An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR016912
NCT01664728
April 2007
September 2012
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