deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT02631590

Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

Phase II Study of Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

Sponsor: Bayer

Conditions Biliary Carcinoma Cholangiocarcinoma Gall Bladder Carcinoma Gastrointestinal Tumor
Interventions Cisplatin Copanlisib Gemcitabine
Updated 20 times since 2017 Last updated: Aug 3, 2021 Started: Jul 5, 2016 Primary completion: Oct 25, 2019 Completion: Mar 5, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02631590, this PHASE2 trial focuses on Biliary Carcinoma and Cholangiocarcinoma and remains completed. Sponsored by Bayer, it has been updated 20 times since 2016, 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 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Dec 2017 · 9 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Apr 2019 · 5 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Sep 2019 · 4 months · monthly snapshot~Sep 2019 – ~Feb 2020 · 5 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Aug 2020 · 5 months · monthly snapshot~Aug 2020 – ~Dec 2020 · 4 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Dec 2022 · 15 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

20 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

  5. Sep 2021 — Dec 2022 [monthly]

    Completed PHASE2

▶ Show 15 earlier versions

  1. May 2021 — Sep 2021 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE2

  3. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Aug 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE2

  5. Mar 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE2

  6. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE2

  7. Sep 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2

  8. May 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  9. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE2

  10. Nov 2018 — Apr 2019 [monthly]

    Recruiting PHASE2

  11. Jun 2018 — Nov 2018 [monthly]

    Recruiting PHASE2

  12. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

  13. Mar 2017 — Dec 2017 [monthly]

    Recruiting PHASE2

  14. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE2

  15. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Jul 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

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

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

Study Locations