[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639605":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":37,"collaborators":19,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":19,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":19,"enrollmentInfo":48,"targetDuration":19,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Kissei Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Olutasidenib","EXPERIMENTAL","Olutasidenib will be administered orally twice daily under fasting condition.",[13],"Drug: Olutasidenib",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Olutasidenib: Oral administration",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Yumi Ikezaki","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Kissei Pharmaceutical Co., Ltd","CONTACT","Email only","rinsyousiken@pharm.kissei.co.jp",[31],{"facility":32,"status":33,"city":34,"state":19,"zip":19,"country":35,"countryCode":36,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Research Site","RECRUITING","Tokyo and Other Japanese Cities","Japan","JP",{"type":38,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100639605","phase-2-a-clinical-trial-of-olutasidenib-in-patients-with-acute-myeloid-leukemia-100639605",false,"NCT07604064","A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia","A Phase II Clinical Trial of Olutasidenib in Patients With Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Japanese patients who personally provide written informed consent to participate in this clinical trial\n* Patients with a confirmed diagnosis of AML based on WHO classification (2022 edition) (except acute promyelocytic leukemia with t (15:17) translocation)\n* Patients with relapsed or refractory AML who may or may not have undergone allogeneic hematopoietic stem cell transplantation.\n* Patients with IDH1 gene mutation confirmed by central confirmation after relapse or refractoriness\n\nExclusion Criteria:\n\n* Patients with IDH2 mutations or patients with a history of IDH2 inhibitor treatment\n* Patients who are intolerant to IDH1 inhibitors\n* Patients who are deemed inappropriate for the clinical trial by the investigator or sub-investigator","ALL","18 Years",{"count":49,"type":50},3,"ESTIMATED","INTERVENTIONAL",[53],"PHASE2","This clinical trial is a multicenter, single-arm, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of olutasidenib administered orally twice daily under fasting conditions for one cycle of 28 days in at least 3 Japanese patients with relapsed or refractory IDH1 mutation-positive AML.",[56],"Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia","2026-05-22",{"date":59,"type":60},"2026-05-27","ACTUAL",{"date":62,"type":50},"2026-06",{"date":64,"type":50},"2030-09",{"name":5,"class":6},1]