Study design
This was an open-label, single-arm, phase Ib/II study conducted at 13 centers in Japan. The study was in two parts: the dose-escalation part (phase Ib) to determine the recommended dose and the expansion part (phase II) to evaluate the antitumor activity and safety of the recommended dose of copanlisib.The protocol was reviewed and approved by each study site’s Independent Ethics Committee/Institutional Review Board before the start of the study, as were all protocol amendments at the time of their implementation. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonisation guideline E6: Good Clinical Practice. All patients voluntarily provided written informed consent prior to any study procedures being undertaken.