Spots Global Cancer Trial Database for Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors
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Trial Identification
Brief Title: Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors
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 Advanced and/or Treatment-Refractory Hematological Malignancies
Study ID: NCT02071888
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 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Keith W Orford, MD, PhD
Affiliation: Calithera Biosciences
Role: STUDY_DIRECTOR
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