[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426636":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":48,"interventions":69,"overallOfficials":41,"centralContacts":87,"locations":93,"responsibleParty":330,"collaborators":41,"id":332,"slug":41,"hasResults":333,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":41,"eligibilityCriteria":337,"healthyVolunteers":333,"sex":338,"minAge":339,"maxAge":41,"enrollmentInfo":340,"targetDuration":41,"studyType":343,"phases":344,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":96,"whyStopped":41,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":361},{"fullName":5,"class":6},"Kartos Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":41},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Part 1: Maximum tolerated dose (MTD)\u002Fmaximum administered dose (MAD) of KRT-232","DLTs will be used to establish the MTD\u002FMAD of KRT-232 in combination with dasatinib or nilotinib","28 Days",{"measure":14,"description":15,"timeFrame":16},"Part 2, Arm A and B: Major molecular response (MMR) rate","The proportion of subjects who achieved complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) according to modified ELN criteria","6 months",{"measure":18,"description":19,"timeFrame":16},"Part 2, Arm C: Major hematological response (MaHR) rate","The proportion of subjects who achieved MaHR according to modified ELN criteria",[21,25,29,32,35,38],{"measure":22,"description":23,"timeFrame":24},"CCyR rate","The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arms A and B","12 months",{"measure":26,"description":27,"timeFrame":28},"MCyR rate","The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arm C","47 months",{"measure":30,"description":31,"timeFrame":28},"Duration of response","DOR (Kaplan-Meier estimate) defined as the time from first observation of response to progression\u002Frelapse or death, whichever comes first",{"measure":33,"description":34,"timeFrame":28},"Rate of complete hematologic response (CHR)","The proportion of subjects who achieve a CHR according to modified ELN criteria in Arms A and B",{"measure":36,"description":37,"timeFrame":28},"Progression-free survival (PFS) in each Arm","PFS is defined as the time from the first treatment dose date to progression\u002Frelapse or death, whichever comes first",{"measure":39,"description":40,"timeFrame":28},"Overall survival (OS) in each Arm","OS is defined as the time from the first treatment dose date to death from any cause",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE",[49,57,61,65],{"label":50,"type":51,"description":52,"interventionNames":53},"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.",[54,55,56],"Drug: KRT-232","Drug: Dasatinib","Drug: Nilotinib",{"label":58,"type":51,"description":59,"interventionNames":60},"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.",[54,55],{"label":62,"type":51,"description":63,"interventionNames":64},"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.",[54,56],{"label":66,"type":51,"description":67,"interventionNames":68},"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.",[54,55,56],[70,75,81],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":41},"DRUG","KRT-232","KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.",[50,58,62,66],{"type":71,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Dasatinib","Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.",[50,58,66],[80],"Dasatinib Zentiva",{"type":71,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"Nilotinib","Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.",[50,62,66],[86],"Tasigna",[88],{"name":89,"role":90,"phone":91,"phoneExt":41,"email":92},"John Mei","CONTACT","650-542-0136","jmei@kartosthera.com",[94,108,118,128,138,148,160,171,180,186,195,207,216,220,229,240,251,260,269,278,287,292,297,304,313,322],{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":41},"University of Alabama Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":103,"coordinates":104},"Point",[105,106],-86.80249,33.52066,{"lat":106,"lon":105},{"facility":109,"status":96,"city":110,"state":111,"zip":112,"country":100,"countryCode":101,"cosmosGeoPoint":113,"geoPoint":117,"contacts":41},"Georgia Cancer Center at Augusta University","Augusta","Georgia","30912",{"type":103,"coordinates":114},[115,116],-81.97484,33.47097,{"lat":116,"lon":115},{"facility":119,"status":96,"city":120,"state":121,"zip":122,"country":100,"countryCode":101,"cosmosGeoPoint":123,"geoPoint":127,"contacts":41},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15232",{"type":103,"coordinates":124},[125,126],-79.99589,40.44062,{"lat":126,"lon":125},{"facility":129,"status":96,"city":130,"state":131,"zip":132,"country":100,"countryCode":101,"cosmosGeoPoint":133,"geoPoint":137,"contacts":41},"Texas Oncology- Sammons CC at Baylor","Dallas","Texas","75246",{"type":103,"coordinates":134},[135,136],-96.80667,32.78306,{"lat":136,"lon":135},{"facility":139,"status":96,"city":140,"state":141,"zip":142,"country":100,"countryCode":101,"cosmosGeoPoint":143,"geoPoint":147,"contacts":41},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":103,"coordinates":144},[145,146],-87.90647,43.0389,{"lat":146,"lon":145},{"facility":149,"status":96,"city":150,"state":151,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":159,"contacts":41},"Princess Margaret Cancer Center","Toronto","Ontario","M5G 2C1","Canada","CA",{"type":103,"coordinates":156},[157,158],-79.39864,43.70643,{"lat":158,"lon":157},{"facility":161,"status":96,"city":162,"state":41,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":41},"Centre Leon Berard","Lyon","69008","France","FR",{"type":103,"coordinates":167},[168,169],4.84789,45.74906,{"lat":169,"lon":168},{"facility":172,"status":96,"city":173,"state":41,"zip":174,"country":164,"countryCode":165,"cosmosGeoPoint":175,"geoPoint":179,"contacts":41},"APHM Hopital de la Timone","Marseille","13005",{"type":103,"coordinates":176},[177,178],5.38107,43.29695,{"lat":178,"lon":177},{"facility":181,"status":96,"city":173,"state":41,"zip":182,"country":164,"countryCode":165,"cosmosGeoPoint":183,"geoPoint":185,"contacts":41},"Institut 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Katowice","Katowice","40-519","Poland","PL",{"type":103,"coordinates":236},[237,238],19.02173,50.2597,{"lat":238,"lon":237},{"facility":241,"status":96,"city":242,"state":41,"zip":243,"country":244,"countryCode":245,"cosmosGeoPoint":246,"geoPoint":250,"contacts":41},"National Medical Research Center of Hematology","Moscow","125167","Russia","RU",{"type":103,"coordinates":247},[248,249],37.61781,55.75204,{"lat":249,"lon":248},{"facility":252,"status":96,"city":253,"state":41,"zip":254,"country":244,"countryCode":245,"cosmosGeoPoint":255,"geoPoint":259,"contacts":41},"Almazov National Medical Research Center","Saint Petersburg","197341",{"type":103,"coordinates":256},[257,258],30.31413,59.93863,{"lat":258,"lon":257},{"facility":261,"status":96,"city":262,"state":41,"zip":263,"country":244,"countryCode":245,"cosmosGeoPoint":264,"geoPoint":268,"contacts":41},"Samara State Medical University","Samara","443001",{"type":103,"coordinates":265},[266,267],50.13553,53.20767,{"lat":267,"lon":266},{"facility":270,"status":96,"city":271,"state":41,"zip":41,"country":272,"countryCode":41,"cosmosGeoPoint":273,"geoPoint":277,"contacts":41},"Kyungpook National University Hospital","Daegu","South Korea",{"type":103,"coordinates":274},[275,276],128.59111,35.87028,{"lat":276,"lon":275},{"facility":279,"status":96,"city":280,"state":41,"zip":281,"country":272,"countryCode":41,"cosmosGeoPoint":282,"geoPoint":286,"contacts":41},"Samsung Medical Center","Seoul","135-710",{"type":103,"coordinates":283},[284,285],126.9784,37.566,{"lat":285,"lon":284},{"facility":288,"status":96,"city":280,"state":41,"zip":41,"country":272,"countryCode":41,"cosmosGeoPoint":289,"geoPoint":291,"contacts":41},"Seoul National University Hospital",{"type":103,"coordinates":290},[284,285],{"lat":285,"lon":284},{"facility":293,"status":96,"city":280,"state":41,"zip":41,"country":272,"countryCode":41,"cosmosGeoPoint":294,"geoPoint":296,"contacts":41},"Severance Hospital",{"type":103,"coordinates":295},[284,285],{"lat":285,"lon":284},{"facility":298,"status":96,"city":299,"state":300,"zip":301,"country":302,"countryCode":303,"cosmosGeoPoint":41,"geoPoint":41,"contacts":41},"Clínica Universidad de Navarra","Madrid","Navarre","28027","Spain","ES",{"facility":305,"status":96,"city":306,"state":300,"zip":307,"country":302,"countryCode":303,"cosmosGeoPoint":308,"geoPoint":312,"contacts":41},"Clinica Universidad de Navarra","Pamplona","31008",{"type":103,"coordinates":309},[310,311],-1.64323,42.81687,{"lat":311,"lon":310},{"facility":314,"status":96,"city":315,"state":41,"zip":316,"country":302,"countryCode":303,"cosmosGeoPoint":317,"geoPoint":321,"contacts":41},"Hospital Universitari Vall d'Hebron","Barcelona","08035",{"type":103,"coordinates":318},[319,320],2.15899,41.38879,{"lat":320,"lon":319},{"facility":323,"status":96,"city":299,"state":41,"zip":324,"country":302,"countryCode":303,"cosmosGeoPoint":325,"geoPoint":329,"contacts":41},"Hospital Universitario La Paz","28046",{"type":103,"coordinates":326},[327,328],-3.70256,40.4165,{"lat":328,"lon":327},{"type":331,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","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":341,"type":342},109,"ESTIMATED","INTERVENTIONAL",[345,346],"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.",[349],"Chronic Myeloid Leukemia",[351],"navtemadlin","2022-03-04",{"date":354,"type":355},"2022-03-21","ACTUAL",{"date":357,"type":355},"2021-05-07",{"date":359,"type":342},"2026-06-30",{"name":5,"class":6},26]