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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02071862
Other study ID # CX-839-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2014
Est. completion date March 2019

Study information

Verified date February 2020
Source Calithera Biosciences, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - Advanced malignancy that is relapsed and/or refractory to all available therapies that will confer clinical benefit. Newly diagnosed patients who refuse standard treatment regimens are also eligible - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Life Expectancy of at least 3 months - Adequate hepatic, renal, cardiac, and hematologic function - Measurable disease by RECIST criteria - Ability to provide written informed consent in accordance with federal, local, and institutional guidelines Exclusion Criteria - Any other current or previous malignancy - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological therapy, or investigational agent within 21 days - Unable to receive medications oral medications - Major surgery within 28 days before Cycle 1 Day 1 - Active infection requiring within 2 weeks prior to first dose of study drug - Patients who have HIV, Hepatitis A, B or C or CMV reactivation - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose of study drug - Conditions that could interfere with treatment or protocol-related procedures

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CB-839
CB-839 monotherapy
Pac-CB
CB-839 in combination with standard dose paclitaxel
CBE
CB-839 in combination with standard dose everolimus
CB-Erl
CB-839 in combination with standard dose erlotnib
CBD
CB-839 in combination with standard dose docetaxel
CB-Cabo
CB-839 in combination with standard dose cabozantinib

Locations

Country Name City State
United States Winship Cancer Institute of Emory School of Medicine Atlanta Georgia
United States NIH - NCI - Center for Cancer Research Bethesda Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Tennessee Oncology, PLLC Nashville Tennessee
United States Columbia University Medical Center New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Florida Cancer Specialists Sarasota Florida
United States Stanford University Medical Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Calithera Biosciences, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of CB-839: Incidence of adverse events Every 21 days from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months
Secondary Pharmacokinetics: Area under the Curve (AUC) of CB-839 concentration in blood Study Days 1, 15, and 22
Secondary Pharmacodynamics: % inhibition of glutaminase in blood Study Days 1 and 15
Secondary Clinical activity: Change in tumor volume from baseline Every 9 weeks until disease progression or unacceptable toxicity, assessed for an expected average of 6 months
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