Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT00091832
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2004-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: