Status:
COMPLETED
A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Human Genome Sciences Inc., a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 positiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00712855
Start Date
June 1 2008
End Date
August 1 2012
Last Update
October 30 2012
Active Locations (6)
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1
Cedars-Sinai Health System
Los Angeles, California, United States, 90048
2
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
3
University of Florida
Gainesville, Florida, United States, 32610
4
Mayo Clinic
Rochester, Minnesota, United States, 55905