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

NCT01484847

Last updated date
Study Location
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Head and Neck Squamous Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Head and Neck Squamous Cell CarcinomaA Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT01484847
  1. Toronto, Ontario
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18 Years+
years
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Advanced Information
Descriptive Information
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
 (submitted: July 9, 2015)
6
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2011)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Lillian Siu, MDUniversity Health Network/Princess Margaret Hospital
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