drugset / Trial / NCT02253420
COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients
Non-randomizedSingle-groupOpen-labelOther
Summary
To evaluate the effect of itraconazole or rifampin on the absorption, distribution, metabolism and elimination of COPANLISIB (BAY80-6946). To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety.
Timeline
- Start
- 2014-10-08
- Primary completion
- 2018-03-12
- Completion
- 2019-08-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copanlisib | Small molecule | 12 mg | Intravenous |
| Subject | Copanlisib | Small molecule | 30 mg | Intravenous |
| Subject | Copanlisib | Small molecule | 60 mg | Intravenous |
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | Rifampin | Small molecule | 600 mg | Oral |
Indications
No indication recorded.