drugset / Trial / NCT04079738

Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib

NCT04079738

Phase 1/2 Terminated 8 enrolled H Scott Boswell Takeda · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase I/II study augmenting TAK-659 action in relapsed/refractory AML by addition of the proteasome inhibitor Ixazomib. Phase I of the study will determine the safety, tolerability, and maximum tolerated dose (MTD) of the combination of TAK-659 and Ixazomib. During the phase I, dose escalation will be conducted according to a standard 3+3 dose escalation schema, and up to 18 response-evaluable patients will be enrolled. Phase II of the study will evaluate the efficacy of the combination by measuring the overall response rate (ORR).

Timeline

Start
2019-09-20
Primary completion
2021-09-22
Completion
2022-02-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Ixazomib Unknown
Subject mivavotinib Small molecule