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Sequencing Abiraterone and Enzalutamide in mCRPC
NCT02125357Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- Feb 2020
- Countries
- 1
- Sponsor
- BC Cancer
- Modality
- Small Molecules
- Conditions
- metastatic castration-resistant prostate cancer (mCRPC)
01
Overview
Phase 2, randomised, open-label trial of Abiraterone Acetate Tablets (I) and enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) (2 arms), sponsored by BC Cancer. Primary endpoint: Prostate-Specific Antigen Response Rate in Second-Line Therapy at 1 year. Started Sep 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Abiraterone -> Enzalutamide
Abiraterone acetate 1000mg PO OD + Prednisone, followed by Enzalutamide 160mg PO OD upon progression.
Enzalutamide -> Abiraterone
Enzalutamide 160mg PO OD, followed by Abiraterone acetate 1000mg PO OD + Prednisone upon progression.
03
Who it enrols
Adult males with metastatic castration-resistant prostate cancer (adenocarcinoma) who have progressed on castration therapy. Patients must be chemotherapy-naive for mCRPC and have no prior exposure to CYP17 inhibitors or enzalutamide.
04
Endpoints
Primary
Prostate-Specific Antigen Response Rate in Second-Line Therapy
Secondary
Biomarkers Associated with Treatment Efficacy and Resistance
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