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Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01419717
Recruitment Status : Completed
First Posted : August 18, 2011
Results First Posted : September 9, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Bone Metastases in Subjects With Advanced Breast Cancer
Intervention Drug: Denosumab
Enrollment 129
Recruitment Details This study was conducted at 65 centers in Europe, Latin America, Japan, and South Africa. Participants were enrolled from 22 November 2011 to 27 October 2014.
Pre-assignment Details  
Arm/Group Title Denosumab
Hide Arm/Group Description Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Period Title: Overall Study
Started 129
Received Denosumab 128
Completed 4
Not Completed 125
Reason Not Completed
Protocol-specified Criteria             62
Adverse Event             19
Death             17
Withdrawal by Subject             10
Disease Progression             9
Other             4
Lost to Follow-up             2
Administrative Decision             1
Noncompliance             1
Arm/Group Title Denosumab
Hide Arm/Group Description Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Overall Number of Baseline Participants 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants
65.74  (11.48)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
18 - 64 years
60
  46.5%
65 - 74 years
36
  27.9%
75 - 84 years
28
  21.7%
≥ 85 years
5
   3.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
Female
97
  75.2%
Male
32
  24.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
Hispanic or Latino
28
  21.7%
Not Hispanic or Latino
101
  78.3%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
White
103
  79.8%
Asian
15
  11.6%
Black or African American
6
   4.7%
Other
4
   3.1%
Unknown
1
   0.8%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment.

Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where 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. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.

Time Frame From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of denosumab in study 20110113
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
All adverse events
98
  76.6%
Serious adverse events
45
  35.2%
AE leading to discontinuation of denosumab
28
  21.9%
AE leading to discontinuation from study
22
  17.2%
Fatal adverse events
18
  14.1%
AE grade 3, 4, or 5
46
  35.9%
Treatment-related adverse event
26
  20.3%
Treatment-related serious adverse event
10
   7.8%
TRAE leading to discontinuation of denosumab
18
  14.1%
TRAE leading to discontinuation from study
16
  12.5%
Treatment-related fatal adverse events
0
   0.0%
Treatment-related AE grade 3, 4, or 5
8
   6.3%
2.Secondary Outcome
Title Number of Participants With Anti-denosumab Binding Antibodies
Hide Description A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.
Time Frame Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of denosumab in study 20110113 and with at least 1 antibody sample tested.
Arm/Group Title Denosumab
Hide Arm/Group Description:
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Overall Number of Participants Analyzed 86
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Denosumab
Hide Arm/Group Description Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
All-Cause Mortality
Denosumab
Affected / at Risk (%)
Total   18/128 (14.06%) 
Hide Serious Adverse Events
Denosumab
Affected / at Risk (%)
Total   45/128 (35.16%) 
Blood and lymphatic system disorders   
Anaemia  1  3/128 (2.34%) 
Febrile neutropenia  1  2/128 (1.56%) 
Cardiac disorders   
Arrhythmia  1  1/128 (0.78%) 
Cardiac arrest  1  1/128 (0.78%) 
Cardiac failure  1  1/128 (0.78%) 
Cardiopulmonary failure  1  1/128 (0.78%) 
Gastrointestinal disorders   
Abdominal pain  1  2/128 (1.56%) 
Ascites  1  2/128 (1.56%) 
Intestinal obstruction  1  2/128 (1.56%) 
Melaena  1  1/128 (0.78%) 
Nausea  1  1/128 (0.78%) 
Vomiting  1  2/128 (1.56%) 
General disorders   
Asthenia  1  1/128 (0.78%) 
Disease progression  1  2/128 (1.56%) 
General physical health deterioration  1  2/128 (1.56%) 
Hepatobiliary disorders   
Cholecystitis acute  1  1/128 (0.78%) 
Jaundice  1  1/128 (0.78%) 
Infections and infestations   
Abscess jaw  1  1/128 (0.78%) 
Cellulitis  1  1/128 (0.78%) 
Myelitis  1  1/128 (0.78%) 
Osteomyelitis  1  3/128 (2.34%) 
Pneumonia  1  4/128 (3.13%) 
Pulpitis dental  1  1/128 (0.78%) 
Septic shock  1  1/128 (0.78%) 
Upper respiratory tract infection  1  1/128 (0.78%) 
Injury, poisoning and procedural complications   
Fall  1  1/128 (0.78%) 
Femur fracture  1  1/128 (0.78%) 
Metabolism and nutrition disorders   
Cachexia  1  2/128 (1.56%) 
Hypoglycaemia  1  1/128 (0.78%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  1/128 (0.78%) 
Muscular weakness  1  1/128 (0.78%) 
Osteonecrosis of jaw  1  7/128 (5.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  2/128 (1.56%) 
Cardiac myxoma  1  1/128 (0.78%) 
Metastases to liver  1  1/128 (0.78%) 
Neoplasm malignant  1  1/128 (0.78%) 
Prostate cancer  1  2/128 (1.56%) 
Nervous system disorders   
Hemiparesis  1  1/128 (0.78%) 
Paraplegia  1  1/128 (0.78%) 
Radiculopathy  1  1/128 (0.78%) 
Vertebrobasilar insufficiency  1  1/128 (0.78%) 
Renal and urinary disorders   
Acute kidney injury  1  1/128 (0.78%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  1/128 (0.78%) 
Dyspnoea  1  1/128 (0.78%) 
Pleural effusion  1  3/128 (2.34%) 
Pleurisy  1  1/128 (0.78%) 
Respiratory failure  1  2/128 (1.56%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Denosumab
Affected / at Risk (%)
Total   66/128 (51.56%) 
Blood and lymphatic system disorders   
Anaemia  1  8/128 (6.25%) 
Gastrointestinal disorders   
Abdominal pain  1  9/128 (7.03%) 
Diarrhoea  1  11/128 (8.59%) 
Nausea  1  15/128 (11.72%) 
Toothache  1  9/128 (7.03%) 
Vomiting  1  11/128 (8.59%) 
General disorders   
Asthenia  1  15/128 (11.72%) 
Fatigue  1  12/128 (9.38%) 
Metabolism and nutrition disorders   
Decreased appetite  1  14/128 (10.94%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  15/128 (11.72%) 
Back pain  1  16/128 (12.50%) 
Osteonecrosis of jaw  1  8/128 (6.25%) 
Pain in extremity  1  13/128 (10.16%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  7/128 (5.47%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01419717    
Other Study ID Numbers: 20110113
First Submitted: August 4, 2011
First Posted: August 18, 2011
Results First Submitted: August 1, 2019
Results First Posted: September 9, 2019
Last Update Posted: September 24, 2019