A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804
18 Years
N/A
Both
Non-Small Cell Lung Cancer (NSCLC)
Trial Information
A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804
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 patients were enrolled since the study initiated in February 2010.
Based on this low accrual rate it was determined that the study was highly unlikely to
complete accrual and provide meaningful data. The discontinuation of the study is not due
to any safety issue.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
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
Outcome Time Frame:
30 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A7471031
NCT ID:
NCT00971191
Start Date:
February 2010
Completion Date:
May 2012
Related Keywords:
- Non-Small Cell Lung Cancer (NSCLC)
- Stage I - III surgical resection molecular change brief pre-operative exposure
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Blendora, California 91740 |
