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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00950911
First received: July 30, 2009
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
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
Drug: amg 162
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of Participants Survived [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2009
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950911

Locations
Czech Republic
Research Site
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
United Kingdom
Research Site
Chichester, United Kingdom, PO19 4SE
Research Site
Leeds, United Kingdom, LS9 7TF
Research Site
London, United Kingdom, W2 1NY
Research Site
London, United Kingdom, SE1 9RT
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
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00950911     History of Changes
Other Study ID Numbers: 20080540
Study First Received: July 30, 2009
Results First Received: December 17, 2012
Last Updated: December 19, 2013
Health Authority: Czech Republic: Statni ustav pro kontrolu leciv
United Kingdom: Main Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amgen:
Bone metastases
Hormone-refractory prostate cancer
Multiple myeloma
Denosumab
Breast cancer
20050103
20050136
20050244
Advanced cancer
Tumor
Prostate cancer
Zoledronic acid

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Breast Neoplasms
Multiple Myeloma
Neoplasm Metastasis
Neoplasms
Neoplasms, Plasma Cell
Neoplasms, Second Primary
Prostatic Neoplasms
Blood Protein Disorders
Bone Diseases
Breast Diseases
Cardiovascular Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Musculoskeletal Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplastic Processes
Paraproteinemias
Pathologic Processes
Prostatic Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014