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

Sponsor

Human Genome Sciences Inc., a GSK Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00712855

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Locations

Arm

Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Biological: mapatumumab Drug: sorafenib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Nexavar

Arm

Intervention/Treatment

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 Names:

Nexavar

Outcome Measures

Primary Outcome Measures

Type, frequency, and severity of adverse events. [Until disease progression or unacceptable toxicity develops]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Health System	Los Angeles	California	United States	90048
2	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
3	University of Florida	Gainesville	Florida	United States	32610
4	Mayo Clinic	Rochester	Minnesota	United States	55905
5	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States	27599
6	University of Pennsylvania- Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104