drugset / Trial / NCT01755767

Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy

Phase 3 Completed 383 enrolled Daiichi Sankyo ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.

Timeline

Start: 2012-12-27
Primary completion: 2017-03-28
Completion: 2017-07-31

Outcome

Missed primary endpoint

paper Tivantinib did not improve overall survival compared with placebo in patients with MET-high advanced hepatocellular carcinoma previously treated with sorafenib. PMID 29625879 ↗

paper hazard ratio 0·97; 95% CI 0·75-1·25; p=0·81 PMID 29625879 ↗

release “today announced that the METIV-HCC phase 3 study of tivantinib in hepatocellular carcinoma (HCC) did not meet its primary endpoint of improving overall survival.” daiichisankyo.com ↗

Publications

Rimassa L, Assenat E, Peck-Radosavljevic M, Pracht M, Zagonel V, Mathurin P, Rota Caremoli E, Porta C, Daniele B, Bolondi L, Mazzaferro V, Harris W, Damjanov N, Pastorelli D, Reig M, Knox J, Negri F, Trojan J, Lopez Lopez C, Personeni N, Decaens T, Dupuy M, Sieghart W, Abbadessa G, Schwartz B, Lamar M, Goldberg T, Shuster D, Santoro A, Bruix J. Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study. Lancet Oncol. 2018 May;19(5):682-693. doi: 10.1016/S1470-2045(18)30146-3. Epub 2018 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tivantinib	Small molecule	120 mg	Oral
Subject	Tivantinib	Small molecule	240 mg	Oral