Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only

Phase 3

Completed

• Conditions: Bone 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
• Interventions: Drug: amg 162

• Registration Number: NCT00950911
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-08-03
• Primary Completion: 2012-02
• Study Completion: 2012-04
• Results First Submitted: 2012-12-17
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Results First Posted: 2014-02-11
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	amg 162	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Survived	2 years

Trial Locations

Locations (1)

Research Site; 🇬🇧 York, United Kingdom