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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Head and Neck Neoplasms

Treatments: Drug: PF-00299804

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768664

A7471027

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

69 participants in 1 patient group

A

Experimental group

Treatment:

Drug: PF-00299804