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

Sponsor
GlaxoSmithKline
Study ID
NCT00371566
Phase
PHASE2
Status
Completed

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib oral tablets — DRUG
  • Placebo — DRUG

Study Details

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.

Key Dates

Start date
Mar 31, 2006
Status verified
Apr 2010
Primary completion
Dec 31, 2007
Completion
Dec 31, 2007

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change From Baseline of the Apoptotic Index During Treatment Phase [ Time Frame: Baseline and Week 2 ]

Related Studies