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NCT00815295 · ClinicalTrials.gov registry record · Phase 1
Study of Sorafenib/Cetuximab in Head and Neck Cancer
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00815295: Completed Phase 1 study, sponsored by Duke University.
NCT00815295 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00815295, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
In this Phase I B/II trial, we seek to determine the safety and efficacy of sorafenib with standard dose cetuximab in the treatment of patients with Recurrent and /or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).
Primary Outcome
The MTD is based upon dose-limiting (DLTs) experienced during Cycle 1 of treatment. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience DLT. Using Common Toxicity Criteria for Adverse EVents (CTCAE) version 3.0, DLTs are defined as any Grade 4 hematologic toxicity, or Grade 3 or 4 non-hematologic toxicity. A DLT will not be considered to have occurred in the case of a grade 3 or 4 allergic reaction due to cetuximab.
Interventions
- DRUG Cetuximab
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-01 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
What the finished NCT00815295 record still lists
NCT00815295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT00815295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00815295 about?
NCT00815295 is a clinical study titled "Study of Sorafenib/Cetuximab in Head and Neck Cancer". In this Phase I B/II trial, we seek to determine the safety and efficacy of sorafenib with standard dose cetuximab in the treatment of patients with Recurrent and /or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).
What is the current status of trial NCT00815295?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2008-01. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00815295?
The interventions under investigation include: Cetuximab (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00815295?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00815295's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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