At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 340 enrolled
Drug / intervention
Methotrexate +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 Methotrexate and Afatinib for Head and Neck Neoplasms. Completed, enrolled 340 participants across 53 sites in 8 countries.
Detailed Summary
This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Neoplasms
CountriesChina, Egypt, Hong Kong, India, Philippines, South Korea, Taiwan, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJun 2013
Primary CompletionAug 2018
Study CompletionOct 2024
TodayJul 2026
First PostedMay 17, 2013
Enrollment StartJun 7, 2013
Primary CompletionAug 22, 2018
Study CompletionOct 2, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 13.1 years ago
Interventions
Methotrexatedrug
intravenous bolus injection once weekly
Afatinibdrug
oral intake of one film-coated tablet once daily