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A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 3 of 5 changed
See other at-risk trials from Children's Oncology Group

Record History

The 50 most recent of 52 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Lead sponsor: Children's Oncology Group to Children's Oncology Group · Eligibility criteria shortened, about 22 words · Study description revised · 1 more Show 4 more changesShow less
    • Lead sponsor: Children's Oncology Group to Children's Oncology Group
    • Eligibility criteria shortened, about 22 words
    • Study description revised
    • Site details revised at 54 of 98 sites
  2. Completion pushed from Apr 10, 2027 to Dec 31, 2032 Interventions: Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography Test (Procedure), Magnetic Resonance Imaging… to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography Test (Procedure), Magnetic Resonance Imaging… · Eligibility criteria revised · Study sites revised (98)v51 Show 3 more changesShow less
    • Interventions: Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography Test (Procedure), Magnetic Resonance Imaging… to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography Test (Procedure), Magnetic Resonance Imaging…
    • Eligibility criteria revised
    • Study sites revised (98)

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment reduced: 35 → 31 participants Completion moved earlier from Dec 31, 2032 to Apr 10, 2027v50 Show 1 more changeShow less
    • Completion moved earlier from Dec 31, 2032 to Apr 10, 2027
  4. Completion date: Mar 31, 2026 to Dec 31, 2032v49
  5. Primary and study completion dates: Dec 31, 2025 to Mar 31, 2026 Study sites revised (98)v48 Show 1 more changeShow less
    • Study sites revised (98)

    See this version in full on ClinicalTrials.gov ↗

Show 45 earlier versionsHide 45 earlier versions
  1. Primary and study completion dates: Sep 30, 2025 to Dec 31, 2025v47
  2. Primary and study completion dates: Jun 30, 2025 to Sep 30, 2025 Study sites revised (98)v46 Show 1 more changeShow less
    • Study sites revised (98)

    See this version in full on ClinicalTrials.gov ↗

  3. Interventions: Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography (Procedure), Magnetic Resonance Imaging (Procedure)… to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography Test (Procedure), Magnetic Resonance Imaging…v45
  4. Primary and study completion dates: Mar 31, 2025 to Jun 30, 2025v44
  5. Re-verified, no change to tracked fieldsv43
  6. Primary and study completion dates: Dec 31, 2024 to Mar 31, 2025v42
  7. Study sites revised (98)v41 See this version in full on ClinicalTrials.gov ↗
  8. Re-verified, no change to tracked fieldsv40
  9. Study sites revised (98)v39 See this version in full on ClinicalTrials.gov ↗
  10. Re-verified, no change to tracked fieldsv38
  11. Eligibility criteria expanded, about 5 wordsv37 See this version in full on ClinicalTrials.gov ↗
  12. Eligibility criteria expanded, about 4 wordsv36 See this version in full on ClinicalTrials.gov ↗
  13. Re-verified, no change to tracked fieldsv35
  14. Primary endpoints revised (5) Start date: Sep 21, 2020 to Oct 7, 2020 · Interventions: Nirogacestat (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration (Other) to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography (Procedure), Magnetic Resonance Imaging (Procedure)…v34 Show 2 more changesShow less
    • Start date: Sep 21, 2020 to Oct 7, 2020
    • Interventions: Nirogacestat (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration (Other) to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography (Procedure), Magnetic Resonance Imaging (Procedure)…

    See this version in full on ClinicalTrials.gov ↗

  15. Site details revised at 1 of 98 sitesv33
  16. 3 versions Re-verified since Apr 21, 2023, no change to tracked fieldsv30-v32
  17. Study sites: 96 to 98 Eligibility criteria expanded, about 54 wordsv29 Show 1 more changeShow less
    • Eligibility criteria expanded, about 54 words

    See this version in full on ClinicalTrials.gov ↗

  18. Primary and study completion dates: Mar 31, 2025 to Dec 31, 2024v28
  19. Trial status: Recruiting to Active, Not Recruiting Site details revised at 96 of 96 sitesv27 Show 1 more changeShow less
    • Site details revised at 96 of 96 sites
  20. Site details revised at 3 of 96 sitesv26
  21. Study sites: 93 to 96v25
  22. Site details revised at 2 of 93 sitesv24
  23. Study sites: 92 to 93v23
  24. Study sites: 90 to 92v22
  25. Site details revised at 6 of 90 sitesv21
  26. Primary and study completion dates: Dec 31, 2024 to Mar 31, 2025v20
  27. Study sites: 87 to 90v19
  28. Study sites: 86 to 87v18
  29. Study sites: 80 to 86v17
  30. Study sites: 75 to 80v16
  31. Primary and study completion dates: Mar 31, 2027 to Dec 31, 2024v15
  32. Site details revised at 1 of 75 sitesv14
  33. Study sites: 73 to 75v13
  34. Study sites: 69 to 73v12
  35. Study sites: 64 to 69v11
  36. Study sites: 52 to 64v10
  37. Study sites: 38 to 52v9
  38. Primary and study completion dates: May 30, 2025 to Mar 31, 2027 Study sites: 29 to 38v8 Show 1 more changeShow less
    • Study sites: 29 to 38
  39. Study sites: 2 to 29v7
  40. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Sep 11, 2020 to Sep 21, 2020v6 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 11, 2020 to Sep 21, 2020
  41. Enrollment target: 30 to 35v5
  42. Start date: Mar 11, 2020 to Sep 11, 2020v4
  43. Study Status, Outcome Measuresv3
  • 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 phase II trial studies the side effects and how well nirogacestat works in treating patients less than 18 years of age with desmoid tumors that has grown after at least one form of treatment by mouth or in the vein that cannot be removed by surgery. Nirogacestat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Details
NCT Number NCT04195399
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI), Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions Desmoid Fibromatosis, Recurrent Desmoid Fibromatosis, Unresectable Desmoid Fibromatosis
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov