A Multicenter, randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Levantinib (E7080) versus Sorafenib in First Line Treatment of Subjects with Unresectable Hepatocellular Carcinoma
ID Number 13-0983Principal Investigator(s)
Max W Sung
Department(s) or Division(s)
Hematology and Medical Oncology
Lenvatinib (E7080) is a drug that is being developed for the treatment of cancer, including unresectable hepatocellular carcinoma. The main purpose of this study is to test the effect on survival of lenvatinib (E7080) on subjects with your type of liver cancer. In order to evaluate lenvatinib, this study will be comparing lenvatinib against sorafenib (Nexavar®). Levantinib is an experimental drug, meaning it is not approved by the United States Food and Drug Administration for use except in research studies like this one.
Sorafenib is an FDA-approved drug for the treatment of your type of advanced liver cancer, as well as for kidney cancer. The purpose of the study is to see if there is any shrinkage of tumors and for how long any effect on the tumor lasts. The study will also collect information on how long subjects live and the side effects that subjects may experience during the study. Lenvatinib is being evaluated to see if it can stop the formation of new blood vessels that help tumors to grow and spread. It is not known whether the study drug will have any better effect on your cancer compared to what is normally expected for liver cancer with approved treatments.
Recruiting Patients: Yes