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Clinical Trial 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.


Clinical Trial 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 dose of 45 mg once daily orally for 7-11 days or to Matching Placebo for 7-11 days depending on surgery schedule. The target is a total of 8 days of treatment but with a minimum of 7 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 baseline tumor biopsy or consent to provide a tumor block from existing primary diagnostic tumor biopsy completed within 90 days will be evaluated for primary and secondary pharmacodynamic endpoints. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01116843
Study type Interventional
Source University Health Network, Toronto
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 2010
Completion date February 2014

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