NCT00960258

Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

Phase I, Uncontrolled, Open-label, Non-randomized Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Advanced, Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.

Conditions

• Tumors

Interventions

Type	Name	Description
DRUG	Regorafenib (BAY73-4506)	The patients will be treated on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, the patients will be treated with BAY 73-4506 (160 mg once daily orally, 21 days on/ 7 days off schedule). Dose level : 160 mgDose level-1: 120 mgDose level-2: 60 mg

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-04-26
• Completion: 2013-11-11
• First posted: 2009-08-17
• Last updated: 2017-09-27

Locations

4 sites across 1 country: Japan