Trial of ARQ 197 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Who Have Failed One Prior Systemic Therapy

Phase 2 Completed 107 enrolled ArQule, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a global randomized, placebo-controlled, double-blinded Phase 2 study designed to compare treatment of ARQ 197 versus placebo in patients with unresectable HCC who had radiographic disease progression after systemic first line therapy or were unable to tolerate the therapy.

Timeline

Start: 2009-09
Primary completion: 2011-10
Completion: 2012-03

Outcome

Met primary endpoint

paper Time to progression was longer for patients treated with tivantinib PMID 23182627 ↗

paper than placebo (1·4 months [1·4-1·5]; hazard ratio [HR] 0·64, 90% CI 0·43-0·94; p=0·04). PMID 23182627 ↗

Publications

Santoro A, Rimassa L, Borbath I, Daniele B, Salvagni S, Van Laethem JL, Van Vlierberghe H, Trojan J, Kolligs FT, Weiss A, Miles S, Gasbarrini A, Lencioni M, Cicalese L, Sherman M, Gridelli C, Buggisch P, Gerken G, Schmid RM, Boni C, Personeni N, Hassoun Z, Abbadessa G, Schwartz B, Von Roemeling R, Lamar ME, Chen Y, Porta C. Tivantinib for second-line treatment of advanced hepatocellular carcinoma: a randomised, placebo-controlled phase 2 study. Lancet Oncol. 2013 Jan;14(1):55-63. doi: 10.1016/S1470-2045(12)70490-4. Epub 2012 Nov 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tivantinib	Small molecule	240 mg	Oral
Subject	Tivantinib	Small molecule	360 mg	Oral