A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)

NCT02029157 ↗

Phase 3 Completed 386 enrolled Kyowa Kirin, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.

Timeline

Start: 2014-01
Primary completion: 2017-08
Completion: 2017-08

Outcome

Missed primary endpoint

paper Median progression-free survival was 2.8 (95% confidence interval: 2.7-2.9) and 2.3 (1.5-2.8) mo in the tivantinib and placebo groups, respectively (hazard ratio = 0.74, 95% confidence interval: 0.52-1.04, P = .082). PMID 32716114 ↗

paper This study did not confirm the significant efficacy of tivantinib as a second-line treatment for Japanese patients with MET-high hepatocellular carcinoma. PMID 32716114 ↗

release “top-line results of a Japanese Phase 3 study of ARQ 197 (generic name: tivantinib) did not meet its primary endpoint.” kyowakirin.com ↗

Publications

Kudo M, Morimoto M, Moriguchi M, Izumi N, Takayama T, Yoshiji H, Hino K, Oikawa T, Chiba T, Motomura K, Kato J, Yasuchika K, Ido A, Sato T, Nakashima D, Ueshima K, Ikeda M, Okusaka T, Tamura K, Furuse J. A randomized, double-blind, placebo-controlled, phase 3 study of tivantinib in Japanese patients with MET-high hepatocellular carcinoma. Cancer Sci. 2020 Oct;111(10):3759-3769. doi: 10.1111/cas.14582. Epub 2020 Aug 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tivantinib	Small molecule	120 mg	Oral