Reduced Dose-density of Denosumab for Unresectable GCTB
Status:
Terminated
Trial end date:
2020-07-30
Target enrollment:
Participant gender:
Summary
This study is a multi-center, multi-national, open label, single arm phase 2 study of
single-agent denosumab.
The objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance
setting in patients requiring long-term use (> 1 year) of denosumab. For that purpose, the
treatment schedule with reduced dose density (120mg SC 12-weekly instead of 4-weekly) will be
investigated, starting after 1-year (12-15 months) of denosumab full dose, as per current
label. The impact on OsteoNecrosis of the Jaw (ONJ) without compromising disease control will
be assessed.
Phase:
Phase 2
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC