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Therapeutic Areas: Oncology | Nephrology/Urology
Disease Category: Liver Cancer

Trial Information

A Phase 1 Open Label/Phase 2 Randomized, Double-Blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar) in Patients with Advanced Hepatocellular Carcinoma

You have been asked to participate in this research study because you have Hepatocellular cancer (cancer of the liver). The purpose of the first part of this study is to determine the highest dose of the study drug RAD001 that can be added without causing unmanageable side effects to sorafenib, a drug recently approved and considered to be an effective therapy for patients with this type and stage of liver cancer.  The purpose of the second part of this study is to compare the feasibility and effectiveness of adding the study drug RAD001 to sorafenib to treatment with sorafenib plus placebo (capsule that looks like RAD001 but that contains no active drug). The study also includes biomarker research using previously collected tumor samples (if available) and blood collected during the study. Biomarkers are chemicals in the blood that may be associated with liver cancer. Analyzing changes in biomarkers over the course of treatment will help scientists better understand how RAD001 works in the body, identify persons with liver cancer who will have the best possible response to RAD001, and identify persons who will have fewer side effects from RAD001. Repeated blood samples will be taken to study the levels of RAD001 that stay in the body over time. Your treatment on this study is expected to last for as long as your tumor is not growing and you are not having any unmanageable side effects. After your treatment on this study is complete, your medical condition will be followed on this study for one year after the end of the entire study.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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