A Phase 2 Open-label Extension Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
This is a multi-center extension study in subjects with prostate cancer who have completed
MDV3100 treatment study 9785-CL-0007 to assess the long-term safety of continued
administration of MDV3100, when judged by the investigator to be in the best interest of the
For the study duration, all subjects with castration-resistant prostate cancer (CRPC) will
have to maintain androgen deprivation with a Luteinizing Hormone Releasing Hormone (LHRH)
agonist/antagonist unless they underwent bilateral orchiectomy.
Subjects will be discontinued from study drug when continued administration of study drug is
deemed to be not in the subject's best interest by the investigator based on clinical
Throughout the study, safety and tolerability will be assessed by the recording of adverse
events, monitoring of vital signs and physical examinations, safety laboratory evaluations,
and 12-lead electrocardiograms (ECGs).
Subjects will have a safety follow-up visit 30 days after their last dose of study drug.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Long term safety of continued administration of MDV3100 through assessment of adverse events, vital signs, ECGs, physical examinations and laboratory evaluations
Until Subject Discontinuation (up to 5 years)
Clinical Study Manager
Astellas Pharma Europe B.V.
South Africa: Medicines Control Council