A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma - Full Text View

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

This study is currently recruiting participants.

Verified by Human Genome Sciences, July 2008

First Received: July 8, 2008 Last Updated: November 19, 2008 History of Changes

Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00712855

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 (HCC)

Condition	Intervention	Phase
Hepatocellular Carcinoma	Biological: mapatumumab Drug: sorafenib	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	A Two-Stage, 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:

MedlinePlus related topics: Cancer

Drug Information available for: Sorafenib Sorafenib tosylate Mapatumumab

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

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

Estimated Enrollment:	18
Study Start Date:	June 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712855

Contacts

Contact: Dan Odenheimer, PhD

1-866-447-9749

Dan_Odenheimer@hgsi.com

Locations

United States, California
Cedars-Sinai Health System	Recruiting
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado Cancer Center	Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center	Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
University of Pennsylvania- Abramson Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Director:

Norma Lynn Fox, PhD

Human Genome Sciences, Inc

More Information

No publications provided

Responsible Party:	Human Genome Sciences, Inc ( Dan Odenheimer, PhD )
Study ID Numbers:	HGS1012-C1077
Study First Received:	July 8, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00712855 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut

Keywords provided by Human Genome Sciences:

Liver Cancer

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Protein Kinase Inhibitors
Carcinoma
Liver Neoplasms
Antibodies, Monoclonal
Antibodies

Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular Carcinoma
Sorafenib
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Hepatocellular
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009