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Clinical Phase 2 Multicenter Trial Of PF-00299804 In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasms

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Trial Information

Clinical Phase 2 Multicenter Trial Of PF-00299804 In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response Rate

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A7471027

NCT ID:

NCT00768664

Start Date:

November 2008

Completion Date:

April 2012

Related Keywords:

  • Head and Neck Neoplasms
  • recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence
  • Neoplasms
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

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