Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: Olverembatinib (HQP1351): Route of Administration - Oral
Part A
Olverembatinib is administered orally, 30 mg, once every other day (QOD) with food.
Part B
Olverembatinib is administered
Sponsors
Ascentage Pharma Group Inc.,
IQVIA RDS INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must meet all of the following criteria. 1 Age 18 years or above. 2 Diagnosis of CML-CP 3 Part A: Previously treated with at least two approved TKIs Part B: with T315I mutation at screening. 4 Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2. 5 Written informed consent obtained prior to any screening procedures. 6 Patients with adequate organ functions
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Randomized Controlled Arms: To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib Part B: Single Arm: To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutationTimepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Randomized Controlled Arms: To compare the MMR rate at 96 weeks of olverembatinib versus bosutinib Part B: Single Arm: To evaluate the MMR rate by 96 weeks of olverembatinib in CML-CP patients with T315I mutationTimepoint: 96 weeks;Part A: Randomized Controlled Arms Other Secondary Objectives 1 To compare additional efficacy parameters of olverembatinib versus bosutinib 2 To compare the safety profile of olverembatinib versus bosutinib 3 To characterize the population pharmacokinetics (Pop PK) of olverembatinib in the CML-CP population 4 To evaluate Patient-Reported Outcome (PRO) measures of olverembatinib vs. bosutinib based on Europol 5 Dimension (EQ-5D). 5 To evaluate Health Economics Outcomes Research (HEOR) measures of olverembatinib vs. bosutinib based on EORTC QLQ-C30. Timepoint: 4 weeks & 8 weeks;Part B: Single Arm Other Secondary Objectives 1 To evaluate additional efficacy parameters of olverembatinib in CML-CP patients with T315I mutation 2 To evaluate the safety profile of olverembatinib in CML-CP patients with T315I mutation 3 To characterize the population PK of olverembatinib in the CML-CP population with T315I mutation 4 To evaluate patient-reported outcomes (PRO) measures of olverembatinib using Europol 5 Dimension (EQ-5D) 5 To evaluate Health Economics Outcomes Research (HEOR) measures of olverembatinib based on EORTC QLQ-C30. Timepoint: 4 weeks & 8 weeks | — |
Countries
Australia, Belgium, Canada, France, Germany, India, Italy, Poland, Republic of Korea, Russian Federation, Singapore, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed