Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04464226 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

StatusActive, Not Recruiting
PhasePhase 3
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 67 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (335)v67 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 383 to 335v66 Show 1 more changeShow less
    • Study sites: 383 to 335
  3. Study sites: 382 to 383v65
  4. Study sites revised (382)v64 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 381 to 382v63
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 376 to 381v62
  2. Study sites: 369 to 376v61
  3. Enrollment target: 678 to 402 Study sites: 374 to 369v60 Show 1 more changeShow less
    • Study sites: 374 to 369
  4. Study sites: 372 to 374v59
  5. Study sites revised (372)v58 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 373 to 372v57
  7. Study sites revised (373)v56 See this version in full on ClinicalTrials.gov ↗
  8. Study sites revised (373)v55 See this version in full on ClinicalTrials.gov ↗
  9. Study sites revised (373)v54 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 352 to 373v53
  11. Study sites: 351 to 352v52
  12. Primary and study completion dates: Jun 25, 2025 to Jun 26, 2028 Study sites revised (351)v51 Show 1 more changeShow less
    • Study sites revised (351)

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites revised (351)v50 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (351)v49 See this version in full on ClinicalTrials.gov ↗
  15. Study sites revised (351)v48 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (351)v47 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (351)v46 See this version in full on ClinicalTrials.gov ↗
  18. Site details revised at 7 of 351 sitesv45
  19. Study sites: 350 to 351v44
  20. Site details revised at 5 of 350 sitesv43
  21. Study sites revised (350)v42 See this version in full on ClinicalTrials.gov ↗
  22. Study sites revised (350)v41 See this version in full on ClinicalTrials.gov ↗
  23. Study sites revised (350)v40 See this version in full on ClinicalTrials.gov ↗
  24. Study sites revised (350)v39 See this version in full on ClinicalTrials.gov ↗
  25. Site details revised at 1 of 350 sitesv38
  26. Study sites revised (350)v37 See this version in full on ClinicalTrials.gov ↗
  27. Enrollment target: 679 to 678 Site details revised at 14 of 350 sitesv36 Show 1 more changeShow less
    • Site details revised at 14 of 350 sites
  28. Study sites: 336 to 350v35
  29. Site details revised at 1 of 336 sitesv34
  30. Enrollment target: 676 to 679 Study sites revised (336)v33 Show 1 more changeShow less
    • Study sites revised (336)

    See this version in full on ClinicalTrials.gov ↗

  31. Study sites revised (336)v32 See this version in full on ClinicalTrials.gov ↗
  32. Study sites revised (336)v31 See this version in full on ClinicalTrials.gov ↗
  33. Study sites revised (336)v30 See this version in full on ClinicalTrials.gov ↗
  34. Site details revised at 28 of 336 sitesv29
  35. Study sites: 335 to 336v28
  36. Study sites: 334 to 335v27
  37. Study sites: 333 to 334v26
  38. Study sites revised (333)v25 See this version in full on ClinicalTrials.gov ↗
  39. Study sites: 324 to 333v24
  40. Enrollment target: 730 to 676 Study sites: 322 to 324v23 Show 1 more changeShow less
    • Study sites: 322 to 324
  41. Study sites: 315 to 322 Primary endpoints revised (4)v22 Show 1 more changeShow less
    • Primary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  42. Study sites: 303 to 315v21
  43. Study sites: 299 to 303v20
  44. Study sites: 295 to 299v19
  45. Enrollment target: 500 to 730v18
  • 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.
Bayer
131 trials monitored
See 7 trials at risk
The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.
Trial Details
NCT Number NCT04464226
Lead Sponsor Bayer
Conditions Cancer
Enrollment 402 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov