At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 enrolled
Drug / intervention
Lapatinib oral tablets +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, Single Blinded, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 2 clinical trial evaluating Lapatinib oral tablets and Placebo for Squamous Cell Carcinoma of Head and Neck. Completed, enrolled 107 participants across 9 sites in 5 countries.
Detailed Summary
This is a study comparing the activity of lapatinib versus placebo followed by chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced squamous cell carcinoma of head and neck.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of Head and Neck
CountriesFrance, Greece, India, Peru, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedSep 2006
Primary CompletionDec 2007
TodayJul 2026
First PostedSep 4, 2006
Enrollment StartMar 1, 2006
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.8 years ago
Interventions
Lapatinib oral tabletsdrug
Placebodrug