CClinicalTrials.gg
Sign In
CompletedNCT00712855HCCUpdated Oct 30, 2012

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

A Phase 1 interventional study of mapatumumab and sorafenib in Hepatocellular Carcinoma, sponsored by Human Genome Sciences Inc., a GSK Company. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-30.

Sponsored by Human Genome Sciences Inc., a GSK Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Liver Cancer
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 23 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Human Genome Sciences Inc., a GSK Company is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    A

    mapatumumab and sorafenib

    Biological: mapatumumab · Drug: sorafenib

Interventions

  • Biologicalmapatumumab

    3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle

  • Drugsorafenib

    400 mg orally, twice a day continuously in each cycle

    Also known as: Nexavar

06

What researchers measure

Primary outcomes

  1. Type, frequency, and severity of adverse events.

    Time frame: Until disease progression or unacceptable toxicity develops

07

Study locations

6 sites
  • Cedars-Sinai Health System
    Los Angeles, California 90048, United States
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • UNC Lineberger Comprehensive Cancer Center
    Chapel Hill, North Carolina 27599, United States
  • University of Pennsylvania- Abramson Cancer Center
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00712855
Lead sponsor
Human Genome Sciences Inc., a GSK Company
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 10, 2008
Start date
Jun 2008
Primary completion
Aug 2011
Completion
Aug 2012
Last update
Oct 30, 2012

Study contacts

Norma Lynn Fox, PhD
study director · Human Genome Sciences Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma→

Other studies from this sponsor

Human Genome Sciences Inc., a GSK Company

Start the discussion