Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy
Patients will be treated until progressive disease, unacceptable toxicity, or patient's
refusal of further study treatment. All patients will be followed when on study treatment
and after completion of study treatment during follow up period until death or the study
cutoff date, whichever comes first.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
up to 57 months
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
EFC11784
NCT01308567
May 2011
December 2017
Name | Location |
---|---|
Investigational Site Number 840021 | Minneapolis, Minnesota 55426 |
Investigational Site Number 840003 | San Diego, California 92123 |
Investigational Site Number 840014 | San Francisco, California 94143 |
Investigational Site Number 840030 | Tustin, California 92780 |
Investigational Site Number 840009 | Modesto, California 95355 |
Investigational Site Number 840005 | Lansing, Michigan 48912 |
Investigational Site Number 840004 | Muscle Shoals, Alabama 35661 |
Investigational Site Number 840012 | San Francisco, California 94143 |
Investigational Site Number 840019 | Denver, Colorado 80262 |
Investigational Site Number 840013 | Boca Raton, Florida 33486 |
Investigational Site Number 840035 | Jacksonville, Florida 32256 |
Investigational Site Number 840001 | Port St. Lucie, Florida 34952 |
Investigational Site Number 840015 | Decatur, Illinois 62526 |
Investigational Site Number 840018 | Wichita, Kansas 67214 |
Investigational Site Number 840010 | Paducah, Kentucky 42002 |
Investigational Site Number 840008 | New Orleans, Louisiana 70112 |
Investigational Site Number 840006 | Rockville, Maryland 20850 |
Investigational Site Number 840238 | Boston, Massachusetts 02114 |
Investigational Site Number 840138 | Boston, Massachusetts 02115 |
Investigational Site Number 840038 | Brookline, Massachusetts 02115 |
Investigational Site Number 840016 | Kansas City, Missouri 64128 |
Investigational Site Number 840020 | Lincoln, Nebraska 68506 |
Investigational Site Number 840017 | East Orange, New Jersey 07018 |
Investigational Site Number 840033 | Albuquerque, New Mexico 87109 |
Investigational Site Number 840036 | Raleigh, North Carolina 27607 |
Investigational Site Number 840011 | Washington, North Carolina 27889 |
Investigational Site Number 840026 | Akron, Ohio 44302 |
Investigational Site Number 840023 | Cleveland, Ohio 44106 |
Investigational Site Number 840032 | Dunmore, Pennsylvania 18512 |
Investigational Site Number 840007 | Pawtucket, Rhode Island 02860 |
Investigational Site Number 840037 | Myrtle Beach, South Carolina 29572 |
Investigational Site Number 840028 | Chattanooga, Tennessee 37404 |