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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

Last updated on May 11, 2018

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

- prior Epidermal Growth Factor Receptor (EGFR) therapy;

- interstitial lung disease;

- primary of nasopharynx

NCT00768664
Pfizer
Completed
Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Head and Neck Neoplasms
Drug: PF-00299804
45 mg by continuous oral dosing
Experimental: A
Intervention: Drug: PF-00299804
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.
 
Completed
69
April 2012
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00768664
A7471027
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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