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

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Angiogenesis Modulating Agents; Molecular Mechanisms of Pharmacological Action; Niacinamide; Sorafenib

Criteria

Inclusion Criteria

• Histologic or cytologic diagnosis with unresectable or metastatic HCC

• Child Pugh Class A

• ECOG performance status 0-1

• Adequate hematologic, hepatic, and renal function

Exclusion Criteria

• Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC

• Prior local therapy (including liver-directed therapy) within 4 weeks from entry

• Untreated brain or meningeal metastases

• Current treatment on another clinical trial

• Pregnancy or breastfeeding