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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.

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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

FieldValue
Enrollment Target 617 participants
Start Date 2011-10-17
Est. Completion 2016-09-12
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.