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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Part A

Primary Objective:

Secondary Objectives:

To compare the MMR rate at 96 weeks for olverembatinib versus bosutinib
To compare additional parameters of the efficacy of olverembatinib versus bosutinib
To compare the safety profile of olverembatinib versus bosutinib
To characterize the Population PK of olverembatinib in the CML-CP population
To evaluate Patient-Reported Outcome (PRO) measures of olverembatinib
To evaluate Health Economics Outcomes Research (HEOR) measures of olverembatinib

Part B

Primary Objective:

To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation

Secondary Objectives:

To evaluate the MMR rate by 96 weeks of olverembatinib in CML-CP patients with T315I mutation
To compare additional parameters of the efficacy of olverembatinib in CML-CP patients with T315I mutation
To evaluate the safety profile of olverembatinib in CML-CP patients with T315I mutation
To characterize the population PK of olverembatinib in the CML-CP population with T315I mutation
To evaluate PRO measures of olverembatinib
To evaluate HEOR measures of olverembatinib

Eligibility

Inclusion Criteria:

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 Criteria:

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices