28
Participants
Start Date
October 31, 2015
Primary Completion Date
December 31, 2017
Study Completion Date
December 31, 2017
EPI-506
"Patients will receive EPI-506 as an oral softgel capsule.~Part 1:~Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. During the Single-Dose Period, patients will first receive a dose of EPI-506 in the fasted state followed by 2 days of washout, and then patients will receive a second dose of EPI-506 in the fed state followed by 2 days of washout. Patients will then enter the Multiple Dosing and Long-term Dosing Period where they will receive once or twice daily dosing in a fed or fasted state until they meet discontinuation criteria.~Part 2:~The dose in Part 2 will be determined in Part 1 of the study. Patients will receive the Part 2 dose daily until they meet discontinuation criteria."
University of Michigan Health System, Ann Arbor
Karmanos Cancer Institute, Detroit
Scottsdale Healthcare Hospitals DBA HonorHealth, Scottsdale
Seattle Cancer Care Alliance, Seattle
British Columbia Cancer Agency - Vancouver Centre, Vancouver
Lead Sponsor
ESSA Pharmaceuticals
INDUSTRY