NCT00858871

First Line Hepato Cellular Carcinoma (HCC)

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,714 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

Conditions

• Hepato Cellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Brivanib	Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
DRUG	Placebo	Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity
DRUG	Sorafenib	Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity
DRUG	Placebo	Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-06-01
• Completion: 2013-09-01
• First posted: 2009-03-10
• Last updated: 2016-10-17

Locations

173 sites across 26 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hong Kong, India, Italy, Japan, Mexico, Poland, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom