A Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With CML (POLARIS-2)

May 16, 2024 updated by: Ascentage Pharma Group Inc.

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Myeloid Leukemia

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

285

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 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 TKIs
Drug: olverembatinib
olverembatinib QOD
Drug: Bosutinib
Bosutnib QD
Other: Arm B:
To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously
Drug: olverembatinib
olverembatinib QOD

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascentage Pharma Group Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HQP1351CG301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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