Trials / Completed
CompletedNCT03498430
Copanlisib Chinese PK Study
An Open Label, Phase I Study of Copanlisib to Evaluate the Pharmacokinetics, Safety and Tolerability in Chinese Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Copanlisib (Aliqopa, BAY80-6946) | Copanlisib will be administered intravenously on 60mg once in a 3 weeks-on/1 week-off dose regimen (on Days 1, 8 and 15) |
Timeline
- Start date
- 2018-04-27
- Primary completion
- 2019-08-06
- Completion
- 2020-06-02
- First posted
- 2018-04-13
- Last updated
- 2021-05-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03498430. Inclusion in this directory is not an endorsement.