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
Phase 1
Active, not recruiting
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)MedDRA version: 14.1Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2009-013435-38-BE
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 900
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
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
- Secondary Outcome Measures
Name Time Method