Copanlisib Chinese PK Study

Summary

This study will be conducted primarily to determine the pharmacokinetics of copanlisib in Chinese patients with relapsed iNHL. The primary objective of the study is to determine the pharmacokinetics of copanlisib administered on Day1, 8, and 15 of a 28-days cycle (3 weeks-on/1 week off dosing regimen) as a 1 hour intravenous infusion to Chinese patients with relapsed iNHL. The secondary objectives include the evaluation of safety, tolerability, and tumor response of Chinese patients treated with Copanlisib. Determine the pharmacokinetics of M-1 metabolite.

Timeline

Start

2018-04-27

Primary completion

2019-08-06

Completion

2020-06-02

Publications

• Liu W, Ping L, Xie Y, Sun Y, Du T, Niu Y, Cisternas G, Huang F, Garcia-Vargas J, Childs BH, Mehra A, Reschke S, Wang X, Song Y, Zhu J. A phase I pharmacokinetic study of copanlisib in Chinese patients with relapsed indolent non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2022 Jun;89(6):825-831. doi: 10.1007/s00280-022-04417-3. Epub 2022 Mar 23.

Drugs

Indications