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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,168 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01308567
The ClinicalTrials.gov registry entry for NCT01308567 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01308567 reports 0 study locations.
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.
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