Trials / Recruiting

RecruitingNCT05735184

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

Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 420 (estimated)

Sponsor: Kura Oncology, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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 efficacy of ziftomenib in combination with SOC drugs to treat AML.

Conditions

Interventions

Type	Name	Description
DRUG	Ziftomenib	Oral Administration
DRUG	Venetoclax	Oral Administration
DRUG	Azacitidine	Subcutaneous or Intravenous Administration
DRUG	Daunorubicin	Intravenous Administration
DRUG	Cytarabine	Intravenous Administration
DRUG	Quizartinib	Oral Administration

Timeline

Start date: 2023-07-18
Primary completion: 2030-04-01
Completion: 2030-04-01
First posted: 2023-02-21
Last updated: 2026-03-13

Locations

44 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05735184. Inclusion in this directory is not an endorsement.