Study of the Glutaminase Inhibitor CB-839 in Leukemia
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.