At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 129 enrolled
Drug / intervention
Denosumabdrug
Likely dose
Not stated in 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.
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
In Brief
A Phase 3 clinical trial evaluating Denosumab for Bone Metastases in Men With Hormone-Refractory Prostate Cancer and Bone Metastases in Subjects With Advanced Breast Cancer. Completed, enrolled 129 participants across 64 sites in 19 countries.
Detailed Summary
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
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
CountriesArgentina, Austria, Belgium, Brazil, Czechia, France, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Panama, Peru, Poland, Russia, South Africa, Spain, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartNov 2011
Primary CompletionAug 2018
TodayJul 2026
First PostedAug 18, 2011
Enrollment StartNov 22, 2011
Primary CompletionAug 10, 2018
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 14.9 years ago
Interventions
Denosumabdrug
Administered by subcutaneous injection every 4 weeks (Q4W)