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XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
NCT00417079 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00417079
The ClinicalTrials.gov registry entry for NCT00417079 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 755 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00417079 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, New Jersey, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00417079?
The interventions under investigation include: prednisone (DRUG), cabazitaxel (XRP6258) (RPR116258) (DRUG), mitoxantrone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00417079?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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