A randomized, double‐blind, placebo‐controlled, phase 3 study of tivantinib in Japanese patients with MET‐high hepatocellular carcinoma

• DOI: 10.1111/cas.14582
• Publication Date: 2020-07-27T10:40:27Z
• Authors: Masatoshi Kudo; Manabu Morimoto; Michihisa Moriguchi; Namiki Izumi; Tetsuji Takayama; Hitoshi Yoshiji; Keisuke Hino; Takayoshi Oikawa; Tetsuhiro Chiba; Kenta Motomura; Junko Kato; Kentaro Yasuchika; Akio Ido; Takashi Sato; Daisuke Nakashima; Kazuomi Ueshima; Masafumi Ikeda; Takuji Okusaka; Kazuo Tamura; Junji Furuse
• Keywords: Discontinuation; Clinical endpoint

A previous randomized phase 2 study of hepatocellular carcinoma revealed that the c-Met inhibitor tivantinib as second-line treatment significantly prolonged progression-free survival in a subpopulation whose tumor samples highly expressed (MET-high). Accordingly, this 3 was conducted to evaluate efficacy for Japanese patients with MET-high carcinoma. This randomized, double-blind, placebo-controlled at 60 centers Japan. Hepatocellular one prior sorafenib and those were eligible inclusion. Registered randomly assigned either or placebo group 2:1 ratio treated twice-a-day oral (120 mg bid) until discontinuation criteria met. The primary endpoint while secondary endpoints included overall safety. Between January 2014 June 2016, 386 provided consent, 195 (n = 134) 61) group. Median 2.8 (95% confidence interval: 2.7-2.9) 2.3 (1.5-2.8) mo groups, respectively (hazard 0.74, 95% 0.52-1.04, P .082). 10.3 8.1-11.6) 8.5 (6.2-11.4) group, 0.82, 0.58-1.15). most common tivantinib-related grade ≥3 adverse events neutropenia (31.6%), leukocytopenia (24.8%), anemia (12.0%). did not confirm significant (NCT02029157).