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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Jul 2020

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At a glance

  • Drugs Copanlisib (Primary) ; Itraconazole; Rifampicin
  • Indications Non-Hodgkin's lymphoma; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Bayer

    • Most Recent Events

    • 30 Aug 2019 Status changed from active, no longer recruiting to completed.
    • 16 Mar 2019 Results of physiologically-based pharmacokinetic modeling data presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 06 Jan 2019 Planned End Date changed from 19 Dec 2018 to 30 Sep 2019.

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