CRC 13091: A Phase III, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
Purpose: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.
January 01, 1900
Cancer () - Liver
Philip Gold, M.D.
Swedish Cancer Institute
- Histological or cytological diagnosis of HCC.
- The subject has disease that is not amenable to a curative treatment approach.
- Received prior sorafenib.
- Progression following at least 1 prior systemic treatment for HCC.
- ECOG performance status of 0 or 1.
- Child-Pugh Score of A.
- No fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- No more than 2 prior systemic therapies for advanced HCC
- No prior cabozantinib treatment
- No radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization