[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-stromal-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-stromal-neoplasm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100405330","surgery-in-gastrointestinal-stromal-tumors-gists-for-treatment-tumor-modeling-and-genomic-analysis-100405330",false,"NCT04557969","Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","* INCLUSION CRITERIA:\n* Histological confirmation or clinical presentation suspicious of GIST; histological confirmation will be preferably by review of archival tissue if available, fresh biopsy will not be required if inadequate tissue sample.\n* Age \\>= 6 years\n* ECOG performance status \\\u003C= 2 (Karnofsky or Lansky \\>= 60%)\n* Ability of participant or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n\\- Non-modifiable medical comorbidities that would preclude cytoreductive surgery.","ALL","6 Years",{"count":19,"type":20},400,"ESTIMATED","OBSERVATIONAL","Objective:\n\nTo follow people with GISTs and collect tumor tissue so that it can be studied in the lab.\n\nEligibility:\n\nPeople age 6 and older who have a GIST.\n\nDesign:\n\nParticipants will be screened with a review of their medical records and samples.\n\nParticipants will enroll in 1 other NIH study, and may be asked to enroll in 2 other optional NIH studies.\n\nParticipants will have a medical history and physical exam. Data about how they function in their daily activities will be obtained.\n\nParticipants may speak with a genetic counselor. They may have genetic testing.\n\nParticipants will give blood samples. They may have a cheek swab. For this, small brush will be rubbed against the inside of the cheek.\n\nParticipants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis. Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the abdomen and pelvis.\n\nParticipants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to 5 years after surgery.\n\nIf a participant has surgery, tumor tissue samples and research specimen will be taken.\n\nIf a participant does not need surgery, their participation will end after 10 years. If they have surgery, the 5-year monitoring period will restart after each surgery.",[24,25,26,27,28],"Gastric Cancer","Gastric Neoplasm","Gastrointestinal Stromal Sarcoma","Gastrointestinal Stromal Neoplasm","Gastrointestinal Stromal Tumor (GIST)",[30,31,32,33,34,35],"Tyrosine Kinase Inhibitor (TKI) Therapy","Wild-Type GISTs (WT GISTs)","PDGFRA Mutation","KIT Mutation","SDH Mutation","Natural History","RECRUITING","2026-06-23",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":40},"2020-12-18",{"date":44,"type":20},"2040-12-30",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100566443","phase-1-a-study-of-ziftomenib-in-combination-with-imatinib-in-patients-with-advanced-gastrointestinal-stromal-tumors-gist-100566443","NCT06655246","A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)","A Phase 1a\u002F1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of the Oral Menin Inhibitor Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure","Key Inclusion Criteria:\n\n* Documented diagnosis of advanced\u002Fmetastatic KIT-mutant GIST.\n* Documented disease progression on imatinib as current or prior therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.\n* At least 1 measurable lesion per RECIST v1.1 modified for GIST.\n* Negative pregnancy test for participants of childbearing potential.\n* Adequate organ function per protocol requirements.\n* Resolution of all clinically significant toxicities from prior therapy to \\\u003CGrade 1 (or participant baseline) within 1 week before the first dose of study intervention.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure.\n\nKey Exclusion Criteria:\n\n* Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.\n* History of prior or current cancer that has potential to interfere with obtaining study results.\n* Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study intervention.\n* Active central nervous system metastases.\n* Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Mean corrected QT interval (QTcF) greater than 470ms.\n* Left ventricular ejection fraction (LVEF) \\\u003C50%.\n* Major surgery within 2 weeks before the first dose of study intervention.\n* Is pregnant or breastfeeding.\n* Gastrointestinal abnormalities that may impact taking study intervention by mouth.\n* Actively bleeding, excluding hemorrhoidal or gum bleeding.","18 Years",{"count":58,"type":20},157,"INTERVENTIONAL",[61],"PHASE1","In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.",[28,64,27,65,66],"Gastrointestinal Stromal Cancer","Gastrointestinal Stromal Tumor, Malignant","Gastrointestinal Stromal Cell Tumors",[68,64,27],"Gastrointestinal Stromal Tumor","2026-02-03",{"date":71,"type":40},"2026-02-05",{"date":73,"type":40},"2025-03-27",{"date":75,"type":20},"2028-12",{"name":77,"class":78},"Kura Oncology, Inc.","INDUSTRY",32]