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

Hepatocellular Carcinoma Clinical Trial

— HCC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712855
• Other study ID #: HGS1012-C1077
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2008
• Last updated: October 26, 2012
• Start date: June 2008
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Cedars-Sinai Health System	Los Angeles	California
United States	University of Pennsylvania- Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, frequency, and severity of adverse events.		Until disease progression or unacceptable toxicity develops	Yes