NCT01755767

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Expression of c-Met in tumors correlates with aggressive hepatocellular carcinoma (HCC) features. Overexpression of the receptor in tumor samples or high level of blood HGF in subjects is related to higher recurrence rate after surgery for HCC, while high c-Met expression correlates with shorter survival in HCC subjects. In summary, c-Met holds an important prognostic role in the natural history of HCC. This Phase 3 study in MET Diagnostic-High inoperable HCC subjects has been designed based on the results from the randomized, controlled Phase 2 study conducted by ArQule, Inc. with tivantinib versus placebo in subjects with MET Diagnostic-High inoperable HCC who have failed one prior systemic therapy, mentioned above. The purpose of this study is to confirm the efficacy of tivantinib in MET Diagnostic-High HCC subjects who were previously treated with one systemic therapy, and to further evaluate the safety profile of the experimental drug in this subject population.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Tivantinib	Tivantinib tablets
DRUG	Placebo	Matching placebo tablets

Timeline

• Start date: 2012-12-27
• Primary completion: 2017-03-28
• Completion: 2017-07-31
• First posted: 2012-12-24
• Last updated: 2021-04-06
• Results posted: 2020-07-15

Locations

112 sites across 16 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Italy, Netherlands, New Zealand, Portugal, Spain, Sweden, Switzerland