XGEVA®

Generic Name: denosumab
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20040113Advanced breast cancer with bone metastasis2

A Randomized, Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy

20040114Bone metastases of solid tumors (except lung) or multiple myeloma bone disease2

A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects with Advanced Cancer Currently Being Treated with Intravenous Bisphosphonates

20040215Treatment of giant cell tumor of bone2

An Open-Label, Multicenter, Phase 2 Safety of Denosumab (AMG 162) in Subjects with Recurrent or Unresecteable Giant Cell Tumor (GCT) of Bone

20050103Treatment of bone metastases in men with hormone- refractory prostate cancer3

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared withZoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer

20050134For the treatment of patients with relapsed or plateauphase multiple myeloma2

An Open-Label Multicenter Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma

20050136Treatment of bone metastases in subjects with advanced breast cancer3

A Randomized, Double-blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer

20050147Prolonging bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer3

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer

20050209Treatment of therapy-induced bone loss to reduce occurrence of fractures in patients undergoing estrogen deprivation therapy3A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects with Non-metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy
20050244Treatment of bone metastases in subjects with advanced cancer (excluding breast and prostate cancer) or multiple myeloma3

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma 

20070315Treatment of Hypercalcemia of Malignancy (HCM) not responding to recent IV Bisphosphonates2

A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy (HCM) in Subjects with Elevated Serum Calcium Despite Recent Treatment with Intravenous (IV) Bisphosphonates

20080540Treatment of bone metastases in subjects with advanced cancer or multiple myeloma3

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab in the Treatment of Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma

20080585Prolonging bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer3

An Open-label, Single-arm, Extension Study to Evaluate the Long-term Safety of Denosumab for Prolonging Bone Metastasis-free Survival in Men with Hormone-refractory Prostate Cancer

20101335postmenopausal osteoporosisNAEstimation of Off-Label Use of XGEVA® (denosumab) Using Population-Based Databases in Denmark
20110102prevention of skeletal related events (SREs) in adults with bone metastases from solid tumours4Survey of Oncology Practitioners Prescribing XGEVA in Europe to Evaluate Their Knowledge of XGEVA Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw