19 (CD19), Immune System, Stem Cells/Other Cell Therapies, T lymphocytes; THERAPY: Combination; LEAD SPONSOR: Kite, A Gilead Company; CRITERIA: Key Inclusion Criteria: 1. Histologically confirmed DLBCL 2. Chemotherapy-refractory disease, defined as one or more of the following: - Stable disease (duration of stable disease must be less than or equal to 6 months) or progressive disease as best response to most recent chemotherapy containing regimen - Disease progression or recurrence less than or equal to 12 months of prior autologous stem cell transplantation (SCT) 3. Individuals must have received adequate prior therapy including at a minimum: - anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative; and - an anthracycline containing chemotherapy regimen 4. At least one measurable lesion per revised International Working Group (IWG) Response Criteria 5. Age 18 years or older 6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 7. Adequate organ and bone marrow function 8. All individuals or legally appointed representatives/caregivers, must personally sign and date the institutional review board (IRB)/independent ethics committee (IEC) approved consent form before initiating any study specific procedures or activities. Key Exclusion Criteria: 1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years 2. History of allogeneic stem cell transplantation 3. Prior CAR therapy or other genetically modified T cell therapy 4. Clinically significant active infection 5. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) 6. Individuals with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases 7. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement 8. History of autoimmune disease. Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and participants with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study. 9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed. 10. Prior treatment with PD-L1 inhibitor, PD-1 inhibitor, anti-CTLA4, anti-CD137, anti-OX40 or other immune checkpoint blockade or activator therapy with the exception of Individuals who received atezolizumab in this study and are eligible for re-treatment 11. Prior CD19 targeted therapy Note: Other protocol defined Inclusion/Exclusion criteria may apply ; PRIMARY OUTCOME: Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs); SECONDARY OUTCOME 1: Phase 1 and 2: 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 I - w/GLPG2451; BRIEF: The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given to healthy female subjects compared to placebo as well as of multiple doses of the combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo. ; DRUG USED: ABBV-2222; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Female between 18-65 years of age inclusive, on the day of signing informed consent form (ICF). - Of non-childbearing potential defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]). In addition a determination of follicle stimulating hormone (FSH) can be performed with FSH >35 mIU/ml to further confirm postmenopausal status without menstruation for ≥12 months. - A body mass index (BMI) between 18-30 kg/m2, inclusive. - Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), Holter monitoring and a laboratory profile prior to the initial study drug administration. - Discontinuation of all medications (including over-the-counter medications and herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks prior to the first study drug administration. In addition, subjects must agree not to take any medications (including over-the-counter medication and herbal supplements), or alcohol during the course of the study.-non-smokers and non-users of any nicotine-containing products. - Non-smokers and non-users of any nicotine-containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to the screening. A non-user is defined as an individual who has abstained from any nicotine containing products for at least 1 year prior to the screening. - Negative urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) and alcohol breath test. - Able and willing to sign the ICF as approved by the IEC, prior to screening evaluations, and willing to adhere to the prohibitions and restrictions. Exclusion Criteria: - Known hypersensitivity or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization. - Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A. - History of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection). - Symptoms of clinically significant illness in the 3 months before the initial study drug administration. - Presence or having sequelae of gastrointestinal, liver or kidney (creatinine clearance ≤ 80 mL/min using the Cockroft formula; if calculated result ≤ 80 mL/min, a 24-hour urine collection to determine actual value can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. - History of malignancy within the past 5 years (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence). - Clinically relevant abnormalities detected on ECG and/or Holter regarding either rhythm or conduction (e.g. QTcF ≥ 470 msec, or a known long QT syndrome). A first degree heart block will not be considered as a significant abnormality. - Family history (if known) of long QT syndrome in a primary relative. - Clinically relevant abnormalities detected on vital signs. - Significant blood loss (including blood donation [> 500 mL]), or having had a transfusion of any blood product within 12 weeks prior to the initial study drug administration. ; PRIMARY OUTCOME: Change versus placebo in the proportion of subjects with adverse events; SECONDARY OUTCOME 1: Maximum observed plasma concentration of GLPG2451 (Cmax) given alone[/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 - inTandem1 (North America); BRIEF: This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy. ; DRUG USED: Zynquista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Lexicon Pharmaceuticals; CRITERIA: Inclusion Criteria: - Participants had given written informed consent to participate in the study in accordance with local regulations. - Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent. - Participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). - Willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary as required per protocol. - At the Screening Visit, A1C must be between 7.0% to 11.0%. - Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test . Exclusion Criteria: - Use of antidiabetic agent other than insulin or insulin analog at the time of screening. - Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to randomization. - Chronic systemic corticosteroid use. - Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator. ; PRIMARY OUTCOME: Change From Baseline in A1C at Week 24; SECONDARY OUTCOME 1: Percentage of Participants With A1C <7.0% (at Week 24) and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) Upto Week 24[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 301 (DERMIS-1); BRIEF: This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP. ; DRUG USED: ARQ-151; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Phosphodiesterase 4 (PDE4); THERAPY: Monotherapy; LEAD SPONSOR: Arcutis Biotherapeutics, Inc.; CRITERIA: Inclusion Criteria: - Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws - Males and females ages 2 years and older (inclusive) - Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator - Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial. - In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis. - Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator. Exclusion Criteria: - Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. - Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. - Previous treatment with ARQ-151 or its active ingredient - Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. - Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product - Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigators opinion, makes them unsuitable for clinical study participation ; PRIMARY OUTCOME: Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8; SECONDARY OUTCOME 1: Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase Ib/II - B-Cell Malignancies (U.S.); BRIEF: This is an open-label Phase 1b/2 study in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)or non hodgkins lymphoma (NHL) who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication. ; DRUG USED: Vecabrutinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hematologic Cancer; TARGET: Brutons Tyrosine Kinase (BTK); THERAPY: Monotherapy; LEAD SPONSOR: Sunesis Pharmaceuticals; CRITERIA: Inclusion Criteria (Key factors listed): - Eastern Cooperative Oncology Group Performance Status of ≤2. - Confirmed malignancy with relapsed/refractory disease after ≥2 lines of standard systemic therapy including prior BTK inhibitor therapy having CLL, LPL/WM, MCL or MZL and for DLBCL-ABC and FL, after ≥2 lines of standard systemic therapy (Phase 1b). For Phase 2, CLL/SLL patients with confirmed malignancy with relapsed/refractory disease after ≥1 line of standard systemic therapy including prior BTK inhibitor therapy - Presence of measurable disease through various assessments depending on specific cancer type. - Current medical need for therapy of the B-lymphoid malignancy. Exclusion Criteria (Key factors listed): - Active central nervous system involvement. - History of second primary malignancy that has progressed or required systemic treatment in the past 2 years. Exceptions include: local cancers of the skin, cervix or breast cancers, non-invasive bladder cancer, hormone sensitive prostate cancer with stable PSA ≥3 months, and other localized solid tumors in situ/other low risk cancers. - Significant cardiovascular disease or electrocardiogram (ECG) abnormalities - Ongoing risk for bleeding due to bleeding diathesis, platelet function disorder, uncontrolled peptic ulcer disease, oral anticoagulation medications. - Evidence of uncontrolled systemic bacterial, fungal or viral infections at the start of drug therapy. - Demonstrated intolerance to BTK inhibitor as shown by discontinuation due to adverse effects. - Use of a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit). ; PRIMARY OUTCOME: Maximum tolerated dose and/or Recommended dose of SNS-062 (Phase 1b); SECONDARY OUTCOME 1: Safety as assessed through reported AEs, SAEs, DLTs and abnormal lab findings (Phase 1b and Phase 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 - PRIME; BRIEF: This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Men or women must be at least 18 years of age at the time of screening - Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by: - PASI score of >10 - Affected body surface area (BSA) > 10% - DLQI >10 - Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patients medical history or reported by the patient or determined by the investigator at screening. Exclusion Criteria (abbreviated): - Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline - Ongoing use of other prohibited psoriasis and non-psoriasis treatment. - Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations - Patients with severe liver diseases - Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers - Patients with severe kidney diseases or serum creatinine above 1 x ULN - Patients with known hematological disease or lab abnormalities - Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary) ; PRIMARY OUTCOME: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24; SECONDARY OUTCOME 1: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PEARL 3 Ext (Study 234); BRIEF: Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia. ; DRUG USED: Latuda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Entry Criteria: - Screening for the present study will take place after subjects participation in Study D1050233 has been completed, and after providing informed consent. Inclusion Criteria: - Completed all required assessments on the final study visit in Study D1050233. - Suitable for treatment in an outpatient setting. Exclusion Criteria: - Any chronic organic disease of the CNS (other than schizophrenia). - Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. ; PRIMARY OUTCOME: Relapse of Psychotic Symptoms; SECONDARY OUTCOME 1: Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Women; BRIEF: The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential. ; DRUG USED: ResVax; DRUG CLASS: Vaccine; INDICATION: Respiratory Syncytial Virus (RSV) Prevention; TARGET: Immune System, RSV, Respiratory Syncytial Virus; THERAPY: Monotherapy; LEAD SPONSOR: Novavax; CRITERIA: Inclusion Criteria: - Healthy adult females, ≥ 18 and ≤ 35 years of age. Healthy shall be defined by the absence of any illness, acute or chronic, that requires ongoing systemic therapy for the control of symptoms or prevention of disability. - Subjects on stable (no change in ≥ 3 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with symptoms or disability are eligible, as are users of hormonal contraceptives. - Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with mitral valve prolapse) are eligible. - Ongoing therapy will be defined as continuous or, if intermittent, more frequent than once every 3 months (e.g., use of an inhaled bronchodilator for exercise-induced bronchospasm more than once every 3 months). Immunosuppressives are subject to exclusion criterion #5 below. - Persons being treated for illnesses or conditions that would become acutely symptomatic or disabling in the absence of treatment are not eligible. - Willing and able to give informed consent prior to study enrollment. - Able to comply with study requirements. - Women who are not surgically sterile must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD. Exclusion Criteria: - Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination. - History of a serious reaction to any prior vaccination. - Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time. - Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination. - Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. - Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration). - Known disturbance of coagulation. - Women who are pregnant or breastfeeding, or plan to become pregnant during the study. - Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse. - Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). ; PRIMARY OUTCOME: Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups; SECONDARY OUTCOME 1: Immunogenicity based on neturalizing antibody titer[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II - Proof-of-Concept; BRIEF: - Thirty six patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 or matching placebo for 4 weeks. - During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined. ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Galapagos NV; CRITERIA: Inclusion Criteria: - Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL; - Have received methotrexate for six months or longer and at a stable dose of 7.5 to 25 mg/week (extremes included) for at least four weeks prior to screening and willing to continue on this regimen for the duration of the study; - If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening; - If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least two weeks prior to screening; - Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses); - Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least four weeks after the last dose of study drug. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and - Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments. Exclusion Criteria: - Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate; - Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents); - Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening; - Receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening; - Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis, requiring hospitalization; - Positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A; - History of any inflammatory rheumatological disorders other than RA; - History of tuberculosis (TB) infection; - Pregnant or lactating women. ; PRIMARY OUTCOME: The number of patients with an ACR20 score at Week 4 as a measure of efficacy; SECONDARY OUTCOME 1: The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy[/INST]Yes</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Tacrolimus; BRIEF: The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients. ; DRUG USED: Zortress; DRUG CLASS: New Molecular Entity (NME); INDICATION: Liver Transplant Rejection; TARGET: Mammalian Target of Rapamycin (mTOR)/mTORC; THERAPY: Combination; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria: - Written informed consent - Subject aged ≥18 years of a primary, orthotopic liver allograft, from a living donor - Subject negative for HIV Incusion criteria at Randomization: - Subject was initated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression Exclusion criteria: - Subjects transplanted for acute liver failure - HCV negativesubjects receiving a transplant from HCV positive donor - Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant. - Subjects receiving an ABO incompatible allograft. - MELD-score > 35 within 1 month prior to transplantation. - Use of immunosuppressive or antibody induction agents not specified in the protocol. - History of malignancy of any organ system (except hepatocellular carcinoma or localized basal cell carcinoma of the skin) - Hepatocellular carcinoma with extrahepatic spread or macrovascular invasion - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 weeks after the last dose of study medication - History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients Exclusion criteria at Randomization: - Any post-transplant history of thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava at any time during the run-in period prior to randomization. - Subjects with a confirmed spot urine protein/creatinine ratio that indicates ≥ 1.0 g/24 hrs of proteinuria - Subjects who have severe hypercholesterolemia (>350 mg/dL; >9.1 mmol/L) or hypertriglyceridemia (>500 mg/dL; >5.6 mmol/L) at randomization. - Subjects with platelet count < 30,000/mm3. - Subjects with an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³. - Subjects with systemic infection requiring active use of IV antibiotics. - Subjects requiring life support measures such as ventilation, dialysis, vasopressor agents. - Subjects who require renal replacement therapy within 7 days prior to randomization. - Subjects with detectable HBV DNA at time of randomization - Subjects meeting the following criteria for acute rejection during the run in period: - Any acute rejection in the week prior to randomization. - 2 treated acute rejections. - Any rejection requiring antibody treatment. - Any severe cellular (and/or any humoral) rejection. Long term extension for patients in Japan: Inclusion criteria - Written informed consent must be obtained before any extension specific assessment is performed. - Ability and willingness to adhere to study regimen. - Completed Month 24 visit of core study and continuously being treated with assigned regimen. Exclusion criteria: - Use of medication that is prohibited by the study protocol at Month 24. - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. - History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients ; PRIMARY OUTCOME: Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus; SECONDARY OUTCOME 1: Renal Function by Estimated Glomerular Filtration Rate (eGFR) From Randomization[/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 - Type I/II GM1; BRIEF: Background: GM1 gangliosidosis is a disorder that destroys nerve cells. It is fatal. There is no treatment. People with GM1 are deficient in a certain enzyme. A gene therapy may help the body make this enzyme. This could improve GM1 symptoms. Objective: To test if a gene therapy helps Type I and Type II GM1 gangliosidosis symptoms. Eligibility: Type I subjects will be male and female >= 6 months <= 12 months of age at the time of full ICF signing. Type II subjects will be male and female > 12 months old and < 12 years old at the time of full ICF signing. Design: Participants will be screened with their medical history and a phone survey. Participants will stay at NIH for 8-10 weeks. Participants will have baseline tests: Blood, urine, and heart tests Hearing tests Ultrasound of abdomen EEG: Sticky patches on the participant s head will measure brain function. Lumbar puncture: A needle will be stuck into the participant s spine to remove fluid. MRI scans, bone x-rays, and bone scans: Participants will lie in a machine that takes pictures of the body IQ tests Neurology exams Central line placement Skin biopsy: A small piece of the participant s skin will be removed. Speech tests Participants will have an x-ray while swallowing food. Participants will take drugs by mouth and IV. This will get their immune system ready for therapy. Participants will get the gene therapy by IV. They may stay at NIH for a week to watch for side effects. Participants will have visits 3 and 6 months after treatment. Then visits will be every 6 months for 2 years. Then they will have a visit at 3 years. Visits will take 4-5 days. Participants will return to NIH once a year for 2 years for tests in an extension study.... ; DRUG USED: AXO-AAV-GM1; DRUG CLASS: Biologic; INDICATION: GM1 Gangliosidosis; TARGET: Ganglioside GM1/fucosyl GM1; THERAPY: Monotherapy; LEAD SPONSOR: National Human Genome Research Institute (NHGRI); CRITERIA: - INCLUSION CRITERIA: Type I subjects - Male or female subjects >= 6 months old and <= 12 months old at time of full ICF signing - Biallelic mutations in GLB1 - Documented deficiency of Beta-galactosidase enzyme by clinical laboratory testing - Phenotype consistent with a diagnosis of Type I GM1 gangliosidosis - Symptomatic subjects: as determined by the opinion of the Principal Investigator and based on the criteria set forth by Brunetti-Pierri et al: - Age of symptom onset <= 6 months of age - Rapidly progressive with developmental delay and hypotonia - Pre- symptomatic subjects: must have mutations confirmed to be associated with the Type I subtype - AAV9 antibody titers <=1:50 - Agree to reside within 50 miles of the study site for at least 1 month following treatment Type II subjects - Vineland-3 Adaptive Behavior composite standard score greater than or equal to 40 - Male or female subjects > 6 months old and < 12 years old at time of full ICF signing - Biallelic mutations in GLB1 - Documented deficiency of beta-galactosidase enzyme by clinical laboratory testing - Phenotype consistent with a diagnosis of Type II GM1 gangliosidosis, with symptom onset after the first year of life - AAV9 antibody titers <=1:50 - Agree to reside within 50 miles of the study site for at least 1 month following treatment EXCLUSION CRITERIA: - AAV9 antibody titers >1:50 - Contraindications to concomitant medications - Serious illness that would not allow travel to the study site - Unwilling to undergo study interventions as outlined in the Schedule of Events - Subjects receiving other unapproved, off-label or experimental therapies for GM1 gangliosidosis (i.e. miglustat, Tanganil) within the last 60 days - Any prior participation in a study in which a gene therapy vector or stem cell transplantation was administered - Pregnant or lactating subjects - Immunizations of any kind in the month prior to screening - Evidence of cardiomyopathy on history, exam, or additional testing (echocardiogram or electrocardiogram) or other cardiac disease that in the opinion of the investigator would deem the subject unsafe to participate in the trial - Indwelling ferromagnetic devices that would preclude MRI/fMRI/MRS imaging - Ongoing medical condition that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study - History of infection with human immunodeficiency virus (HIV), hepatitis A, B, C or tuberculosis. - History of or current chemotherapy, radiotherapy or other immunosuppressive therapy within the past 30 days. Corticosteroid treatment may be permitted at the discretion of the PI - Abnormal laboratory values considered clinically significant per the investigator - Failure to thrive, defined as: -- Falling 20 percentiles (20/100) in body weight in the 3 months preceding Screening/Baseline - Underlying defect in immune function - History of multiple and severe life-threatening infections ; PRIMARY OUTCOME: Safety; SECONDARY OUTCOME 1: Overall survival[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II; BRIEF: This study investigates the effectiveness and safety of 12 weeks of treatment with JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of effectiveness is the change in body weight at a clinically relevant dosage level during treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry which is a specialized x-ray test that measures body composition), fasting glucose, lipid levels, and blood pressure. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting. ; DRUG USED: JNJ-16269110; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: Microsomal Triglyceride Transfer Protein (MTP); THERAPY: Monotherapy; LEAD SPONSOR: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; CRITERIA: Inclusion Criteria: - Obese or overweight at screening defined as: BMI greater than or equal to 30 kg/m2 and <50 kg/m2 or BMI greater than or equal to 27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia. For patients receiving antihypertensive and/or hypolipidemic medications, these should have been at a stable dosage for at least 2 months before the start of the run-in period. Controlled hypertension is defined as a diastolic blood pressure <100 mmHg and a systolic blood pressure <160 mmHg, in the presence of antihypertensive drug treatment. For patients who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C greater than or equal to 3.4 mmol/L (130 mg/dL), HDL C <1 mmol/L (40 mg/dL) for men or <1.3 mmol/L (50 mg/dL) for women, or triglycerides greater than or equal to 1.7 mmol/L (150 mg/dL) - A stable weight, i.e., increasing or decreasing not more than 5 kg in the 3 months before the start of the run-in period - Consumption of breakfast and dinner on a daily basis - Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in diameter) with water, as judged by e.g., the patientss history of having no difficulty with swallowing e.g., capsules or intact tablets - Fasting plasma glucose <7.0 mmol/L (126 mg/dL) at screening - Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control Exclusion Criteria: - History of obesity with a known cause (e.g., Cushings disease) - History of anorexia nervosa, bulimia, or binge-eating disorder - An established diagnosis of diabetes mellitus or treatment with glucose lowering prescription drugs at screening - Prior exposure or known contraindication or hypersensitivity to R256918 - History of weight-reducing diet or receiving any drugs to treat obesity within the 3 months prior to screening - Treatment with any investigational drug or device within 1 month before the start of the run-in period - History or evidence of liver or renal impairment - History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology - History of clinically significant gastro-intestinal disease - History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy - Previous gastric restrictive surgery or other surgical procedures to induce weight loss - Liposuction within the last 3 months before screening - Pregnant or nursing women, or women who plan to become pregnant during the study - History of significant cardiovascular disease or hypertension - Elevated levels of thyroid-stimulating hormone (TSH) - A significant change in smoking habits within 3 months of the start of the run-in period - Malignancy or a history of a malignancy within 5 years before the start of the run-in period, other than basal cell carcinomas of the skin or in situ cervical carcinoma - History of seizures or significant central nervous system-related disorders - History of significant psychiatric disorder, including, schizophrenia, or psychosis ; PRIMARY OUTCOME: Mean change in body weight from baseline to Week 12.; SECONDARY OUTCOME 1: Changes in body weight, body mass index (BMI), body composition, blood pressure, glucose, intestinal hormone levels, beta cell function and lipid parameters.[/INST]No</s>
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - VBMCP-VBAD/V (PETHEMA/Gem, <=65y); BRIEF: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus Thalidomide/Velcade. ; DRUG USED: Velcade; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: PETHEMA Foundation; CRITERIA: Inclusion Criteria: 1. Must be able to comply with the protocol requirements 2. Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care, 3. Age <65 years and possibly to do an autologous transplant. 4. Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma. 5. Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours. 6. ECOG < 2. 7. El patient has a life-expectancy > 3 months. 8. Patient has the following laboratory values before beginning induction treatment: 1. Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed if they are due to marrow infiltration. 2. Corrected serum calcium <14mg/dl. 3. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. 4. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. 5. Total bilirubin: ≤1.5 x the upper limit of normal. 6. Serum creatinine ≤ 2 mg/dl. 9. For Patients included in Thalidomide branches: women of childbearing age must not have sex unless they use two anticonceptive methods beginning 4 weeks before the first dose, during all the study until 4 weeks after the last one. Exclusion Criteria: 1. Non-secretor Myeloma. 2. Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment. 3. Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment. 4. Patient had major surgery within 4 weeks before enrolment. 5. Patient has hypersensitivity to bortezomib, boron or mannitol or Thalidomide. 6. Patient has received other investigational drugs within 30 days before enrolment. 7. Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection. 8. Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 9. Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason. 10. Pregnancy or breast-feed women. ; PRIMARY OUTCOME: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone.; SECONDARY OUTCOME 1: Evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide[/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 - Patients w/Prior Therapy (China); BRIEF: AC0010 Maleate Capsules is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor.Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the sigal signal transduction system of EGFR, and close the function of ras/raf/MAPK downstream. at last block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010 Maleate Capsules has three characters: 1. Irreversible combination with EGFR; 2.Efficient suppress the EGFR mutant tumor cell and has no suppression to EGFR wild-type cell; 3. Efficient suppress the EGFR T790M drug-resistant mutation tumor cell. ; DRUG USED: Abivertinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), T790M EGFR, Tyrosine Kinases; THERAPY: Monotherapy; LEAD SPONSOR: Sun Yat-sen University; CRITERIA: Inclusion Criteria: - Patients of either gender, aged from 18 years older to 70. - Histologically or cytologically confirmed metastatic, or unresectable locally advanced, recurrent NSCLC. - At least one measurable disease by CT or MRI, according to RECIST Version 1.1. - Documented evidence of any activating EGFR mutation in the tumor tissue. - Have undergone or are able to undergo a biopsy of either primary or metastatic tumor tissue within 28 days of dosing of Avitinib, and have tissue available to send to central lab for further genetic profiling especially the status of T790M. - Life expectancy of at least 3 months. - ECOG performance status of 0 to 1. - Adequate hematological and physiological functions of heart, lung, liver, and kidney according to definitions given in Appendix D. - Disease progression under at least one treatment with current marketed EGFR TKI therapy for at least 30 days (e.g. Erlotinib, or Gefitinib, or Afatinib) with intervening treatment after most recent EGFR TKI therapy. The washout period for an EGFR TKI (Erlotinib, or Gefitinib) is at a minimum of 7 days. The washout period for an irreversible EGFR inhibitor (Afatinib) and chemotherapy is at a minimum of 14 days. - Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less. - NSCLC patients with asymptomatic brain metastasis or drug-controllable brain metastasis. - Signed consent on an Independent Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation. Exclusion Criteria: - No pathology confirmation - History of interstitial lung disease related to prior EGFR inhibitor therapy. - Symptomatic brain metastases or uncontrollable or unstable brain metastasis. - Positive to HCV or HIV antibody. - Treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal, or immunotherapy) ≤14 days prior to treatment with Avitinb. - Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericias method (QTcF) >450 msec (males) or >470 msec (females). - Family history of long QT syndrome. - Treatment with any Category 1 and 2 drugs (See:https://www.crediblemeds.org/ or www.qtdrug.org). - Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled psychiatric condition, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism). - Any other reasons for the investigator to consider the patient should not participate in the study. ; PRIMARY OUTCOME: Safety, tolerability and ORR of AC0010; SECONDARY OUTCOME 1: Plasma concentrations and pharmacokinetic parameters of single dose AC0010[/INST]No</s>

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Contains:

TRIAL NAME
BRIEF
DRUG USED
DRUG CLASS
INDICATION
TARGET
THERAPY
LEAD SPONSOR
CRITERIA
PRIMARY OUTCOME
SECONDARY OUTCOME 1

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