RecruitingPhase 3NCT06423911
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
Sponsor
Ascentage Pharma Group Inc.
Enrollment
285 participants
Start Date
Feb 5, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Eligibility
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria7
- Patients eligible for inclusion in this study must meet all of the following criteria.
- Age ≥ 18 years old.
- Diagnosis of CML-CP
- Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- Written informed consent obtained prior to any screening procedures.
- Patients with adequate organ functions
Exclusion Criteria7
- Patients eligible for this study must not meet any of the following criteria.
- For Part A only: T315I mutation at any time prior to starting study treatment.
- Active infection that requires systemic drug therapy
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
- Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
- Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
- Pregnant or nursing (lactating) women.
Interventions
DRUGolverembatinib
olverembatinib QOD
DRUGBosutinib
Bosutnib QD
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06423911
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