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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Type, frequency, and severity of adverse events.

Outcome Time Frame:

Until disease progression or unacceptable toxicity develops

Safety Issue:

Yes

Principal Investigator

Norma Lynn Fox, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Human Genome Sciences Inc., a GSK Company

Authority:

United States: Food and Drug Administration

Study ID:

HGS1012-C1077

NCT ID:

NCT00712855

Start Date:

June 2008

Completion Date:

August 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Mayo ClinicRochester, Minnesota  55905
University of Colorado Cancer CenterDenver, Colorado  80262
University of FloridaGainesville, Florida  32610-0277
UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  
Cedars-Sinai Health SystemLos Angeles, California  90048
University of Pennsylvania- Abramson Cancer CenterPhiladelphia, Pennsylvania  19104