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CompletedPhase 2NCT00818441
Official study title

Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDacomitinib (PF-00299804) and Dacomitinib (PF-00299804)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 8, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?41 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Pfizer
Interventions being studied
Drug: Dacomitinib (PF-00299804); Drug: Dacomitinib (PF-00299804)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
EGFR→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California, IrvineOrange, California
  • Chao Family Comprehensive Cancer Center UC Irvine Medical CenterOrange, California
  • Bay Area Cancer Research Group, LLCPleasant Hill, California
  • Pacific Cancer CareSalinas, California
  • San Francisco General HospitalSan Francisco, California
  • University of Colorado Clinical Trials Office (CTO)Aurora, Colorado
  • University of Colorado HospitalAurora, Colorado
  • Florida Cancer SpecialistsFort Myers, Florida
  • National Institutes of Health National Cancer InstituteBethesda, Maryland
  • Massachusetts General HospitalBoston, Massachusetts
  • Brigham & Women's HospitalBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 8, 2019. Always confirm current availability with the study team.

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