drugset / Trial / NCT00371566

A Study Of Lapatinib Versus Placebo Followed By Chemoradiation In Patients With Locally Advanced Head And Neck Cancer

NCT00371566 ↗

Phase 2 Completed 107 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2006-03
Primary completion
2007-12
Completion
2007-12

Outcome

Missed primary endpoint

registry Placebo vs Lapatinib; p = .394; Mean Difference (Net) -1.7 (95% CI -5.50 to 2.19); ANCOVA NCT00371566 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lapatinib Small molecule — Oral