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

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
PF-00299804
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

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

Sites / Locations

  • BC Cancer Agency, Vancouver Centre
  • Fairmont Medical Building
  • Hamilton Health Sciences
  • London Health Sciences Centre
  • London Regional Cancer Centre
  • The Ottawa Hospital Cancer Centre
  • The Ottawa Hospital Cancer Centre
  • Sunnybrook Health Sciences Centre: Odette Cancer Center
  • Princess Margaret Hospital
  • Hopital Notre-dame du CHUM - Oncology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
Overall Survival at 6 Months and 1 Year
Probability of survival 26 weeks and 52 weeks after the first dose of study treatment.
Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat Dosing
Trough concentrations of dacomitinib in plasma measured as nanograms per milliliter (ng/mL).
Ctrough of Dacomitinib After Repeat Dosing In Participants Requiring Administration of Dacomitinib With a Feeding Tube
Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube
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).
Time to Reach Maximum Observed Plasma Concentration (Tmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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.
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.
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.

Full Information

First Posted
October 7, 2008
Last Updated
January 20, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00768664
Brief Title
Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
Official Title
CLINICAL PHASE 2 MULTICENTER TRIAL OF PF-00299804 IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2008 (Actual)
Primary Completion Date
May 5, 2010 (Actual)
Study Completion Date
April 18, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-00299804
Intervention Description
45 mg by continuous oral dosing
Primary Outcome Measure Information:
Title
Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
Description
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.
Time Frame
Baseline up to 18 months
Secondary Outcome Measure Information:
Title
Duration of Response (DR)
Description
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).
Time Frame
Baseline up to 18 months
Title
Duration of Stable Disease (SD)
Description
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.
Time Frame
Baseline up to 18 months
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Baseline up to 18 months
Title
Progression-Free Survival (PFS) at 6 Months and at 1 Year
Description
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.
Time Frame
Baseline up to 52 weeks
Title
Overall Survival (OS)
Description
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.
Time Frame
Baseline up to 18 months
Title
Overall Survival at 6 Months and 1 Year
Description
Probability of survival 26 weeks and 52 weeks after the first dose of study treatment.
Time Frame
Baseline up to Week 52
Title
Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat Dosing
Description
Trough concentrations of dacomitinib in plasma measured as nanograms per milliliter (ng/mL).
Time Frame
Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1
Title
Ctrough of Dacomitinib After Repeat Dosing In Participants Requiring Administration of Dacomitinib With a Feeding Tube
Time Frame
Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1
Title
Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube
Time Frame
Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) In Participants Requiring Administration of Dacomitinib With a Feeding Tube
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Time Frame
Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube
Time Frame
Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
Title
Plasma Decay Half-Life (t1/2)
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
Title
Correlation Between Biomarkers Status and Best Overall Response
Description
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.
Time Frame
Baseline up to 18 months
Title
H-Score at Baseline and Post-baseline for Paired Biopsy Biomarkers
Description
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.
Time Frame
Baseline up to 18 Months
Title
H-Score at Ratio to Baseline for Paired Biopsy Biomarkers
Description
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.
Time Frame
Baseline up to 18 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: prior therapy for recurrence; platelets < 75,000; prior Epidermal Growth Factor Receptor (EGFR) therapy; interstitial lung disease; primary of nasopharynx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
BC Cancer Agency, Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Fairmont Medical Building
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1H7
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4K7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre: Odette Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Notre-dame du CHUM - Oncology Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
25057165
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471027&StudyName=Open-Label%20Trial%20Of%20Oral%20PF-00299804%20By%20Continuous%20Dosing%20In%20Patients%20With%20Recurrent%20Or%20Metastatic%20Head%20And%20Neck%20Squamous%20Cell%20Cancer
Description
To obtain contact information for a study center near you, click here.

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

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