Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286091
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2006-02-02
Brief Title:
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory androgen independent prostate cancer who have no bone metastasis at baseline
Detailed Description:
Participants were randomized to receive denosumab 120 mg or placebo every 4 weeks Q4W until approximately 660 participants developed bone metastasis or died and the primary efficacy and safety analyses were completed
All participants undergoing scheduled assessments were offered open-label denosumab 120 mg subcutaneous SC until they either developed a bone metastasis obtained access to commercially available product in this setting or for up to 3 years whichever came first For participants who ended participation before the open-label extension OLE phase or withdrew from investigational product during the OLE phase their survival data was to be collected every 6 months for up to 3 years after their last dose of investigational product
Participants in the Czech Republic and United Kingdom were enrolled under a separate protocol for the OLE phase per Health Authority request and are reported separately Study 20080585 NCT01824342
All participants undergoing scheduled assessments were offered open-label denosumab 120 mg subcutaneous SC until they either developed a bone metastasis obtained access to commercially available product in this setting or for up to 3 years whichever came first For participants who ended participation before the open-label extension OLE phase or withdrew from investigational product during the OLE phase their survival data was to be collected every 6 months for up to 3 years after their last dose of investigational product
Participants in the Czech Republic and United Kingdom were enrolled under a separate protocol for the OLE phase per Health Authority request and are reported separately Study 20080585 NCT01824342
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None