drugset / Trial / NCT01404390

Japanese BAY80-6946 Monotherapy Phase I Study

NCT01404390

Phase 1 Completed 10 enrolled Bayer
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

EvaluationDrugModalityDoseRoute
Subject Copanlisib Small molecule 0.4 mg/kg Intravenous
Subject Copanlisib Small molecule 0.8 mg/kg Intravenous

Indications