Spots Global Cancer Trial Database for A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma

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Trial Identification

Brief Title: A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma

Official Title: Pharmacokinetic Assessment of PF-00299804 in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Following Administration Through a Gastrojejunostomy Feeding Tube

Study ID: NCT01484847

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

PF-00299804

Study Description

Brief Summary: This is a study to assess how much of the investigational drug, PF-00298804, is in the blood stream over a period of time (called pharmacokinetic tests or PK) in patients with locally advanced head and neck squamous cell carcinoma who have a (gastrojejunostomy) feeding tube.

Detailed Description: This is a single arm pharmacokinetic assessment study conducted at Princess Margaret Hospital in which eligible patients will be enrolled successively to receive a single dose of PF-00299804 in an open-labelled, unblinded manner. All patients will receive 45 mg of PF-00299804 via Gastrostomy (GT) once only on an empty stomach (i.e. 2 hours before or after oral food intake or GT feeds (food intake of less than 500 calories permitted)) as an inpatient. All patients will be admitted for an overnight inpatient stay (approximately 24 hours) to facilitate pharmacokinetic assessment. There will be no dose reductions or modifications. Blood sampling for pharmacokinetics will occur on day 1 immediately prior to the dose of PF-00299804 (t=0), then at t=30 minutes, t=1 hour, t=2 hours, t=3 hours, t=4 hours, t=6 hours, t=12 hours, t=24 hours, t=48 hours, t=72 hours, t=96 hours, t=144 hours, t=168 hours, t=192 hours, and t=216 hours.