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NCT01258608 · ClinicalTrials.gov registry record · Phase 1
Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
A Phase 1 study, sponsored by Human Genome Sciences Inc., a GSK Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT01258608 is a Phase 1 study that has completed, run by Human Genome Sciences Inc., a GSK Company. The registered enrollment target is 101 participants.
The verdict
NCT01258608, a Phase 1 study, has completed, sponsored by Human Genome Sciences Inc., a GSK Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Sorafenib
- DRUG Mapatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2011-02-08 |
| Est. Completion | 2017-11-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01258608
The ClinicalTrials.gov registry entry for NCT01258608 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Human Genome Sciences Inc., a GSK Company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01258608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01258608 about?
NCT01258608 is a clinical study titled "Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma". 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). T...
What is the current status of trial NCT01258608?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2011-02-08. Estimated completion is 2017-11-29.
What interventions are being tested in trial NCT01258608?
The interventions under investigation include: Placebo (DRUG), Sorafenib (DRUG), Mapatumumab (DRUG).
Who is sponsoring clinical trial NCT01258608?
This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
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