Clinical Trial Information
Protocol: ECOG – EA2187
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Patient must be ≥ 18 years of age.
- Patient must have an ECOG Performance Status 0-1.
- Patient must have histologically confirmed intrahepatic cholangiocarcinoma or biphasic hepatocellular carcinoma and cholangiocarcinoma that is metastatic or unresectable and who have progressed on or been intolerant of one prior line of systemic gemcitabine containing chemotherapy regimen.
NOTE: Prior immunotherapy or targeted therapies are allowed and will not be considered a line of therapy unless administered with cytotoxic chemotherapy.
- Patient must have measurable disease.
- Patient must not have had major surgery within 14 days before randomization. Patients with surgery planned during study period are ineligible.
- Patient must not be receiving any other investigational agents.
- Patient must not have received chemotherapy or radiotherapy within 2 weeks prior to randomization. Prior treatment with radiation therapy involving ≥ 25% of hematopoietically active bone marrow will be ineligible.
- Patient must not have received immunotherapy within 8 weeks prior to randomization.
- Patient must not be receiving any treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug as below. Clinically significant metabolic enzyme inducers are not permitted during the study. Patients must not be receiving any medications or substances that are strong inducers of CYP3A4/5 (i.e. phenytoin, rifampin, St. Johns wort) or inhibitors of BCRP (i.e. cyclosporine). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if a new medication need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Inhibitors of CYP3A4/5 are allowed.