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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: October 7, 2008
Last updated: June 1, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Head and Neck Neoplasms Drug: PF-00299804 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Phase 2 Multicenter Trial Of PF-00299804 In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Best Overall Response Rate [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) , PFS at 6 months and PFS at 1 year [ Time Frame: 18 months ]
  • Pharmacokinetic parameters: Trough concentration of PF-00299804 in plasma after repeated dosing [ Time Frame: 18 months ]
  • Duration of Response (DR) [ Time Frame: 18 months ]
  • Duration of Stable Disease [ Time Frame: 18 months ]
  • Overall Survival (OS), OS at 6 months and OS at 1 year; [ Time Frame: 2 years ]
  • Overall safety profile characterized by type, frequency, severity (as graded using NCI CTCAE v. 3.0.1) of adverse events [ Time Frame: 18 months ]
  • Potential predictive tissue biomarkers derived from available archival SCCHN tumor tissue samples [ Time Frame: 12 months ]
  • Potential serum and tissue pharmacodynamic biomarkers derived from serum (HER2), and paired SCCHN biopsy samples obtained, as feasible, pre- and on-treatment [ Time Frame: 12 months ]

Enrollment: 69
Study Start Date: November 2008
Study Completion Date: April 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: PF-00299804
45 mg by continuous oral dosing


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00768664

Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E6
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z1H7
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8V 5C2
Pfizer Investigational Site
London, Ontario, Canada, N6A 4L6
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1Y 4K7
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT00768664     History of Changes
Other Study ID Numbers: A7471027
Study First Received: October 7, 2008
Last Updated: June 1, 2012

Keywords provided by Pfizer:
recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site processed this record on June 23, 2017