Clinical trial · Interventional
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
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
NCT00950911CI-TRIAL-00013732completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases in Men With Hormone-Refractory Prostate Cancer | — | UNRESOLVED | — |
| Bone Metastases in Subjects With Advanced Breast Cancer | — | UNRESOLVED | — |
| Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amg 162 | Drug | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: amg 162
Primary outcomes (1)
- measure
- Number of Participants Survived
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects currently enrolled in study 20050103, 20050136, or 20050244 * 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 20050103, 20050136, or 20050244 study * Currently receiving any unapproved investigational product other than denosumab * Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment * Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment * Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment * 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
References
Publications (0)
Data not yet available
No reference posted for this study.