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Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00838201
First received: February 5, 2009
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.


Condition Intervention Phase
Cancer
Carcinoma
Castrate-Resistant Prostate Cancer
Prostate Cancer
Tumors
 Drug: Denosumab
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer

Resource links provided by NLM:

Drug Information available for: Denosumab
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety endpoints in subjects previously treated with denosumab who receive up to 5 years of denosumab administration. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Adverse events incidences, serious adverse event incidence, changes in safety laboratory analytes and subject incidence of anti-denosumab antibody formation.


Secondary Outcome Measures:
  • Safety endpoints in subjects previously treated with placebo who receive up to 2 years of denosumab administration. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes, and subject incidence of anti-denosumab antibody formation.


Enrollment: 384
Study Start Date: February 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be currently participating in the 20040138 Amgen study
  • Subjects must sign the informed consent before any study specific procedures are performed.

Exclusion Criteria

  • Subjects with any prior diagnosis of bone metastasis
  • Known hypocalcemia
  • Developed sensitivity to mammalian cell derived drug products during the 20040138 study
  • Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838201

  Show 74 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00838201     History of Changes
Other Study ID Numbers: 20080537
Study First Received: February 5, 2009
Last Updated: August 8, 2012
Health Authority: Canada: Health Canada
Mexico: Ministry of Health
United States: Food and Drug Administration
Czech Republic: Státní ústav pro kontrolu léciv (SUKL)
Finland: Finnish Medicines Agency
Hungary: National Institute for Quality- and Organizational Development in Healthcare and Medicines / National Institute of Pharmacy Directorate
Netherlands: Centrale Commissie Mesgebonden Onderzoek (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Swissmedic

Keywords provided by Amgen:
Androgen deprivation therapy for non-metastatic prostate cancer

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013