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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00680992 |
To determine how safe denosumab is in treating subjects with giant cell tumor of bone
Condition | Intervention | Phase |
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Cancer GCT Giant Cell Tumor of Bone |
Drug: Denosumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | An Open-Label, Multi-Center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Denosumab: Experimental
120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.
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Drug: Denosumab
120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key inclusion criteria:
Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone [eg, humerus with closed growth epiphyseal plate])
Key exclusion criteria:
Contact: Amgen Call Center | 866-572-6436 |
United States, California | |
Research Site | Recruiting |
Santa Monica, California, United States | |
United States, District of Columbia | |
Research Site | Recruiting |
Washington, District of Columbia, United States | |
United States, Michigan | |
Research Site | Recruiting |
Ann Arbor, Michigan, United States | |
United States, Minnesota | |
Research Site | Recruiting |
Minneapolis, Minnesota, United States | |
United States, Pennsylvania | |
Research Site | Recruiting |
Radnor, Pennsylvania, United States | |
Australia | |
Research Site | Recruiting |
East Melbourne, Australia | |
Austria | |
Research Site | Recruiting |
Perth, Austria | |
Research Site | Recruiting |
Wien, Austria | |
France | |
Research Site | Recruiting |
Lyon, France | |
Research Site | Recruiting |
Villejuif, France | |
Germany | |
Research Site | Recruiting |
Bad Saarow, Germany | |
Italy | |
Research Site | Recruiting |
Bologna, Italy | |
Research Site | Recruiting |
Milano, Italy | |
Netherlands | |
Research Site | Recruiting |
Leiden, Netherlands | |
Spain | |
Research Site | Recruiting |
Palma de Mallorca, Spain | |
Research Site | Recruiting |
Barcelona, Spain |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20062004 |
Study First Received: | May 15, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00680992 History of Changes |
Health Authority: | Australia: Therapeutic Goods Administration; European Union: European Medicines Agency; United States: Food and Drug Administration |
Giant Cell Tumor of Bone |
Neoplasms, Connective and Soft Tissue Giant Cell Tumors Musculoskeletal Diseases Bone Neoplasms |
Giant Cell Tumor of Bone Bone Diseases Recurrence |
Neoplasms, Connective and Soft Tissue Neoplasms Giant Cell Tumors Neoplasms, Bone Tissue Neoplasms by Histologic Type Neoplasms by Site |
Musculoskeletal Diseases Bone Neoplasms Neoplasms, Connective Tissue Giant Cell Tumor of Bone Bone Diseases |