drugset / Trial / NCT01287598

BAY73-4506 Probe Substrate Study

NCT01287598

Phase 1 Completed 41 enrolled Bayer
Non-randomizedParallel-groupOpen-labelTreatment

Summary

* To evaluate the effect of BAY73-4506 on the pharmacokinetics of probe substrates of CYP 2C9 (warfarin), 2C19 (omeprazole) and 3A4 (midazolam) administered in a cocktail approach and on the pharmacokinetics of a probe substrate of CYP 2C8 (rosiglitazone) * To evaluate safety, anti-tumor activity, pharmacokinetics, and pharmacodynamics of BAY73-4506 in patients with advanced solid tumors

Timeline

Start
2011-08-02
Primary completion
2018-07-03
Completion
2018-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule
Subject Omeprazole Other / unclassified
Subject Regorafenib Small molecule
Subject Rosiglitazone Small molecule
Subject Warfarin Small molecule

Indications