deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 5-arm NCT03458728

Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients

A Non-randomized, Open-label, Multi-center, Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma

Sponsor: Bayer

Conditions Ewing Sarcoma Neuroblastoma Osteosarcoma Relapsed or Refractory Solid Tumors or Lymphoma in Children Rhabdomyosarcoma
Interventions Copanlisib (BAY806946)
Updated 59 times since 2018 Last updated: Nov 29, 2023 Started: Apr 30, 2018 Primary completion: Feb 1, 2023 Completion: Feb 1, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

no anticipated benefit over available standard therapies

Other terminated trials from Bayer

See all terminations from Bayer

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A PHASE1/PHASE2 clinical study on Ewing Sarcoma and Neuroblastoma, this trial is terminated or withdrawn. The trial is conducted by Bayer and has accumulated 59 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · 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 – ~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 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~Jan 2024 · 9 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

59 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jan 2024 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

  5. Apr 2023 — Jan 2024 [monthly]

    Terminated PHASE1_PHASE2

    Status: Recruiting → Terminated

▶ Show 54 earlier versions

  1. Feb 2023 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  2. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE1_PHASE2

  3. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE1_PHASE2

  4. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE1_PHASE2

  5. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  7. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE1_PHASE2

  8. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  9. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

  10. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

  12. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE1_PHASE2

  13. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE1_PHASE2

  14. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE1_PHASE2

  15. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1_PHASE2

  16. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  17. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE1_PHASE2

  18. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE1_PHASE2

  19. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1_PHASE2

  20. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  21. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1_PHASE2

  22. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  23. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1_PHASE2

  24. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE1_PHASE2

  25. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE1_PHASE2

  26. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE1_PHASE2

  27. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE1_PHASE2

  28. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE1_PHASE2

  29. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE1_PHASE2

  30. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE1_PHASE2

  31. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE1_PHASE2

  32. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE1_PHASE2

  33. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE1_PHASE2

  34. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE1_PHASE2

  35. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE1_PHASE2

  36. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE1_PHASE2

  37. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE1_PHASE2

  38. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE1_PHASE2

  39. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE1_PHASE2

  40. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  41. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  42. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE1_PHASE2

  43. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE1_PHASE2

  44. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE1_PHASE2

  45. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE1_PHASE2

  46. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE1_PHASE2

  47. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE1_PHASE2

  48. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE1_PHASE2

  49. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE1_PHASE2

  50. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE1_PHASE2

  51. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE1_PHASE2

  52. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  53. May 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  54. Mar 2018 — May 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bayer
Data source: Bayer

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

Study Locations

Atlanta, United States , Aurora, United States , Birmingham, United States , Boston, United States , Cincinnati, United States , Houston, United States , Indianapolis, United States , Memphis, United States , New York, United States , Orange, United States and 4 more locations