[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426636":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":47,"locations":53,"responsibleParty":290,"collaborators":34,"id":292,"slug":293,"hasResults":294,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":34,"eligibilityCriteria":298,"healthyVolunteers":294,"sex":299,"minAge":300,"maxAge":34,"enrollmentInfo":301,"targetDuration":34,"studyType":304,"phases":305,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":56,"whyStopped":34,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},{"fullName":5,"class":6},"Kartos Therapeutics, Inc.","INDUSTRY",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP","EXPERIMENTAL","KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. TKI (dasatinib or nilotinib) will be administered orally, per locally prescribed dose and schedule.",[13,14,15],"Drug: KRT-232","Drug: Dasatinib","Drug: Nilotinib",{"label":17,"type":10,"description":18,"interventionNames":19},"Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)","KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasastinib will be administered orally, per locally prescribed dose and schedule.",[13,14],{"label":21,"type":10,"description":22,"interventionNames":23},"Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP)","KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Nilotinib will be administered orally, per locally prescribed dose and schedule.",[13,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)","KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasatinib or Nilotinib will be administered orally, per locally prescribed dose and schedule.",[13,14,15],[29,35,41],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","KRT-232","KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.",[9,17,21,25],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Dasatinib","Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.",[9,17,25],[40],"Dasatinib Zentiva",{"type":30,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Nilotinib","Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.",[9,21,25],[46],"Tasigna",[48],{"name":49,"role":50,"phone":51,"phoneExt":34,"email":52},"John 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Hospital",{"type":63,"coordinates":250},[244,245],{"lat":245,"lon":244},{"facility":253,"status":56,"city":240,"state":34,"zip":34,"country":232,"countryCode":34,"cosmosGeoPoint":254,"geoPoint":256,"contacts":34},"Severance Hospital",{"type":63,"coordinates":255},[244,245],{"lat":245,"lon":244},{"facility":258,"status":56,"city":259,"state":260,"zip":261,"country":262,"countryCode":263,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"Clínica Universidad de Navarra","Madrid","Navarre","28027","Spain","ES",{"facility":265,"status":56,"city":266,"state":260,"zip":267,"country":262,"countryCode":263,"cosmosGeoPoint":268,"geoPoint":272,"contacts":34},"Clinica Universidad de Navarra","Pamplona","31008",{"type":63,"coordinates":269},[270,271],-1.64323,42.81687,{"lat":271,"lon":270},{"facility":274,"status":56,"city":275,"state":34,"zip":276,"country":262,"countryCode":263,"cosmosGeoPoint":277,"geoPoint":281,"contacts":34},"Hospital Universitari Vall d'Hebron","Barcelona","08035",{"type":63,"coordinates":278},[279,280],2.15899,41.38879,{"lat":280,"lon":279},{"facility":283,"status":56,"city":259,"state":34,"zip":284,"country":262,"countryCode":263,"cosmosGeoPoint":285,"geoPoint":289,"contacts":34},"Hospital Universitario La Paz","28046",{"type":63,"coordinates":286},[287,288],-3.70256,40.4165,{"lat":288,"lon":287},{"type":291,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100426636","phase-1-krt-232-and-tki-study-in-chronic-myeloid-leukemia-100426636",false,"NCT04835584","KRT-232 and TKI Study in Chronic Myeloid Leukemia","An Open-Label, Multicenter, Phase 1b\u002F2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)","Inclusion Criteria:\n\n* Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP\n* Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP\n* Subject is resistant (relapsed or refractory) and\u002For intolerant to at least 1 prior TKI.\n* Adults ≥ 18 years of age.\n* ECOG performance status of 0 to 2\n* Adequate hematologic, hepatic, and renal functions\n\nExclusion Criteria:\n\n* Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP\n* Documented Ph+, BCR-ABL+ CML-BC\n* Known T315I mutation.\n* Prior treatment with MDM2 antagonist therapies.\n* Intolerance to current TKI therapy.","ALL","18 Years",{"count":302,"type":303},109,"ESTIMATED","INTERVENTIONAL",[306,307],"PHASE1","PHASE2","This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).\n\nThis study is a global, open label Phase 1b\u002F2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.",[310],"Chronic Myeloid Leukemia",[312],"navtemadlin","2022-03-04",{"date":315,"type":316},"2022-03-21","ACTUAL",{"date":318,"type":316},"2021-05-07",{"date":320,"type":303},"2026-06-30",{"name":5,"class":6},26]