NCT00600535

A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer

A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation in Patients With Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Cougar Biotechnology, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Neoplasms

Interventions

Type	Name	Description
DRUG	Stage 1 Group 1: abiraterone acetate	1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose.
DRUG	Stage 1 Group 2: abiraterone acetate	1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose.
DRUG	Stage 2: abiraterone acetate	1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.
DRUG	Stage 3: abiraterone acetate	1000 mg tablets/day orally for 12 cycles (28 days/cycle).
DRUG	Stage 3: glucocorticoid	prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).
DRUG	Stage 4: abiraterone acetate	1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).
DRUG	Stage 4: glucocorticoid	prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).

Timeline

• Start date: 2007-07-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-01-25
• Last updated: 2013-04-17

Locations

3 sites across 2 countries: United States, United Kingdom