drugset / Trial / NCT01096030

Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

NCT01096030

Phase 1 Completed 33 enrolled Bayer
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.

Timeline

Start
2010-07
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Regorafenib Small molecule 160 mg Oral

Indications