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Brief Title: BIBW 2992 (Afatinib) in Head & Neck Cancer
Official Title: A Randomized, Open-label Phase II Study of BIBW 2992 Versus Cetuximab (Erbitux) in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy With a Cross-over Period for Progressing Patients
Study ID: NCT00514943
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
1200.28.0010 Boehringer Ingelheim Investigational Site, Stanford, California, United States
1200.28.0001 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States
1200.28.0005 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States
1200.28.0011 Boehringer Ingelheim Investigational Site, Harvey, Illinois, United States
1200.28.0022 Boehringer Ingelheim Investigational Site, Indianapolis, Indiana, United States
1200.28.0024 Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States
1200.28.0012 Boehringer Ingelheim Investigational Site, Ann Arbor, Michigan, United States
1200.28.0021 Boehringer Ingelheim Investigational Site, St. Joseph, Michigan, United States
1200.28.0016 Boehringer Ingelheim Investigational Site, Rochester, Minnesota, United States
1200.28.0002 Boehringer Ingelheim Investigational Site, Jackson, Mississippi, United States
1200.28.0006 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States
1200.28.0008 Boehringer Ingelheim Investigational Site, New Hyde Park, New York, United States
1200.28.0017 Boehringer Ingelheim Investigational Site, Chapel Hill, North Carolina, United States
1200.28.0004 Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States
1200.28.0013 Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States
1200.28.0007 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
1200.28.0009 Boehringer Ingelheim Investigational Site, Madison, Wisconsin, United States
1200.28.0020 Boehringer Ingelheim Investigational Site, Milwaukee, Wisconsin, United States
1200.28.0030 Boehringer Ingelheim Investigational Site, Bruxelles, , Belgium
1200.28.0031 Boehringer Ingelheim Investigational Site, Gent, , Belgium
1200.28.0032 Boehringer Ingelheim Investigational Site, Leuven, , Belgium
1200.28.0062A Boehringer Ingelheim Investigational Site, Ales, , France
1200.28.0062B Boehringer Ingelheim Investigational Site, Ales, , France
1200.28.0059A Boehringer Ingelheim Investigational Site, Avignon, , France
1200.28.0052A Boehringer Ingelheim Investigational Site, Lille, , France
1200.28.0051A Boehringer Ingelheim Investigational Site, Lyon, , France
1200.28.0050A Boehringer Ingelheim Investigational Site, Montpellier cedex 5, , France
1200.28.0058A Boehringer Ingelheim Investigational Site, Nimes cedex 9, , France
1200.28.0061A Boehringer Ingelheim Investigational Site, Poitiers, , France
1200.28.0055G Boehringer Ingelheim Investigational Site, Rouen, , France
1200.28.0040 Boehringer Ingelheim Investigational Site, Barcelona, , Spain
1200.28.0044 Boehringer Ingelheim Investigational Site, Barcelona, , Spain
1200.28.0043 Boehringer Ingelheim Investigational Site, Madrid, , Spain
1200.28.0042 Boehringer Ingelheim Investigational Site, Malaga, , Spain
1200.28.0045 Boehringer Ingelheim Investigational Site, Santander, , Spain
1200.28.0041 Boehringer Ingelheim Investigational Site, Valencia, , Spain
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR