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Head and Neck Squamous Cell CarcinomaNCT01484847

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

A study testing PF-00299804 in people with Head and Neck Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
PF-00299804
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
Dec 2011to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
PF-00299804
Keywords
advanced, PF-00299804, head and neck, pharmacokinetic, squamous cell carcinoma, gastrojejunostomy, feeding tube
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-00299804Drug

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

Study groups in NCT01484847
Study groupRoleWhat they receive
PF-00299804ExperimentalPatients 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
Receives: Drug: PF-00299804

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3-6 months

Secondary outcomes (2)

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

    Tmax=4-24 hrs, Cmax = 28.1 ng/ml, AUCtau=47 hr*ng/ml, t1/2=85.1

    Measured: 3-6 months

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

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2013
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484847
Sponsor's protocol ID
WS1544542/Pan-HER-GT-001
Status last verified
Jul 2015
First submitted
30 Sep 2011
Last updated
10 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing PF-00299804 in people with Head and Neck Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite (or Profile) of Pharmacokinetics Time Frame: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose (time frame: 3-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01484847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.

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