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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
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00712855     History of Changes
Other Study ID Numbers: HGS1012-C1077
Study First Received: July 8, 2008
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Liver Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014