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

Official Title

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 Tumours and Non-Hodgkin's Lymphoma


To evaluate the effect of itraconazole or rifampin on the absorption, distribution, metabolism and elimination of COPANLISIB (BAY80-6946) To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety

Trial Description

Primary Outcome:

  • AUC (0-168)
  • AUC
  • Cmax
  • QTcF
Secondary Outcome:
  • AUC(0-tlast)
  • tmax
  • tlast
  • t1/2
  • Urine [AE,ur(0-24)]
  • Number of participants with adverse events as a measure of safety and tolerability
  • PR intervals
  • QRS intervals
  • ECG waveform morphology
  • Left ventricular ejection fraction (LVEF)

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Canadian Cancer Society

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