Status:
COMPLETED
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
Lead Sponsor:
Amgen
Conditions:
Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Bone Metastases in Subjects With Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 previou...
Eligibility Criteria
Inclusion
- Subjects currently enrolled in study 20050103, 20050136, or 20050244
- Subjects must sign the informed consent before any study specific procedures are performed
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00950911
Start Date
July 1 2009
End Date
April 1 2012
Last Update
February 11 2014
Active Locations (17)
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1
Research Site
Jindřichův Hradec, Czechia, 377 01
2
Research Site
Kroměříž, Czechia, 767 55
3
Research Site
Olomouc, Czechia, 775 20
4
Research Site
Prague, Czechia, 110 00