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

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.

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Key information

Conditions

Bone Metastases in Men With Hormone-Refractory Prostate Cancer Blood Protein Disorders Bone Metastases in Subjects With Advanced Breast Cancer Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma Breast Diseases Breast Neoplasms Cardiovascular Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Jindřichův Hradec, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 162

Drug

120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.

Primary outcomes

Number of Participants Survived

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Aug 3, 2009
Registry last updated: Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed