A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
A6181092
NCT00372775
March 2007
December 2009
Name | Location |
---|---|
Pfizer Investigational Site | Bronx, New York 10461 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Clearwater, Florida 33761 |
Pfizer Investigational Site | Columbia, Missouri 65201 |
Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
Pfizer Investigational Site | Farmington, Connecticut 06030-3805 |
Pfizer Investigational Site | Livingston, New Jersey 07039 |