Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients
Status:
Withdrawn
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
The FDA and Health Canada have approved regorafenib at a daily dose of 160mg for the
treatment of metastatic colorectal cancer and gastrointestinal stromal cancer; however, the
160 mg dose is not well tolerated by patients, especially women. The purpose of this study is
to determine if lean body mass and acidity in the intestinal tract impact how regorafenib is
absorbed into the bloodstream and then broken down and removed from the body. This may
explain the side effects experienced at the 160 mg dose, especially by women, and inform
regorafenib dosing in the future.