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MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

Study acronym: ReNeu
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 91 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 5 of 5 entries
    • Study sites revised (43)
  2. Trial sites reduced: 50 → 43 locationsv90
  3. Sponsor changed: SpringWorks Therapeutics, Inc. to SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germanyv89
  4. 2 versions Re-verified since Mar 2, 2026, no change to tracked fieldsv87-v88
  5. Results first posted: Aug 7, 2025v86
Show 44 earlier versionsHide 44 earlier versions
  1. Secondary endpoints: details revised at 5 of 5 entriesv85
  2. Primary endpoint revised
    • Secondary endpoints revised (5)
    v84
  3. Primary endpoint revised
    • Study completion date: May 23, 2025 to Dec 22, 2028
    v83
  4. 4 versions Re-verified since Mar 27, 2024, no change to tracked fieldsv79-v82
  5. Primary completion date changed from estimate of Nov 23, 2023 to Sep 20, 2023v78
  6. Re-verified, no change to tracked fieldsv77
  7. Start date: Sep 6, 2019 to Sep 29, 2019v76
  8. 3 versions Re-verified since Nov 17, 2022, no change to tracked fieldsv73-v75
  9. Study Status, Study Description, Outcome Measuresv72
  10. Re-verified, no change to tracked fieldsv71
  11. Primary completion date: Jul 31, 2022 to Nov 23, 2023v70 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 114
    • Study completion date: Jul 31, 2022 to May 23, 2025
    • Site details revised at 50 of 50 sites
  12. Study sites: 54 to 50v69
  13. Study sites: 53 to 54v68
  14. Site contacts updated at 1 of 53 sitesv67
  15. Study sites revised (53)v66
  16. Site contacts updated at 1 of 53 sitesv65
  17. Site contacts updated at 2 of 53 sitesv64
  18. Site contacts updated at 2 of 53 sitesv63
  19. Site contacts updated at 9 of 53 sitesv62
  20. Study sites: 52 to 53v61
  21. Study sites revised (52)v60
  22. Site contacts updated at 2 of 52 sitesv59
  23. Study sites: 54 to 52v58
  24. Study sites: 53 to 54v57
  25. Site contacts updated at 2 of 53 sitesv56
  26. Site contacts updated at 1 of 53 sitesv55
  27. Site contacts updated at 11 of 53 sitesv54
  28. Study sites: 52 to 53v53
  29. Study sites revised (52)v52
  30. Study sites revised (52)v51
  31. Study sites revised (52)v50
  32. Site details revised at 1 of 52 sitesv49
  33. Study sites revised (52)v48
  34. Study sites: 51 to 52v47
  35. Study sites revised (51)v46
  36. Study sites revised (51)v45
  37. Study sites revised (51)v44
  38. Study sites: 52 to 51v43
  39. Study sites revised (52)v42
  • 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.
This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901). Eligible participants may continue in a long-term follow-up phase.
Trial Details
NCT Number NCT03962543
Lead Sponsor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Conditions
(from sponsor)		 Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1)
Related terms Neurofibroma, Neurofibroma, Plexiform, Neurofibromatoses, Neurofibromatosis 1
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov