deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT02253420

COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients

An Open-label Non-randomized, Phase 1 Study to Evaluate the Effect of (a) Itraconazole or Rifampin on the Pharmacokinetics of a Single Intravenous Dose of Copanlisib and (b) Copanlisib on Cardiovascular Safety in Subjects With Advanced Solid Tumors and Non-Hodgkin's Lymphoma

Sponsor: Bayer

Conditions Medical Oncology
Interventions Copanlisib (BAY80-6946) Itraconazole Rifampin
Updated 24 times since 2017 Last updated: Dec 11, 2020 Started: Oct 8, 2014 Primary completion: Mar 12, 2018 Completion: Aug 13, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Medical Oncology and is currently completed. Bayer leads this study, which shows 24 recorded versions since 2014 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Apr 2017 · 3 months · monthly snapshot~Apr 2017 – ~Aug 2017 · 4 months · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~May 2018 · 8 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 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Aug 2020 · 10 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 23 months · monthly snapshot

Change History

24 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE1

  5. Oct 2019 — Aug 2020 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

▶ Show 19 earlier versions

  1. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE1

  2. Jun 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1

  3. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1

  4. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE1

  5. Mar 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE1

  6. Feb 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE1

  7. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE1

  8. Dec 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE1

  9. Nov 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE1

  10. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE1

  11. Sep 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE1

  12. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE1

  13. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE1

  14. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE1

  15. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  16. Sep 2017 — May 2018 [monthly]

    Recruiting PHASE1

  17. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE1

  18. Apr 2017 — Aug 2017 [monthly]

    Recruiting PHASE1

  19. Jan 2017 — Apr 2017 [monthly]

    Recruiting PHASE1

    First recorded

Oct 2014

Trial started

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

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