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Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03301857
Recruitment Status : Active, not recruiting
First Posted : October 4, 2017
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.

Condition or disease Intervention/treatment Phase
Giant Cell Tumor of Bone Drug: Denosumab (Cohort A) Phase 4

Detailed Description:
Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up. Collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : July 19, 2023
Estimated Study Completion Date : July 19, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer
Drug Information available for: Denosumab

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.

Drug: Denosumab (Cohort A)
Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
Other Name: AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand

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).




Primary Outcome Measures :
  1. 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. ]
    Evaluate adverse events of interest in subjects with GCTB treated with denosumab.


Secondary Outcome Measures :
  1. 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. ]
    Evaluate treatment-emergent adverse events for subjects who are receiving denosumab.

  2. 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. ]
    Evaluate serious adverse events for all subjects.

  3. 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. ]
    Summarize the rate of disease progression or recurrence of GCTB for all subjects.

  4. 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. ]
    Summarize the use of GCTB interventions for all subjects.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03301857


Locations
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United States, California
Research Site
Santa Monica, California, United States, 90403
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20010
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55455
United States, New York
Research Site
New York, New York, United States, 10003
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19106
Australia, New South Wales
Research Site
Camperdown, New South Wales, Australia, 2250
France
Research Site
Lyon CEDEX 08, France, 69373
Research Site
Villejuif, France, 94805
Italy
Research Site
Bologna, Italy, 40136
Poland
Research Site
Warszawa, Poland, 01-211
Research Site
Warszawa, Poland, 02-781
Spain
Research Site
Palma de Mallorca, Baleares, Spain, 07010
Sweden
Research Site
Lund, Sweden, 221 85
United Kingdom
Research Site
Birmingham, United Kingdom, B31 2AP
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: NCT03301857     History of Changes
Other Study ID Numbers: 20140114
2017-001758-32 ( EudraCT Number )
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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 (or other new use) 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.
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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Giant Cell Tumors
Bone Neoplasms
Giant Cell Tumor of Bone
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Denosumab
Physiological Effects of Drugs
Bone Density Conservation Agents