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

December 19, 2013 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Jindrichuv Hradec, Czech Republic, 377 01
        • Research Site
      • Kromeriz, Czech Republic, 767 55
        • Research Site
      • Olomouc, Czech Republic, 775 20
        • Research Site
      • Praha 1, Czech Republic, 110 00
        • Research Site
      • Praha 4, Czech Republic, 140 00
        • Research Site
      • Praha 4, Czech Republic, 140 44
        • Research Site
      • Praha 5, Czech Republic, 150 06
        • Research Site
      • Praha 6, Czech Republic, 160 00
        • Research Site
      • Zlin, Czech Republic, 762 75
        • Research Site
  • United Kingdom
      • Chichester, United Kingdom, PO19 4SE
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • London, United Kingdom, W2 1NY
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
      • Peterborough, United Kingdom, PE3 9GZ
        • Research Site
      • York, United Kingdom, YO31 8HE
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: amg 162
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Survived
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 30, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

August 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

December 19, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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