Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
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
2 other identifiers
interventional
18
2 countries
9
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 cancer. Patients currently participating in the phase 3 study 20050147 (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is determined in the 20050147 study. The primary endpoint of the 20050147 study is bone metastases-free survival determined by the time to first occurrence of bone metastases (either symptomatic or asymptomatic) or death from any cause. Participants will receive open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they developed a bone metastasis or for up to 3 years, whichever comes first.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Typical duration for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
March 5, 2015
CompletedMarch 5, 2015
February 1, 2015
3.1 years
April 1, 2013
February 19, 2015
February 19, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths
A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard. The adverse event severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The investigator assessed whether each adverse event was possibly related to the investigational product (IP).
From the first dose of open-label denosumab until 4 weeks after the last; maximum time on study was 37 months. Follow-up survival information was collected for up to 3 years after the last dose of blinded investigation product in the 20050147 study.
Percent Change From Baseline in Laboratory Values
Baseline and Week 49
Number of Participants With Anti-denosumab Neutralizing Antibody Formation
3 years
Secondary Outcomes (1)
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Baseline and Week 49
Study Arms (1)
Denosumab
EXPERIMENTALParticipants received denosumab 120 mg subcutaneously every 4 weeks for up to 3 years in this open-label extension study.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (9)
Research Site
Hradec Králové, 500 05, Czechia
Research Site
Pelhřimov, 393 38, Czechia
Research Site
Prague, 128 08, Czechia
Research Site
Prague, 160 00, Czechia
Research Site
Tábor, 390 03, Czechia
Research Site
Newcastle, NE7 7DN, United Kingdom
Research Site
Northwood, HA6 2RN, United Kingdom
Research Site
Sheffield, S10 2SJ, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 4, 2013
Study Start
January 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 5, 2015
Results First Posted
March 5, 2015
Record last verified: 2015-02