NCT00424255

Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery

A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects With Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 688 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.

Detailed description

A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Conditions

• Neoplasms, Head and Neck

Interventions

Type	Name	Description
DRUG	Lapatinib	Dual ErbB1/2 inhibitor
RADIATION	Chemoradiation	Radiation plus platinum based chemotherapy
OTHER	Placebo	Placebo

Timeline

• Start date: 2006-12-01
• Primary completion: 2013-03-01
• Completion: 2013-11-01
• First posted: 2007-01-19
• Last updated: 2014-07-18
• Results posted: 2014-02-11

Locations

117 sites across 22 countries: United States, Argentina, Austria, Canada, China, Croatia, Czechia, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Philippines, Russia, Slovakia, Spain, Thailand, United Kingdom