XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

755

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
NeoplasmsProstatic Neoplasms
Interventions
DRUG

cabazitaxel (XRP6258) (RPR116258)

25 mg/m\^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle

DRUG

mitoxantrone

12 mg/m\^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle

DRUG

prednisone

10 mg daily administered by oral route

Trial Locations (26)

08807

sanofi-aventis US, Bridgewater

Unknown

sanofi-aventis Argentina, Buenos Aires

sanofi-aventis Belgium, Diegem

sanofi-aventis Brazil, São Paulo

sanofi-aventis Canada, Laval

sanofi-aventis Chile, Santiago

sanofi-aventis Czech Republic, Prague

sanofi-aventis Denmark, Hørsholm

sanofi-aventis Finland, Helsinki

sanofi-aventis France, Paris

sanofi-aventis Germany, Berlin

Sanofi-Aventis Hungaria, Budapest

sanofi-aventis India, Mumbai

sanofi-aventis Italy, Milan

sanofi-aventis Mexico, México

sanofi-aventis Netherlands, Gouda

sanofi-aventis Russia, Moscow

sanofi-aventis Singapore, Singapore

sanofi-aventis Slovakia, Bratislava

sanofi-aventis South Africa, Midrand

sanofi-aventis South Korea, Seoul

sanofi-aventis Spain, Barcelona

sanofi-aventis Sweden, Bromma

sanofi-aventis Taiwan, Taipei

sanofi-aventis Turkey, Istanbul

sanofi-aventis UK, Guildford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY