Spots Global Cancer Trial Database for XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
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Trial Identification
Brief Title: XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
Official Title: A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen
Study ID: NCT00417079
Study Description
Brief Summary: This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
sanofi-aventis US, Bridgewater, New Jersey, United States
sanofi-aventis Argentina, Buenos Aires, , Argentina
sanofi-aventis Belgium, Diegem, , Belgium
sanofi-aventis Brazil, Sao Paulo, , Brazil
sanofi-aventis Canada, Laval, Quebec, Canada
sanofi-aventis Chile, Santiago, , Chile
sanofi-aventis Czech Republic, Praha, , Czech Republic
sanofi-aventis Denmark, Horsholm, , Denmark
sanofi-aventis Finland, Helsinki, , Finland
sanofi-aventis France, Paris, , France
sanofi-aventis Germany, Berlin, , Germany
Sanofi-Aventis Hungaria, Budapest, , Hungary
sanofi-aventis India, Mumbai, , India
sanofi-aventis Italy, Milano, , Italy
sanofi-aventis South Korea, Seoul, , Korea, Republic of
sanofi-aventis Mexico, Mexico, , Mexico
sanofi-aventis Netherlands, Gouda, , Netherlands
sanofi-aventis Russia, Moscow, , Russian Federation
sanofi-aventis Singapore, Singapore, , Singapore
sanofi-aventis Slovakia, Bratislava, , Slovakia
sanofi-aventis South Africa, Midrand, , South Africa
sanofi-aventis Spain, Barcelona, , Spain
sanofi-aventis Sweden, Bromma, , Sweden
sanofi-aventis Taiwan, Taipei, , Taiwan
sanofi-aventis Turkey, Istanbul, , Turkey
sanofi-aventis UK, Guildford, Surrey, United Kingdom
Contact Details
Name: ICD
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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