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

NCT00768664

Last updated date
Study Location
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 4E6, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Head and Neck Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- prior therapy for recurrence;


- platelets < 75,000;


- prior Epidermal Growth Factor Receptor (EGFR) therapy;


- interstitial lung disease;


- primary of nasopharynx

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Head and Neck NeoplasmsOpen-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer NCT00768664
  1. Vancouver, British Columbia
  2. Vancouver, British Columbia
  3. Hamilton, Ontario
  4. London, Ontario
  5. Ottawa, Ontario
  6. Ottawa, Ontario
  7. Toronto, Ontario
  8. Toronto, Ontario
  9. Montreal, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
Official Title  ICMJE Clinical Phase 2 Multicenter Trial Of PF-00299804 In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Neoplasms
Intervention  ICMJE Drug: PF-00299804
45 mg by continuous oral dosing
Study Arms  ICMJE Experimental: A
Intervention: Drug: PF-00299804
Publications * Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-15. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2011)
69
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2008)
56
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00768664
Other Study ID Numbers  ICMJE A7471027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP