The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment.
This is an open-label (identity of study drug will be known) extended access study to evaluate the safety and efficacy of continued administration of abiraterone acetate in patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment. Patients will continue with the same dose regimen administered at the end of Study COU-AA-001 and will receive a low-dose glucocorticoid daily. Patients will be followed every 3 months for disease progression and survival for up to 3 years following study entry. Safety will be monitored throughout the study up to 30 days after the last dose of study medication.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily
prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily
Unnamed facility
Sutton, United Kingdom
Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
Time frame: Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry
Overall survival
Time frame: every 3 months up to 3 years after study entry
Number of participants with adverse events
Time frame: up to 30 days after the last dose of study medication
Time to disease progression
Time frame: every 3 months up to 3 years after study entry
Time to prostate specific antigen progression
Time frame: every 3 months up to 3 years after study entry
Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: every 3 months up to 3 years after study entry
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