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NCT00939627 · ClinicalTrials.gov registry record · Phase 2
Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00939627: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00939627 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00939627, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cetuximab is more effective when given alone or together with sorafenib tosylate in treating patients with head and neck cancer. This randomized phase II trial is studying cetuximab to see how well it works when given together with or without sorafenib tosylate in treating patients with refractory, recurrent, and/or metastatic head and neck cancer.
Primary Outcome
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- PROCEDURE quality-of-life assessment
- BIOLOGICAL cetuximab
- DRUG sorafenib tosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT00939627 record still lists
NCT00939627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00939627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00939627 about?
NCT00939627 is a clinical study titled "Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab". Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some o...
What is the current status of trial NCT00939627?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2009-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00939627?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), quality-of-life assessment (PROCEDURE), cetuximab (BIOLOGICAL), sorafenib tosylate (DRUG).
Who is sponsoring clinical trial NCT00939627?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00939627's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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