Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417079
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2006-12-28
Brief Title:
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open Label Multi-Center Study of XRP6258 at 25 mgm2 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
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TROPIC
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 responseprogression pain responseprogression 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None