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Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 43 days later Jan 14, 2031 → Feb 26, 2031
See other at-risk trials from SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 4 of 23 sites
  2. Re-verified, no change to tracked fieldsv16
  3. Primary and study completion pushed from Jan 14, 2031 to Feb 26, 2031v15
  4. Primary and study completion moved earlier from Apr 24, 2031 to Jan 14, 2031
    • Study sites revised (23)
    v14
  5. Study sites: 21 to 23v13
  6. Sponsor changed: SpringWorks Therapeutics, Inc. to SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germanyv12
  7. Primary completion pushed from Feb 28, 2031 to Apr 24, 2031
    • Study sites: 20 to 21
    • Study completion date: Mar 30, 2031 to Apr 24, 2031
    v11
  8. Re-verified, no change to tracked fieldsv10
  9. Study sites: 19 to 20v9
  10. Study sites: 18 to 19v8
  11. Study sites: 17 to 18v7
  12. Study sites: 9 to 17v6
  13. Study sites: 8 to 9v5
  14. Study sites: 7 to 8v4
  15. Study sites: 6 to 7v3
  16. Study sites: 1 to 6
    • Start date changed from estimate of Sep 30, 2025 to Sep 17, 2025
    v2
  17. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis.
Trial Details
NCT Number NCT07176689
Lead Sponsor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Conditions
(from sponsor)		 Desmoid Tumor, Aggressive Fibromatosis
Related terms Desmoid Tumors
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov