Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
- Conditions
- Bone metastases in subjects with advanced cancer or multiple myelomaMedDRA version: 14.0 Level: LLT Classification code 10005993 Term: Bone metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-009374-27-GB
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
Subjects currently enrolled in study 20050103, 20050136, or 20050244
Subjects must sign the informed consent before any study specific procedures are performed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: 2 Years;<br> Primary end point(s): • Subject incidence of treatment-emergent adverse events<br> • Changes in laboratory values<br> • Incidence of anti-denosumab antibody (binding and neutralizing) formation<br> • Brief Pain Inventory – Short Form worst” pain score<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable