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Xgeva (denosumab) is an antibody that binds to RANKL protein, inhibiting osteoclast activity (NCI Drug Dictionary). Xgeva (denosumab) is FDA approved for use in patients with giant cell tumor of the bone (FDA.gov).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Denosumab||Xgeva||AMG162|AMG-162|AMG 162|Prolia||Xgeva (denosumab) is an antibody that binds to RANKL protein, inhibiting osteoclast activity and is FDA approved for use in patients with giant cell tumor of the bone (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||bone giant cell tumor||not applicable||Denosumab||FDA approved||Actionable||In a Phase II clinical trial that supported FDA approval, Xgeva (denosumab) treatment resulted in an overall objective response rate of 25% (47/187) in patients with giant cell bone tumor, with a median duration of response of 20 months among patients demonstrating response (PMID: 25617146).||detail... 25617146|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03301857||Phase III||Denosumab||Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004||Active, not recruiting||USA||7|
|NCT03070002||Phase II||Denosumab||Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells||Terminated||USA||0|
|NCT01545648||Phase II||Denosumab||Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer||Terminated||USA||0|
|NCT03839459||Phase II||Denosumab||Denosumab for Smoldering Multiple Myeloma||Recruiting||USA||0|
|NCT02470091||Phase II||Denosumab||Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma||Active, not recruiting||USA | CAN||1|
|NCT01345019||Phase III||Denosumab Zoledronic acid||Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Subjects With Multiple Myeloma||Completed||USA | CAN||27|
|NCT02900469||Phase 0||Denosumab||Safety Study of Denosumab to Treat Breast Cancer||Completed||USA||0|
|NCT01952054||Phase II||Denosumab||Denosumab for Breast Cancer With Bone Mets||Terminated||USA||0|
|NCT00680992||Phase II||Denosumab||Study of Denosumab in Subjects With Giant Cell Tumor of Bone||Completed||USA | CAN||10|
|NCT02833610||Phase II||Denosumab||A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency||Recruiting||USA||0|