Last updated on December 2018

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


Brief description of study

The purpose of 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). Safety and tolerability of ASP2215 will also be evaluated. This study will also 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.

Detailed Study Description

This study is composed of the dose-evaluation part and the expansion part.

In the dose-evaluation part, at least 3 subjects will receive ASP2215 at each dose (low, middle, and high) for determination of MTD and/or RED. Treatment of AML in this study is composed of 3 periods of therapy: remission induction, consolidation, and maintenance. The decision of whether or not to proceed to the next dose will be made based on the occurrence of DLT during Cycle 1 of the induction period.

In the expansion part, a maximum of 3 subjects will receive ASP2215 at RED that has been recommended in the dose-evaluation part and the safety will be assessed based on the onset of DLTs during Cycle 1 of the induction and consolidation periods.

Clinical Study Identifier: NCT02310321

Contact Investigators or Research Sites near you

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Clinical Development Administration Dept.,

Site JP00001
Fukuoka, Japan