Lung Cancer Clinical Trial

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

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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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Eligibility Criteria

Inclusion 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.

Exclusion 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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT01858389

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 8 Locations for this study

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Tower Hematology Oncology Medical Group
Beverly Hills California, 90211, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles California, 90048, United States
Georgetown University Hospital-Lombardi Comprehensive Cancer Center
Washington, D.C. District of Columbia, 20007, United States
Georgetown University Medical Center Department of Pharmacy, Research
Washington, D.C. District of Columbia, 20007, United States
Memorial Sloan-Kettering Cancer Center-Rockefeller Outpatient Pavilion
New York New York, 10022, United States
Investigational Drug Service, Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
UT Southwestern Medical Center-Simmons Cancer Center Pharmacy
Dallas Texas, 75390, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
UT Southwestern University Hospital - William P. Clements, Jr.
Dallas Texas, 75390, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas Texas, 75390, United States
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
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How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT01858389

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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