Non-Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804
Verified date | June 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 to the study drug.
Status | Terminated |
Enrollment | 22 |
Est. completion date | May 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Birmingham | Alabama |
United States | Pfizer Investigational Site | Los Angeles | California |
United States | Pfizer Investigational Site | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To identify the molecular changes which occur in human non-small cell lung cancer tissue after short-term exposure to PF-00299804 administered at 45 mg daily after a loading dose | 30 months | No | |
Secondary | To correlate molecular changes with specific gene and protein changes (eg, mutations, amplifications, over expression) in members of the EGFR and HER2 signal transduction pathways (eg, KRAS, EGFR, HER2) | 30 months | No | |
Secondary | To assess the effect of short term treatment of PF-00299804 on serum levels of the extracellular domain of EGFR and other serum markers of HER signaling (eg, serum HER2/neu and serum E-cadherin) | 30 months | No | |
Secondary | To assess the relationship between the pharmacokinetic parameters with molecular changes detected in non-small cell lung cancer | 30 months | No | |
Secondary | To assess the safety and tolerability of PF-00299804 in this setting | 30 months | Yes |
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