[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-phase-cml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-phase-cml":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100576580","phase-1-elvn-001-for-the-treatment-of-chronic-myeloid-leukemia-with-and-without-t315i-mutation-in-japanese-participants-100576580",false,"NCT06787144","ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants","A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants","CML","Inclusion Criteria:\n\n* BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.\n* ECOG performance status of 0 to 2.\n* The patient was born in Japan and both parents and grandparents are Japanese.\n* Adequate hematologic, hepatic and renal function.\n* Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.\n\nExclusion Criteria:\n\n* Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.\n* History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.\n* QTc \\>470 ms.","ALL","18 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.",[27,28],"CML (Chronic Myelogenous Leukemia)","Chronic Phase CML",[15,30,31,32,33],"Tyrosine Kinase Inhibitor","T315I","T315I Mutant","BCR-ABL","RECRUITING","2025-06-27",{"date":37,"type":38},"2025-07-01","ACTUAL",{"date":40,"type":38},"2025-01-23",{"date":42,"type":21},"2028-01",{"name":44,"class":45},"Enliven Therapeutics","INDUSTRY",4]