Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen
Patients will be treated until progressive disease, unacceptable toxicity, patient's refusal
of further study treatment or for a maximum of 10 cycles. 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 6 years
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
EFC11785
NCT01308580
April 2011
September 2017
Name | Location |
---|---|
Investigational Site Number 840001 | Vallejo, California 94589 |
Investigational Site Number 840024 | Charlotte, North Carolina 28204 |
Investigational Site Number 840003 | Orlando, Florida 32806 |
Investigational Site Number 840008 | Los Angeles, California 90048 |
Investigational Site Number 840025 | Jackson, Tennessee 38305 |
Investigational Site Number 840013 | Boca Raton, Florida 33486 |
Investigational Site Number 840002 | Muscle Shoals, Alabama 35661 |
Investigational Site Number 840004 | Hot Springs, Arkansas 71913 |
Investigational Site Number 840010 | San Francisco, California 94143 |
Investigational Site Number 840021 | Stamford, Connecticut 06902 |
Investigational Site Number 840023 | Jacksonville, Florida 32256 |
Investigational Site Number 840007 | New Orleans, Louisiana 70112 |
Investigational Site Number 840014 | Baltimore, Maryland 21231 |
Investigational Site Number 840005 | Rockville, Maryland 20850 |
Investigational Site Number 840017 | St Louis Park, Minnesota 55416 |
Investigational Site Number 840011 | Jackson, Mississippi 39202 |
Investigational Site Number 840016 | Lincoln, Nebraska 68506 |
Investigational Site Number 840015 | East Orange, New Jersey 07018 |
Investigational Site Number 840020 | Akron, Ohio 44302 |
Investigational Site Number 840006 | Pawtucket, Rhode Island 02860 |
Investigational Site Number 840012 | Corpus Christi, Texas 78405 |