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: MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 100000004864
Castrate-resistant prostate cancer
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-021846-23-CZ

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 18

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

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

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

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;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;Timepoint(s) of evaluation of this end point: 3 years

Secondary Outcome Measures