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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:
ClinicalTrials.gov Identifier:
NCT00712855
First Posted: July 10, 2008
Last Update Posted: October 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
  Purpose
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.

Condition Intervention Phase
Hepatocellular Carcinoma Biological: mapatumumab Drug: sorafenib Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):

Primary Outcome Measures:
  • Type, frequency, and severity of adverse events. [ Time Frame: Until disease progression or unacceptable toxicity develops ]

Enrollment: 23
Study Start Date: June 2008
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
mapatumumab and sorafenib
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712855


Locations
United States, California
Cedars-Sinai Health System
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
University of Pennsylvania- Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: Norma Lynn Fox, PhD Human Genome Sciences Inc.
  More Information

Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT00712855     History of Changes
Other Study ID Numbers: HGS1012-C1077
First Submitted: July 8, 2008
First Posted: July 10, 2008
Last Update Posted: October 30, 2012
Last Verified: October 2012

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Liver Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Niacinamide
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Immunologic Factors