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

Completed · Phase 2

Conditions studied: Carcinoma, Non-small Cell

In brief

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.

Key facts

Study ID

NCT00818441

Run by

Pfizer

People needed

119

Starts

2009-03-11

Expected to finish

2015-04-30

Last updated by the study team

2019-01-08

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Irvine — Orange, California, United States
• Chao Family Comprehensive Cancer Center UC Irvine Medical Center — Orange, California, United States
• Bay Area Cancer Research Group, LLC — Pleasant Hill, California, United States
• Pacific Cancer Care — Salinas, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• University of Colorado Clinical Trials Office (CTO) — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• National Institutes of Health National Cancer Institute — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber Cancer lnstitute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• St. John's Hospital, — Springfield, Missouri, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Stony Brook University Medical Center - Cancer Center — Stony Brook, New York, United States
• Investigational Drug Service, Pharmacy Department, UNC Hospitals — Chapel Hill, North Carolina, United States
• Division of Hemotology/Oncology — Chapel Hill, North Carolina, United States
• UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Morris Cancer Center — Durham, North Carolina, United States
• Legacy Pharma Research — Bismarck, North Dakota, United States
• Mid Dakota Clinic, P.C — Bismarck, North Dakota, United States

Full record on ClinicalTrials.gov

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