A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean plasma concentrations of abiraterone
Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
No
Cougar Biotechnology Clinical Trial
Study Director
Cougar Biotechnology, Inc.
United States: Food and Drug Administration
CR016933
NCT00600535
July 2007
March 2012
Name | Location |
---|---|
Fountain Valley, California 92708 |