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Head and Neck NeoplasmsPhase 2NCT00768664

Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer

A Phase 2 study testing PF-00299804 in people with Head and Neck Neoplasms, run by Pfizer at 10 sites 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 study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Head and Neck Neoplasms
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
69 participants
Where
10 sitesCanada
Study dates
4 Nov 2008to 18 Apr 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;
  • Measurable disease;
  • Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;
  • Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;

Who cannot join

  • prior therapy for recurrence;
  • platelets < 75,000;
  • prior Epidermal Growth Factor Receptor (EGFR) therapy;
  • interstitial lung disease;
  • primary of nasopharynx

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Canada10 sites

  • Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Hopital Notre-dame du CHUM - Oncology Center

    Montreal, Quebec, H2L 4M1

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1Y 4K7

  • Sunnybrook Health Sciences Centre: Odette Cancer Center

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency, Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • Fairmont Medical Building

    Vancouver, British Columbia, V5Z1H7

Other trials in Canada

About this study

Official title: CLINICAL PHASE 2 MULTICENTER TRIAL OF PF-00299804 IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer.

Being tested
PF-00299804
Keywords
recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence
Medical subject headings
Head and Neck Neoplasms, Recurrence

What participants receive

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

  • PF-00299804Drug

    45 mg by continuous oral dosing

Study groups in NCT00768664
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: PF-00299804

What is being measured

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

  1. Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)

    Percentage of participants with best OR of confirmed CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) relative to total number of evaluable participants for response. CR defined as disappearance of all target/non-target lesions. PR defined as at least a 30 percent (%) decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR and PR) were those that persisted on a follow-up imaging assessment greater than or equal to (≥)4 weeks after the initial objective documentation of response.

    Measured: Baseline up to 18 months

Secondary outcomes (15)

  1. Duration of Response (DR)

    Time in weeks from the first documentation of objective tumor response (CR or PR) to progression or death due to progressive disease (PD). DR was calculated as (the date of the first documentation of PD or death due to PD minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response (CR or PR).

    Measured: Baseline up to 18 months

  2. Duration of Stable Disease (SD)

    Time in weeks from start of treatment to date of objective disease progression (based on RECIST criteria). SD defined as neither sufficient shrinkage for PR nor sufficient increase for PD, taking as a reference the smallest sum of the longest dimensions since treatment start. Participants last known to be alive, not to have started new anticancer treatment, to be progression free, and who had a baseline and at least 1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of PD. Participants who died not due to PD censored on death date.

    Measured: Baseline up to 18 months

  3. Progression-Free Survival (PFS)

    Time in weeks from date of enrollment to first documentation of PD, death due to any cause, symptomatic deterioration, or start of secondary anticancer therapy, whichever occurred first. PFS calculated as (first event date minus enrollment date plus 1). Documentation of progression determined from objective disease assessment based on RECIST criteria. PD defined as at least a 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since treatment started or the appearance of 1 or more new lesions.

    Measured: Baseline up to 18 months

  4. Progression-Free Survival (PFS) at 6 Months and at 1 Year

    Probability of being event-free (event defined as PD, death due to any cause, symptomatic deterioration, or start of secondary anticancer therapy) at 26 weeks and 52 weeks after the first dose of study treatment.

    Measured: Baseline up to 52 weeks

  5. Overall Survival (OS)

    Time in weeks from the start date of enrollment to date of death due to any cause. OS was calculated as (the death date minus the enrollment date plus 1). Participants without death dates, last known to be alive were censored at last contact.

    Measured: Baseline up to 18 months

  6. Overall Survival at 6 Months and 1 Year

    Probability of survival 26 weeks and 52 weeks after the first dose of study treatment.

    Measured: Baseline up to Week 52

  7. Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat Dosing

    Trough concentrations of dacomitinib in plasma measured as nanograms per milliliter (ng/mL).

    Measured: Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1

  8. Ctrough of Dacomitinib After Repeat Dosing In Participants Requiring Administration of Dacomitinib With a Feeding Tube

    Measured: Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1

  9. Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose

  10. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) In Participants Requiring Administration of Dacomitinib With a Feeding Tube

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose

  11. Time to Reach Maximum Observed Plasma Concentration (Tmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose

  12. Plasma Decay Half-Life (t1/2)

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose

  13. Correlation Between Biomarkers Status and Best Overall Response

    The best overall response was best response recorded from the start of the treatment until disease progression/recurrence. In this outcome measure, biomarkers status and best overall response was reported in terms of correlation coefficient.

    Measured: Baseline up to 18 months

  14. H-Score at Baseline and Post-baseline for Paired Biopsy Biomarkers

    H-score is a measure of the immunohistochemistry staining positivity. The range for H-score is between 0 and 300. A higher score refers to stronger staining of a particular marker.

    Measured: Baseline up to 18 Months

  15. H-Score at Ratio to Baseline for Paired Biopsy Biomarkers

    H-score is a measure of the immunohistochemistry staining positivity. The range for H-score is between 0 and 300. A higher score refers to stronger staining of a particular marker.

    Measured: Baseline up to 18 Months

Timeline

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

  1. First posted8 Oct 2008 (estimated)
  2. Study start4 Nov 2008
  3. Primary completion5 May 2010
  4. Study completion18 Apr 2012

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00768664
Sponsor's protocol ID
A7471027
Status last verified
Jan 2021
First submitted
7 Oct 2008
Last updated
9 Feb 2021
Data monitoring committee
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

    PubMed 25057165

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-00299804 in people with Head and Neck Neoplasms, run by Pfizer at 10 sites 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 4 inclusion and 5 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR) (time frame: Baseline up to 18 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 NCT00768664, which also lists 1 linked publication.

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 9 Feb 2021.

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