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NCT01308567 · ClinicalTrials.gov registry record · Phase 3
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,168
- Enrollment target
NCT01308567: Completed Phase 3 study, sponsored by Sanofi.
NCT01308567 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,168 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01308567, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,168 participants
- Enrollment target
Study Summary
Primary Objective: * To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: * To evaluate safety in the 3 treatment arms. * To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for: * Progression Free Survival (PFS) (RECIST 1.1) * Tumor progression free survival (RECIST 1.1) * Tumor response in participants with measurable disease (RECIST 1.1), * PSA response * PSA-Progression free survival (PSA-PFS). * Pain response in participants with stable pain at baseline * Pain progression free survival * Time to occurrence of any skeletal related events (SRE) * To compare Health-Related Quality of Life (HRQL). * To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.
Primary Outcome
OS 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, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.
Interventions
- DRUG Prednisone
- DRUG Cabazitaxel (XRP6258)
- DRUG Docetaxel (XRP6976)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,168 participants |
| Start Date | 2011-05-05 |
| Est. Completion | 2018-05 |
| Phase | Phase 3 |
What the finished NCT01308567 record still lists
NCT01308567 is an interventional study that assigns participants to a tested intervention. Its 1,168 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01308567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01308567 about?
NCT01308567 is a clinical study titled "Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer". Primary Objective: * To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously tr...
What is the current status of trial NCT01308567?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,168 participants. The study started on 2011-05-05. Estimated completion is 2018-05.
What interventions are being tested in trial NCT01308567?
The interventions under investigation include: Prednisone (DRUG), Cabazitaxel (XRP6258) (DRUG), Docetaxel (XRP6976) (DRUG).
Who is sponsoring clinical trial NCT01308567?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01308567's enrollment target sits among peer trials
1,168 237th of 2000 higher than 1,764 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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