Trials / Completed
CompletedNCT01258608
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Human Genome Sciences Inc., a GSK Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Mapatumumab is a fully human, agonist monoclonal antibody that activates the cell death pathway in tumor cells by specifically binding to TRAIL-R1 with high affinity. Sorafenib, a multikinase inhibitor, is the standard of care for treatment of patients with advanced hepatocellular carcinoma (HCC). The mechanisms of sorafenib and mapatumumab action suggest that these agents could interact synergistically. This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mapatumumab | Mapatumumab will be supplied as a lyophilized formulation in 10 mL vials containing 100 mg mapatumumab for intravenous infusion at the dose of 30 mg/kg. |
| DRUG | Placebo | Normal saline solution for intravenous infusion will be administered as placebo for mapatumumab |
| DRUG | Sorafenib | Sorafenib will be supplied as tablets, each containing 274 mg sorafenib tosylate, equivalent to 200 mg of sorafenib, to be administered 400 mg (2 x 200 mg tablets) orally twice daily. |
Timeline
- Start date
- 2011-02-08
- Primary completion
- 2013-05-31
- Completion
- 2017-11-29
- First posted
- 2010-12-13
- Last updated
- 2018-12-19
- Results posted
- 2018-12-19
Locations
43 sites across 7 countries: United States, Germany, Poland, Puerto Rico, Romania, Russia, Ukraine
Source: ClinicalTrials.gov record NCT01258608. Inclusion in this directory is not an endorsement.