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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
amg 162
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bone Metastases in Men With Hormone-Refractory Prostate Cancer focused on measuring Bone metastases, Hormone-refractory prostate cancer, Multiple myeloma, Denosumab, Breast cancer, 20050103, 20050136, 20050244, Advanced cancer, Tumor, Prostate cancer, Zoledronic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Survived

Secondary Outcome Measures

Full Information

First Posted
July 30, 2009
Last Updated
December 19, 2013
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00950911
Brief Title
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Bone metastases, Hormone-refractory prostate cancer, Multiple myeloma, Denosumab, Breast cancer, 20050103, 20050136, 20050244, Advanced cancer, Tumor, Prostate cancer, Zoledronic acid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
amg 162
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants Survived
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czech Republic
Facility Name
Research Site
City
Kromeriz
ZIP/Postal Code
767 55
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Research Site
City
Praha 1
ZIP/Postal Code
110 00
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 44
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Research Site
City
Zlin
ZIP/Postal Code
762 75
Country
Czech Republic
Facility Name
Research Site
City
Chichester
ZIP/Postal Code
PO19 4SE
Country
United Kingdom
Facility Name
Research Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Research Site
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Research Site
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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