Trial Information

An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer

This is a multicenter, open-label study of 24 (up to a total of 28) men to assess the
short-term safety of oral abiraterone acetate 1 g and oral prednisone 5 mg twice daily
administered in the modified fasted state and after meals of various fat contents. All
patients will take daily abiraterone acetate for the first 7 days in the modified fasted
state (no food for 2 hours before and 1 hour after the dose). In Cohort 1, up to 6 evaluable
patients will take abiraterone acetate daily for 7 days after a standardized low-fat meal
from Cycle 1 Day 8 to Cycle 1 Day 14; or, in Cohort 2, up to 6 evaluable patients will take
abiraterone acetate daily for 7 days after a standardized high-fat meal from Cycle 1 Day 8
to Cycle 1 Day 14. All patients will then continue to take abiraterone acetate daily in the
modified fasted state starting on Cycle 1 Day 15 until disease progression. Toxicity related
to dosing after the low-fat or high-fat meals is defined as Grade 3 or higher AEs of special
interest; or Grade 3 or higher serious adverse events (SAEs) that occur during the food
safety evaluation period. Cohort 2 may be expanded to a total of 18 evaluable patients if
deemed to be safe. Decisions regarding the escalation of cohort or expansion of cohorts will
be made by a study evaluation team. Pharmacokinetic evaluation for each cohort will be
performed on Cycle 1 Days 7 and 14 at predose and multiple timepoints postdose over 24
hours; Cycle 1 Days 8 and 11 at 2 hours following abiraterone acetate dose administration.
Abiraterone acetate, 1 g (four 250-mg tablets) orally (taken by mouth) once daily. Patients
may take abiraterone acetate until progression of clinical disease. Prednisone, 5 mg,
orally, twice a day.