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NCT00417079 · ClinicalTrials.gov registry record · Phase 3
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
A Phase 3 study of Neoplasms and Prostatic Neoplasms, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 755
- Enrollment target
- 20
- Study locations
NCT00417079: Completed Phase 3 study of Neoplasms and Prostatic Neoplasms, sponsored by Sanofi.
NCT00417079 is a Phase 3 study of Neoplasms and Prostatic Neoplasms that has completed, run by Sanofi. The registered enrollment target is 755 participants, below the 1,617-participant average among 158 other Neoplasms trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00417079, a Phase 3 study of Neoplasms and Prostatic Neoplasms, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 755 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
Conditions Studied
Interventions
- DRUG prednisone
- DRUG cabazitaxel (XRP6258) (RPR116258)
- DRUG mitoxantrone
Study Locations (20)
Other
- sanofi-aventis Argentina - Buenos Aires
- sanofi-aventis Belgium - Diegem
- sanofi-aventis Brazil - São Paulo
- sanofi-aventis Chile - Santiago
- sanofi-aventis Czech Republic - Prague
- sanofi-aventis Denmark - Hørsholm
- sanofi-aventis Finland - Helsinki
- sanofi-aventis France - Paris
- sanofi-aventis Germany - Berlin
- Sanofi-Aventis Hungaria - Budapest
- sanofi-aventis India - Mumbai
- sanofi-aventis Italy - Milan
- sanofi-aventis Mexico - México
- sanofi-aventis Netherlands - Gouda
- sanofi-aventis Russia - Moscow
- sanofi-aventis Singapore - Singapore
- sanofi-aventis Slovakia - Bratislava
- sanofi-aventis South Africa - Midrand
New Jersey
- sanofi-aventis US - Bridgewater
Quebec
- sanofi-aventis Canada - Laval
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 755 participants |
| Start Date | 2007-01 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00417079 record still lists
NCT00417079 is an interventional study that assigns participants to a tested intervention. The registered 755 participants enrollment target is mid-sized for trials with a published cap, below the 1,617-participant average among 158 other Neoplasms trials with a reported enrollment target (53% lower).
The record links to 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which prednisone is the first listed.
NCT00417079 names 20 study sites across 3 states, led by Other, New Jersey, Quebec.
Frequently Asked Questions
What is clinical trial NCT00417079 about?
NCT00417079 is a clinical study titled "XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer". 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...
What is the current status of trial NCT00417079?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 755 participants. The study started on 2007-01. Estimated completion is 2009-09.
What conditions does trial NCT00417079 study?
This clinical trial studies the following conditions: Neoplasms, Prostatic Neoplasms.
What interventions are being tested in trial NCT00417079?
The interventions under investigation include: prednisone (DRUG), cabazitaxel (XRP6258) (RPR116258) (DRUG), mitoxantrone (DRUG).
Who is sponsoring clinical trial NCT00417079?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00417079 being conducted?
This trial has 20 study locations across New Jersey, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00417079's enrollment target sits among peer trials
755 18th of 158 higher than 141 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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