NCT01254279

Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Multicentre, Single-arm, Open Label Clinical Trial Intended to Provide Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen and to Document Safety of Cabazitaxel in These Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 984 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients. Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	CABAZITAXEL	Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-12-06
• Last updated: 2015-01-21

Locations

165 sites across 29 countries: Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Denmark, Finland, Hungary, India, Ireland, Italy, Kazakhstan, Luxembourg, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, Spain, Sweden, Taiwan, United Kingdom