At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 35 enrolled
Drug / intervention
amg 162drug
Likely dose
amg 162 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
In Brief
A Phase 3 clinical trial evaluating amg 162 for Bone Metastases in Men With Hormone-Refractory Prostate Cancer and 2 related conditions. Completed, enrolled 35 participants across 17 sites in 2 countries.
Detailed Summary
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
CountriesCzechia, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedAug 2009
Primary CompletionFeb 2012
Study CompletionApr 2012
TodayJul 2026
First PostedAug 3, 2009
Enrollment StartJul 1, 2009
Primary CompletionFeb 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.9 years ago
Interventions
amg 162drug
120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.