[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548662":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Ascentage Pharma Group Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A, RCT, olverembatinib arm and bosutinib arm","OTHER","Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs",[13,14],"Drug: olverembatinib","Drug: Bosutinib",{"label":16,"type":10,"description":17,"interventionNames":18},"Part B, SAT, olverembatinib arm","To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","olverembatinib","olverembatinib QOD",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Bosutinib","Bosutnib QD",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Kate Shantz","CONTACT","301-509-0038","kate.shantz@ascentage.com",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},"Huanshan Guo","huanshan.guo@ascentage.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-95.36327,29.76328,{"lat":52,"lon":51},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100548662","phase-3-study-of-olverembatinib-hqp1351-in-patients-with-cp-cml-100548662",false,"NCT06423911","Study of Olverembatinib (HQP1351) in Patients With CP-CML","This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia","POLARIS-2","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria.\n\n1. Age ≥ 18 years old.\n2. Diagnosis of CML-CP\n3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.\n5. Written informed consent obtained prior to any screening procedures.\n6. Patients with adequate organ functions\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria.\n\n1. For Part A only: T315I mutation at any time prior to starting study treatment.\n2. Active infection that requires systemic drug therapy\n3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs\n4. Previous treatment with or known \u002F suspected hypersensitivity to olverembatinib or any of its excipients.\n5. Previous treatment with or known \u002F suspected hypersensitivity to bosutinib or any of its excipients.\n6. Pregnant or nursing (lactating) women.","ALL","18 Years","99 Years",{"count":68,"type":69},285,"ESTIMATED","INTERVENTIONAL",[72],"PHASE3","A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)",[75,76,77],"Chronic Myeloid Leukemia","CML","CML, Chronic Phase","2025-05-29",{"date":80,"type":81},"2025-06-03","ACTUAL",{"date":83,"type":81},"2024-02-05",{"date":85,"type":69},"2026-02",{"name":5,"class":6},1]