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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 688 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00424255
The ClinicalTrials.gov registry entry for NCT00424255 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 688 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00424255 reports 0 study locations.
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.
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