Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

Official Title

A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination With Venetoclax in Adult Patients With Acute Myeloid Leukemia

Summary:

The Phase 1 portion of this study is a single-arm, open-label, multicentre, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will follow the same overall study design as Phase 1.

Trial Description

Primary Outcome:

  • Pharmacokinetic parameter: AUC0-24
  • Pharmacokinetic parameter: Cmax
  • Complete Response (CR)
Secondary Outcome:
  • Pharmacokinetic parameter: AUC0-24
  • Pharmacokinetic parameter: Cmax
  • Pharmacokinetic parameter: AUC0-8
  • Pharmacokinetic parameter: AUC0-inf
  • Pharmacokinetic parameter: 5-day AUC
  • Safety: Participants with TEAEs
  • Complete response (CR)
  • Time to Response
  • Duration of Response
  • Overall Survival

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