[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656493":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":69,"studyPopulation":66,"armGroups":70,"interventions":84,"overallOfficials":66,"centralContacts":98,"locations":66,"responsibleParty":107,"collaborators":66,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":66,"enrollmentInfo":119,"targetDuration":66,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":130,"whyStopped":66,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":66},{"fullName":5,"class":6},"Vivace Therapeutics, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Survival (OS)","Time from randomization to death from any cause. Participants without an observed death will be censored at the last date known alive or the analysis cut-off date, whichever is earlier.","Approximately 32-35 months after first randomization",[14,18,22,26,30,34,37,41,44,47],{"measure":15,"description":16,"timeFrame":17},"Progression-Free Survival by BICR","Time from randomization to the first BICR-assessed radiologic progressive disease or death, using protocol-defined censoring rules.","From randomization through radiologic progression, death, up to approximately 3 years or more",{"measure":19,"description":20,"timeFrame":21},"Treatment-Emergent Adverse Events and Serious Adverse Events","Incidence and severity of Treatment-Emergent Adverse Events and Serious Adverse Events","From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.",{"measure":23,"description":24,"timeFrame":25},"Disease-related symptoms and health-related quality of life outcomes","Disease-related symptoms, treatment side effects, functioning, and health-related quality of life outcomes and time to deterioration.","Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more",{"measure":27,"description":28,"timeFrame":29},"Overall Response Rate by BICR","Overall Response Rate by BICR Proportion with best overall response of complete response or partial response by RECIST v1.1 and\u002For modified RECIST v1.1, assessed by BICR.","Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more",{"measure":31,"description":32,"timeFrame":33},"Duration of Response","Among participants with a complete or partial response, time from first documented response to progressive disease or death, with protocol-defined censoring.","From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more",{"measure":35,"description":36,"timeFrame":29},"Disease Control Rate by BICR","Proportion with best overall response of complete response, partial response, or stable disease by RECIST v1.1 and\u002For modified RECIST v1.1, assessed by BICR.",{"measure":38,"description":39,"timeFrame":40},"Time to Response","Time from randomization to the first documented complete or partial response by RECIST v1.1 and\u002For modified RECIST v1.1.","From randomization to first documented response; up to approximately 3 years or more",{"measure":42,"description":43,"timeFrame":25},"EORTC QLQ-LC13","Lung cancer- and treatment-related symptoms using the EORTC Quality of Life Questionnaire Lung Cancer Module 13.",{"measure":45,"description":46,"timeFrame":25},"EQ-5D-5L","Health status and health-related quality of life using the EuroQol 5 Dimension-5 Levels instrument.",{"measure":48,"description":49,"timeFrame":50},"Time to Deterioration","Time to protocol-defined deterioration in disease-related symptoms and health-related quality of life; detailed definition will be specified in the Statistical Analysis Plan.","From baseline\u002Frandomization through protocol-defined deterioration; up to approximately 3 years or more",[52,56,59],{"measure":53,"description":54,"timeFrame":55},"Pharmacokinetic Evaluation - Cmax","Peak plasma concentration of VT3989","Up to Cycle 9 (each cycle is 28 days)",{"measure":57,"description":58,"timeFrame":55},"Pharmacokinetic Evaluation - AUC","Area under the plasma concentration versus time curve (AUC)",{"measure":60,"description":60,"timeFrame":55},"Correlation between VT3989 exposure",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":66,"timePerspective":66,"maskingInfo":67},"RANDOMIZED","PARALLEL","Participants will be randomized 1:1 to VT3989 or Investigator's choice chemotherapy (gemcitabine or vinorelbine).","TREATMENT",null,{"masking":68,"maskingDescription":66,"whoMasked":66},"NONE","Approximately 350 participants will be randomized 1:1 to VT3989 (Arm A) or Investigator's choice chemotherapy with gemcitabine or vinorelbine (Arm B).\n\nVT3989 will be administered orally at 100 mg once daily for 2 weeks on treatment followed by 2 weeks off treatment in each 4-week cycle. Comparator treatment will be gemcitabine or vinorelbine using the protocol-specified regimen or local prescribing\u002Finstitutional practice.\n\nThe trial includes screening, treatment, safety follow-up, and survival follow-up periods. A QTc Sub-Study will evaluate cardiac repolarization using time-matched pharmacokinetic samples and ECGs in approximately 25 Arm A participants. Overall survival is the primary endpoint; BICR-assessed progression-free survival is the key secondary endpoint.",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Arm A - VT3989","EXPERIMENTAL","VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason.",[76],"Drug: VT3989",{"label":78,"type":79,"description":80,"interventionNames":81},"Arm B - Investigator's Choice Chemotherapy","ACTIVE_COMPARATOR","The Investigator selects 21-day cycle of gemcitabine or vinorelbine. Administration and dose modification may follow the protocol, local prescribing information, or institutional practice.",[82,83],"Drug: gemcitabine","Drug: Vinorelbine",[85,90,94],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":66},"DRUG","VT3989","• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W\u002F2W) in each 4-week cycle",[72],{"type":86,"name":91,"description":92,"armGroupLabels":93,"otherNames":66},"gemcitabine","• 1,000 mg\u002Fm2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information\u002Finstitutional practice",[78],{"type":86,"name":95,"description":96,"armGroupLabels":97,"otherNames":66},"Vinorelbine","• 25-30 mg\u002Fm2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information\u002Finstitutional practice",[78],[99,104],{"name":100,"role":101,"phone":102,"phoneExt":66,"email":103},"Arick Wong","CONTACT","650-666-2753","vt3989-003@vivacetherapeutics.com",{"name":105,"role":101,"phone":102,"phoneExt":66,"email":106},"Dereck Amakye","info@vivacetherapeutics.com",{"type":108,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100656493","phase-3-a-phase-3-trial-in-advanced-epithelioid-mesothelioma-100656493",false,"NCT07824986","A Phase 3 Trial in Advanced Epithelioid Mesothelioma","A Phase 3, Randomized, Open-label Trial Comparing VT3989 Versus Gemcitabine or Vinorelbine in Participants With Advanced Epithelioid Mesothelioma, Who Previously Received Platinum-Based Systemic Chemotherapy and Immunotherapy","sTEADfast","Inclusion Criteria:\n\n* Male or female, age 18 years or older at informed consent.\n* Pathologically confirmed advanced epithelioid pleural mesothelioma previously treated with platinum-based systemic chemotherapy and immunotherapy, given sequentially or concurrently.\n* Radiologically measurable disease by modified RECIST v1.1 or RECIST v1.1.\n* ECOG: 0-1.\n* Adequate organ functions, including the liver, kidneys, and hematopoietic system.\n\nExclusion Criteria:\n\n* Active brain metastases or primary CNS (central nervous system) tumors.\n* History of leptomeningeal metastases\n* Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy\n* Known HIV positive or active Hepatitis B or Hepatitis C\n* Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents\n* Corrected QT (QTcF) interval \\> 470 msec (using Fridericia's correction formula).\n* Women who are pregnant or breastfeeding\n* Non-pleural mesothelioma at initial diagnosis or an aggressive histologic type such as sarcomatoid or biphasic mesothelioma.\n* Prior treatment with a TEAD inhibitor, including VT3989 or another agent targeting the same molecular pathway.\n* Prior receipt of both comparator treatments, gemcitabine and vinorelbine, alone or in combination, or known hypersensitivity to both. A participant who received only one comparator may enroll but must not be assigned to that same comparator.","ALL","18 Years",{"count":120,"type":121},350,"ESTIMATED","INTERVENTIONAL",[124],"PHASE3","This randomized, open-label, multicenter Phase 3 trial will compare VT3989 with Investigator's choice of gemcitabine or vinorelbine in adults with advanced epithelioid pleural mesothelioma whose disease progressed after prior platinum-based systemic chemotherapy and immunotherapy.",[127,128],"Pleural Mesothelioma","Mesothelioma",[128],"NOT_YET_RECRUITING","2026-09-11",{"date":133,"type":134},"2026-09-17","ACTUAL",{"date":136,"type":121},"2026-12-01",{"date":138,"type":121},"2031-01-01",{"name":5,"class":6}]