Safety, Tolerability, and Efficacy of TAK-659 in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (AML)

Summary

The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in participants with relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate preliminary efficacy of TAK-659 in relapsed or refractory AML as measured by overall response rate (ORR).

Timeline

Start

2015-03-09

Primary completion

2018-06-08

Completion

2018-08-15

Outcome

Outcome not reported

Stopped (Business): “Business Decision; No Safety or Efficacy Concerns.”

Publications

• Pratz KW, Kaplan J, Levy M, Bixby D, Burke PW, Erba H, Wise-Draper TM, Roboz GJ, Papadantonakis N, Rajkhowa T, Hernandez D, Dobler I, Gregory RC, Li C, Wang S, Stumpo K, Kannan K, Miao H, Levis M. A phase Ib trial of mivavotinib (TAK-659), a dual SYK/FLT3 inhibitor, in patients with relapsed/refractory acute myeloid leukemia. Haematologica. 2023 Mar 1;108(3):705-716. doi: 10.3324/haematol.2022.281216.

Drugs

Indications