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) - LiGHT

• Conditions: Advanced Hepatocellular Carcinoma (HCC); MedDRA version: 12.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectable; MedDRA version: 12.0Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrent

• Registration Number: EUCTR2009-013435-38-CZ
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-02
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

- Histologic or cytologic diagnosis with unresectable or metastatic HCC
- Child Pugh Class A
- ECOG performace status 0-1
- Adequate hematologic, hepatic, and renal function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the overall survival of oral linifanib given as monotherapy daily compared to sorafenib given twice daily as standard of care in subjects with advanced or metastatic HCC.;Secondary Objective: To evaluate time to progression and objective response rate in those subjects treated with linifanib compared with sorafenib.;Primary end point(s): Overall survival.