[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646585":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":21,"locations":11,"responsibleParty":30,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":11,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":11},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Velzatinib","EXPERIMENTAL",null,[13],"Drug: Velzatinib",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Velzatinib will be administered.",[9],[20],"GSK6042981",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":28,"role":24,"phone":29,"phoneExt":11,"email":26},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":31,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100646585","phase-2-a-study-of-velzatinib-in-participants-with-metastatic-andor-unresectable-gist-after-imatinib-sunitinib-regorafenib-and-pimitespib-100646585",false,"NCT07689201","A Study of Velzatinib in Participants With Metastatic and\u002For Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib","A Phase 2, Single-arm, Multicenter, Open-Label Study of Velzatinib (GSK6042981) in Participants With Metastatic and\u002For Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib, Sunitinib, Regorafenib, and Pimitespib Therapies (StrateGIST J)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed GIST that is metastatic and\u002For surgically unresectable.\n* Documented disease progression on or intolerance to imatinib, sunitinib, regorafenib, and pimitespib.\n* Documented mutation status of KIT and\u002For PDGFRA.\n* Tumor tissue must be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy.\n* Is willing to use adequate contraception male and\u002For female participants.\n\nExclusion Criteria:\n\n* Known untreated or active central nervous system metastases.\n* Has significant, uncontrolled, or active cardiovascular disease.\n* Participants with a known allergy or hypersensitivity to any component of velzatinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of metastatic disease.\n* Prior treatment with ripretinib or other investigational agents that are currently under clinical development for GIST.\n* Is pregnant or breastfeeding.\n* Any condition or illness that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the safety of the study treatment.","ALL","18 Years",{"count":42,"type":43},24,"ESTIMATED","INTERVENTIONAL",[46],"PHASE2","The goal of this study is to evaluate the study drug velzatinib (GSK6042981 \u002F IDRX-42) to see whether velzatinib can shrink or control tumors and is safe and tolerated in Japan participants with gastrointestinal tumors (GIST) who progressed or were intolerant to standard therapies.",[49],"Gastrointestinal Neoplasms",[9,20,51,52],"IDRX-42","Gastrointestinal Stromal Tumors (GIST)","NOT_YET_RECRUITING","2026-07-01",{"date":56,"type":57},"2026-07-08","ACTUAL",{"date":59,"type":43},"2026-08-31",{"date":61,"type":43},"2029-08-31",{"name":5,"class":6}]