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NCT00514943 · ClinicalTrials.gov registry record · Phase 2
BIBW 2992 (Afatinib) in Head & Neck Cancer
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT00514943: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00514943 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00514943, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.
Primary Outcome
Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline. Mean calculated i
Interventions
- DRUG Cetuximab
- DRUG BIBW 2992
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2007-08 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
What the finished NCT00514943 record still lists
NCT00514943 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT00514943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00514943 about?
NCT00514943 is a clinical study titled "BIBW 2992 (Afatinib) in Head & Neck Cancer". The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor res...
What is the current status of trial NCT00514943?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2007-08. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00514943?
The interventions under investigation include: Cetuximab (DRUG), BIBW 2992 (DRUG).
Who is sponsoring clinical trial NCT00514943?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00514943's enrollment target sits among peer trials
124 564th of 2000 higher than 1,437 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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