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.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00768664
First received: October 7, 2008
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) , PFS at 6 months and PFS at 1 year [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters: Trough concentration of PF-00299804 in plasma after repeated dosing [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of Stable Disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS), OS at 6 months and OS at 1 year; [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall safety profile characterized by type, frequency, severity (as graded using NCI CTCAE v. 3.0.1) of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Potential predictive tissue biomarkers derived from available archival SCCHN tumor tissue samples [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00768664

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00768664     History of Changes
Other Study ID Numbers: A7471027
Study First Received: October 7, 2008
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration

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:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on October 19, 2014