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NCT01345669 · ClinicalTrials.gov registry record · Phase 3
LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 3
- Development phase
- 617
- Enrollment target
NCT01345669 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 617 participants.
The verdict
NCT01345669, a Phase 3 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 617 participants
- Enrollment target
Study Summary
This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.
Interventions
- DRUG Placebo
- DRUG Afatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 617 participants |
| Start Date | 2011-10-17 |
| Est. Completion | 2016-09-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01345669
The ClinicalTrials.gov registry entry for NCT01345669 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 617 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01345669 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01345669 about?
NCT01345669 is a clinical study titled "LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy". This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-r...
What is the current status of trial NCT01345669?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2011-10-17. Estimated completion is 2016-09-12.
What interventions are being tested in trial NCT01345669?
The interventions under investigation include: Placebo (DRUG), Afatinib (DRUG).
Who is sponsoring clinical trial NCT01345669?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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