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

NCT01484847 | Completed

• 1 other identifier: WS1544542/Pan-HER-GT-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

advanced; PF-00299804; head and neck; pharmacokinetic; squamous cell carcinoma; gastrojejunostomy; feeding tube

Outcome Measures

Primary Outcomes (1)

• Composite (or Profile) of Pharmacokinetics Time Frame: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose

  Cmax, Area Under Curve, Tmax

  3-6 months

Secondary Outcomes (2)

• Comparison of pharmacokinetic parameters of study subjects with existing phase I pharmacokinetic data following administration of PF-00299804.

  3-6 months

• Overall safety profile as per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

  3-6 months

Study Arms (1)

PF-00299804

EXPERIMENTAL

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

Drug: PF-00299804

Interventions

PF-00299804 DRUG

Tablet, single dose of 45 mg via gastrojejunostomy tube (G-Tube) on an empty stomach

PF-00299804

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Pfizer: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Lillian Siu, MD

  University Health Network/Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: December 2, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2015
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

CA (1)