Clinical Trial TitleA phase 1b/2, open label, dose escalation and expansion study of the glutaminase inhibitor telaglenastat (CB-839) in combination with the CDK4/6 inhibitor palbociclib in patients with advanced or metastatic solid tumors.
National Clinical Trial Number:NCT02071862
Clinical Trial Protocol Description:
The purpose of this study is to determine a safe and tolerable dose of telaglenastat (an “investigational” drug), given together with palbociclib (an “approved” drug), and if it has an effect on your type of cancer. An "investigational" drug means that the drug has not been approved by the United States Food and Drug Administration (FDA) or any other health authority in the world for use outside of research studies and must be tested to see if it is a safe and effective treatment for the disease or condition being studied. An “approved” drug means that the drug has been tested and approved for sale by the FDA and can be prescribed by your doctor. The combination of using telaglenastat together with palbociclib is also investigational and has not been approved by the United States Food and Drug Administration (FDA) or any other health authority in the world for use outside of research studies.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 yearsof age or older.
- Have at least a measurable disease with one tumor lesion/lymph node that meets the Response Evaluation Criteria in Solid Tumors.
- Fresh tumor biopsy is mandatory if archival tissue not available.
- Have a serum creatinine ≤ 2.0 × upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockcroft-Gault equation.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.