A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT01484847
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- Signed, voluntary informed consent provided
- Willing and able to comply with visits, treatment plan, pharmacokinetics, tests, other procedures
- Confirmed SCCHN. Other primary sites of head and neck carcinoma: nasopharynx, skin, maxillary sinus or unknown primary, are allowed
- Must have functioning gastrojejunostomy tube
- May be receiving concurrent chemoradiation, radiation alone or recently completed surgery for locally advanced disease
- Prior treatment with agents targeted to epidermal growth factor receptor not allowed.
- Any treatment-related toxicity, including laboratory abnormalities, must have recovered to CTCAE Grade 2 (v.4.0) or baseline, except toxicity not considered safety risk. Chronic dysphagia, xerostomia or other local effect from prior surgery or radiation will not be considered exclusion criterion if stable for ≥ 3 months.
- ECOG performance status 0-2
- Must have adequate organ function determined by: Serum creatinine ≤ 1.5 ULN (upper limit of normal) or calculated creatinine clearance of ≥ 50 mL/min using the formula: Creatinine clearance = [(140-age) x wt (kg) x Constant] / creatinine (µmol/L) [Constant = 1.23 for men; 1.04 for women]. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Leukocytes ≥ 3.0 x 109/L; Hemoglobin ≥ 80 g/L (or > 8 g/dL); Platelets ≥ 100 x 109/L. Total bilirubin ≤ ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN. 12-Lead electrocardiogram (ECG) with normal tracing, or clinically non-significant with no medical intervention; QTc interval ≤ 470 msec, without history of Torsades de Pointes or other QTc abnormality
- Cannot be enrolled on another clinical trial
- Prior investigational drug therapy within 30 days or 5 half-lives preceding first dose
of study drug (whichever longer)
- Requirement for drugs highly dependent on CYP2D6 for metabolism since PF-00299804 is a
potent CYP2D6 inhibitor
- Patients currently taking drugs with risk of Torsades de Pointes
- Any acute/chronic medical, psychiatric condition or laboratory abnormality that could
increase risk of participation, trial drug administration or interfere with
interpretation of trial results and, investigator feels, would make patient
inappropriate for entry. Including: History of interstitial lung disease; Uncontrolled
hypertension, unstable angina, myocardial infarction, symptomatic congestive heart
failure within past year, uncontrolled cardiac arrhythmia, diagnosed/suspected
congenital long QT syndrome; history of stroke, deep vein thrombosis, or stable for 6
months without requiring antiarrhythmics/significant change in medical management;
Active bacterial, fungal or viral infection including hepatitis B/C, and human
immunodeficiency virus. Testing not required at baseline with no symptoms of
infection. History of significant bleeding disorder, or concurrent medications that
investigator feels may lead to unacceptable coagulation during perioperative interval,
including: congenital bleeding disorders; acquired bleeding disorder within a year
- Other serious uncontrolled medical disorder or active infection that would impair
ability to receive study treatment as determined by investigator
- Dementia or altered mental status that would limit ability to obtain informed consent
and compliance with requirements of the protocol
- Patients breastfeeding or pregnant are excluded. Those with reproductive potential
must have negative pregnancy test within 72 hours of treatment. Patients of
reproductive potential include any female who has experienced menarche and who has not
undergone successful surgical sterilization, or is not postmenopausal. Patients of
reproductive potential/partners must agree to effective contraception while receiving
trial treatment and for at least 3 months after. Effective contraception will be
judgment of principal investigator or designate
- Inability/lack of willingness to comply with visits, treatment plans, assessments or
tests
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Descriptive Information | ||||
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Brief Title ICMJE | A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma | |||
Official Title ICMJE | Pharmacokinetic Assessment of PF-00299804 in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Following Administration Through a Gastrojejunostomy Feeding Tube | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic | |||
Condition ICMJE | Head and Neck Squamous Cell Carcinoma | |||
Intervention ICMJE | Drug: PF-00299804
Tablet, single dose of 45 mg via gastrojejunostomy tube (G-Tube) on an empty stomach | |||
Study Arms ICMJE | Experimental: PF-00299804
Patients with locally advanced head and neck squamous cell carcinoma will be treated with a single dose (45mg) of PF-00299804 via G-Tube on an empty stomach Intervention: Drug: PF-00299804 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 6 | |||
Original Estimated Enrollment ICMJE | 10 | |||
Actual Study Completion Date ICMJE | July 2015 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01484847 | |||
Other Study ID Numbers ICMJE | WS1544542/Pan-HER-GT-001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University Health Network, Toronto | |||
Study Sponsor ICMJE | University Health Network, Toronto | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | University Health Network, Toronto | |||
Verification Date | July 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |