An Extended Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy and Completed Clinical Study COU-AA-003
This is an open-label study (identity of study drug will be known) to provide additional
treatment of abiraterone acetate (CB7630) to patients with advanced prostate cancer who have
completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-003 and
continue to receive clinical benefit from such treatment. Patients will continue taking
abiraterone acetate at the dose they were receiving at the end of Study COU-AA-003
concurrently with a glucocorticoid (such as prednisone/prednisolone 5 mg oral twice daily,
or dexamethasone 0.5 mg once daily). Efficacy and safety will be monitored throughout the
study. Study treatment will end when the patient dies, is lost to follow-up, withdraws
informed consent, experiences sustained side-effects, has disease progression, or the
sponsor discontinues the study. After the end of study visit is completed, patients' status
will be followed every 12 weeks for survival for up to 3 years following study entry.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate specific antigen (PSA) response
PSA decline >=50% according to Prostate Specific Antigen Working Group criteria
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
CR016918
NCT01798615
December 2008
July 2012
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