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Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

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

Record History

The 50 most recent of 65 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 11 of 71 sites
  2. Site details revised at 3 of 71 sitesv64
  3. Site details revised at 8 of 71 sitesv63
  4. Study sites: 72 to 71v62
  5. Site details revised at 2 of 72 sitesv61
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 8 of 72 sitesv60
  2. Site details revised at 1 of 72 sitesv59
  3. 2 versions Re-verified since May 5, 2025, no change to tracked fieldsv57-v58
  4. Site details revised at 2 of 72 sitesv56
  5. 2 versions Re-verified since Feb 27, 2025, no change to tracked fieldsv54-v55
  6. Site details revised at 1 of 72 sitesv53
  7. Enrollment target: 234 to 233v52
  8. Re-verified, no change to tracked fieldsv51
  9. Primary and study completion dates: Jun 9, 2025 to Jun 9, 2027 Enrollment target: 233 to 234 · Study sites revised (72)v50 Show 2 more changesShow less
    • Enrollment target: 233 to 234
    • Study sites revised (72)

    See this version in full on ClinicalTrials.gov ↗

  10. Site details revised at 3 of 72 sitesv49
  11. Study sites revised (72)v48 See this version in full on ClinicalTrials.gov ↗
  12. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 252 to confirmed 233 · Study sites: 73 to 72v47 Show 2 more changesShow less
    • Enrollment target: estimated 252 to confirmed 233
    • Study sites: 73 to 72
  13. Site details revised at 4 of 73 sitesv46
  14. Study sites revised (73)v45 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 72 to 73v44
  16. Site details revised at 1 of 72 sitesv43
  17. Study sites revised (72)v42 See this version in full on ClinicalTrials.gov ↗
  18. Study sites revised (72)v41 See this version in full on ClinicalTrials.gov ↗
  19. Site details revised at 1 of 72 sitesv40
  20. Study sites revised (72)v39 See this version in full on ClinicalTrials.gov ↗
  21. Site details revised at 1 of 72 sitesv38
  22. Site details revised at 1 of 72 sitesv37
  23. Site details revised at 1 of 72 sitesv36
  24. Site details revised at 5 of 72 sitesv35
  25. Primary and study completion dates: Jan 31, 2023 to Jun 9, 2025 Site details revised at 17 of 72 sitesv34 Show 1 more changeShow less
    • Site details revised at 17 of 72 sites
  26. Site details revised at 6 of 72 sitesv33
  27. Site details revised at 9 of 72 sitesv32
  28. Site details revised at 1 of 72 sitesv31
  29. Site details revised at 3 of 72 sitesv30
  30. Site details revised at 7 of 72 sitesv29
  31. Re-verified, no change to tracked fieldsv28
  32. Site details revised at 5 of 72 sitesv27
  33. Site details revised at 2 of 72 sitesv26
  34. Site details revised at 8 of 72 sitesv25
  35. Site details revised at 2 of 72 sitesv24
  36. Site details revised at 3 of 72 sitesv23
  37. Primary completion date: Dec 14, 2020 to Jan 31, 2023 Completion date: Dec 31, 2021 to Jan 31, 2023 · Site details revised at 3 of 72 sitesv22 Show 2 more changesShow less
    • Completion date: Dec 31, 2021 to Jan 31, 2023
    • Site details revised at 3 of 72 sites
  38. Site details revised at 2 of 72 sitesv21
  39. Site details revised at 7 of 72 sitesv20
  40. Study sites: 71 to 72v19
  41. Site details revised at 1 of 71 sitesv18
  42. Site details revised at 4 of 71 sitesv17
  43. Study sites: 70 to 71v16
  • 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
The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.
Trial Details
NCT Number NCT02584933
Lead Sponsor Novartis Pharmaceuticals
Conditions ALK Positive Malignancies
Enrollment 233 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov