Tivantinib in MET-high hepatocellular carcinoma patients and the ongoing Phase III clinical trial.

ABSTRACT: There is no available effective systemic treatment for patients with advanced hepatocellular carcinoma (HCC) who are intolerant of sorafenib or who have disease that has progressed on sorafenib. In Phase I and II studies, tivantinib (ARQ 197), an oral inhibitor of MET, demonstrated promising antitumor activity in patients with HCC, both as monotherapy and in combination with sorafenib. A randomized Phase II trial in second-line HCC showed improved overall survival (hazard ratio: 0.38; p = 0.01) in patients with MET-high tumors, as demonstrated by immunohistochemistry, treated with tivantinib versus placebo. Here we present the treatment rationale and study design of the METIV-HCC Phase III study. This randomized, double-blind study will investigate tivantinib monotherapy as second-line tre

SUBMITTER: Rimassa L 

PROVIDER: S-EPMC6095177 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature