A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Completed · Phase 1
Conditions studied: Hepatocellular Carcinoma
In brief
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.
Key facts
- Study ID
- NCT00712855
- Run by
- Human Genome Sciences Inc., a GSK Company
- People needed
- 23
- Starts
- 2008-06-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2012-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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