A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC
Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.
Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CRAD001C2240
NCT00410124
November 2006
October 2011
Name | Location |
---|---|
Novartis Investigative Site | Southfield, Michigan 48075 |
Novartis Investigative Site | Portland, Oregon 97239 |
Novartis Investigative Site | Spokane, Washington 99202 |
Novartis Investigative Site | Philadelphia, Pennsylvania 19111-2497 |
Novartis Investigative Site | Sacramento, California 95817 |
Novartis Investigative Site | St. Louis, Missouri 63110 |
Novartis Investigative Site | Buffalo, New York 14263 |
Novartis Investigative Site | Durham, North Carolina 27710 |
Novartis Investigative Site | Cleveland, Ohio 44195 |
Novartis Investigative Site | Miami, Florida 33176-2197 |
Novartis Investigative Site | Beech Grove, Indiana 46107 |
Novartis Investigative Site | Louisville, Kentucky 40202 |
Novartis Investigative Site | Baltimore, Maryland 21201 |
Novartis Investigative Site | Minneapolis, Minnesota 55455 |
Novartis Investigative Site | Dallas, Texas 75235-9179 |
Novartis Investigative Site | Fayetteville, Arkansas 72703 |
Novartis Investigative Site | Las Vegas, Nevada 89135 |
Novartis Investigative Site | Morgantown, West Virginia 26506 |