An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Rich Tumors of Bone
An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant).
• Pathologically proven giant cell rich tumor:
• Aneurysmal bone cysts (ABC)
• Giant cell granuloma (GCG)
• Other giant cell rich lesions (primary bone, non-malignant, pathology and radiology to be reviewed during multidisciplinary meeting LUMC)
• Patients with surgically unsalvageable disease (e.g., sacral, spinal giant cell rich tumors, or multiple lesions including pulmonary metastases) OR patients whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
• Measurable evidence of active disease within 1 year before study enrollment
• Albumin-adjusted serum calcium level ≥ 2.0 mmol/L (8.0 mg/dL)
• Aged 18 years and up and skeletally mature
• ECOG performance status 0, 1 or 2
• Written signed informed consent