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Denosumab in Subjects With Giant Cell Rich Tumors of Bone

NCT03605199 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-26

No results posted yet for this study

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).

Conditions

  • Aneurysmal Bone Cysts
  • Giant Cell Granuloma
  • Osteoblastoma
  • Chondroblastoma
  • Chondromyxoid Fibroma

Interventions

DRUG

Denosumab

Denosumab will be given in a dose of 120mg subcutaneously (SC) on day 1 of every 4 week cycle with a loading dose of 120mg SC on days 8 and 15 of the first cycle.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • AJ Gelderblom, Prof · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2021-06-30
Completion
2023-06-30

Countries

  • France
  • Italy
  • Netherlands

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03605199 on ClinicalTrials.gov