NCT00514943

BIBW 2992 (Afatinib) in Head & Neck Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	BIBW 2992	experimental drug taken once daily orally
DRUG	Cetuximab	active comparator administered weekly intravenously

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-03-01
• Completion: 2013-07-01
• First posted: 2007-08-10
• Last updated: 2016-07-26
• Results posted: 2013-12-25

Locations

36 sites across 4 countries: United States, Belgium, France, Spain