drugset / Trial / NCT03298984

Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).

NCT03298984

Phase 1 Completed 32 enrolled Sumitomo Pharma America, Inc.
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

EvaluationDrugModalityDoseRoute
Subject alvocidib Small molecule 30 mg/m2 Intravenous
Background Cytarabine Small molecule 100 mg/m2 Intravenous
Background Daunorubicin Small molecule 60 mg/m2 Intravenous