Clinical Trial: NCT02485691
Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent
Status:
COMPLETEDPhase:
Phase 4| Lead Sponsor: | Sanofi |
| Information Provided By: | Sanofi |
| Last Update Posted: | 2022-05-27 |
Study Overview
Brief Summary
Primary Objective:
To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (less than or equal to [<=]12 months, either before or after docetaxel).
Secondary Objective:
- To compare efficacy for:
- Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).
- Progression-free survival (PFS).
- Overall survival (OS).
- Tumor response rate and duration of tumor response.
- Pain response and time to pain progression.
- Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.
- Health status and Health-related Quality of Life (HRQOL).
- To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs.
- To evaluate safety in the 2 treatment arms.
Official Title
Conditions
Intervention / Treatment
- Drug: cabazitaxel XRP6258
- Drug: enzalutamide
- Drug: abiraterone acetate
- Drug: prednisone
Other Study ID Numbers
- LPS14201
- 2014-004676-29
- U1111-1166-5329
- 2014
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Sanofi |
| Information Provided By: | Sanofi |
| Last Update Posted: | 2022-05-27 |
Study Overview
Brief Summary
Primary Objective:
To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (less than or equal to [<=]12 months, either before or after docetaxel).
Secondary Objective:
- To compare efficacy for:
- Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).
- Progression-free survival (PFS).
- Overall survival (OS).
- Tumor response rate and duration of tumor response.
- Pain response and time to pain progression.
- Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.
- Health status and Health-related Quality of Life (HRQOL).
- To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs.
- To evaluate safety in the 2 treatment arms.
Official Title
Conditions
Intervention / Treatment
- Drug: cabazitaxel XRP6258
- Drug: enzalutamide
- Drug: abiraterone acetate
- Drug: prednisone
Other Study ID Numbers
- LPS14201
- 2014-004676-29
- U1111-1166-5329
- 2014