Overview

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.

Status:
Active, not recruiting

Trial end date:
2022-12-31

Target enrollment:

Participant gender:

Summary

The purpose of phase 1 part in this study is to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly diagnosed Acute Myeloid Leukemia (AML) subjects. Phase 1 part will also evaluate safety and tolerability and characterize the pharmacokinetic (PK) parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluate the PK parameters of cytarabine concomitant with ASP2215. The purpose of phase 2 part is to evaluate efficacy of ASP2215 in combination with induction therapy. Phase 2 cohort will also evaluate safety and characterize the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Astellas Pharma Inc

Treatments:

Cytarabine
Idarubicin