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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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Oral Cavity Cancer
Princess Margaret Hospital
University Health Network, Toronto
Published on BioPortfolio: 2014-08-27T03:13:58-0400
This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (
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 squam...
There are three arms to this study (A, B and C) The purpose of this research study during Arm A is to see how much of PF-00299804 gets into the brain tumor. For many brain tumors, one rea...
This randomized phase IIb trial studies how well ACTOplus met XR works in treating in patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive treatment. Ch...
The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.
The purpose of this study was to determine the influence of insurance status on treatment and outcomes in oral cavity cancer. Patients were identified in the National Cancer Database (NCDB). Data were...
The purpose of this study was to determine the impact of adjuvant radiotherapy (RT) in locoregionally advanced oral cavity cancer.
Oral cavity cancer is the most common malignant disease of the head and neck. The natural course of the disease is poorly characterized and unavailable for patient consideration during initial treatme...
Oral cancer includes cancer of lips, oral cavity and oropharynx. Oral cancer is the sixth most life-threatening disease affecting 65% of population. The delivery of cytotoxic chemotherapeutic anticanc...
Development of extra-nodal extension (ENE) has been associated with poor survival in patients with oral cavity squamous cell carcinoma (OSCC). Here we sought to confirm the role of ENE as a poor pr...
The oval-shaped oral cavity located at the apex of the digestive tract and consisting of two parts: the vestibule and the oral cavity proper.
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Uptake of substances into the body via the mucosal surfaces (MUCOUS MEMBRANE) of the oral cavity.
A dental specialty concerned with pathology of the oral cavity.
A hereditary disease characterized by multiple ectodermal, mesodermal, and endodermal nevoid and neoplastic anomalies. Facial trichilemmomas and papillomatous papules of the oral mucosa are the most characteristic lesions. Individuals with this syndrome have a high risk of BREAST CANCER; THYROID CANCER; and ENDOMETRIAL CANCER. This syndrome is associated with mutations in the gene for PTEN PHOSPHATASE.
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...