The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken with and without food in patients with prostate cancer.
This is an open-label study (identity of assigned study drug will be known) to evaluate the pharmacokinetics of abiraterone acetate in patients with prostate cancer. The study will be conducted in 4 stages: Stage 1 will measure blood levels after patients take 1 daily dose of abiraterone tablet or capsule formulations with and without food; Stage 2 will measure blood levels of single daily doses of abiraterone tablet formulation taken with or without food in parallel design until disease progression (up to 12 cycles \[28 days per cycle\]); Stages 3 and 4 will evaluate the safety and antitumor effects of abiraterone tablet formulation administered with a low dose glucocorticoid in a fasted state for up to 12 months for each stage. As of Protocol Amendment 4, all patients who have completed 12 cycles of abiraterone acetate treatment and continue to receive clinical benefit from such a treatment will enter Stage 4 and receive abiraterone acetate in a fasted condition with a low-dose glucocorticoid. Patients will continue in Stage 4 for an additional 24 cycles. After patients complete the last study visit, they will be followed every 3 months for disease progression and survival for up to 3 years. Serial pharmacokinetic samples will be collected during Stages 1 and 2. Efficacy and safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose.
1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose.
1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Glasgow, United Kingdom
Unnamed facility
Sutton, United Kingdom
Mean plasma concentrations of abiraterone
Time frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Maximum plasma concentrations of abiraterone
Time frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Time to reach the maximum plasma concentration of abiraterone
Time frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Area under the plasma-concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
Time frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Area under the plasma-concentration-time curve from time 0 to infinite time of abiraterone
Time frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Elimination half-life of abiraterone
Time frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Steady state trough concentration of abiraterone
Time frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Number of participants affected by an adverse event
Time frame: Up to 30 days after the last dose of study medication
Number of patients with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
Time frame: Screening; Stage 1 Day 14; Stages 2-3 Day 1, Cycles 1-12; Stage 4 every 3 cycles past Cycle 12
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1000 mg tablets/day orally for 12 cycles (28 days/cycle).
prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).
1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).
prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).
Number of patients with circulating tumor cells isolated from peripheral blood samples defined by cell counts
Time frame: Screening; Stage 1 Days 1 and 8; Stage 2 Day 1 Cycless 1, 4, 7, and 10; Stage 4 every 3 cycles past Cycle 12
Number of patients with circulating tumor cells isolated from peripheral blood samples defined by molecular characterization
Time frame: Screening; Stage 2 Day 1 Cycle 1