CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 755 enrolled
Drug / intervention
cabazitaxel (XRP6258) (RPR116258) +2 moredrug
Likely dose
cabazitaxel (XRP6258) (RPR116258) 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00417079
NCT00417079Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Dec 29, 2006·Updated Mar 10, 2011

In Brief

A Phase 3 clinical trial evaluating cabazitaxel (XRP6258) (RPR116258), mitoxantrone, and 1 other intervention for Neoplasms and Prostatic Neoplasms. Completed, enrolled 755 participants across 26 sites in 26 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Prostatic Neoplasms
CountriesArgentina, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Finland, France, Germany, Hungary, India, Italy, Mexico, Netherlands, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 29, 2006
Enrollment StartJan 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.5 years ago

Interventions

cabazitaxel (XRP6258) (RPR116258)drug

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

mitoxantronedrug

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

prednisonedrug

10 mg daily administered by oral route