Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
CLINICAL PHASE 2 MULTICENTER TRIAL OF PF-00299804 IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
1 other identifier
interventional
69
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2008
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedStudy Start
First participant enrolled
November 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2012
CompletedResults Posted
Study results publicly available
February 9, 2021
CompletedFebruary 9, 2021
January 1, 2021
1.5 years
October 7, 2008
August 12, 2020
January 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline up to 18 months
Secondary Outcomes (15)
Duration of Response (DR)
Baseline up to 18 months
Duration of Stable Disease (SD)
Baseline up to 18 months
Progression-Free Survival (PFS)
Baseline up to 18 months
Progression-Free Survival (PFS) at 6 Months and at 1 Year
Baseline up to 52 weeks
Overall Survival (OS)
Baseline up to 18 months
- +10 more secondary outcomes
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- prior therapy for recurrence;
- platelets \< 75,000;
- prior Epidermal Growth Factor Receptor (EGFR) therapy;
- interstitial lung disease;
- primary of nasopharynx
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (10)
BC Cancer Agency, Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Fairmont Medical Building
Vancouver, British Columbia, V5Z1H7, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1Y 4K7, Canada
Sunnybrook Health Sciences Centre: Odette Cancer Center
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Hopital Notre-dame du CHUM - Oncology Center
Montreal, Quebec, H2L 4M1, Canada
Related Publications (1)
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.
PMID: 25057165DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 8, 2008
Study Start
November 4, 2008
Primary Completion
May 5, 2010
Study Completion
April 18, 2012
Last Updated
February 9, 2021
Results First Posted
February 9, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
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.