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An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Feb 13, 2032 → Mar 15, 2032
See other at-risk trials from Novartis

Record History

The 50 most recent of 54 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 13, 2032 to Mar 15, 2032 Completion pushed from Sep 4, 2035 to Oct 4, 2035 Show 1 more changeShow less
    • Completion pushed from Sep 4, 2035 to Oct 4, 2035
  2. New version filed on ClinicalTrials.gov
  3. Enrollment target: 167 to 168v52
  4. Enrollment target: 166 to 167v51
  5. Enrollment target: 165 to 166v50
  6. Enrollment closed, study ongoing Trial sites reduced: 69 → 66 locations · Enrollment target: estimated 155 to confirmed 165v49 Show 2 more changesShow less
    • Trial sites reduced: 69 → 66 locations
    • Enrollment target: estimated 155 to confirmed 165
  7. Primary completion moved earlier from Mar 29, 2032 to Feb 13, 2032 Completion moved earlier from Oct 19, 2035 to Sep 4, 2035 · Enrollment target: 150 to 155 · Study sites: 67 to 69v48 Show 3 more changesShow less
    • Completion moved earlier from Oct 19, 2035 to Sep 4, 2035
    • Enrollment target: 150 to 155
    • Study sites: 67 to 69
  8. Site contacts updated at 2 of 67 sitesv47
  9. Study sites: 65 to 67v46
  10. Study sites: 64 to 65v45
  11. Study sites: 63 to 64v44
  12. Study sites: 62 to 63v43
  13. Study sites: 61 to 62v42
  14. Study sites: 60 to 61v41
  15. Study sites: 59 to 60 Completion date: Nov 7, 2035 to Oct 19, 2035v40 Show 1 more changeShow less
    • Completion date: Nov 7, 2035 to Oct 19, 2035
  16. Study sites: 57 to 59v39
  17. Study sites: 56 to 57 Completion date: Oct 19, 2035 to Nov 7, 2035v38 Show 1 more changeShow less
    • Completion date: Oct 19, 2035 to Nov 7, 2035
  18. Study sites: 55 to 56 Primary completion date: Apr 19, 2032 to Mar 29, 2032 · Completion date: Nov 7, 2035 to Oct 19, 2035v37 Show 2 more changesShow less
    • Primary completion date: Apr 19, 2032 to Mar 29, 2032
    • Completion date: Nov 7, 2035 to Oct 19, 2035
  19. Study sites: 54 to 55v36
  20. Site contacts updated at 1 of 54 sitesv35
  21. Study sites: 52 to 54v34
  22. Study sites: 53 to 52v33
  23. Study sites: 52 to 53v32
  24. Study sites: 50 to 52v31
  25. Study sites: 49 to 50v30
  26. Study sites: 48 to 49v29
  27. Study sites: 47 to 48v28
  28. Study sites: 43 to 47v27
  29. Study sites: 42 to 43v26
  30. Study sites: 40 to 42v25
  31. Study sites: 38 to 40v24
  32. Study sites: 36 to 38v23
  33. Study sites: 33 to 36v22
  34. Study sites: 32 to 33v21
  35. Study sites: 27 to 32v20
  36. Study sites: 26 to 27 Primary completion date: Feb 26, 2032 to Apr 19, 2032 · Completion date: Sep 17, 2035 to Nov 7, 2035v19 Show 2 more changesShow less
    • Primary completion date: Feb 26, 2032 to Apr 19, 2032
    • Completion date: Sep 17, 2035 to Nov 7, 2035
  37. Study sites: 24 to 26v18
  38. Study sites: 22 to 24v17
  39. Study sites: 21 to 22v16
  40. Study sites: 17 to 21v15
  41. Study sites: 16 to 17 Primary completion date: Feb 17, 2032 to Feb 26, 2032 · Completion date: Sep 8, 2035 to Sep 17, 2035v14 Show 2 more changesShow less
    • Primary completion date: Feb 17, 2032 to Feb 26, 2032
    • Completion date: Sep 8, 2035 to Sep 17, 2035
  42. Study sites: 12 to 16v13
  43. Study sites: 11 to 12v12
  44. Study sites: 9 to 11v11
  45. Study sites: 7 to 9v10
  46. Study sites: 8 to 7v9
  47. Study sites: 7 to 8v8
  48. Study sites: 4 to 7v7
  49. Study sites: 3 to 4v6
  50. Study sites revised (3)v5 See this version in full on ClinicalTrials.gov ↗
  • 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.
Novartis
555 trials monitored
See 31 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated
Trial Details
NCT Number NCT06991556
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Hormone-sensitive Prostate Cancer
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov