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

Amgen

Status and phase

Completed

Phase 3

Conditions

Bone Metastases in Subjects With Advanced Breast Cancer

Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Bone Metastases in Men With Hormone-Refractory Prostate Cancer

Treatments

Drug: amg 162

Study type

Interventional

Funder types

Industry

Identifiers

NCT00950911

20080540

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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