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

December 7, 2010
December 10, 2012
December 2010
December 2013   (final data collection date for primary outcome measure)
Time to Progression [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Time to Progression [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01258608 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Progression-Free Survival [ Designated as safety issue: No ]
  • Overall Response
  • Disease Control
  • Overall Survival
  • Time to Response
  • Duration of Response
Not Provided
Not Provided
 
Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • 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
  • Placebo Comparator: A
    placebo and sorafenib
    Intervention: Drug: sorafenib
  • Experimental: B
    mapatumumab and sorafenib
    Interventions:
    • Drug: sorafenib
    • Biological: mapatumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Ukraine
 
NCT01258608
HGS1012-C1103
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP