Overview

This trial is active, not recruiting.

Condition carcinoma, non-small cell
Treatments dacomitinib (pf-00299804)
Phase phase 2
Sponsor Pfizer
Start date March 2009
End date April 2012
Trial size 119 participants
Trial identifier NCT00818441, A7471017

Summary

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
dacomitinib (pf-00299804)
Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
(Experimental)
Dacomitinib in patients with HER2 mutated or amplified NSCLC
dacomitinib (pf-00299804)
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.

Primary Outcomes

Measure
Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort A] PFS is defined as the interval from enrollment to date of objective progression or death due to any cause.
time frame: 10 months

Secondary Outcomes

Measure
Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort B]
time frame: 6 months
--Duration of Response (DR) per cohort
time frame: 10 months
Overall Survival (OS) per cohort
time frame: 2 years
Progression-free Survival (PFS) per cohort
time frame: 10 months
Overall safety profile
time frame: 12 months
Patient Reported Outcomes of health related quality of life and disease/treatment-related symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Lung Cancer module (LC13)
time frame: 10 months
Trough concentrations of PF-00299804 in blood after repeated dosing
time frame: 10months
Best Overall Response (BOR) per RECIST per cohort
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Advanced adenocarcinoma of lung, measurable disease - Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR - patients with known EGFR activating mutation regardless of smoking status - ECOG(Eastern Cooperative Oncology Group) 0-1. Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy Exclusion Criteria: - Active brain metastases - Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy. - known EGFR wild type NSCLC

Additional Information

Official title A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Pfizer.