At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 483 enrolled
Drug / intervention
Afatinib +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 Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy
In Brief
A Phase 3 clinical trial evaluating Afatinib and Methotrexate for Head and Neck Neoplasms and Carcinoma, Squamous Cell. Completed, enrolled 483 participants across 101 sites in 19 countries.
Detailed Summary
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Neoplasms, Carcinoma, Squamous Cell
CountriesArgentina, Austria, Belgium, Brazil, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Russia, South Africa, Spain, Sweden, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJan 2012
Primary CompletionMar 2014
Study CompletionDec 2016
TodayJul 2026
First PostedMay 2, 2011
Enrollment StartJan 5, 2012
Primary CompletionMar 15, 2014
Study CompletionDec 6, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.2 years ago
Interventions
Afatinibdrug
Once daily
Methotrexatedrug
Weekly