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Spots Global Cancer Trial Database for Study of the Glutaminase Inhibitor CB-839 in Leukemia

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Trial Identification

Brief Title: Study of the Glutaminase Inhibitor CB-839 in Leukemia

Official Title: A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients With Relapsed and/or Treatment-Refractory Leukemia

Study ID: NCT02071927

Interventions

CB-839
CB-Aza

Study Description

Brief Summary: Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with leukemia. This study is an open-label Phase 1 evaluation of CB-839 in subjects with leukemia. Part 1 is a dose escalation study to identify the recommended Phase 2 dose as a single agent and in combination with azacitidine. Patients enrolled into Part 2 will be treated with the recommended Phase 2 dose. As an extension of Part 2, patients with relapsed/ refractory or newly diagnosed AML will be treated with CB-839 in combination with azacitidine. All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Colorado Blood Cancer Institute, Denver, Colorado, United States

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Tennessee Oncology, PLLC, Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Keith W Orford, MD, PhD

Affiliation: Calithera Biosciences

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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