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Roll-over Study to Allow Continued Access to Ribociclib

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

Record History

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Re-verified, no change to tracked fields
  4. Eligibility criteria expanded, about 14 words Site details revised at 6 of 73 sites Show 1 more changeShow less
    • Site details revised at 6 of 73 sites
  5. Site details revised at 2 of 73 sitesv41
Show 39 earlier versionsHide 39 earlier versions
  1. Site details revised at 2 of 73 sitesv40
  2. Re-verified, no change to tracked fieldsv39
  3. Site details revised at 2 of 73 sitesv38
  4. Study sites: 74 to 73v37
  5. Eligibility criteria expanded, about 166 words Secondary endpoints: details revised at 1 of 1 entry · Study description expanded, about 84 words · Site details revised at 1 of 74 sitesv36 Show 3 more changesShow less
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 84 words
    • Site details revised at 1 of 74 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 5 of 74 sitesv35
  7. Site details revised at 9 of 74 sitesv34
  8. Re-verified, no change to tracked fieldsv33
  9. Site details revised at 1 of 74 sitesv32
  10. Re-verified, no change to tracked fieldsv31
  11. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 137 to confirmed 134 · Site details revised at 74 of 74 sitesv30 Show 2 more changesShow less
    • Enrollment target: estimated 137 to confirmed 134
    • Site details revised at 74 of 74 sites
  12. Site details revised at 3 of 74 sitesv29
  13. Site details revised at 2 of 74 sitesv28
  14. Primary completion date: Jul 31, 2030 to Jun 28, 2030 Completion date: Jul 31, 2030 to Aug 14, 2030 · Site details revised at 2 of 74 sitesv27 Show 2 more changesShow less
    • Completion date: Jul 31, 2030 to Aug 14, 2030
    • Site details revised at 2 of 74 sites
  15. Primary completion date: Jan 19, 2028 to Jul 31, 2030 Study sites: 59 to 74 · Completion date: Feb 16, 2028 to Jul 31, 2030v26 Show 2 more changesShow less
    • Study sites: 59 to 74
    • Completion date: Feb 16, 2028 to Jul 31, 2030
  16. Primary completion date: Feb 26, 2030 to Jan 19, 2028 Completion date: Mar 26, 2030 to Feb 16, 2028 · Site details revised at 13 of 59 sitesv25 Show 2 more changesShow less
    • Completion date: Mar 26, 2030 to Feb 16, 2028
    • Site details revised at 13 of 59 sites
  17. Study sites: 57 to 59v24
  18. Study sites: 53 to 57v23
  19. Primary completion date: Aug 6, 2029 to Feb 26, 2030 Completion date: Sep 3, 2029 to Mar 26, 2030 · Study sites revised (53)v22 Show 2 more changesShow less
    • Completion date: Sep 3, 2029 to Mar 26, 2030
    • Study sites revised (53)

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 51 to 53v21
  21. Study sites: 50 to 51v20
  22. Site details revised at 2 of 50 sitesv19
  23. Primary completion date: Jan 19, 2028 to Aug 6, 2029 Completion date: Feb 16, 2028 to Sep 3, 2029 · Site details revised at 2 of 50 sitesv18 Show 2 more changesShow less
    • Completion date: Feb 16, 2028 to Sep 3, 2029
    • Site details revised at 2 of 50 sites
  24. Site details revised at 3 of 50 sitesv17
  25. Study sites: 49 to 50v16
  26. Study sites: 46 to 49v15
  27. Site details revised at 3 of 46 sitesv14
  28. Study sites: 45 to 46v13
  29. Study sites: 43 to 45v12
  30. Study sites: 37 to 43v11
  31. Study sites: 34 to 37v10
  32. Study sites: 32 to 34v9
  33. Study sites: 27 to 32v8
  34. Study sites: 20 to 27v7
  35. Study sites: 6 to 20v6
  36. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 6 · Primary completion date: Jan 6, 2028 to Jan 19, 2028 · Completion date: Feb 3, 2028 to Feb 16, 2028v5 Show 3 more changesShow less
    • Study sites: 0 to 6
    • Primary completion date: Jan 6, 2028 to Jan 19, 2028
    • Completion date: Feb 3, 2028 to Feb 16, 2028
  37. Start date: Jun 17, 2022 to Jul 7, 2022v4
  38. Start date: May 16, 2022 to Jun 17, 2022v3
  39. Start date: Mar 23, 2022 to May 16, 2022 Primary completion date: Oct 5, 2027 to Jan 6, 2028 · Completion date: Nov 2, 2027 to Feb 3, 2028v2 Show 2 more changesShow less
    • Primary completion date: Oct 5, 2027 to Jan 6, 2028
    • Completion date: Nov 2, 2027 to Feb 3, 2028
  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.
Novartis
555 trials monitored
See 31 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).
Trial Details
NCT Number NCT05161195
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Breast Cancer
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov