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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01258608
First received: December 7, 2010
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma.


Condition Intervention Phase
Hepatocellular Carcinoma
 Drug: sorafenib
Biological: mapatumumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center, Blinded, Placebo-Controlled Study Of Mapatumumab ([HGS1012], A Fully Monoclonal Antibody To TRAIL-R1) In Combination With Sorafenib As A First-Line Therapy In Subjects With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Overall Response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Disease Control [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
placebo and sorafenib
 Drug: sorafenib
400 mg orally twice a day continuously in each cycle
Experimental: B
mapatumumab and sorafenib
 Drug: sorafenib
400 mg orally twice a day continuously in each cycle
Biological: mapatumumab
30 mg/kg IV (in the vein), on day 1 of each 21 day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child-Pugh Class A
  • BCLC Stage B or C
  • Measurable Liver Cancer
  • ECOG Performance Status of 0, 1, or 2
  • Age 18 years or older

Exclusion Criteria:

  • Received prior investigational or non-investigational agent to treat hepatocellular carcinoma
  • Previously received mapatumumab and/or sorafenib
  • Major surgery within 4 weeks before enrollment
  • Minor surgery within 2 weeks before enrollment
  • Systemic steroids within 1 week of enrollment
  • Hepatic encephalopathy
  • History of clinically significant gastrointestinal bleeding
  • Gastrointestinal disease resulting in the inability to take oral medication
  • History of infection requiring hospitalization or IV antibiotics
  • Known brain or spinal cord metastases
  • Known HIV infection
  • Unstable angina, myocardial infarction, or cerebrovascular accident within 6 months before enrollment
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
  • Uncontrolled hypertension
  • Using and unable to discontinue use of CYP3A4 inducers
  • Pregnant or breast-feeding women
  • Acute or chronic severe renal insufficiency
  • Hepatitis B virus DNA levels >2,000IU/mL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258608

  Show 37 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01258608     History of Changes
Other Study ID Numbers: HGS1012-C1103
Study First Received: December 7, 2010
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by GlaxoSmithKline:
Liver Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
 Sorafenib
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013