An Open-label Non-randomized, Phase 1 Single Dose Study to Evaluate the Pharmacokinetics and Safety of Copanlisib in Subjects With Impaired Hepatic or Renal Function in Comparison to Healthy Subjects

Trial Profile

An Open-label Non-randomized, Phase 1 Single Dose Study to Evaluate the Pharmacokinetics and Safety of Copanlisib in Subjects With Impaired Hepatic or Renal Function in Comparison to Healthy Subjects

Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Jan 2018

At a glance

  • Drugs Copanlisib (Primary)
  • Indications Breast cancer; Cholangiocarcinoma; Diffuse large B cell lymphoma; Endometrial cancer; Follicular lymphoma; Mantle-cell lymphoma; Marginal-zone-B-cell-lymphoma; Non-Hodgkin's lymphoma; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 24 Jan 2018 Planned End Date changed from 20 Nov 2018 to 17 Jul 2019.
    • 24 Jan 2018 Planned primary completion date changed from 28 Aug 2018 to 10 Apr 2019.
    • 18 Dec 2017 Planned number of patients changed from 32 to 44.
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