drugset / Trial / NCT05457257
Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations
Phase 4
Active not recruiting
43 enrolled
AstraZeneca
Foundation Medicine · collabMerck Sharp & Dohme LLC · collabMyriad Genetics, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (Enzalutamide or Abiraterone Acetate) in Chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have BRCA1/2 mutations.
Timeline
- Start
- 2022-07-29
- Primary completion
- 2024-10-22
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Comparator | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 5 mg | Oral |