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NCT00387127 · ClinicalTrials.gov registry record · Phase 2
Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT00387127: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00387127 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00387127, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.
Primary Outcome
Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the chemoradiation treatment (CRT), as assessed by independent radiological review. Tumor response was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in fo
Interventions
- DRUG Lapatinib oral tablets
- DRUG radiotherapy
- DRUG cisplatin chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2006-11 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT00387127 record still lists
NCT00387127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Lapatinib oral tablets is the first listed.
NCT00387127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00387127 about?
NCT00387127 is a clinical study titled "Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer". This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response...
What is the current status of trial NCT00387127?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2006-11. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00387127?
The interventions under investigation include: Lapatinib oral tablets (DRUG), radiotherapy (DRUG), cisplatin chemotherapy (DRUG).
Who is sponsoring clinical trial NCT00387127?
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 NCT00387127's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 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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