Condition
Solid Tumors|Triple-Negative Breast Cancer|Non Small Cell Lung Cancer|Renal Cell Carcinoma|Mesothelioma|Fumarate Hydratase (FH)-Deficient Tumors|Succinate Dehydrogenase (SDH)-Deficient Gastrointestinal Stromal Tumors (GIST)|Succinate Dehydrogenase (SDH)-Deficient Non-gastrointestinal Stromal Tumors|Tumors Harboring Isocitrate Dehydrogenase-1 (IDH1) and IDH2 Mutations|Tumors Harboring Amplifications in the cMyc Gene
Estimated Enrollment: 205
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: CX-839-001
Study First Received: February 14, 2014
Last Updated: August 18, 2016
Estimated Primary Completion Date: June 2017
Primary Outcome Measures:
Safety and tolerability of CB-839: Incidence of adverse events|Pharmacokinetics: Area under the Curve (AUC) of CB-839 concentration in blood|Pharmacodynamics: % inhibition of glutaminase in blood|Clinical activity: Change in tumor volume from baseline
Sponsors and Collaborators:
Calithera Biosciences, Inc
Website Link: https://ClinicalTrials.gov/show/NCT02071862
