Safety and Anti-Tumor Study of Oral EPI-506 for Patients With Metastatic Castration-Resistant Prostate Cancer

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions
Prostatic NeoplasmsGenital Neoplasms, MaleGenital Diseases, MaleProstatic Diseases
Interventions
DRUG

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."

Trial Locations (5)

48109

University of Michigan Health System, Ann Arbor

48201

Karmanos Cancer Institute, Detroit

85258

Scottsdale Healthcare Hospitals DBA HonorHealth, Scottsdale

98109

Seattle Cancer Care Alliance, Seattle

V5Z 4E6

British Columbia Cancer Agency - Vancouver Centre, Vancouver

Sponsors
All Listed Sponsors
lead

ESSA Pharmaceuticals

INDUSTRY