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A Study of Brequinar in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:
A Phase 1b/2a Open-label, Multi-center Study to Assess the Safety, Efficacy and Pharmacokinetics of Intrapatient Dose-adjusted Brequinar and Inhibition of Dihydroorotate Dehydrogenase (DHODH) in Adult Subjects With AML

Clinical Trial Summary

A Phase 1b/2a multi-center, open-label, non-randomized study to assess the safety, tolerability and efficacy of dose-adjusted brequinar in adult subjects with acute myeloid leukemia (AML). Ribavirin BID may be added to brequinar twice weekly in eligible subjects.

Clinical Trial Description

Up to 27 subjects will be entered in this Phase 1b/2a multi-center, open-label, non-randomized study to assess the safety, tolerability and efficacy of dose-adjusted brequinar in adult subjects with acute myeloid leukemia (AML). Active Cohort 2 subjects on brequinar alone twice weekly may roll over into brequinar twice weekly + ribavirin BID. Cohort 3 subjects will begin treatment with brequinar alone twice weekly then move to brequinar twice weekly + ribavirin BID as tolerated. Both the brequinar and ribavirin doses may be adjusted based on safety, tolerability, and enzyme inhibition levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03760666
Study type Interventional
Source Clear Creek Bio, Inc.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date December 20, 2018
Completion date February 9, 2021
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