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NCT01308580 · ClinicalTrials.gov registry record · Phase 3
Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
NCT01308580 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,200 participants.
The verdict
NCT01308580, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
Study Summary
Primary Objective: \- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen. Secondary Objectives: * To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m². * To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for: * Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause; * PSA Progression; * Pain progression; * Tumor response in participants with measurable disease (RECIST 1.1); * PSA response; * Pain response in participants with stable pain at baseline. * To compare Health-related Quality of Life (HRQoL). * To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.
Interventions
- DRUG Cabazitaxel (XRP6258)
- DRUG Prednisone (or Prednisolone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01308580
The ClinicalTrials.gov registry entry for NCT01308580 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,200 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 2 interventions - of which Cabazitaxel (XRP6258) is the first listed.
NCT01308580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01308580 about?
NCT01308580 is a clinical study titled "Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer". Primary Objective: \- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetax...
What is the current status of trial NCT01308580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2011-04. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01308580?
The interventions under investigation include: Cabazitaxel (XRP6258) (DRUG), Prednisone (or Prednisolone) (DRUG).
Who is sponsoring clinical trial NCT01308580?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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