[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04835584":3,"trial-entities:NCT04835584":295,"trial-summary:NCT04835584":301},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":51,"secondary_outcomes":63,"sex":84,"minimum_age":85,"maximum_age":15,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":102,"locations":105,"central_contacts":286,"overall_officials":292,"references":293,"see_also_links":294},"NCT04835584","KRT-232-117","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)","UNKNOWN","2026-06-30","2022-03","2022-03-21","2021-05-07","Kartos Therapeutics, Inc.","INDUSTRY",null,"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.",[18],"Chronic Myeloid Leukemia",[20],"navtemadlin","INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},109,"ESTIMATED",[30,39,45],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","KRT-232","KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.",[35,36,37,38],"Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP","Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)","Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP)","Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP)",{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Dasatinib","Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.",[35,36,38],[44],"Dasatinib Zentiva",{"type":31,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Nilotinib","Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.",[35,37,38],[50],"Tasigna",[52,56,60],{"measure":53,"description":54,"timeFrame":55},"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":57,"description":58,"timeFrame":59},"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":61,"description":62,"timeFrame":59},"Part 2, Arm C: Major hematological response (MaHR) rate","The proportion of subjects who achieved MaHR according to modified ELN criteria",[64,68,72,75,78,81],{"measure":65,"description":66,"timeFrame":67},"CCyR rate","The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arms A and B","12 months",{"measure":69,"description":70,"timeFrame":71},"MCyR rate","The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arm C","47 months",{"measure":73,"description":74,"timeFrame":71},"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":76,"description":77,"timeFrame":71},"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":79,"description":80,"timeFrame":71},"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":82,"description":83,"timeFrame":71},"Overall survival (OS) in each Arm","OS is defined as the time from the first treatment dose date to death from any cause","ALL","18 Years",false,{"inclusion":88,"exclusion":95,"raw_text":101},[89,90,91,92,93,94],"Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP","Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP","Subject is resistant (relapsed or refractory) and\u002For intolerant to at least 1 prior TKI.","Adults ≥ 18 years of age.","ECOG performance status of 0 to 2","Adequate hematologic, hepatic, and renal functions",[96,97,98,99,100],"Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP","Documented Ph+, BCR-ABL+ CML-BC","Known T315I mutation.","Prior treatment with MDM2 antagonist therapies.","Intolerance to current TKI therapy.","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.",[103,104],"ADULT","OLDER_ADULT",[106,116,124,132,140,148,157,165,172,176,183,192,199,203,210,218,226,233,240,247,254,257,260,266,273,280],{"facility":107,"status":108,"city":109,"state":110,"zip":111,"country":112,"geoPoint":113},"University of Alabama Birmingham","RECRUITING","Birmingham","Alabama","35294","United States",{"lat":114,"lon":115},33.52066,-86.80249,{"facility":117,"status":108,"city":118,"state":119,"zip":120,"country":112,"geoPoint":121},"Georgia Cancer Center at Augusta University","Augusta","Georgia","30912",{"lat":122,"lon":123},33.47097,-81.97484,{"facility":125,"status":108,"city":126,"state":127,"zip":128,"country":112,"geoPoint":129},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15232",{"lat":130,"lon":131},40.44062,-79.99589,{"facility":133,"status":108,"city":134,"state":135,"zip":136,"country":112,"geoPoint":137},"Texas Oncology- Sammons CC at Baylor","Dallas","Texas","75246",{"lat":138,"lon":139},32.78306,-96.80667,{"facility":141,"status":108,"city":142,"state":143,"zip":144,"country":112,"geoPoint":145},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"lat":146,"lon":147},43.0389,-87.90647,{"facility":149,"status":108,"city":150,"state":151,"zip":152,"country":153,"geoPoint":154},"Princess Margaret Cancer Center","Toronto","Ontario","M5G 2C1","Canada",{"lat":155,"lon":156},43.70643,-79.39864,{"facility":158,"status":108,"city":159,"zip":160,"country":161,"geoPoint":162},"Centre Leon Berard","Lyon","69008","France",{"lat":163,"lon":164},45.74906,4.84789,{"facility":166,"status":108,"city":167,"zip":168,"country":161,"geoPoint":169},"APHM Hopital de la Timone","Marseille","13005",{"lat":170,"lon":171},43.29695,5.38107,{"facility":173,"status":108,"city":167,"zip":174,"country":161,"geoPoint":175},"Institut Paoli-Calmettes","13009",{"lat":170,"lon":171},{"facility":177,"status":108,"city":178,"zip":179,"country":161,"geoPoint":180},"Centre Hospitalier Lyon Sud","Saint-Genis-Laval","69310",{"lat":181,"lon":182},45.69542,4.79316,{"facility":184,"status":108,"city":185,"state":186,"zip":187,"country":188,"geoPoint":189},"Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda","Milan","MI","20122","Italy",{"lat":190,"lon":191},42.78235,12.59836,{"facility":193,"status":108,"city":194,"zip":195,"country":188,"geoPoint":196},"Azienda Ospedaliero - Universitaria Mater Domini","Catanzaro","88100",{"lat":197,"lon":198},38.88247,16.60086,{"facility":200,"status":108,"city":201,"zip":202,"country":188},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori","Meldola FC","47014",{"facility":204,"status":108,"city":205,"zip":206,"country":188,"geoPoint":207},"Fondazione IRCCS Policlinico San Matteo","Pavia","27100",{"lat":208,"lon":209},45.19205,9.15917,{"facility":211,"status":108,"city":212,"zip":213,"country":214,"geoPoint":215},"Pratia Onkologia Katowice","Katowice","40-519","Poland",{"lat":216,"lon":217},50.2597,19.02173,{"facility":219,"status":108,"city":220,"zip":221,"country":222,"geoPoint":223},"National Medical Research Center of Hematology","Moscow","125167","Russia",{"lat":224,"lon":225},55.75204,37.61781,{"facility":227,"status":108,"city":228,"zip":229,"country":222,"geoPoint":230},"Almazov National Medical Research Center","Saint Petersburg","197341",{"lat":231,"lon":232},59.93863,30.31413,{"facility":234,"status":108,"city":235,"zip":236,"country":222,"geoPoint":237},"Samara State Medical University","Samara","443001",{"lat":238,"lon":239},53.20767,50.13553,{"facility":241,"status":108,"city":242,"country":243,"geoPoint":244},"Kyungpook National University Hospital","Daegu","South Korea",{"lat":245,"lon":246},35.87028,128.59111,{"facility":248,"status":108,"city":249,"zip":250,"country":243,"geoPoint":251},"Samsung Medical Center","Seoul","135-710",{"lat":252,"lon":253},37.566,126.9784,{"facility":255,"status":108,"city":249,"country":243,"geoPoint":256},"Seoul National University Hospital",{"lat":252,"lon":253},{"facility":258,"status":108,"city":249,"country":243,"geoPoint":259},"Severance Hospital",{"lat":252,"lon":253},{"facility":261,"status":108,"city":262,"state":263,"zip":264,"country":265},"Clínica Universidad de Navarra","Madrid","Navarre","28027","Spain",{"facility":267,"status":108,"city":268,"state":263,"zip":269,"country":265,"geoPoint":270},"Clinica Universidad de Navarra","Pamplona","31008",{"lat":271,"lon":272},42.81687,-1.64323,{"facility":274,"status":108,"city":275,"zip":276,"country":265,"geoPoint":277},"Hospital Universitari Vall d'Hebron","Barcelona","08035",{"lat":278,"lon":279},41.38879,2.15899,{"facility":281,"status":108,"city":262,"zip":282,"country":265,"geoPoint":283},"Hospital Universitario La Paz","28046",{"lat":284,"lon":285},40.4165,-3.70256,[287],{"name":288,"role":289,"phone":290,"email":291},"John Mei","CONTACT","650-542-0136","jmei@kartosthera.com",[],[],[],{"nct_id":4,"conditions":296,"biomarkers":298},[297],"Chronic Myeloid Leukemia, BCR-ABL1 Positive",[299,300],"BCR\u002FABL1 Fusion Gene","Pancreatic Hormone",{"nct_id":4,"found":302,"summary":303,"prompt_version":312},true,{"design":304,"status":305,"heading":6,"summary":306,"follow_up":307,"word_count":308,"commitments":309,"compensation":310,"drugs_mentioned":311},"This is an interventional study, meaning participants will receive specific treatments. It is a global, open-label Phase 1b\u002F2 study, which means both you and your doctors will know which treatment you are receiving.","completed","This study is testing a new oral drug called KRT-232, along with existing drugs like Dasatinib or Nilotinib, for people with Chronic Myeloid Leukemia (CML). KRT-232 is an experimental MDM2 inhibitor, which is a type of anticancer drug. This study is for adults whose CML has not responded well to previous treatments with Tyrosine Kinase Inhibitors (TKIs) or who couldn't tolerate them. The researchers want to find the safest and most effective dose of KRT-232 and see how many participants achieve a major molecular response (a significant reduction in leukemia cells) or a major hematological response (improvement in blood counts) within 6 months. The study aims to enroll 109 participants, but its current status is unclear.","The main goals of the study are measured at 28 days for KRT-232 dosing and at 6 months for treatment response.",116,"Not specified in the trial record.","Not stated in the trial record.",[32,40,46],"v2"]