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
- Conditions
- Castrate-resistant prostate cancerMedDRA version: 14.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-021846-23-GB
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab;Secondary Objective: To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received placebo;<br> Primary end point(s): • Subject incidence of treatment-emergent adverse events<br> • Changes in laboratory values<br> • Subject incidence of anti-denosumab neutralizing antibody formation<br> ;Timepoint(s) of evaluation of this end point: 3 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable