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
Phase of Trial: Phase I
Latest Information Update: 24 Dec 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
- 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.