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
  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:


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

  Hide Study Locations
Locations
United States, Mississippi
North Mississippi Hematolgy and Oncology Associates, ltd
Tupelo, Mississippi, United States, 38801
United States, New Jersey
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
United States, Pennsylvania
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
UPMC Cancer Center- Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Germany
Johann-Wolfgang-Goethe University Frankfurt
Frankfurt, Germany, 60590
University Hospital Hamburg-Eppendorf
Hamburg, Germany, 20246
Medical University Hannover
Hanover, Germany, 30623
University Hospital Munich
München, Germany, 81377
Poland
Academic Clinical Centre, Oncology and Radiotherapy Department
Gdansk, Poland
Healthcare Facility of the Ministry of Internal Affairs and Administration and Warminsko-Mazurskie Oncology Centre in Olsztyn, Department of Chemotherapy.
Olsztyn, Poland
West Pomeranian Oncology Centre, Department of Clinical Oncology
Szczecin, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie, Klinika Onkologii i Hematologii
Warszawa, Poland, 02-507
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927
Romania
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department
Cluj-Napoca, Romania
"Prof. Dr. I. Chiricuta" Institute of Oncology, Medical Oncology Department
Cluj-Napoca, Romania
SC Oncolab SRL, Medical Oncology Department
Craiova, Romania
"Sf. Spiridon" Emergency County Clinical Hospital, Medical Oncology Department
Iasi, Romania
Russian Federation
Regional State Healthcare Institution: Sverdlovsk Regional Oncology Center
Ekaterinburg, Russian Federation
Regional State Public Healthcare Institution: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
Krasnoyarsk, Russian Federation
Federal State Institution: Moscow Oncology Research Institute n.a. P. A. Gertsen under the Ministry of Healthcare and Social Development
Moscow, Russian Federation
Russian Academy of Medical Sciences Institution: Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of Medical Sciences
Moscow, Russian Federation
Russian Academy of Medical Sciences Institution
Moscow, Russian Federation, 115478
State Healthcare Institution: Pyatigorsk Oncology Center
Pyatigorsk, Russian Federation
St. Petersburg State Healthcare Institution: City Clinical Oncology Center
Saint-Petersburg, Russian Federation
Russian Academy of Sciences Institution: St. Petersburg Clinical Hospital under Russian Academy of Sciences
Saint-Petersburg, Russian Federation
State Higher Educational Institution:
Saint-Petersburg, Russian Federation
Regional State Medical Institution: Tomsk Regional Oncology Centre
Tomsk, Russian Federation
State Healthcare Institution for Yaroslavl Region: Regional Clinical Oncology Hospital
Yaroslavl, Russian Federation
Ukraine
City General Clinical Hospital #4
Dnipropetrovsk, Ukraine
Public Clinical Treatment and Prophylaxis Institution
Donetsk, Ukraine, 83092
Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center
Kharkiv, Ukraine, 61070
Lviv State Regional Diagnostic Oncology Center
Kyiv, Ukraine
Kyiv City Clinical Hospital # 10
Kyiv, Ukraine
National Cancer Institute
Kyiv, Ukraine
Zakarpatya Regional Clinical Oncology Center
Uzhorod, Ukraine
City Clinical Hospital # 3
Zaporizhia, Ukraine
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
Antibodies, Monoclonal
Sorafenib
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014