A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer
On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of
Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria
and was unlikely to meet its primary endpoint to demonstrate a statistically significant
improvement in progression-free survival (PFS) in patients treated with sunitinib plus
paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators
involved in the study and regulatory agencies of these findings. Enrollment in this study
has been stopped.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4
From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
A6181094
NCT00373256
November 2006
August 2011
Name | Location |
---|---|
Pfizer Investigational Site | Birmingham, Alabama 35205 |
Pfizer Investigational Site | Blendora, California 91740 |
Pfizer Investigational Site | Atlanta, Georgia 30342 |
Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
Pfizer Investigational Site | Rochester, Minnesota 55905 |
Pfizer Investigational Site | Cincinnait, Ohio 45236 |
Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
Pfizer Investigational Site | Bronx, New York 10461 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Richmond, Virginia 23249 |
Pfizer Investigational Site | Federal Way, Washington 98003 |
Pfizer Investigational Site | Flagstaff, Arizona 86001 |
Pfizer Investigational Site | North Little Rock, Arkansas 72117 |
Pfizer Investigational Site | Aurora, Colorado 80012 |
Pfizer Investigational Site | Clearwater, Florida 33761 |
Pfizer Investigational Site | Carmel, Indiana 46032 |
Pfizer Investigational Site | Kansas City, Kansas 66112 |
Pfizer Investigational Site | Westminster, Maryland 21157 |
Pfizer Investigational Site | North Adams, Massachusetts 01247 |
Pfizer Investigational Site | Columbia, Missouri 65201 |
Pfizer Investigational Site | Las Vegas, Nevada 89128 |
Pfizer Investigational Site | Santa Fe, New Mexico 87505 |
Pfizer Investigational Site | Asheville, North Carolina 28801 |
Pfizer Investigational Site | Eugene, Oregon 97401 |
Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
Pfizer Investigational Site | Easley,, South Carolina 29640 |
Pfizer Investigational Site | Farmington, Connecticut 06030-3805 |
Pfizer Investigational Site | Omaha, Nebraska 68198 |
Pfizer Investigational Site | Bristol, Tennessee 37620 |
Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
Pfizer Investigational Site | Salt Lake City, Utah 84112 |
Pfizer Investigational Site | Morgantown, West Virginia 26506 |