SANOFI-EFC6193

Study Sponsor : Sanofi

Study Title

A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m2 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

Medicine or Vaccine (generic name)

Cabazitaxel

Sponsor Identification Number

EFC6193

Trial Registry Identification Number(#'s)

NCT00417079

Medical Condition

Prostatic Neoplasm, Prostate Cancer

Phase

Phase 3

Link to study details on the Sanofi Clinical Study Register

https://www.sanofi.com/en/science-and-innovation/clinical-trials-and-results/our-disclosure-commitments/pharma/letter-c/

Link to study details on ClinicalTrials.gov (if available)

https://clinicaltrials.gov/ct2/show/NCT00417079?term=00417079&rank=1

Link to study details on EudraCT (if available)

Not available

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Datasets and document are available as per Sanofi Policy and criteria

Date Added to this Site

August 2017