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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: November 1, 2013
Last verified: November 2013

February 5, 2009
November 1, 2013
February 2009
July 2012   (final data collection date for primary outcome measure)
Overall Survival Through Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and incidence of anti-denosumab antibody formation in subjects previously treated with denosomuab [ Time Frame: 5 years of treatment on denosumab ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00838201 on ClinicalTrials.gov Archive Site
Not Provided
adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and incidence of anti-denosumab antibody formation in subjects previously treated with denosomuab [ Time Frame: 2 years of treatment on denosumab ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Carcinoma
  • Castrate-Resistant Prostate Cancer
  • Prostate Cancer
  • Tumors
Drug: Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
Experimental: Arm 1
Intervention: Drug: Denosumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
384
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   Hungary,   Mexico,   Poland
 
NCT00838201
20080537
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP