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A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00712855
First received: July 8, 2008
Last updated: October 26, 2012
Last verified: October 2012
History of Changes

July 8, 2008
October 26, 2012
June 2008
August 2011   (final data collection date for primary outcome measure)
Type, frequency, and severity of adverse events. [ Time Frame: Until disease progression or unacceptable toxicity develops ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00712855 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
A Phase 1B, Multi-center, Open Label, Dose Escalation Study of Mapatumumab ([HGS1012], a Fully-human Monoclonal Antibody to TRAIL-R1) in Combination With Sorafenib as a First Line Therapy in Subjects With Advanced Hepatocellular Carcinoma

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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Biological: mapatumumab
    3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
  • Drug: sorafenib
    400 mg orally, twice a day continuously in each cycle
    Other Name: Nexavar
Experimental: A
mapatumumab and sorafenib
Interventions:
  • Biological: mapatumumab
  • Drug: sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
August 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00712855
HGS1012-C1077
No
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Study Director: Norma Lynn Fox, PhD Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP