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

Tracking Information

First Received Date ^ICMJE

February 5, 2009

Last Updated Date

August 8, 2012

Start Date ^ICMJE

February 2009

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00838201 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer
Carcinoma
Castrate-Resistant Prostate Cancer
Prostate Cancer
Tumors

Intervention ^ICMJE

Drug: Denosumab

60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

Study Arm (s)

Experimental: Arm 1

Intervention: Drug: Denosumab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

384

Completion Date

July 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Finland, Hungary, Mexico, Poland

Administrative Information

NCT Number ^ICMJE

NCT00838201

Other Study ID Numbers ^ICMJE

20080537

Has Data Monitoring Committee

Responsible Party

Amgen

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

August 2012

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

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