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

NCT00950911 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2014-02-11

Study results available
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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.

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

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-02-29
Completion
2012-04-30

Countries

  • Czechia
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950911 on ClinicalTrials.gov