The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
160 mg BAY73-4506
Unnamed facility
Regensburg, Bavaria, Germany
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Essen, North Rhine-Westphalia, Germany
Unnamed facility
Mainz, Rhineland-Palatinate, Germany
Adverse Event Collection
Time frame: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration
Time to progression
Time frame: Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression
Objective response rate
Time frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Disease control rate
Time frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Overall survival
Time frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Trough concentration of Regorafenib and metabolites (for Europe only)
Time frame: Cycle 1 Day 15 and Cycle 2 Day 1
Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only)
Time frame: Cycle 1 Day 21 to Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Magdeburg, Saxony-Anhalt, Germany
Unnamed facility
Rozzano, Milano, Italy
Unnamed facility
Bologna, Italy
Unnamed facility
Milan, Italy
Unnamed facility
Milan, Italy
Unnamed facility
Roma, Italy
...and 3 more locations