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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

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Completed to Active, Not Recruiting Completion date: Jul 30, 2025 to Dec 31, 2026v29 Show 1 more changeShow less
    • Completion date: Jul 30, 2025 to Dec 31, 2026
  2. Results first posted: Dec 19, 2025 Primary endpoint revised · Trial status: Active, Not Recruiting to Completed · Study completion date changed from estimate of Sep 30, 2025 to Jul 30, 2025 · 1 morev28 Show 4 more changesShow less
    • Primary endpoint revised
    • Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Sep 30, 2025 to Jul 30, 2025
    • Secondary endpoints revised (8)

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv27
  4. Site details revised at 21 of 35 sitesv26
  5. Re-verified, no change to tracked fieldsv25
Show 23 earlier versionsHide 23 earlier versions
  1. Primary completion date changed from estimate of Sep 2, 2024 to Oct 22, 2024v24
  2. Primary completion date: Aug 5, 2024 to Sep 2, 2024v23
  3. Primary completion date: Jun 28, 2024 to Aug 5, 2024 Site details revised at 2 of 35 sitesv22 Show 1 more changeShow less
    • Site details revised at 2 of 35 sites
  4. Re-verified, no change to tracked fieldsv21
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 42 to confirmed 43 · Study sites: 37 to 35v20 Show 2 more changesShow less
    • Enrollment target: estimated 42 to confirmed 43
    • Study sites: 37 to 35
  6. Site details revised at 1 of 37 sitesv19
  7. 3 versions Re-verified since Sep 6, 2023, no change to tracked fieldsv16-v18
  8. Primary completion date: Dec 29, 2023 to Jun 28, 2024 Completion date: Feb 28, 2025 to Sep 30, 2025v15 Show 1 more changeShow less
    • Completion date: Feb 28, 2025 to Sep 30, 2025
  9. Re-verified, no change to tracked fieldsv14
  10. Site details revised at 2 of 37 sitesv13
  11. Site details revised at 2 of 37 sitesv12
  12. Study sites: 36 to 37v11
  13. Site details revised at 8 of 36 sitesv10
  14. Site details revised at 5 of 36 sitesv9
  15. Site details revised at 3 of 36 sitesv8
  16. Site details revised at 7 of 36 sitesv7
  17. Study sites: 35 to 36v6
  18. Study sites: 34 to 35v5
  19. Study sites: 25 to 34v4
  20. Study sites: 8 to 25v3
  21. Trial status: Not Yet Recruiting to Recruiting Study sites: 6 to 8v2 Show 1 more changeShow less
    • Study sites: 6 to 8
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
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.
Trial Details
NCT Number NCT05457257
Lead Sponsor AstraZeneca
Collaborators: Merck Sharp & Dohme LLC, Foundation Medicine, Myriad Genetics, Inc.
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 43 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov