drugset / Trial / NCT03298984
Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this Phase I study is to determine the safety and tolerability including the maximum dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML
Timeline
- Start
- 2017-09-25
- Primary completion
- 2020-03-20
- Completion
- 2020-03-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | alvocidib | Small molecule | 30 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Background | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |