A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
NCT ID: NCT00712855
Last Updated: 2012-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2008-06-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
mapatumumab and sorafenib
mapatumumab
3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
sorafenib
400 mg orally, twice a day continuously in each cycle
Interventions
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mapatumumab
3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
sorafenib
400 mg orally, twice a day continuously in each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Human Genome Sciences Inc., a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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Norma Lynn Fox, PhD
Role: STUDY_DIRECTOR
Human Genome Sciences Inc.
Locations
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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
Countries
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Other Identifiers
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HGS1012-C1077
Identifier Type: -
Identifier Source: org_study_id