Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia (CML) to Characterize the Efficacy and Safety of a Range of Doses

Official Title

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Summary:

The purpose of this study is to compare and characterize the efficacy and safety of ponatinib in patients with resistant chronic myeloid leukemia (CML) in chronic phase (CP) in a range of doses.

Trial Description

Primary Outcome:

  • Major cytogenetic response (MCyR)
Secondary Outcome:
  • Rates of vascular occlusive events (VOEs), adverse events (AEs), and serious AEs (SAEs)
  • Safety measured by comparing frequencies of AEs, SAEs and VOEs
  • Analysis of the relationship between steady-state plasma ponatinib exposure [peak plasma concentration (CMAX) and area-under-the-curve (AUC)] and safety measures (VOEs and any AEs that occur in at least 30 patients)
  • Analysis of the relationship between steady-state plasma ponatinib exposure (AUC and CMAX) and efficacy measures (MCyR, MR2, and MMR)
This is a multi-centre, randomized, phase 2 trial to characterize the safety and efficacy of ponatinib over a range of 3 starting doses. Eligible patients must have chronic phase chronic myeloid leukemia (CP-CML) and be resistant to at least 2 tyrosine kinase inhibitors (TKIs).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society