A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Phase 1
Completed
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Biological: mapatumumab
- Registration Number
- NCT00712855
- Lead Sponsor
- Human Genome Sciences Inc., a GSK Company
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of escalating doses of mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma who are positive for hepatitis B surface antigen or hepatitis C antibody.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- Moderate liver disease
- Test positive for hepatitis B surface antigen or hepatitis C antibody
- Locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma
- Age 18 years or older
Exclusion Criteria
- Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma.
- Received radiation therapy within 4 weeks before randomization
- Major surgery within 4 weeks before randomization
- Minor surgery within 2 weeks before randomization
- Systemic steroids within 1 week before randomization
- Hepatic encephalopathy, per the investigator's evaluation
- History of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment
- History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
- Known brain or spinal cord metastases
- History of other cancers within 5 years before enrollment
- Pregnant or breast-feeding women
- Known HIV infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A mapatumumab mapatumumab and sorafenib A sorafenib mapatumumab and sorafenib
- Primary Outcome Measures
Name Time Method Type, frequency, and severity of adverse events. Until disease progression or unacceptable toxicity develops
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Cedars-Sinai Health System
🇺🇸Los Angeles, California, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
University of Pennsylvania- Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States