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

NCT00424255 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2014-07-18

Study results available
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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.

Conditions

  • Neoplasms, Head and Neck

Interventions

DRUG

Lapatinib

Dual ErbB1/2 inhibitor

RADIATION

Chemoradiation

Radiation plus platinum based chemotherapy

OTHER

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2013-03-31
Completion
2013-11-30

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00424255 on ClinicalTrials.gov