Study of the Glutaminase Inhibitor CB-839 in Leukemia
- Conditions
- Acute Myeloid Leukemia (AML)Acute Lymphocytic Leukemia (ALL)
- Interventions
- Drug: CB-Aza
- Registration Number
- NCT02071927
- Lead Sponsor
- Calithera Biosciences, Inc
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CB-839 CB-839 CB-839 administered as oral capsules two (BID) or three times daily (TID) in 21-day cycles until disease progression or unacceptable toxicity CB-Aza CB-839 CB-839 administered as oral capsules twice daily (BID) in combination with azacitidine in 28-day cycles until disease progression or unacceptable toxicity CB-Aza CB-Aza CB-839 administered as oral capsules twice daily (BID) in combination with azacitidine in 28-day cycles until disease progression or unacceptable toxicity
- Primary Outcome Measures
Name Time Method Safety and tolerability of CB-839: Incidence of adverse events Every 21 days from study start until disease progression or unacceptable toxicity, assessed an expected average of 6 months
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Area under the Curve (AUC) of CB-839 concentration in blood Study Days 1, 15, and 22 Clinical Activity: % of Tumor Cells in Bone Marrow Every 21 days from study start, assessed for an expected average of 6 months Pharmacodynamics: % inhibition of glutaminase in blood Study Days 1 and 15
Trial Locations
- Locations (5)
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States