A Randomized, Single Blind, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

• Conditions: Sqamous Cell Carcinoma of the Head & Neck (SCCHN)

• Registration Number: EUCTR2005-002485-11-GR
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Willing and able to sign a written informed consent.
2.Histologically or cytologically confirmed diagnosis of SCCHN.
3.Stage III, IVA and IVB disease will be eligible, who are to receive chemoradiation therapy as primary treatment (total dose = 66 Gy). Subjects with distant metastases (stage IVC) will be excluded.
4.Willing and able to have a tumour biopsy taken at screening and a second tumour biopsy taken during lapatinib/placebo administration.
5.Male or female 18 years of age.
6.ECOG performance status 0, 1 or 2.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects with paranasal sinuses and nasal cavity tumours;
2.Subjects who have received prior systemic chemotherapy given with curative intent;
3.Subjects who received prior radiotherapy;
4.Prior or concurrent treatment with tyrosine kinase inhibitors;
5.Use of any investigational agent within 30 days or 5 half-lives, whichever is longer, preceding the first dose of lapatinib;
6.Concurrent use of CYP3A4 inducers or inhibitors;
7.Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
8.Distant metastases, ie Stage IVC;
9.Subjects taking any prohibited medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified