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CompletedPhase 2NCT01858389
Official study title

A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

Study summary

This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDacomitinib and Dacomitinib

The study team can explain what participation involves.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 18, 2017 · 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?14 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; Drug: Dacomitinib
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
MET→
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
  • Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
  • Evidence of T790M mutation to enroll in Cohort A.
  • Evidence of measurable disease by radiographic technique.
  • Adequate organ function.
Reasons someone may not be able to joinExclusion criteria
  • Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
  • Symptomatic brain metastases.
  • Uncontrolled or significant cardiovascular disease.
  • Pregnant or breastfeeding.

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

  • Tower Hematology Oncology Medical GroupBeverly Hills, California
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California
  • Georgetown University Hospital-Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
  • Georgetown University Medical Center Department of Pharmacy, ResearchWashington D.C., District of Columbia
  • Memorial Sloan-Kettering Cancer Center-Rockefeller Outpatient PavilionNew York, New York
  • Investigational Drug Service, Hillman Cancer CenterPittsburgh, Pennsylvania
  • University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
  • UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
  • UT Southwestern Medical Center-Simmons Cancer Center PharmacyDallas, Texas
  • UT Southwestern Medical CenterDallas, Texas
  • UT Southwestern University Hospital - William P. Clements, Jr.Dallas, Texas
  • UT Southwestern University Hospital - Zale LipshyDallas, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 18, 2017. Always confirm current availability with the study team.

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