At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 124 enrolled
Drug / intervention
BIBW 2992 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating BIBW 2992 and Cetuximab for Head and Neck Neoplasms and Carcinoma, Squamous Cell. Completed, enrolled 124 participants across 36 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Neoplasms, Carcinoma, Squamous Cell
CountriesBelgium, France, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedAug 2007
Primary CompletionMar 2010
Study CompletionJul 2013
TodayJul 2026
First PostedAug 10, 2007
Enrollment StartAug 1, 2007
Primary CompletionMar 1, 2010
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.9 years ago
Interventions
BIBW 2992drug
experimental drug taken once daily orally
Cetuximabdrug
active comparator administered weekly intravenously