Phase 3
N=18
Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
Castrate-resistant Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01824342 ↗Enrolled (actual)
18
Serious AEs
61.1%
Results posted
Mar 2015
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths — 11; 7; 7; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Denosumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Amgen
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths |
11; 7; 7; 4; 2; 0 | — |
| PRIMARY Percent Change From Baseline in Laboratory Values |
-0.9; 1.1; -23.8; -1.6; 16.3; 2.4 | — |
| PRIMARY Number of Participants With Anti-denosumab Neutralizing Antibody Formation |
0; 0 | — |
| SECONDARY Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01824342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.