drugset / Trial / NCT01404390
Japanese BAY80-6946 Monotherapy Phase I Study
Non-randomizedFactorialOpen-labelTreatment
Summary
This study will be conducted as an open label, single centre, Phase I study of PI3K (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8 and Day 15 with three weeks on and one week off in each treatment cycle.
Timeline
- Start
- 2011-08-18
- Primary completion
- 2012-03-22
- Completion
- 2012-07-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copanlisib | Small molecule | 0.4 mg/kg | Intravenous |
| Subject | Copanlisib | Small molecule | 0.8 mg/kg | Intravenous |