NCT04079738

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

Phase I/II Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition of the Proteasome Inhibitor Ixazomib: Big Ten Cancer Research Consortium BTCRC-HEM17-092

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: H Scott Boswell · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• AML
• AML, Adult

Interventions

Type	Name	Description
DRUG	TAK-659	TAK-659
DRUG	Ixazomib	Ixazomib

Timeline

• Start date: 2019-09-20
• Primary completion: 2021-09-22
• Completion: 2022-02-23
• First posted: 2019-09-06
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study