deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT02584647

PLX3397 Plus Sirolimus in Unresectable Sarcoma and Malignant Peripheral Nerve Sheath Tumors (PLX3397)

Phase I Study Evaluating Combination Therapy With the Receptor Tyrosine Kinase Inhibitor PLX3397 and Sirolimus in Patients With Unresectable Sarcoma and Phase II Study in Malignant Peripheral Nerve Sheath Tumors

Sponsor: Daiichi Sankyo

Conditions Malignant Peripheral Nerve Sheath Tumors Sarcoma
Interventions PLX3397 sirolimus
Updated 19 times since 2017 Last updated: Mar 6, 2025 Started: Nov 4, 2015 Primary completion: Jul 31, 2023 Completion: Oct 1, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Poor enrollment

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This PHASE1/PHASE2 trial investigates Malignant Peripheral Nerve Sheath Tumors and Sarcoma and is currently terminated or withdrawn. Daiichi Sankyo leads this study, which shows 19 recorded versions since 2015 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Oct 2017 · 8 months · monthly snapshot~Oct 2017 – ~Mar 2018 · 5 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Jul 2019 · 4 months · monthly snapshot~Jul 2019 – ~Apr 2020 · 9 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2022 · 15 months · monthly snapshot~Dec 2022 – ~Mar 2023 · 3 months · monthly snapshot~Mar 2023 – ~Mar 2024 · 12 months · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

19 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Apr 2025 — Sep 2025 [monthly]

    Terminated PHASE1/PHASE2

    Status: Active Not Recruiting → Terminated

  3. Sep 2024 — Apr 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

▶ Show 14 earlier versions

  1. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE1_PHASE2

  2. Mar 2023 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

  3. Dec 2022 — Mar 2023 [monthly]

    Recruiting PHASE1_PHASE2

  4. Sep 2021 — Dec 2022 [monthly]

    Recruiting PHASE1_PHASE2

  5. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  6. Apr 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  7. Jul 2019 — Apr 2020 [monthly]

    Recruiting PHASE1_PHASE2

  8. Mar 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  9. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE1_PHASE2

  10. Jun 2018 — Feb 2019 [monthly]

    Recruiting PHASE1_PHASE2

  11. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  12. Oct 2017 — Mar 2018 [monthly]

    Recruiting PHASE1_PHASE2

  13. Feb 2017 — Oct 2017 [monthly]

    Recruiting PHASE1_PHASE2

  14. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Nov 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Daiichi Sankyo
  • Gulam Manji
Data source: Columbia University

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

Study Locations