Ignite Creation Date:
2024-05-05 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00770848
Status:
COMPLETED
Last Update Posted:
2014-03-10
First Post:
2008-10-09
Brief Title:
AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 1b2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2014-02
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 primary objectives of this study are the following
Phase 1b To identify a safe dose level of AMG 102 up to 15 mgkg Q3W to combine with mitoxantrone and prednisone MP Phase 2 To estimate with adequate precision the effect of the addition of AMG 102 to MP compared with placebo plus MP as assessed by the hazard ratio HR for overall survival OS of previously treated subjects with castrate-resistant prostate cancer CRPC
Phase 1b To identify a safe dose level of AMG 102 up to 15 mgkg Q3W to combine with mitoxantrone and prednisone MP Phase 2 To estimate with adequate precision the effect of the addition of AMG 102 to MP compared with placebo plus MP as assessed by the hazard ratio HR for overall survival OS of previously treated subjects with castrate-resistant prostate cancer CRPC
Detailed Description:
None
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