CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 383 enrolled
Drug / intervention
Tivantinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01755767
NCT01755767Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects With MET Diagnostic-High Inoperable Hepatocellular Carcinoma Treated With One Prior Systemic Therapy

Daiichi Sankyo·interventional·Posted Dec 24, 2012·Updated Apr 6, 2021

In Brief

A Phase 3 clinical trial evaluating Tivantinib and Placebo for Hepatocellular Carcinoma. Completed, enrolled 383 participants across 112 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Italy, Netherlands, New Zealand, Portugal, Spain, Sweden, Switzerland, United States
CollaboratorsArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2012
Enrollment StartDec 27, 2012
Primary CompletionMar 28, 2017
Study CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.5 years ago

Interventions

Tivantinibdrug

Tivantinib tablets

Placebodrug

Matching placebo tablets