NCT03620149

Reduced Dose-density of Denosumab for Unresectable GCTB

Reduced Dose-density of Denosumab for Maintenance Therapy of Unresectable Giant Cell Tumor of Bone: a Multicenter Phase II Study "REDUCE"

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Giant Cell Tumor

Interventions

Type	Name	Description
DRUG	Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]	Denosumab 120 mg, SC, on day 1 of every 12-week cycle

Timeline

• Start date: 2019-09-26
• Primary completion: 2020-07-30
• Completion: 2020-07-30
• First posted: 2018-08-08
• Last updated: 2021-01-06

Locations

8 sites across 4 countries: Italy, Netherlands, Spain, United Kingdom