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Trial record 1 of 2 for:    20050147
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Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01824342
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
This is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer. Patients currently participating in the phase 3 study 20050147 (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is determined in the 20050147 study. The primary endpoint of the 20050147 study is bone metastases-free survival determined by the time to first occurrence of bone metastases (either symptomatic or asymptomatic) or death from any cause. Participants will receive open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they developed a bone metastasis or for up to 3 years, whichever comes first.

Condition or disease Intervention/treatment Phase
Castrate-resistant Prostate Cancer Biological: Denosumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
Study Start Date : January 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Denosumab
Participants received denosumab 120 mg subcutaneously every 4 weeks for up to 3 years in this open-label extension study.
Biological: Denosumab
Administered by subcutaneous injection
Other Name: XGEVA®




Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths [ Time Frame: From the first dose of open-label denosumab until 4 weeks after the last; maximum time on study was 37 months. Follow-up survival information was collected for up to 3 years after the last dose of blinded investigation product in the 20050147 study. ]
    A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard. The adverse event severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The investigator assessed whether each adverse event was possibly related to the investigational product (IP).

  2. Percent Change From Baseline in Laboratory Values [ Time Frame: Baseline and Week 49 ]
  3. Number of Participants With Anti-denosumab Neutralizing Antibody Formation [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: Baseline and Week 49 ]
    A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work); 2 = Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair; 5 = Dead.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study 20050147
  • 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 20050147 study
  • Currently receiving any unapproved investigational product other than denosumab
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824342


Locations
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Czech Republic
Research Site
Hradec Kralove, Czech Republic, 500 05
Research Site
Pelhrimov, Czech Republic, 393 38
Research Site
Praha 2, Czech Republic, 128 08
Research Site
Praha 6, Czech Republic, 160 00
Research Site
Tabor, Czech Republic, 390 03
United Kingdom
Research Site
Newcastle, United Kingdom, NE7 7DN
Research Site
Northwood, United Kingdom, HA6 2RN
Research Site
Sheffield, United Kingdom, S10 2SJ
Research Site
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01824342    
Other Study ID Numbers: 20080585
2010-021846-23 ( EudraCT Number )
First Posted: April 4, 2013    Key Record Dates
Results First Posted: March 5, 2015
Last Update Posted: March 5, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs