drugset / Trial / NCT05735184
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
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-07-18
- Primary completion
- 2030-04
- Completion
- 2030-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ziftomenib | Small molecule | 200 mg | Oral |
| Subject | Ziftomenib | Small molecule | 400 mg | Oral |
| Subject | Ziftomenib | Small molecule | 600 mg | Oral |
| Background | Azacitidine | Other / unclassified | — | Subcutaneous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Daunorubicin | Small molecule | — | Intravenous |
| Background | Quizartinib | Small molecule | — | Oral |
| Background | Venetoclax | Small molecule | — | Oral |