Bone Metastases in Subjects With Advanced Breast Cancer Clinical Trial
Official title:
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | April 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects currently enrolled in study 20050103, 20050136, or 20050244 - Subjects must sign the informed consent before any study specific procedures are performed Exclusion Criteria: - Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study - Currently receiving any unapproved investigational product other than denosumab - Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment - Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment - Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment - Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Research Site | Jindrichuv Hradec | |
| Czech Republic | Research Site | Kromeriz | |
| Czech Republic | Research Site | Olomouc | |
| Czech Republic | Research Site | Praha 1 | |
| Czech Republic | Research Site | Praha 4 | |
| Czech Republic | Research Site | Praha 4 | |
| Czech Republic | Research Site | Praha 5 | |
| Czech Republic | Research Site | Praha 6 | |
| Czech Republic | Research Site | Zlin | |
| United Kingdom | Research Site | Chichester | |
| United Kingdom | Research Site | Leeds | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Northwood | |
| United Kingdom | Research Site | Peterborough | |
| United Kingdom | Research Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Czech Republic, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Survived | 2 years | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00091832 -
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
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Phase 2 | |
| Completed |
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Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
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Phase 3 | |
| Completed |
NCT00104650 -
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
|
Phase 2 |