Trials / Completed
CompletedNCT02342665
Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL
Open-label, Uncontrolled, Single-arm, Phase Ib/II Study of Intravenous Copanlisib in Japanese Patients With Indolent B-cell Non Hodgkin's Lymphomas Relapsed After or Refractory to Standard Therapy
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess the safety profile of copanlisib at the recommended dose (primary endpoint). The recommended dose of copanlisib for Japanese patients will be determined in the dose escalation/safety evaluation part.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Copanlisib (BAY80-6946) | Dosing is weekly for the first 3 weeks (on Days 1, 8, and 15) of a 28-day cycle, followed by a 1-week break (i.e., no infusion on Day 22). |
Timeline
- Start date
- 2015-04-21
- Primary completion
- 2018-09-14
- Completion
- 2022-02-10
- First posted
- 2015-01-21
- Last updated
- 2023-01-20
Locations
13 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02342665. Inclusion in this directory is not an endorsement.