Trials / Completed
CompletedNCT00950911
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Bone Metastases in Men With Hormone-Refractory Prostate Cancer
- Bone Metastases in Subjects With Advanced Breast Cancer
- Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | amg 162 | 120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first. |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2012-02-01
- Completion
- 2012-04-01
- First posted
- 2009-08-03
- Last updated
- 2014-02-11
- Results posted
- 2014-02-11
Locations
17 sites across 2 countries: Czechia, United Kingdom
Source: ClinicalTrials.gov record NCT00950911. Inclusion in this directory is not an endorsement.