CB-839 in Advanced and/or Treatment-Refractory Solid Tumors
A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839, as a Single Agent and in Combination with Standard Chemotherapy in Patients with Advanced/Treatment-Refractory Solid Tumors
This study is being done to determine how patients with advanced or refractory solid tumors (cancer that continues to grow in spite of receiving standard treatment) respond to increasing doses of an investigational drug, CB-839, to determine the dose of CB-839 that can be given without causing severe side effects and to look for early signs of clinical activity. CB-839 blocks the production of glutamate which is critical for tumor cell growth. Investigational means that has not been approved by the United States Food and Drug Administration (FDA) for use outside of research studies. This study will also determine the effect of the study drug by analyzing biomarkers. Biomarkers are substances in your body that can be used to detect a disease or to find out how the cancer is responding to treatment. In this study, biomarkers found in tumor tissue and blood will be collected and tested to see if the study drug causes changes in the way the cancer behaves.
Are you Eligible? (Inclusion Criteria)
To be in this study you must be 18 years or older. Patients with confirmed diagnosis of locally-advanced, inoperable, metastatic and/or have solid tumors that are not responding to treatment are eligible for this study. The following types of cancer are included in this study: Triple negative breast cancer, Non-small cell lung cancer, mesothelioma, renal cell carcinoma, melanoma, head and neck squamous cell carcinoma, colorectal cancer, sarcoma and pancreatic cancer.