Status:
COMPLETED
Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
Lead Sponsor:
Amgen
Conditions:
Castrate-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate canc...
Eligibility Criteria
Inclusion
- Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study 20050147
- Subjects must sign the informed consent before any study specific procedures are performed
Exclusion
- Developed sensitivity to mammalian cell derived drug products during the 20050147 study
- Currently receiving any unapproved investigational product other than denosumab
- 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 :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01824342
Start Date
January 1 2011
End Date
February 1 2014
Last Update
March 5 2015
Active Locations (9)
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1
Research Site
Hradec Králové, Czechia, 500 05
2
Research Site
Pelhřimov, Czechia, 393 38
3
Research Site
Prague, Czechia, 128 08
4
Research Site
Prague, Czechia, 160 00