An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Rich Tumors of Bone

Who is this study for? Adult patients with Giant Cell-Rich Tumors
What treatments are being studied? Denosumab
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
France
Centre Léon Bérard
Not yet recruiting
Lyon
Italy
Istituto Ortopedico Rizzoli
Not yet recruiting
Bologna
Netherlands
Leiden University Medical Center
Recruiting
Leiden
Contact Information
Primary
A Lipplaa, MD
a.lipplaa@lumc.nl
Backup
AJ Gelderblom
+31715269111
Time Frame
Start Date: June 18, 2018
Estimated Completion Date: June 2023
Participants
Target number of participants: 60
Treatments
Experimental: Denosumab active treatment
Denosumab active treatment
Authors
AJ Gelderblom
Sponsors
Collaborators: Amgen
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov

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