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Denosumab in Giant Cell Rich Tumors of Bone
2016-005244-42Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2018
- Countries
- 1
- Sponsor
- Leiden University Medical Center
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- denosumab
- Conditions
- aneurysmal bone cyst (ABC)central giant cell granuloma (CGCG)Giant Cell Tumor of Bone (GCTB)Peripheral giant cell granuloma (PGCG)
01
Overview
Phase 2, open-label, single-arm trial of denosumab in aneurysmal bone cyst (ABC), central giant cell granuloma (CGCG), Giant Cell Tumor of Bone (GCTB) and 1 more, sponsored by Leiden University Medical Center. Primary endpoint: Safety and tolerability of denosumab. Started Jan 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Denosumab monotherapy
Patients with salvageable non-malignant giant cell rich bone tumors receive open-label denosumab.
03
Who it enrols
Patients with salvageable, non-malignant giant cell rich tumors of bone including aneurysmal bone cysts and giant cell granulomas; patients with classic giant cell tumor of bone are excluded.
04
Endpoints
Primary
Safety and tolerability of denosumab
Secondary
Frequency of adverse events
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