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Study to Assess Biomarkers in Patients With Resectable Oral Cavity Cancer Randomized to Receive Preoperative Treatment

2014-08-27 03:13:58 | BioPortfolio

Summary

The objective of this study is to assess the biological effects in the primary tumor following a short, pre-operative course of treatment with PF-00298804 in patients with Oral Cavity Cancer.

Description

This is a single-center, randomized, double-blinded, biomarker driven, preoperative window of opportunity study with a pharmacodynamic primary endpoint. Patients with resectable, histologically confirmed OCC for whom surgical treatment is planned as definitive management, will be randomized 2:1 to receive PF-00299804 pre-operatively at a loading dose of 45 mg twice daily orally for 3 days, followed by 5 days of dosing at 45 mg once daily orally (plus or minus 3 days depending on surgery schedule), or to Matching Placebo for 8 days (plus or minus 3 days depending on surgery schedule). The target is a total of 8 days of treatment but with a minimum of 5 and a maximum of 11 dosing days. All patients will receive surgery as per standard of care without delay. Biomarkers from the surgical specimen and mandatory baseline tumor biopsy will be evaluated for primary and secondary pharmacodynamic endpoints.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Oral Cavity Cancer

Intervention

PF-00299804/Placebo

Location

Princess Margaret Hospital
Toronto
Ontario
Canada
M5G 2M9

Status

Recruiting

Source

University Health Network, Toronto

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:58-0400

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