Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

ClinicalTrials.gov ID: NCT02071862

Public ClinicalTrials.gov record NCT02071862. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Ph1 Study of the Safety, PK, and PDn of Escalating Oral Doses of the Glutaminase Inhibitor CB-839, as a Single Agent and in Combination With Standard Chemotherapy in Patients With Advanced and/or Treatment-Refractory Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 solid tumors. This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839 capsules orally twice or three times daily. In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D) Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation tumors. As an extension of Parts 1 \& 2, patients will be treated with CB-839 in combination with standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo. Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated with cabozantinib in combination with CB-839. 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.

Study identification

NCT ID: NCT02071862
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Calithera Biosciences, Inc; Industry
Enrollment: 210 participants

Conditions and interventions

Conditions

Interventions

CB-839 Drug
Pac-CB Drug
CBE Drug
CB-Erl Drug
CBD Drug
CB-Cabo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 31, 2014
Primary completion: Feb 28, 2019
Completion: Feb 28, 2019
Last update posted: Jul 19, 2022

2014 – 2019

United States locations

U.S. sites: 13
U.S. states: 9
U.S. cities: 10

Facility	City	State	ZIP	Site status
UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	94143	—
Stanford University Medical Center	Stanford	California	94305	—
Florida Cancer Specialists	Sarasota	Florida	34232	—
Winship Cancer Institute of Emory School of Medicine	Atlanta	Georgia	30322	—
NIH - NCI - Center for Cancer Research	Bethesda	Maryland	20892	—
Massachusetts General Hospital	Boston	Massachusetts	02114	—
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	—
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	—
Columbia University Medical Center	New York	New York	10032	—
Memorial Sloan Kettering Cancer Center	New York	New York	10065	—
University of Pennsylvania, Abramson Cancer Center	Philadelphia	Pennsylvania	19104	—
Tennessee Oncology, PLLC	Nashville	Tennessee	37203	—
University of Texas MD Anderson Cancer Center	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02071862, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 19, 2022 · Synced Sep 7, 2026

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