Spots Global Cancer Trial Database for Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib
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Trial Identification
Brief Title: Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib
Official Title: 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
Study ID: NCT04079738
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Contact Details
Name: H Scott Boswell, MD
Affiliation: Indiana University Melvin and Bren Simon Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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