DENOSUMAB-GCTB-INTERIM

NCT00680992 📎

Regimen

Experimental
Denosumab 120 mg SC Q4W with 120 mg loading doses on days 8 and 15 of cycle 1
Control
none (parallel single-arm cohorts)

Population

Three parallel cohorts: surgically unsalvageable GCTB; GCTB with surgery associated with severe morbidity; previously enrolled from phase 2. Adults and skeletally mature adolescents.

Key finding

Confirmed in ~280 patients that denosumab provides durable disease control and enables surgical de-escalation in the majority of GCTB patients. Became the definitive registration dataset.

Source: PMID 23867211

Timeline

    Guideline citations

    • NCCN BONE (p.20)