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NCT00954226 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00954226: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00954226 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00954226, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This randomized phase Ib trial studies standard-dose or high-dose erlotinib hydrochloride before surgery in treating patients with head and neck cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Modulation of phospho-Akt (difference in immunohistochemistry \[IHC\] score between the surgical specimen and the baseline biopsy) will be compared between the two treatment arms (i.e., standard-dose and high-dose) with the use of Wilcoxon rank sum test.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Erlotinib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2009-08-05 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 1 |
What the finished NCT00954226 record still lists
NCT00954226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00954226 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00954226 about?
NCT00954226 is a clinical study titled "Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer". This randomized phase Ib trial studies standard-dose or high-dose erlotinib hydrochloride before surgery in treating patients with head and neck cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT00954226?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2009-08-05. Estimated completion is 2025-04-30.
What interventions are being tested in trial NCT00954226?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Erlotinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00954226?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00954226's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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