Trial Information
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of treatment-emergent adverse events
Outcome Time Frame:
4 weeks after the last dose of open label treatment
Safety Issue:
Yes
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20080585
NCT ID:
NCT01824342
Start Date:
January 2011
Completion Date:
May 2014
Related Keywords:
- Castrate-Resistant Prostate Cancer
- Neoplasm Metastasis
- Prostatic Neoplasms