Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

Study acronym: ABLE-32
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 111 → 114 locations
  2. Study sites: 111 to 112
  3. Study sites: 110 to 111
  4. Trial sites expanded: 107 → 110 locations
    • Eligibility criteria expanded, about 20 words
  5. Study sites: 106 to 107v45
  6. Trial sites expanded: 103 → 106 locationsv44
  7. Study sites: 102 to 103v43
  8. Study sites: 101 to 102v42
  9. Trial sites expanded: 98 → 101 locationsv41
  10. Study sites: 97 to 98v40
  11. Trial sites expanded: 94 → 97 locations
    • Trial sites expanded: 82 → 94 locations
    • Eligibility criteria expanded, about 19 words
    v39
  12. Study sites: 82 to 94v38
  13. Trial sites expanded: 79 → 82 locationsv37
  14. Study sites: 77 to 79v36
  15. Study sites: 75 to 77v35
  16. Study sites: 70 to 75v34
  17. Study sites: 68 to 70v33
  18. Study sites: 65 to 68v32
  19. Study sites: 64 to 65v31
  20. Study sites: 63 to 64v30
  21. Study sites: 52 to 63v29
  22. Study sites revised (52)v28
  23. Study sites: 51 to 52v27
  24. Study sites: 43 to 51v26
  25. Study sites: 42 to 43v25
  26. Primary completion date: Mar 31, 2030 to Jun 30, 2028
    • Study sites: 39 to 42
    • Study completion date: Mar 31, 2030 to Jun 30, 2031
    • Eligibility criteria revised
    v24
  27. Study sites: 35 to 39v23
  28. Study sites: 33 to 35v22
  29. Study sites: 28 to 33v21
  30. Study sites: 24 to 28v20
  31. Study sites: 21 to 24v19
  32. Study sites: 20 to 21v18
  33. Study sites: 19 to 20v17
  34. Study sites: 17 to 19v16
  35. Study sites: 16 to 17v15
  36. Primary completion date: Aug 1, 2028 to Mar 31, 2030
    • Study sites: 15 to 16
    • Study completion date: Jun 30, 2031 to Mar 31, 2030
    v14
  37. Study sites: 14 to 15v13
  38. Study sites: 13 to 14v12
  39. Study sites: 11 to 13v11
  40. Study sites: 10 to 11v10
  41. Study completion date: Jan 1, 2031 to Jun 30, 2031v9
  42. Study sites: 9 to 10v8
  43. Study sites: 8 to 9v7
  44. Study sites: 5 to 8v6
  45. Study sites: 1 to 5v5
  46. Eligibility criteria revisedv4
  47. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 30, 2024 to Oct 1, 2024
    v3
  48. Study title shortened, about 2 wordsv2
  49. Study First Submitted
  • 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.
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Trial Details
NCT Number NCT06510374
Lead Sponsor Ferring Pharmaceuticals
Conditions
(from sponsor)		 Intermediate Risk Non-Muscle Invasive Bladder Cancer
Enrollment 454 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov