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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-04

Study Completion Date

2012-04-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

45 mg by continuous oral dosing

Interventions

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PF-00299804

45 mg by continuous oral dosing

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No