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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: Completed Phase 1 study, sponsored by Human Genome Sciences Inc., a GSK Company.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to progression is defined as the time from randomization to radiologic disease progression based on blinded independent review (BICR) of imaging scans using modified Response Evaluation Criteria in Solid Tumors assessment (mRECIST) for hepatocellular carcinoma. The primary analysis was performed using Kaplan Meier methods. The median time to progression is reported with one-sided 90% confidence interval. Analysis was performed on the modified Intent to Treat (mITT) Population which comprise
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 |
What the finished NCT01258608 record still lists
NCT01258608 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01258608 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01258608's enrollment target sits among peer trials
101 546th of 2000 higher than 1,455 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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