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NCT00424255 · ClinicalTrials.gov registry record · Phase 3
Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 688
- Enrollment target
NCT00424255: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00424255 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 688 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00424255, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 688 participants
- Enrollment target
Study Summary
This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.
Primary Outcome
DFS is defined as the time from randomization until the earliest date of disease recurrence (evidence of local, regional, or distant disease progression, second primary tumor) or death due to any cause. Disease recurrence was based on the assessments from the blinded, independent reviewer (radiological and clinical). Participants who initiated alternative anti-cancer therapy prior to disease recurrence or death were treated as censored at the last assessment prior to the time of this initiation.
Interventions
- OTHER Placebo
- RADIATION Chemoradiation
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 688 participants |
| Start Date | 2006-12 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT00424255 record still lists
NCT00424255 is an interventional study that assigns participants to a tested intervention. The registered 688 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00424255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00424255 about?
NCT00424255 is a clinical study titled "Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery". This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination wi...
What is the current status of trial NCT00424255?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 688 participants. The study started on 2006-12. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00424255?
The interventions under investigation include: Placebo (OTHER), Chemoradiation (RADIATION), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00424255?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00424255's enrollment target sits among peer trials
688 525th of 2000 higher than 1,476 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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