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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06423911
Other study ID # HQP1351CG301
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 2024
Est. completion date February 2026

Study information

Verified date May 2024
Source Ascentage Pharma Group Inc.
Contact Ben Little
Phone 301-509-3222
Email ben.little@ascentage.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)


Description:

This is a global, multi-center, open-label randomized and registrational phase 3 study of olverembatinib: Part A is a 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 tyrosine kinase inhibitors (TKIs). Part B is to evaluate the efficacy and safety of olverembatinib in the CML- CP patients with T315I mutation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 285
Est. completion date February 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: Patients eligible for inclusion in this study must meet all of the following criteria. 1. Age = 18 years old. 2. Diagnosis of CML-CP 3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2. 5. Written informed consent obtained prior to any screening procedures. 6. Patients with adequate organ functions Exclusion Criteria: Patients eligible for this study must not meet any of the following criteria. 1. For Part A only: T315I mutation at any time prior to starting study treatment. 2. Active infection that requires systemic drug therapy 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients. 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients. 6. Pregnant or nursing (lactating) women.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
olverembatinib
olverembatinib QOD
Bosutinib
Bosutnib QD

Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Ascentage Pharma Group Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary MMR rate Part A To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib 24 weeks
Primary MMR rate Part B To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation 24 weeks
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