Phase 3
Completed N=35
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
Bone Metastases in Men With Hormone-Refractory Prostate Cancer · Bone Metastases in Subjects With Advanced Breast Cancer · Multiple Myeloma
Source: ClinicalTrials.gov NCT00950911 ↗
Enrolled (actual)
35
Serious AEs
51.4%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants Survived — 13; 12 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Survived |
13; 12 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00950911). 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. Informational only — not medical advice.