Study of Olverembatinib (HQP1351) in Patients With CP-CML
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAscentage Pharma Group Inc.
About this trial
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- olverembatinib
- Bosutinib
Treatment groups
285 Participants
are divided into 2 treatment groupsLocations
1MD Anderson Cancer Center77030, HoustonTexas, United States
Sponsors and collaborators
Ascentage Pharma Group Inc.
Lead sponsor
Source ClinicalTrials.gov