[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657816":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":11,"studyPopulation":11,"armGroups":27,"interventions":33,"overallOfficials":11,"centralContacts":40,"locations":11,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":11},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15,17,19],{"measure":10,"description":11,"timeFrame":12},"Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)",null,"Up to 224 weeks",{"measure":14,"description":11,"timeFrame":12},"Duration of TEAEs and SAEs",{"measure":16,"description":11,"timeFrame":12},"Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity",{"measure":18,"description":11,"timeFrame":12},"Number of participants with adverse events or serious adverse events leading to dose modification or study intervention discontinuation",{"measure":20,"description":11,"timeFrame":12},"Number of participants with clinically significant changes in vital signs, laboratory parameters, cardiac function, and Eastern Cooperative Oncology Group (ECOG) performance status changes",{"allocation":22,"interventionModel":23,"interventionModelDescription":11,"primaryPurpose":24,"observationalModel":11,"timePerspective":11,"maskingInfo":25},"NA","SINGLE_GROUP","TREATMENT",{"masking":26,"maskingDescription":11,"whoMasked":11},"NONE",[28],{"label":29,"type":30,"description":11,"interventionNames":31},"Velzatinib","EXPERIMENTAL",[32],"Drug: Velzatinib",[34],{"type":35,"name":29,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Velzatinib will be administered.",[29],[39],"GSK6042981",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":47,"role":43,"phone":48,"phoneExt":11,"email":45},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657816","phase-2-a-legacy-study-in-participants-with-gastrointestinal-stromal-tumors-gist-100657816",false,"NCT07843641","A Legacy Study in Participants With Gastrointestinal Stromal Tumors (GIST)","A Phase 2, StrateGIST Legacy Study to Provide Continued Treatment With Velzatinib to Participants With Gastrointestinal Stromal Tumors (GIST) Who Have Completed a Velzatinib Parent Study","Inclusion Criteria:\n\n* Participant is currently receiving treatment with velzatinib for gastrointestinal stromal tumors in a velzatinib parent study that has fulfilled the requirement for the primary objective.\n* Participant is benefiting from treatment with velzatinib as assessed by the investigator.\n* Participant can understand the study procedures and will agree to participate in the study by providing written informed consent.\n* Participant is willing and able to comply with scheduled visit assessments, treatment plans, and any other study procedures.\n* Participant has not developed any condition which would preclude further treatment as per parent study.\n* For female participants of childbearing potential, have a negative serum or urine (as required by local regulations) beta - Human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to the first dose of study drug.\n* Female participants of childbearing potential, if not postmenopausal or surgically sterile, must agree to abstain from heterosexual intercourse or use a highly effective form of contraception with their sexual partners during the dosing period and for a period of at least 30 days after the end-of-treatment. Male participants with partners of childbearing potential must agree that they will abstain from heterosexual intercourse or use condoms and their partners will use highly effective contraceptive methods during the dosing period until at least 30 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Participant has permanently discontinued velzatinib treatment in a velzatinib parent study for any reason.\n* Participant has received any other systemic anticancer therapy between last dose on the parent study and entering this study.\n* Any laboratory abnormality or clinically significant adverse event that, in the opinion of the investigator, represents a clinically significant risk to the participant if enrolled.\n* Participant is pregnant or breastfeeding.","ALL","18 Years",{"count":61,"type":62},72,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","This study aims to evaluate the long-term safety and tolerability of velzatinib (GSK6042981) in adults with GIST who have previously received velzatinib in parent study and continue to benefit from the treatment. Participants will be monitored for side effects and overall health to better understand the effects of long-term treatment and support future care for adults with GIST.",[68],"Gastrointestinal Neoplasms",[29,39,70],"Gastrointestinal Stromal Tumors","NOT_YET_RECRUITING","2026-09-22",{"date":74,"type":75},"2026-09-28","ACTUAL",{"date":77,"type":62},"2026-10-13",{"date":79,"type":62},"2031-01-31",{"name":5,"class":6}]