drugset / Trial / NCT03850535
A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission
Non-randomizedSequentialOpen-labelTreatment
Summary
This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).
Timeline
- Start
- 2019-03-25
- Primary completion
- 2020-09-10
- Completion
- 2020-09-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 1.5 g | Intravenous |
| Subject | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Idasanutlin | Small molecule | — | Oral |