Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
- Conditions
- Head and Neck Neoplasms
- Interventions
- Drug: PF-00299804
- Registration Number
- NCT00768664
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- 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;
- prior therapy for recurrence;
- platelets < 75,000;
- prior Epidermal Growth Factor Receptor (EGFR) therapy;
- interstitial lung disease;
- primary of nasopharynx
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A PF-00299804 -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR) Baseline up to 18 months 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
Name Time Method Duration of Response (DR) Baseline up to 18 months 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) Baseline up to 18 months 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) Baseline up to 18 months 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 Baseline up to 52 weeks 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) Baseline up to 18 months 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 Baseline up to Week 52 Probability of survival 26 weeks and 52 weeks after the first dose of study treatment.
Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat Dosing Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1 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 Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1 Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) In Participants Requiring Administration of Dacomitinib With a Feeding Tube Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose 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 Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose Plasma Decay Half-Life (t1/2) Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose 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 Baseline up to 18 months 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 Baseline up to 18 Months 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 Baseline up to 18 Months 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.
Trial Locations
- Locations (9)
Hopital Notre-dame du CHUM - Oncology Center
🇨🇦Montreal, Quebec, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Fairmont Medical Building
🇨🇦Vancouver, British Columbia, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
BC Cancer Agency, Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Sunnybrook Health Sciences Centre: Odette Cancer Center
🇨🇦Toronto, Ontario, Canada