CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 119 enrolled
Drug / intervention
Dacomitinib (PF-00299804) +1 moredrug
Likely dose
Dacomitinib (PF-00299804) 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00818441
NCT00818441Phase 2Completed
CompareCT.gov

A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG

Pfizer·interventional·Posted Jan 7, 2009·Updated Jan 8, 2019

In Brief

A Phase 2 clinical trial evaluating Dacomitinib (PF-00299804) for Carcinoma, Non-small Cell. Completed, enrolled 119 participants across 41 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-small Cell
CountriesHong Kong, Japan, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2009
Enrollment StartMar 11, 2009
Primary CompletionApr 27, 2012
Study CompletionApr 30, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.5 years ago

Interventions

Dacomitinib (PF-00299804)drug

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).

Dacomitinib (PF-00299804)drug

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.