Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 whos...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

July 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2015

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT01858389

Start Date

July 1 2013

End Date

September 1 2015

Last Update

July 18 2017

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Tower Hematology Oncology Medical Group

Beverly Hills, California, United States, 90211

2

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States, 90048

3

Georgetown University Hospital-Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States, 20007

4

Georgetown University Medical Center Department of Pharmacy, Research

Washington D.C., District of Columbia, United States, 20007