Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors
Completed · Phase 1
Conditions studied: Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma, Waldenstrom's Macroglobulinemia (WM), Other B-cell NHL Subtypes, Including WM, T-cell NHL
In brief
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 advanced hematologic malignancies. This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological tumors. Patients will receive CB-839 capsules orally two or three times daily. The study will be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended Phase 2 dose and will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM) In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM). 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. As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with relapsed or refractory disease following at least 2 prior treatment regimens will be enrolled to receive CB-839 in combination with standard-dose pomalidomide and low-dose dexamethasone to further evaluate this triple combination.
Key facts
- Study ID
- NCT02071888
- Run by
- Calithera Biosciences, Inc
- People needed
- 25
- Starts
- 2014-02-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2018-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Any other current malignancy
- Treatment with an unapproved, investigational therapeutic agent, immunotherapy or biological therapy within 21 days prior to the first dose of study drug
- Recent bone marrow transplant
- Unable to receive medications by mouth
- Major surgery within 28 days before the first dose of study drug
- Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation
- Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to the first dose of study drug
- Refractory nausea and vomiting or other situation that may preclude adequate absorption
- Other conditions that could interfere with treatment
Where it is running
- Mayo Clinic — Scottsdale, Arizona, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Winship Cancer Institute of Emory School of Medicine — Atlanta, Georgia, United States
- John Theruer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
- Weill Cornell Medical College — New York, New York, United States
- University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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