MedTrace Logo

BIBW 2992 (Afatinib) in Head & Neck Cancer

NCT00514943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2016-07-26

Study results available
· View outcomes & findings →

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.

Conditions

  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell

Interventions

DRUG

BIBW 2992

experimental drug taken once daily orally

DRUG

Cetuximab

active comparator administered weekly intravenously

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-03-31
Completion
2013-07-31

Countries

  • United States
  • Belgium
  • France
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00514943 on ClinicalTrials.gov