Therapy Detail

Therapy Name Denosumab
Synonym
Therapy Description

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).

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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 (NCI Drug Dictionary). Xgeva (denosumab) 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). 25617146
BRCA1 mutant breast cancer not applicable Denosumab Clinical Study Emerging In a clinical study, Xgeva (denosumab) inhibited cell proliferation in normal breast tissues of BRCA1 mutation carriers, provided a potential strategy to prevent breast cancer in this population (PMID: 27322743). 27322743
Clinical Trial Phase Therapies Title Recruitment Status
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
NCT01545648 Phase II Denosumab Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer Active, not recruiting
NCT00680992 Phase II Denosumab Study of Denosumab in Subjects With Giant Cell Tumor of Bone Completed
NCT02833610 Phase II Denosumab A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency Recruiting
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
NCT01345019 Phase III Denosumab Zoledronic acid Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Subjects With Multiple Myeloma Completed
NCT03839459 Phase II Denosumab Denosumab for Smoldering Multiple Myeloma Recruiting
NCT02900469 Phase 0 Denosumab Safety Study of Denosumab to Treat Breast Cancer Recruiting
NCT01952054 Phase II Denosumab Denosumab for Breast Cancer With Bone Mets Completed
NCT02470091 Phase II Denosumab Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma Active, not recruiting