Clinical Trial: NCT01308580
Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Sanofi |
| Information Provided By: | Sanofi |
| Last Update Posted: | 2017-04-17 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Cabazitaxel (XRP6258)
- Drug: Prednisone (or Prednisolone)
Other Study ID Numbers
- EFC11785
- 2010-022163-35
Start Date
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Sanofi |
| Information Provided By: | Sanofi |
| Last Update Posted: | 2017-04-17 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Cabazitaxel (XRP6258)
- Drug: Prednisone (or Prednisolone)
Other Study ID Numbers
- EFC11785
- 2010-022163-35