Back to resultsOpen-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Primary Purpose
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Denosumab
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastases in Men With Hormone-Refractory Prostate Cancer focused on measuring cancer, bone metastases, breast cancer, prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Subject was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study.
- Subject or subject's legally acceptable representative has provided informed consent.
Exclusion Criteria:
- Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment.
- Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge.
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Denosumab
Arm Description
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
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.
Secondary Outcome Measures
Number of Participants With Anti-denosumab Binding Antibodies
A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01419717
Brief Title
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Official Title
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 22, 2011 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Keywords
cancer, bone metastases, breast cancer, prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Denosumab
Arm Type
Experimental
Arm Description
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Intervention Type
Drug
Intervention Name(s)
Denosumab
Other Intervention Name(s)
Xgeva
Intervention Description
Administered by subcutaneous injection every 4 weeks (Q4W)
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
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.
Secondary Outcome Measure Information:
Title
Number of Participants With Anti-denosumab Binding Antibodies
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study.
Subject or subject's legally acceptable representative has provided informed consent.
Exclusion Criteria:
Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment.
Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment.
Subject has known sensitivity to any of the products to be administered during dosing.
Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge.
Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Research Site
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Research Site
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Research Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Santo Andre
State/Province
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04262-000
Country
Brazil
Facility Name
Research Site
City
Sorocaba
State/Province
São Paulo
ZIP/Postal Code
18030-200
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22640-000
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
01209-000
Country
Brazil
Facility Name
Research Site
City
Kromeriz
ZIP/Postal Code
767 55
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 44
Country
Czechia
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Research Site
City
Dombovar
ZIP/Postal Code
7200
Country
Hungary
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Research Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Research Site
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Research Site
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Research Site
City
Sora
ZIP/Postal Code
03039
Country
Italy
Facility Name
Research Site
City
Kure-shi
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0833
Country
Japan
Facility Name
Research Site
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Research Site
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Research Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Research Site
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Facility Name
Research Site
City
Panama
Country
Panama
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 18
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-171
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
00-631
Country
Poland
Facility Name
Research Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Research Site
City
Krasnogorsky District
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Research Site
City
St Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Research Site
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46009
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
We'll reach out to this number within 24 hrs