deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03785964

Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) (DeFi)

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Sponsor: SpringWorks Therapeutics, Inc.

Conditions Aggressive Fibromatosis Desmoid Tumor
Interventions Nirogacestat oral tablet Placebo Oral Tablet
Updated 35 times since 2019 Last updated: Jan 17, 2025 Started: Apr 17, 2019 Primary completion: Apr 7, 2022 Completion: Oct 17, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Aggressive Fibromatosis and Desmoid Tumor and is currently completed. SpringWorks Therapeutics, Inc. leads this study, which shows 35 recorded versions since 2019 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2019 – ~Apr 2019 · 3 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Jun 2021 · 4 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Sep 2022 · 8 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jul 2023 · 2 months · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

35 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Sep 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Jul 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

▶ Show 30 earlier versions

  1. May 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE3

  2. Apr 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE3

  3. Feb 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

  6. Jan 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  7. Sep 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  8. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Feb 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  10. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  11. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  12. Sep 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  13. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  14. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  15. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  16. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  17. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  18. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  19. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  20. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  21. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  22. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  23. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  24. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  25. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  26. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  27. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  28. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  29. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  30. Jan 2019 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • SpringWorks Therapeutics, Inc.
Data source: SpringWorks Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amsterdam, Netherlands , Ann Arbor, United States , Aurora, United States , Baltimore, United States , Berlin, Germany , Bologna, Italy , Boston, United States , Brussels, Belgium , Candiolo, Italy , Chicago, United States and 36 more locations