deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT01528046

Metformin in Children With Relapsed or Refractory Solid Tumors

A Phase I Trial of Dose Escalation of Metformin in Combination With Vincristine, Irinotecan, and Temozolomide in Children With Relapsed or Refractory Solid Tumors

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Updated 27 times since 2017 Last updated: Jan 12, 2023 Started: Sep 24, 2012 Primary completion: Sep 26, 2019 Completion: Feb 3, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01528046, this PHASE1 trial focuses on Primary Brain Tumors and Solid Tumors and remains completed. Sponsored by H. Lee Moffitt Cancer Center and Research Institute, it has been updated 27 times since 2012, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Feb 2018 · 6 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Dec 2018 · 5 months · monthly snapshot~Dec 2018 – ~May 2019 · 5 months · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Mar 2020 · 2 months · monthly snapshot~Mar 2020 – ~May 2020 · 2 months · monthly snapshot~May 2020 – ~Aug 2020 · 3 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Nov 2021 · 5 months · monthly snapshot~Nov 2021 – ~Feb 2022 · 3 months · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Sep 2022 · 4 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

27 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Feb 2023 — Jul 2024 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

  5. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1

Show 22 earlier versions
  1. May 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  2. Apr 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE1

  3. Feb 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE1

  4. Nov 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE1

  5. Jun 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE1

  6. Jan 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE1

  7. Aug 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  8. May 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE1

  9. Mar 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE1

  10. Jan 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE1

  11. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE1

  12. Oct 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1

  13. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  14. May 2019 — Aug 2019 [monthly]

    Recruiting PHASE1

  15. Dec 2018 — May 2019 [monthly]

    Recruiting PHASE1

  16. Jul 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

  17. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1

  18. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE1

  19. Aug 2017 — Feb 2018 [monthly]

    Recruiting PHASE1

  20. Jun 2017 — Aug 2017 [monthly]

    Recruiting PHASE1

  21. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE1

  22. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Sep 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • H. Lee Moffitt Cancer Center and Research Institute
  • Pediatric Cancer Foundation
Data source: H. Lee Moffitt Cancer Center and Research Institute

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