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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: sorafenib

Biological: mapatumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00712855

HGS1012-C1077

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No 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