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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mapatumumab
sorafenib
Sponsored by
Human Genome Sciences Inc., a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cedars-Sinai Health System
  • University of Colorado Cancer Center
  • University of Florida
  • Mayo Clinic
  • UNC Lineberger Comprehensive Cancer Center
  • University of Pennsylvania- Abramson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

mapatumumab and sorafenib

Outcomes

Primary Outcome Measures

Type, frequency, and severity of adverse events.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2008
Last Updated
October 26, 2012
Sponsor
Human Genome Sciences Inc., a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00712855
Brief Title
A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc., a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
mapatumumab and sorafenib
Intervention Type
Biological
Intervention Name(s)
mapatumumab
Intervention Description
3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
Intervention Type
Drug
Intervention Name(s)
sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
400 mg orally, twice a day continuously in each cycle
Primary Outcome Measure Information:
Title
Type, frequency, and severity of adverse events.
Time Frame
Until disease progression or unacceptable toxicity develops

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma Lynn Fox, PhD
Organizational Affiliation
Human Genome Sciences Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Health System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Pennsylvania- Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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