Hepatocellular CarcinomaPhase 1HCCNCT00712855
A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
A Phase 1 study testing mapatumumab and sorafenib in people with Hepatocellular Carcinoma, run by Human Genome Sciences Inc., a GSK Company at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- mapatumumab and sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2008to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
University of Florida
Gainesville, Florida, 32610
Cedars-Sinai Health System
Los Angeles, California, 90048
University of Pennsylvania- Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- mapatumumab, sorafenib
- Keywords
- Liver Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mapatumumabBiological
3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
sorafenibDrug
Also called Nexavar
400 mg orally, twice a day continuously in each cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | mapatumumab and sorafenib Receives: Biological: mapatumumab; Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, frequency, and severity of adverse events.
Measured: Until disease progression or unacceptable toxicity develops
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Genome Sciences Inc., a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Norma Lynn Fox, PhD, Study director, Human Genome Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712855
- Sponsor's protocol ID
- HGS1012-C1077
- Acronym
- HCC
- Status last verified
- Oct 2012
- First submitted
- 8 Jul 2008
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00712855
- Acronym / sponsor ID
- HCC / HGS1012-C1077
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Human Genome Sciences Inc., a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: mapatumumab, Drug: sorafenibmapatumumab and sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mapatumumab3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle | Biological | A |
| sorafenibAlso: Nexavar400 mg orally, twice a day continuously in each cycle | Drug | A |
Primary outcome
Type, frequency, and severity of adverse events.
Time frame: Until disease progression or unacceptable toxicity develops
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norma Lynn Fox, PhD study director
Human Genome Sciences Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mapatumumab and sorafenib in people with Hepatocellular Carcinoma, run by Human Genome Sciences Inc., a GSK Company at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, frequency, and severity of adverse events. (time frame: Until disease progression or unacceptable toxicity develops). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.