deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT03429803

DAY101 In Gliomas and Other Tumors

A Phase I Study of Tovorafenib/DAY101 (Formerly TAK-580, MLN2480) for Children With Low-Grade Gliomas and Other RAS/RAF/MEK/ERK Pathway Activated Tumors

Sponsor: Day One Biopharmaceuticals, Inc.

Conditions Low-grade Glioma
Interventions DAY101
Updated 26 times since 2018 Last updated: Feb 17, 2026 Started: Feb 27, 2018 Primary completion: Dec 31, 2025 Completion: Dec 31, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03429803, this PHASE1 trial focuses on Low-grade Glioma and remains completed. Sponsored by Day One Biopharmaceuticals, Inc., it has been updated 26 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshot~Apr 2019 – ~Jul 2019 · 3 months · monthly snapshot~Jul 2019 – ~Oct 2019 · 3 months · monthly snapshot~Oct 2019 – ~Mar 2020 · 5 months · monthly snapshot~Mar 2020 – ~Jun 2020 · 3 months · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Jan 2022 · 3 months · monthly snapshot~Jan 2022 – ~Jul 2022 · 6 months · monthly snapshot~Jul 2022 – ~Jun 2023 · 11 months · monthly snapshot~Jun 2023 – ~Jun 2024 · 12 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~Sep 2025 · 6 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 3 months · monthly snapshot

Change History

26 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  2. Sep 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE1

  3. Mar 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1

  4. Sep 2024 — Mar 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

▶ Show 21 earlier versions

  1. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  2. Jun 2023 — Jun 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Jul 2022 — Jun 2023 [monthly]

    Active Not Recruiting PHASE1

  4. Jan 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  5. Oct 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  6. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  7. Apr 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  8. Feb 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

  9. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  10. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  11. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1

  12. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE1

  13. Jul 2020 — Oct 2020 [monthly]

    Recruiting PHASE1

  14. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE1

  15. Mar 2020 — Jun 2020 [monthly]

    Recruiting PHASE1

    Status: Active Not Recruiting → Recruiting · Phase: PHASE1_PHASE2 → PHASE1

  16. Oct 2019 — Mar 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  17. Jul 2019 — Oct 2019 [monthly]

    Recruiting PHASE1_PHASE2

  18. Apr 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  19. Jun 2018 — Apr 2019 [monthly]

    Recruiting PHASE1_PHASE2

  20. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  21. Mar 2018 — May 2018 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Feb 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Day One Biopharmaceuticals, Inc.
  • Karen D. Wright, MD
  • National Cancer Institute (NCI)
  • PLGA Fund at Pediatric Brain Tumor Foundation
  • Pacific Pediatric Neuro-Oncology Consortium
  • Team Jack Foundation
Data source: Dana-Farber Cancer Institute

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

Study Locations

Baltimore, United States , Boston, United States , Gainesville, United States , Los Angeles, United States , Minneapolis, United States , Philadelphia, United States , Portland, United States , Salt Lake City, United States , San Diego, United States , San Francisco, United States and 3 more locations