KRT-232 and TKI Study in Chronic Myeloid Leukemia

Official Title

An Open-Label, Multicentre, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

Summary:

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

Trial Description

Primary Outcome:

  • Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232
  • Part 2, Arm A and B: Major molecular response (MMR) rate
  • Part 2, Arm C: Major hematological response (MaHR) rate
Secondary Outcome:
  • CCyR rate
  • MCyR rate
  • Duration of response
  • Rate of complete hematologic response (CHR)
  • Progression-free survival (PFS) in each Arm
  • Overall survival (OS) in each Arm

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