Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-Free Survival (PFS)
PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
A6181058
NCT00265317
June 2006
January 2012
Name | Location |
---|---|
Pfizer Investigational Site | Birmingham, Alabama 35205 |
Pfizer Investigational Site | Blendora, California 91740 |
Pfizer Investigational Site | Cincinnait, Ohio 45236 |
Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Columbia, Missouri 65201 |
Pfizer Investigational Site | Asheville, North Carolina 28801 |