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

Completed · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01858389

Run by

Pfizer

People needed

41

Starts

2013-07-01

Expected to finish

2015-09-01

Last updated by the study team

2017-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tower Hematology Oncology Medical Group — Beverly Hills, California, United States
• Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• Georgetown University Hospital-Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• Georgetown University Medical Center Department of Pharmacy, Research — Washington D.C., District of Columbia, United States
• Memorial Sloan-Kettering Cancer Center-Rockefeller Outpatient Pavilion — New York, New York, United States
• Investigational Drug Service, Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center-Simmons Cancer Center Pharmacy — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• UT Southwestern University Hospital - William P. Clements, Jr. — Dallas, Texas, United States
• UT Southwestern University Hospital - Zale Lipshy — Dallas, Texas, United States
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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