A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
A study to assess the safety of continued administration of MDV3100 in subjects with Prostate Cancer who have already undergone treatment with MDV3100 and showed benefit.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Long term safety of continued administration of MDV3100 through assessment of adverse events, vital signs, ECGs, physical examinations and laboratory evaluations [ Time Frame: Until Subject Discontinuation (up to 5 years) ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2022|
|Estimated Primary Completion Date:||December 2022 (Final data collection date for primary outcome measure)|
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 subject.
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 assessment.
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.
|George, South Africa, 6529|
|Port Elizabeth, South Africa, 6045|
|Study Chair:||Clinical Study Manager||Astellas Pharma Europe B.V.|