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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-13
• Study Completion: 2007-12-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced SCCHN.;<br> Secondary Objective: Secondary objectives of this trial include the assessment of effects of lapatinib on tumour cell proliferation, evaluation of clinical activity and safety of lapatinib, correlation of early radiologial responses with biologic markers and the identification of potential genetic predictors that may enhance response to lapatinib in the patient population.<br> ;Primary end point(s): To estimate the percentage of apoptosis/necrosis in tumour biopsy samples of subjects with SCCHN following two-six weeks of lapatinib/placebo treatment.