Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer

CLINICAL PHASE 2 MULTICENTER TRIAL OF PF-00299804 IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer.

Inclusion Criteria:

• Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;
• Measurable disease;
• Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;
• Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;

Exclusion Criteria:

• prior therapy for recurrence;
• platelets < 75,000;
• prior Epidermal Growth Factor Receptor (EGFR) therapy;
• interstitial lung disease;
• primary of nasopharynx