NCT01009593

Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,035 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.

Detailed description

The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.

Conditions

• Hepatocellular Carcinoma Non-resectable
• Hepatocellular Carcinoma Recurrent
• Carcinoma, Hepatocellular
• Liver Diseases
• Neoplasms by Histologic Type
• Digestive System Neoplasms
• Carcinoma
• Liver Neoplasms
• Neoplasms
• Neoplasms by Site
• Digestive System Diseases
• Adenocarcinoma
• Neoplasms, Glandular and Epithelial

Interventions

Type	Name	Description
DRUG	ABT-869	Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity
DRUG	Sorafenib	Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-11-06
• Last updated: 2012-09-10

Locations

163 sites across 29 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, Denmark, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Taiwan