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

Summary

The purpose of phase 1 part in this study was 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 also evaluated safety and tolerability and characterized the pharmacokinetic (PK) parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluated the PK parameters of cytarabine concomitant with ASP2215. The purpose of phase 2 part was to evaluate efficacy of ASP2215 in combination with induction therapy. Phase 2 cohort also evaluated safety and characterized the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects.

Timeline

Start

2015-02-26

Primary completion

2021-08-25

Completion

2024-07-09

Publications

• Sawa M, Miyamoto T, Kim HJ, Hiramatsu Y, Cheong JW, Ikezoe T, Naoe T, Akashi K, Morita S, Kosako M, Shimura M, Terada W, Kadokura T, Hill J, Miyawaki S, Gill SC, Heinloth A, Hasabou N. A phase I/II study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia: final analysis. Ther Adv Hematol. 2026 Mar 11;17:20406207261419953. doi: 10.1177/20406207261419953. eCollection 2026.

Drugs

Indications