drugset / Trial / NCT01938638

Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer

NCT01938638 ↗

Phase 1 Completed 80 enrolled Bayer
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents. The purpose of this study Part B is: Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.

Timeline

Start
2013-09-26
Primary completion
2016-08-17
Completion
2016-09-19

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY1143572 Unknown — —

Indications