A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion. The purpose of this study is to assess the safety, tolerability, and early signs of effi

Trial Details

NCT ID
NCT05735184
Phase
PHASE1
Sponsor
Kura Oncology, Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Ziftomenib
  • Venetoclax
  • Azacitidine
  • Daunorubicin
  • Cytarabine
  • Quizartinib
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
  • Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-tar…
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Adequate liver, renal, and cardiac function according to protocol defined criteria

For full eligibility, visit ClinicalTrials.gov.

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