Status:
TERMINATED
A Study In Patients Who Will Undergo Surgical Removal Of Non-Small Cell Lung Cancer To Evaluate Molecular Changes That Occur In Tumor Tissue After Short Term Exposure To PF-00299804
Lead Sponsor:
Pfizer
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will enroll patients who are planned to undergo surgical removal of their tumor. The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8 days) exposure...
Detailed Description
The A7471031 study was terminated on May 2, 2012. The decision for unplanned study termination was triggered by feasibility of further conduct of this trial as only 22 of the protocol-specified 75 pat...
Eligibility Criteria
Inclusion
- Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.
- Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.
Exclusion
- Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent.
- Prior or concurrent radiation therapy to tumor at site of planned resection.
- Congestive heart failure (LVEF \< 50%), uncontrolled hypertension, significant ventricular arrythmia.
- Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to have a risk of causing Torsades de Pointes.
- Prior or concurrent radiation therapy to tumor at site of planned resection.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00971191
Start Date
February 1 2010
End Date
May 1 2012
Last Update
June 22 2012
Active Locations (3)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
2
Pfizer Investigational Site
Los Angeles, California, United States, 90048
3
Pfizer Investigational Site
Los Angeles, California, United States, 90095