Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01258608
First received: December 7, 2010
Last updated: December 10, 2012
Last verified: December 2012
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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
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Hide Study LocationsLocations
| 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 |
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 May 19, 2013