drugset / Trial / NCT02047890

Japanese BAY1000394 Monotherapy Phase I Study

NCT02047890

Phase 1 Completed 12 enrolled Bayer
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety, tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in Japanese subjects with advanced malignancies.

Timeline

Start
2014-05-19
Primary completion
2015-01-06
Completion
2018-07-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Roniciclib Small molecule 2.5 mg
Subject Roniciclib Small molecule 5 mg

Indications