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NCT01345682 · ClinicalTrials.gov registry record · Phase 3
LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 483
- Enrollment target
NCT01345682 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 483 participants.
The verdict
NCT01345682, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 483 participants
- Enrollment target
Study Summary
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
Interventions
- DRUG Afatinib
- DRUG Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 483 participants |
| Start Date | 2012-01-05 |
| Est. Completion | 2016-12-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01345682
The ClinicalTrials.gov registry entry for NCT01345682 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 483 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 Afatinib is the first listed.
NCT01345682 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01345682 about?
NCT01345682 is a clinical study titled "LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy". This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
What is the current status of trial NCT01345682?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 483 participants. The study started on 2012-01-05. Estimated completion is 2016-12-06.
What interventions are being tested in trial NCT01345682?
The interventions under investigation include: Afatinib (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT01345682?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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