- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03301857
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
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Lyon CEDEX 08, France, 69373
- Centre Leon Berard
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Villejuif, France, 94805
- Institut Gustave Roussy
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Bologna, Italy, 40136
- Istituti Ortopedici Rizzoli
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Warszawa, Poland, 01-211
- Instytut Matki i Dziecka
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Warszawa, Poland, 02-781
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy
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Baleares
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Palma de Mallorca, Baleares, Spain, 07010
- Hospital Universitari Son Espases
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Lund, Sweden, 221 85
- Skåne Universitetssjukhus
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Birmingham, United Kingdom, B31 2AP
- Royal Orthopaedic Hospital
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California
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Santa Monica, California, United States, 90403
- Sarcoma Oncology Research Center LLC
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Cancer Institute at MedStar Washington Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center Fairview
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New York
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New York, New York, United States, 10003
- Mount Sinai Beth Israel Downtown
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- Abramson Cancer Center at Pennsylvania Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject was previously enrolled in Study 20062004.
- Subject or subject's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
Exclusion Criteria:
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- Females of childbearing potential on denosumab and not willing to continue to use 1 highly effective method of contraception during treatment and for 5 months after the end of treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Denosumab
Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently. |
Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
Other Names:
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No Intervention: Safety Follow up
Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A). Subjects who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit (Cohort B). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of adverse events of interest in subjects with GCTB treated with denosumab
Time Frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Evaluate adverse events of interest in subjects with GCTB treated with denosumab.
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Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of treatment-emergent adverse events for subjects who are receiving denosumab.
Time Frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Evaluate treatment-emergent adverse events for subjects who are receiving denosumab.
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Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Rate of serious adverse events for all subjects.
Time Frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Evaluate serious adverse events for all subjects.
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Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Rate of disease progression or recurrence of GCTB for all subjects.
Time Frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Summarize the rate of disease progression or recurrence of GCTB for all subjects.
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Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Rate of GCTB interventions for all subjects.
Time Frame: Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Summarize the use of GCTB interventions for all subjects.
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Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Musculoskeletal Diseases
- Bone Diseases
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Bone Neoplasms
- Giant Cell Tumors
- Giant Cell Tumor of Bone
- Physiological Effects of Drugs
- Immunologic Factors
- Bone Density Conservation Agents
- Immunoglobulins
- Immunoglobulin G
- Denosumab
Other Study ID Numbers
- 20140114
- 2017-001758-32 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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